DETAILED ACTION
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0193151 (Fallin).
Regarding claim 1, Fallin discloses a method of fixating spinal bones for fusion, the method comprising: positioning a first leg (126) of a staple (100) connected to an inserter (300) in a first implant hole (962) of a first vertebra (956) and a second leg (124) of the staple connected to the inserter in a second implant hole (962) of a second vertebra (958) (see Figs. 54-57 and paragraph [0090]; implant 100 may be used instead of implant 900, as implant 900 includes a spacer 904 and through-screws 914 which are stated to be optional), wherein the first leg of the staple is connected to the second leg of the staple by a bridge (104), wherein the staple is positioned such that a bottom surface (132/106/134) of the staple faces the first vertebra and the second vertebra and a top surface (136/108/138) of the staple faces away from the first vertebra and the second vertebra (see Figs. 1B and 54-57), wherein the staple comprises a first coupling receptacle (160) having a bottom end (164) closed by a solid portion of the first leg of the staple (see Fig. 9) and a second coupling receptacle (160) having a bottom end (164) closed by a solid portion of the second leg of the staple (see Fig. 9; both legs 124/126 have coupling receptacles 160, see paragraph [0058]), and the inserter is connected to the staple through the top surface of the staple via the first coupling receptacle and the second coupling receptable without positioning the inserter between the bottom surface of the bridge of the staple and the first vertebra and the second vertebra (see Figs. 9, 15-18, 54-57; inserter does not travel inside the receptacles 160 below the bottom surface 106 of the bridge 104).
Further regarding claim 1, Fallin fails to explicitly state the step of detaching the inserter from the staple, but shows in Fig. 36 the inserter 300 is absent after installation of the staple 100 into bone portions in Fig. 35. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to include the step of detaching the inserter from the staple in order to protect the health of the patient by removing all tools used to implant the staple from within the patient.
Regarding claim 3, Fallin discloses wherein the inserter is connected at the first coupling receptacle to the first side of the staple through the top surface of the first side of the staple without contacting an outer perimeter of the first side of the staple (see Figs. 15-18 and paragraphs [0066] and [0067]), and wherein the inserter is connected at the second coupling receptacle to the second side of the staple through the top surface of the second side of the staple without contacting an outer perimeter of the second side of the staple (see Figs. 15-18 and paragraphs [0066] and [0067]).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of U.S. Patent Application Publication No. 2017/0196604 (Hartdegen).
Regarding claim 2, Fallin discloses further comprising: (i) connecting the inserter at the first coupling receptacle to a first side of the staple having the first leg through the top surface of the first side of the staple (see Figs. 15-18 and paragraphs [0066] and [0067]) and (ii) connecting the inserter at the second coupling receptacle to a second side of the staple having the second leg through the top surface of the second side of the staple (see Figs. 15-18 and paragraphs [0066] and [0067]). Fallin is silent regarding the connecting steps happening prior to positioning the legs of the staple at the implant holes. However, Hartdegen discloses a method of assembling a staple (300) and inserter (400) that includes connecting the staple and inserter together prior to positioning a first leg of the staple at a first implant hole and a second leg of the staple at a second implant hole (see paragraphs [0006], [0109], and [0138]); implant and inserter pre-assembled). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Fallin to pre-assemble the inserter and staple as suggested by Hartdegen in order to facilitate optimal placement and function of the staple (see Hartdegen, paragraphs [0006], [0109], and [0138]).
Regarding claim 12, Fallin is silent regarding the staple being titanium. However, Hartdegen discloses a method of using a bone staple wherein the staple is titanium (see paragraph [0126]), and it would have been prima facie obvious to have staple of Fallin be titanium in order to provide mechanical properties such as manipulation to achieve multiple configurations useful in surgical bone staples (see Hartdegen, paragraph [0126]).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of U.S. Patent Application Publication No. 2018/0008263 (Goldstein).
