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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 24 November 2025. As directed by the amendment: claims 1, 4, 9, 15, and 17 have been amended. Claims 1-19 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are correspondingly withdrawn. However, further claim objections as necessitated by the claim amendments are presented below.
Response to Arguments
Applicant's arguments filed 24 November 2025 with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant contends that importing Mebarak’s (US 9,138,244) threaded drill guide and sleeve architecture would require substantial redesign or defeat Segina’s (US 8,709,092) intended targeting purpose. Examiner respectfully submits that Mebarak is relied upon as a teaching of the sleeve architecture and the interaction of the drill guide and the plate. Adding threaded interaction between the drill guide and the plate would only increase the stability of the device. Segina already requires alignment of the targeting guide, plate, and nail, and adding a threaded interaction between the drill guide and the plate would not defeat this intended purpose or require substantial redesign or affect the targeting function.
The added claim limitations of the targeting guide rotating around the longitudinal axis of the nail when the nail is inserted in bone can be achieved in various ways by Segina/Mebarak. As articulated in the below rejections, when the intramedullary nail is disposed in bone as in Segina FIG. 2 and the bone itself is rotated around the intramedullary nail longitudinal axis, the targeting guide will also be rotated around the intramedullary nail longitudinal axis along with the bone to which it is attached, while the cylindrical passageway maintains the simultaneous alignment so that drilling can occur since the device and bone are attached to each other and will rotate as one. The bone may be rotated around the intramedullary nail longitudinal axis, and/or the patient/table may be rotated around the axis, to adjust the position of the bone for easier surgical access or viewing. Therefore the targeting guide rotating would not affect the alignment disclosed by Segina since the device disclosed by Segina would rotate as a whole and maintain relative positioning of the nail, plate, and targeting guide.
The center-to-center distance equality and matching, as well as the simultaneous alignment, are disclosed by Segina, and they are not impacted by the targeting guide rotating as interpreted above since the nail, plate, and targeting guide maintain their relative positioning throughout the rotation since the device rotates as a whole along with the bone.
Examiner notes that the targeting guide is not positively recited. Therefore any limitations regarding the targeting guide are interpreted as language of intended use, and the reliance on “capable of” rotation of Segina/Mebarak meets this intended use. The targeting guide in Segina is recited in the rejection in the interest of compact prosecution; however, a targeting guide need not be disclosed to meet the claim, since the targeting guide is not positively recited. The tubular section(s) need only be capable of being received in an opening of a targeting guide that would maintain a fixed orientation. Any further limitations regarding the targeting guide would not make it less not positively recited.
As to claim 17, Applicant contends that Segina is silent as to sole drill guide support with free sliding while maintaining alignment, and Mebarak’s threaded fixation suggests securing the plate rather than enabling the claimed free sliding. Examiner respectfully submits that in view of Mebarak, the drill guide solely supports the plate, i.e. is threadedly secured to the plate as suggested by Applicant. The drill guide is slidably positioned in the targeting guide at least during assembly, and is fully capable of sliding freely in the targeting guide, so that, because the bone plate is supported solely by the drill guides, the bone plate is fully capable is sliding freely in a direction parallel to a longitudinal axis of the drill guide and perpendicular to the longitudinal axes of the intramedullary nail and the bone plate (in the direction of sliding of the drill guides in the targeting guide). Again, since the targeting guide is not positively recited, and the limitation recites that the bone plate is configured to slide freely in a direction parallel to a longitudinal axis of the drill guide, this could be met by free handedly translating the drill guide with attached bone plate toward the nail, i.e. the claim does not require that the drill guide slides freely in the targeting guide (that the free sliding is governed by the targeting guide) and even if it did, the targeting guide is not positively recited.
Claim Objections
Claims 1-3 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 23: “the second longitudinal axis”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-19 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 4, the specification is silent as to “wherein the simultaneous alignment is maintained while the first implant is disposed in bone and the targeting guide is rotated around the first implant longitudinal axis during drilling” (lines 27-29) because the specification does not recite that the targeting guide is rotated around the first implant longitudinal axis during drilling. Drilling does not occur during rotation of the targeting guide, but rather after rotation has been completed, otherwise the drilling would not take a linear path through the bone.
As to claim 17, the specification is silent as to “while the simultaneous alignment is maintained during rotation of the targeting guide around the intramedullary nail longitudinal axis with the intramedullary nail being disposed in bone during drilling” (lines 32-35) because the specification does not recite that the targeting guide is rotated around the intramedullary nail longitudinal axis during drilling. Drilling does not occur during rotation of the targeting guide, but rather after rotation has been completed, otherwise the drilling would not take a linear path through the bone.
