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 .
Examiner’s Note
See image below for the intended meanings of X-axis, Y-axis, and Z-axis herein:
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Herein, X-axis rotation, Y-axis rotation, and Z-axis rotation refer to rotations with respect to an axis parallel to the X-axis, Y-axis, and Z axis respectively.
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 8 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 8 recites the limitation "a third magnet member… and a fourth magnet member" without prior reference to a first or a second magnet member. There is insufficient antecedent basis for this limitation in claim 8 or in claims 2 and 7, from which claim 8 depends. For examination purposes the phrases "a third magnet member” and “a fourth magnet member" have been construed to mean “a first magnet member” and “a second magnet member” respectively.
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.
Claims 2, 3, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0120006 Bell et al. (hereinafter Bell ‘006), in view of US 2023/0363936 Lim et al. (hereinafter Lim).
Regarding claim 2, Bell ‘006 teaches:
an endoscopic surgery training apparatus comprising:
a housing comprising a training space formed inside for training a surgery, and a support plate forming a bottom surface of the training space (Paragraph 0009 discloses a surgery simulating apparatus in an enclosed box and Paragraph 0020 discloses the enclosure box having a floor);
a driving part, wherein the driving part changes the position of the central platform within the training space through three degree-of-freedom movement including three distinct linear movements (Paragraphs 0009 and 0042 disclose a driving system with at least 1 motor, and Paragraph 0013 discloses the driving system comprising 3 motors that move a central platform in the X, Y, and Z directions);
a channel forming part formed in the housing to form an entry path of an endoscopic device entering the training space from the outside (Paragraph 0009 discloses an aperture in the housing, through which a training instrument is meant to be inserted); and
a controller for controlling the driving part (Paragraph 0009 discloses a computer program for receiving location data from a motor and controlling the driving system).
Bell ‘006 does not teach:
a holder configured to fix a training target member; and
a driving part comprising a holder support member and configured to change the position of the holder through four degree-of-freedoms.
However, Lim teaches a surgical platform system comprising:
a holder configured to fix a target (Fig. 1B shows a head support portion, Label 132, designed to hold a human head);
a holder support member (Fig. 1B shows a platform portion, Label 12, which supports the head support portion);
a driving part configured to allow the holder and holder support member to move through four degrees-of-freedom (Fig. 1A, in light of Paragraph 0032, shows an axel, Label 98, that allows extension through the X-axis and from which the holder support member is suspended; a rotational/tilt positioner, Label 90, which controls rotation about the X-axis and tilt about the Y-axis; and a telescoping column, Label 80, which allows extension through the Z-axis).
Lim teaches that the disclosed configuration allows the patient examination platform to have more articulation than conventional platforms (Abstract).
The device of Bell ‘006 is only capable of moving in linear movements, so it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified the device of Bell ‘006 to rotatably articulate as disclosed by Lim. One could perform this modification by placing the telescoping column, the rotational/tilt positioner, and the platform portion taught by Lim onto the central platform of the device of Bell ‘006. While the central platform could move in linear directions, adding a column vertically connected to a rotational/tilt positioner which is then connected to platform via an axle, as in Lim’s configuration, would allow a target sitting on said platform to move both linearly and rotationally. One would be motivated to add these components to allow a target to articulate about different axes to help trainees learn surgeries that require three-dimensional orientation.
It also would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified the device of Bell ‘006 by adding a holder to hold a target as taught by Lim. Lim teaches a holder meant to hold a human head, regardless one of ordinary skill in the art, before the effective filing date of the claimed invention, could have replaced a head holder with a holder more appropriate for the scale of endoscopic surgery. One would be motivated to add such a holder since the modification of the device with additional rotation components introduces new points of articulation, and a holder would better secure a training target through new movements.
