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 17 August 2026. As directed by the amendment: claims 1, 19, and 25 have been amended, claims 7 and 22 are cancelled, and claims 11 and 28-33 stand withdrawn. Claims 1-6, 8-21, and 23-33 currently stand pending in the application.
Response to Arguments
Applicant's arguments filed 17 August 2026 with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) as anticipated by Berger (US 8,414,594) have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Any deficiencies in Berger are remedied by modification in view of Garcia (US 10,639,084).
In the interest of compact prosecution, Applicant contends that Berger does not disclose that the screw can be removed from the magazine, and instead teaches unidirectional movement of the screw in a first insertion direction. Examiner respectfully submits that the screw is fully capable of being removed from the magazine in a second direction. If the top protruding portion of the screw head (shown in FIG. 5 as above projections 18) can be forced distally through the projections 18 (from the position of FIG. 5 to be further inserted), then the projections must be resilient enough to also allow removal of the screw in a proximal direction past the projections. The screw may also be removed in the second direction before the head is engaged with the projections.
Claim Objections
Claims 1-6, 8-10, 12-21, 23, and 24 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 14: “the proximal segment and defining a bottom end,”
Claim 19 / line 9: “proximal segment and defining a bottom end,”
Claim 20 / line 2: “[[the]] a length”
Claim 21 / line 2: “[[the]] a length”
Claim Rejections - 35 USC § 112
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 19-21 and 23-27 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 19, the limitation “a cross section of the orthopedic device” (line 10) renders the claims indefinite, because the term “the orthopedic device” lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as a cross section of an orthopedic device. Further as to claim 19, the limitation “to receive an orthopedic device” (lines 12-13) renders the claims indefinite, because it is unclear if this refers to the previously recited orthopedic device of line 10, or to a different orthopedic device. For examination purposes, the limitation will be interpreted as to receive the orthopedic device.
As to claim 25, the limitation “a cross section of the orthopedic device” (lines 16-17) renders the claims indefinite, because it is unclear if the term “orthopedic device” refers to the first or the second orthopedic device. For examination purposes, the limitation will be interpreted as one of the first or second orthopedic devices.
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, 3, 14-21, and 23-27 rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 8,414,594 to Berger et al. (hereinafter, “Berger”) in view of U.S. Patent No. US 10,639,084 to Garcia et al. (hereinafter, “Garcia”).
As to claim 1, Berger discloses an orthopedic system, FIGS. 7-11, comprising: (a) an orthopedic device (16) comprising an orthopedic device engagement feature (23) (col. 6 / lines 26-28); (b) an orthopedic instrument (24) comprising an elongated instrument shaft and an instrument engagement feature (col. 6 / lines 26-28), FIG. 8; and (c) an orthopedic device caddy (8), comprising: (i) a caddy body comprising two planar exterior surfaces (top surface and planar portion on the side/side panel) that are perpendicular to each other, FIGS. 8 and 10-11; (ii) an elongated opening (10) (col. 6 / line 66 – col. 7 / line 8) extending into the caddy body extending through at least one of the two planar exterior surfaces and into the caddy body at a non-perpendicular and non-parallel angle relative to at least one of the planar exterior surfaces of the caddy body, FIG. 8, the elongated opening comprising an alignment portion (proximal portion of interior of 10) extending along a proximal segment of the elongated opening, an orthopedic device retention portion (distal portion of interior of 10) extending along a segment of the elongated opening distal to the proximal segment defining a bottom end (distal end portion of the distal portion of interior of 10), and an opening (distal exit opening) extending through the bottom end having a smaller cross section than a cross section of the orthopedic device (a cross section of the orthopedic device can be taken along its longitudinal axis); (iii) wherein the orthopedic device retention portion is configured to receive the orthopedic device in a first direction (in a distal/insertion direction of movement), hold the orthopedic device in the elongated opening (the distal portion of the interior of 10 is configured to hold at least a distal portion of the orthopedic device or other portions of the orthopedic device as it is pushed through the elongated opening and then into the bone plate), and allow for removal of the device in a second direction opposite the first direction (the orthopedic device retention portion allows for removal of the device in a second proximal/removal direction of movement which is opposite the first direction, because the orthopedic device can be removed proximally from/backed out of the caddy before the surgery if the surgeon decides to use a different device, for example, or if it is not needed and is removed during disassembly); (iv) wherein the alignment portion is configured to receive a portion of the instrument shaft and align the instrument engagement feature relative to the orthopedic device engagement feature (during insertion of the orthopedic device into the bone plate, the instrument shaft will pass into the alignment portion of the elongated opening), FIG. 8.
