Detailed Action
This office action is for US application number 18/697,668 evaluates the claims as filed on June 11, 2026.
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 June 11, 2026 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 Examiner asserts that Choe, Forstein, and Davis 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 Choe and Forstein do not disclose the newly claimed flat surface (Remarks p. 8-9), Examiner notes that Davis has been provided in the below rejections in regards to this limitation.
With regards to Applicant’s argument that the methods disclosed in Choe do not prevent the bone segment from moving towards the bone plate but instead bring the bone plate and segment towards one another as ¶33 discloses that relative rotation of 150 and 154 such as 152 advancing relative to 154 toward the bone plate so that the tip 164 pushes against the wall 81 or hole 82 bringing the bone and plate toward one another (Remarks p. 9-11), Examiner notes that the cited partial sentence is taken a bit out of context. Review of ¶33 discloses that temporary fixator 150 is used to pull/push bone 60 and the fixation device 150 toward one another, that tubular component 152 is threadably rotated about shaft 154 so that the function cited by Applicant can be achieved, and allows adjustment of the relative position of bone plate 80 on the bone 60 in any direction. That is, the disclosure of ¶33 is not as narrow as Applicant has emphasized but instead discloses adjustment of the relative position of bone plate 80 on the bone 60 in any direction and specifically mentions push/pull functionality. Further review of Choe shows that such provides instruments used in affixing internal fixation plates to bone portions including targeting jigs for the fixation plates, irrigation instruments for use with bone drilling, and push-pull reduction devices (¶1) where the targeting device 100 is used to target, drill, and insert bone screws 88 into any of the holes 82 of the bone plate 80 (¶26). Thus, while Choe does not expressly disclose the method steps, Choe does disclose providing such tools as a kit (¶34), use of their devices together (¶1) and the function of the separate components (¶s 26 and 33). Accordingly, it appears that the most obvious and reasoned explanation is that one would adjust the relative positioning of the bone and bone plate to as desired and then insert the screws into the bone and bone plate to permanently secure the bone in that position, i.e. by using the tools to maintain that position while the screw is inserted aka preventing the bone segment from moving relative to the bone plate while inserting the screws. Further, there appears to be no alternative reason to assert that one would use the temporary fixator 150 with push rod 154 and guide 152 to adjust the relative positioning of the bone and plate and do something other than fixate the bone plate to the bone while maintaining the achieved positioning, i.e. preventing the bone segment from moving relative to the bone plate while inserting the screws.
Claim Objections
Claim(s) 6 and 8 is/are objected to because of the following informalities:
Claim 6 lines 3-4 should read “the guide is configured to be engaged.”.
Claim 8 line 20 should read “segment; wherein maintaining the position of the realigned fractured bone segment”.
Appropriate correction is required.
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, 3, 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (US 2007/0276401, hereinafter “Choe”) in view of Davis (US 5,626,583) and Forstein et al. (US 2006/0173458, hereinafter “Forstein”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1, 3, and 4, Choe discloses a bone alignment system (80, 100, 150, Figs. 1-15C) arranged and capable of aligning a fractured bone segment (Figs. 8 and 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the bone alignment system comprising: a bone plate (80) including a plurality of screw holes (82s); a push rod (154, Figs. 10-14, 15B and 15C) including a proximal end (155 and to the right as shown in Figs. 15B and 15C, Figs. 15B and 15C), a distal end (156 and to the left as shown in Figs. 15B and 15C, Figs. 15B and 15C), and a central longitudinal axis (horizontal as shown in Figs. 15B and 15C, Figs. 15B and 15C) extending between the proximal and distal ends (Figs. 15B and 15C), the distal end comprising a blunt, sharpened, or spiked tip (158, Figs. 11-15C, ¶31) arranged and capable of contacting a patient's fractured bone segment to realign a position of the bone segment (Fig. 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); and a guide (152) arranged and capable of associating the push rod with the bone plate (Fig. 10, ¶s 32 and 33), the guide including a proximal end (157 and to the right as shown in Figs. 11, 12, and 15A, Figs. 11, 12, and 15A), a distal end (164 and to the left as shown in Figs. 11, 12, and 15A, Figs. 11, 12, and 15A), and a longitudinal bore (opening within 152 disclosed to receive 154 as shown in Figs. 10-12 and comprising internal threading in ¶32, Figs. 10-12) extending from the proximal end to the distal end (¶31 discloses 154 being received in 152, i.e. as shown in Figs. 10-12, ¶32 discloses 157 including internal threading for rotational coupling with 155 of 154), the distal end of the guide comprising a mechanism (adaptations of ¶32, Figs. 10-12 and 15A, where ¶32 discloses that 164 is adapted to interface in contact with an inner wall of hole 82, and ¶33 discloses that the interfacing of the 164 and the inner wall 81 