The modification would yield a device further comprising:
a holder configured to fix a training target member; and
a driving part comprising a holder support member and configured to change the position of the holder through four degree-of-freedoms including a first linear movement (linear movement across the X-axis), a first rotation (rotation about the Y-axis via the modification), a second rotation (rotation about the X-axis via the modification), and a second linear movement (linear movement across the Y-axis).
Regarding claim 3, the modified device, as discussed above, and as applied to claim 2, comprises:
a first linear driving part configured to linearly move the holder support member along the X-axis direction (via Bell ‘006: the motor that actuates X-axis movement; see Paragraph 0013); and
a second linear driving part configured to linearly move the holder support member in a direction perpendicular to the second rotation axis (via Bell ‘006: the motor that actuates the Y-axis movement; see Paragraph 0013. The Y-axis is perpendicular to the second rotation axis since the second rotation axis is parallel to the X-axis);
and Lim teaches the holder support member wherein:
a first rotational driving part rotates the holder support member around a first rotation axis (Fig. 1B shows a tilt portion, Label 100, which rotates the platform portion about the Y-axis);
a second rotational driving part rotates the holder support member around a second rotation axis (Fig. 1B shows a rotational portion, Label 94, which rotates the platform portion about the X-axis);
a first part of the holder support member is coupled to the holder (see Fig. 1B, the platform portion, Label 12, comprises a horizontally aligned portion, Label 110, which is coupled to the head support);
the first part of the holder support member is arranged to be parallel to the second rotation axis (Fig. 1B shows the horizontally aligned portion parallel to the X-axis); and
the first part of the holder support member is spaced apart from the second rotation axis (Fig. 1B shows the horizontally aligned portion, Label 110, a distance from the axle, Label 98, about which the X-axis rotation occurs).
Regarding claim 13, the modified device, as discussed above, and as applied to claim 2, comprises wherein the controller drives the driving part such that the holder support member moves while the training target member is changed to a specific simulation position of an organ for training by driving the driving part. (via Bell ‘006: Paragraph 0009 discloses a computer program for receiving location data from a motor and controlling the driving system, and Paragraph 0024 discloses that the target placed on the central platform can be a simulated biological organ).
Regarding claim 19, Bell ‘006 teaches wherein an operating part of user operation generates a user input signal to change the training target member to a specific simulation position of an organ (Paragraph 0138 discloses a motor control board that can be set with user commands);
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bell ‘006, in view of Lim, and further in view of US 2013/0288217 Hammerman (hereinafter Hammerman).
The modified device, as discussed above, and as applied to claims 2 and 3, comprises all the limitations of claim 3 but lacks:
wherein when the holder support member is placed in an initial position by the driving part, while the holder is coupled to the first part, the center of the holder is placed in a straight line with the first rotation axis, which is the central axis for a first rotation of the holder support member.
However, Hammerman teaches an enclosed surgery simulating device with a surface coupled to a spindle that allows the surface to rotate on a base (Paragraph 0032 discloses a spindle that couples to a base and axially rotates about the Z-axis; see Fig 9, axis of rotation, Label AD). Hammerman teaches that the disclosed configuration allows for orientation flexibility (Paragraph 0028).
It would have been obvious to one or ordinary skill in the art, before the filing date of the claimed invention, to have further modified the device, as discussed above, and as applied to claims 2 and 3, to be capable of rotating about the Z-axis as taught by Hammerman. One could have modified the device by adapting the platform portion of Lim to receive a spindle coupled to a surface, as taught by Hammerman, and placing the spindle and the surface in between the platform portion and the holder. One would be motivated to make this modification to allow for yet more orientation flexibility.
