DETAILED ACTION
This office action is responsive to the amendment filed 6/9/2025 and 12/24/2025. As directed, claims 1-15, 26, and 27 have been canceled, claims 16, 29, and 30 have been amended, and no claims have been added. Thus claims 16-25 and 28-58 are currently pending.
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
In view of the appeal brief filed on 4/23/2026, PROSECUTION IS HEREBY REOPENED. Modified ground(s) of rejection to claim 50 and 53 are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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 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.
Claim(s) 16-22 and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick (2014/0123976) in view of Rutgers (2015/0366445) and Ianchulev (2013/0035548).
Regarding claim 16, McCormick discloses a stylet device (10) able to guide insertion of an endotracheal tube into a subject’s airway (abstract) comprising: an elongate stylet body (12) having a proximal end (proximal end) and a distal end (distal tip); a pivoting tip (14) affixed by a bidirectional hinge (16) (as shown the portion 16 is a hinge; [0042] lines 1-10, [0043] lines 1-20 disclose at least a living hinge moves in two directions) to the distal end (distal end); a control mechanism (18, 22); an actuator (18, 20) at the proximal end; wherein said bidirectional hinge (16) is configured to alternately bend only in at least first (14’) and second (14”) opposing coplanar directions relative to a neutral position (14) ([0034] lines 1-10 disclose bending about axis A-A thus in coplanar, xy plane, opposing directions) without causing a change in the shape of the stylet body portion([0041] lines 1-15); and the actuator (18, 20) is useable to operate the control mechanism (18, 22)which controls the pivoting deflection of the distal tip ([0035] lines 1-20).
McCormick substantially teaches the claimed invention except for the control mechanism comprises a first length of flexible line or wire extending through the stylet body and connected to a first location on the pivotable tip, distal to the hinge and a second length of flexible line or wire which extends through the stylet body and is connected to a second location on the pivotable tip, distal to the hinge: and the actuator is configured to alternately cause a) proximal retraction of the first control member causing bending at the hinge in the first direction and proximal retraction of the second control member causing bending at the hinge in the second direction. However, Rutgers teaches a first line and a second line extending through the body to connect with the tip distal to the hinge ([0020] lines 1-20 disclose multiple lines) configured such that application of tension to the first line causes the distal portion to deflect in the first direction and application of tension to the second line causes the distal portion to deflect in the second direction ([0098] lines 1-20, [0020] lines 1-30 disclose pulling on one of the cable is to change the angle and pulling on the other one of the cable is to restore to neutral or change direction). 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 wire of McCormick to include multiple tensioning wires as taught by Rutgers to provide the advantage of more control and prevention of undesired angles as disclosed by Rutgers in abstract lines 1-10.
McCormick substantially taches the claimed invention except for the control mechanism has a plurality of discrete, predetermined, incremental stopping points which provide releasable locking of the distal portion at discrete incremental predetermined deflection angles. However, Ianchulev teaches the control mechanism has a plurality of discrete, predetermined, stopping stopping points ([0006] last 15 lines, [0030] lines 1-20 disclose wounding control wire 50 around a spool 102 such that there are discrete predetermined incremental stopping points adjacent each end of the wire) which provide locking of the distal portion at discrete incremental deflection angles ([0030] last 15 lines disclose applying sufficient tension to fix the distal end in position). 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 stylet of McCormick to include discreet locking positions as taught by Ianchulev to provide the advantage of enhanced control and ease of use.
Regarding claims 17, McCormick discloses the actuator comprises a dial ([0045] last 3 lines).
Regarding claim 18, McCormick discloses the actuator comprises a dial ([0045] last 3 lines) and the modified McCormick discloses that application of tension to the first line causes the distal portion to deflect in the first direction and application of tension to the second line causes the distal portion to deflect in the second direction ([0098] lines 1-20, [0020] lines 1-30 of Rutgers disclose pulling on one of the cable is to change the angle and pulling on the other one of the cable is to restore to neutral or change direction).