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 4-19 are rejected under 35 U.S.C. 112(b) 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.
As to claim 4, the limitation “first and second drill guide holes of the targeting guide” (lines 32-33) render the claims indefinite, because it is unclear if the drill guide holes refer back to the previously recited opening in the targeting guide (claim 4 / line 14) or to different drill guide holes. For examination purposes, the limitation will be interpreted in the former instance, as the opening in the targeting guide is adapted to be a first drill guide hole, and the targeting guide comprises a second drill guide hole.
As to claim 6, the limitation “a first drill guide hole” renders the claims indefinite, because it is unclear if this refers back to the previously recited first drill guide hole of the targeting guide (claim 4 / lines 32-33) or to a different first drill guide hole. For examination purposes, the limitation will be interpreted in the former instance, as the first drill guide hole. However, this would not be further limiting and claim 6 is suggested to be deleted.
As to claim 15, the limitation “an alternative opening in the targeting guide” renders the claims indefinite, because it is unclear if this refers back to the previously recited second drill guide hole of the targeting guide (claim 4 / lines 32-33) or to a different alternative opening. For examination purposes, the limitation will be interpreted in the former instance, as the second drill guide hole. Corresponding amendment would need to be made to claim 16.
As to claim 17, the limitation “the drill guide(s)” (line 30) renders the claims indefinite because it is unclear if this encompasses a plurality of drill guides, and if so, a plurality of drill guides lacks proper antecedent basis in the claims. There is “a drill guide” recited in claim 17 / line 8 but not “drill guides.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 fails to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 2, and 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 8,709,092 to Segina et al. (hereinafter, “Segina”), in view of U.S. Patent No. US 9,138,244 to Mebarak et al. (hereinafter, “Mebarak”).
As to claim 1, Segina discloses a drill guide device (207) comprising: a first tubular section having a first outer diameter and aligned with an opening in a first bone implant (204A, 204B, 204C) of a pair of bone implants, FIG. 2, the first bone implant including a first longitudinal axis (axis of distal end of plate, parallel to axis of bone), a second bone implant (201) of the pair of bone implants including a second longitudinal axis (axis extending along the solid line drawn through the bone in FIG. 2, parallel to the first longitudinal axis), the first bone implant rotatable around the second longitudinal axis while maintaining the second longitudinal axis in parallel with the first longitudinal axis (the first bone implant is fully capable of rotating around the second longitudinal axis, for example when not disposed in/attached to the bone, and since the first and second longitudinal axes are parallel, at least at their distal ends in FIG. 2, rotating around the second longitudinal axis, about the solid line drawn through the bone in FIG. 2, would maintain the axes in parallel, i.e. the axes are parallel so rotating about one axis/maintaining that axis stationary would not change the parallel position of the other axis); an opening of a targeting guide (205), the targeting guide adapted to maintain a fixed orientation between the opening in the targeting guide and an opening in the second bone implant (in order to maintain alignment between the openings to guide the drill guide device and drill/screw 206 through the opening in the targeting guide and into the opening in the second bone implant, FIG. 2), the opening of the targeting guide adapted to be aligned with the opening in the first bone implant (one drill guide passes through the opening of the targeting guide and the aligned opening in the first bone implant), FIG. 2; wherein the drill guide device has a cylindrical passage having an inner diameter smaller than the first outer diameter, the cylindrical passage adapted to simultaneously align: a drill for drilling bone (interpreted as intended use; the cylindrical passageway is fully capable of accepting a drill, and/or a screw could be interpreted as a drill if self-drilling), the opening in the first bone implant, and the opening in the second bone implant (201) of the pair of bone implants, FIG. 2, wherein, when the second bone implant is inserted in bone and the targeting guide is rotated around the longitudinal axis of the second bone implant, the cylindrical passage maintains the simultaneous alignment during drilling (when the second bone implant is inserted in bone as in FIG. 2 and the bone is rotated around the longitudinal axis of the second bone implant, the targeting guide will also be rotated around the longitudinal axis of the second bone implant along with the bone to which it is attached, while the cylindrical passage maintains the simultaneous alignment so that drilling can occur since the device and bone are attached to each other and will rotate as one; the bone may be rotated around the longitudinal axis of the second bone implant, and/or the patient/table may be rotated around the axis, to adjust the position of the bone for easier surgical access or viewing).