Upon this modification, it also would have been obvious to add a motor to actuate the Z-axis rotation. All linear and rotational movements in the device are actuated by a motor, so one would be motivated to make this modification to make the mechanism of adjustment consistent across all movements for user convenience. Additionally, this modification would enable a user to perform a Z-axis rotation more easily, especially while the enclosure box is sealed. These modifications would yield a device further comprising:
an additional axis of rotation (via the modification enabling Z-rotation, here considered the first axis of rotation);
a new holder support member, a first part of which is parallel to the second rotation axis (via Hammerman; Fig 6A shows the flat surface of the substrate, Label 26 considered the new holder support member, parallel to the X-axis);
the holder support member is spaced apart from the second rotation axis (via Lim; Fig. 1B shows the platform portion, Label 12, upon which the substrate is located, laying a distance from a line running through the axle, Label 98, which represents the axis about which X rotation occurs);
when the holder support member is placed in an initial position, the center of the holder is in a straight line with the first rotation axis (via Hammerman; the spindle which defines the axis for Z rotation, is centered under the substrate, and the holder lays on top of the substrate);
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bell ‘006, in view of Lim, and further in view of US 2012/0237416 Lockwood et al. (hereinafter Lockwood). The modified device, as discussed above, and as applied to claim 2, lacks:
wherein the holder comprises a holder body comprising a mounting part that is detachably coupled to one side of the driving part and a plurality of leg parts that extend from the mounting part, and a plurality of gripping members that are detachably coupled to the plurality of leg parts so as to be able to grip the training target member.
However, Lockwood teaches a clamp for securing laboratory containers, said clamp comprising:
a mounting part that magnetically attaches to a platform (Fig. 2, bottom base plate, Label 24, connects to base magnetically; see Paragraph 0006);
a plurality of leg parts that extend from the mounting part (Fig. 6, shows fingers, Label 140, extending from the base); and
a plurality of gripping members that are coupled to the plurality of legs (Fig. 6, shows a plurality of rollers, Label 138, for gripping containers that have silicon covers stretched over them; see Paragraph 0008);
Lockwood teaches that a magnetic attachment mechanism is preferrable to other mounting methods, for example screws, because it avoids the hassle associated with removing more permanent mounts (Paragraph 0005). Further, Lockwood teaches that the disclosed fingers and rollers provide a means to reduce point contact and surface stress on an object being held (Paragraph 0008).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device, as discussed above, and as applied to claim 2, with a means for the substrate to magnetically receive a holder body with a plurality of legs as taught by Lockwood. One would be motivated to modify the substate so it would be compatible with a variety of holder types and could conveniently attach to holders magnetically. One would be motivated to modify the holder by adding the rollers and silicon covers of the clamp of Lockwood to better secure a target object through motion, while maintaining low contact and surface stress on said target object.
Lockwood lacks an explicit teaching of gripping members that are detachably coupled to the plurality of leg parts. Regardless, it would have been an improvement to have made the rollers in Lockwood’s device to be replaceable since rubber degrades over periods of contact. One of ordinary skill in the art, before the filing date of the claimed invention, could have modified the rollers of the modified device to be removable so that the rubberized covers could be replaced when worn.
Claims 7 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bell ‘006, in view of Lim, and further in view US 2016/0331363 Green et al. (hereinafter Green).
Regarding claim 7, the modified device, as discussed above, and as applied to claim 2, comprises all the limitations of claim 2 and additionally comprises:
A first linear driving part comprising a moving member (via Bell ‘006; central platform) that reciprocates linearly along the X-axis via a first driving motor (via Bell ‘006; motor actuates X-direction motion); and
a second linear driving part comprising a fourth driving motor that provides a driving force for reciprocating a linear movement of the holder support member along a direction perpendicular to the Z-axis (via Bell ‘006; motor actuates Y-direction motion);
but lacks:
the fourth driving motor is fixedly coupled to the second mounting member;
a first rotational driving part comprising a second driving motor that is fixedly coupled to the moving member, a first rotation axis that rotates around the Z-axis that is perpendicular to the X-axis with respect to the moving member through a driving force of the second driving motor, and a first mounting member that is fixedly coupled to the first rotation axis; and
a second rotational driving part comprising a third driving motor that is fixedly coupled to the first mounting member, a second rotation axis that rotates around an axis that is parallel to the XY plane and perpendicular to the Z axis with respect to the first mounting member through a driving force of the third driving motor, and a second mounting member that is fixedly coupled to the second rotation axis.