Regarding claim 19, McCormick discloses control member retainers (proximal housing) through which they extend.
Regarding claim 20, the modified McCormick teaches the first and second flexible line or wire segments are parts of a single line or wire ([0020] lines 1-20 of Rutgers disclose U shaped cables; each segment being on leg of the U).
Regarding claim 21, the modified McCormick discloses the first flexible line or wire segments is separate from the second flexible line or wire segment ([0020] lines 1-15 of Rutgers disclose multiple separate U-shaped cables).
Regarding claim 22, McCormick discloses the distal portion (distal end) is alternately deflectable to deflection angles within a range of from at least +10° to -10° from a neutral position ([0034] last 20 lines disclose -10 to 40 degrees which is within the claimed range of at least -10 to at least +10).
Regarding claim 30, the modified McCormick teaches the control mechanism remains locked without requiring holding of the actuator by the operator (as shown in fig. 1 and [0030] of Ianchulev the device can be pushed or pulled by touch and does not require a user holding the device).
Regarding claim 31, McCormick discloses the actuator comprises a wheel or lever ([0045] last 3 lines).
Regarding claim 32, McCormick substantially teaches the claimed invention except for image acquisition device on the tip. However, Rutgers teaches image acquisition device (26) for imaging an area selected from: an area distal to the tip ([0027] last 15 lines disclose visualizing vocal cords). 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 stylet of McCormick to include an endoscope as taught by Rutgers to provide the advantage of enhanced accuracy and detection.
Regarding claim 33, the modified McCormick discloses that the image acquisition stylet device comprises a digital image sensor/monitor for displaying images ([0025] lines 1-10 of Rutgers).
Claims 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick (2014/0123976) in view of Rutgers and Ianchulev, as applied to claim16 above, and further in view of Yoshida (8,746,239).
Regarding claim 23, the modified McCormick substantially teaches the claimed invention except for an attaching portion of the stylet is configured for attachment to a connector of an endotracheal tube. However, Yoshida teaches an attaching portion (tapered distal portion of handle 72) of the stylet is configured for attachment to a connector (proximal end) of an endotracheal tube (as shown in figs. 12 and 13, the proximal end of the endotracheal tube frictionally attaches to the tapered distal end of the handle portion). 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 stylet of McCormick to include an attachment portion as taught by Yoshida to provide the advantage of enhanced protection against inadvertent removal.
Regarding claim 24, the modified McCormick teaches (see figs. 1-13 of Yoshida), the attaching portion (tapered distal end of handle 72) is integrally formed with the body of the actuator (71, 74, 76) (as shown in figs. 10, 14 of Yoshida the tapered end is integrally formed with the actuating mechanism).
Regarding claim 25, the modified McCormick discloses the attaching portion has a port (interior space) for connection to an air line (i.e. distal interior space of stylet) (as shown in figs. 10-16 of Yoshida, the distal end of the handle has a hollow space fluidly connected to the hollow space of the stylet thereby containing air as air line).
Claim(s) 16, 34-39, 41-46 under 35 U.S.C. 103 as being unpatentable over Marks (2015/0096556) in view of Rutgers and Ianchulev.
Regarding claim 16, Marks discloses a stylet device about to guide insertion an endotracheal tube comprising: an elongate stylet body (52) having a bidirectional hinge (58, 60), a distal portion (80) that extends distally from the hinge (58, 60) and a proximal portion (proximal end) that extends proximally from the hinge; a control mechanism (52); said bidirectional hinge (58, 60) being configured to pivot or bend in a manner that allows the distal portion to alternately bend only in at least first and second opposing coplanar directions relative to a neutral position ([0034] lines 1-20 disclose common plane P1) without concurrent change in shape of the stylet body (as shown the proximal end doesn’t curve); and a proximal actuator (62) useable to operate a control mechanism (52) useable to cause said deflection of the distal tip ([0033] lines 1-20).