of the hole 82 allows adjustment of the relative position of the fixation device 80 on the bone 60 in any direction) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 10, ¶s 32 and 33) capable of affixing the guide to the bone plate (¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment), and the push rod being capable of inserting within the longitudinal bore formed in the guide (Figs. 10, 11, and 12, ¶31), the push rod being capable of advancing relative to the affixed guide through the engaged screw hole when rotated within the longitudinal bore in the guide (Figs. 10-12, ¶s 31 and 32; where ¶32 discloses rotational coupling of 152 and 154 via internal threading of 157 and threaded portion 155 respectively) until the blunt, sharpened, or spiked tip contacts and engages with the fractured bone segment (¶33) to realign and maintain the position of the bone segment relative to the bone plate (Fig. 10, ¶s 25, 26, and 33, where ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶33 discloses adjustment of the relative position of the fixation device 80 on the bone 60 in any direction via relative rotation of 154 and 152 to push/pull the bone and bone plate) during subsequent fixation of the bone plate to the fractured bone segment (via screws 88, Fig. 10, ¶s 25, 26, and 32; where Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157). As to claim 3, Choe discloses that the push rod includes external threads (155, Figs. 15B and 15C, ¶s 31 and 32) capable of threadably engaging internal threads formed on a portion of the guide (¶s 31 and 32). As to claim 4, Choe discloses that the threaded engagement of the push rod to the guide is capable of maintaining a position of the push rod during the subsequent fixation of the bone plate to the fractured bone segment (¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction).
Choe is silent to the distal end comprising a generally flat surface extending generally perpendicular to the central longitudinal axis, the flat surface arranged and configured to contact a patient's fractured bone segment to realign a position of the bone segment, and the mechanism being a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate.
Davis teaches a similar bone alignment push rod (10, Figs. 1, 2, and 5) capable of aligning a fractured bone segment (Fig. 5, col. 5 line 65- col. 6 line 10 disclose insertion into bone and use to maneuver bone), the bone alignment push rod comprising: a push rod (10, Figs. 1, 2, and 5) including a proximal end (1), and a distal end (5, 6), and a central longitudinal axis (Fig. 1) extending between the proximal and distal ends (Fig. 1), the distal end comprising a generally flat surface (7) extending generally perpendicular to the central longitudinal axis (Fig. 2) and a blunt, sharpened, or spiked tip (6), the flat surface and the tip are capable of contacting a patient's fractured bone segment (col. 4 line 65 – col. 5 line 4 disclose face 7 providing a stop abutment for engagement with the bone hole) capable of realigning a position of the bone segment (col. 5 line 65- col. 6 line 10 disclose insertion into bone and use to maneuver bone); the push rod being capable of advancing until the blunt, sharpened, or spiked tip contacts and engages with the fractured bone segment (col. 4 lines 27-34) capable of realigning and maintaining the position of the bone segment relative to the bone plate during fixation of the fractured bone segment (col. 5 line 65- col. 6 line 10 disclose insertion into bone and use to maneuver bone).
Forstein teaches a similar bone alignment system (250, 255, 258, Fig. 41) arranged and configured to align a fractured bone segment (abstract), the bone alignment system comprising: a bone plate (255) including a plurality of screw holes (257s); a rod (shown in Fig. 41 inserted within and extending from 258, Fig. 41); and a guide (258) arranged and capable of associating the push rod with the bone plate (Fig. 41), the guide including a proximal end (upper end of 258 as shown in Fig. 41, Fig. 41), a distal end (lower end of 258 as shown in Fig. 41, Fig. 41), and a longitudinal bore (opening shown holding the rod in Fig. 41, Fig. 41), the distal end of the guide comprising a coupling mechanism (¶115 discloses that 258 is threaded into screw hole 257, i.e. 258 is threaded) comprising external threads (¶115 disclose that 258 is threaded into screw hole 257, i.e. 258 is threaded) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 41, ¶115) capable of rigidly affixing the guide to the bone plate (¶115), and the push rod being capable inserting within the longitudinal bore formed in the guide (Fig. 41).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the distal end as disclosed by Choe by adding the generally flat surface as taught by Davis in order to provide a stop abutment for engagement with the bone hole to limit insertion of the push rod into the bone to prevent over-penetration both during insertion and positioning manipulation of the bone segment (Davis col. 4 line 65 – col. 5 line 4). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the mechanism/interface of the guide tip and plate surface as well as screw heads as disclosed by Choe to be threaded as taught by Forstein in order to fix the relative positions (Forstein ¶115) to fix the position of bone fragments relative to the bone plate (Forstein ¶s 93 and 100) to aid in pulling/pushing a bone fragment and the bone plate (Choe ¶33) by securing the guide to the plate to enhance control of the relative positions of the bone and plate.
