Detailed Action
This is the final office action for US application number 17/294,180. Claims are evaluated as filed on August 11, 2025.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed August 11, 2025 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Garlock, Thorsgard, Masse, Volpi, Paulos, Okuno, and Re teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that none of the reference disclose the newly claimed distal section having the threads with a diameter less than any of the proximal plurality of sections as the office action points Thorsgard to show a pivot locking screw with threads but does not teach this feature (Remarks p. 6-8), Examiner disagrees. As details below and on at least pages 6-8 of the non-final office action dated May 13, 2025, Masse is provided as a teaching of the pivot locking screw with decreasing diameters and threads on the smallest diameter portion at the distal end as shown in Figs. 4 and 5 (shown below for convenience) and described in paragraph 24 as having fixing nut 44 screwed onto the screw 43 until members 37, 38 are fixed to each other.
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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 of this title, 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, 4-11, 13, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garlock et al. in view of Thorsgard (US 2006/0025776), Masse et al. (US 2009/0264884, hereinafter “Masse”), and Volpi et al. (US 2008/0103506, hereinafter “Volpi”).
As to claims 1 and 4-7, Garlock discloses a drill guide assembly (Figs. 2A-8 and 9B, abstract, ¶s 18 and 22) comprising: a guide arm (24) having a first end (left end of 24 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a second end (right end of 24 as shown in Figs. 2A and 2B, Figs. 2A and 2B) with a curved slot (30, 54s, Figs. 2A and 8) extending from the first end toward the second end (Figs. 2A and 8), wherein the second end is a forked end (right end as shown in Fig. 3A, Fig 3A) comprising a first arm (56, Fig. 3A, ¶29), wherein the first arm is cannulated (58, Fig. 3A, ¶29 discloses that 58 is a bore for receiving knob 34) and capable of receiving a guidewire therethrough (Fig. 3A, ¶29 discloses that 58 is a bore for receiving knob 34); a curved guide extension arm (28, Figs. 2A, 2B, and 5A-5C, ¶33 discloses that portion 68 extends into 54 to guide the movement of 28 within 30, which is shown to be curved) comprising a first end (left end of 28 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a second end (right end of 28 as shown in Figs. 2A and 2B, Figs. 2A and 2B), the first end capable of sliding within the curved slot of the guide arm (along path CP of ¶41 and Fig. 8, Figs. 2A and 8, ¶s 33 and 41); a probe arm (26) capable of rotating connected in abutment with the first arm (Fig .2A, ¶s 29 and 30) to the second end of the guide arm (when 34 is loose, Figs. 2A and 8, ¶s 26, 30, and 40) via a pivot locking screw (34, Figs. 2A, 2B, and 8, ¶s 26, 30, and 40); and wherein the pivot locking screw: includes a first end and a second end (Fig. 2B), appears to include a proximal plurality of sections of decreasing diameters from the first end to the second end extending in the distal direction (Fig. 2B), and has a distal section positioned at the second end disclosed to engage the pivot locking screw with the keeper ring (35) by twisting the pivot locking screw (¶26), is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 8) and preventing the probe arm from rotating with respect to the guide arm (in as much as Applicant’s, i.e., Garlock ¶26 discloses that pivot locking screw 34 is twisted in a first direction to lock the positions of probe arm 26 and guide arm 24 or twisting in a second direction enables rotation between probe arm 26 and guide arm 24; Applicant discloses in ¶29 that pivot locking screw 206 can be used to lock the prove arm 320 after the desired angle has been achieved by tightening 206 in a clockwise direction). As to claim 4, Garlock discloses that the probe arm is rotatable up to 240 degrees (Figs. 2A, 2B, and 8, ¶s 26, 30, and 40). As to claim 5, Garlock discloses a drill guide (25) extending through the second end of the curved guide extension arm (as defined, Fig. 8). As to claim 6, Garlock discloses a probe (38) extending through the probe arm (through bore 36, Fig. 8, ¶27). As to claim 7, Garlock discloses that the probe and the drill guide converge at a drill space (Fig. 8).
