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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 22-30, 32-36, 38-40 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the first anterior cortical surface" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 22 depends from canceled claim 1. It appears that claim 22 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 23 recites the limitation "the at least one first bone fastener" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 23 depends from canceled claim 1. It appears that claim 23 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 24 recites the limitation "the bone fasteners" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 24 depends from canceled claim 1. It appears that claim 24 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 25 recites the limitation "the bone fasteners" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 25 depends from canceled claim 1. It appears that claim 25 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 26 recites the limitation "the bone fasteners" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 26 depends from canceled claim 1. It appears that claim 26 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 27 recites the limitation "the distal portion" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 27 depends from canceled claim 1. It appears that claim 27 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 28 recites the limitation "the at least one first bone fastener" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 28 depends from canceled claim 1. It appears that claim 28 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 29 recites the limitation "the at least one plate" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 29 depends from canceled claim 1. It appears that claim 29 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 30 recites the limitation "the spinal implant" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 30 depends from canceled claim 1. It appears that claim 30 should instead depend from claim 21 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 32 recites the limitation "the first cortical surface" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 32 depends from canceled claim 11. It appears that claim 32 should instead depend from claim 31 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 33 recites the limitation "the bone fasteners" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 33 depends from canceled claim 11. It appears that claim 33 should instead depend from claim 31 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 34 recites the limitation "the at least one cephalad bone fastener" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 34 depends from canceled claim 11. It appears that claim 34 should instead depend from claim 31 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 35 recites the limitation "the spinal implant system" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 35 depends from canceled claim 11. It appears that claim 35 should instead depend from claim 31 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 36 recites the limitation "the surgical driver" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 36 depends from canceled claim 11. It appears that claim 36 should instead depend from claim 31 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 38 recites the limitation "the step of delivering" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 38 depends from canceled claim 17. It appears that claim 38 should instead depend from claim 37 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 39 recites the limitation "the at least one first bone fastener" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 39 depends from canceled claim 17. It appears that claim 39 should instead depend from claim 37 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim 40 recites the limitation "the spinal implant" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 40 depends from canceled claim 17. It appears that claim 40 should instead depend from claim 37 in order to have sufficient antecedent basis for this limitation in the claim and to depend from a non-cancelled claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-22, 24, 28-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer (U.S. Pub. No. 2017/0049485 A1, hereinafter “Meyer”).
Meyer discloses, regarding claim 21, a spinal implant comprising: at least one plate (90, see Fig. 19) including a first end and a second end (see annotated Fig. 19 below); and at least one first bone fastener (40A, see Fig. 16) extending from the first end (see annotated Fig. 19 below) and at least one second bone fastener (40B, see Fig. 16) extending from the second end (see annotated Fig. 19 below), each bone fastener including a proximal portion and a distal portion (see annotated Fig. 16 below), the proximal portion being engageable with a surgical driver having a surgical navigation component that generates data for display of an image representing position of the spinal implant relative to the vertebra (see Fig. 16, note that proximal portion is capable of being engageable with a surgical driver via 70A-B), the proximal portion of the first bone fastener being fixable with an anterior cortical surface (see Fig. 6, see paras. [0064] and [0082]) of a cephalad cervical vertebra (see para. [0010] “cervical spine regions”) and the distal portion of the first bone fastener being fixable with a cortical surface of a pedicle (28, see Fig. 6, see paras. [0064] and [0082]) of the cephalad cervical vertebra (see para. [0010] “cervical spine regions”), the proximal portion of the second bone fastener being fixable with an anterior cortical surface (see Fig. 6, see paras. [0064] and [0082]) of a caudal cervical vertebra (see para. [0010] “cervical spine regions”) and the distal portion of the second bone fastener being fixable with a cortical surface of a pedicle (28, see Fig. 6, see paras. [0064] and [0082]) of the caudal cervical vertebra (see para. [0010] “cervical spine regions”).
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Regarding claim 22, wherein the first anterior cortical surface is spaced apart from the second cortical surface for bi-cortical fixation (see Fig. 6).