As to claim 2, Segina discloses the drill guide device of claim 1, wherein the drill guide device is a drill guide assembly comprising: a drill guide including the first tubular section, wherein the first outer diameter is an outer diameter of the drill guide, and the cylindrical passage extends throughout an entire length of the drill guide.
Segina is silent as to the drill guide device comprising the first tubular section having a threaded end configured to engage a threaded opening in a first bone implant of a pair of bone implants; a second tubular section having a second outer diameter greater than the first outer diameter, the second tubular section configured to be slidably received within an opening in a targeting guide, the opening of the targeting guide adapted to be aligned with the threaded opening in the first bone implant; a third tubular section having a third outer diameter greater than an inner diameter of the opening of the targeting guide, the third tubular section configured to prevent the drill guide device from falling through the opening of the targeting guide, wherein the drill guide device has a cylindrical passage extending from the threaded end of the first tubular section to an end of the drill guide device opposite the threaded end (claim 1); a sleeve including the second tubular section and the third tubular section, the sleeve having a second passage with a second inner diameter adapted to receive the drill guide (claim 2).
As to claim 1, Mebarak teaches a drill guide device, FIGS. 41-47, comprising: a first tubular section (1404) having a first outer diameter (outer diameter at 1404) (col. 19 / lines 42-46), the first tubular section having a threaded end (1414) configured to engage a threaded opening in a first bone implant (1010a; col. 20 / lines 14-19), FIGS. 41 and 46, of a pair of bone implants (1010a and 1010; interpreted as language of intended use without positive recitation of the first or pair of bone implants, and deemed anticipated by the prior art if the prior art is capable of performing said intended use; the relationship of the pair of bone implants with each other and with the drill guide device is undefined, and Mebarak’s drill guide device is fully capable of use with each of the pair of bone implants if that is implied); a second tubular section (1204) having a second outer diameter greater than the first outer diameter (since 1404 is received in 1204), FIGS. 41 and 43, the second tubular section configured to be slidably received within an opening (1110) in a targeting guide (1102), FIG. 41, the opening of the targeting guide adapted to be aligned with the threaded opening in the first bone implant, FIG. 41; a third tubular section (1202) having a third outer diameter greater than an inner diameter of the opening of the targeting guide, FIGS. 41 and 43, the third tubular section configured to prevent the drill guide device from falling through the opening of the targeting guide, wherein the drill guide device has a cylindrical passage (1406) extending from the threaded end of the first tubular section to an end of the drill guide device opposite the threaded end (col. 19 / lines 44-46), FIG. 45, the cylindrical passage having an inner diameter smaller than the first outer diameter, the cylindrical passage adapted to receive and simultaneously align a drill for drilling bone (col. 20 / lines 24-28) and the threaded opening in the first bone implant, FIG. 41.
As to claim 2, Mebarak teaches the drill guide device of claim 1, wherein the drill guide device is a drill guide assembly comprising: a drill guide (1400) including the first tubular section, FIG. 44, wherein the first outer diameter is an outer diameter of the drill guide, and the cylindrical passage extends throughout an entire length of the drill guide, FIG. 45; a sleeve (1200) including the second tubular section and the third tubular section, FIG. 43, the sleeve having a second passage with a second inner diameter adapted to receive the drill guide, FIG. 41.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include drill guide devices in Segina’s system, the drill guide devices including an inner drill guide and an outer sleeve, as taught by Mebarak, so that the outer sleeve can be received in the openings in Segina’s targeting guide to guide placement of various tools, such as drivers and screws, throughout the procedure so that all of the tools are aligned with the first and second implant holes, with the inserted inner drill guide providing a close fit to an inserted drill bit for accurately guiding the drill bit. As taught by Mebarak, the drill guide device would have a first tubular section having a first outer diameter and a threaded end, and the bone plate (first bone implant) in Segina would be modified to have correspondingly threaded openings with mating threads to receive the threaded ends for secure connection. The drill guide device would have the sleeve including the second and third tubular sections, where the third outer diameter prevents the drill guide from falling through the opening of the targeting guide. The drill guide is configured to engage and hold the bone plate (first bone implant) via the threaded interaction. The drill guide is slidably positioned in the targeting guide at least during assembly, and is fully capable of being slidable in the targeting guide for moving the bone plate relative to the intramedullary nail, if the drill guides are not fully seated in the targeting guide while attached to the bone plate, or backed out of the targeting guide while attached to the bone plate. As applied to Segina, the drill guide device would have a cylindrical passage extending from the threaded end to an opposite end, as taught by Mebarak, the cylindrical passage having an inner diameter smaller than the first outer diameter, the cylindrical passage adapted to receive and simultaneously align a drill (interpreted as intended use; the cylindrical passageway is fully capable of accepting a drill, and/or a screw could be interpreted as a drill if self-drilling), the threaded opening in the first bone implant (bone plate), and an opening in a second bone implant (intramedullary nail 201 in Segina, FIG. 2) of the pair of bone implants, since Segina requires this alignment so that a single screw can pass through the aligned openings of the two implants.
