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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-18 of U.S. Patent No. 12,256,961 B2 in view of Zimek et al. (U.S. Pub. No. 2019/0059949 A1, hereinafter “Zimek”).
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A method of performing a spinal deformity correction for a plurality of vertebral bodies comprising: inserting into each one of a plurality of vertebral bodies a staple having a ring and a plurality of prongs extending downwardly from the ring for engaging bone; for each inserted staple, inserting through the inserted staple a threaded shaft of a bone screw into a respective vertebral body, each bone screw having a threaded tulip extending upwardly from the threaded shaft, each threaded tulip having a pair of upwardly extending arms defining a cord path; placing a flexible tensioning line in a flexible tube extending from a tensioner having a pair of handles; for one of the inserted bone screw, placing the distal end of the flexible tube near the one inserted bone screw; squeezing the handles of the tensioner towards each other to apply a compressive force to the flexible tensioning line until an appropriate tensioning force is achieved; when the appropriate tensioning force is achieved, tightening a threaded locking cap in the threaded tulip of the one inserted bone screw to lock the flexible tensioning line to the one inserted bone screw.
11. The method of claim 1, wherein the flexible tensioning line includes a flexible cord to be placed in the threaded tulips of the inserted bone screws and a flexible threaded shaft coupled to the cord, and the step of placing a flexible tensioning line in a flexible tube includes inserting the flexible threaded shaft into the flexible tube.
1. A method of performing a spinal deformity correction for a plurality of vertebral bodies comprising: inserting into each one of a plurality of vertebral bodies a staple having a ring and a plurality of prongs extending downwardly from the ring for engaging bone; for each staple, inserting through the staple a threaded shaft of a bone screw into a respective vertebral body, each bone screw having a threaded head extending upwardly from the threaded shaft; placing a flexible tensioning line in a flexible tube extending from a tensioner having a pair of handles, wherein the flexible tensioning line includes a flexible cord to be placed in the threaded heads of the inserted bone screws and a flexible threaded shaft coupled to the cord, and placing a flexible tensioning line in a flexible tube comprises inserting the flexible threaded shaft into the flexible tube; for one of the inserted bone screw, placing the distal end of the flexible tube near the one inserted bone screw; squeezing the handles of the tensioner towards each other to apply a compressive force to the flexible tensioning line until an appropriate tensioning force is achieved; when the appropriate tensioning force is achieved, tightening a threaded locking cap in the threaded head of the one inserted bone screw to lock the flexible tensioning line to the one inserted bone screw.
2. The method of claim 1, further comprising repeating the steps of placing the distal end of the flexible tube near the one inserted bone screw, squeezing the handles and inserting a threaded locking cap for each of the remaining inserted bone screws.
2. The method of claim 1, further comprising repeating the steps of placing the distal end of the flexible tube near the one inserted bone screw, squeezing the handles and inserting a threaded locking cap for each of the remaining inserted bone screws.
3. The method of claim 1, wherein the tensioner includes a tension release mechanism and after the threaded locking cap is tightened, activating the tension release mechanism.
3. The method of claim 1, wherein the tensioner includes a tension release mechanism and after the threaded locking cap is tightened, activating the tension release mechanism.
4. The method of claim 1, wherein the tensioner includes a tension release button and after the threaded locking cap is inserted, activating the tension release button to unlock the flexible tensioning line.
4. The method of claim 1, wherein the tensioner includes a tension release button and after the threaded locking cap is inserted, activating the tension release button to unlock the flexible tensioning line.
5. The method of claim 1, wherein the tensioner includes a plurality of force indicia and a movable force gauge such that when the tensioner handles are being squeezed, the force gauge moves along the plurality of indicia to indicate the force being applied by the tensioner.
5. The method of claim 1, wherein the tensioner includes a plurality of force indicia and a movable force gauge such that when the tensioner handles are being squeezed, the force gauge moves along the plurality of indicia to indicate the force being applied by the tensioner.
6. The method of claim 1, wherein the tensioner includes a fine tuning thumbwheel that provides a fine tuning of the compressive force to the flexible tensioning line.
6. The method of claim 1, wherein the tensioner includes a fine tuning thumbwheel that provides a fine tuning of the compressive force to the flexible tensioning line.