Garlock is silent to the forked end comprising a second arm separated by a first space from the first arm, wherein the second arm is cannulated and the cannulation of each of the first and second arm includes a guidewire positioned therethrough, the probe arm within the first space between the first arm and the second arm of the forked end, the pivot locking screw specifically including the proximal plurality of sections of decreasing diameters from the first end to the second end extending in the distal direction and the distal section including threads having a diameter less than any of the proximal plurality of sections, and the pivot locking screw being cannulated and includes the guidewire positioned therethrough.
Thorsgard teaches a similar drill guide assembly (Figs. 4-8, abstract, ¶s 42 and 43) comprising: a guide arm (54) having a first end and a second end (Figs. 4-6), wherein the second end is a forked end (Figs. 4 and 5) comprising a first arm (upper protruding portion shown on the left side of 54 in Fig. 4, Fig. 4) and a second arm (lower protruding portion shown on the left side of 54 in Fig. 4, Fig. 4) separated by a first space (gap/space between the first and second arm as defined, i.e. shown occupied by a protrusion of 52 in Fig. 4, Fig. 4), wherein each of the first arm and second arm are cannulated (“axial bores” of ¶42, which is shown as dashed lines in Fig. 4, Fig. 4, ¶42 discloses the connection of arm 54 to frame 52/53a via pin 56 where 53a and 54 are “provided with barrels or knuckles that have axial bores, and which are arranged in an alternating manner to form a hinge structure that is held together by pin 56”) and capable of receiving a guidewire therethrough (by insertion through the axial bore/cannulation, Fig. 4, ¶42); a probe arm (52) comprising a third arm (protrusion of 52 shown in Fig. 4 occupying the first space, Fig. 4), the probe arm capable of rotating connected within the first space between the first arm and the second arm of the forked end of the guide arm (Figs. 4 and 5) via a pivot locking screw (56, Figs. 4 and 5, ¶42 discloses that 56 includes a threaded end that couples to fastening element 57 to secure 54 in a particular orientation to 52); and wherein the pivot locking screw: includes a first end and a second end (Fig. 4); includes a section positioned at the second end including threads (¶42); is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 5, ¶42) and preventing the probe arm from rotating with respect to the guide arm (¶42).
Masse teaches a similar drill guide assembly (Figs. 1-13, abstract, ¶s 12, 21, and 26) comprising: a guide arm (37, Figs. 1 and 5) with a curved slot (42, Figs. 1 and 5, ¶24) extending from a first end toward a second end (Figs. 1 and 5); a probe arm (38) capable of rotating and connected to the guide arm via a pivot locking screw (43, Figs. 1 and 5, ¶24); and wherein the pivot locking screw: includes a first end and a second end (Fig. 5); includes a proximal plurality of sections of decreasing diameters (Fig. 5) from the first end to the second end extending in the distal direction (Fig. 5), and a distal section positioned at the second end including threads (Fig. 5, ¶24 discloses that fixing nut 44 is screwed onto screw 43 to fix 37, 38 to each other; thus 43 includes threads) having a diameter less than any of the proximal plurality of sections (Figs. 4 and 5); is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 5) and preventing the probe arm from rotating with respect to the guide arm (Fig. 1, ¶24).