Regarding claim 24, wherein at least one of the bone fasteners is threaded entirely from the proximal portion to the distal portion (see Figs. 6 and 16).
Regarding claim 28, wherein the at least one first bone fastener and the at least one second bone fastener are delivered via divergent anterior pedicle trajectories (see Fig. 6, note that the trajectories are divergent from the anterior-posterior midline toward the pedicle).
Regarding claim 29, wherein the at least one plate includes a plurality of plates disposed in a selected orientation with the vertebrae (see paras. [0009] and [0061] “plates”).
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) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer, as applied to claim 21 above, and in view of Smith (U.S. Pub. No. 2014/0148853 A1, hereinafter “Smith”).
Meyer discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 25, wherein at least one of the bone fasteners is threaded at the proximal portion and the distal portion for fixation with the cortical surfaces and is non-threaded at an intermediate portion.
Smith discloses a spinal implant (see Fig. 2a), wherein the implant includes at least one bone fastener (200), wherein the bone fastener has a threaded proximal portion (225) and a threaded distal portion (215), and further includes a non-threaded intermediate portion (220, see Fig. 2a) in order to minimize potential thread contact with the nerve root or spinal cord (see para. [0035]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify an intermediate portion of the bone fastener in Meyer in view of Kang to be non-threaded in further view of Smith in order to minimize potential thread contact with the nerve root or spinal cord.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer, as applied to claim 21 above, and in view of Poulos (U.S. Pub. No. 2014/0277188 A1, hereinafter “Poulos”).
Meyer discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 26, wherein at least one of the bone fasteners includes a cannulated shaft having at least one fenestration configured for delivery of a cement to the vertebra.
Poulos discloses a spinal implant (see Fig. 8), that includes at least one bone fastener (1), wherein the bone fastener is cannulated (7) and includes at least one fenestration (11, see Fig. 12) in order to enable cement to be delivered into the surrounding bone structure (see para. [0038]) to better stabilize the bone structure and increase the purchase of the bone screw into the bone structure (see para. [0003])
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify bone fastener in Meyer to include a cannulation and at least one fenestration configured for delivery of a cement in view of Poulos in order in order to enable cement to be delivered into the surrounding bone structure to better stabilize the bone structure and increase the purchase of the bone screw into the bone structure.
Claim(s) 23 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer, as applied to claim 21 above, and in view of Brennan (U.S. Pub. No. 2014/0046445 A1, hereinafter “Brennan”).
Meyer discloses all of the features of the claimed invention, as previously set forth above except regarding claim 23, wherein the at least one first bone fastener includes a first cephalad bone fastener and a second cephalad bone fastener extending from the first end, and the at least one second bone fastener includes a first caudal bone fastener and a second caudal bone fastener extending from the second end; and claim 27, wherein the distal portion includes a mating surface engageable with a mating surface of a pop-on head.
Brennan discloses a spinal implant (see Fig. 25) comprising at least one first bone fastener (100) and at least one second bone fastener (100), having proximal portions being fixable with an anterior cortical surface (see Fig. 25) and a distal portion of the first bone fastener being fixable with a cortical surface of a pedicle (see Fig. 25), with at least one bone plate (90), wherein the distal portion includes a mating surface engageable with a mating surface of a pop-on head (140, see para. [0073]), and wherein the at least one first bone fastener includes a first and a second cephalad bone fasteners (100, received over wires 86 and 86’, see Figs. 15 and 18) and wherein the at least one second fastener includes first and second caudal bone fasteners (100, received over wires 88 and 88’, see Figs. 15 and 19) extending from a first end and second of the plate (e.g. end of 90 that receives 86 and 86’ and end of 90 that receives 88 and 88’) in order to enable connection of the screws with a spinal rod on the posterior side of the vertebrae (see para. [0077]) and in order to enable connection to screws on both sides of the midline on the anterior side of the vertebrae (see paras. [0072] and [0075]) in order to provide stabilization of the vertebrae on both sides the anterior and posterior sides of the vertebrae, as well as on both sides of the midline of the vertebrae (see paras. [0072] and [0075]) to provide a construct that is mechanically linked and therefore more resistant to failure (see para. [0051]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal end of the bone fasteners in Meyer and to modify the at least one first and second bone fasteners in Meyer to include first and second bone fasteners extending from the first and second ends to include a mating surface engageable with a mating surface of a pop-on head in view of Brennan in order to enable connection of the screws with a spinal rod on the posterior side of the vertebrae and to the plate on the posterior side of the vertebrae in order to provide stabilization of the vertebrae on both sides the anterior and posterior sides of the vertebrae, as well as on both sides of the midline of the vertebrae to provide a construct that is mechanically linked and therefore more resistant to failure.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer, as applied to claim 21 above, and in view of Cronen (U.S. Pub. No. 2016/0051284 A1, hereinafter “Cronen”).
