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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) below have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See PTO-892 for art of cited interest, in particular other clamps where first and second jaws are monolithic with a hinged end.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mata US 2002/0042613 in view of Gray US 6,277,069.
Regarding Claim 1, Mata discloses a clamping device for an external fixation system, comprising:
a clamp body (see Fig below) including: a first jaw including a first jaw end (see Fig below) and a second jaw including a second jaw end (see Fig below),
wherein the first jaw end and the second jaw end are spaced by a gap that includes an open end portion (see Fig below) and a slot (see Fig below) where the first jaw and the second jaw are not in contact with one another (see Fig below, Fig 2, where due to the gap, the jaws are not in contact with each other), and the first jaw and the second jaw form a groove disposed adjacent to the gap (see Fig below),
the groove configured to receive an external fixation component through the gap (see Fig below, paragraph 29, the gap is able to receive a rod or shaft of an external fixation component):
a hinged end (see Fig below) connected the first jaw and second jaw (Fig 1-2, see Fig below, paragraph 27), wherein the first jaw and second jaw rotate about the hinged end (Fig 1-2, paragraph 29);
a bore (see Fig below) configured to receive a bone pin (Fig 1-2 able to receive a cylindrical shaft of a bone pin, see Fig 1 where it can receive a shaft #13), wherein the bore is located in the clamp body (Fig 2) between the groove and the hinged end (Fig 2); and
a locking assembly (#6 and #10) coupled to the clamp body and configured to receive the bone pin and change state between at least an unlocked state, wherein the first jaw and the second jaw are further from one another (paragraph 29 where the unlocked state is that state where the jaws are further from one another when a rod or hop is initially inserted) than a locked state when they are closer to one another (paragraph 29, actuating of nut #10 changes the locking assembly from the unlocked state to the locked state, where in the locked state the jaws are closer together than the unlocked state)(it is noted that in an alternative interpretation, the locked state is when the nut is tightened such that the space defining the slot is reduced and the unlocked state is when there is no compressive force acting on the slut such that the space defining the slot is not reduced);
wherein the external fixation component is configured to translate within the groove and the bore does not restrict the bone pin from translating within the bore when the locking assembly is in the unlocked state (paragraph 29, prior to tightening the nut the shaft of an external component can translate within the groove while a bone pin can also translate in the bore); and
wherein the first jaw and the second jaw restrict movement of the external fixation component within the groove and the bore restricts the bone pin from translating within the bore when the locking assembly is in the locked state (paragraph 29).
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Regarding Claim 2, Mata discloses the locking assembly comprises a first locking component (#6) including a shaft (see annotated Fig 2 above) configured to be received within the bore and configured to receive the bone pin (Fig 2, the shaft is hollow and is capable of receiving a bone pin, paragraph 29).
Regarding Claim 3, Mata discloses the slot (see Fig in claim 1 above, Figs 1-2) extends between a first surface of the first jaw and a second surface of the second jaw (opposing surfaces of the first and second jaws that define the slot, Fig 1-2, fig above in claim 1) and in communication with the groove, wherein the bore extends through the slot (Fig 2).
Regarding Claim 4, Mata discloses wherein changing the locking assembly from the unlocked state to the locked state causes the first jaw to move closer to the second jaw to secure the external fixation component within the groove (as discussed in claim 1 above, paragraph 27) and the shaft to compress around the bone pin to secure the bone pin within the bore (paragraph 29).
Regarding Claim 5, Mata discloses, wherein changing the locking assembly from the unlocked state to the locked state simultaneously causes the first jaw to move closer to the second jaw to secure the external fixation component within the groove and the shaft to compress around the bone pin to secure the bone pin within the bore (as discussed in claim 4 above, paragraph 27, 29 tightening of the nut #10 simultaneously moves the jaws together and compresses the shaft).
Mata does not disclose the hinged end is monolithic the first jaw and second jaw.
