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 .
Claim Objections
Claim 25 is objected to because of the following informalities: in lines 5-6, “the angle of the other connection points” should read “an angle of the other connection points” for consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-6, 13, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levin (U.S. Patent No. 5,649,957).
Regarding claim 1, Levin discloses a surgical clamp (10; FIGs. 1-5) comprising: two pivot arms (22, 24) pivotably coupled to each other via a hinge (26), each of the pivot arms having a handle portion disposed proximal to the hinge (Annotated FIG. 3 below) and a jaw portion disposed distal to the hinge (Annotated FIG. 3), the jaw portion of each pivot arm comprising: a plurality of articulable segments (22A/22B, 24A/24B) being pivotably and releasably coupled to at least one adjacent articulable segment (FIG. 2: 22A/24A are releasably attached to 22B/24B on pins 28) to enable providing the jaw portion with an adjustable shape (FIGs. 1 and 5: the pivot of 22A/22B relative to 22B/24B changes the shape of the jaw portions).
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Regarding claim 2, Levin further discloses each of the plurality of articulable segments has a first end (FIG. 3: the proximal end) and a second end (FIG. 3: the distal end), and the plurality of articulable segments are pivotably and releasably coupled to each other in an end-to-end configuration (FIGs. 1-5: 22A/22B and 24A/24B are releasably coupled to each other in a proximal-to-distal configuration, and can pivot on pins 28).
Regarding claim 5, Levin further discloses the handle portion and the jaw portion of at least one of the two pivot arms are releasably coupled to each other (FIG. 1: the jaw portions of 22 and 24 are part of 20, which is detachable from the member 12, which includes the handle portions, based on the dotted line separating them).
Regarding claim 6, Levin further discloses the releasable coupling between the handle portion and the jaw portion facilitates the handle portion with a second handle portion or replacing the jaw portion with a second jaw portion (FIG. 1: since 20 and 12 can be detached from each other, they can each be interchanged with new versions of themselves).
Regarding claim 13, Levin discloses a surgical clamp (10; FIGs. 1-5) comprising: two pivot arms (22, 24) pivotably coupled to each other via a hinge (26), each of the pivot arms having a handle portion disposed proximal to the hinge (Annotated FIG. 3 above) and a jaw portion disposed distal to the hinge (Annotated FIG. 3), wherein the jaw portion of each pivot arm comprises a plurality of articulable segments (22A/22B, 24A/24B) being pivotably and releasably coupled to at least one adjacent articulable segment (FIG. 2: 22A/24A are releasably attached to 22B/24B on pins 28) to enable providing the jaw portion with an adjustable shape (FIGs. 1 and 5: the pivot of 22A/22B relative to 22B/24B changes the shape of the jaw portions); and wherein the handle portion and the jaw portion of the two pivot arms are releasably coupled to each other (FIG. 1: the jaw portions 22 and 24 are part of 20, which is detachable from the member 12, which includes the handle portions, based on the dotted line separating them).
Regarding claim 25, Levin discloses each articulable segment having and adjacent articulable segment defines a connection point between the two articulable segments (FIG. 3: pins 28 are the connection point between 22A/22B and 24A/24B), and each connection point is independently articulable relative to each other connection point (FIG. 2: each 28 is independent of the other) such that each connection point has a modifiable angle that does not affect the angle of the other connection points (FIG. 2: the angle formed by 22 and 24 on each side is not affected by the other unless the jaws have been pressed together).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-4 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Patani et al. (Pub. No. 2014/0107697).
Regarding claim 3, Levin discloses the invention as claimed in claim 1, as discussed above, and further discloses a first articulating segment (22A and 24A) is adjacent a second articulating segment (22B and 24B), and that a first angle is formed between the first and the second articulating segments (FIGs. 1 and 5). Levin does not disclose a third articulating segment adjacent the second articulating segment, a second angle is formed between the second and third articulating segments, and the first angle is pivotable to a new angle without affecting the second angle.