As to claim 14, Berger discloses the orthopedic system of claim 1 wherein: (i) the orthopedic device comprises a first orthopedic device (16); (ii) wherein the orthopedic device retention portion of the orthopedic device caddy further comprises a first orthopedic device retention portion of the elongated opening; (iii) wherein the first orthopedic device retention portion is configured to hold the first orthopedic device (as above) (col. 7 / lines 9-13), FIG. 8.
As to claim 15, Berger discloses the orthopedic system of claim 14 wherein the first orthopedic device retention portion is distal to the alignment portion.
Berger is silent as to the opening having a smaller cross section than a cross section of the orthopedic device; wherein the orthopedic device retention portion is configured to hold the orthopedic device in the elongated opening in contact with the bottom end (claim 1); wherein the alignment portion is at least three times a length of the orthopedic device (claim 3); a second orthopedic device; wherein the orthopedic device retention portion of the orthopedic device caddy further comprises a second orthopedic device retention portion of the elongated opening spaced from the first orthopedic device retention portion along the elongated opening; wherein the second orthopedic device retention portion is configured to hold the second orthopedic device (claim 14); wherein the second orthopedic device retention portion is either proximal to or in the alignment portion (claim 15); wherein the second orthopedic device is cannulated and configured to receive the elongated instrument shaft of the orthopedic instrument such that the elongated instrument shaft extends through the cannulation of the second orthopedic device (claim 16).
As to claim 1, Garcia teaches an orthopedic system, FIG. 48, comprising: (a) an orthopedic device (1125 and 1150; both orthopedic devices because they are used in orthopedic surgery) comprising an orthopedic device engagement feature (head driving recess on 1125 and 1155 on 1150) (col. 22 / lines 36-37); (b) an orthopedic instrument (driver; tip shown proximal to 1150 in FIG. 48) comprising an elongated instrument shaft and an instrument engagement feature (distal surface of tip); and (c) an orthopedic device caddy (1144) (col. 22 / lines 19-22), comprising: (i) a caddy body; (ii) an elongated opening (1149) extending into the caddy body (col. 22 / lines 34-37), the elongated opening comprising an alignment portion (proximal portion of interior of 1149) extending along a proximal segment of the elongated opening, an orthopedic device retention portion (distal portion of interior of 1149) extending along a segment of the elongated opening distal to the proximal segment defining a bottom end (end portion of the elongated opening), and an opening (distal exit opening) extending through the bottom end having a smaller cross section than a cross section of the orthopedic device (the cross section of the distal exit opening is smaller than a cross section of the orthopedic device at the larger diameter proximal portion of 1150, FIG. 48); (iii) wherein the orthopedic device retention portion is configured to receive the orthopedic device in a first direction (in a distal/insertion direction of movement), hold the orthopedic device in the elongated opening (the distal portion of the interior of 1149 is configured to hold at least a distal portion of the orthopedic device or other portions of the orthopedic device as it is pushed through the elongated opening and then into the bone plate) in contact with the bottom end (at least portion 1150 of the orthopedic device is held in contact with the bottom end as it is pushed therethrough up to the stop since their diameters are complementary), and allow for removal of the device in a second direction opposite the first direction (the orthopedic device retention portion allows for removal of the device in a second proximal/removal direction of movement which is opposite the first direction, because the orthopedic device can be removed proximally from/backed out of the caddy before the surgery if the surgeon decides to use a different device, for example, or if it is not needed and is removed during disassembly); (iv) wherein the alignment portion is configured to receive a portion of the instrument shaft and align the instrument engagement feature relative to the orthopedic device engagement feature (during insertion of the orthopedic device into the bone plate, the instrument shaft will pass into the alignment portion of the elongated opening, where the instrument shaft and its instrument engagement feature are aligned with the orthopedic devices and their engagement features).