Marks substantially teaches the claimed invention except for the control mechanism comprises a first length of flexible line or wire extending through the stylet body and connected to a first location on the pivotable tip, distal to the hinge and a second length of flexible line or wire which extends through the stylet body and is connected to a second location on the pivotable tip, distal to the hinge: and the actuator is configured to alternately cause a) proximal retraction of the first control member causing bending at the hinge in the first direction and proximal retraction of the second control member causing bending at the hinge in the second direction. However, Rutgers teaches a first line and a second line extending through the body to connect with the tip distal to the hinge ([0020] lines 1-20 disclose multiple lines) configured such that application of tension to the first line causes the distal portion to deflect in the first direction and application of tension to the second line causes the distal portion to deflect in the second direction ([0098] lines 1-20, [0020] lines 1-30 disclose pulling on one of the cable is to change the angle and pulling on the other one of the cable is to restore to neutral or change direction). 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 wire of Marks to include multiple tensioning wires as taught by Rutgers to provide the advantage of more control and prevention of undesired angles as disclosed by Rutgers in abstract lines 1-10.
Mark substantially taches the claimed invention except for the control mechanism has a plurality of discrete, predetermined, incremental stopping points which provide releasable locking of the distal portion at discrete incremental predetermined deflection angles. However, Ianchulev teaches the control mechanism has a plurality of discrete, predetermined, stopping points ([0006] last 15 lines, [0030] lines 1-20 disclose wounding control wire 50 around a spool 102 such that there are discrete predetermined incremental stopping points adjacent each end of the wire) which provide locking of the distal portion at discrete incremental deflection angles ([0030] last 15 lines disclose applying sufficient tension to fix the distal end in position). 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 stylet of Mark to include discreet locking positions as taught by Ianchulev to provide the advantage of enhanced control and ease of use.
Regarding claims 34 and 41, Marks discloses a system comprising a stylet device according to claim 16 in combination with an endotracheal tube (10); wherein the endotracheal tube (10) has a bending portion (18), a proximal portion(proximal portions) located proximal to the bending portion and a distal portion (distal end) located distal to the bending portion(18); wherein the stylet device (52) is insert able into the endotracheal tube (10) to a position where the pivoting or hinged location of the stylet device (58, 60) is within the bending portion of the endotracheal tube ([0031] lines 1-10) and deflection of the distal portion of the stylet device will cause concurrent deflection of the distal portion of the endotracheal tube ([0032] lines 1-20) without concurrent change in configuration of the proximal portion (proximal end) of the stylet device (as shown, the proximal end doesn’t bend).
Regarding claims 35 and 36, Marks substantially teaches the claimed invention except for image acquisition device located on the tip for imaging an area distal to the tip. However, Rutgers teaches image acquisition device (26, 28) located on the tip (as shown lens 28 is on the tip) for imaging an area distal to the tip ([0027] last 15 lines disclose visualizing vocal cords). 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 stylet of Marks to include an endoscope as taught by Rutgers to provide the advantage of enhanced accuracy and detection.
Regarding claim 37, Marks discloses a distal end of the endotracheal tube (distal end), and the modified Marks discloses when fully inserted, the image acquisition device (26, 28) captures images distal to the distal end of an endotracheal tube ([0027] last 15 lines of Rutgers disclose visualizing vocal cords).
Regarding claim 38, Marks teaches the stylet (52) can be withdrawn and removed from the endotracheal tube after use ([0025] lines 1-8).
Regarding claim 39, the modified Marks discloses the image acquisition device (26, 28) captures images radial to the longitudinal axis ([0027] last 15 lines of Rutgers disclose visualizing vocal cords which would be radial or perpendicular to the axis when approached).
Regarding claims 42 and 54, Marks discloses the bending region has a corrugated configuration (as shown, the bending region includes many openings as folds as corrugated; see [0027] lines 1-10).
Regarding claims 43 and 55, Marks discloses the bending region comprises a concertina or accordion segment ([0027] lines 1-10).
Regarding claims 44 and 56, Marks discloses the endotracheal tube (10) has a wall (outer wall) and wherein the wall within the bending region has an area which is thinner than the remainder of the endotracheal tube wall ([0027] lines 10-28).
