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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/03/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 13 and 28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, none of either Cushen, Boebel or Shelton are relied upon to disclose the amended limitations of “a biasing member coupled to the wheel”, “wherein said biasing member is configured to bias the wheel to the first axial position” or “wherein said biasing member is disposed between said first gear and said second gear”.
Nelson (US 2010/0063437 A1)(previously of record) is now relied upon to disclose the amended limitations as Nelson teaches wherein a spring (spring 44, see Fig. 7C) may be placed adjacent a slidable and rotatable member (gear 42, see Fig. 7C and Para. [0110]), configured to slide into operable engagement with an interfacing unit (gear 43, see Fig. 7C) which is configured to rotate to adjust the orientation of an end effector (see Para. [0112]-[0113]), to help the rotatable member maintain engagement with a corresponding interfacing unit (see Para. [0110]) when at rest.
The Examiner contends that 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 slidable wheel of Cushen, as modified by Boebel, to comprise a compression spring placed adjacent thereto and along the slidable track of said slidable wheel as taught and suggested by Nelson to, in this case, help maintain the wheel in operable engagement with the hub (24) responsible for altering the orientation of the distal end effector as the default resting position (see Nelson Para. [0112]-[0113]) such that the wheel is always engaged even when not actively manipulated by a user. The wheel may be biased towards the opposing hub, compressing the spring of Nelson, to adjust the orientation of the bend before being re-biased back towards the end effector hub by the spring, defined as the “rest” position.
In the submitted arguments, Applicant contends that one of ordinary skill in the art would not have relied upon Nelson (previously relied upon to disclose the limitations of now-canceled claim 29) to disclose the limitations of “a biasing member coupled to said wheel and configured to bias said actuator assembly to be in said first mode” (previously cited in now-canceled claim 29) on the grounds that the spring (44) of Nelson is never configured to be decoupled from gear (43) and thus would not be suitable to incorporate into the device of Cushen, as modified by Boebel since the gear of Nelson is not configured to return a device to a mode in which components are decoupled and recoupled to one-another.
The Examiner respectfully disagrees. Broadly, Nelson teaches wherein a compression spring may be incorporated into a slidable actuation mechanism to compress against and bias a slidable actuation member (i.e., gear 42) (see Nelson Para. [0110] and [0112]-[0113]) to help maintain engagement between a pair of gear members. While the configuration of Nelson may differ from that of the combined device of Cushen and Boebel, the function of the compression spring is understood to be applicable in the slidable actuation mechanism of Boebel, as incorporated into the device of Cushen. Since the wheel of Cushen has been modified to be axially slidable between two axially-opposing hub portions (i.e., hubs 22 and 24 of Boebel) to selectively engage either a bend orienting gear or an end effector orienting gear, the compression spring of Nelson is understood to be beneficial in maintaining engagement between the gears in an “at rest” position such that the wheel does not axially move during use without user input. This ensures that axially slidable wheel of Cushen is maintained at a set position until acted upon by a user to slide said wheel to the opposing axial position. The Examiner therefore contends that, while the gear configurations of Nelson and Boebel are different, the function of the gear element is applicable within the system of Boebel, as incorporated into the device of Cushen.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-16 and 18-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation "wherein said biasing member is disposed between said first gear and said second gear". There is insufficient antecedent basis for this limitation in the claim as no “biasing member” has been previously established or introduced within the limitations of claim 13. For the purposes of examination, the cited limitation is interpreted to read “wherein a biasing member is disposed between said first gear and said second gear”
Claims 14-16 and 18-20 are rendered indefinite due to their dependency from and further modification of claim 13.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 5-8, 10-11, 13-16, 18-19, 28 and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cushen (WO 2017163226 A1)(previously of record) in view of Boebel (US 2011/0106143 A1)(previously of record), further in view of Nelson (US 2010/0063437 A1)(previously of record).
