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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application claim 1, 3 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 14 of U.S. Patent No. 12,150,662. Although the claims at issue are not identical, they are not patentably distinct from each other because
Regarding application claim 1, claim 14 of U.S. Patent No. 12,150,662 claims
A medical handle comprising:
a proximal arm and a distal arm, wherein the distal arm includes a first port, a second port, and a distal extension extending distally of the distal arm, wherein the distal extension includes a slot, wherein the first port is fluidly connected to an outer tube, wherein the second port is fluidly connected to an inner tube, and wherein the inner tube is positioned within the outer tube;
(A medical device, comprising: a handle, wherein the handle includes a proximal arm, a distal arm, and a lever, wherein the distal arm includes a first port, a first internal lumen fluidly connected to the first port, a second port, a second internal lumen fluidly connected to the second port, and a seal at a proximal end of the distal arm; an outer tube coupled to the first internal lumen; an inner tube coupled to the second internal lumen) (See claim 9 of U.S. Patent No. 12,150,662)
a drive wire positioned within the inner tube, wherein a distal portion of the drive wire extends from the inner tube, and wherein the drive wire is movable through the inner tube; and
(a wire, wherein a portion of the wire is positioned within the inner tube and moveable through the second internal lumen, and wherein movement of the proximal arm and the distal arm relative to each other controls a position of the wire relative to the inner tube; it is noted that since “a wire” claimed by claim 9 of U.S. Patent No. 12,150,662 has a controllable position moved or driven by movement of the proximal arm and the distal arm relative to each other, claim 9 “wire” is interpreted as a “drive wire”) (See claim 9 of U.S. Patent No. 12,150,662)
a lever positioned on the distal extension of the distal arm, wherein the lever is slidably positioned within the slot on the distal extension, and wherein the lever is coupled to the a proximal portion of the drive wire; and
(A medical device, comprising: a handle, wherein the handle includes a proximal arm, a distal arm, and a lever) (See claim 9 of U.S. Patent No. 12,150,662); (The medical device of claim 9, wherein the distal arm of the handle includes a distal extension, wherein the distal extension includes a slot, and wherein the lever is slidably positioned within the slot) (See claim 14 of U.S. Patent No. 12,150,662)
wherein the first port is couplable to one of a fluid source or a suction source to deliver fluid or apply suction through the outer tube; and wherein the second port is couplable to the other of the fluid source or the suction source to deliver fluid or apply suction through the inner tube
(wherein the first port is couplable to a fluid source to deliver fluid through the outer tube, wherein the second port is couplable to a suction source to apply suction through the inner tube, and wherein the outer tube is fixedly coupled to the lever) (See claim 9 of U.S. Patent No. 12,150,662).
Regarding application claim 3, claim 14 of U.S. Patent No. 12,150,662 claims
wherein the distal arm includes a first internal lumen and a second internal lumen, wherein the first internal lumen is fluidly connected to the first port and the outer tube, and wherein the second internal lumen is fluidly connected to the second port and the inner tube.
(wherein the distal arm includes a first port, a first internal lumen fluidly connected to the first port, a second port, a second internal lumen fluidly connected to the second port, and a seal at a proximal end of the distal arm; an outer tube coupled to the first internal lumen; an inner tube coupled to the second internal lumen) (See claim 9 of U.S. Patent No. 12,150,662).
Regarding application claim 11, claim 3 of U.S. Patent No. 12,150,662 claims
A medical handle, comprising:
a proximal arm and a distal arm, wherein the distal arm includes a first port, a second port, and a distal extension, wherein the first port is fluidly connected to an outer tube, wherein the second port is fluidly connected to an inner tube, and wherein the inner tube is positioned within the outer tube;
a drive wire positioned within the inner tube; and
(A medical device, comprising: a handle, wherein the handle includes a proximal arm and a distal arm, wherein the distal arm includes a first port, a first internal lumen fluidly connected to the first port, a second port, and a second internal lumen fluidly connected to the second port; … an outer tube coupled to the first internal lumen; an inner tube coupled to the second internal lumen; a wire, wherein a portion of the wire is positioned within the inner tube and moveable through the second internal lumen … and wherein movement of the proximal arm and the distal arm relative to each other controls a position of the wire relative to the inner tube; it is noted that since “a wire” claimed by claim 1 of U.S. Patent No. 12,150,662 has a controllable position moved or driven by movement of the proximal arm and the distal arm relative to each other, claim 1 “wire” is interpreted as a “drive wire”) (See claim 1 of U.S. Patent No. 12,150,662)
a rotary knob positioned on the distal extension of the distal arm and operable to rotate the drive wire relative to the outer tube.