7. The method of claim 1, wherein the tensioner includes a ratcheting mechanism configured to apply a one-way compressive force to the flexible tensioning line.
7. The method of claim 1, wherein the tensioner includes a ratcheting mechanism configured to apply a one-way compressive force to the flexible tensioning line.
8. The method of claim 7, wherein the ratcheting mechanism includes a pawl having a plurality of teeth and coupled between the two handles.
8. The method of claim 7, wherein the ratcheting mechanism includes a pawl having a plurality of teeth and coupled between the two handles.
9. The method of claim 1, wherein the flexible tube includes an end cap at the distal end of the flexible tube.
9. The method of claim 1, wherein the flexible tube includes an end cap at the distal end of the flexible tube.
10. The method of claim 9, wherein the end cap is made of PEEK material.
10. The method of claim 9, wherein the end cap is made of PEEK material.
12. A method of performing a spinal deformity correction for a plurality of vertebral bodies comprising: providing a tensioner having a tubular body, a pair of handles coupled to the tubular body, a plurality of force indicia on the tubular body, a movable force gauge movable along the plurality of force indicia to indicate a force being applied by the tensioner; attaching a flexible tube to a distal end of the tubular body; on a convex side of the deformity, inserting into each one of a plurality of vertebral bodies a staple having a ring and a plurality of prongs extending downwardly from the ring for engaging bone; through the ring of each inserted staple, inserting a threaded shaft of a bone screw into a respective vertebral body, each bone screw having a threaded tulip extending upwardly from the threaded shaft, each threaded tulip having a pair of upwardly extending arms defining a cord path; for one of the inserted bone screw, placing the distal end of the flexible tube near the one inserted bone screw; squeezing the handles of the tensioner towards each other to apply a compressive force to a flexible tensioning line disposed in the flexible tube until an appropriate tensioning force is achieved; when the appropriate tensioning force is achieved, tightening a threaded locking cap in the threaded tulip of the one inserted bone screw to lock the flexible tensioning line to the one inserted bone screw.
20. The method of claim 12, wherein the flexible tensioning line includes a flexible cord to be placed in the threaded tulips of the inserted bone screws and a flexible threaded shaft coupled to the cord, and the step of placing a flexible tensioning line in a flexible tube includes inserting the flexible threaded shaft into the flexible tube.
11. A method of performing a spinal deformity correction for a plurality of vertebral bodies comprising: providing a tensioner having a tubular body, a pair of handles coupled to the tubular body, a plurality of force indicia on the tubular body, a movable force gauge movable along the plurality of force indicia to indicate a force being applied by the tensioner; attaching a flexible tube to a distal end of the tubular body; on a convex side of the deformity, inserting into each one of a plurality of vertebral bodies a staple having a ring and a plurality of prongs extending downwardly from the ring for engaging bone; through the ring of each inserted staple, inserting a threaded shaft of a bone screw into a respective vertebral body, each bone screw having a threaded head extending upwardly from the threaded shaft; placing a flexible tensioning line in a flexible tube extending from a tensioner having a pair of handles, wherein the flexible tensioning line includes a flexible cord to be placed in the threaded heads of the inserted bone screws and a flexible threaded shaft coupled to the cord, and placing a flexible tensioning line in a flexible tube comprises inserting the flexible threaded shaft into the flexible tube for one of the inserted bone screw, placing the distal end of the flexible tube near the one inserted bone screw; squeezing the handles of the tensioner towards each other to apply a compressive force to the flexible tensioning line until an appropriate tensioning force is achieved; when the appropriate tensioning force is achieved, tightening a threaded locking cap in the threaded head of the one inserted bone screw to lock the flexible tensioning line to the one inserted bone screw.
13. The method of claim 12, wherein the tensioner includes a tension release mechanism and after the threaded locking cap is tightened, activating the tension release mechanism to release the tensioning force on the flexible tensioning line.
12. The method of claim 11, wherein the tensioner includes a tension release mechanism and after the threaded locking cap is tightened, activating the tension release mechanism to release the tensioning force on the flexible tensioning line.
14. The method of claim 12, wherein the tensioner includes a fine tuning thumbwheel that provides a fine tuning of the compressive force to the flexible tensioning line.
13. The method of claim 11, wherein the tensioner includes a fine tuning thumbwheel that provides a fine tuning of the compressive force to the flexible tensioning line.