Meyer discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 30, wherein the spinal implant includes an interbody device configured for engagement with the vertebrae and at least one of the bone fasteners.
Cronen discloses a spinal implant system (see Fig. 1H), with bone fasteners (120) and an interbody device (110) configured for engagement with the vertebrae and at least one of the bone fasteners (see Fig. 1H) in order to provide an anchor point that helps prevent fastener pullout (see para. [0018]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system in Meyer to include an interbody device in view of Cronen in order to provide an anchor point that helps prevent fastener pullout.
Claim(s) 31-32, 36 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (U.S. Pub. No. 2017/0049485 A1, hereinafter “Meyer”) in view of Kang et al. (U.S. Pub. No. 2019/0090966 A1, hereinafter “Kang”).
Meyer discloses, regarding claim 31, a spinal implant system comprising: a spinal implant including at least one plate (90, see Fig. 19) including a first end and a second end (see annotated Fig. 19 above), and at least one cephalad bone fastener (40A, see Fig. 16) including a proximal portion and a distal portion (see annotated Fig. 16 above), and at least one caudal bone fastener (40B, see Fig. 16) including a proximal portion and a distal portion (see annotated Fig. 16 above); the proximal portion of the at least one cephalad bone fastener being fixable with a first anterior cortical surface (see Fig. 6, see paras. [0064] and [0082]) of a cephalad cervical vertebra (see para. [0010] “cervical spine regions”) and the distal portion of the at least one cephalad bone fastener being fixable with a cortical surface of a pedicle of the cephalad cervical vertebra (28, see Fig. 6, see paras. [0064] and [0082]), the proximal portion of the at least one caudal bone fastener being fixable with a second anterior cortical surface (see Fig. 6, see paras. [0064] and [0082]) of a caudal cervical vertebra (see para. [0010] “cervical spine regions”) and the distal portion of the at least one caudal bone fastener being fixable with a cortical surface of a pedicle of the caudal cervical vertebra (28, see Fig. 6, see paras. [0064] and [0082]).
Regarding claim 32, wherein the first cortical surface is an anterior surface that is spaced apart from the second cortical surface for bi-cortical fixation (see Fig. 6).