However, Green teaches an organ manipulator apparatus, wherein an organ supporting portion (Fig. 1E shows a bottom most platform that is laying in the XY plane) rotates about a vertical shaft in the Z-direction (Fig. 1E, Label 130, maneuverable arm whose length spans in the Z-direction).
Since the device, as discussed above, and as applied to claim 2, only rotates about the X and Y axes, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the device, discussed above, and as applied to claim 2, to be able to rotate about an axis parallel to the length of a vertically aligned support beam as taught by Green. One could have further modified the device to rotate about an axis parallel to the length of the telescoping column according to Lim. One would be motivated to perform this modification to allow yet more orientation flexibility to facilitate trainee learning.
Upon this modification, it also would have been obvious to add a motor to actuate the Z-axis rotation. All linear and rotational movements in the device are actuated by a motor, so one would be motivated to perform said modification to make the mechanism of adjustment consistent across all movements for user convenience. Additionally, this modification would enable a user to perform a Z-axis rotation more easily while the enclosure box is sealed. These modifications would yield a device further comprising:
a first rotational driving part comprising a second driving motor that is fixedly coupled to the moving member (a second motor according to the Green modification is located at the junction between the central platform according to Bell ‘006, considered the moving member, and the telescoping column according to Lim);
a first rotation axis that rotates around the Z-axis that is perpendicular to the X-axis with respect to the moving member (the axis of rotation of the modification according to Green is parallel to the length of the telescoping column, which spans a length in the Z-direction) through a driving force of the second driving motor (rotation is actuated by the second motor);
a first mounting member that is fixedly coupled to the first rotation axis (the telescoping column, upon which all horizontally aligned components are mounted is centered at the axis of rotation);
a second rotation axis that rotates around an axis that is parallel to the XY plane and perpendicular to the Z-axis (via Lim; Fig. 1B, rotation about the Y-axis is achieved through the tilt portion, Label 100) through a driving force of the third motor (motor, Label 102);
a second mounting member that is fixedly coupled to the second rotation axis (clevis, Label 92, is fixedly centered about the Y-axis rotation); and
a second linear driving part comprising a fourth driving motor (via Lim; Fig. 1B shows a motor, Label 96) fixedly coupled to the second mounting member (the clevis, Label 92, connects to the motor) and provides a driving force for reciprocating a linear movement of the holder support member along a direction perpendicular to the Z-Axis (Paragraph 0032 discloses extension through the axis, Label 98, in the X-direction).
Regarding claim 9, Bell ‘006 teaches:
a first slider movably coupled to a first guide rail so as to be able to move linearly in the X-axis direction along the first guide rail (Paragraph 0122 discloses a moving platform sliding along the X direction along a guiderail. Paragraph 0093 discloses the central platform being moved by the moving platform);
a first rack gear fixedly coupled to one side of the moving member so as to be parallel to the longitudinal direction of the first guide rail and a first pinion gear meshed with the first rack gear while being axially coupled to the first driving motor (Paragraph 0115 discloses that movement in the X direction is accomplished by a rack and pinion drive assembly wherein the pinion gear engages the rack and pushes the moving platform forward and backwards. The moving platform in turn moves the central platform, considered the moving member. Paragraph 0117 discloses the motors that are responsible for said x motion); and
wherein the moving member moves in a reciprocating linear manner along the X-axis with respect to the support plate (Paragraph 0122 discloses a moving platform sliding along the X direction along a guiderail, and the moving platform in turn moves the central platform, considered the moving member).
Bell ‘006 lacks explicit teachings of:
the first guide rail fixed to the support plate; and
the first slider fixed to one side.
Regardless, Paragraph 0019 discloses guiderails may be affixed to at least one side of an enclosure box. The general conditions of the claim are discovered, and the choice to fix the guiderail to a specific panel has a lack of criticality to and an absence of unexpected results, as taught by Bell ‘006; therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the first guide rail fixed to the support plate.