Volpi teaches a similar drill guide assembly (Figs. 1-10) comprising: a guide arm (26, 12, 16); a curved guide extension arm (30) comprising a first end capable of sliding relative to the guide arm (Fig 4); a probe arm (10, 11) capable of sliding connected to the second end of the guide arm (Fig. 4); and wherein the probe arm is capable of moving to a position that is non-planar relative to the guide arm (Fig. 4) via an angled portion (12) comprising a cannulated member (40a, Fig. 4, ¶28) including a guidewire (50a, Fig. 4, ¶32) positioned therethrough (Fig. 4, ¶32).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the forked end and the probe arm as disclosed by Garlock to include the first, second, and third arms and first space as taught by Thorsgard in order to provide a known drill guide structure (Thorsgard abstract, ¶s 42 and 43) for permitting relative rotation between components (Thorsgard Figs. 4 and 5, ¶42) as well as securing the components in a desired orientation (Thorsgard Figs. 4 and 5, ¶42). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the pivot locking screw that appears to include decreasing diameters and the structure engaged by twisting as disclosed by Garlock to clearly include decreasing diameters extending in the distal direction and threads on the distal section that have a diameter less than any of the proximal plurality of sections as taught by Masse in order to provide a known rotational engagement structure (Masse ¶24) for coupling articulable members (Masse Fig. 1 ¶24; Garlock Fig. 2A). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the pivot locking screw and assembly as disclosed by Garlock to be cannulated and include a guidewire positioned therein as taught by Volpi in order to help secure the arm and visually gauge a desired position (Volpi ¶32) of the guide assembly relative to bone.
As to claims 8-11 and 13, Garlock discloses a drill guide assembly (Figs. 2A-8 and 9B, abstract, ¶s 18 and 22) comprising: a guide arm (24) having a first end (left end of 24 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a second end (right end of 24 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a curved slot (30, 54s, Figs. 2A and 8) extending from the first end toward the second end (Figs. 2A and 8), wherein the second end is a forked end (right end as shown in Fig. 3A, Fig 3A) comprising a first arm (56, Fig. 3A, ¶29), wherein the first arm is cannulated (58, Fig. 3A, ¶29 discloses that 58 is a bore for receiving knob 34) and capable of receiving a guidewire therethrough (Fig. 3A, ¶29 discloses that 58 is a bore for receiving knob 34); a curved guide extension arm (28, Figs. 2A, 2B, and 5A-5C, ¶33 discloses that portion 68 extends into 54 to guide the movement of 28 within 30, which is shown to be curved) having a first end (left end of 28 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a second end (right end of 28 as shown in Figs. 2A and 2B, Figs. 2A and 2B), the first end capable of sliding within the curved slot of the guide arm (along path CP of ¶41 and Fig. 8, Figs. 2A and 8, ¶s 33 and 41); a drill guide (25) attached to the second end of the curved guide extension arm (as defined via 44, Figs. 7 and 8, ¶24), the drill guide extending along a first axis (generally vertical as shown in Fig. 7, Fig. 7); a probe arm (26) having a first end (left end of 26 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a second end (right end of 26 as shown in Figs. 2A and 2B, Figs. 2A and 2B), the first end capable of rotating connected in abutment with the first arm (Fig .2A, ¶s 29 and 30) to the second end of the guide arm (when 34 is loose, Figs. 2A and 8, ¶s 26, 30, and 40) via a pivot locking screw (34, Figs. 2A and 8, ¶s 26, 30, and 40); wherein the pivot locking screw includes a first end and a second end (Fig. 2B); appears to include a proximal plurality of sections of decreasing diameters from the first end to the second end extending in the distal direction (Fig. 2B), and has a distal section positioned at the second end disclosed to engage the pivot locking screw with the keeper ring (35) by twisting the pivot locking screw (¶26), is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 8) and preventing the probe arm from rotating with respect to the guide arm (in as much as Applicant’s, i.e., Garlock ¶26 discloses that pivot locking screw 34 is twisted in a first direction to lock the positions of probe arm 26 and guide arm 24 or twisting in a second direction enables rotation between probe arm 26 and guide arm 24; Applicant discloses in ¶29 that pivot locking screw 206 can be used to lock the prove arm 320 after the desired angle has been achieved by tightening 206 in a clockwise direction); wherein, the probe arm is capable of rotating toward the curved guide extension arm (when in the position shown in Fig. 2A and when 34 is loose, Figs. 2A and 8, ¶s 26, 30, and 40); and a probe (38) attached to the second end the probe arm (as defined, through bore 36 and knob 40, Fig. 8, ¶27), the probe extending along a second axis (A1, Fig. 4B, ¶31); and wherein, in a first configuration (Fig. 2A), the first axis is at a first angle relative to the second axis (Fig. 2A) and, in a second configuration (Fig. 8), the first axis is at a second angle relative to the second axis (Fig. 8); and wherein the first angle is different from the second angle (Figs. 2A and 8). As to claim 9, Garlock discloses that, in the first configuration, the curved guide extension arm is at a first position within the curved slot (Fig. 2A), in the second configuration, the curved guide extension arm is at a second position within the curved slot (Fig. 8), and the first and second positions are different (Figs. 2A and 8). As to claim 10, Garlock discloses that, in the first configuration, the first axis is transverse with respect to the second axis (Fig. 2A). As to claim 11, Garlock discloses that, in the first configuration and the second configuration, the probe and the drill guide converge at a drill space (Figs. 2A and Fig. 8). As to claim 13, Garlock discloses that the drill guide is cannulated (Fig. 7) and capable of receiving a drill pin therethrough (Fig. 7, ¶s 18, 22, and37).