Gray discloses a clamping device (Fig 1-7) comprising:
a clamp body (see Fig below) including: a first jaw including a first jaw end (see Fig below) and a second jaw including a second jaw end (see Fig below),
wherein the first jaw end and the second jaw end are spaced by a gap that includes an open end portion (see Fig below) and a slot (see Fig below) where the first jaw and the second jaw are not in contact with one another (see Fig below, Fig 1, where due to the gap, the jaws are not in contact with each other), and the first jaw and the second jaw form a groove disposed adjacent to the gap (see Fig below),
the groove configured to receive an external fixation component through the gap (see Fig below, col 4 lines 40-55, the gap is able to receive a rod or shaft of an external fixation component):
a hinged end (see Fig below) monolithic the first jaw and second jaw (Fig 1-7), wherein the first jaw and second jaw rotate about the hinged end (see Fig below, col 4 lines 40-55);
a bore (see Fig below);
a locking assembly (#61, #16, #81, #23) coupled to the clamp body (Fig below, Fig 1) and configured to change state between at least an unlocked state, wherein the first jaw and the second jaw are further from one another (see Fig below, Fig 5) than a locked state when they are closer to one another (as seen in Fig 6, Col 6 lines 25-35).
the hinged end allows for the first and second jaws to rotate such that the bore is able to receive a rod or shaft and clamp onto a rod or shaft (Col 4 lines 40-55).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention modify the hinged end of Mata to be monolithic with the first and second jaws because this provides a known alternative configuration to allow the first and second jaws to rotate such that the bore is able to receive a rod or shaft and clamp onto a rod or shaft. Examiner notes that with the modification, spring/clip #11a of Mata would not be required.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mata US 2002/0042613 and Gray US 6,277,069, as applied to claim 2, and in further view of view of Francis US 2007/0123860.
Mata as modified discloses the claimed invention as discussed above but does not disclose the first locking component includes a protrusion and the clamp body includes recess configured to receive the protrusion to prevent rotation of the first locking component within the clamp body.
Francis discloses a similar clamping device (Fig1, fig below) with a clamp body (see Fig below), the bore configured to receive a bone pin (#23), a locking assembly (#26, #28) coupled to the clamp body and configured to change state between at least an unlocked state and a locked state (paragraph 57), wherein the external fixation component is configured to translate within the groove and the bore does not restrict the bone pin from translating within the bore when the locking assembly is in the unlocked state (Fig 1-7, see Fig below, paragraph 57, prior to locking via the locking assembly, one can translate a rod/shaft of the external fixation component and the bone pin can also translate); and the first jaw and the second jaw restrict movement of the external fixation component within the groove and the bore restricts the bone pin from translating within the bore when the locking assembly is in the locked state (paragraph 57),
wherein the locking assembly comprises a first locking component (#26) including a shaft (#26) configured to be received within the bore and configured to receive the bone pin (paragraph 55), and
wherein the first locking component includes a protrusion (#68 which includes opposing flat sides #72, paragraph 50, Fig 18) and the clamp body includes recess (#46) configured to receive the protrusion to prevent rotation of the first locking component within the clamp body (paragraph 50, 54 Fig 5, where due to the flat sides rotation is prevented) and allows the first locking component to move easily within the bore (paragraph 50).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first locking component and clamp body of Mata as modified to include a protrusion (with the flat sides) and recess, respectively, in view of Francis above because this provides a known shape for a locking member to move easily within the bore but not rotate therein.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mata US 2002/0042613 and Gray US 6,277,069, as applied to claim 1 above, and in further view of view of Rezach US 2007/0233066.
Mata as modified discloses the claimed invention as discussed but does not disclose wherein the clamp body further includes an insert positioned within the clamp body such that a portion of the insert is shaped to define the open end and receives the external fixation component to restrict movement of the external fixation component when the locking assembly is in the locked state.