Patani et al. discloses a surgical clamp (1000; FIGs. 40-43; [0186]) comprising: two pivot arms (1010a and 1010b) pivotably coupled to each other via a hinge (1006) each of the pivot arms having a handle portion disposed proximal to the hinge (1008) and a jaw portion disposed distal to the hinge (1002), the jaw portion of each pivot arm comprising: a plurality of articulable segments (FIG. 40: the segments between joints 1011, 1013, and 1015) being pivotably coupled to at least one adjacent articulable segment (FIG. 40: each segment between 1011, 1013, and 1015 is connected by the joints to at least one other segment) to enable providing the jaw portion with an adjustable shape ([0190] the joints can be adjustable during use to change the shape of jaws), the plurality of articulable segments comprising a first articulating segment (FIG. 40: most distal segment after joint 1011) adjacent a second articulating segment (FIG. 40: segment between 1011 and 1013), a first angle is formed between the first and the second articulating segments (FIG. 40: the angle on 1011), the second articulating segment is adjacent a third articulating segment (FIG. 40: segment between 1013 and 1015), a second angle is formed between the second and the third articulating segments (FIG. 40: the angle on 1013), and the first angle is pivotable to a new angle without affecting the second angle ([0190] 1011 and 1013 are independently adjustable) for the purpose of refining the angular transitions based on clinical factors such as the size and geometry of the tissue mass being avoided ([0190]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Levin to include a third articulating segment, as taught by Patani et al., for the purpose of refining the angular transitions based on clinical factors such as the size and geometry of the tissue mass being avoided.
Regarding claim 4, Levin as modified by Patani et al. further discloses each of the first, second, and third articulable segments are configured to be pivoted to and locked at a finite number of discrete angles with respect to their respective adjacent articulable segments (Patani et al. [0190] the segments between 1011, 1013, and 1015, can be fixed in one angle, which is a finite number).
Regarding claim 22, Levin as modified by Patani et al. further discloses the first and second angles are fixed when the two pivot arms are open or closed (Patani et al. [0190] the segments between 1011, 1013, and 1015, can be fixed in place, which would be consistent regardless of whether 1010a and 1010b are open or closed).
Claim(s) 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Huitema et al. (U.S. Patent No. 5,823,066).
Regarding claims 18-20, Levin discloses a surgical clamp (10; FIGs. 1-5) comprising: two pivot arms (22, 24) pivotably coupled to each other via a hinge (26), each of the pivot arms having a handle portion disposed proximal to the hinge (Annotated FIG. 3 below) and a jaw portion disposed distal to the hinge (Annotated FIG. 3), the jaw portion of each pivot arm comprising: a plurality of articulable segments (22A/22B, 24A/24B) being pivotably and releasably coupled to at least one adjacent articulable segment (FIG. 2: 22A/24A are releasably attached to 22B/24B on pins 28) to enable providing the jaw portion with an adjustable shape (FIGs. 1 and 5: the pivot of 22A/22B relative to 22B/24B changes the shape of the jaw portions), wherein each of the plurality of articulable segments comprises: a main body (22A/22B and 24A/24B), the main body comprising: a first end (Annotated FIG. 3: the proximal end), a coupling portion extending outwardly from the first end of the main body (Annotated FIG. 3: the teeth of 40 on the proximal end), the coupling portion having a shaped opening formed therein (Annotated FIG. 3: the teeth of 40 form a shaped opening); and a second end (Annotated FIG. 3: the distal end) having a recess formed therein (Annotated FIG. 3: the teeth of 40 on the proximal end), and a slot formed therein (30), the slot intersecting the recess (FIG. 2: 30 goes through each 40), and the slot configured to receive a coupling portion of an adjacent articulating segment (FIG. 2: 30 receives 28).
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Levin does not disclose a releasable engagement mechanism configured to selectively engage the coupling portion of the adjacent articulating segment at a desired angle with respect to the articulating segment, the releasable engagement mechanism comprising a pushbutton and a paddle disposed within the recess, the pushbutton configured to move the paddle into and out of selective engagement with the coupling portion of the adjacent articulating segment positioned within the slot of the articulating segment, and a spring to bias a position of the paddle within the recess.
Huitema et al. teaches in the field of articulation transmission assemblies for articulating end effectors, and discloses an articulation transmission assembly (FIG. 3) comprising a main body (50), a button (47), a paddle (49), and a spring (74), where the button, the paddle, the spring, and the main body are configured in a stacked configuration (FIG. 3), and the button is positioned above the spring in the stack (FIG. 3: 47 is above 74) for the purpose of keeping the main body and the paddle biased away from the button so that when the button is pressed, the spring is compressed, which allows the paddle to change the orientation of the main body to articulate the segment, and to lock the main body and the paddle in place when the button is not pressed (C7:L48-C8:L20).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the articulating segments of Levin to have a button and a spring at the intersection of two adjacent articulating segments, as taught by Huitema et al., for the purpose of keeping the main body and the paddle biased away from the button so that when the button is pressed, the spring is compressed, which allows the paddle to change the orientation of the main body to articulate the segment, and to lock the main body and the paddle in place when the button is not pressed. This modification would make have the stack comprised of a button on top to be capable of being compressed, then the spring to keep the button off of the paddle unless the button is compressed, then the main body of the adjacent articulating segment to allow for contact with the paddle, then the paddle, and finally the main body of the articulating segment to be in contact with the paddle so that the compression of the button will move only the main body of the adjacent articulating segment relative to the paddle and main body of the articulating segment.