(The medical device of claim 1, wherein a distal end of the wire includes an end effector, wherein movement of the wire within the inner tube controls a position of the end effector) (The medical device of claim 2, wherein the handle further includes a knob and a seal, wherein the knob is positioned distal to the distal arm such that rotation of the knob rotates the end effector, and wherein the seal surrounds a portion of the wire at a proximal end of the distal arm; it is noted that since applicant’s Specification describes the distal extension as being distal to the distal arm, the rotary knob is interpreted as positioned on the distal extension (See applicant’s Specification P. [0013] - - “a medical device may include a handle including a proximal arm, a distal arm, a distal extension extending from the distal arm, and a rotary knob partially surrounded by one or more portions of the distal extension. The medical device may also include a tube coupled to the distal extension distal to the rotary knob, and a drive wire coupled to an end effector” ) (See claims 2, 3 of U.S. Patent No. 12,150,662)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3- 6 and 16- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al. (WO 9724074 A1) in view of Rigby et al. (US Pat. No. 5,254,117).
Regarding claim 1, Isaacson discloses a medical handle comprising:
a proximal arm (39) (Fig. 1A) and a distal arm (38) (Fig. 1A), wherein the distal arm (38) includes a first port (47) (Fig. 1A), a second port (46) (Fig. 1A), and a distal extension (12) (Fig. 1A) extending distally of the distal arm (38), wherein the first port (47) is fluidly connected to an outer tube (17) (Fig. 1C), wherein the second port (46) is fluidly connected to an inner tube (19) (Fig. 1C), and wherein the inner tube (19) is positioned within the outer tube (17);
a drive wire (23) (Fig. 1C) positioned within the inner tube (19), wherein a distal portion of the drive wire (23) extends from the inner tube (19), and wherein the drive wire (23) is movable through the inner tube (19); and
wherein the first port (47) is couplable to a suction source to apply suction through the outer tube (17) (p. 7, l. 6- 9; p. 7, l. 17- 18 - - Second fluid channel 31 is formed between outer sheath 17 and inner sheath 19. Second fluid channel 31 allows fluid proximate to the distal end 16 to proximal end 14; Fluid is removed from fluid inlet 35 through second fluid channel 31 to fluid outlet port 47; it is noted that a suction source is not positively claimed by applicant, additionally, fluid outlet port 47 is capable of being attached to a suction source to apply suction);
and wherein the second port (46) is couplable to the fluid source (34) (Fig. 1A) to deliver fluid through the inner tube (19) (p. 7, l. 2- 5; p. 8, l. 12- 13 - - A first fluid channel 29 is formed within inner sheath 19 for allowing isotonic fluid to flow to an aperture at the distal end of the probe 12; A fluid source or reservoir 34 provides a fluid to probe 12 through conduit 46).
Isaacson does not disclose
(claim 1) a lever as claimed.