Regarding claim 1, Cushen discloses:
A surgical cutting assembly (see Fig. 1) comprising:
a housing (housing 15, see Fig. 1);
a tube assembly coupled to said housing (tube assembly 20, see Fig. 1) and comprising an outer tube extending from said housing (covering tube 30, see Fig. 1);
an intermediate tube (outer tube 26, see Fig. 1) coaxially and rotatably disposed within said outer tube (see Para. [0079]); and
an inner tube (inner tube 28, see Fig. 9) coaxially and rotatably disposed within said intermediate tube (see Para. [0083]);
wherein said tube assembly further comprises a bend (see Fig. 1 and Para. [0048]), and a cutting window positioned distal to said bend (cutting window 22, see Fig. 3); and
an actuator assembly (manually movable member 56 and drive assembly 12, see Fig. 2 and Para. [0005], [0047] and [0063]) coupled to said housing and said tube assembly (see Fig. 2), said actuator assembly comprising a wheel (wheel 58, see Fig. 2 and Para. [0064]).
However, while Cushen discloses wherein the intermediate tube may be rotated to orient the distal cutting window (see Para. [0005]and [0084]), and wherein the covering tube may be rotated to reorient the bent portion thereon (see Para. [0079] and [0082]) Cushen does not expressly disclose:
a biasing member coupled to the wheel;
wherein said actuator assembly is operable in a first mode in which said wheel is rotatable in a first axial position to rotate said intermediate tube for orienting said cutting window, and a second mode in which said wheel is rotatable in a second axial position to rotate said outer tube for orienting said bend; and
wherein said biasing member is configured to bias the wheel to the first axial position.
In the same field of endeavor, namely surgical devices comprising a proximal handle for controlling a series of rotatable sheath members extending therefrom, Boebel teaches wherein a surgical assembly (see Fig. 1) comprising a handle (handle 4, see Fig. 1), an outer tube (shank 2, see Fig. 1) rotatably coupled to the handle (see Para. [0052]) and comprising a bend (see Fig. 1 and Para. [0052]), and an intermediate tube (tube 8, see Para. [0052]) rotatably coupled to the handle and disposed within the outer tube (see Para. [0052]) and comprising an end effector at the distal end thereof (tool 6, see Para. [0052]), and an actuator assembly (actuation device 12, see Fig. 1) comprising a wheel (star wheel 14, see Fig. 1 and Para. [0053]) that is operable in a first mode in which said wheel is slidable in a first axial position to engage with a hub (24) coupled to the intermediate tube in a first mode to rotate said intermediate tube for orienting the distal end effector thereon (see Para. [0005]-[0007] and [0055]-[0063]), and a second mode in which said wheel is slidable in a second axial position to engage with a hub (22) coupled to the outer tube in a second mode to rotate said outer tube for orienting the distal bend thereon (see Para. [0005]-[0007] and [0055]-[0063]) to provide an actuation system that can manipulate both an intermediate and outer tubular member with one hand, providing a more ergonomic handling, even with different hand sizes of a user (see Para. [0003]-[0007]).
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 actuation mechanism of Cushen to allow the actuation of the intermediate tube and outer tube thereof to be selectively actuatable with a single rotatable wheel (i.e., wheel 58) that may be slid in different axial positions, engaging different interfaceable hub elements, to enable engagement of either one of the intermediate tube or outer tube as taught and suggested by Boebel to, in this case, provide an actuation system that can manipulate both an intermediate and outer tubular member with one hand, providing a more ergonomic handling, even with different hand sizes of a user (see Boebel Para. [0003]-[0007]). The “first axial position” in the resulting combination would be the axial position in which the wheel of Cushen in engaged with a hub (24) in which rotational movement thereof would cause rotation of the cutting window. The “second axial position” is therefore defined as the axial position in which the wheel of Cushen is engaged with the opposing hub (22) in which rotation movement thereof would cause rotation of the bend.
However, while the combination discloses wherein the wheel of Cushen may be biased in two different axial directions to selectively engage different actuation hubs, the combination does not expressly disclose:
a biasing member coupled to the wheel; and
wherein said biasing member is configured to bias the wheel to the first axial position.
In the same field of endeavor, namely surgical devices comprising a control handle, distal end effector and rotatable control knob for manipulation of said distal end effector, Nelson teaches wherein a spring (spring 44, see Fig. 7C) may be placed adjacent a slidable and rotatable member (gear 42, see Fig. 7C and Para. [0110]), configured to slide into operable engagement with an interfacing unit (gear 43, see Fig. 7C) which is configured to rotate to adjust the orientation of an end effector (see Para. [0112]-[0113]), to help the rotatable member maintain engagement with a corresponding interfacing unit (see Para. [0110]) when at rest.