Rezach discloses a similar clamp body (#20, Fig 1-2) with first and second jaws (#26a, #26b), that are spaced by a gap (see Fig below) that includes an open end portion (see Fig below) and a slot (#38a) where the jaws are not in contact with each other (Fig 1), the jaws form a groove (#24) adjacent the gap (Fig 1), the groove (#24) configured to receive a rod (#13, Fig 9-10), a hinged end (#28) joining the first jaw and second jaw (Fig 1-2), wherein the first and second jaws rotate about the hinged end (paragraph 28), wherein the clamp body further includes an insert (#40) positioned within the clamp body (Fig 1) such that a portion of the insert is shaped to define the open end (see Fig below, Fig 1 where gap #52 of the insert is very similar in size to the gap #38) and receives the rod to restrict movement of the external fixation component when the locking assembly is in the locked state (paragraph 37 the jaws and insert are compressed/clamped via screw #60), the insert also a gap (#52) and a hinged end (#54) that allows the gap of the insert to increase or decrease in size (paragraph 30) allows the insert allows the rod (#13) to pivot (via spherical outer surfaces #46) relative to the clamp body (#20) to a desired orientation (paragraph 29) prior to being the locked state (paragraph 37).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the clamp body of Mata as modified to include an insert in view of Rezach above because the insert allows the rod to pivot relative to the clamp body to a desired orientation prior to being in the locked state. The examiner notes that with the modification, it is noted that the insert would also be hinged and its gap would match the gap of that to Mata, where it would also be obvious that the external fixation component would be received through the gap.
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mata US 2002/0042613 in view of Gray US 6,277,069 and Witzel US 4,920,959.
Regarding Claim 9, Mata discloses an external fixator system (Fig 1-2, paragraph 2) comprising:
an external fixation component (“rod” not shown, paragraph 17, 29) extending between a first end and a second end (not shown but a rod would have opposing first and second ends),
a rod (#13) coupled to the external fixation component (Fig 1, coupled via a clamping device #1); and
a clamping device (#1) including: a clamp body having
(i) a first jaw including a first jaw end and a second jaw including a second jaw end (see Fig below), wherein the first jaw end and the second jaw end are spaced by a gap (see Fig below) that includes an open end portion (see Fig below) and a slot where the first jaw and the second jaw are not in contact with one another (see Fig below, Fig 2, where due to the jaws are not in contact with each other they form the slot), and the first jaw and the second jaw define a groove (see Fig below) extending along a first axis (see Fig 2, first axis would extend perpendicular to the page) and configured to receive the external fixation component through the gap (Fig 1-2, paragraph 17),
(ii) a hinged end (see Fig below) connected with and connecting the first jaw and second jaw (Fig 1-2, see Fig below, paragraph 27), wherein the first jaw and second jaw rotate about the hinged end (paragraph 29, Fig 1-2), and
(iii) a bore (see Fig below) extending along a second axis (Fig 1, second axis extending along #13), through the clamp body, wherein the first axis is perpendicular to the second axis (Fig 1-2), wherein the bore is located in the clamp body between the groove and the hinged end (Fig below, Fig 1-2); and
a locking assembly (#6 and #10) configured to receive the rod (Fig 1-2), wherein the locking assembly includes comprises a first locking component (#6) including a shaft configured to be received within the bore and configured to receive the rod (see Fig below, paragraph 29), wherein the locking assembly is configured to change state between at least an unlocked state, wherein the first jaw and second jaw are further from one another (paragraph 29 where the unlocked state is that state where the jaws are further from one another when a rod or hop is initially inserted) than a locked state when they are closer to one another (paragraph 29, actuating of nut #10 changes the locking assembly from the unlocked state to the locked state, where in the locked state the jaws are closer together than the unlocked state)(it is noted that in an alternative interpretation, the locked state is when the nut is tightened such that the space defining the slot is reduced and the unlocked state is when there is no compressive force acting on the slot such that the space defining the slot is not reduced);
wherein the external fixation component is configured to translate within the groove and the bore does not restrict the bone pin from translating within the bore while the locking assembly is in the unlocked state (paragraph 29, prior to tightening the nut the shaft of the external component can translate within the groove while a bone pin can also translate in the bore); and
the first jaw and the second jaw restrict movement of the external fixation component within the groove and the bore restricts the bone pin from translating within the bore while the locking assembly is in the locked state (paragraph 29).
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Regarding Claim 10, Mata discloses wherein changing the locking assembly from the unlocked state to the locked state causes the first jaw to move closer to the second jaw to secure the external fixation component within the groove (as discussed in claim 1 above, paragraph 27) and the shaft to compress around the rod to secure the bone pin within the bore (paragraph 29).
Regarding Claim 11, Mata discloses, wherein changing the locking assembly from the unlocked state to the locked state simultaneously causes the first jaw to move closer to the second jaw to secure the external fixation component within the groove and the shaft to compress around the rod to secure the rod within the bore (as discussed in claim 10 above, paragraph 27, 29 tightening of the nut #10 simultaneously moves the jaws together and compresses the shaft).