As to claim 4, Segina discloses a system comprising: a first implant (201) including first and second screw receiving holes (col. 5 / lines 8-12), FIG. 2, and a first implant longitudinal axis (axis extending along the solid line drawn through the bone in FIG. 2), the first and second screw receiving holes having respective first and second hole longitudinal axes aligned with a respective transverse axis of the first implant, FIG. 2; a second implant (204A, 204B, 204C) including third and fourth screw receiving holes, FIG. 2, and a second implant longitudinal axis (axis of distal end of plate, parallel to the axis of bone and the first implant longitudinal axis), the third and fourth screw receiving holes having respective third and fourth hole longitudinal axes aligned with a respective transverse axis of the second implant, the second implant rotatable around the first implant longitudinal axis while maintaining the second implant longitudinal axis in parallel with the first implant longitudinal axis (the second implant is fully capable of rotating around the first longitudinal axis, for example when not disposed in/attached to the bone, and since the first and second longitudinal axes are parallel, at least at their distal ends in FIG. 2, rotating around the first longitudinal axis, about the solid line drawn through the bone in FIG. 2, would maintain the axes in parallel, i.e. the axes are parallel so rotating about one axis/maintaining that axis stationary would not change the parallel position of the other axis); and a drill guide (207) including a first tubular section having a first outer diameter and aligned with the third screw receiving hole; an opening of a targeting guide (205), the targeting guide adapted to maintain a fixed orientation between the opening in the targeting guide and the first screw receiving hole (in order to maintain alignment between the opening in the targeting guide and the first screw receiving hole to guide the drill guide and drill/screw 206 through the opening in the targeting guide and into the first screw receiving hole, FIG. 2), the opening of the targeting guide adapted to be aligned with the third screw receiving hole (one drill guide passes through the opening of the targeting guide and the aligned third screw receiving hole in the second implant), FIG. 2; wherein the drill guide has a cylindrical passageway having an inner diameter smaller than the first outer diameter, the cylindrical passageway adapted to simultaneously align a drill (interpreted as intended use; the cylindrical passageway is fully capable of accepting a drill, and/or a screw could be interpreted as a drill if self-drilling), the first screw receiving hole, and the third screw receiving hole (the first and third screw receiving holes comprise holes in the implants that are aligned in FIG. 2 and accept the same drill/screw 206), FIG. 2, wherein the simultaneous alignment is maintained while the first implant is disposed in bone, FIG. 2, and the targeting guide is rotated around the first implant longitudinal axis during drilling (when the first implant is disposed in bone as in FIG. 2 and the bone is rotated around the first implant longitudinal axis, the targeting guide will also be rotated around the first implant longitudinal axis along with the bone to which it is attached, while the cylindrical passageway maintains the simultaneous alignment so that drilling can occur since the device and bone are attached to each other and will rotate as one; the bone may be rotated around the first implant longitudinal axis, and/or the patient/table may be rotated around the axis, to adjust the position of the bone for easier surgical access or viewing), and wherein a center-to-center distance between the first and second screw receiving holes of the first implant equals a center-to-center distance between the third and fourth screw receiving holes of the second implant and a center-to-center distance between first and second drill guide holes of the targeting guide, FIG. 2.
As to claim 5, Segina discloses the system of claim 4, wherein the drill guide is positioned within the second implant and the targeting guide (205), FIG. 2.
As to claim 6, Segina discloses the system of claim 4, wherein the opening in the targeting guide (205) is adapted to be a first drill guide hole, FIG. 2.
As to claim 7, Segina discloses the system of claim 6, wherein the first drill guide hole is configured for receipt of the drill guide, FIG. 2.
As to claim 8, Segina discloses the system of claim 4, wherein the targeting guide alone holds the first implant, FIG. 2.
As to claim 10, Segina discloses the system of claim 5, wherein the first implant is an intramedullary nail, and the second implant is a bone plate, FIG. 2.
As to claim 11, Segina discloses the system of claim 10, wherein the first implant longitudinal axis and the second implant longitudinal axis being perpendicular to the first, second, third, and fourth hole longitudinal axes, FIG. 2.