As to claim 3, Garcia teaches the orthopedic system of claim 1 wherein the alignment portion is at least three times a length of the orthopedic device (three times the length of the first orthopedic device 1125).
As to claim 14, Garcia teaches the orthopedic system of claim 1 wherein: (i) the orthopedic device comprises a first orthopedic device (1125) and a second orthopedic device (1150) (both orthopedic devices because they are used in orthopedic surgery); (ii) wherein the orthopedic device retention portion of the orthopedic device caddy further comprises a first orthopedic device retention portion (smaller diameter distal portion of 1149) of the elongated opening and a second orthopedic device retention portion (portion of 1149 that holds 1150, proximal to the shoulder in 1149) of the elongated opening spaced from the first orthopedic device retention portion along the elongated opening; (iii) wherein the first orthopedic device retention portion is configured to hold the first orthopedic device; and (iv) wherein the second orthopedic device retention portion is configured to hold the second orthopedic device (col. 22 / lines 34-52).
As to claim 15, Garcia teaches the orthopedic system of claim 14 wherein the first orthopedic device retention portion is distal to the alignment portion and wherein the second orthopedic device retention portion is either proximal to or in the alignment portion (the second orthopedic device retention portion is in the alignment portion).
As to claim 16, Garcia teaches the orthopedic system of claim 15 wherein the second orthopedic device is cannulated (at 1155) and configured to receive the elongated instrument shaft (a distal portion of the shaft) of the orthopedic instrument such that the elongated instrument shaft extends through the cannulation (the distal portion of the instrument shaft extends through or into the cannulation) of the second orthopedic device.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Berger’s system to include a second orthopedic device (a driver bit) to facilitate driving of the first orthopedic device, and to modify the caddy and its elongated openings to accommodate the first and second orthopedic devices by elongating the length of the elongated opening and providing the stepped interior to allow holding of each of the orthopedic devices in their respective retention portions, as taught by Garcia. Driver bits are well known in the orthopedic art and would allow use of the same instrument shaft to drive different orthopedic devices with different engagement features by simply changing the corresponding engagement features of the second orthopedic device/driver bit. As taught by Garcia, the alignment portion is at least three times a length of the orthopedic device to accommodate the second orthopedic device/driver bit. The orthopedic device retention portion of the elongated opening would include a first orthopedic device retention portion (smaller diameter distal portion) to receive and hold the first orthopedic device, and a second orthopedic device retention portion (portion proximal to the shoulder) spaced from the first orthopedic device retention portion along the elongated opening to receive and hold the second orthopedic device, as taught by Garcia. The distal exit opening extending through the bottom end has a smaller cross section than a cross section of the orthopedic device taken at the larger diameter proximal portion of the second orthopedic device/driver bit, as taught by Garcia, since the second orthopedic device has a shoulder, proximal to which it has a larger diameter. The orthopedic device retention portion is configured to hold the orthopedic device in the elongated opening with at least the second orthopedic device/driver bit held in contact with the bottom end as it is pushed therethrough up to the stop since their diameters are complementary.
As to claims 17 and 18, Berger is silent as to wherein the caddy body further comprises a port extending into the caddy body proximate the second orthopedic device retention portion (claim 17); wherein the second orthopedic device is physically manipulable through the port when the second orthopedic device is located in the second orthopedic device retention portion.
In another embodiment, Garcia teaches a port (slit in 1044) extending into the caddy body, FIG. 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 in the caddy body of Berger a port extending into the caddy body as taught by Garcia, to facilitate cleaning and sterilization and allow viewing of the orthopedic devices therein. The port would be proximate the second orthopedic device retention portion since it extends a length of the elongated opening, and the second orthopedic device would be physically manipulable through the port (since the port is a through opening) when the second orthopedic device is located in the second orthopedic device retention portion.
