DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-4, 7, 11, and 15 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Godlewski (US Patent No. 5,350,101).
Regarding claim 1, Godlewski discloses an apparatus for manipulating a surgical guidewire used in surgery comprising:
a chuck (36) for selectively coupling motive force to a surgical guidewire (12) (see Figures 1-2 and col. 4, lines 11-13 – “FIGS. 1 and 2 also show a substantially rigid chuck 36 which surrounds collet 28 and which is axially movable relative to advancer 20”); and
an actuator (58), coupled to the chuck, for imparting an axial motive force to the chuck (see Figures 1-2 and col. 5, lines 35-50 – “Once collet 28 has gripped tube 12, any distal movement of actuator 58 (i.e., toward the left in FIGS. 1 and 2) causes tube 12 to be advanced along with actuator 58. Alternatively, actuator 58 could be manipulated to retract tube 12 (i.e., move tube 12 to the right in FIGS. 1 and 2) if desired by the operator of device 10”).
Regarding claim 2, Godlewski discloses the actuator imparts a rotary motive force to the chuck (see col. 4, lines 48-52 – “More specifically, though extension 56 is slidingly received in groove 54 of chuck 36 and thus will not inhibit any rotation of chuck 36, extension 56 can be urged against either side 59 or side 61 of groove 54” and col. 5, lines 31-34 – “Importantly, tube 12 may be rotated by a rotating motor (not shown) as tube 12 extends through tube feeder device 10, even when collet 28 clamps tube 12 as disclosed above”).
Regarding claim 3, Godlewski discloses the chuck comprises a locking mechanism for selectively locking the chuck to a surgical guidewire (see col. 5, lines 15-21 – “As shown in FIG. 2, further proximal motion of actuator 58 will not move advancer 20 but will instead cause chuck 36 to slide along the tapered portions 34 of collet segments 30 to thereby clamp collet 28 around tube 12. More specifically, as chuck 36 slides along collet 28, resilient collet segments 30 are thereby urged against tube 12 to grip tube 12, as shown in FIG. 2” and lines 58-61 – “Once unconstrained by chuck 36, collet segments 30a, b resiliently retract from tube 12 to their normal, biased position shown in FIG. 3 to release the grip of collet 28 on tube 12”).
Regarding claim 4, Godlewski discloses the chuck comprises: a coupler (54, 56) for receiving the motive force from the actuator (see col. 4, lines 46-48 – “FIG. 2 also shows a radial groove 54 which is formed on chuck 36 for the purpose of receiving an extension 56 of an actuator 58”); a hub (36) coupled to the coupler (see Figure 2); a wedge (30) positioned within a window in the coupler and retained in the window by the hub (see Figure 2), the wedge have an angled surface (34a, b) that interacts with the hub to move the wedge between a guidewire locked position and a guidewire unlocked position (see Figure 2 and col. 3, lines 58-67 – “As best seen in FIG. 2, each collet segment 30a, b has a substantially linear portion 32a, b and a tapered portion 34a, b, respectively. Importantly, the angle of taper 31 of the portions 34a, b relative to the longitudinal axis defined by tube 12 is established to be in the range 5° to 15°. As the skilled artisan will appreciate, because collet segments 30 are resilient and are radially spaced from each other, the segments 30 may be compressed inwardly around tube 12 into a position which allows the segments 30 to grip tube 12”).
Regarding claim 7, Godlewski discloses the actuator further comprises a linear actuator coupled to the chuck (see Figures 1-2 and col. 5, lines 35-50 – “Once collet 28 has gripped tube 12, any distal movement of actuator 58 (i.e., toward the left in FIGS. 1 and 2) causes tube 12 to be advanced along with actuator 58. Alternatively, actuator 58 could be manipulated to retract tube 12 (i.e., move tube 12 to the right in FIGS. 1 and 2) if desired by the operator of device 10”).