However, Rigby teaches an endoscopic electrosurgical apparatus in the same field of endeavor (Abstract)
(claim 1) A medical handle (10) (Figs. 1- 6, 10) comprising:
a distal extension (42) (Figs. 1, 5- 6), wherein the distal extension (42) includes a slot (34) (Fig. 1),
a drive wire (26) (Figs. 1- 4, 6) positioned within the inner tube (24) (Figs. 1- 6, 9), wherein a distal portion of the drive wire (26) extends from the inner tube (24), and wherein the drive wire (26) is movable through the inner tube (24); and
a lever (36) (Figs. 1- 2, 5- 6) positioned on the distal extension (42), wherein the lever (36) is slidably positioned within the slot (34) on the distal extension (42), and wherein the lever (36) is coupled to the a proximal portion of the drive wire (26) (Col. 11, l. 11- 25 - - In the presently preferred embodiment, fourth the control means advantageously comprises a trigger 36, selectively slidable along and through trigger slot 34, and shaped to allow a finger to easily extend and retract the electro-surgical tip 26. With reference to FIG. 6, trigger 36 engages flange 36A by trigger tab 36B through trigger slot 34. The flange 36A engages the tab 16A so as to secure the trigger 36 to the most proximal end of the cutting tip 26. With such a configuration, the electro-surgical tip 26 can be selectively extended by the forward motion of the trigger 36 toward the distal end 25 of the probe apparatus 10 and positioned out past the most distal end of the multi-lumen tube 24 up to the full extension);
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the distal extension of the distal arm associated with Isaacson to include a slot and a lever, wherein the lever is slidably positioned within the slot on the distal extension, and wherein the lever is coupled to the a proximal portion of the drive wire according to the teachings of Rigby because the lever is advantageously and selectively slidable along and through the slot, and shaped to allow a finger to easily extend and retract the drive wire such that the guide wire can be selectively extended by the forward motion of the lever toward the distal end of the distal extension and positioned out past the most distal end of the distal extension up to the full extension of the guide wire (Rigby - - Col. 11, l. 11- 25).
Regarding claim 3, Isaacson in view of Rigby discloses the apparatus of claim 1, Isaacson further disclosing wherein the distal arm (38) includes a first internal lumen (31) (Fig. 1C) and a second internal lumen (29) (Fig. 1C), wherein the first internal lumen (31) is fluidly connected to the first port (47) and the outer tube (17), and wherein the second internal lumen (29) is fluidly connected to the second port (46) and the inner tube (19) p. 7, l. 2- 5; p. 7, l. 6- 9 - - A first fluid channel 29 is formed within inner sheath 19 for allowing isotonic fluid to flow to an aperture at the distal end of the probe 12; Second fluid channel 31 is formed between outer sheath 17 and inner sheath 19. Second fluid channel 31 allows fluid proximate to the distal end 16 to proximal end 14).
Regarding claim 4, Isaacson in view of Rigby discloses the apparatus of claim 3, Isaacson further disclosing wherein the first internal lumen (31) is angled relative to a longitudinal axis of the outer tube (17) (See Fig. 1A - - showing first port (47) approximately perpendicular or angled to the longitudinal axis of the outer tube), and wherein the second internal lumen (29) is angled relative to a longitudinal axis of the inner tube (19) (See Fig. 1A - - showing second port (46) perpendicular to the longitudinal axis of the inner tube (19)). It is noted that Fig. 1A is similar to applicant’s port 24, which is angled relative to a longitudinal axis.
Regarding claim 5 and claim 6, Isaacson in view of Rigby discloses the apparatus of claim 3, but Isaacson does not disclose
(claim 5) further comprising a trigger positioned on a portion of the distal arm, wherein, in an extended position, the trigger closes an internal connection between the first port and the outer tube, and wherein, in a depressed position, the trigger opens the internal connection between the first port and the outer tube;
(claim 6) wherein the slot faces a direction opposite the first port and the second port.
However, Rigby teaches an endoscopic electrosurgical apparatus in the same field of endeavor (Abstract)
(claim 5) further comprising a trigger (18) (Figs. 1- 6), wherein, in an extended position, the trigger (18) closes an internal connection between the first port (12) (Figs. 1- 6) and the outer tube (24) (Figs. 1- 6, 9), and wherein, in a depressed position, the trigger (18) opens the internal connection between the first port (12) and the outer tube (24) (Col. 5, l. 24- 32 - - Extending past and secured through a proximal end 15 of the probe apparatus 10 by end plug 17 are suction and irrigation hoses, at 12 and 16 respectively, and electrocautery cable 14. Suction hose 12 connects to a source of negative pressure, not shown, the flow of which is operatively controlled by a suction push-button valve 18 such that fluids and debris can be siphoned away from the operative site when needed to clear the field of vision);
(claim 6) wherein the slot (34) faces a direction opposite the first port (12) and the second port (14) (See Fig. 6 - - showing slot (34) opposite the distal portion of first port (12) second port (14) at the distal end of pistol grip 42).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the medical handle associated with Isaacson to include a trigger positioned on a portion of the distal arm and opposite the slot because it would allow a user to control the flow of suction such that fluids and debris can be siphoned away from the operative site when needed to clear the field of vision (Rigby - - Col. 5, l. 24- 32).