15. The method of claim 12, wherein the tensioner includes a ratcheting mechanism configured to apply a one-way compressive force to the flexible tensioning line.
14. The method of claim 11, wherein the tensioner includes a ratcheting mechanism configured to apply a one-way compressive force to the flexible tensioning line.
16. The method of claim 16, wherein the ratcheting mechanism includes a pawl having a plurality of teeth and coupled between the two handles.
15. The method of claim 14, wherein the ratcheting mechanism includes a pawl having a plurality of teeth and coupled between the two handles.
17. The method of claim 16, wherein the flexible tube includes an end cap attached to the distal end of the flexible tube.
16. The method of claim 15, wherein the flexible tube includes an end cap attached to the distal end of the flexible tube.
18. The method of claim 12, wherein the flexible tube includes an end cap at the distal end of the flexible tube.
17. The method of claim 11, wherein the flexible tube includes an end cap at the distal end of the flexible tube.
19. The method of claim 18, wherein the end cap is made of PEEK material.
18. The method of claim 17, wherein the end cap is made of PEEK material.
As is evident from the table above, the Patent claims 1 and 11 disclose all of the features of the application claims, except regarding claim 1, inserting the threaded shaft of the bone screw through the inserted staple; each bone screw having a threaded tulip extending upwardly from the threaded shaft, each threaded tulip having a pair of upwardly extending arms defining a cord path; and regarding claim 12, each bone screw having a threaded tulip extending upwardly from the threaded shaft, each threaded tulip having a pair of upwardly extending arms defining a cord path.
Zimek discloses a method of performing a spinal deformity correction for a plurality of vertebral bodies (see para. [0042]) that comprises: inserting a bone screw (106) into an inserted staple (104, see para. [0041]); each bone screw having a threaded tulip extending upwardly from threaded shaft defining a cord path (see para. [0042], “receiving channel defined in the head” and “set screw can be placed in the head”) in order to better control the trajectory of the bone screw to avoid unnecessary tissue displacement by prior placement of the staple (see para. [0041]), and in order to aid in reduction of the spinal curvature through retaining of tensioning, translation and compression applied to the spine (see para. [0042]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Patent claims 1 and 11 to include inserting the bone screw through the inserted staple and modifying each bone screw to include a threaded tulip having a pair of upwardly extending arms defining a cord path in view of Zimek in order to better control the trajectory of the bone screw to avoid unnecessary tissue displacement by prior placement of the staple, and in order to aid in reduction of the spinal curvature through retaining of tensioning, translation and compression applied to the spine.
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.
Claim(s) 1-6, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mast (U.S. Pub. No. 2019/0059958 A1, hereinafter “Mast”) in view of Zimek et al. (U.S. Pub. No. 2019/0059949 A1, hereinafter “Zimek”) and in view of Bosshard et al. (U.S. Pub. No. 2018/0185080 A1, hereinafter “Bosshard”).
Mast discloses, regarding claim 1, a method of performing a spinal deformity correction for a plurality of vertebral bodies (see para. [0016]) comprising: inserting a threaded shaft of a bone screw (106, see para. [0017] “threaded fastener”) into a respective vertebral body (see para. [0017], see also step 502 in Fig. 6, note that the bone screw has already been inserted prior to coupling it with the tensioner); placing a flexible tensioning line (108, see para. [0017] “cord” “or similar flexible ligature”, see also steps 506 and 508 of Fig. 6) in a tube (226) extending from a tensioner (102, see annotated Fig. 2 below) having a pair of handles (218 220, see Fig. 2); for one of the inserted bone screw, placing the distal end of the tube near the one inserted bone screw (see Fig. 1, note that note that the distal end of the tube is placed at the top of the counter tensioner 104 which is coupled to the bone screw 106 and is therefore considered to be placed near the bone screw 106); squeezing the handles of the tensioner towards each other to apply a compressive force to the flexible tensioning line until an appropriate tensioning force is achieved (see paras. [0020] and [0027]).
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Regarding claim 3, wherein the tensioner includes a tension release mechanism (216) and after the cord is secured to the bone screw (see para. [0019] “shaft lock 216 can be released … if the tension on the cord 108 needs to be released, such as once the cord 108 is secured within the implant 106”), activating the tension release mechanism (see para. [0019]).
