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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “retention feature” in claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-3, 12, 14, 15, 17, 18, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0196604 (Hartdegen) in view of U.S. Patent Application Publication No. 2019/0298421 (Capote).
Regarding claim 1, Hartdegen discloses a method of fixating bones for fusion (see paragraph [0002], e.g.), the method comprising: positioning a first leg (one of leg members 325) of a staple (300) connected to an inserter (400) in a first implant hole (hole in a first bone made by drill, see Fig. 5 and paragraph [0114]) of a first bone and a second leg (other of leg members 325) of the staple connected to the inserter in a second implant hole (hole in a second bone made by a drill, see Fig. 6 and paragraph [0114]) of a second bone, wherein the first leg of the staple is connected to the second leg of the staple by a bridge (310), wherein the staple is positioned such that a bottom surface of the staple faces the first bone and the second bone and a top surface of the staple faces away from the first bone and the second bone (see Fig. 9 and Figs. 15A-16B below), wherein the inserter is connected to the staple through the top surface of the staple without extending under the bottom surface of the staple (connected via openings 330, see Figs. 15A-16B and paragraph [0120]); and detaching the inserter from the staple (see paragraph [0115]; removal of inserter after implant is in final position).
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Further regarding claim 1, Hartdegen fails to disclose the bones being spinal bones, the first and second bones being first and second vertebrae. However, Hartdegen discloses that its fixation system is for bones of all types (see paragraph [0002]). Additionally, Capote discloses a method of fixating spinal bones (12) for fusion (see paragraph [0039]), the method including placing two legs (400) of a staple (10) into two vertebral bones (12) (see paragraph [0039] and Fig. 1). 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 method of Hartdegan to spinal bones including a first vertebra and second vertebra, as Hartdegan suggests its method may be applied to bones of all types (see Hartdegan, paragraph [0002]), and Capote suggests that vertebral spinal bones are suitable for fixation for bone fusion (see Capote, paragraph [0039]).
Regarding claim 2, Hartdegen discloses further comprising: prior to positioning the first leg of the staple at the first implant hole and the second leg of the staple at the second implant hole (see paragraphs [0006], [0109], and [0138]); implant and inserter pre-assembled), (i) connecting the inserter to a first side of the staple having the first leg through the top surface of the first side of the staple without extending under the bottom surface of the first side of the staple (connected via an opening 330 above one of the legs 325 on a first side of staple 300, see Figs. 15A-16B and paragraph [0120]) and (ii) connecting the inserter to a second side of the staple having the second leg through the top surface of the second side of the staple without extending under the bottom surface of the second side of the staple (connected via an openings 330 above the other of the legs 325 on an opposite, second side of staple 300, see Figs. 15A-16B and paragraph [0120]).
Regarding claim 3, Hartdegen discloses wherein the inserter is connected to the first side of the staple through the top surface of the first side of the staple without extending under the bottom surface of the first side of the staple and without contacting an outer perimeter of the first side of the staple (connected via an opening 330 above one of the legs 325 on a first side of staple 300, see Figs. 15A-16B and paragraph [0120]; understood to mean the inserter does not contact an outer surface of the staple except via the top surface of the staple), and wherein the inserter is connected to the second side of the staple through the top surface of the second side of the staple without extending under the bottom surface of the second side of the staple and without contacting an outer perimeter of the second side of the staple (connected via an opening 330 above one of the legs 325 on a first side of staple 300, see Figs. 15A-16B and paragraph [0120]; understood to mean the inserter does not contact an outer surface of the staple except via the top surface of the staple).
Regarding claim 12, Hartdegan discloses wherein the staple is titanium (see paragraph [0126]).