Garlock is silent to the forked end comprising a second arm separated by a first space from the first arm, wherein the second arm is cannulated and the cannulation of each of the first and second arm includes a guidewire positioned therethrough, the probe arm within the first space between the first arm and the second arm of the forked end, the pivot locking screw specifically including the proximal plurality of sections of decreasing diameters from the first end to the second end extending in the distal direction and the distal section including threads having a diameter less than any of the proximal plurality of sections, and the pivot locking screw being cannulated and includes the guidewire positioned therethrough.
Thorsgard teaches a similar drill guide assembly (Figs. 4-8, abstract, ¶s 42 and 43) comprising: a guide arm (54) having a first end and a second end (Figs. 4-6), wherein the second end is a forked end (Figs. 4 and 5) comprising a first arm (upper protruding portion shown on the left side of 54 in Fig. 4, Fig. 4) and a second arm (lower protruding portion shown on the left side of 54 in Fig. 4, Fig. 4) separated by a first space (gap/space between the first and second arm as defined, i.e. shown occupied by a protrusion of 52 in Fig. 4, Fig. 4), wherein each of the first arm and second arm are cannulated (“axial bores” of ¶42, which is shown as dashed lines in Fig. 4, Fig. 4, ¶42 discloses the connection of arm 54 to frame 52/53a via pin 56 where 53a and 54 are “provided with barrels or knuckles that have axial bores, and which are arranged in an alternating manner to form a hinge structure that is held together by pin 56”) and capable of receiving a guidewire therethrough (by insertion through the bores/cannulation, Fig. 4, ¶42); a probe arm (52) comprising a third arm (protrusion of 52 shown in Fig. 4 occupying the first space, Fig. 4), the probe arm capable of rotating connected within the first space between the first arm and the second arm of the forked end of the guide arm (Figs. 4 and 5) via a pivot locking screw (56, Figs. 4 and 5, ¶42 discloses that 56 includes a threaded end that couples to fastening element 57 to secure 54 in a particular orientation to 52); and wherein the pivot locking screw: includes a first end and a second end (Fig. 4); includes a section positioned at the second end including threads (¶42); is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 5, ¶42) and preventing the probe arm from rotating with respect to the guide arm (¶42).
Masse teaches a similar drill guide assembly (Figs. 1-13, abstract, ¶s 12, 21, and 26) comprising: a guide arm (37, Figs. 1 and 5) with a curved slot (42, Figs. 1 and 5, ¶24) extending from a first end toward a second end (Figs. 1 and 5); a probe arm (38) capable of rotating and connected to the guide arm via a pivot locking screw (43, Figs. 1 and 5, ¶24); and wherein the pivot locking screw: includes a first end and a second end (Fig. 5); includes a proximal plurality of sections of decreasing diameters (Fig. 5) from the first end to the second end extending in the distal direction (Fig. 5), and a distal section positioned at the second end including threads (Fig. 5, ¶24 discloses that fixing nut 44 is screwed onto screw 43 to fix 37, 38 to each other; thus 43 includes threads) having a diameter less than any of the proximal plurality of sections (Figs. 4 and 5); is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 5) and preventing the probe arm from rotating with respect to the guide arm (Fig. 1, ¶24).