Regarding claims 45 and 57, Marks discloses the bending region comprises an area that is made from a different material from the remainder of the endotracheal tube ([0027] lines 10-28 disclose use of different materials).
Regarding claim 46, Marks discloses the endotracheal tube (10) further comprises an inflatable cuff (24).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marks (2015/0096556) in view of Rutgers and Ianchulev, as applied to claim 34 above, and further in view of Karlson (2020/0023151).
Marks substantially teaches the claimed invention except for the endotracheal tube has a Murphey’s eye formed near the distal end configured to prevent the stylet from protruding through the eye. However, Karlsson teaches in fig, 39 a Murphey’s eye near the distal end (125) and a stylet (121) configured to not protrude through the eye (as shown in fig. 42, the stylet does not protrude through the eye). 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 endotracheal tube of Marks to include a Murphey eye as taught by Karlsson to provide the advantage of enhanced safety providing patent flow in the case of distal blockage.
Claim(s) 47-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marks (2015/0096556) in view of Rutgers and Ianchulev, as applied to claim 16 above, and further in view of in view of Yoshida.
Regarding claims 47 and 48, Marks substantially discloses the claimed invention except for the proximal portion of the style that further comprises a lumen formed therein, a malleable rod that is insertable into and removable from the lumen. However, Yoshida teaches the proximal portion of the stylet further comprises a non-circular rod receiving lumen (lumen of sheath member 74; figs. 14-16; col. 8 lines 50-62) and wherein the stylet device further comprises a malleable rod (76, 85) that is insertable into and removable from the lumen (as shown, the rod is extensible; col. 5 lines 44-46, col. 6 lines 43-50). 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 stylet of Marks to include an extensible member from a lumen as taught by Yoshida to provide the advantage of enhanced extensions for visualization.
Regarding claim 49, the modified Marks inserting the rod into the lumen (as shown, the rod is extensible; col. 5 lines 44-46, col. 6 lines 43-50) and bending the endotracheal tube , proximal portion, and rod to a curved shape causing the rod to deform and thereby maintain the curved shape (as shown in fig. 13 of Yoshida, the flexible endotracheal tube can also conform to the shape of the rod and stylet as the endotracheal tube is slid of the stylet during intubation; the rod maintain the shape; col. 8 lines 1-11 of Yoshida) (col. 5 lines 44-47 of Yoshida disclose the rod 85 makes the end more formable and fig, 9 of Yoshida shows the end formed with a curve).
Regarding claim 50, Marks discloses a method for using a system according to claim 38 for endotracheal intubation of a patient airway, said method comprising the steps of:
trans-orally inserting the endotracheal tube ([0002] lines 1-10), with the stylet device inserted in the endotracheal tube at said position where the pivoting or hinged location of the stylet device is within the bending region of the endotracheal tube ([0031] lines 1-20); advancing the endotracheal tube and stylet to a location where the distal portion of the endotracheal tube is within an oropharynx of the patient ([0005] lines 1-10); using the control mechanism to cause deflection of the distal portion of the stylet device and concurrent deflection of the distal portion of the endotracheal tube without concurrent change in configuration of the proximal portion of the stylet device ([0005] lines 1-10, [0008] lines 1-20 disclose bending the distal end to place the endotracheal tube and stylet wherein the proximal end doesn’t bend), advancing the endotracheal tube through true vocal chords of the patient and into the trachea of the patient ([0004] lines 1-10 disclose placement of the endotracheal tube in the trachea which is thereby past vocal cords) removing the stylet device ([0006] lines 1-10); and ventilating the patient through the endotracheal tube ([0026] last 5 lines, [0002] lines 1-10).
Marks substantially discloses the claimed invention except for the proximal portion of the stylet further comprises a lumen formed therein, a malleable rod that is insertable into and removable from the lumen. However, Yoshida teaches the proximal portion of the stylet further comprises a non-circular rod receiving lumen (lumen of sheath member 74; figs. 14-16; col. 8 lines 50-62) and wherein the stylet device further comprises a malleable rod (76, 85) that is insertable into and removable from the lumen (as shown, the rod is extensible; col. 5 lines 44-46, col. 6 lines 43-50). 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 stylet of Marks to include an extensible member from a lumen as taught by Yoshida to provide the advantage of enhanced extensions for visualization.