Regarding claim 11, Godlewski discloses a method of manipulating a surgical guidewire during surgery comprising:
threading a guidewire (12) through a guidewire manipulation device (see Figures 1-2 and col. 5, lines 8-10 – “Tube 12 is first inserted through housing 16, advancer 20, spacer 66, and opening 64 of abutment 62”);
locking the guidewire to the guidewire manipulation device (see col. 5, lines 15-21 – “As shown in FIG. 2, further proximal motion of actuator 58 will not move advancer 20 but will instead cause chuck 36 to slide along the tapered portions 34 of collet segments 30 to thereby clamp collet 28 around tube 12. More specifically, as chuck 36 slides along collet 28, resilient collet segments 30 are thereby urged against tube 12 to grip tube 12, as shown in FIG. 2”); and
activating the guidewire manipulation device to impart axial motive force to the guidewire (see Figures 1-2 and col. 5, lines 35-50 – “Once collet 28 has gripped tube 12, any distal movement of actuator 58 (i.e., toward the left in FIGS. 1 and 2) causes tube 12 to be advanced along with actuator 58. Alternatively, actuator 58 could be manipulated to retract tube 12 (i.e., move tube 12 to the right in FIGS. 1 and 2) if desired by the operator of device 10”).
Regarding claim 15, Godlewski discloses the activating step further comprises activating a linear actuator to impart the axial motive force to the guidewire (see Figures 1-2 and col. 5, lines 35-50 – “Once collet 28 has gripped tube 12, any distal movement of actuator 58 (i.e., toward the left in FIGS. 1 and 2) causes tube 12 to be advanced along with actuator 58. Alternatively, actuator 58 could be manipulated to retract tube 12 (i.e., move tube 12 to the right in FIGS. 1 and 2) if desired by the operator of device 10”).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 5-6, 8-10, and 16-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Godlewski, further in view of Kuban et al. (US Patent No. 8,460,214 B2).
Regarding claim 5, it is noted Godlewski does not specifically teach the hub comprises a dimpled surface for interacting with a protrusion, where the actuator imparts rotary motive force to the hub and the dimpled surface interacting with the protrusion produces axial motive force. However, Kuban et al. teaches the hub (178, 182) comprises a dimpled surface for interacting with a protrusion (176), where the actuator (174) imparts rotary motive force to the hub and the dimpled surface interacting with the protrusion produces axial motive force (see Figures 3-4 and col. 5, lines 54-60 – “Upon operation of the motor 174, the carriage 166 is moved along the longitudinal central axis 134 of the handle 36 by interaction between the screw 176 and the nut 178. The second or proximal motor 174 is a reversible electric motor which is operable to rotate the screw 176 in either a clockwise or counterclockwise direction. The screw 176 is connected with the reversible electric motor 174 by a third gripper 182” and col. 6, lines 1-12 – “Rotation of the motor output shaft 184 is effective to rotate the gripper 182 and drive screw 176 about their longitudinal central axes which are coincident with the longitudinal central axis 134 of the handle 36. Rotation of the drive screw 176 causes longitudinal movement of the carriage 166 and the first or distal motor 132 (FIG. 4) along the central axis 134 of the handle 36. Since the output shaft 138 of the motor 132 is fixedly connected to the core wire 56 by the gripper 116, longitudinal movement of the carriage 166 and motor 132, by operation of the motor 174, is effective to move the proximal end portion 54 (FIG. 5) of the core wire 56 longitudinally relative to the tubular outer member or sheath 58”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Godlewski to include the hub comprises a dimpled surface for interacting with a protrusion, where the actuator imparts rotary motive force to the hub and the dimpled surface interacting with the protrusion produces axial motive force, as disclosed in Kuban et al., so as to move the guidewire longitudinally relative to an outer tubular member or sheath (see Kuban et al.: col. 6, lines 7-12).