Regarding claim 16 and claim 17, Isaacson discloses a medical handle, comprising:
a proximal arm (39) (Fig. 1A) and a distal arm (38) (Fig. 1A), wherein the distal arm (28) includes a first port (47) (Fig. 1A), a first internal lumen (31) fluidly connected to the first port (47), a second port (46) (Fig. 1A), and a second internal lumen (29) fluidly connected to the second port (46);
an outer tube (17) (Fig. 1C) coupled to the first internal lumen (31) (Fig. 1C);
an inner tube (19) (Fig. 1C) coupled to the second internal lumen (29) (Fig. 1C);
a drive wire (23) (Fig. 1C) positioned within the inner tube (19) and movable relative to the inner tube (19); and
wherein the first port (47) is configured to be coupled a suction source to apply suction through the outer tube (17) (p. 7, l. 6- 9; p. 7, l. 17- 18 - - Second fluid channel 31 is formed between outer sheath 17 and inner sheath 19. Second fluid channel 31 allows fluid proximate to the distal end 16 to proximal end 14; Fluid is removed from fluid inlet 35 through second fluid channel 31 to fluid outlet port 47; it is noted that a suction source is not positively claimed by applicant, additionally, fluid outlet port 47 is capable of being attached to a suction source to apply suction), and wherein the second port (46) is configured to be to the fluid source (34) (Fig. 1A) to deliver fluid through the inner tube (19) (p. 7, l. 2- 5; p. 8, l. 12- 13 - - A first fluid channel 29 is formed within inner sheath 19 for allowing isotonic fluid to flow to an aperture at the distal end of the probe 12; A fluid source or reservoir 34 provides a fluid to probe 12 through conduit 46).
Isaacson does not disclose
(claim 16) a trigger positioned on the distal arm, wherein the trigger is operable to selectively open or close an internal connection between the first port and the outer tube;
(claim 17) wherein, in an extended position, the trigger closes the internal connection between the first port and the outer tube, and wherein, in a depressed position, the trigger opens the internal connection between the first port and the outer tube.
However, Rigby teaches an endoscopic electrosurgical apparatus in the same field of endeavor (Abstract)
(claim 16) a trigger (18) (Figs. 1- 6), wherein the trigger (18) is operable to selectively open or close an internal connection between the first port (47) and the outer tube (17) (Col. 5, l. 24- 32 - - Extending past and secured through a proximal end 15 of the probe apparatus 10 by end plug 17 are suction and irrigation hoses, at 12 and 16 respectively, and electrocautery cable 14. Suction hose 12 connects to a source of negative pressure, not shown, the flow of which is operatively controlled by a suction push-button valve 18 such that fluids and debris can be siphoned away from the operative site when needed to clear the field of vision);
(claim 17) wherein, in an extended position, the trigger (18) (Figs. 1- 6) closes the internal connection between the first port (12) (Figs. 1- 6) and the outer tube (24) (Figs. 1- 6, 9), and wherein, in a depressed position, the trigger (18) opens the internal connection between the first port (12) and the outer tube (24).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the medical handle associated with Isaacson to include a trigger positioned on a portion of the distal arm because it would allow a user to control the flow of suction such that fluids and debris can be siphoned away from the operative site when needed to clear the field of vision (Rigby - - Col. 5, l. 24- 32).
Regarding claim 18, Isaacson in view of Rigby discloses the apparatus of claim 16, Isaacson further disclosing wherein the first internal lumen (31) is angled relative to a longitudinal axis of the outer tube (17) (See Fig. 1A - - showing first port (47) perpendicular to the longitudinal axis of the outer tube), and wherein the second internal lumen (29) is angled relative to a longitudinal axis of the inner tube (19) (See Fig. 1A - - showing second port (46) perpendicular to the longitudinal axis of the inner tube (19)). It is noted that Fig. 1A is similar to applicant’s port 24, which is angled relative to a longitudinal axis.