Volpi teaches a similar drill guide assembly (Figs. 1-10) comprising: a guide arm (26, 12, 16); a curved guide extension arm (30) comprising a first end capable of sliding relative to the guide arm (Fig 4); a probe arm (10, 11) capable of sliding connected to the second end of the guide arm (Fig. 4); and wherein the probe arm is capable of moving to a position that is non-planar relative to the guide arm (Fig. 4) via an angled portion (12) comprising a cannulated member (40a, Fig. 4, ¶28) including a guidewire (50a, Fig. 4, ¶32) positioned therethrough (Fig. 4, ¶32).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the forked end and the probe arm as disclosed by Garlock to include the first, second, and third arms and first space as taught by Thorsgard in order to provide a known drill guide structure (Thorsgard abstract, ¶s 42 and 43) for permitting relative rotation between components (Thorsgard Figs. 4 and 5, ¶42) as well as securing the components in a desired orientation (Thorsgard Figs. 4 and 5, ¶42). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the pivot locking screw that appears to include decreasing diameters and the structure engaged by twisting as disclosed by Garlock to clearly include decreasing diameters extending in the distal direction and threads on the distal section that have a diameter less than any of the proximal plurality of sections as taught by Masse in order to provide a known rotational engagement structure (Masse ¶24) for coupling articulable members (Masse Fig. 1 ¶24; Garlock Fig. 2A). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the pivot locking screw and assembly as disclosed by Garlock to be cannulated and include a guidewire positioned therein as taught by Volpi in order to help secure the arm and visually gauge a desired position (Volpi ¶32) of the guide assembly relative to bone.
As to claims 15-18, Garlock discloses a drill guide assembly (Figs. 2A-8 and 9B, abstract, ¶s 18 and 22) comprising: a guide arm (24) having a first end (left end of 24 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a second end (right end of 24 as shown in Figs. 2A and 2B, Figs. 2A and 2B) with a curved slot (30, 54s, Figs. 2A and 8) extending from the first end toward the second end (Figs. 2A and 8), wherein the second end is a forked end (right end as shown in Fig. 3A, Fig 3A) comprising a first arm (56, Fig. 3A, ¶29), wherein the first arm is cannulated (58, Fig. 3A, ¶29 discloses that 58 is a bore for receiving knob 34) and capable of receiving a guidewire therethrough (Fig. 3A, ¶29 discloses that 58 is a bore for receiving knob 34); a curved guide extension arm (28, Figs. 2A, 2B, and 5A-5C, ¶33 discloses that portion 68 extends into 54 to guide the movement of 28 within 30, which is shown to be curved) having a first end (left end of 28 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a second end (right end of 28 as shown in Figs. 2A and 2B, Figs. 2A and 2B), the first end capable of sliding within the curved slot of the guide arm (along path CP of ¶41 and Fig. 8, Figs. 2A and 8, ¶s 33 and 41); a probe arm (26) having a first end (left end of 26 as shown in Figs. 2A and 2B, Figs. 2A and 2B) and a second end (right end of 26 as shown in Figs. 2A and 2B, Figs. 2A and 2B), the first end capable of rotating connected in abutment with the first arm (Fig .2A, ¶s 29 and 30) to the second end of the guide arm (when 34 is loose, Figs. 2A and 8, ¶s 26, 30, and 40) via a pivot locking screw (34, Figs. 2A and 8, ¶s 26, 30, and 40); wherein the pivot locking screw includes a first end and a second end (Fig. 2B); appears to include a proximal plurality of sections of decreasing diameters from the first end to the second end extending in the distal direction (Fig. 2B), and has a distal section positioned at the second end disclosed to