Regarding claim 6, it is noted Godlewski does not specifically teach the coupler (178, 182) comprises radially extending flange having a dimpled surface for interacting with a protrusion (176), where the actuator (174) imparts rotary motive force to the coupler and the dimpled surface interacting with the protrusion produces axial motive force (see Figures 3-4 and col. 5, lines 54-60 – “Upon operation of the motor 174, the carriage 166 is moved along the longitudinal central axis 134 of the handle 36 by interaction between the screw 176 and the nut 178. The second or proximal motor 174 is a reversible electric motor which is operable to rotate the screw 176 in either a clockwise or counterclockwise direction. The screw 176 is connected with the reversible electric motor 174 by a third gripper 182” and col. 6, lines 1-12 – “Rotation of the motor output shaft 184 is effective to rotate the gripper 182 and drive screw 176 about their longitudinal central axes which are coincident with the longitudinal central axis 134 of the handle 36. Rotation of the drive screw 176 causes longitudinal movement of the carriage 166 and the first or distal motor 132 (FIG. 4) along the central axis 134 of the handle 36. Since the output shaft 138 of the motor 132 is fixedly connected to the core wire 56 by the gripper 116, longitudinal movement of the carriage 166 and motor 132, by operation of the motor 174, is effective to move the proximal end portion 54 (FIG. 5) of the core wire 56 longitudinally relative to the tubular outer member or sheath 58”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Godlewski to include the coupler comprises radially extending flange having a dimpled surface for interacting with a protrusion, where the actuator imparts rotary motive force to the coupler and the dimpled surface interacting with the protrusion produces axial motive force, as disclosed in Kuban et al., so as to move the guidewire longitudinally relative to an outer tubular member or sheath (see Kuban et al.: col. 6, lines 7-12).
Regarding claim 8, it is noted Godlewski does not specifically teach a controller, coupled to the actuator, for controlling activation of the actuator. However, Kuban et al. teaches a controller (192), coupled to the actuator, for controlling activation of the actuator (see col. 6, line 63-col. 7, line 3 – “A control apparatus 192 (FIG. 1) is provided to control the operation of the motors 132 and 174 (FIGS. 2-4). The control apparatus 192 includes a switch assembly 196 (FIGS. 1 and 7) which may be held by one of the hands, for example, the hand illustrated schematically at 40 in FIG. 1, of an individual utilizing the vascular guidewire system 30. In addition, the control apparatus 192 includes a control unit 200 (FIGS. 1 and 8)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Godlewski to include a controller, coupled to the actuator, for controlling activation of the actuator, as disclosed in Kuban et al., so as to control operation of the actuator(s) (see Kuban et al.: col. 6, lines 63-64).
Regarding claim 9, Kuban et al. teaches the controller is programmed with a plurality of motive force patterns (see col. 10, lines 26-44 – “Although the foregoing has described either the translation motor 174 or the rotation motor 132 as being operated in accordance with a predetermined program and in response to manual actuation of the switch assembly 196 (FIG. 7), it is contemplated that both the translation motor 174 and rotation motor 132 (FIG. 12) may be operated in response to a signal sent by the transmitter 230 to the receiver 260. If this is to be done, both the rotation control switch 272 and translation control switch 268 would be programmed to desired directions and extent of operation of the first or rotation motor 132 and second or translation motor 174. If this was done, the first or rotation motor 132 would be operated to rotate the proximal end portion 54 of the core wire 56 in a direction and to an extent corresponding to the programming of the rotation control switch 272. Similarly, the second or translation motor 174 would rotate the screw 176 to move the first or rotation motor 132 and the proximal end portion 54 of the core wire 56 through a distance and in a direction corresponding to the programming of the translation control switch 268”).
Regarding claim 10, it is noted Godlewski does not specifically teach a housing sized to fit in a palm of a user. However, Kuban et al. teaches a housing (36) sized to fit in a palm of a user (see Figure 1 and col. 2, lines 57-60 – “The vascular guidewire system 30 includes a handle or connector 36 which is gripped by the hands 38 and 40 of a person using the vascular guidewire system”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Godlewski to include a housing sized to fit in a palm of a user, as disclosed in Kuban et al., so as to facilitate manual gripping of the housing and manual longitudinal moving and rotation of the guidewire (see Kuban et al.: col. 6, lines 14-19).