Mata does not disclose the hinged end is monolithic the first jaw and second jaw. Mata discloses the external fixator is used for fractures (paragraph 2) but does not specifically disclose the rod (#13) is a bone pin.
Gray discloses a clamping device (Fig 1-7) comprising:
a clamp body (see Fig below) including: a first jaw including a first jaw end (see Fig below) and a second jaw including a second jaw end (see Fig below),
wherein the first jaw end and the second jaw end are spaced by a gap that includes an open end portion (see Fig below) and a slot (see Fig below) where the first jaw and the second jaw are not in contact with one another (see Fig below, Fig 1, where due to the gap, the jaws are not in contact with each other), and the first jaw and the second jaw form a groove disposed adjacent to the gap (see Fig below),
the groove configured to receive an external fixation component through the gap (see Fig below, col 4 lines 40-55, the gap is able to receive a rod or shaft of an external fixation component):
a hinged end (see Fig below) monolithic the first jaw and second jaw (Fig 1-7), wherein the first jaw and second jaw rotate about the hinged end (see Fig below, col 4 lines 40-55);
a bore (see Fig below);
a locking assembly (#61, #16, #81, #23) coupled to the clamp body (Fig below, Fig 1) and configured to change state between at least an unlocked state, wherein the first jaw and the second jaw are further from one another (see Fig below, Fig 5) than a locked state when they are closer to one another (as seen in Fig 6, Col 6 lines 25-35).
the hinged end allows for the first and second jaws to rotate such that the bore is able to receive a rod or shaft and clamp onto a rod or shaft (Col 4 lines 40-55).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention modify the hinged end of Mata to be monolithic with the first and second jaws because this provides a known alternative configuration to allow the first and second jaws to rotate such that the bore is able to receive a rod or shaft and clamp onto a rod or shaft. Examiner notes that with the modification, spring/clip #11a of Mata would not be required.
Witzel discloses a similar external fixator system (Fig 1-4) comprising:
an external fixation component in the form of a rod (#11) extending between a first end and a second end (Fig 1, opposing ends of #11),
a bone pin (#15) coupled to the external fixation component (Fig 1, coupled via a clamping device #12),
a clamping device (#12) having a groove that accepts the external fixation component (#11, Fig 1-4) and having a bore that accepts the bone pin (#15, Fig 1-4), the bone pin securing the external fixation across a bone fracture (Fig 1, Col 4 line 1-5).
It would also have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the rod (#13) of Mata to be in the form of a bone pin, where the external fixation component would extend across a fracture during use in view of Witzel above because this provides a known configuration to treat fractures.
Regarding Claim 10, Mata as modified discloses wherein changing the locking assembly from the unlocked state to the locked state causes the first jaw to move closer to the second jaw to secure the external fixation component within the groove (as discussed in claim 9 above, paragraph 27 in Mata) and the shaft to compress around the bone pin to secure the bone pin within the bore (paragraph 29 in Mata).
Regarding Claim 11, Mata as modified discloses, wherein changing the locking assembly from the unlocked state to the locked state simultaneously causes the first jaw to move closer to the second jaw to secure the external fixation component within the groove and the shaft to compress around the bone pin to secure the bone pin within the bore (as discussed in claim 10 above, paragraph 27, 29 in Mata tightening of the nut #10 simultaneously moves the jaws together and compresses the shaft).
Regarding Claim 12, Mata as modified discloses the claimed invention, where Mata further discloses wherein the locking assembly further includes a second locking component including a knob (#10, paragraph 27-28, able to be gripped like a knob) positioned outside of the bore (Fig 1-2), wherein the first locking component (#6) is configured to engage with the second locking component such that the first locking component (#6) is coupled to the second locking component (first and second locking components are engaged via threads paragraph 27-28).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mata US 2002/0042613, Gray US 6,277,069 and Witzel US 4,920,959, as applied to claim 9 above, and in further view of Francis US 2007/0123860.
Mata as modified discloses the claimed invention as discussed above but does not disclose the first locking component includes a protrusion and the clamp body includes recess configured to receive the protrusion to prevent rotation of the first locking component within the clamp body.