Regarding claims 10 and 11, the modified device, discussed above, and as applied to claim 7, additionally teaches:
wherein the first mounting member rotates around the Z-axis, which is perpendicular to the X-axis, with respect to the moving member (the telescoping column according to Lim rotates about the Z-axis via the modification resulting in the placement of an actuator under the telescoping column); and
wherein the second mounting member rotates around an axis perpendicular to the Z-axis with respect to the first mounting member through a rotation of the second axis (the axle according to Lim, see Fig. 1B, Label 104, rotates about the Y-axis);
but lacks wherein:
the second driving motor is axially connected to a first driving gear and a first driven gear that is axially coupled to the first rotation axis;
the third driving motor is axially connected to a second driving gear and a second driven gear that is axially coupled to the second rotation axis;
Regardless, one of ordinary skill in the art, before the effective filing date of the invention, could have modified the device, as discussed in claim 7, by adding gears in between components to be articulated and the actuators that power the articulation. The placement of gears to transfer power would allow a motor in the device to be placed remotely from the component to be moved. One would be motivated to perform this modification so that the motor responsible for Z-axis rotation could be placed flexibly and not exclusively under the telescoping column, and so the motor responsible for Y-axis rotation could be placed flexibly and not exclusively at the tilt positioner.
Claims 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bell ‘006, in view of Lim, and further in view of US 2013/0131867 Olds et al. (hereinafter Olds).
The modified device, discussed above, and as applied to claim 2, lacks but Olds teaches a steady hand micromanipulation robot for surgery (Paragraph 0005) comprising:
Claim 16: a support part capable to steadying a surgical tool to be used by a surgeon (see Paragraph 0008 and Fig. 4);
Claim 17: the support part changing position through a motor (see Paragraph 0012);
a controller that drives the support part towards a target (Paragraph 0008 discloses that the robot senses a surgeon’s pressure on a tool through a force sensor and moves accordingly);
Claim 18: a slider fixed to a coupling member that is coupled to a support plate (see Fig. 4, bottom most plane which is attached to the sliders of the XYZ linear stage); and
a guide rail that is movably coupled to the slider so as to move in the X-axis direction and has the support fixedly coupled to it (see Fig. 4 XYZ linear stage).
Olds teaches that the device allows surgeons to perform surgery with significantly reduced hand tremor (Paragraph 0065).
It would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the device, as discussed in claim 2, by adding the micromanipulation robot as taught by Olds. One would have been motivated to make this modification so that trainees could have additional support as needed to reduce hand tremors for newer trainees. This option would allow trainees to focus attention on other aspects of endoscopic surgery independently. It also would have been obvious to use the rack gear mechanism along the X-axis on the guide rail of the support to make the mechanism of adjustment consistent with the X and Y axis linear movements of the central platform as taught by Bell ‘006. This would have additional manufacturing benefits as the device would call for manufacturing a smaller range of components.
Claim 6, is rejected under 35 U.S.C. 103 as being unpatentable over Bell ‘006, in view of Lim, further in view Lockwood, and further in view of US 6,824,511 Bell et al. (hereinafter Bell ‘511). The modified device, discussed above, and as applied to claim 5 lacks:
wherein the holder comprises a plurality of first magnet members that are provided on each of the plurality of leg parts, and a plurality of second magnet members that are provided on each of the plurality of gripping members so as to correspond to the plurality of first magnet members, and wherein each of the plurality of gripping members is detachably coupled to the holder body through the first magnet member and second magnet member corresponding to each other.
However, Bell ‘511 teaches a surgical tissue stabilization device comprising:
a base and a plurality of leg parts that magnetically attach to the base (Col. 2, lines 59-61); and
a plurality of gripping members that magnetically attach to the plurality of leg parts (Fig. 2 and Col. 9, Lines 50-55 disclose a rook, Label 68, magnetically connecting to a gripping member, pawn, Label 64).