Regarding claim 4, wherein the tensioner includes a tension release button (216) and after the cord is secured to the bone screw (see para. [0019] “shaft lock 216 can be released … if the tension on the cord 108 needs to be released, such as once the cord 108 is secured within the implant 106”), activating the tension release button to unlock the flexible tensioning line (see para. [0019]).
Regarding claim 5, wherein the tensioner includes a plurality of force indicia (128) and a movable force gauge (122) such that when the tensioner handles are being squeezed (see para. [0020]), the force gauge moves along the plurality of indicia to indicate the force being applied by the tensioner (see para. [0020]).
Regarding claim 6, wherein the tensioner includes a fine tuning thumbwheel (232) that provides a fine tuning of the compressive force to the flexible tensioning line (see para. [0019]).
Regarding claim 9, wherein the flexible tube includes an end cap at the distal end of the tube (see annotated Fig. 2 above, note that the flared portion of 226 distal to the detent 236 is being considered an end cap, since it is a distinct wider portion disposed at the end of the tube).
Mast fails to disclose, regarding claim 1, inserting into each one of a plurality of vertebral bodies a staple having a ring and a plurality of prongs extending downwardly from the ring for engaging bone; for each inserted staple, inserting the threaded shaft of the bone screw through the inserted staple a threaded shaft; each bone screw having a threaded tulip extending upwardly from the threaded shaft, each threaded tulip having a pair of upwardly extending arms defining a cord path; when the appropriate tensioning force is achieved, tightening a threaded locking cap in the threaded tulip of the one inserted bone screw to lock the flexible tensioning line to the one inserted bone screw; and wherein the tube is flexible; and regarding claim 2, further comprising repeating the steps of placing the distal end of the flexible tube near the one inserted bone screw, squeezing the handles and inserting a threaded locking cap for each of the remaining inserted bone screws; and regarding claims 3-4, wherein the cord is secured to the bone screw by tightening the threaded locking cap.
Zimek discloses a method of performing a spinal deformity correction for a plurality of vertebral bodies (see para. [0042]) that comprises: inserting into each one of a plurality of vertebral bodies (see para. [0041]) a staple (104) having a ring (see Fig. 1, see also para. [0039] “washer”) and a plurality of prongs extending downwardly from the ring for engaging bone (see Fig. 1, see also para. [0039] “with spikes”); for each staple, inserting through the staple the threaded shaft of the bone screw (106, see paras. [0039] and [0041]); each bone screw having a threaded tulip extending upwardly from threaded shaft, each threaded tulip having a pair of upwardly extending arms defining a cord path (see para. [0042] “receiving channel defined in the head” and “set screw can be placed in the head”); tightening a threaded locking cap (see para. [0042] “set screws”) in the threaded tulip of one inserted bone screw to lock the flexible tensioning line to the one inserted bone screw (see para. [0042]); further comprising repeating the steps of placing the distal end of the flexible tube near the one inserted bone screw, squeezing the handles and inserting a threaded locking cap for each of the remaining inserted bone screws (see para. [0042]) in order to better control the trajectory of the bone screw to avoid unnecessary tissue displacement by prior placement of the staple (see para. [0041]) and in order to aid in reduction of the spinal curvature through retaining of tensioning, translation and compression applied to the spine (see para. [0042]).
Bosshard discloses an instrument (400, see Fig. 4A) for tensioning a cord (510), wherein the instrument comprises a body (420) having an opening (e.g. opening in body 420 that receives tube 410, see Fig. 4A), a flexible tube (410, see para. [0115] “flexible”) extending distally from the opening (see Figs. 4A-4B), the flexible tube configured to receive the cord (see Fig. 4A), a distal end of the flexible tube configured to apply tension on the cord (see para. [0113]) in order to provide a tube that is flexible and easily deformable to enable the cord to be grasped and tensioned without damage to the cord (see para. [0129]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Mast to include inserting a plurality of staples that comprises a ring with a plurality of prongs, inserting the bone screw through the staple, and modifying the bone screw to include a threaded tulip and a threaded locking cap in view of Zimek in order to better control the trajectory of the bone screw to avoid unnecessary tissue displacement by prior placement of the staple and in order to aid in reduction of the spinal curvature through retaining of tensioning, translation and compression applied to the spine. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tube in the instrument in Mast to be flexible in view of Bosshard in order to provide a tube that is flexible and easily deformable to enable the cables to be grasped and tensioned without damaging the cord.