Regarding claim 21, Levin discloses the invention as claimed in claim 1, as discussed above, and further discloses each articulating segment is comprised of a main body (22A/22B and 24A/24B) and a paddle (40), the paddle and a main body of an adjacent articulating segment are configured in a stacked orientation (FIG. 2), the paddle is positioned at a bottom of the stack (FIG. 2), and the main body has a slot on a first end (FIG. 2: 40 has a mating surface), within which is located the portion on the second end of the adjacent articulating segment (C3:L55-60: the mating surfaces of corresponding 40s of 22A/22B and 24A/24B come together at opposite ends of each 22A/22B and 24A/24B). Levin does not disclose each articulating segment is further comprised of a button and a spring, where the button and the spring are part of the stack, the button is positioned above the spring in the stack, and the main body of the adjacent articulating segment has a portion on the second end that is positioned between the spring and the paddle.
Huitema et al. teaches in the field of articulation transmission assemblies for articulating end effectors, and discloses an articulation transmission assembly (FIG. 3) comprising a main body (50), a button (47), a paddle (49), and a spring (74), where the button, the paddle, the spring, and the main body are configured in a stacked configuration (FIG. 3), and the button is positioned above the spring in the stack (FIG. 3: 47 is above 74) for the purpose of keeping the main body and the paddle biased away from the button so that when the button is pressed, the spring is compressed, which allows the paddle to change the orientation of the main body to articulate the segment, and to lock the main body and the paddle in place when the button is not pressed (C7:L48-C8:L20).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the articulating segments of Levin to have a button and a spring at the intersection of two adjacent articulating segments, as taught by Huitema et al., for the purpose of keeping the main body and the paddle biased away from the button so that when the button is pressed, the spring is compressed, which allows the paddle to change the orientation of the main body to articulate the segment, and to lock the main body and the paddle in place when the button is not pressed. This modification would make have the stack comprised of a button on top to be capable of being compressed, then the spring to keep the button off of the paddle unless the button is compressed, then the main body of the adjacent articulating segment to allow for contact with the paddle, then the paddle, and finally the main body of the articulating segment to be in contact with the paddle so that the compression of the button will move only the main body of the adjacent articulating segment relative to the paddle and main body of the articulating segment.
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levin in view of Patani et al., and in further view of Arnold et al. (Pub. No. 2019/0350579).
Regarding claims 23-24, Levin as modified by Patani et al. discloses the invention as claimed in claim 4, as discussed above. The modified invention does not disclose either that there are only five finite number of discrete angles that each articulable segment is lockable at (90, 45, 0, -45, and -90) or that there are only seven finite number of discrete angles that each articulable segment is lockable at (90, 60, 30, 0, -30, -60, -90), though Levin uses interlocking surfaces 40 to set the angle of the articulating segments (FIGs. 1 and 5).
Arnold et al. teaches in the field of articulation controls, and discloses that a plurality of detents can be positioned along the surface of the articulation control corresponding to particular articulation angles, such as 0 degrees, 15 degrees, 45 degrees, and such, or with equal distribution ([0071]) for the purpose of preventing unintentional articulation and providing a user with knowledge of what degree of articulation has been selected ([0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Levin to have the interlocking surfaces correspond to particular articulation angle intervals, such as 30 degrees or 45 degrees, as taught by Arnold et al., for the purpose of preventing unintentional articulation and providing a user with knowledge of what degree of articulation has been selected. The modification will set the number of discrete angles that each articulable segment can be locked at depending on which number is selected: if 45 degree intervals are selected, then the only five angles that the segment can achieve will be the claimed angles in claim 23; and if 30 degree intervals are selected, then the only seven angles that the segment can achieve will be the claimed angles in claim 24. Furthermore, Applicant does not place any criticality on those particular sets of claimed intervals or angles, stating in [0057] of the present Specification that fewer or greater numbers of angular adjustments may be accomplished if and as needed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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