Regarding claim 16, Godlewski discloses an apparatus for manipulating a surgical guidewire used in surgery comprising:
a chuck (36) for selectively coupling motive force to a surgical guidewire, where the chuck comprises (see Figures 1-2 and col. 4, lines 11-13 – “FIGS. 1 and 2 also show a substantially rigid chuck 36 which surrounds collet 28 and which is axially movable relative to advancer 20”);
a coupler (45, 46); a hub (36), coupled to the coupler (see Figure 2);
a wedge (30) positioned within a window in the coupler and retained in the window by the hub (see Figure 2), the wedge have an angled surface (34a, b) that interacts with the hub to move the wedge between a guidewire locked position and a guidewire unlocked position (see Figure 2 and col. 3, lines 58-67 – “As best seen in FIG. 2, each collet segment 30a, b has a substantially linear portion 32a, b and a tapered portion 34a, b, respectively. Importantly, the angle of taper 31 of the portions 34a, b relative to the longitudinal axis defined by tube 12 is established to be in the range 5° to 15°. As the skilled artisan will appreciate, because collet segments 30 are resilient and are radially spaced from each other, the segments 30 may be compressed inwardly around tube 12 into a position which allows the segments 30 to grip tube 12”); and
an actuator, coupled to the chuck (see Figures 1-2 and col. 5, lines 35-50 – “Once collet 28 has gripped tube 12, any distal movement of actuator 58 (i.e., toward the left in FIGS. 1 and 2) causes tube 12 to be advanced along with actuator 58. Alternatively, actuator 58 could be manipulated to retract tube 12 (i.e., move tube 12 to the right in FIGS. 1 and 2) if desired by the operator of device 10”).
It is noted Godlewski does not specifically teach a hub having a dimpled surface for interacting with a protrusion, or the actuator imparting rotary motive force to the coupler, where the actuator imparts rotary motive force to the coupler and the dimpled surface of the hub interacting with the protrusion produces axial motive force upon the chuck. However, Kuban et al. teaches a hub (178, 182) having a dimpled surface for interacting with a protrusion (176), and the actuator (174) imparting rotary motive force to the coupler, where the actuator imparts rotary motive force to the coupler and the dimpled surface of the hub interacting with the protrusion produces axial motive force upon the chuck (see Figures 3-4 and col. 5, lines 54-60 – “Upon operation of the motor 174, the carriage 166 is moved along the longitudinal central axis 134 of the handle 36 by interaction between the screw 176 and the nut 178. The second or proximal motor 174 is a reversible electric motor which is operable to rotate the screw 176 in either a clockwise or counterclockwise direction. The screw 176 is connected with the reversible electric motor 174 by a third gripper 182” and col. 6, lines 1-12 – “Rotation of the motor output shaft 184 is effective to rotate the gripper 182 and drive screw 176 about their longitudinal central axes which are coincident with the longitudinal central axis 134 of the handle 36. Rotation of the drive screw 176 causes longitudinal movement of the carriage 166 and the first or distal motor 132 (FIG. 4) along the central axis 134 of the handle 36. Since the output shaft 138 of the motor 132 is fixedly connected to the core wire 56 by the gripper 116, longitudinal movement of the carriage 166 and motor 132, by operation of the motor 174, is effective to move the proximal end portion 54 (FIG. 5) of the core wire 56 longitudinally relative to the tubular outer member or sheath 58”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Godlewski to include a hub having a dimpled surface for interacting with a protrusion, and the actuator imparting rotary motive force to the coupler, where the actuator imparts rotary motive force to the coupler and the dimpled surface of the hub interacting with the protrusion produces axial motive force upon the chuck, as disclosed in Kuban et al., so as to move the guidewire longitudinally relative to an outer tubular member or sheath (see Kuban et al.: col. 6, lines 7-12).
Regarding claim 17, it is noted Godlewski does not specifically teach a controller, coupled to the actuator, for controlling activation of the actuator. However, Kuban et al. teaches a controller (192), coupled to the actuator, for controlling activation of the actuator (see col. 6, line 63-col. 7, line 3 – “A control apparatus 192 (FIG. 1) is provided to control the operation of the motors 132 and 174 (FIGS. 2-4). The control apparatus 192 includes a switch assembly 196 (FIGS. 1 and 7) which may be held by one of the hands, for example, the hand illustrated schematically at 40 in FIG. 1, of an individual utilizing the vascular guidewire system 30. In addition, the control apparatus 192 includes a control unit 200 (FIGS. 1 and 8)”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Godlewski to include a controller, coupled to the actuator, for controlling activation of the actuator, as disclosed in Kuban et al., so as to control operation of the actuator(s) (see Kuban et al.: col. 6, lines 63-64).