And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tube in the instrument in Mast to be flexible in view of Bosshard in order to provide a tube that is flexible and easily deformable to enable the cables to be grasped and tensioned without damaging the cord.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mast in view of Zimek and in view of Bosshard, as applied to claim 1 above, and in further view of Cohen (U.S. Pub. No. 2002/0072753 A1, hereinafter “Cohen”).
Mast in view of Zimek and in view of Bosshard disclose all of the features of the claimed invention, as previously set forth above, except regarding claim 7, wherein the tensioner includes a ratcheting mechanism configured to apply a one-way compressive force to the flexible tensioning line; and regarding claim 8, wherein the ratcheting mechanism includes a pawl having a plurality of teeth and coupled between the two handles.
Cohen discloses an instrument (100, see Fig. 2) for tensioning a cord (“E”, see Fig. 9), with a ratcheting mechanism (130); wherein the ratchet includes a pawl (114) on the first handle portion (see Fig. 2); wherein the ratchet includes a plurality of uni-directional teeth to apply one-way compressive force (130, see Fig. 3) in order to provide releasably incremental movement of the actuating member while preventing loosening movement, as well as providing an audible signal to indicate the progression of the tensioning procedure (see para. [0030]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal ends of the first and second handles in Mast in view of Zimek and in view of Bosshard to be connected by a ratchet and to modify the first handle to include a pawl and to modify the instrument in Mast in view of Zimek and in view of Bosshard to include a force gauge and a plurality of indicia in further view of Cohen in order to provide releasably incremental movement of the actuating member while preventing loosening movement, as well as providing an audible signal to indicate the progression of the tensioning procedure and to indicate to the user the degree of tension of the cable.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mast in view of Zimek and in view of Bosshard, as applied to claim 1 above, and in further view of Rice et al. (U.S. Pub. No. 2018/0353217 A1, hereinafter “Rice”).
Mast in view of Zimek and in view of Bosshard discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 10, wherein the end cap is made of PEEK material.
Rice discloses a tensioning instrument (T, see Fig. 4), wherein the components can be made of PEEK material (see para. [0032]) in order to manufacture the device out of a biologically acceptable material suitable for medical applications (see para. [0032]).
It would have bene obvious to one having ordinary skill in the art at the time the invention was made to modify the end cap in Mast in view of Zimek and in view of Bosshard to be made of PEEK material in further view of Rice in order to manufacture the device out of a biologically acceptable material suitable for medical applications.
Claim(s) 12-14, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mast (U.S. Pub. No. 2019/0059958 A1, hereinafter “Mast”) in view of Zimek et al. (U.S. Pub. No. 2019/0059949 A1, hereinafter “Zimek”) and in view of Bosshard et al. (U.S. Pub. No. 2018/0185080 A1, hereinafter “Bosshard”) and in view of Serhan et al. (U.S. Pub. No. 2006/0217715 A1, hereinafter “Serhan”).
Mast discloses, regarding claim 12, a method of performing a spinal deformity correction for a plurality of vertebral bodies (see para. [0016]) comprising: providing a tensioner (102, see Fig. 1) having a tubular body (124), a pair of handles (218 and 220) coupled to the tubular body (see Fig. 2), a plurality of force indicia (128) on the tubular body (see Fig. 1), a movable force gauge (122) movable along the plurality of force indicia to indicate a force being applied by the tensioner (see para. [0020]); attaching a tube (226) to a distal end of the tubular body (see Fig. 2); inserting a threaded shaft of a bone screw (106, see para. [0017] “threaded fastener”) into a respective vertebral body (see para. [0017], see also step 502 in Fig. 6, note that the bone screw has already be inserted prior to coupling it with the tensioner); for one of the inserted bone screw, placing the distal end of the tube near the one inserted bone screw (see Fig. 1, note that note that the distal end of the tube is placed at the top of the counter tensioner 104 which is coupled to the bone screw 106 and is therefore considered to be placed near the bone screw 106); squeezing the handles of the tensioner towards each other to apply a compressive force to a flexible tensioning line (108, see para. [0017] “cord” “or similar flexible ligature”) disposed in the tube until an appropriate tensioning force is achieved (see paras. [0020] and [0027]).