The modified Marks inserting the rod into the lumen (as shown, the rod is extensible; col. 5 lines 44-46, col. 6 lines 43-50) and bending the endotracheal tube , proximal portion, and rod to a curved shape causing the rod to deform and thereby maintain the curved shape (as shown in fig. 13 of Yoshida, the flexible endotracheal tube can also conform to the shape of the rod and stylet as the endotracheal tube is slid of the stylet during intubation; the rod maintain the shape; col. 8 lines 1-11 of Yoshida) (col. 5 lines 44-47 of Yoshida disclose the rod 85 makes the end more formable and fig, 9 of Yoshida shows the end formed with a curve).
Claim(s) 51 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marks (2015/0096556) in view of Rutgers and Yoshida and Ianchulev, as applied to claim 50 above, and further in view of Rutgers.
Regarding claims 51 and 52, Marks substantially teaches the claimed invention except for image acquisition device to view images of the anatomy and facilitate advancement of the endotracheal tube through vocal cords into the trachea, However, Rutgers teaches image acquisition device (26, 28) used for visualization of the vocal cords and for visualization of a trachea of a patient to facilitate the endotracheal tube passing through the vocal cords into the trachea ([0014] last 5 lines of Rutgers). 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 stylet of Marks to include an endoscope as taught by Rutgers to provide the advantage of enhanced accuracy and detection.
Claim(s) 53-58 under 35 U.S.C. 103 as being unpatentable over Marks (2015/0096556).
Regarding claim 53, Marks discloses an endotracheal tube (10) with elongate tube body (10) comprising tubular wall having a lumen (interior passage) extending therethrough and an inflatable cuff (24) through which the tubular wall extends (as shown, the wall extends through the cuff 24) and wherein the tubular wall (120) comprises a bending portion located entirely within the cuff (as shown in fig. 7, the tube includes many portions that bend such that a bending portion which is located entirely within the cuff is entirely within interior regions of the cuff).
Regarding claim 54, Marks discloses the bending region has a corrugated configuration (as shown, the bending region includes many openings as folds as corrugated; see [0027] lines 1-10).
Regarding claim 55, Marks discloses the bending region comprises a concertina or accordion segment ([0027] lines 1-10).
Regarding claim 56, Marks discloses the endotracheal tube (10) has a wall (outer wall) and wherein the wall within the bending region has an area which is thinner than the remainder of the endotracheal tube wall ([0027] lines 10-28).
Regarding claim 57, Marks discloses the bending region comprises an area that is made from a different material from the remainder of the endotracheal tube ([0027] lines 10-28 disclose use of different materials).
Regarding claim 58, Marks discloses a stylet (52) having a hinge (58, 60), a distal portion (80) that extends distally from the hinge (58, 60) and a proximal portion (proximal end) that extends proximally from the hinge; wherein the stylet device (52) is insert able into the endotracheal tube (10) to a position where the pivoting or hinged location of the stylet device (58, 60) is within the bending region of the endotracheal tube ([0031] lines 1-10) and deflection of the distal portion of the stylet device will cause concurrent deflection of the distal portion of the endotracheal tube ([0032] lines 1-20) without concurrent change in configuration of the proximal portion (proximal end) of the stylet device (as shown, the proximal end doesn’t bend).
Allowable Subject Matter
Claim 28 is allowed.
Claim 29, if dependent on claim 28, is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 4/23/2026 have been fully considered but they are not persuasive.