As to claim 12, Segina discloses the system of claim 11, wherein the targeting guide is configured to support the bone plate with the first implant longitudinal axis parallel to the second implant longitudinal axis, FIG. 2.
As to claim 14, Segina discloses the system of claim 11, wherein the targeting guide with the intramedullary nail attached thereto can rotate around the first implant longitudinal axis of the intramedullary nail (the assembled system is fully capable of rotating around the first implant longitudinal axis of the nail, before implantation, to achieve appropriate alignment of the nail within the bone).
Segina is silent as to the drill guide including a first tubular section having a first outer diameter and a threaded end configured to engage the third screw receiving hole, where the third screw receiving hole is a threaded opening; a second tubular section having a second outer diameter greater than the first outer diameter, the second tubular section configured to be slidably received within an opening in a targeting guide, the opening of the targeting guide adapted to be aligned with the threaded opening; a third tubular section having a third outer diameter greater than an inner diameter of the opening of the targeting guide, the third tubular section configured to prevent the drill guide from falling through the opening of the targeting guide, wherein the drill guide has a cylindrical passageway defined from the threaded end of the first tubular section to an end of the drill guide opposite the threaded end, the cylindrical passageway having an inner diameter smaller than the first outer diameter, the cylindrical passageway adapted to align a drill (claim 4); the drill guide is configured to engage and hold the second implant (claim 8); wherein the threaded opening and an alternative threaded opening have mating threads for engaging the threaded end (claim 9); wherein the drill guide is slidably positioned in the targeting guide while threaded into the threaded opening of the bone plate, for moving the bone plate relative to the intramedullary nail (claim 13); further comprising a fourth tubular section having a fourth outer diameter greater than the first outer diameter, the fourth tubular section configured to be slidably received within an alternative opening in the targeting guide, the alternative opening of the targeting guide adapted to be aligned with the fourth screw receiving hole; wherein the second tubular section and the fourth tubular section are slidably mounted in the targeting guide, and the drill guide is concentrically held inside the second tubular section or the fourth tubular section (claim 15); wherein the fourth tubular section has a shoulder for retaining the fourth tubular section within the alternative opening of the targeting guide (claim 16).
As to claim 4, Mebarak teaches a system comprising: a first implant (1010) including first and second screw receiving holes (1016) and a first implant longitudinal axis, the first and second screw receiving holes having respective first and second hole longitudinal axes aligned with a respective transverse axis of the first implant, FIG. 31; a second implant (1010a) including third and fourth screw receiving holes (1016) and a second implant longitudinal axis, the third and fourth screw receiving holes having respective third and fourth hole longitudinal axes aligned with a respective transverse axis of the second implant, FIGS. 39 and 41; and a drill guide including a first tubular section (1404) having a first outer diameter (outer diameter at 1404) (col. 19 / lines 42-46) and a threaded end (1414) configured to engage a threaded opening in the third screw receiving hole, where the third screw receiving hole is a threaded opening (col. 20 / lines 14-19), FIGS. 41 and 46; a second tubular section (1204) having a second outer diameter greater than the first outer diameter (since 1404 is received in 1204), FIGS. 41 and 43, the second tubular section configured to be slidably received within an opening (1110) in a targeting guide (1102), FIG. 41, the opening of the targeting guide adapted to be aligned with the threaded opening, FIG. 41; a third tubular section (1202) having a third outer diameter greater than an inner diameter of the opening of the targeting guide, FIGS. 41 and 43, the third tubular section configured to prevent the drill guide from falling through the opening of the targeting guide, wherein the drill guide has a cylindrical passageway (1406) defined from the threaded end of the first tubular section to an end of the drill guide opposite the threaded end (col. 19 / lines 44-46), FIG. 45, the cylindrical passageway having an inner diameter smaller than the first outer diameter, the cylindrical passageway adapted to receive and simultaneously align a drill (col. 20 / lines 24-28) and the third screw receiving hole, FIG. 41.
As to claim 5, Mebarak teaches the system of claim 4, wherein the drill guide is positioned within the second implant and the targeting guide, FIG. 41.
As to claim 6, Mebarak discloses the system of claim 4, wherein the opening in the targeting guide is adapted to be a first drill guide hole (1110), FIG. 41.
As to claim 7, Mebarak teaches the system of claim 6, wherein the first drill guide hole is configured for receipt of the drill guide, FIG. 41.