Regarding claim 18, Kuban et al. teaches the controller is programmed with a plurality of motive force patterns (see col. 10, lines 26-44 – “Although the foregoing has described either the translation motor 174 or the rotation motor 132 as being operated in accordance with a predetermined program and in response to manual actuation of the switch assembly 196 (FIG. 7), it is contemplated that both the translation motor 174 and rotation motor 132 (FIG. 12) may be operated in response to a signal sent by the transmitter 230 to the receiver 260. If this is to be done, both the rotation control switch 272 and translation control switch 268 would be programmed to desired directions and extent of operation of the first or rotation motor 132 and second or translation motor 174. If this was done, the first or rotation motor 132 would be operated to rotate the proximal end portion 54 of the core wire 56 in a direction and to an extent corresponding to the programming of the rotation control switch 272. Similarly, the second or translation motor 174 would rotate the screw 176 to move the first or rotation motor 132 and the proximal end portion 54 of the core wire 56 through a distance and in a direction corresponding to the programming of the translation control switch 268”).
Regarding claim 19, it is noted Godlewski does not specifically teach a housing, supporting the chuck and the actuator, sized to fit in a palm of a user. However, Kuban et al. teaches a housing (36), supporting the chuck and the actuator, sized to fit in a palm of a user (see Figure 1 and col. 2, lines 57-60 – “The vascular guidewire system 30 includes a handle or connector 36 which is gripped by the hands 38 and 40 of a person using the vascular guidewire system”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Godlewski to include a housing, supporting the chuck and the actuator, sized to fit in a palm of a user, as disclosed in Kuban et al., so as to facilitate manual gripping of the housing and manual longitudinal moving and rotation of the guidewire (see Kuban et al.: col. 6, lines 14-19).
Claims 12-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Godlewski, further in view of Stalker et al. (US Patent No. 5,908,395).
Regarding claim 12, it is noted Godlewski does not specifically teach the threading step further comprises threading the guidewire through a longitudinally oriented passage through the guidewire manipulation device, where the passage is defined by an axle coupled to a rotary actuator. However, Stalker et al. teaches the threading step further comprises threading the guidewire through a longitudinally oriented passage (57) through the guidewire manipulation device, where the passage is defined by an axle (54, 58) coupled to a rotary actuator (51) (see Figures 9-10 and col. 6, lines 2-6 – “The cam 53 imparts reciprocating motion to a reciprocating member 54, the guidewire tube 12, a collet 56, and a guidewire 13 positioned within the guidewire tube 12 and collet 56. The reciprocating member 54 generally has a bore 57 to connect with the guidewire tube 12”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Godlewski to include the threading step further comprises threading the guidewire through a longitudinally oriented passage through the guidewire manipulation device, where the passage is defined by an axle coupled to a rotary actuator, as disclosed in Stalker et al., so as to allow the guidewire to reciprocate with the axle while remaining free to rotate around the guidewire longitudinal axis (see Stalker et al.: col. 6, lines 20-22).
Regarding claim 13, the combination of Godlewski and Stalker et al. teaches the locking step further comprises selectively locking a chuck to the guidewire (see Godlewski: col. 5, lines 15-21 – “As shown in FIG. 2, further proximal motion of actuator 58 will not move advancer 20 but will instead cause chuck 36 to slide along the tapered portions 34 of collet segments 30 to thereby clamp collet 28 around tube 12. More specifically, as chuck 36 slides along collet 28, resilient collet segments 30 are thereby urged against tube 12 to grip tube 12, as shown in FIG. 2”), where the chuck is coupled to the axle (see Stalker et al.: Figures 10-13 and col. 6, lines 38-43 – “FIG. 10 shows the rotating lock ring 70 in a locked position in which the guidewire tube 12 will contact the arms 72 if rotation is attempted but remains free to reciprocate longitudinally through the opening 77. FIG. 13 shows the rotating lock ring 70 in the unlocked position in which the arms 72 are not in contact with the boss 78”).
Claims 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Godlewski and Stalker et al., further in view of Kuban et al.