As to claim 6, Choe discloses the invention of claim 4 and appears to disclose that following removal of the push rod and the guide from the bone plate, a bone fastener (88) can be inserted into one of the plurality of screw holes with which the guide is capable of being engaged (Figs. 2 and 9 show that the screw holes are similarly sized and are thus capable of receiving screws 88 when the push rod and guide are not inserted therein).
Forstein further teaches that following removal of the rod and the guide from the bone plate (¶100), a bone fastener (screw of ¶100, ¶100) can be inserted into one of the plurality of screw holes with which the guide is capable of being engaged (¶100).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to clarify the apparent disclosure of Choe to specifically include, following removal of the rod and the guide from the bone plate, a bone fastener inserted into the screw hole used by the guide as taught by Forstein in order to fix the position of bone fragments relative to the bone plate (Forstein ¶93).
Claim(s) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe et al. (US 2007/0276401, hereinafter “Choe”) in view of Forstein et al. (US 2006/0173458, hereinafter “Forstein”).
As to claims 8, 9, and 11-13, Choe discloses a method (Figs. 1-15C) of aligning and securing a fractured bone segment (bone fragment/portion of ¶33, Figs. 8 and 10) to a bone plate (80) including a plurality of screw holes (82s, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the method comprising: positioning a bone plate (80) comprising a plurality of screw holes (82s) across a patient's bone (Figs. 8 and 10) including a fracture (bone fragment/portion of ¶33); securing a first portion of the bone plate to the patient's bone (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100); securing a second portion of the bone plate to the patient's bone (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100); identifying one or more bone fragments requiring alignment (¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); affixing a guide (152) to the bone plate (Fig. 10, ¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment); the guide comprising a mechanism (adaptations of ¶32, Figs. 10-12 and 15A, where ¶32 discloses that 164 is adapted to interface in contact with an inner wall of hole 82, and ¶33 discloses that the interfacing of the 164 and the inner wall 81 of the hole 82 allows adjustment of the relative position of the fixation device 80 on the bone 60 in any direction) capable of engaging one of the plurality of screw holes in the bone plate (Fig. 10, ¶s 32 and 33) capable of affixing the guide to the bone plate (¶33 discloses that the interface allows adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment); inserting a push rod (154) comprising a blunt, sharpened, or spiked tip (158, Figs. 11-15C, ¶31) on a distal end of the push rod (Figs. 11-15C) into the guide (Figs. 10-12, ¶31 discloses 154 being received in 152, i.e. as shown in Figs. 10-12, ¶132 discloses 157 including internal threading for rotational coupling with 155 of 154); advancing the push rod through the engaged screw hole until the blunt, sharpened, or spiked tip contacts the fractured bone segment (Fig. 10, ¶31 discloses that threaded portion 156 terminates at bone-gripping tip 158, ¶33 discloses using to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction), the push rod capable of advancing relative to the affixed guide when rotated within a bore (opening within 152 disclosed to receive 154 as shown in Figs. 10-12 and comprising internal threading in ¶32, Figs. 10-12) in the guide (Figs. 10-12, ¶s 31 and 32; where ¶32 discloses rotational coupling of 152 and 154 via internal threading of 157 and threaded portion 155 respectively); realigning the fractured bone segment (¶33 discloses using to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction); maintaining a position of the realigned fractured bone segment (Fig. 10, ¶s 25, 26, and 33, where ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, and ¶33 discloses adjustment of the relative position of the fixation device 80 on the bone 60 in any direction via relative rotation of 154 and 152 to push/pull the bone and bone plate); and subsequently securing bone fixation elements (88s) through additional screw holes (82s) of the plurality of screw holes in the bone plate to secure the bone plate to the fractured bone segment (¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100); wherein maintaining the position of the realigned fractured bone segment prevents the bone segment from moving towards the bone plate (¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction). As to claim 9, Choe discloses that realigning the fractured bone segment comprises moving the fractured bone fragment away from the bone plate (Fig. 