As to claim 19, Berger discloses an orthopedic system, FIGS. 7-11, comprising an orthopedic device caddy (8), the orthopedic device caddy comprising: (a) a caddy body; (b) an elongated opening (10) (col. 6 / line 66 – col. 7 / line 8) extending into the caddy body at a non-perpendicular and non-parallel angle relative to a planar exterior surface (top surface of 8) of the caddy body, FIG. 8, the elongated opening comprising an alignment portion (proximal portion of interior of 10) extending along a proximal segment of the elongated opening, an orthopedic device retention portion (distal portion of interior of 10) extending along a segment of the elongated opening distal to the proximal segment defining a bottom end (distal end portion of the distal portion of interior of 10), and an opening (distal exit opening) extending through the bottom end having a smaller cross section than a cross section of the orthopedic device (a cross section of the orthopedic device can be taken along its longitudinal axis), wherein the elongated opening has a length greater than a length of the caddy body (since the elongated opening is at a diagonal), FIG. 9; (c) wherein the orthopedic device retention portion is configured to receive an orthopedic device (16) in a first direction (in a distal/insertion direction of movement), hold the orthopedic device in the elongated opening (the distal portion of the interior of 10 is configured to hold at least a distal portion of the orthopedic device or other portions of the orthopedic device as it is pushed through the elongated opening and then into the bone plate), and allow for removal of the orthopedic device in a second direction opposite the first direction (the orthopedic device retention portion allows for removal of the device in a second proximal/removal direction of movement which is opposite the first direction, because the orthopedic device can be removed proximally from/backed out of the caddy before the surgery if the surgeon decides to use a different device, for example, or if it is not needed and is removed during disassembly), the orthopedic device comprising an orthopedic device engagement feature (23) (col. 6 / lines 26-28); (d) wherein the alignment portion is configured to align an instrument engagement feature of an orthopedic instrument (24) relative to the orthopedic device engagement feature (col. 6 / lines 26-28).
As to claim 20, Berger discloses the orthopedic system of claim 19 wherein the alignment portion is at least three times the length of the orthopedic device retention portion (since the alignment portion and the orthopedic device retention portion are proximal and distal portions of the elongated opening, and the elongated opening can be divided into the portions such that the alignment portion is at least three times the length of the orthopedic device retention portion).
As to claim 21, Berger discloses the orthopedic system of claim 19 wherein the alignment portion is at least twice the length of the orthopedic device retention portion (since the alignment portion and the orthopedic device retention portion are proximal and distal portions of the elongated opening, and the elongated opening can be divided into the portions such that the alignment portion is at least twice the length of the orthopedic device retention portion).
As to claim 23, Berger discloses the orthopedic system of claim 21 wherein the caddy body is configured to allow visualization of the orthopedic device in the orthopedic device retention portion of the elongated opening (the orthopedic device can be visualized through a top opening of the elongated opening).
As to claim 24, Berger discloses the orthopedic system of claim 21 wherein the caddy body comprises at least one additional opening (11) extending into the caddy body configured to retain an additional orthopedic device (col. 6 / line 66 – col. 7 / line 8), FIG. 8.
Berger is silent as to the opening having a smaller cross section than a cross section of the orthopedic device; wherein the orthopedic device retention portion is configured to hold the orthopedic device in the elongated opening in contact with the bottom end (claim 19).