Regarding claim 4, Fallin appears to discloses further comprising: applying a load force at the staple using the inserter, wherein, as the load force is applied at the staple using the inserter, the first leg and the second leg are caused to move apart from one another (see paragraphs [0056]. [0058], and [0066]; divergence of legs). Alternatively, Goldstein discloses an orthopedic staple (20/50/70) and an inserter (41), wherein a method of implanting the staple with the inserter comprises applying a load force at the staple using the inserter, wherein, as the load force is applied at the staple using the inserter, the first leg and the second leg are caused to move apart from one another (see Figs. 3-4 and paragraphs [0022] and [0023]). Regarding claim 5, Goldstein discloses further comprising: removing the load force from the staple (i) after positioning the first leg in the first implant hole and the second leg in the second implant hole and (ii) prior to detaching the inserter from the staple, wherein removing the load force from the staple causes the first leg and the second leg to move toward one another to apply a compression force at the first vertebra and the second vertebra (see paragraphs [0022] and [0023]; clips or suitable retainers holding staple under tension). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of to apply a load force at the staple using the inserter to move the legs of the staple apart before implantation and allows the legs to move back toward one another to apply a compression force as suggested by Goldstein in order to provide ancillary fixation between the bones (see Goldstein, paragraph [0026]). Additionally, it would be obvious to remove the clips or suitable retainers holding the staple under tension prior to removal of the staple from the inserter to ensure the staple can be adjusted if necessary if the positioning and compression is not to the satisfaction of the user.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of Goldstein, and further in view of U.S. Patent Application Publication No. 2009/0018556 (Prandi).
Regarding claim 6, Fallin discloses wherein the inserter comprises a first coupling shaft (one of locking bolts 312) connected at the first coupling receptacle (see Figs. 15-18 and paragraphs [0066] and [0067]) and a second coupling shaft (another of locking bolts 312) connected at the second coupling receptacle (see Figs. 15-18 and paragraphs [0066] and [0067]). Fallin and Goldstein fail to suggest wherein applying the load force comprises biasing the first coupling shaft and the second coupling shaft toward each other. However, Prandi discloses a method of applying a load force to a bone clip (2) that comprises using an inserter (1) and biasing a first coupling shaft (3) and a second coupling shaft (4) toward each other (see Fig. 3 and paragraph [0034]).
Regarding claim 9, Prandi discloses wherein a connector (11) joins the first coupling shaft and the second coupling shaft (shafts 3/4) to bias the first coupling shaft and the second coupling shaft toward each other and maintain the load force at the staple while the connector joins the first coupling shaft and the second coupling shaft (see Fig. 3 and paragraphs [0035] and [0044] and Figs. 3 and 4).
Regarding claim 10, Prandi discloses further comprising: removing the connector from the first coupling shaft and the second coupling shaft to cause the first coupling shaft to move away from the second coupling shaft (see paragraphs [0035] and [0044] and Figs. 3 and 4).
Further regarding claims 6, 9, and 10, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Fallin in view of Goldstein to bias coupling shafts of the inserter of toward each other, as Prandi suggests such a technique is suitable for applying a load force to move legs (21/22) of the bone staple/clip apart from each other (see Prandi, paragraph [0034]), and such a modification merely involves substituting one known technique for biasing bone staple/clip legs apart for another such known technique without any unpredictable results.
Regarding claim 7, Fallin suggests wherein detaching the inserter from the staple comprises detaching the first coupling shaft from the first coupling receptacle and detaching the second coupling shaft from the second coupling receptacle (see Figs. 15-18 and paragraphs [0066] and [0067]; attaching of the inserter to the staple via rotating of knobs 314 to attach the coupling shafts 312 to the coupling receptacles 160; it would be obvious to detach the inserter from the staple via rotating of knobs 314 in an opposite rotational direction to detach the coupling shafts 312 from the coupling receptacles 160 in order to protect the health of the patient by removing all tools used to implant the staple from within the patient).
Regarding claim 8, Fallin discloses wherein the first coupling shaft is connected through the top surface of the staple over the first leg of the staple and the second coupling shaft is connected through the top surface of the staple over the second leg of the staple (see Figs. 15-18 and paragraphs [0066] and [0067]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of U.S. Patent Application Publication No. 2016/0331414 (Etminan).