Francis discloses a similar clamping device (Fig1, fig below) with a clamp body (see Fig below), the bore configured to receive a bone pin (#23), a locking assembly (#26, #28) coupled to the clamp body and configured to change state between at least an unlocked state and a locked state (paragraph 57), wherein the external fixation component is configured to translate within the groove and the bore does not restrict the bone pin from translating within the bore when the locking assembly is in the unlocked state (Fig 1-7, see Fig below, paragraph 57, prior to locking via the locking assembly, one can translate a rod/shaft of the external fixation component and the bone pin can also translate); and the first jaw and the second jaw restrict movement of the external fixation component within the groove and the bore restricts the bone pin from translating within the bore when the locking assembly is in the locked state (paragraph 57),
wherein the locking assembly comprises a first locking component (#26) including a shaft (#26) configured to be received within the bore and configured to receive the bone pin (paragraph 55), and
wherein the first locking component includes a protrusion (#68 which includes opposing flat sides #72, paragraph 50, Fig 18) and the clamp body includes recess (#46) configured to receive the protrusion to prevent rotation of the first locking component within the clamp body (paragraph 50, 54 Fig 5, where due to the flat sides rotation is prevented) and allows the first locking component to move easily within the bore (paragraph 50).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first locking component and clamp body of Mata as modified to include a protrusion (with the flat sides) and recess, respectively, in view of Francis above because this provides a known shape for a locking member to move easily within the bore but not rotate therein.
Claims 15-16, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mata US 2002/0042613 in view of Gray US 6,277,069 and Witzel US 4,920,959.
Regarding Claim 15, Mata discloses a method of fixating a bone fixator system (Fig 1-2), the bone fixator system comprising an external fixation component (“rod” not shown, paragraph 17, 29), the method comprising:
providing a clamping device (Fig 1-2), the clamping device including:
a clamp body (Fig 1-2) having
(i) a first jaw including a first jaw end (see Fig below) and a second jaw including a second jaw end (see Fig below), wherein the first jaw end and the second jaw end are spaced by a gap (see Fig below) that includes an open end portion (see Fig below) and a slot (see Fig below) where the first jaw and the second jaw are not in contact with one another (see Fig below, Fig 2, where due to the jaws are not in contact with each other they form the slot), and the first jaw and the second jaw define a groove (see Fig below) configured to receive the external fixation component through the gap (paragraph 17, 29),
(ii) a hinged end (see Fig below) connected with and connecting the first jaw and second jaw (Fig 1-2, see Fig below, paragraph 27), wherein the first jaw and second jaw rotate about the hinged end (paragraph 29, Fig 1-2); and
(iii) a bore (see Fig below) extending through the clamp body (see Fig below) wherein the bore is located in the clamp body between the groove and the hinged end (see Fig below, Fig 1-2), and
a locking assembly (#6 and #10) configured to receive a rod (#13), wherein the locking assembly includes comprises a first locking component (#6) including a shaft (#6) configured to be received within the bore and configured to receive the rod (#13), wherein the locking assembly is configured to be tightened (paragraph 29) such that when tightened the first jaw and the second jaw move closer to one another to engage the rod (paragraph 29, the jaws are moved closer to one another when tightened to engage and lock the rod);
providing the rod (#13) through the first locking component (Fig 1)t; and
tightening the locking assembly (paragraph 29), wherein tightening the locking assembly causes the first jaw and the second jaw to restrict movement of the external fixation component within the groove and causes the first locking component to restrict the rod from translating within the bore (paragraph 29).
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Mata does not disclose the hinged end is monolithic the first jaw and second jaw. Mata discloses the external fixator is used for fractures (paragraph 2) where specific steps were not explicitly disclosed and Mata does not specifically disclose positioning the first external fixation component adjacent at least one target bone; aligning the clamping device with the at least one target bone, the rod (#13) is a bone pin, placing the bone pin into the at least one target bone.