As to claim 19, Garcia teaches an orthopedic system, FIG. 48, comprising an orthopedic device caddy (1144) (col. 22 / lines 19-22), the orthopedic device caddy comprising: (a) a caddy body; (b) an elongated opening (1149) extending into the caddy body (col. 22 / lines 34-37), the elongated opening comprising an alignment portion (proximal portion of interior of 1149) extending along a proximal segment of the elongated opening, an orthopedic device retention portion (distal portion of interior of 1149) extending along a segment of the elongated opening distal to the proximal segment defining a bottom end (end portion of the elongated opening), and an opening (distal exit opening) extending through the bottom end having a smaller cross section than a cross section of the orthopedic device (the cross section of the distal exit opening is smaller than a cross section of the orthopedic device at the larger diameter proximal portion of 1150, FIG. 48); (c) wherein the orthopedic device retention portion is configured to receive an orthopedic device (1125 and 1150; both orthopedic devices because they are used in orthopedic surgery) in a first direction (in a distal/insertion direction of movement), hold the orthopedic device in the elongated opening (the distal portion of the interior of 1149 is configured to hold at least a distal portion of the orthopedic device or other portions of the orthopedic device as it is pushed through the elongated opening and then into the bone plate) in contact with the bottom end (at least portion 1150 of the orthopedic device is held in contact with the bottom end as it is pushed therethrough up to the stop since their diameters are complementary), and allow for removal of the orthopedic device in a second direction opposite the first direction (the orthopedic device retention portion allows for removal of the device in a second proximal/removal direction of movement which is opposite the first direction, because the orthopedic device can be removed proximally from/backed out of the caddy before the surgery if the surgeon decides to use a different device, for example, or if it is not needed and is removed during disassembly), the orthopedic device comprising an orthopedic device engagement feature (head driving recess on 1125 and 1155 on 1150) (col. 22 / lines 36-37); (d) wherein the alignment portion is configured to align an instrument engagement feature of an orthopedic instrument (driver; tip shown proximal to 1150 in FIG. 48) relative to the orthopedic device engagement feature (during insertion of the orthopedic device into the bone plate, the instrument shaft will pass into the alignment portion of the elongated opening, where the instrument shaft and its instrument engagement feature are aligned with the orthopedic devices and their engagement features).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Berger’s system to include a second orthopedic device (a driver bit) to facilitate driving of the first orthopedic device, and to modify the caddy and its elongated openings to accommodate the first and second orthopedic devices by elongating the length of the elongated opening and providing the stepped interior to allow holding of each of the orthopedic devices in their respective retention portions, as taught by Garcia. Driver bits are well known in the orthopedic art and would allow use of the same instrument shaft to drive different orthopedic devices with different engagement features by simply changing the corresponding engagement features of the second orthopedic device/driver bit. The distal exit opening extending through the bottom end has a smaller cross section than a cross section of the orthopedic device taken at the larger diameter proximal portion of the second orthopedic device/driver bit, as taught by Garcia, since the second orthopedic device has a shoulder, proximal to which it has a larger diameter. The orthopedic device retention portion is configured to hold the orthopedic device in the elongated opening with at least the second orthopedic device/driver bit held in contact with the bottom end as it is pushed therethrough up to the stop since their diameters are complementary.
As to claim 25, Berger discloses an orthopedic system, FIGS. 7-11, comprising an orthopedic device caddy (8 and 1), the orthopedic device caddy comprising: (a) a caddy body; (b) an elongated opening (10 and 6) (col. 6 / line 66 – col. 7 / line 8) extending into the caddy body from a proximal end to a distal end, the elongated opening comprising a first portion (distal portion) and a second portion (proximal portion) proximal to the first portion; (c) a first orthopedic device (16) removably positioned in the first portion of the elongated opening (at least a distal portion of the orthopedic device is removably positioned in the distal portion of the elongated opening or other portions of the orthopedic device are removably positioned in the distal portion as it is pushed through the elongated opening); wherein the first portion is configured to receive the first orthopedic device in a first direction (in a distal/insertion direction of movement), retain the first orthopedic device in contact with a bottom end (at 1) of a first retention portion (distal portion) of the elongated opening (the first orthopedic device is in contact with the bottom end at 1 when it is inserted therein), the elongated opening defining an opening (exit opening of 6) extending through the bottom end having a smaller cross section than a cross section of the orthopedic device (the opening at the exit of 6 has a smaller cross section than a cross section of a head of the orthopedic device so that the orthopedic device does not fall through) and allow for removal of the first orthopedic device in a second direction opposite the first direction (the first portion allows for removal of the device in a second proximal/removal direction of movement which is opposite the first direction, because the orthopedic device can be removed proximally from/backed out of the caddy before the surgery if the surgeon decides to use a different device, for example, or if it is not needed and is removed during disassembly).