Regarding claim 14, Hartdegen discloses a surgical technique (see paragraph [0002], e.g.) comprising: surgically accessing a first bone and a second bone of a patient (see Fig. 4 and paragraph [0114], e.g.); applying a staple (300) to the first bone and the second bone to promote fusion of the bones (see paragraph [0002], Fig. 9 and Figs. 15A-16B), wherein applying the staple comprises positioning a first leg (one of leg members 325) of the staple connected to an inserter (400) in a first implant hole (hole in a first bone made by drill, see Fig. 5 and paragraph [0114]) of the first bone and a second leg (other of leg members 325) of the staple connected to the inserter in a second implant hole (hole in a second bone made by a drill, see Fig. 6 and paragraph [0114]) of the second bone with a bridge (310) extending between the first leg and the second leg (see Figs 9 and 15A-16B), the inserter being attached to a top surface (connected via openings 330, see Figs. 15A-16B and paragraph [0120]) of the staple facing away from the first and second bones without extending under a bottom surface of the staple (see Fig. 9 and Figs. 15A-16B above), and subsequently detaching the inserter from the staple (see paragraph [0115]; removal of inserter after implant is in final position).
Further regarding claim 14, Hartdegen fails to disclose the surgical technique being a spinal surgical technique, the first and second bones being first and second vertebrae of a spine of the patient, the surgical technique further involving 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, Hartdegen discloses that its fixation system is for bones of all types (see paragraph [0002]). Additionally, 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) such that a bridge (120/220) of the staple is positioned over the intervertebral space (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, Capote 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 Hartdegan to facilitate fusion of spinal bones including a first vertebra and second vertebra in methods as suggested by Capote, as Hartdegan suggests its method may be applied to bones of all types (see Hartdegan, paragraph [0002]), and Capote suggests that vertebral spinal bones are suitable for fixation for bone fusion (see Capote, paragraph [0039]).
Claims 4, 5, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen in view of Capote, and further in view of U.S. Patent Application Publication No. 2018/0008263 (Goldstein).
Regarding claims 4 and 23, Hartdegen 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 [0117]-[0120]; divergence of legs 325). 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 claims 5 and 24, 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 Hartdegen 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. Additionally, Hartdegen suggests positioning the implant in its final position prior to removal of the implant from the inserter (see paragraph [0007]).
Claims 6-10 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen in view of Capote and Goldstein, and further in view of U.S. Patent Application Publication No. 2009/0018556 (Prandi).
Regarding claims 6 and 25, Hartdegen discloses wherein the inserter comprises a first coupling shaft (one of engagement pins 410, see Figs. 17A-17C) connected through the top surface of the staple without extending under the bottom surface of the staple (connected via openings 330, see Figs. 15A-16B and paragraph [0120]) and a second coupling shaft (other of engagement pins 410, see Figs. 17A-17C) connected through the top surface of the staple without extending under a bottom surface of the staple (connected via openings 330, see Figs. 15A-16B and paragraph [0120]). Hartdegen, Capote, 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 claims 9 and 25, 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 claims 10 and 25, 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, 10, and 25, 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 Hartdegen 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.
Regarding claim 7, Hartdegen discloses wherein detaching the inserter from the staple comprises detaching, from the top surface, the first coupling shaft and the second coupling shaft from the staple (detach via openings 330, see Figs. 15A-18C and paragraphs [0006] and [0007]).
Regarding claim 8, Hartdegen 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 (connected via openings 330 over respective legs 325, see Figs. 15A-18C and paragraph [0120]).
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen in view of Capote, and further in view of U.S. Patent Application Publication No. 2016/0331414 (Etminan).
Regarding claims 13 and 20, Hartdegen and Capote fail 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); and 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 (claim 20). 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 Hartdegen 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]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hartdegen in view of Capote, and further in view of U.S. Patent No. 6,585,769 (Muhanna).
Regarding claim 16, Hartdegen 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 Hartdegen 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 Hartdegen 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]).
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.
The following is a statement of reasons for the indication of allowable subject matter: claim 11 has not been rejected because no reference, or reasonable combination of references, can be found which disclose or suggest the feature of “wherein the connector comprises a first receptacle and a second receptacle, wherein the first coupling shaft includes a first retention feature and the second coupling shaft includes a second retention feature, and wherein the connector joins the first coupling shaft and the second coupling shaft at least by holding the first retention feature of the first coupling shaft in the first receptacle and holding the second retention feature of the second coupling shaft in the second receptacle.” The closest prior art are the Hartdegen, Goldstein, and Prandi references, as applied in claims 1-10 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The Serhan reference discloses a bone stable for use in a spine of a patient.
The Frey reference discloses a spinal implant inserter tool.
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, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773