engage the pivot locking screw with the keeper ring (35) by twisting the pivot locking screw (¶26) is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 8) and preventing the probe arm from rotating with respect to the guide arm (in as much as Applicant’s, i.e., Garlock ¶26 discloses that pivot locking screw 34 is twisted in a first direction to lock the positions of probe arm 26 and guide arm 24 or twisting in a second direction enables rotation between probe arm 26 and guide arm 24; Applicant discloses in ¶29 that pivot locking screw 206 can be used to lock the prove arm 320 after the desired angle has been achieved by tightening 206 in a clockwise direction); and a tapered probe (38, Figs. 8 and 9B) attached to the second end of the probe arm (via 40, Fig. 8, ¶27). As to claim 16, Garlock discloses that the tapered probe has a first end (left end of 38 as shown in Fig. 9B, Fig. 9B) and a second end (right end of 38 as shown in Fig. 9B, Fig. 9B), the tapered probe decreasing in diameter from the first end toward the second end (Fig. 9B). As to claim 17, Garlock discloses a cap (enlarged portion at the left-most end of Fig 9B, Fig. 9B) at the first end of the tapered probe (as defined, Fig. 9B). As to claim 18, Garlock discloses that the second end of the tapered probe is spherical (Fig. 9B).
Garlock is silent to the forked end comprising a second arm separated by a first space from the first arm, wherein the second arm is cannulated and the cannulation of each of the first and second arm includes a guidewire positioned therethrough the probe arm within the first space between the first arm and the second arm of the forked end, the pivot locking screw specifically including the proximal plurality of sections of decreasing diameters from the first end to the second end extending in the distal direction and the distal section including threads having a diameter less than any of the proximal plurality of sections, and the pivot locking screw being cannulated and includes the guidewire positioned therethrough.
Thorsgard teaches a similar drill guide assembly (Figs. 4-8, abstract, ¶s 42 and 43) comprising: a guide arm (54) having a first end and a second end (Figs. 4-6), wherein the second end is a forked end (Figs. 4 and 5) comprising a first arm (upper protruding portion shown on the left side of 54 in Fig. 4, Fig. 4) and a second arm (lower protruding portion shown on the left side of 54 in Fig. 4, Fig. 4) separated by a first space (gap/space between the first and second arm as defined, i.e. shown occupied by a protrusion of 52 in Fig. 4, Fig. 4), wherein each of the first arm and second arm are cannulated (“axial bores” of ¶42, which is shown as dashed lines in Fig. 4, Fig. 4, ¶42 discloses the connection of arm 54 to frame 52/53a via pin 56 where 53a and 54 are “provided with barrels or knuckles that have axial bores, and which are arranged in an alternating manner to form a hinge structure that is held together by pin 56”) and capable of receiving a guidewire therethrough (by insertion through the bores/cannulation, Fig. 4, ¶42); a probe arm (52) comprising a third arm (protrusion of 52 shown in Fig. 4 occupying the first space, Fig. 4), the probe arm capable of rotating connected within the first space between the first arm and the second arm of the forked end of the guide arm (Figs. 4 and 5) via a pivot locking screw (56, Figs. 4 and 5, ¶42 discloses that 56 includes a threaded end that couples to fastening element 57 to secure 54 in a particular orientation to 52); and wherein the pivot locking screw: includes a first end and a second end (Fig. 4); includes a section positioned at the second end including threads (¶42); is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 5, ¶42) and preventing the probe arm from rotating with respect to the guide arm (¶42).