Berger is silent as to the second portion is wider than the first portion, the caddy body defining a shoulder between the first portion and the second portion; a second orthopedic device removably positioned in the second portion of the elongated opening, wherein the second portion is configured to receive the second orthopedic device in a first direction, retain the second orthopedic device in a second retention portion of the elongated opening, and allow for removal of the second orthopedic device in a second direction opposite the first direction (claim 25); wherein the second orthopedic device is cannulated, with the cannulation extending from a proximal end of the second orthopedic device to a distal end of the second orthopedic device (claim 26); wherein, when the first and second orthopedic devices are removably positioned in the first and second portions of the elongated opening, the distal end of the second orthopedic device is spaced apart from a proximal end of the first orthopedic device (claim 27).
As to claim 25, Garcia teaches an orthopedic system, FIG. 48, comprising an orthopedic device caddy (1144 and 1116) (col. 22 / lines 19-22), the orthopedic device caddy comprising: (a) a caddy body; (b) an elongated opening (1149 and 1121) extending into the caddy body from a proximal end to a distal end (col. 22 / lines 34-37), the elongated opening comprising a first portion (distal portion) and a second portion (proximal portion) proximal to the first portion that is wider than the first portion, FIG. 48, the caddy body defining a shoulder between the first portion and the second portion, FIG. 48; (c) a first orthopedic device (1125) removably positioned in the first portion of the elongated opening; and (d) a second orthopedic device (1150; both orthopedic devices because they are used in orthopedic surgery) removably positioned in the second portion of the elongated opening (col. 22 / lines 34-52), wherein the first portion and the second portion are configured to receive the first orthopedic device and the second orthopedic device in a first direction (in a distal/insertion direction of movement), retain the first orthopedic device in contact with a bottom end (at 1116) of a first retention portion (distal portion) of the elongated opening (the first orthopedic device is in contact with the bottom end at 1116 when it is inserted therein) and retain the second orthopedic device in a second retention portion of the elongated opening, the elongated opening defining an opening (exit opening of 1121) extending through the bottom end having a smaller cross section than a cross section of the orthopedic device (the opening at the exit of 1121 has a smaller cross section than a cross section of a head of the orthopedic device so that the orthopedic device does not fall through) and allow for removal of the first orthopedic device and the second orthopedic device in a second direction opposite the first direction (the first portion and the second portion allow for removal of the devices in a second proximal/removal direction of movement which is opposite the first direction, because the orthopedic devices can be removed proximally from/backed out of the caddy before the surgery if the surgeon decides to use a different device, for example, or if it is not needed and is removed during disassembly).
As to claim 26, Garcia teaches the orthopedic system of claim 25 wherein the second orthopedic device is cannulated (at 1155), with the cannulation extending from a proximal end (proximal end portion) of the second orthopedic device to a distal end (distal end portion) of the second orthopedic device (where the distal end extends up to the end of 1155 so that 1155 extends to the distal end).
As to claim 27, Garcia teaches the orthopedic system of claim 26 wherein, when the first and second orthopedic devices are removably positioned in the first and second portions of the elongated opening, FIG. 48, the distal end of the second orthopedic device is spaced apart from a proximal end of the first orthopedic device (at least in the position of FIG. 48, and even when the first device is in the elongated opening, the distal end of the second device is spaced apart from the proximal end of the first device before driving engagement, and even during driving engagement, a proximal section of the distal end would be spaced apart).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Berger’s system to include a second orthopedic device (a driver bit) to facilitate driving of the first orthopedic device, and to modify the caddy and its elongated openings to accommodate the first and second orthopedic devices by elongating the length of the elongated opening and providing the stepped interior to allow holding of each of the orthopedic devices in their respective first or second portions, as taught by Garcia. Driver bits are well known in the orthopedic art and would allow use of the same instrument shaft to drive different orthopedic devices with different engagement features by simply changing the corresponding engagement features of the second orthopedic device/driver bit. The first portion would be a smaller diameter distal portion to hold the first orthopedic device, and the second portion would be wider than the first portion and separated therefrom by a shoulder to hold the second orthopedic device, as taught by Garcia.