In the device of Bell ‘511, the top surface of the rook is magnetic and receives a magnet of the pawn; however, the top surface of the rook is not disclosed as having a magnet itself, thus Bell ‘511 lacks a teaching wherein first magnet members on legs attach to second magnet members on gripping members. Regardless, the specific number of magnets and whether they are placed on one of or both of magnetically attaching components could be varied to yield similar results. For instance, one could change the single magnet configuration to a configuration of two magnets of less strength, such that they impart an equivalent coupling attraction as the single magnet would. This would provide the additional benefit of flexible manufacturing capabilities under different constraints such as supply availability.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device, discussed above, and as applied to claim 5, by adding magnets to both the legs and the gripping rollers. One would have been modified to make this modification so that the type of gripping member could be conveniently swapped, for example to grab different types of targets.
Claim 8, as interpreted in light of the 35 U.S.C. 112(b) issue identified above, is rejected under 35 U.S.C. 103 as being unpatentable over Bell ‘006, in view of Lim, further in view of Green, and further in view of Lockwood. The modified device, as discussed above, and as applied to claim 7 lacks:
wherein the endoscopic surgery training apparatus further comprises a first magnet member provided on the holder support member, and a second magnet member provided on the holder to correspond to the third magnet member, and wherein the holder is detachably coupled to the holder support member via the third magnetic magnet member and the fourth magnetic magnet member.
However, for the same reasoning as that applied to claim 5, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have further modified the device, as discussed in claim 7, by adding a means for the substrate to magnetically receive a holder body with a plurality of legs as taught by Lockwood, then further modify the device to comprise a first magnet member on the substrate, considered the holder support member, and a second magnet member on the holder to which the substrate could magnetically attach.
Claims 14, 15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bell ‘006, in view of Lim, further in view of Thompson US 2014/0370474 (hereinafter Thompson), and further in view of US 2022/0241029 Hendrick et al. (hereinafter Hendrick).
Regarding claim 14, the modified device, as substantially discussed and as applied to claim 2 above, comprises:
a housing comprising a training space formed inside for training a surgery, and a support plate forming a bottom surface of the training space;
a holder configured to fix a training target member;
a driving part comprising a holder support member to which the holder is coupled, and configured to change a position of the holder coupled to the holder support member within the training space through at least one degree-of-freedom movement so as to change the training target member fixed to the holder to a specific simulation position of an organ for training within the training space;
a channel forming part formed in the housing so as to form an entry path of an endoscopic device entering the training space from the outside;
and a controller for controlling the driving part (all above limitations of the instant claim have been substantially discussed);
The device lacks wherein the channel forming part comprises:
a channel case coupled to the housing;
a path part formed to be recessed from one surface of the channel case so as to form an entry path for the endoscopic device;
a path maintenance member formed in a hollow shape such that the endoscopic device passes through and detachably coupled to the path part;
wherein the path part comprises:
a first path forming part formed to be connected to the training space and have a certain length; and
a second path forming part and a third path forming part each extending from the first path forming part so as to branch in different directions from the other end of the first path forming part; and
wherein the path maintenance member is mounted on the path part so as to be positioned at the first path forming part and the second path forming part to form a first entry path or is mounted on the path part so as to be positioned at the first path forming part and the third path forming part to form a second entry path.
However, Thompson teaches an endoscopy training box comprising:
a channel case coupled to the housing of the box (Fig. 6 shows a first internal chamber, Label 46, considered the channel case);
a path part formed to be recess from one surface of the channel case so as to form an entry path for the endoscopic device (Fig. 6, shows an access port, Label 48, through which an endoscopic device is to be inserted, leading to a straight channel, Label 52);
a first path forming part formed to be connected to the training space (Fig. 6 shows the straight channel, Label 52)
a second path forming part and a third path forming part each extending from the first path forming part so as to branch in different directions from the first path forming part (Fig. 6 shows two junctions, from which the straight channel, Label 52, branches).