Gray discloses a clamping device (Fig 1-7) comprising:
a clamp body (see Fig below) including: a first jaw including a first jaw end (see Fig below) and a second jaw including a second jaw end (see Fig below),
wherein the first jaw end and the second jaw end are spaced by a gap that includes an open end portion (see Fig below) and a slot (see Fig below) where the first jaw and the second jaw are not in contact with one another (see Fig below, Fig 1, where due to the gap, the jaws are not in contact with each other), and the first jaw and the second jaw form a groove disposed adjacent to the gap (see Fig below),
the groove configured to receive an external fixation component through the gap (see Fig below, col 4 lines 40-55, the gap is able to receive a rod or shaft of an external fixation component):
a hinged end (see Fig below) monolithic the first jaw and second jaw (Fig 1-7), wherein the first jaw and second jaw rotate about the hinged end (see Fig below, col 4 lines 40-55);
a bore (see Fig below);
a locking assembly (#61, #16, #81, #23) coupled to the clamp body (Fig below, Fig 1) and configured to change state between at least an unlocked state, wherein the first jaw and the second jaw are further from one another (see Fig below, Fig 5) than a locked state when they are closer to one another (as seen in Fig 6, Col 6 lines 25-35).
the hinged end allows for the first and second jaws to rotate such that the bore is able to receive a rod or shaft and clamp onto a rod or shaft (Col 4 lines 40-55).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention modify the hinged end of Mata to be monolithic with the first and second jaws because this provides a known alternative configuration to allow the first and second jaws to rotate such that the bore is able to receive a rod or shaft and clamp onto a rod or shaft. Examiner notes that with the modification, spring/clip #11a of Mata would not be required.
Witzel discloses a method of fixating a bone fixator system (Fig 11, the examiner notes that Fig 11 follows the same steps of Fig 1), the bone fixator system comprising an external fixation component in the form of a rod (left or right rod #11, Fig 11), the method comprising:
positioning the first external fixation component adjacent at least one target bone (Fig 1);
aligning a clamping device (#12d, Fig 11, Fig 1) with the at least one target bone (Fig 1), the clamping device including:
a clamp body having (i) a first jaw (#40, Fig 11) including a first jaw end (left or right end in Fig 11, adjacent to gap #42) and a second jaw (#41) including a second jaw end (left or right end in Fig 11, adjacent to gap #42), wherein the first jaw end and the second jaw end are spaced by a gap (left or right gap #42), and the first jaw and the second jaw define a groove (groove where external fixation component #11 is located, Fig 11) extending along a first axis (Fig 11, axis extending perpendicular to the page) and configured to receive the external fixation component through the gap (Fig 11, Col 6 lines 20-30 where when the first and second jaws are distinct components, such that, in an unlocked state, the jaws can be separated a sufficient amount to allow the external fixation component to enter the groove through the gap) , and (ii) a bore (Fig 11, bone pin #15 located in the bore) extending along a second axis (Fig 11, second axis extending through the longitudinal axis of the bone pin #15) through the clamp body (Fig 11), and
a locking assembly (#14) configured to receive a bone pin (#15, Fig 11), wherein the locking assembly includes comprises a first locking component (#39 and “G” including a shaft (#39 and “G”, Fig 11, where G is threaded, Col 6 lines 60-67) configured to be received within the bore and configured to receive the bone pin (Fig 11), wherein the locking assembly is configured to be tightened (Col 6 lines 5-27);
providing the bone pin through the first locking component and into the at least one target bone (Fig 1); and
tightening the locking assembly, wherein tightening the locking assembly causes the first jaw and the second jaw to restrict movement of the external fixation component within the groove and causes the first locking component to restrict the bone pin from translating within the bore (Col 6 lines 5-27, once tightened, the system is locked and sliding/translation is restricted),
this arrangement provides a known configuration to treat fractures (Fig 1 Col 4 lines 2-6 ), where the bone pin anchors the clamping device to the target bone (Fig 1 Col 4 lines 35-50).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the method of Mata to have positioning the first external fixation component adjacent at least one target bone; aligning the clamping device with the at least one target bone, the rod (#13) to be a bone pin, placing the bone pin into the at least one target bone in view of Wetzel above because this placement provides a known configuration to treat fractures, where the bone pin anchors the clamping device to the target bone.
Regarding Claim 16, Mata as modified discloses, wherein tightening the locking assembly simultaneously causes the first jaw to move closer to the second jaw to secure the external fixation component within the groove and the shaft to compress around the bone pin to secure the bone pin within the bore (as discussed in claim 15 above, paragraph 27, 29 in Mata tightening of the nut #10 simultaneously moves the jaws together and compresses the shaft).