Regarding claim 13, wherein the tensioner includes a tension release mechanism (216) and after the cord is secured to the bone screw (see para. [0019] “shaft lock 216 can be released … if the tension on the cord 108 needs to be released, such as once the cord 108 is secured within the implant 106”), activating the tension release mechanism to release the tensioning force on the flexible tensioning line (see para. [0019]).
Regarding claim 14, wherein the tensioner includes a fine tuning thumbwheel (232) that provides a fine tuning of the compressive force to the flexible tensioning line (see para. [0019]).
Regarding claim 17, wherein the tube includes an end cap (see annotated Fig. 2 above, note that the flared portion of 226 distal to the detent 236 is being considered an end cap, since it is a distinct wider portion disposed at the end of the tube) attached to the distal end of the tube (see annotated Fig. 2 above, note that the wider portion is attached to the rest of the tube proximal to detent 236).
Regarding claim 18, wherein the tube includes an end cap (see annotated Fig. 2 above, note that the flared portion of 226 distal to the detent 236 is being considered an end cap, since it is a distinct wider portion disposed at the end of the tube) at the distal end of the tube (see annotated Fig. 2 above).
Mast fails to disclose, regarding claim 12, wherein the tube is flexible; wherein the staple and bone screw are inserted on a convex side of the deformity; inserting into each one of a plurality of vertebral bodies a staple having a ring and a plurality of prongs extending downwardly from the ring for engaging bone; for each inserted staple, inserting the threaded shaft of the bone screw through the inserted staple a threaded shaft; each bone screw having a threaded tulip extending upwardly from the threaded shaft, each threaded tulip having a pair of upwardly extending arms defining a cord path; when the appropriate tensioning force is achieved, tightening a threaded locking cap in the threaded tulip of the one inserted bone screw to lock the flexible tensioning line to the one inserted bone screw; and wherein the tube is flexible; and regarding claim 13, wherein the cored is secured to the implant by tightening the threaded locking cap.
Zimek discloses a method of performing a spinal deformity correction for a plurality of vertebral bodies (see para. [0042]) that comprises: inserting into each one of a plurality of vertebral bodies (see para. [0041]) a staple (104) having a ring (see Fig. 1, see also para. [0039] “washer”) and a plurality of prongs extending downwardly from the ring for engaging bone (see Fig. 1, see also para. [0039] “with spikes”); for each staple, inserting through the staple the threaded shaft of the bone screw (106, see paras. [0039] and [0041]); each bone screw having a threaded tulip extending upwardly from threaded shaft, each threaded tulip having a pair of upwardly extending arms defining a cord path (see para. [0042] “receiving channel defined in the head” and “set screw can be placed in the head”); tightening a threaded locking cap (see para. [0042] “set screws”) in the threaded tulip of one inserted bone screw to lock the flexible tensioning line to the one inserted bone screw (see para. [0042]) in order to better control the trajectory of the bone screw to avoid unnecessary tissue displacement by prior placement of the staple (see para. [0041]) and in order to aid in reduction of the spinal curvature through retaining of tensioning, translation and compression applied to the spine (see para. [0042]).
Bosshard discloses an instrument (400, see Fig. 4A) for tensioning a cord (510), wherein the instrument comprises a body (420) having an opening (see Fig. 4A), a flexible tube (410, see para. [0115] “flexible”) extending distally from the opening (see Figs. 4A-4B), the flexible tube configured to receive the cord (see Fig. 4A), a distal end of the flexible tube configured to apply tension on the cord (see para. [0113]) in order to provide a tube that is flexible and easily deformable to enable the cord to be grasped and tensioned without damage to the cord (see para. [0129]).