Thompson teaches that the plurality of channels creates a means for evaluating difference in skill between novice and experienced endoscopists (0047).
Further, Hendrick teaches a path maintenance tube designed for guiding an endoscope. (Fig. 14 and Paragraph 0018 discloses a sheath and a channel in the sheath comprising a guide tube). Hendrick teaches that the shape of the guide tube allows for a greater approach angle with endoscopic tools (Paragraph 0065).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the instant device by adding a channel case comprising branching paths, as taught by Thompson. One would have been motivated to make this modification so that experienced endoscopists could selectively approach a training target with a path considered more difficult to navigate. This would provide additional training benefit to experienced endoscopists. Upon this modification, it would also have been obvious to provide an optional guide tube for novice endoscopists, so they could be guided through the elliptical portion (Label 50) more easily since the guide tube facilitates a greater approach angle. This way, novice endoscopists could train on both paths in an assisted manner and in line with their skill.
Regarding claim 15, Hendrick teaches a guide tube comprising:
a hollow pipe having a predetermined length (see Paragraph 0018); and
the hollow pipe having coupling ports at each end (the exit and entry points of the pipe);
Hendrick lacks an explicit teaching of a connecting path that spans from the entry point in the aperture to an end point of an elliptical path in the device. Regardless, it would have been obvious to made the modification according to Hendrick, as discussed in claim 14, to have spanned the length from the entry point in the aperture, to the far end in an elliptical path since a novice would benefit from a guide starting from the entry point and ending at the end of a curved portion, since as taught by Hendrick, the guide tube facilitates a greater angle of approach, and a curved portion is often harder for novices to navigate.
Regarding claim 21, the modified device as discussed in claim 14, comprises:
An endoscopic surgery training apparatus, comprising
a housing comprising a training space formed inside for training a surgery, and a support plate forming a bottom surface of the training space;
a holder configured to fix a training target member;
a driving part comprising a holder support member to which the holder is coupled, and configured to change a position of the holder coupled to the holder support member within the training space through at least one degree-of-freedom movement so as to change the training target member fixed to the holder to a specific simulation position of an organ for training within the training space;
a channel forming part formed in the housing so as to form an entry path of an endoscopic device entering the training space from the outside;
a controller for controlling the driving part,
(all above limitations regarding the instant claim have been substantially discussed);
The device lacks explicit teachings wherein:
while the holder is changed to a specific simulation position of an organ through the driving part, a training target member that is mounted on the holder implements an inner wall of the organ; and
an endoscope device that enters the training space through the channel forming part is positioned such that a tip faces one surface of the training target member.
However, Thompson discloses that one of a plurality of training objects lays at the end of a path from which an endoscopic training tool enters (see Paragraph 0048 and Fig. 6 wherein the tip of a tool, Label 36, is oriented towards a training object, Label 54);
Additionally, Bell ‘006 discloses that target may a simulated organ and be any shape or size within design constraints and can be customizable to differently sized and shaped elements at any angle (see Paragraph 0024).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device as discussed in claim 14, by using a target representative of an inner wall of an organ. One would have been motivated to use such a target so that trainees could practice surgery on ruptured organs.