As to claim 8, Mebarak teaches the system of claim 4, wherein the targeting guide alone holds the first implant (when so used with and attached to the first implant, via the base shown in FIG. 41, before the drill guides are attached), and the drill guide is configured to engage and hold the second implant (when so used with and attached to the second implant, via the threaded end).
As to claim 9, Mebarak discloses the system of claim 5, wherein the fourth screw receiving hole is an alternative threaded opening and the threaded opening and the alternative threaded opening in the fourth screw receiving hole have mating threads for engaging the threaded end (col. 20 / lines 14-19).
As to claim 13, Mebarak teaches wherein the drill guide is slidably positioned in the targeting guide (at least during assembly) while threaded into the threaded opening of the bone plate, for moving the bone plate relative to the intramedullary nail (interpreted as language of intended use; the drill guide is fully capable of being slidable in the targeting guide for moving the bone plate relative to the intramedullary nail, if the drill guides are not fully seated in the targeting guide while threadedly attached to the bone plate, or backed out of the targeting guide while threadedly attached to the bone plate; note that the targeting guide is not positively recited and any guide such as a guide with unthreaded holes could be used with the drill guides, so that the drill guides are slidably positioned therein).
As to claim 15, Mebarak teaches further comprising a fourth tubular section (another 1204), FIG. 41, having a fourth outer diameter greater than the first outer diameter (since 1404 is received in 1204), the fourth tubular section configured to be slidably received (at least during assembly) within an alternative opening (any of the plurality of 1110s) in the targeting guide, FIG. 41, the alternative opening of the targeting guide adapted to be aligned with an alternative threaded opening in the fourth screw receiving hole which is an alternative threaded opening, FIG. 41; wherein the second tubular section and the fourth tubular section are slidably mounted in the targeting guide (at least during assembly), and the drill guide is concentrically held inside the second tubular section or the fourth tubular section (depending on which one is being drilled at the moment, as shown in FIG. 41).
As to claim 16, Mebarak teaches the system of claim 15, wherein the fourth tubular section has a shoulder (distal surface of 1202) for retaining the fourth tubular section within the alternative opening of the targeting guide, FIGS. 41 and 43.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include drill guides in Segina’s system, the drill guides including an inner drill guide and an outer sleeve, as taught by Mebarak, so that the outer sleeve can be received in the openings in Segina’s targeting guide to guide placement of various tools, such as drivers and screws, throughout the procedure so that all of the tools are aligned with the first and second implant holes, with the inserted inner drill guide providing a close fit to an inserted drill bit for accurately guiding the drill bit. As taught by Mebarak, the drill guide would have a first tubular section having a first outer diameter and a threaded end, and the bone plate (second implant) in Segina would be modified to have correspondingly threaded openings with mating threads to receive the threaded ends for secure connection. The drill guide would have the sleeve including the second and third tubular sections, where the third outer diameter prevents the drill guide from falling through the opening of the targeting guide. The drill guide is configured to engage and hold the bone plate (second implant) via the threaded interaction. The drill guide is slidably positioned in the targeting guide at least during assembly, and is fully capable of being slidable in the targeting guide for moving the bone plate relative to the intramedullary nail, if the drill guides are not fully seated in the targeting guide while attached to the bone plate, or backed out of the targeting guide while attached to the bone plate. As also taught by Mebarak, there would be another sleeve including a fourth tubular section, slidably received in another opening of the targeting guide, to provide guidance through a plurality of the openings of the targeting guide for guidance to respective aligned holes of the implants. As applied to Segina, the drill guide would have a cylindrical passageway defined from the threaded end to an opposite end, as taught by Mebarak, the cylindrical passageway having an inner diameter smaller than the first outer diameter, the cylindrical passageway adapted to receive and simultaneously align a drill (interpreted as intended use; the cylindrical passageway is fully capable of accepting a drill, and/or a screw could be interpreted as a drill if self-drilling), the first screw receiving hole, and the third screw receiving hole, since Segina requires this alignment so that a single screw can pass through the aligned first and third screw receiving holes of the two implants.