Regarding claim 14, Stalker et al. teaches activating the rotary actuator to rotate the axle and the chuck (see col. 5, line 64-col. 6, line 6 – “The internal components of the vibration device 10 shown in FIG. 1 are best illustrated in FIGS. 9 and 10. Referring now to FIG. 9, the housing 11 has an interior chamber 50 containing a motor 51 with a rotary output shaft 52. The motor output shaft 52 turns a cam 53 which travels in an orbital motion. The cam 53 imparts reciprocating motion to a reciprocating member 54, the guidewire tube 12, a collet 56, and a guidewire 13 positioned within the guidewire tube 12 and collet 56. The reciprocating member 54 generally has a bore 57 to connect with the guidewire tube 12”). It is noted neither Godlewski nor Stalker et al. specifically teach the chuck interacts with a protrusion to impart the axial motive force to the guidewire. However, Kuban et al. teaches the chuck (178, 182) interacts with a protrusion (176) to impart the axial motive force to the guidewire (see Figures 3-4 and col. 5, lines 54-60 – “Upon operation of the motor 174, the carriage 166 is moved along the longitudinal central axis 134 of the handle 36 by interaction between the screw 176 and the nut 178. The second or proximal motor 174 is a reversible electric motor which is operable to rotate the screw 176 in either a clockwise or counterclockwise direction. The screw 176 is connected with the reversible electric motor 174 by a third gripper 182” and col. 6, lines 1-12 – “Rotation of the motor output shaft 184 is effective to rotate the gripper 182 and drive screw 176 about their longitudinal central axes which are coincident with the longitudinal central axis 134 of the handle 36. Rotation of the drive screw 176 causes longitudinal movement of the carriage 166 and the first or distal motor 132 (FIG. 4) along the central axis 134 of the handle 36. Since the output shaft 138 of the motor 132 is fixedly connected to the core wire 56 by the gripper 116, longitudinal movement of the carriage 166 and motor 132, by operation of the motor 174, is effective to move the proximal end portion 54 (FIG. 5) of the core wire 56 longitudinally relative to the tubular outer member or sheath 58”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Godlewski and Stalker et al. to include the chuck interacts with a protrusion to impart the axial motive force to the guidewire, as disclosed in Kuban et al., so as to move the guidewire longitudinally relative to an outer tubular member or sheath (see Kuban et al.: col. 6, lines 7-12).
Claims 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Godlewski and Kuban et al., further in view of Rollins et al. (US Publication No. 2008/0097465 A1).
Regarding claim 20, it is noted neither Godlewski nor Kuban et al. specifically teach the actuator comprises a plurality of gears to selectively impart rotary motive force in a counterclockwise direction and a clockwise direction. However, Rollins et al. teaches the actuator comprises a plurality of gears (155, 156A, 156B, 158Ato selectively impart rotary motive force in a counterclockwise direction and a clockwise direction (see Figures 11-15 and [0011] – “Such patterns include, but are limited to a full clockwise rotation, a full counterclockwise rotation, continuous clockwise or counterclockwise rotations or any combination of the above” and [0054] – “As seen in FIGS. 11-15, the motor 152 includes a worm gear 155 that engages a first gear section 156B of shaft 156. A second gear section 156A of shaft 156 engages gearing 158A on the outer surface of tube 148. In this respect, when the motor 152 is activated, it ultimately rotates the roller assembly, or tube 148”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Godlewski and Kuban et al. to include the actuator comprises a plurality of gears to selectively impart rotary motive force in a counterclockwise direction and a clockwise direction, as disclosed in Rollins et al., so as to allow the user to choose between various rotation patterns dependent on need including full clockwise rotation, a full counterclockwise rotation, continuous clockwise or counterclockwise rotations or any combination of the above (see Rollins et al.: [0011]).
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.
Claims 1-10 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8,926,529 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are fully anticipated by the reference claims.
In particular, present claims 1-2, 4, and 10 are fully anticipated by reference claim 1.
Present claim 3 is fully anticipated by reference claim 2.
Present claim 5 is fully anticipated by reference claim 3.
Present claim 6 is fully anticipated by reference claim 4.
Present claim 7 is fully anticipated by reference claim 5.
Present claim 8 is fully anticipated by reference claim 6.
Present claim 9 is fully anticipated by reference claim 7.
Present claim 16 is fully anticipated by reference claim 8.
Present claim 17 is fully anticipated by reference claim 9.
Present claim 18 is fully anticipated by reference claim 10.
Present claim 19 is fully anticipated by reference claim 11.
Present claim 20 is fully anticipated by reference claim 12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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, Robert (Tse) Chen can be reached at (571) 272-3672. 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.
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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