It also would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the device as discussed in claim 14, by configuring the entry point of the box, such that when an instrument enters the box, it faces one surface of the training target, as taught by Thompson. One would have been motivated to make this modification so that the default configuration is such that a trainee may immediately make contact with the target without additional navigation. Since the target is on a moving platform in the device, it would be obvious to make the default configuration tailored to a new trainee, and have experienced endoscopists change the position of the target with the controller to change the difficulty as needed.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bell ‘006, in view of Lim, further in view of Hammerman, and further in view of US 2007/0239138 Lawrence et al. (hereinafter Lawrence). The modification of the device of Bell ‘006 with the teachings of Lim, as discussed above, results in an endoscopic surgery training device that comprises:
a housing comprising a training space formed inside for training a surgery, and a support plate forming a bottom surface of the training space;
a holder configured to fix a training target member;
a driving part comprising a holder support member to which the holder is coupled, and configured to change a position of the holder coupled to the holder support member within the training space through at least one degree-of-freedom movement so as to change the training target member fixed to the holder to a specific simulation position of an organ for training within the training space;
a channel forming part formed in the housing so as to form an entry path of an endoscopic device entering the training space from the outside;
a controller for controlling the driving part;
(all above limitations regarding the instant claim have been substantially discussed);
a connector electrically connected to the holder support member (necessitated by the addition of a motor and the modification according to Hammerman, discussed above, and as applied to claim 4);
The device lacks:
a portion of the connector is exposed to the outside of the housing and is coupled to a terminal of a cable that is electrically connected to a cautery; and
wherein the holder that is coupled to the holder support member is electrically connected to the connector.
However, Lawrence teaches an endoscopic surgery tool configured to receive an electric cautery (Paragraph 0095);
Further, Bell ‘006 discloses a device with at least one training instrument (Paragraph 0009) and further discloses an embodiment where an electrical end effector is the training instrument to contact a training target (Paragraph 0010). This configuration necessarily requires wires to be connected to a training instrument. While Bell ‘006 lacks an explicit teaching that said wires run to the outside of the housing, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made electrical connections run to the outside of the housing so that someone could plug in the device to a standard outlet.
It would have been obvious to further modify the device to receive the endoscopic surgery tool taught by Lawrence. One would have been motivated to make this modification so that the device would be able to simulate more surgery scenarios, for example cauterizing a wound to stop bleeding.
The device lacks an explicit teaching of an electrically connected holder. Regardless, the instant specification discloses that the electrical connection to the holder is enabled by conductive contact with the holder support member (Page 39, Lines 27-28). The platform portion according to Lim in the device, considered the holder support member, and the holder according to the modification as discussed in claim 2, are not required to be constructed of any particular material. Thus, both the platform portion in the device and the holder could be modified to be constructed of a conductive metal and still yield the same result of holding and securing a target for training respectively.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 12 is considered allowable for disclosing:
the second guide rail fixed to the second mounting member; and
a second rack gear fixedly coupled to one side of the holder support member so as to be parallel to the longitudinal direction of the second guide rail; and
a second pinion gear meshed with the second rack gear while being axially coupled to the fourth driving motor so as to be able to rotate by the fourth driving motor; and
the linear driving part further comprising a second rack gear fixedly coupled to one side of the holder support member as to be parallel to the longitudinal direction of the second guide rail.
The limitation of claim 7, from which claim 12 depends, that recites “a second mounting member that is fixedly coupled to the second rotation axis”, under a broadest reasonable interpretation, requires that the clevis or axle horizontally aligned in the Y-direction be considered the recited “second mounting member”, since the Y-axis was considered the second axis of rotation as discussed in claim 7.
Given this interpretation, the second guide rail could only be fixed to the clevis, not the axle aligned in the Y-direction, since if it were, it would interfere with both X-axis and Y-axis rotation.
Additionally, the holder support member, considered the substrate, could not have a gear placed parallel to the longitudinal direction of the second guide rail as necessitated the instant limitations, and in light of the need for a linear movement perpendicular to the Z-axis. The substate would have to be at the same vertical location in the Z direction as the clevis and have a pinion gear meshed with a rack gear. This configuration could not be achieved without undue experimentation, for example, by hollowing out the axle aligned in the X direction and running a rack gear along and out of the axle to connect to the substrate. As a result, one of ordinary skill in the art would have instead been drawn to the configuration disclosed by Lim.
Conclusion
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/J.L.G./Examiner, Art Unit 3715
/WILLIAM H MCCULLOCH JR/Primary Examiner, Art Unit 3715
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