As to claim 17, Segina discloses a system comprising: an intramedullary nail (201) including first and second screw receiving holes and an intramedullary nail longitudinal axis (axis extending along the solid line drawn through the bone in FIG. 2) (col. 5 / lines 8-12), FIG. 2; a bone plate (204A, 204B, 204C) including third and fourth screw receiving holes and a bone plate longitudinal axis (axis of distal end of plate, parallel to the axis of bone and the intramedullary nail longitudinal axis), FIG. 2, the bone plate rotatable around the intramedullary nail longitudinal axis while maintaining the bone plate longitudinal axis in parallel with the intramedullary nail longitudinal axis (the bone plate is fully capable of rotating around the intramedullary nail longitudinal axis, for example when not disposed in/attached to the bone, and since the bone plate and intramedullary nail longitudinal axes are parallel, at least at their distal ends in FIG. 2, rotating around the intramedullary nail longitudinal axis, about the solid line drawn through the bone in FIG. 2, would maintain the axes in parallel, i.e. the axes are parallel so rotating about one axis/maintaining that axis stationary would not change the parallel position of the other axis); a drill guide (207) including a first tubular section having a first outer diameter and aligned with the third screw receiving hole; an opening of a targeting guide (205), the targeting guide adapted to maintain a fixed orientation between the opening in the targeting guide and the first screw receiving hole (in order to maintain alignment between the opening in the targeting guide and the first screw receiving hole to guide the drill guide and drill/screw 206 through the opening in the targeting guide and into the first screw receiving hole, FIG. 2), the opening of the targeting guide adapted to be aligned with the opening in the third screw receiving hole (one drill guide passes through the opening of the targeting guide and the aligned opening in the bone plate), FIG. 2; wherein the drill guide has a cylindrical passageway having an inner diameter smaller than the first outer diameter, the cylindrical passageway adapted to receive and align a drill (interpreted as intended use; the cylindrical passageway is fully capable of accepting a drill, and/or a screw could be interpreted as a drill if self-drilling); and wherein the targeting guide is for simultaneously aligning the drill guide, the intramedullary nail, and the bone plate (the targeting guide simultaneously aligns each drill guide with respective aligned holes in the nail and plate), FIG. 2; wherein the targeting guide (205) holds the intramedullary nail, FIG. 2, while the simultaneous alignment is maintained during rotation of the targeting guide around the intramedullary nail longitudinal axis with the intramedullary nail being disposed in bone during drilling (when the intramedullary nail is disposed in bone as in FIG. 2 and the bone is rotated around the intramedullary nail longitudinal axis, the targeting guide will also be rotated around the intramedullary nail longitudinal axis along with the bone to which it is attached, while the cylindrical passageway maintains the simultaneous alignment so that drilling can occur since the device and bone are attached to each other and will rotate as one; the bone may be rotated around the intramedullary nail longitudinal axis, and/or the patient/table may be rotated around the axis, to adjust the position of the bone for easier surgical access or viewing).
As to claim 19, Segina discloses the system of claim 17, wherein the targeting guide with the intramedullary nail attached thereto can rotate around the intramedullary nail longitudinal axis (the assembled system is fully capable of rotating around the longitudinal axis of the nail, before implantation, to achieve appropriate alignment of the nail within the bone).
Segina is silent as to the drill guide including a first tubular section having a first outer diameter and a threaded end configured to engage a threaded opening in the third screw receiving hole, where the third screw receiving hole is a threaded opening; a second tubular section having a second outer diameter greater than the first outer diameter, the second tubular section configured to be slidably received within an opening in a targeting guide, the opening of a targeting guide adapted to be aligned with the threaded opening; a third tubular section having a third outer diameter greater than an inner diameter of the opening of the targeting guide, the third tubular section configured to prevent the drill guide from falling through the opening of the targeting guide, wherein the drill guide has a cylindrical passageway defined from the threaded end of the first tubular section to an end of the drill guide opposite the threaded end, the cylindrical passageway having an inner diameter smaller than the first outer diameter, the cylindrical passageway adapted to receive and align a drill; and wherein the drill guide is configured to engage and support the bone plate, without requiring direct contact between the bone plate and any other object and the bone plate is supported solely by the drill guides and is configured to slide freely in a direction parallel to a longitudinal axis of the drill guide and perpendicular to the longitudinal axes of the intramedullary nail and the bone plate (claim 17); wherein the third and fourth screw receiving holes have mating threads for engaging the threaded end (claim 18).