Masse teaches a similar drill guide assembly (Figs. 1-13, abstract, ¶s 12, 21, and 26) comprising: a guide arm (37, Figs. 1 and 5) with a curved slot (42, Figs. 1 and 5, ¶24) extending from a first end toward a second end (Figs. 1 and 5); a probe arm (38) capable of rotating and connected to the guide arm via a pivot locking screw (43, Figs. 1 and 5, ¶24); and wherein the pivot locking screw: includes a first end and a second end (Fig. 5); includes a proximal plurality of sections of decreasing diameters (Fig. 5) from the first end to the second end extending in the distal direction (Fig. 5), and a distal section positioned at the second end including threads (Fig. 5, ¶24 discloses that fixing nut 44 is screwed onto screw 43 to fix 37, 38 to each other; thus 43 includes threads) having a diameter less than any of the proximal plurality of sections (Figs. 4 and 5); is capable of allowing the probe arm to rotate to a position that is non-planar relative to the guide arm (Fig. 5) and preventing the probe arm from rotating with respect to the guide arm (Fig. 1, ¶24).
Volpi teaches a similar drill guide assembly (Figs. 1-10) comprising: a guide arm (26, 12, 16); a curved guide extension arm (30) comprising a first end capable of sliding relative to the guide arm (Fig 4); a probe arm (10, 11) capable of sliding connected to the second end of the guide arm (Fig. 4); and wherein the probe arm is capable of moving to a position that is non-planar relative to the guide arm (Fig. 4) via an angled portion (12) comprising a cannulated member (40a, Fig. 4, ¶28) including a guidewire (50a, Fig. 4, ¶32) positioned therethrough (Fig. 4, ¶32).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the forked end and the probe arm as disclosed by Garlock to include the first, second, and third arms and first space as taught by Thorsgard in order to provide a known drill guide structure (Thorsgard abstract, ¶s 42 and 43) for permitting relative rotation between components (Thorsgard Figs. 4 and 5, ¶42) as well as securing the components in a desired orientation (Thorsgard Figs. 4 and 5, ¶42). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the pivot locking screw that appears to include decreasing diameters and the structure engaged by twisting as disclosed by Garlock to clearly include decreasing diameters extending in the distal direction and threads on the distal section that have a diameter less than any of the proximal plurality of sections as taught by Masse in order to provide a known rotational engagement structure (Masse ¶24) for coupling articulable members (Masse Fig. 1 ¶24; Garlock Fig. 2A). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the pivot locking screw and assembly as disclosed by Garlock to be cannulated and include a guidewire positioned therein as taught by Volpi in order to help secure the arm and visually gauge a desired position (Volpi ¶32) of the guide assembly relative to bone.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garlock, Thorsgard, Masse, and Volpi in view of Paulos (US 2011/0034933).
As to claim 12, the combination of Garlock, Thorsgard, Masse, and Volpi discloses the invention of claim 8 as well as the drill guide comprises a distal end positioned directly against soft tissue or bone (Garlock Fig 8, ¶41).
The combination of Garlock, Thorsgard, Masse, and Volpi is silent to the distal end having a crown.
Paulos teaches a similar drill guide assembly (Figs. 1-5B and 7) comprising: a guide arm (right end of 270 as shown in Fig. 2, Fig. 2) having a curved slot (272, Fig. 2, ¶36); a curved guide extension arm (280, Fig. 2) having a first end capable of sliding within the curved slot of the guide arm (Figs. 1 and 2, ¶36); a drill guide (240, Fig. 2, ¶45) attached to a second end of the curved guide extension arm (via 286, Figs. 1 and 2, ¶44), the drill guide extending along a first axis (Figs. 1-4); a probe arm (left end of 270 as shown in Fig. 2, Figs. 1 and 2, ¶36); and a probe (220) attached to the second end of the probe arm (Figs. 1 and 2, ¶38), the probe extending along a second axis (Figs. 1-4); and wherein, in a first configuration, the first axis is at a first angle relative to the second axis (Figs. 3 and 4) and, in a second configuration (when 280 is slide relative to 270 from the position shown in Figs. 3 and 4), the first axis is at a second angle relative to the second axis (Figs. 1 and 2; and wherein the first angle is different from the second angle (as defined, Fig. 1-4); wherein the drill guide comprises a distal end (244) having a crown (portion including serrated edge of ¶45, Fig. 2, ¶45).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the drill guide distal end as disclosed by the combination of Garlock, Thorsgard, Masse, and Volpi has a crown as taught by Paulos in order to help secure the cannulated drill guide on bone during surgery and can help bore into the bone when necessary (Paulos ¶45).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garlock, Thorsgard, Masse, and Volpi in view of Okuno et al. (US 2015/0150570, hereinafter “Okuno”).