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 slidable wheel of Cushen, as modified by Boebel, to comprise a compression spring placed adjacent thereto and along the slidable track of said slidable wheel as taught and suggested by Nelson to, in this case, help maintain the wheel in operable engagement with the hub (24) responsible for altering the orientation of the distal end effector as the default resting position (see Nelson Para. [0112]-[0113]) such that the wheel is always engaged even when not actively manipulated by a user. The wheel may be biased towards the opposing hub, compressing the spring of Nelson, to adjust the orientation of the bend before being re-biased back towards the end effector hub by the spring, defined as the “rest” position.
Regarding claim 5, the combination of Cushen, Boebel and Nelson disclose the invention of claim 1, Cushen, as modified by Boebel, further discloses wherein said actuator assembly further comprises a first gear (sections 16a/16b having teeth thereon, see Boebel Fig. 9, incorporated into the wheel of Cushen to provide the engagement teeth for operable engagement with the respective opposing actuation hubs) configured to engage said housing in said first mode (see Boebel Para. [0063] mentioning wherein the wheel may be slid in said first axial direction (i.e., proximally) to engage the teeth of section 16b with the interlocking teeth of the hub 24; in this instance, hub 24 is understood to be located against the more proximal “housing” component to be engaged when the wheel is slid proximally), and be disengaged from said housing in said second mode (see Boebel Para. [0054] and [0061] mentioning wherein the wheel may be slid in said second axial direction (i.e., distally) to disengage teeth 16b from the teeth of hub 24 and engage teeth 16a with the interlocking teeth of adjacent hub 22; in this instance, hub 22 is understood to be located against the distal nose portion of the handle assembly and thus not part of the more proximal “housing” component).
Regarding claim 6, the combination of Cushen, Boebel and Nelson disclose the invention of claim 5, Cushen, as modified by Boebel further disclose a second gear (hub 22, see Boebel Fig. 11) secured to said outer tube (see Boebel Para. [0054] and [0061]; as the cover tube enters the nosecone of Cushen (see Cushen Para. [0079]), the hub 22 is secured thereto through the nosecone to allow manipulation thereof) and configured to disengage from said wheel in said first mode (see Boebel Para. [0054] and [0061] mentioning wherein the teeth 16a are engaged with the hub 22 in the “second mode” and thus would be disengaged in the “first mode”), and be engaged with said wheel in said second mode (see Boebel Para. [0054] and [0061]).
Regarding claim 7, the combination of Cushen, Boebel and Nelson disclose the invention of claim 7, Cushen, as modified by Boebel, further discloses wherein said actuator assembly further comprises a third gear (hub 24, see Boebel Fig. 16) secured to said intermediate tube (see Boebel Para. [0063] mentioning wherein the hub 24 is engaged with teeth 16b to manipulate the intermediate tube), wherein said third gear is configured to engage said wheel in said first mode (see Boebel Para. [0063]), and be disengaged from said wheel in said second mode (see Boebel Para. [0054] and [0061] mentioning wherein in the “second mode” the wheel is engaged with hub 22 and therefore disengaged with hub 24).
Regarding claim 8, the combination of Cushen, Boebel and Nelson disclose the invention of claim 6, Cushen, as modified by Boebel, further discloses wherein said first gear and said second gear comprises complementary keying features configured to prevent relative rotation and permit relative translation between said first gear and said second gear (hub 22 and teeth 16a comprise interlocking teeth (see Boebel Para. [0061]) which, when engaged, prevent relative rotation with one-another while allowing the two components to be separated when the wheel is disengaged therefrom during transition between the “first mode” and “second mode”).
Regarding claim 10, the combination of Cushen, Boebel and Nelson disclose all of the limitations of the invention 6, Cushen, as modified by Boebel and Nelson, further disclose wherein said biasing member is disposed between said first gear and said second gear (when incorporated into the device of Cushen, the spring of Nelson is configured to bias the wheel towards the end effector orientation hub (24) (i.e., the third gear), which is the proximal-most hub element (see Boebel Fig. 6), and would thus need to be disposed on the opposing side, between the hub (22) (i.e., the second gear) and the toothed portions (16a/16b)(i.e., the first gear) to properly bias the wheel in the direction of the hub (24)). See Examiner’s Diagram of Cushen Fig. 5 and Boebel Fig. 6 below illustrating the relative locations of the components, when combined together.