Serhan discloses a method of performing a spinal deformity correction for a plurality of vertebral bodies (see Fig. 18), wherein the implants (10, 10’) and tether (50) on a convex side of the deformity (see Fig. 18, see para. [0095]) in order to halt the growth of the spine on the convex side of the deformity, subsequent growth of the spine on the concave side will cause the deformity to self-correct, thus gradually providing the correction while allowing the patient's overall height to increase (see paras. [0060] and [0095]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Mast to include inserting a plurality of staples that comprises a ring with a plurality of prongs, inserting the bone screw through the staple, and modifying the bone screw to include a threaded shaft, a threaded tulip and a threaded locking cap in view of Zimek in order to better control the trajectory of the bone screw to avoid unnecessary tissue displacement by prior placement of the staple and in order to aid in reduction of the spinal curvature through retaining of tensioning, translation and compression applied to the spine. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tube in the instrument in Mast to be flexible in view of Bosshard in order to provide a tube that is flexible and easily deformable to enable the cables to be grasped and tensioned without damaging the cord. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tube in the instrument in Mast to be flexible in view of Bosshard in order to provide a tube that is flexible and easily deformable to enable the cables to be grasped and tensioned without damaging the cord. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Mast to include placing the implants on a convex side in view of Serhan in order to halt the growth of the spine on the convex side of the deformity, subsequent growth of the spine on the concave side will cause the deformity to self-correct, thus gradually providing the correction while allowing the patient's overall height to increase.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mast in view of Zimek and in view of Bosshard and in view of Serhan, as applied to claim 1 above, and in further view of Cohen (U.S. Pub. No. 2002/0072753 A1, hereinafter “Cohen”).
Mast in view of Zimek and in view of Bosshard and in view of Serhan disclose all of the features of the claimed invention, as previously set forth above, except regarding claim 15, wherein the tensioner includes a ratcheting mechanism configured to apply a one-way compressive force to the flexible tensioning line; and regarding claim 16, wherein the ratcheting mechanism includes a pawl having a plurality of teeth and coupled between the two handles.
Cohen discloses an instrument (100, see Fig. 2) for tensioning a cord (“E”, see Fig. 9), with a ratcheting mechanism (130); wherein the ratchet includes a pawl (114) on the first handle portion (see Fig. 2); wherein the ratchet includes a plurality of uni-directional teeth to apply one-way compressive force (130, see Fig. 3) in order to provide releasably incremental movement of the actuating member while preventing loosening movement, as well as providing an audible signal to indicate the progression of the tensioning procedure (see para. [0030]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal ends of the first and second handles in Mast in view of Zimek and in view of Bosshard to be connected by a ratchet and to modify the first handle to include a pawl and to modify the instrument in Mast in view of Zimek and in view of Bosshard and in view of Serhan to include a force gauge and a plurality of indicia in further view of Cohen in order to provide releasably incremental movement of the actuating member while preventing loosening movement, as well as providing an audible signal to indicate the progression of the tensioning procedure and to indicate to the user the degree of tension of the cable.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mast in view of Zimek and in view of Bosshard and in view of Serhan, as applied to claim 1 above, and in further view of Rice et al. (U.S. Pub. No. 2018/0353217 A1, hereinafter “Rice”).
Mast in view of Zimek and in view of Bosshard and in view of Serhan discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 19, wherein the end cap is made of PEEK material.
Rice discloses a tensioning instrument (T, see Fig. 4), wherein the components can be made of PEEK material (see para. [0032]) in order to manufacture the device out of a biologically acceptable material suitable for medical applications (see para. [0032]).
It would have bene obvious to one having ordinary skill in the art at the time the invention was made to modify the end cap in Mast in view of Zimek and in view of Bosshard and in view of Serhan to be made of PEEK material in further view of Rice in order to manufacture the device out of a biologically acceptable material suitable for medical applications.
Allowable Subject Matter
Claim(s) 11 and 20 would be allowable if a terminal disclaimer is filed to overcome the rejection(s) under nonstatutory double patenting, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof could be found which disclose, or suggest:
A method of performing a spinal deformity correction comprising inserting a staple and inserting a bone screw through the staple and placing a flexible tensioning line in a flexible tube extending from a tensioner having a pair of handles and, as per claim 11, the step of placing a flexible tensioning line in a flexible tube includes inserting the flexible threaded shaft into the flexible tube.
A method of performing a spinal deformity correction comprising providing a tensioner having a tubular body with a pair of handles and a movable force gauge and attaching a flexible tube to a distal end of the tubular body; and inserting a plurality of staples and bone screws into vertebral bodies on a convex side of deformity, and as per claim 20, the step of placing a flexible tensioning line in a flexible tube includes inserting the flexible threaded shaft into the flexible tube.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/M.C.G/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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