As to claim 14, the combination of Garlock, Thorsgard, Masse, and Volpi discloses the invention of claim 8.
The combination of Garlock, Thorsgard, Masse, and Volpi is silent to the probe is cannulated and configured to receive a guidewire therethrough.
Okuno teaches a similar drill guide assembly (Figs. 1-11B, ¶s 49-50) comprising: a guide arm (1C) having a curved slot (Fig. 1C, ¶52); a curved guide extension arm (1d, 1e) having a first end capable of sliding within the curved slot of the guide arm (Figs. 1 and 2, ¶52); a drill guide (3) attached to the second end of the curved guide extension arm (Figs. 1 and 2), the drill guide extending along a first axis (Figs. 1 and 2); a probe arm (1a, 1b); and a probe (2) attached to a second end of the probe arm (Figs. 1 and 2), the probe extending along a second axis (Figs. 1 and 2); and wherein in a first configuration, the first axis is at a first angle relative to the second axis (Figs. 1 and 2) and, in a second configuration (when 1d is slid from the position shown in Figs. 1 and 2), the first axis is at a second angle relative to the second axis (when 1d is slid from the position shown in Figs. 1 and 2); and wherein the first angle is different from the second angle (as defined, Figs. 1 and 2, ¶52);, wherein the probe is cannulated (2e, Fig. 8D) and capable of receiving a guidewire (5, Fig. 8D, ¶79) therethrough (within 2e, Fig. 8D).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the probe as disclosed by the combination of Garlock, Thorsgard, Masse, and Volpi to be cannulated as taught by Okuno in order to insert a tentative fixing pin into bone (Okuno ¶79) for later removal (Okuno ¶89) to aid in temporary fixation to bone.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garlock, Thorsgard, Masse, and Volpi in view of Re (US 2009/0216236).
As to claims 19 and 20, the combination of Garlock, Thorsgard, Masse, and Volpi discloses the invention of claim 18 as well as an outer surface of the spherical second end of the tapered probe (Fig. 9B).
The combination of Garlock, Thorsgard, Masse, and Volpi is silent to a spike extending from the outer surface. As to claim 20, the combination of Garlock, Thorsgard, Masse, and Volpi is silent the spike being substantially perpendicular to a longitudinal axis extending through the probe.
Re teaches as similar drill guide assembly (Figs. 14 and 19, ¶s 39, 40, and 42) comprising: a curved guide extension arm (225, Fig. 19); a probe arm (right end of 220 as shown in Fig. 19, Fig. 19); and a tapered probe (left end of 220 as shown in Fig. 19, Figs. 14 and 19) attached to the second end of the probe arm (Fig. 19); the tapered probe decreasing in diameter from a first end toward a second end (Fig. 19); wherein the second end of the tapered probe is spherical (portion 205 is spherical per ¶36, Figs. 14 and 19); further comprising a spike (215, Figs. 14 and 19) extending from an outer surface of the spherical second end of the tapered probe (Figs. 14 and 19). As to claim 20, Re teaches that the spike is substantially perpendicular to a longitudinal axis extending through the probe (Figs. 14 and 19).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify outer surface of the spherical second end of the tapered probe as disclosed by the combination of Garlock, Thorsgard, Masse, and Volpi adding the spike as taught by Re in order to aid the surgeon in orienting the probe relative to the bone (Re ¶38) and help secure the probe on bone during surgery.
Conclusion
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 extension fee 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 date of this final action.
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/AMY R SIPP/Primary Examiner, Art Unit 3775