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction, where review of Fig. 10 shows that using 154 to push the bone fragment/portion would move the bone fragment/portion away from the bone plate). As to claim 11, Choe discloses that the step of realigning the fractured bone segment comprises advancing the push rod against the fractured bone segment until a sufficient separation of the fractured bone segment from the bone plate is achieved (¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction, where review of Fig. 10 shows that using 154 to push the bone fragment/portion would move the bone fragment/portion away from the bone plate). As to claim 12, Choe discloses that advancing the push rod includes threadably engaging the push rod to the guide (via threads internal on 157 and 155, Figs. 11-12, 15B, and 15C, ¶s 31 and 32, where ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157) so that rotation of the push rod advances the push rod, and hence the fractured bone segment, relative to the bone plate (Figs. 10-15C, ¶s31-33, where ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction). As to claim 13, Choe discloses maintaining the push rod in contact with the fractured bone segment during subsequent fixation (via screws 88, Fig. 10, ¶s 25, 26, and 32; where Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157, and ¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100) capable of maintaining the realigned position of the fractured bone segment relative to the bone plate (Fig. 10 shows many unobstructed 82s through which a screw could be inserted while the positions shown of 150 are maintained, ¶25 discloses the procedure for after the bone plate 80 is placed relative to the bone that culminates in ¶26 with inserting screws 88 into any of the holes 82 not used in attaching the device 100, ¶32 discloses rotational coupling between the guide and the push rod via 155 and threading within 157, ¶26 discloses inserting screws 88 into any of the holes 82 not used in attaching the device 100).
Choe is silent to the mechanism being a coupling mechanism comprising external threads configured to engage one of the plurality of screw holes in the bone plate to rigidly affix the guide to the bone plate as well as an explicit description that maintaining the position of the realigned fractured bone segment prevents the bone segment from moving towards the bone plate.
Forstein teaches a similar method (Fig. 41) of aligning and securing a fractured bone segment (abstract) to a bone plate (255) including a plurality of screw holes (257s), the method comprising: positioning a bone plate (255) comprising a plurality of screw holes (257s) across a patient's bone including a fracture (abstract); securing a first portion of the bone plate to the patient's bone (¶s 93 and 100); securing a second portion of the bone plate to the patient's bone (¶93); affixing a guide (258) to the bone plate (Fig. 41, ¶115), the guide comprising a coupling mechanism (¶115 discloses that 258 is threaded into screw hole 257, i.e. 258 is threaded) comprising external threads (¶115 disclose that 258 is threaded into screw hole 257, i.e. 258 is threaded) capable of engaging one of the plurality of screw holes in the bone plate (¶115) capable of rigidly affixing the guide to the bone plate (¶115), inserting a rod (shown in Fig. 41 inserted within and extending from 258, Fig. 41) into the guide (Fig. 41); and securing bone fixation elements (screw of ¶100, ¶100) through additional screw holes (257s) in the bone plate to secure the bone plate to the fractured bone segment (¶s 100 and 101). As to claim 10, Forstein teaches affixing the guide to the bone plate comprises threadably engaging (in as much as Applicant’s, Fig. 41, ¶115) a distal end of the guide to a screw hole of the plurality of screw holes in the bone plate (in as much as Applicant’s, Fig. 41, ¶115 discloses that 258 is threaded into screw hole 257).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the mechanism/interface of the guide tip and plate surface as well as screw heads as disclosed by Choe to be threaded as taught by Forstein in order to fix the relative positions (Forstein ¶115) to fix the position of bone fragments relative to the bone plate (Forstein ¶s 93 and 100) to aid in pulling/pushing a bone fragment and the bone plate (Choe ¶33) by securing the guide to the plate to enhance control of the relative positions of the bone and plate. Further, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to specify that the maintaining of the position of the realigned fractured bone segment of Choe prevents the bone segment from moving towards the bone plate, since Applicant has not disclosed that such is anything more than one of numerous configurations a person ordinary skill in the art would find obvious for the purpose of temporarily fixating a bone fragment by pushing and pulling the bone fragment relative to the bone plate to adjust the relative positioning of the bone and bone plate (Choe ¶33) with the push rod threadedly connected (Choe ¶32) while inserting a bone screw in to the screw holes of the bone plate (Choe ¶26) which would maintain/prevent inadvertent changes in relative positioning in the absence of relative rotation of the threaded connection due to the disclosed structure, i.e. it would be obvious to specify that the provided threaded connection acts to prevent movement away from the realigned position achieved by the adjustment when the user is not adjusting the threaded connection.