As to claim 17, Mebarak teaches a system comprising: a bone plate (1010a) including third and fourth screw receiving holes (1016) and a bone plate longitudinal axis; a drill guide including a first tubular section (1404) having a first outer diameter (outer diameter at 1404) (col. 19 / lines 42-46) and a threaded end (1414) configured to engage a threaded opening in the third screw receiving hole (col. 20 / lines 14-19), FIGS. 41 and 46; a second tubular section (1204) having a second outer diameter greater than the first outer diameter (since 1404 is received in 1204), FIGS. 41 and 43, the second tubular section configured to be slidably received within an opening (1110) in a targeting guide (1102), FIG. 41, the opening of a targeting guide adapted to be aligned with the threaded opening, FIG. 41; a third tubular section (1202) having a third outer diameter greater than an inner diameter of the opening of the targeting guide, FIGS. 41 and 43, the third tubular section configured to prevent the drill guide from falling through the opening of the targeting guide, wherein the drill guide has a cylindrical passageway (1406) defined from the threaded end of the first tubular section to an end of the drill guide opposite the threaded end (col. 19 / lines 44-46), FIG. 45, the cylindrical passageway having an inner diameter smaller than the first outer diameter, the cylindrical passageway adapted to receive and align a drill (col. 20 / lines 24-28); and wherein the targeting guide is for simultaneously aligning the drill guide and the bone plate, FIG. 41; wherein the drill guide is configured to engage and support the bone plate, without requiring direct contact between the bone plate and any other object (due to the threaded interaction).
As to claim 18, Mebarak teaches the system of claim 17, wherein the third and fourth screw receiving holes have mating threads for engaging the threaded end (col. 20 / lines 14-19), FIGS. 41 and 46.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include drill guides in Segina’s system, the drill guides including an inner drill guide and an outer sleeve, as taught by Mebarak, so that the outer sleeve can be received in the openings in Segina’s targeting guide to guide placement of various tools, such as drivers and screws, throughout the procedure so that all of the tools are aligned with the first and second implant holes, with the inserted inner drill guide providing a close fit to an inserted drill bit for accurately guiding the drill bit. As taught by Mebarak, the drill guide would have a first tubular section having a first outer diameter and a threaded end, and the bone plate in Segina would be modified to have correspondingly threaded openings with mating threads to receive the threaded ends for secure connection. The drill guide would have the sleeve including the second and third tubular sections, where the third outer diameter prevents the drill guide from falling through the opening of the targeting guide. The drill guide is configured to engage and support the bone plate via the threaded interaction. Because the threaded interaction allows the bone plate to be secured to the drill guides and thus to the targeting guide in which the drill guides are disposed, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to not require direct contact between the bone plate and any other object other than the drill guides that threadedly and securely attach to the bone plate, therefore eliminating the need for an additional portion of the targeting guide to connect to the bone plate, which simplifies the device for use and reduces material and manufacturing costs. Therefore the bone plate is supported solely by the drill guides. The drill guide is slidably positioned in the targeting guide at least during assembly, and is fully capable of sliding freely in the targeting guide, so that, because the bone plate is supported solely by the drill guides, the bone plate is fully capable is sliding freely in a direction parallel to a longitudinal axis of the drill guide and perpendicular to the longitudinal axes of the intramedullary nail and the bone plate (in the direction of sliding of the drill guides in the targeting guide). This would be able to move the bone plate relative to the intramedullary nail, if the drill guides are not fully seated in the targeting guide while attached to the bone plate, or backed out of the targeting guide while attached to the bone plate. Because the targeting guide is secured to the intramedullary nail in Segina, the openings of the targeting guide will be aligned with the holes of the nail and therefore drill guides inserted through the targeting guide openings and attached to the bone plate will also align the holes of the bone plate with the holes of the nail. Thus the targeting guide is for simultaneously aligning the drill guide, the intramedullary nail, and the bone plate so that a single screw can pass through the aligned first and third screw receiving holes of the two implants.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Segina in view of Mebarak (hereinafter, “Segina/Mebarak”), as applied to claims 1, 2, and 4-19 above, and further in view of U.S. Patent No. US 6,916,323 to Kitchens.
As to claim 3, Segina/Mebarak discloses wherein: the drill guide has a head (Mebarak, 1402, FIG. 44) at an end opposite the threaded end, the head having an outer diameter greater than the second inner diameter (Mebarak, col. 19 / lines 46-48, FIG. 41), but is silent as to the drill guide has a second thread near the head, and the sleeve has an inner thread adapted to receive the second thread therein.
Kitchens teaches a drill guide (226), FIG. 21, that is received in a sleeve (224), FIG. 19, where the drill guide has a head (246) and a thread (250) near the head, and the sleeve has an inner thread (238) adapted to receive the thread therein (col. 13 / lines 40-49), to fixate the drill guide to the sleeve to prevent undesirable movement during drilling.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Segina/Mebarak’s drill guide with a second thread near the head, and the sleeve with an inner thread adapted to receive the second thread therein, to fixate the drill guide to the sleeve when the drill guide is seated in the sleeve, to prevent undesirable relative movement during drilling.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775