Regarding claim 13, Fallin fails to disclose wherein positioning the first leg of the staple in the first implant hole of the first vertebra and the second leg of the staple in the second implant hole of the second vertebra further comprises positioning a third leg of the staple in a third implant hole of a third vertebra (claim 13). However, Etminan discloses a method of mounting a cervical implant (20/58) to three vertebrae (10/12/14), the method involving surgically accessing the three vertebrae (see Figs. 1A-1B and 8A-10A, e.g.); removing bone from between the first and second vertebrae and from between the second and third vertebrae (Figs. 1A-1B and 8A-10A, e.g.; intervertebral cages 30 inserted into the cleaned out intervertebral disc spaces between the vertebrae 10/12 and 12/14); and applying the implant such that it is anchored in each of the three vertebrae and across the two intervertebral disc spaces (see Figs. 1A-1B and 8A-10A). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Fallin to use a multi-level staple anchored across three vertebrae and two intervertebral disc spaces instead of two vertebrae and one intervertebral disc space as suggested by Etminan in order to allow the surgeon to perform a multilevel fusion as is sometimes necessary for a patient (see Etminan, paragraph [0008]).
Claims 14, 15, 17, 18, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of U.S. Patent Application Publication No. 2019/0298421 (Capote).
Regarding claim 14, Fallin discloses a spinal surgical technique comprising:
surgically accessing a first vertebra (956) and a second vertebra (958) of a patient (see Figs. 54-57 and paragraph [0092]); and applying a staple (100) to the first vertebra and the second vertebra across a space between the first and second vertebrae to promote fusion of the first vertebra and the second vertebra (see Figs. 54-57 and paragraphs [0090] and [0902]; implant 100 may be used instead of implant 900, as implant 900 includes a spacer 904 and through-screws 914 which are stated to be optional), wherein applying the staple comprises positioning a first leg (126) of the staple (100) connected to an inserter (300) in a first implant hole (962) of the first vertebra (956) and a second leg (124) of the staple connected to the inserter in a second implant hole (962) of the second vertebra (958) (see Figs. 54-57 and paragraph [0090]; implant 100 may be used instead of implant 900, as implant 900 includes a spacer 904 and through-screws 914 which are stated to be optional) with a bridge (104) extending between the first leg and the second leg positioned over the space (see Figs. 54-57), wherein the staple comprises a first coupling receptacle (160) having a bottom end (164) closed by a solid portion of the first leg of the staple (see Fig. 9) and a second coupling receptacle (160) having a bottom end (164) closed by a solid portion of the second leg of the staple (see Fig. 9; both legs 124/126 have coupling receptacles 160, see paragraph [0058]), and the inserter is attached to a top surface (136/108/138) of the staple facing away from the first vertebra and the second vertebra via the first coupling receptacle and the second coupling receptacle without positioning the inserter between a bottom surface (106) of the bridge of the staple and the first vertebra and the second vertebra (see Figs. 9, 15-18, 54-57; inserter does not travel inside the receptacles 160 below the bottom surface 106 of the bridge 104).
Further regarding claim 14, Fallin fails to explicitly state the step of subsequently detaching the inserter from the staple, but shows in Fig. 36 the inserter 300 is absent after installation of the staple 100 into bone portions in Fig. 35. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to include the step of detaching the inserter from the staple in order to protect the health of the patient by removing all tools used to implant the staple from within the patient.
Further regarding claim 14, Fallin is silent regarding the step of removing a portion of least one of a vertebral bone and a vertebral disc from the spine to form a space between the first vertebra and the second vertebra; and the bridge extending over the space. However, Capote discloses a spinal surgical technique comprising surgically accessing spinal bones (12) (see paragraph [0039]); removing a portion of least one of a vertebral bone and a vertebral disc from the spine to form a space (intervertebral space) between the first vertebra and the second vertebra (see paragraphs [0030] and [0039] and Figs. 1-3; discectomy between bones 12 to form an intervertebral space), and placing two legs (400) of a staple (10) into the two vertebral bones (12) (see paragraph [0039] and Figs. 1-3).
Regarding claim 15, Capote discloses further comprising filing the space with an interbody device (30), wherein applying the staple across the space comprises applying the staple over the interbody device (see Figs. 1-3 Figs. 8A-8D and paragraphs [0031] and [0039]).