As to claim 10, Choe discloses positioning the guide in the one of the plurality of screw holes positioned nearest an end of the fracture (Fig. 10, ¶s 26, 32, 33, and 26, where ¶33 discloses adjustment of the relative position of 80 on the bone in any direction, i.e. in order to both adjust in both a pushing and a pulling direction, there must be sufficient affixation to enable such adjustment, where ¶26 discloses inserting bone screw 88 into any of the bone plate holes other than those engaged with assembly 120 of targeting device 100).
Choe is silent to an explicit description of positioning the guide in the one of the plurality of screw holes positioned nearest an end of the fracture.
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to specify that positioning the guide in one of the plurality of screw holes to adjust the relative position of the bone and bone plate of Choe includes positioning the guide in the one of the plurality of screw holes positioned nearest an end of the fracture, since Applicant has not disclosed that such is anything more than one of numerous configurations a person ordinary skill in the art would find obvious for the purpose of adjusting the relative position of the bone and bone plate (Choe ¶33) by inserting the guide into one of a finite number of bone screw holes in the bone plate (Choe Fig. 1, ¶33).
As to claim 14, Choe discloses the invention of claim 10 and appears to disclose removing the push rod and the guide (¶24 discloses removing 100), and inserting an additional bone fixation element (88) into the fractured bone segment through the one of the plurality of screw holes previously engaged by the guide and the push rod (Figs. 2 and 9 show that the screw holes are similarly sized and are thus capable of receiving screws 88 when the push rod and guide are not inserted therein).
Forstein further teaches removing the rod and the guide (¶100), and inserting an additional bone fixation element (screw of ¶100, ¶100) into the fractured bone segment through the one of the plurality of screw holes previously occupied by the guide and the rod (¶100).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to clarify the apparent disclosure of Choe to specifically include removing the push rod and the guide and inserting an additional bone fixation element into the fractured bone segment through the screw hole previously occupied by the guide and the push rod as taught by Forstein in order to fix the position of bone fragments relative to the bone plate (Forstein ¶93).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choe and Forstein in view of Davis (US 5,626,583).
As to claim 14, the combination of Choe and Forstein discloses the invention of claim 8 as well as the push rod further comprising a proximal end (155 and to the right as shown in Figs. 15B and 15C, Figs. 15B and 15C) and a central longitudinal axis (horizontal as shown in Figs. 15B and 15C, Figs. 15B and 15C) extending between the proximal and distal ends (Figs. 15B and 15C), wherein the tip are arranged and capable of contacting the patient's fractured bone segment (Fig. 10, ¶33 discloses using 154 to pull/push a bone fragment/portion with 150 to allow adjustment of the relative position of the fixation device/plate 80 on the bone 60 in any direction).
The combination of Choe and Forstein is silent to the distal end comprising a generally flat surface extending generally perpendicular to the central longitudinal axis, wherein the flat surface is arranged and configured to contact the patient's fractured bone segment.
Davis teaches a similar bone alignment push rod (10, Figs. 1, 2, and 5) capable of aligning a fractured bone segment (Fig. 5, col. 5 line 65 - col. 6 line 10 disclose insertion into bone and use to maneuver bone), the bone alignment push rod comprising: a push rod (10, Figs. 1, 2, and 5) including a proximal end (1), and a distal end (5, 6), and a central longitudinal axis (Fig. 1) extending between the proximal and distal ends (Fig. 1), the distal end comprising a generally flat surface (7) extending generally perpendicular to the central longitudinal axis (Fig. 2) and a blunt, sharpened, or spiked tip (6), the flat surface and the tip are capable of contacting a patient's fractured bone segment (col. 4 line 65 – col. 5 line 4 disclose face 7 providing a stop abutment for engagement with the bone hole) capable of realigning a position of the bone segment (col. 5 line 65- col. 6 line 10 disclose insertion into bone and use to maneuver bone); the push rod being capable of advancing until the blunt, sharpened, or spiked tip contacts and engages with the fractured bone segment (col. 4 lines 27-34) capable of realigning and maintaining the position of the bone segment relative to the bone plate during fixation of the fractured bone segment (col. 5 line 65- col. 6 line 10 disclose insertion into bone and use to maneuver bone).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the distal end as disclosed by the combination of Choe and Forstein by adding the generally flat surface as taught by Davis in order to provide a stop abutment for engagement with the bone hole to limit insertion of the push rod into the bone to prevent over-penetration both during insertion and positioning manipulation of the bone segment (Davis col. 4 line 65 – col. 5 line 4).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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