Regarding Claim 18, Mata as modified discloses the claimed invention as discussed in claim 15 above where Mata further discloses the locking assembly further includes a second locking component (#10) including a knob (#10 can be gripped like a knob) positioned outside of the bore (Fig 1-2), wherein the first locking component is configured to engage with the second locking component such that the first locking component is coupled to the second locking component (first and second locking components are engaged via threads paragraph 27-28).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mata US 2002/0042613m Gray US 6,277,069 and Witzel US 4,920,959, as applied to claim 15 above, and in further view of Francis US 2007/0123860.
Mata as modified discloses the claimed invention as discussed above but does not disclose the first locking component includes a protrusion and the clamp body includes recess configured to receive the protrusion to prevent rotation of the first locking component within the clamp body.
Francis discloses a similar clamping device (Fig1, fig below) with a clamp body (see Fig below), the bore configured to receive a bone pin (#23), a locking assembly (#26, #28) coupled to the clamp body and configured to change state between at least an unlocked state and a locked state (paragraph 57), wherein the external fixation component is configured to translate within the groove and the bore does not restrict the bone pin from translating within the bore when the locking assembly is in the unlocked state (Fig 1-7, see Fig below, paragraph 57, prior to locking via the locking assembly, one can translate a rod/shaft of the external fixation component and the bone pin can also translate); and the first jaw and the second jaw restrict movement of the external fixation component within the groove and the bore restricts the bone pin from translating within the bore when the locking assembly is in the locked state (paragraph 57),
wherein the locking assembly comprises a first locking component (#26) including a shaft (#26) configured to be received within the bore and configured to receive the bone pin (paragraph 55), and
wherein the first locking component includes a protrusion (#68 which includes opposing flat sides #72, paragraph 50, Fig 18) and the clamp body includes recess (#46) configured to receive the protrusion to prevent rotation of the first locking component within the clamp body (paragraph 50, 54 Fig 5, where due to the flat sides rotation is prevented) and allows the first locking component to move easily within the bore (paragraph 50).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first locking component and clamp body of Mata as modified to include a protrusion (with the flat sides) and recess, respectively, in view of Francis above because this provides a known shape for a locking member to move easily within the bore but not rotate therein.
Claims 14, 17, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mata US 2002/0042613, Gray US 6,277,069, and Witzel US 4,920,959, as applied to claim 9 and 14 respectively, and in further view of Rezach US 2007/0233066.
Mata as modified discloses the claimed invention as discussed but does not disclose wherein the clamp body further includes an insert positioned within the clamp body such that a portion of the insert is shaped to define the open end and receives the external fixation component to restrict movement of the external fixation component when the locking assembly is in the locked state.
Rezach discloses a similar clamp body (#20, Fig 1-2) with first and second jaws (#26a, #26b), that are spaced by a gap (see Fig below) that includes an open end portion (see Fig below) and a slot (#38a) where the jaws are not in contact with each other (Fig 1), the jaws form a groove (#24) adjacent the gap (Fig 1), the groove (#24) configured to receive a rod (#13, Fig 9-10), a hinged end (#28) joining the first jaw and second jaw (Fig 1-2), wherein the first and second jaws rotate about the hinged end (paragraph 28), wherein the clamp body further includes an insert (#40) positioned within the clamp body (Fig 1) such that a portion of the insert is shaped to define the open end (see Fig below, Fig 1 where gap #52 of the insert is very similar in size to the gap #38) and receives the rod to restrict movement of the external fixation component when the locking assembly is in the locked state (paragraph 37 the jaws and insert are compressed/clamped via screw #60), the insert also a gap (#52) and a hinged end (#54) that allows the gap of the insert to increase or decrease in size (paragraph 30) allows the insert allows the rod (#13) to pivot (via spherical outer surfaces #46) relative to the clamp body (#20) to a desired orientation (paragraph 29) prior to being the locked state (paragraph 37).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the clamp body of Mata as modified to include an insert in view of Rezach above because the insert allows the rod to pivot relative to the clamp body to a desired orientation prior to being in the locked state. The examiner notes that with the modification, it is noted that the insert would also be hinged and its gap would match the gap of that to Mata, where it would also be obvious that the external fixation component would be received through the gap.
Conclusion
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773