Claims 2, 4-6, 8, 10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Berger in view Garcia (hereinafter, “Berger/Garcia”), as applied to claims 1, 3, 14-21, and 23-27 above, and further in view of U.S. Patent No. US 10,245,086 to Treace et al. (hereinafter, “Treace”).
As to claim 2, Berger/Garcia disclose the orthopedic system of claim 1 further comprising a sterile package containing the orthopedic device and the orthopedic device caddy (Berger, col. 7 / line 66 – col. 8 / line 10).
As to claim 4, Berger/Garcia disclose the orthopedic system of claim 2 wherein the alignment portion is at least twice a length of the orthopedic device (in the modification above with respect to claim 1, the alignment portion is at least three times a length of the orthopedic device, which also meets the limitation of at least twice a length).
As to claim 8, Berger/Garcia disclose the orthopedic system of claim 4 wherein the caddy body is configured to allow visualization of the orthopedic device in the orthopedic device retention portion of the elongated opening (the orthopedic device can be visualized through a top opening of the elongated opening).
As to claim 10, Berger/Garcia disclose the orthopedic system of claim 8 where the caddy body comprises a visualization opening (11; for visualization of the screw in 11) extending into the caddy body proximate (at least part of 11 is near the orthopedic device retention portion of 10) the orthopedic device retention portion of the elongated opening, FIG. 8.
As to claim 12, Berger/Garcia disclose the orthopedic system of claim 4 wherein the caddy body comprises at least one additional opening (11) extending into the caddy body configured to retain an additional orthopedic device (col. 6 / line 66 – col. 7 / line 8), FIG. 8.
As to claim 13, Berger/Garcia disclose the orthopedic system of claim 12 wherein the additional orthopedic device comprises an orthopedic screw (16) (col. 7 / lines 9-13), FIG. 8.
Berger/Garcia are silent as to the sterile package containing the orthopedic instrument (claim 2).
Treace teaches that all components of a surgical kit can be included in a single sterile package (col. 29 / lines 18-19).
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 all the components of Berger/Garcia’s system in a single sterile package, as taught by Treace, for ease of shipping and to reduce costs, and to ensure that the practitioner has access to all of the required components of the system when in the operating suite and that the components are ready to use, therefore reducing surgical time. The sterile package would thus contain the orthopedic device, the orthopedic instrument, and the orthopedic device caddy.
As to claims 5 and 6, Berger/Garcia are silent as to wherein an outer diameter of the portion of the instrument shaft is less than 1 mm smaller than an inner diameter of the alignment portion of the elongated opening (claim 5); wherein an outer diameter of the portion of the instrument shaft is less than 0.5 mm smaller than an inner diameter of the alignment portion of the elongated opening (claim 6).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make an outer diameter of the portion of the instrument shaft a negligible amount smaller than an inner diameter of the alignment portion of the elongated opening, as appears to be shown in Berger and Garcia, so that the portion of the instrument shaft can slide into the alignment portion to drive the orthopedic device without significant play so that the alignment portion serves to accurately guide the instrument shaft. It would have been obvious to make the difference in diameters less than 0.5 mm, since discovering an optimum value of a result effective variable involves only routine skill in the art. The portion of the instrument shaft can be only negligibly smaller (less than 0.5 mm) than the alignment portion so that the surfaces slide along each other for accurate guiding.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Berger/Garcia in view Treace (hereinafter, “Berger/Garcia/Treace”), as applied to claims 2, 4-6, 8, 10, 12, and 13 above, and further in view of U.S. Patent No. 5,201,893 to Holloway et al. (hereinafter, “Holloway”).
Berger/Garcia/Treace contemplate wherein the caddy body is made of a sterilizable plastic material such as polypropylene (Berger, col. 5 / lines 46-50) but are silent as to wherein the caddy body is at least partially translucent.
Holloway teaches that clarified polypropylene is translucent and sterilizable (col. 7 / line 61 – col. 8 / line 3).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise the caddy body of translucent clarified polypropylene, since this is taught by Holloway as being easily sterilizable, non-toxic, and relatively rigid, and therefore appropriate for use in Berger/Garcia/Treace’s caddy body, particularly since Berger contemplates the use of polypropylene.
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
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