Regarding claim 19, Isaacson in view of Rigby discloses the apparatus of claim 17, Isaacson further disclosing wherein the proximal arm (38) includes a mechanism (48) (Fig. 1A) positioned on a proximal portion of the proximal arm (38) operable to disconnect the drive wire (18, 20) from the proximal arm (38) (The handle portion 38 of probe 10 includes a … Electrode leads 28,30 emerge from cuff 48 on working element 49 on the handle portion 38 of the probe 12. The proximal ends of electrode leads 28,30 are connected to control unit 32. The distal ends of leads 28,30 connect through conductive assembly 23 to electrode elements 18,20, respectively. The electrode elements 18,20 are connected to an extender, such as an Iglesis extender which pushes the electrodes in and out of the probe 12).
Regarding claim 20, Isaacson in view of Rigby discloses the apparatus of claim 19, Isaacson further disclosing wherein the proximal arm (38) includes a slit, wherein the mechanism includes a screw tab with a projection, and wherein the screw tab is configured to pinch a proximal end of the drive wire within the slit in the proximal arm (The handle portion 38 of probe 10 includes a … Electrode leads 28,30 emerge from cuff 48 on working element 49 on the handle portion 38 of the probe 12. The proximal ends of electrode leads 28,30 are connected to control unit 32. The distal ends of leads 28,30 connect through conductive assembly 23 to electrode elements 18,20, respectively. The electrode elements 18,20 are connected to an extender, such as an Iglesis extender which pushes the electrodes in and out of the probe 12; the openings in control unit 32 are interpreted as a slit and the Iglesis extender is interpreted as a tab).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al. (WO 9724074 A1) in view of Rigby et al. (US Pat. No. 5,254,117) as applied to claim 1 above, and in further view of Yoshihashi (US Pat. No. 4,750,475).
Regarding claim 2, Isaacson in view of Rigby discloses the apparatus of claim 1, but Isaacson in view of Rigby does not disclose
(claim 2) a sealed as claimed.
However, Yoshihashi teaches a handle (10) (Fig. 1- 2, 7) for an endoscope with a guide tube (41) (Figs. 1- 8) for inserting an operating instrument (50) (Fig. 2) into a body cavity in the same field of endeavor (Abstract; Col. 3, l. 25- 30), Yoshihashi further teaching
(claims 2) further comprising a seal (44) (Fig. 3) positioned at a proximal end of the distal arm (42) (Fig. 3), wherein the seal (44) surrounds a portion of the drive wire (51) (Fig. 2) (Col. 3, l. 41- 45 - - The guide tube 41 has a base end thereof inserted into the support ring 42 for turning movement relative thereto. An annular seal member 44 is interposed between the guide tube 41 and the support ring 42 to provide a fluid tightness therebetween).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s invention to modify the proximal portion of the distal arm associated with Isaacson in view of Rigby to include a seal as taught by Yoshihashi such that the drive wire associated with Isaacson in view of Rigby is movable through the seal because it would allow the opening through which instruments are inserted to be fluid tight (Yoshihashi - - Col. 3, l. 41- 45).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al. (WO 9724074 A1) in view of Rigby et al. (US Pat. No. 5,254,117) as applied to claim 1 above, and further in view of Freitas et al. (US Pat. 5,486,185).
Regarding claim 7, Isaacson in view of Rigby discloses the apparatus of claim 1, Rigby further discloses wherein the lever is fixedly coupled to the drive wire, and wherein movement of the lever within the slot translates the drive wire, but Isaacson in view of Rigby does not disclose
(claim 7) wherein the lever is fixedly coupled to the outer tube, and wherein movement of the lever within the slot translates the outer tube.