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Examiner’s Diagram of Cushen Fig. 5
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Examiner’s Diagram of Boebel Fig. 6
Regarding claim 11, the combination of Cushen, Boebel and Nelson disclose the invention of claim 5, Cushen, as modified by Boebel, further discloses wherein said housing comprises a nose portion (connecting hub 86, see Cushen Fig. 1), and a collar spaced apart from said nose portion (ledge 50, see Cushen Fig. 3) to define a void sized to receive said wheel (see Cushen Fig. 3), wherein said nose portion comprises an engagement feature configured to be engaged by said first gear with said actuator assembly in said first mode (the hub 24 of Boebel is secured to the radially-inward face of the connecting hub, as incorporated from the device of Boebel, to allow engagement of the wheel in said “second mode”).
Regarding claim 13, Cushen discloses:
A surgical cutting assembly (see Fig. 1) comprising:
a housing (housing 15, see Fig. 1);
a tube assembly coupled to said housing (tube assembly 20, see Fig. 1)and comprising an outer tube extending from said housing (covering tube 30, see Fig. 1);
an intermediate tube (outer tube 26, see Fig. 1) coaxially and rotatably disposed within said outer tube see Para. [0079]); and
an inner tube (inner tube 28, see Fig. 9) coaxially and rotatably disposed within said intermediate tube (see Para. [0083]);
wherein said tube assembly further comprises a bend (see Fig. 1 and Para. [0048]), and a cutting window positioned distal to said bend (cutting window 22, see Fig. 3); and
an actuator assembly (manually movable member 56 and drive assembly 12, see Fig. 2 and Para. [0005], [0047] and [0063]) comprising a wheel (wheel 58, see Fig. 2 and Para. [0064]);
However, Cushen does not expressly disclose:
wherein the actuator assembly further comprises a first gear, a second gear secured to said outer tube, and a third gear secured to said intermediate tube; and
wherein a biasing member is disposed between said first gear and said second gear.
In the same field of endeavor, namely surgical devices comprising a proximal handle for controlling a series of rotatable sheath members extending therefrom, Boebel teaches wherein a surgical assembly (see Fig. 1) comprising a handle (handle 4, see Fig. 1), an outer tube (shank 2, see Fig. 1) rotatably coupled to the handle (see Para. [0052]) and comprising a bend (see Fig. 1 and Para. [0052]), and an intermediate tube (tube 8, see Para. [0052]) rotatably coupled to the handle and disposed within the outer tube (see Para. [0052]) and comprising an end effector at the distal end thereof (tool 6, see Para. [0052]), and an actuator assembly (actuation device 12, see Fig. 1) comprising a wheel (star wheel 14, see Fig. 1 and Para. [0053]), a first gear (sections 16a/16b having teeth thereon, see Boebel Fig. 9), a second gear (hub 22, see Boebel Fig. 11) secured to the outer tube (see Boebel Para. [0054] and [0061]; as the cover tube enters the nosecone of Cushen (see Cushen Para. [0079]), the hub 22 is secured thereto through the nosecone to allow manipulation thereof) and a third gear (hub 24, see Boebel Fig. 16) secured to said intermediate tube (see Boebel Para. [0063] mentioning wherein the hub 24 is engaged with teeth 16b to manipulate the intermediate tube), wherein the actuator assembly is operable in a first mode in which said wheel is slidable in a first axial position to engage with a hub (24) coupled to the intermediate tube in a first mode to rotate said intermediate tube for orienting the distal end effector thereon (see Para. [0005]-[0007] and [0055]-[0063]), and a second mode in which said wheel is slidable in a second axial position to engage with a hub (22) coupled to the outer tube in a second mode to rotate said outer tube for orienting the distal bend thereon (see Para. [0005]-[0007] and [0055]-[0063]) to provide an actuation system that can manipulate both an intermediate and outer tubular member with one hand, providing a more ergonomic handling, even with different hand sizes of a user (see Para. [0003]-[0007]).