Regarding claim 17, Fallin discloses wherein the first and second vertebrae are adjacent pairs of vertebra separated by a single vertebral disc (see Figs. 54-57); Capote also discloses wherein the first vertebra and the second vertebra are adjacent pairs of vertebra (12) separated by a single vertebral disc (see Abstract and paragraphs [0030] and [0031]; prior to a discectomy or if treatment is employed without an additional discectomy procedure).
Regarding claim 18, Capote discloses where the first vertebra and the second vertebra are cervical vertebra (see paragraphs [0030] and [0039]), and applying the staple to the first vertebra and the second vertebra comprises applying the staple to an anterior side of the first vertebra and the second vertebra (see paragraphs [0025], [0030], [0031], [0037], and [0039]).
Regarding claim 21, Capote discloses wherein removing the portion of at least one of the vertebral bone and the vertebral disc comprises performing a corpectomy (see paragraph [0030]; corpectomy).
Regarding claim 22, Capote discloses wherein removing the portion of at least one of the vertebral bone and the vertebral disc comprises performing a discectomy (see paragraph [0030]; discectomy).
Further regarding claims 14, 15, 17, 18, 21, and 22, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to apply the technique of Fallin to facilitate fusion of spinal bones including a first vertebra and second vertebra in methods as suggested by Capote, as Capote suggests that cervical vertebral spinal bones are suitable for bone fusion via removing spinal tissue and applying a staple to vertebrae (see Capote, see paragraphs [0025], [0030], [0031], [0037], and [0039]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of Capote, and further in view of U.S. Patent No. 6,585,769 (Muhanna).
Regarding claim 16, Fallin and Capote fail to disclose further comprising introducing a graft material into the space, wherein applying the staple across the space comprises applying the staple over the graft material. However, Muhanna discloses a surgical treatment of the spine in which it is suggested either graft material may be placed in an intervertebral disc space to facilitate treatment of the spine (see col. 1, lines 27-44). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to introduce graft material into the space over which the staple extends, as Muhanna discloses a bone graft returns stability to the spinal column in compression and flexing (see Muhanna, col. 1, lines 27-44).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of Capote, and further in view of U.S. Patent Application Publication No. 2009/0138082 (Reah).
Regarding claim 19, Capote discloses where the first vertebra and the second vertebra are lumbar vertebra (see paragraphs [0025], [0030], and [0039]), but fails to disclose applying the staple to the first vertebra and the second vertebra comprises applying the staple to a posterior side of the first vertebra and the second vertebra. However, Reah suggests that a vertebral implant for stabilization of a spinal joint (see Abstract and paragraph [0006]) can be applied to anterior, posterior, and lateral sides of the spine (see paragraph [0176]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to apply the spinal treatment of Fallin in view of Capote to a posterior side of the vertebrae as Reah suggests such an area of the spine is suitable for stabilization (see Reah, paragraphs [0006] and [0176]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of Capote, and further in view of Etminan.
Regarding claim 20, Fallin fails to disclose wherein: surgically accessing the first vertebra and the second vertebra further comprises surgically accessing a third vertebra; removing the portion of at least one of the vertebral bone and the vertebral disc from the spine to form the space between the first vertebra and the second vertebra further comprises removing the portion of at least one of the vertebral bone and the vertebral disc from the spine to form a second space between the second vertebra and the third vertebra; and applying the staple to the first vertebra and the second vertebra across the space to promote fusion of the first vertebra and the second vertebra, further comprises applying the staple to the second vertebra and the third vertebra across the second space to promote fusion of the second vertebra and the third vertebra, wherein positioning the first leg of the staple in the first implant hole of the first vertebra and the second leg of the staple in the second implant hole of the second vertebra further comprises positioning a third leg of the staple in a third implant hole of a third vertebra. However, Etminan discloses a method of mounting a cervical implant (20/58) to three vertebrae (10/12/14), the method involving surgically accessing the three vertebrae (see Figs. 1A-1B and 8A-10A, e.g.); removing bone from between the first and second vertebrae and from between the second and third vertebrae (Figs. 1A-1B and 8A-10A, e.g.; intervertebral cages 30 inserted into the cleaned out intervertebral disc spaces between the vertebrae 10/12 and 12/14); and applying the implant such that it is anchored in each of the three vertebrae and across the two intervertebral disc spaces (see Figs. 1A-1B and 8A-10A). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Fallin in view of Capote to use a multi-level staple anchored across three vertebrae and two intervertebral disc spaces instead of two vertebrae and one intervertebral disc space as suggested by Etminan in order to allow the surgeon to perform a multilevel fusion as is sometimes necessary for a patient (see Etminan, paragraph [0008]).