However, Freitas teaches a medical handle for manipulating microsurgical instruments in the same field of endeavor (Col. 3, l. 34- 35)
(claim 7) wherein the lever (30) (Figs. 1, 2) is fixedly coupled to the outer tube (28) (Figs. 1, 2), and wherein movement of the lever (30) within the slot (32) (Figs. 1, 2) translates the outer tube (28) (Col. 2, l. 20- 28; Col. 3, l. 46- 48 - - Axially disposed over the probe is a probe sleeve which slidably engages the probe and the frame. The probe sleeve is of a sufficient length such that it will extend and by its movement actuate the instrument attached to the end of the probe. At its proximal end the probe cover engages a trigger handle. The trigger handle movably engages the frame and interacts with the probe to cause longitudinal displacement of the probe sleeve in relation to the probe; Attached to probe sleeve 28 is actuating arm 30 which extends from the probe frame body 12 through slot 32).
The lever fixedly coupled to the outer tube taught by Freitas performs the same function of providing relative longitudinal displacement between the drive wire and the outer tube (Freitas - - Col. 2, l. 20- 28; Col. 3, l. 46- 48) as the lever coupled to the drive wire disclosed by Rigby (Rigby - - Col. 11, l. 20- 25 - - the electro-surgical tip 26 can be selectively extended by the forward motion of the trigger 36 toward the distal end 25 of the probe apparatus 10 and positioned out past the most distal end of the multi-lumen tube 24 up to the full extension). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (lever fixedly coupled to the outer tube) for another (lever coupled to the drive wire) since the substitution would have yielded predictable results, namely, providing relative longitudinal displacement between the drive wire and the outer tube. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Claim(s) 8- 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al. (WO 9724074 A1) in view of Rigby et al. (US Pat. No. 5,254,117), Freitas et al. (US Pat. 5,486,185) and Jacobs et al. (US Pub. No. 2014/0222014 A1).
Regarding claims 8- 10, Isaacson in view of Rigby and Freitas discloses the apparatus of claim 7, Isaacson further discloses
(claim 8) wherein distal movement of the drive wire (23) is configured to transition an expandable end effector (18, 20), wherein transitioning the proximal arm (39) toward the distal arm (38) causes the drive wire (23) to move distally and extend from a distal end of the inner tube (12) such that the expandable end effector (23) expands and forms a first size or a first shape (See Fig. 1A) (p. 8, l. 30- p. 9, l. 2 - - Probe 12 has a handle portion 38 at its proximal end 14 and an elongate member 40 that extends from the handle portion 38. The distal end 16 of elongate member 40 includes electrode elements 18,20. Electrode elements 18,20 are able to extend from, or to be retracted within, a substantially circular orifice, which preferably is disposed in the distal end of the probe), but Isaacson in view of Rigby and Freitas does not disclose
(claims 8- 10) the expandable end effector expands and forms a second size or a second shape as claimed.
However, Jacobs teaches a medical handle having a proximal arm (110), distal arm (120), a slot (106), drive wire (140), and a lever (215) disposed within the slot (106) (Figs. 1- 2) (Abstract, P. [0037])
(claim 8) wherein proximal movement of the lever (815) causes the drive wire to move further distally, such that the expandable end effector (855) expands and forms a second size or a second shape (Fig. 8);
(claim 9) wherein, the end effector (855) is configured to form the second size and the second shape (See Fig. 8);
(claim 10) wherein the first shape (See Fig. 4) of the expandable end effector (455) is elliptical, and wherein the second shape (Fig. 8) of the expandable end effector (855) is spherical or rounded (See Fig. 8) (Ps. [0045], [0048] - - Advancing the second handle assembly 415 to the position depicted in FIG. 4 deploys the snare loop 455 from the sheath 450 such that the snare loop 455 has an internal diameter or width w of precisely 10 mm, corresponding to the marking on the first handle assembly 405; Advancing the second handle assembly 815 to the position depicted in FIG. 8 deploys the snare loop 855 from the sheath 850 such that the snare loop 855 has an internal diameter or width w of precisely 30 mm, corresponding to the marking on the first handle assembly 805).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the medical handle associated with Isaacson, Rigby and Freitas to include lever position(s) that cause the expandable end effector to form a first size or shape and a second size and shape as taught by Jacobs because it would provide a surgical snare device having a wire loop that can be repeatedly and precisely extended to multiple different internal diameters wherein the device includes a mechanism to indicate the exact diameter to the surgeon (Jacobs - - P. [0007]).