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 actuation mechanism of Cushen to include the first, second and third gear of Boebel therein to allow the actuation of the intermediate tube and outer tube thereof to be selectively actuatable with a single rotatable wheel (i.e., wheel 58) that may be slid in different axial positions, engaging different interfaceable hub elements, to enable engagement of either one of the intermediate tube or outer tube as taught and suggested by Boebel to, in this case, provide an actuation system that can manipulate both an intermediate and outer tubular member with one hand, providing a more ergonomic handling, even with different hand sizes of a user (see Boebel Para. [0003]-[0007]).
In the same field of endeavor, namely surgical devices comprising a control handle, distal end effector and rotatable control knob for manipulation of said distal end effector, Nelson teaches wherein a spring (spring 44, see Fig. 7C) may be placed adjacent a slidable and rotatable member (gear 42, see Fig. 7C and Para. [0110]), configured to slide into operable engagement with an interfacing unit (gear 43, see Fig. 7C) which is configured to rotate to adjust the orientation of an end effector (see Para. [0112]-[0113]), to help the rotatable member maintain engagement with a corresponding interfacing unit (see Para. [0110]) when at rest.
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 slidable wheel of Cushen, as modified by Boebel, to comprise a compression spring placed adjacent thereto and along the slidable track of said slidable wheel as taught and suggested by Nelson to, in this case, help maintain the wheel in operable engagement with the hub (24) responsible for altering the orientation of the distal end effector as the default resting position (see Nelson Para. [0112]-[0113]) such that the wheel is always engaged even when not actively manipulated by a user. The wheel may be biased towards the opposing hub, compressing the spring of Nelson, to adjust the orientation of the bend before being re-biased back towards the end effector hub by the spring, defined as the “rest” position.
Regarding claim 14, the combination of Cushen, Boebel and Nelson disclose the invention of claim 13, Cushen, as modified by Boebel, further discloses wherein at least one of (i) said first gear is configured to be selectively engaged with said housing, (ii) said second gear is configured to be selectively engaged with said wheel (see Boebel Para. [0054] and [0061] mentioning wherein the teeth 16a of the inner wheel are engaged with the hub 22 in the “second mode” and thus would be disengaged in the “first mode”), and be engaged with said wheel in said second mode (see Boebel Para. [0054] and [0061]), and (iii) said third gear is configured to be selectively engaged with said wheel.
Regarding claim 15, the combination of Cushen, Boebel and Nelson disclose the invention of claim 13, Cushen, as modified by Boebel, further discloses wherein said first gear and said second gear comprises complementary keying features configured to prevent relative rotation and permit relative translation between said first gear and said second gear (hub 22 and teeth 16a comprise interlocking teeth (see Boebel Para. [0061]) which, when engaged, prevent relative rotation with one-another while allowing the two components to be separated when the wheel is disengaged therefrom during transition between the “first mode” and “second mode”).
Regarding claim 16, the combination of Cushen, Boebel and Nelson disclose the invention of claim 13, Cushen, as modified by Boebel, further disclose wherein said actuator assembly further comprises a bearing (face of ring section 32, see Cushen Fig. 16 upon which the wheel and bearing 24 rotate with one-another) disposed between said second gear and said third gear (face of ring section 32 is disposed between the interlocking teeth of bearing 24 and the interlocking teeth of the bearing 22 given their position at opposite ends of the wheel).
Regarding claim 18, the combination of Cushen, Boebel and Nelson disclose the invention of claim 13, Cushen, as modified by Boebel, further disclose wherein said housing comprises an engagement feature configured to be selectively engaged by said first gear (the hub 24 of is secured to the radially-inward face of the housing, as incorporated from the device of Boebel, to allow engagement of the wheel in said “second mode”).
Regarding claim 19, the combination of Cushen, Boebel and Nelson disclose the invention of claim 13, Cushen, as modified by Boebel, further disclose wherein said first gear, said second gear, and said third gear are disposed within said wheel (teeth 16a/16b of Boebel are incorporated directly onto the wheel as shown in Boebel Fig. 9; given that the wheel of Cushen covers the entirety of space between ledge 50 and connecting hub 86 (see Cushen Figs. 1-3), one of ordinary skill in the art would have disposed the hubs 22/24 of Boebel into recessed portions of the wheel of Cushen to be engaged with teeth therein, see Cushen Fig. 28B showing this recessed portion to accommodate the hubs within the confined space housing the wheel).