Applicant argues on page 21 1st paragraph that McCormick does not disclose a bidirectional hinge with coplanar movement. Examiner respectfully disagrees. McCormick discloses in fig. 2 portion 16 functions as a living hinge about which distal tip pivots. Further, lanchulev teaches the control mechanism has a plurality of discrete, predetermined, stopping points ([0006] last 15 lines, [0030] lines 1-20 disclose wounding control wire 50 around a spool 102 such that there are discrete predetermined incremental stopping points adjacent each end of the wire) which provide locking of the distal portion at discrete incremental deflection angles ([0030] last 15 lines disclose applying sufficient tension to fix the distal end in position). Thus, the combination of McCormick and lanchulev teach this limitation as claimed.
Applicant argues on page 24 last paragraph that McCormick does not teach the distal end affixed by the hinge. Examiner respectfully disagrees as portion 16 is between the distal end and the stylet body. Thus, the distal end is connected to the stylet body by way of the hinge portion 16. Thus, McCormick teaches this limitation as claimed.
Applicant argues on page 26 2nd paragraph through page 28 1st paragraph the references do not disclose a pivot point. Examiner respectfully disagrees as fig. 2 of McCormick shows the distal end pivoting about a point in portion 16. Further, lanchulev teaches the control mechanism has a plurality of discrete, predetermined, stopping points ([0006] last 15 lines, [0030] lines 1-20 disclose wounding control wire 50 around a spool 102 such that there are discrete predetermined incremental stopping points adjacent each end of the wire) which provide locking of the distal portion at discrete incremental deflection angles ([0030] last 15 lines disclose applying sufficient tension to fix the distal end in position). Thus, the combination of McCormick and lanchulev teach this limitation as claimed.
Applicant argues on page 36 last paragraph through page 37 2nd paragraph that modification of McCormick would render the device unsuitable for its intended purpose. Examiner respectfully disagrees. McCormick does not disclose any disadvantage to releasably locking and thus does not teach away. McCormick is directed to the problem of pivoting a tip of a stylet to enable intubation. One of ordinary skill upon seeing the releasable locking of lanchulev would recognize that providing releasable locking to the device of McCormick would provide the advantage of enhanced control and ease of use. Thus, lanchulev teaches this limitation as claimed and would not render McCormick unsuitable.
Applicant argues on page39 last 2 paragraphs through page 41 last paragraph that lanchulev does not disclose incremental stopping points and is not similar to a dial disclosed in Applicant's specification. Examiner respectfully disagrees and notes that the limitation of a dial is not found in the language of the claim. lanchulev teaches the control mechanism has a plurality (i.e. 2) of discrete, predetermined, stopping points in the form of ends of a spool. For example [0006], last 15 lines, [0030] lines 1-20 disclose wounding control wire 50 around a spool 102 such that there are discrete predetermined incremental stopping points adjacent each end of the wire. Further, [0030] last 15 lines disclose applying sufficient tension to fix the distal end in position. Thus, the combination of Marks and lanchulev teach this limitation as claimed.
Applicant argues on page 48 1st paragraph through last paragraph that Marks does not teach bidirectional hinge without causing a shape of the stylet body. Examiner respectfully disagrees. Marks discloses a portion 52 as control mechanisms and in [0034] lines 1-20 and fig. 1 pivoting about hinge portion 58, 60 wherein at least the proximal end of the stylet body doesn't curve. Thus, Marks teaches this limitation as claimed.
Applicant’s arguments, see page 52 last paragraph through page 53 last paragraph with respect to the rejection(s) of claim(s) 53 has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Marks.
Applicant argues on page 60 2nd and 3rd paragraphs that Yoshida does not disclose a removable malleable rod. Examiner respectfully disagrees. Yoshida teaches the combination of portions (76,85) as malleable rod that is insertable into and removable from the lumen (as shown, the rod is extensible; col. 5 lines 44-46, col. 6 lines 43-50). Thus, the combination of references teaches this limitation as claimed.
Applicant’s arguments, see page 60 last paragraph through page 61 last paragraph with respect to the rejection(s) of claim(s) 50 has been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Marks (2015/0096556) in view of Rutgers and Ianchulev, as applied to claim 16 above, and further in view of Yoshida.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/Primary Examiner, Art Unit 3785