Claim(s) 11- 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Isaacson et al. (WO 9724074 A1) in view of Klinger et al. (US Pat. No. 5,607,391).
Regarding claim 11, Isaacson discloses a medical handle comprising:
a proximal arm (39) (Fig. 1A) and a distal arm (38) (Fig. 1A), wherein the distal arm (38) includes a first port (47) (Fig. 1A), a second port (46) (Fig. 1A), and a distal extension (12) (Fig. 1A), wherein the first port (47) is fluidly connected to an outer tube (17) (Fig. 1C), wherein the second port (46) is fluidly connected to an inner tube (19) (Fig. 1C), and wherein the inner tube (19) is positioned within the outer tube (17);
a drive wire (23) (Fig. 1C) positioned within the inner tube (19).
Isaacson does not disclose
(claim 11) a rotary knob as claimed.
However, Klinger teaches a medical handle for an endoscopic surgical instrument for aspiration and irrigation of a surgical site in the same field of endeavor (Abstract)
(claim 11) a rotary knob (98) (Figs. 10, 12) positioned on the distal extension of the distal arm and operable to rotate the drive wire (91) (Figs. 10, 12) relative to the outer tube (26) (Figs. 10, 12) (Col. 8, l. 54- 56 - - Thumb wheel 98 is rotatably mounted within handle member 92 and is operatively connected to a proximal end portion of endoscopic portion 91 to facilitate rotational movement of the endoscopic portion 91 and jaws 94).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the medical handle associated with Isaacson because it would facilitate rotational movement of an endoscopic tool end effector (Isaacson - - Col. 8, l. 54- 56).
Regarding claim 12, Isaacson in view of Klinger discloses the apparatus of claim 11, Isaacson further discloses wherein a proximal portion (38 - - handle portion) and a distal portion (16) (Fig. 1A) of the distal extension of the distal arm (12), wherein the proximal portion (38 - - handle portion) and the distal portion (16) are connected by a bridge element (Fig. 1A - - bridge element is longitudinal portion between ports 46, 47). As such, Isaacson in view of Klinger encompasses or makes obvious wherein the rotary knob (98) associated with Klinger is positioned between a proximal portion and a distal portion of the distal extension of the distal arm associated with Isaacson, wherein the proximal portion and the distal portion are connected by a bridge element that encloses a portion of the rotary knob (98). It is further noted further that a bridge element that encloses a portion of the rotary knob (98) would predictably provide an ergonomic hand hold grip and predictably guard the rotary knob location.
Regarding claim 13, Isaacson in view of Klinger encompasses and makes obvious further including a shaft element (92) (Figs. 10, 12) positioned radially between the drive wire (91) and the rotary knob (98), wherein the shaft element (92) is fixedly coupled to the drive wire (91) (See Fig. 10).
Regarding claim 14, Isaacson in view of Klinger encompasses and makes obvious wherein the shaft element (92) and the rotary knob (98) each include at least one engaging surface configured to engage with an inner surface of the rotary knob (98) to rotate the drive wire (91) (Figs. 10, 12) (Col. 8, l. 54- 56 - - Thumb wheel 98 is rotatably mounted within handle member 92 and is operatively connected to a proximal end portion of endoscopic portion 91 to facilitate rotational movement of the endoscopic portion 91 and jaws 94).
Regarding claim 15, Isaacson in view of Klinger encompasses and makes obvious wherein the shaft element (92) is freely slidable in a longitudinal direction through the rotary knob (98), and wherein rotation of the rotary knob (98) in a first direction causes the shaft element (92) and the drive wire (91) to also rotate in the first direction (Figs. 10, 12) (Col. 8, l. 54- 56 - - Thumb wheel 98 is rotatably mounted within handle member 92 and is operatively connected to a proximal end portion of endoscopic portion 91 to facilitate rotational movement of the endoscopic portion 91 and jaws 94).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. 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.
/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771