Regarding claim 28, Cushen discloses:
A surgical cutting assembly (see Fig. 1) comprising:
a housing (housing 15, see Fig. 1);
a tube assembly coupled to said housing (tube assembly 20, see Fig. 1) and comprising an outer tube extending from said housing (covering tube 30, see Fig. 1);
an intermediate tube (outer tube 26, see Fig. 1) coaxially and rotatably disposed within said outer tube (see Para. [0079]); and
an inner tube (inner tube 28, see Fig. 9) coaxially and rotatably disposed within said intermediate tube (see Para. [0083]);
wherein said tube assembly further comprises a bend (see Fig. 1 and Para. [0048]), and a cutting window positioned distal to said bend (cutting window 22, see Fig. 3); and
an actuator assembly (manually movable member 56 and drive assembly 12, see Fig. 2 and Para. [0005], [0047] and [0063]) coupled to said housing and said tube assembly, said actuator assembly comprising a wheel (wheel 58, see Fig. 2 and Para. [0064]).
However, while Cushen discloses wherein the intermediate tube may be rotated to orient the distal cutting window (see Para. [0005]and [0084]), and wherein the covering tube may be rotated to reorient the bent portion thereon (see Para. [0079] and [0082]) Cushen does not expressly disclose:
a biasing member coupled to said wheel;
wherein actuator assembly is operable in a first mode in which said actuator assembly is operably coupled to said intermediate tube and operably decoupled from said outer tube, and a second mode in which said actuator assembly is operably coupled to said outer tube and operably decoupled from said intermediate tube; and
wherein said biasing member is configured to bias said actuator assembly in said first mode.
In the same field of endeavor, namely surgical devices comprising a proximal handle for controlling a series of rotatable sheath members extending therefrom, Boebel teaches wherein a surgical assembly (see Fig. 1) comprising a handle (handle 4, see Fig. 1), an outer tube (shank 2, see Fig. 1) rotatably coupled to the handle (see Para. [0052]) and comprising a bend (see Fig. 1 and Para. [0052]), and an intermediate tube (tube 8, see Para. [0052]) rotatably coupled to the handle and disposed within the outer tube (see Para. [0052]) and comprising an end effector at the distal end thereof (tool 6, see Para. [0052]), and an actuator assembly (actuation device 12, see Fig. 1) comprising a wheel (star wheel 14, see Fig. 1 and Para. [0053]) that is operable in a first mode in which said wheel is slidable in a first axial position to engage with a hub (24) coupled to the intermediate tube in a first mode to rotate said intermediate tube for orienting the distal end effector thereon (see Para. [0005]-[0007] and [0055]-[0063]), and a second mode in which said wheel is slidable in a second axial position to engage with a hub (22) coupled to the outer tube in a second mode to rotate said outer tube for orienting the distal bend thereon (see Para. [0005]-[0007] and [0055]-[0063]) to provide an actuation system that can manipulate both an intermediate and outer tubular member with one hand, providing a more ergonomic handling, even with different hand sizes of a user (see Para. [0003]-[0007]).
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 actuation mechanism of Cushen to allow the actuation of the intermediate tube and outer tube thereof to be selectively actuatable with a single rotatable wheel (i.e., wheel 58) that may be slid in different axial positions, engaging different interfaceable hub elements, to enable engagement of either one of the intermediate tube or outer tube as taught and suggested by Boebel to, in this case, provide an actuation system that can manipulate both an intermediate and outer tubular member with one hand, providing a more ergonomic handling, even with different hand sizes of a user (see Boebel Para. [0003]-[0007]).
In the same field of endeavor, namely surgical devices comprising a control handle, distal end effector and rotatable control knob for manipulation of said distal end effector, Nelson teaches wherein a spring (spring 44, see Fig. 7C) may be placed adjacent a slidable and rotatable member (gear 42, see Fig. 7C and Para. [0110]), configured to slide into operable engagement with an interfacing unit (gear 43, see Fig. 7C) which is configured to rotate to adjust the orientation of an end effector (see Para. [0112]-[0113]), to help the rotatable member maintain engagement with a corresponding interfacing unit (see Para. [0110]) when at rest.