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of Capote, and further in view of Goldstein.
Regarding claim 23, Fallin appears to disclose applying a load force at the staple using the inserter, wherein, as the load force is applied at the staple using the inserter, the first leg and the second leg are caused to move apart from one another (see paragraphs [0056]. [0058], and [0066]; divergence of legs). Alternatively, Goldstein discloses an orthopedic staple (20/50/70) and an inserter (41), wherein a method of implanting the staple with the inserter comprises applying a load force at the staple using the inserter, wherein, as the load force is applied at the staple using the inserter, the first leg and the second leg are caused to move apart from one another (see Figs. 3-4 and paragraphs [0022] and [0023]). Regarding claim 24, Goldstein discloses further comprising: removing the load force from the staple after positioning the first leg in the first implant hole and the second leg in the second implant hole thereby causing the first leg and the second leg to move toward one another to apply a compression force at the first vertebra and the second vertebra (see paragraphs [0022] and [0023]; clips or suitable retainers holding staple under tension). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of to apply a load force at the staple using the inserter to move the legs of the staple apart before implantation and allows the legs to move back toward one another to apply a compression force as suggested by Goldstein in order to provide ancillary fixation between the bones (see Goldstein, paragraph [0026]). Additionally, it would be obvious to remove the clips or suitable retainers holding the staple under tension prior to removal of the staple from the inserter to ensure the staple can be adjusted if necessary if the positioning and compression is not to the satisfaction of the user.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Fallin in view of Capote and Goldstein, and further in view of Prandi.
Regarding claim 25, Fallin discloses wherein the inserter comprises a first coupling shaft (one of locking bolts 312) connected at the first coupling receptacle through the top surface of the staple (see Figs. 15-18 and paragraphs [0066] and [0067]) and a second coupling shaft (another of locking bolts 312) connected at the second coupling receptacle through the top surface of the staple (see Figs. 15-18 and paragraphs [0066] and [0067]). Fallin and Goldstein fail to suggest wherein applying the load force comprises biasing the first coupling shaft and the second coupling shaft toward each other. However, Prandi discloses a method of applying a load force to a bone clip (2) that comprises using an inserter (1) and biasing a first coupling shaft (3) and a second coupling shaft (4) toward each other (see Fig. 3 and paragraph [0034]); wherein a connector (11) joins the first coupling shaft and the second coupling shaft (shafts 3/4) to bias the first coupling shaft and the second coupling shaft toward each other and maintain the load force at the staple while the connector joins the first coupling shaft and the second coupling shaft (see Fig. 3 and paragraphs [0035] and [0044] and Figs. 3 and 4); and removing the connector from the first coupling shaft and the second coupling shaft to cause the first coupling shaft to move away from the second coupling shaft and removing the load force (see paragraphs [0035] and [0044] and Figs. 3 and 4). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Fallin in view of Capote and Goldstein to bias coupling shafts of the inserter of toward each other, as Prandi suggests such a technique is suitable for applying a load force to move legs (21/22) of the bone staple/clip apart from each other (see Prandi, paragraph [0034]), and such a modification merely involves substituting one known technique for biasing bone staple/clip legs apart for another such known technique without any unpredictable results.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The Roedl reference discloses a bone stable for use in a patient, the staple having closed inserter receptacles in each leg of the staple (see Fig. 1).
The Mayer reference discloses a bone stable for use in a patient, the staple having closed inserter receptacles in each leg of the staple (see Fig. 1A).
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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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