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 slidable wheel of Cushen, as modified by Boebel, to comprise a compression spring placed adjacent thereto and along the slidable track of said slidable wheel as taught and suggested by Nelson to, in this case, help maintain the wheel in operable engagement with the hub (24) responsible for altering the orientation of the distal end effector as the default resting position (see Nelson Para. [0112]-[0113]) such that the wheel is always engaged even when not actively manipulated by a user. The wheel may be biased towards the opposing hub, compressing the spring of Nelson, to adjust the orientation of the bend before being re-biased back towards the end effector hub by the spring, defined as the “rest” position.
Regarding claim 30, the combination of Cushen, Boebel and Nelson disclose the invention of claim 28, Cushen, as modified by Boebel, further disclose wherein said actuator assembly further comprises a first gear (sections 16a/16b having teeth thereon, see Boebel Fig. 9) operably coupled to said housing in said first mode (see Boebel Para. [0063] mentioning wherein the wheel may be slid in said first axial direction (i.e., proximally) to engage the teeth of section 16b with the interlocking teeth of the hub 24; in this instance, hub 24 is understood to be located against the more proximal “housing” component to be engaged when the wheel is slid proximally) and operably decoupled from said housing in said second mode (see Boebel Para. [0054] and [0061] mentioning wherein the wheel may be slid in said second axial direction (i.e., distally) to disengage teeth 16b from the teeth of hub 24 and engage teeth 16a with the interlocking teeth of adjacent hub 22; in this instance, hub 22 is understood to be located against the distal nose portion of the handle assembly and thus not part of the more proximal “housing” component).
Regarding claim 31, the combination of Cushen, Boebel and Nelson disclose the invention of claim 28, Cushen, as modified by Boebel, further disclose a second gear (hub 22, see Boebel Fig. 11) secured to said outer tube (see Boebel Para. [0054] and [0061]; as the cover tube enters the nosecone of Cushen (see Cushen Para. [0079]), the hub 22 is secured thereto through the nosecone to allow manipulation thereof) and operably decoupled from said wheel in said first mode (see Boebel Para. [0054] and [0061] mentioning wherein the teeth 16a are engaged with the hub 22 in the “second mode” and thus would be disengaged in the “first mode”), and operably coupled with said wheel in said second mode (see Boebel Para. [0054] and [0061]).
Regarding claim 32, the combination of Cushen, Boebel and Nelson disclose the invention of claim 28, Cushen, as modified by Boebel, further disclose a third gear (hub 24, see Boebel Fig. 16) secured to said intermediate tube (see Boebel Para. [0063] mentioning wherein the hub 24 is engaged with teeth 16b to manipulate the intermediate tube), wherein said third gear is operably coupled with said wheel in said first mode (see Boebel Para. [0063]), and operably decoupled from said wheel in said second mode (see Boebel Para. [0054] and [0061] mentioning wherein in the “second mode” the wheel is engaged with hub 22 and therefore disengaged with hub 24).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cushen (WO 2017163226 A1)(previously of record) in view of Boebel (US 2011/0106143 A1)(previously of record), further in view of Nelson (US 2010/0063437 A1)(previously of record), further in view of Parish (US 2019/0343502 A1)(previously of record).
Regarding claim 20, the combination of Cushen, Boebel and Nelson disclose all of the limitations of the invention of claim 13. Cushen, as modified by Boebel further discloses wherein the wheel (58) comprises a proximal and distal portion thereof, separated along the centerline of the wheel (see Cushen Figs. 1-3).
However, Cushen does not expressly disclose a method of forming said wheel. The claimed phrase “the distal wheel portion and the proximal wheel portion being discrete components coupled to one another” means that the two portions thereof were joined together during fabrication to form the singular piece wheel, as explained in the instant application (see Specification Para. [0010] and [0030]).
Parish teaches that a rotational wheel for a surgical device may be formed from two halves joined together (see Para. [0045]).
Therefore, even if “joining two discrete portions of a rotational wheel together” results in different structural characteristics of the end produce, it would still have been prima facie obvious at the time of the invention to was made to form the wheel of Cushen as two halves joined together since Parish teaches that such a process is recognized as a useful technique for forming a rotational wheel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 11937842 B2 to Magno, US 11622786 B2 to Edwards and US 9452014 B2 to Edwards all disclose surgical grasping or cutting devices having a rotation knob configured to either one of or both of rotating an inner shaft and deflecting an outer shaft member.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771