Meyer discloses, regarding claim 37, a method for treating a spine, the method comprising the steps of: selecting a pathway from an anterior approach that includes cervical vertebrae (see para. [0085] “trajectories”, see also para. [0010] “cervical spine regions”); creating a cavity (60A) in an anterior cortical surface of a cephalad cervical vertebra (see para. [0085]) and a cavity (60A) in a cortical surface of a pedicle of the cephalad cervical vertebra (see para. [0085]); creating a cavity (60B) in an anterior cortical surface of a caudal cervical vertebra (see para. [0085]) and a cavity (60B) in a cortical surface of a pedicle of the caudal cervical vertebra (see para. [0085]); delivering a spinal implant including a plate (90) including a first end and a second end (see annotated Fig. 19 above), at least one first bone fastener (40A) extending from the first end (see Fig. 19) and at least one second bone fastener (40B) extending from the second end (see Fig. 19), each of the bone fasteners including a proximal portion and a distal portion (see annotated Fig. 16 above); fixing the proximal portion of the first bone fastener with an anterior cortical surface (see Fig. 6, see paras. [0064] and [0082]) of a cephalad cervical vertebra (see para. [0010] “cervical spine regions”) and fixing the distal portion of the first bone fastener with a cortical surface of a pedicle of the cephalad cervical vertebra (28, see Fig. 6, see paras. [0064] and [0082]); and fixing the proximal portion of the second bone fastener with an anterior cortical surface (see Fig. 6, see paras. [0064] and [0082]) of a caudal cervical vertebra (see para. [0010] “cervical spine regions”) and fixing the distal portion of the second bone fastener with a cortical surface of a pedicle of the caudal cervical vertebra such that the first bone fastener and the second bone fastener (28, see Fig. 6, see paras. [0064] and [0082]) are disposed along divergent anterior pedicle trajectories with the cervical vertebrae (see Fig. 6, note that the trajectories are divergent from the anterior-posterior midline toward the pedicle), and the cortical surfaces are spaced apart for bi-cortical fixation (see Fig. 6).
Meyer fails to disclose, regarding claim 31, wherein the system includes a surgical driver engageable with the bone fasteners for delivery from an anterior trajectory, the surgical driver includes a surgical navigation component that communicates with a tracking device including a sensor that receives a signal and communicates with a processor to generate data for display of an image from a monitor, the image representing position of the spinal implant relative to one or more cervical vertebra; regarding claim 36, wherein the surgical driver is connected to a guide member having an end effector of a robotic arm; and regarding claim 37, the cavities being created along the pathway via surgical navigation, the cavities being created along the pathway via surgical navigation, wherein the first and second bone fasteners are delivered along the pathway via surgical navigation; and regarding claim 38, wherein the step of delivering includes engaging a surgically navigated driver with the implant, and the surgical navigation communicates with a tracking device including a sensor that receives a signal and communicates with a processor to generate data for display of an image from a monitor, the image representing position of the spinal implant relative to the cervical vertebra.
Kang discloses a spinal implant system (see Figs. 4-5), and a method of treating the spine (see Fig. 12), wherein the system includes a bone fastener (PS), a surgical driver engageable with the bone fasteners (44), and drill (42) for creating cavities (102) in the spine (see para. [0065]), wherein the surgical driver has a surgical navigation component communicates with a tracking device (36) including a sensor (14, see para. [0038] “camera unit (one example of a sensing device)”) that receives a signal and communicates with a processor (see para. [0041 “one or more processors” and “converts the signals received from the localizer 14 into data representative of the position and orientation of the objects being tracked”) to generate data for display of an image from a monitor (18, see para. [0059]), the image representing position of the spinal implant relative to the vertebrae (see para. [0059]); wherein the cavities (102) being created along the pathway via surgical navigation (see para. [0065]); wherein the bone fastener (PS) is delivered via surgical navigation (see para. [0065]); wherein the step of delivering includes engaging a surgically navigated driver (30) with the implant, and the surgical navigation communicates with a tracking device (36) including a sensor (14, see para. [0038] “camera unit (one example of a sensing device)”) that receives a signal and communicates with a processor (see para. [0041 “one or more processors” and “converts the signals received from the localizer 14 into data representative of the position and orientation of the objects being tracked”) to generate data for display of an image from a monitor (18, see para. [0059]), the image representing position of the spinal implant relative to the vertebra (18, see para. [0059]); wherein the surgical driver is connected to a guide member (40) having an end effector (28) of a robotic arm (20) in order to enable the surgeon to pre-operatively plan the spinal treatment (see para. [0056]) and to track movement of and the drill and precisely align the placement of the pedicle screws in their corresponding pilot holes in order to avoid interacting with or damaging the spinal cord (see para. [0065]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spinal implant, spinal implant system, and method of treating the spine in Meyer to include a surgical navigation component that generates data for display of an image representing position of the spinal implant relative to the vertebra; and that communicates with a tracking device including a sensor that receives a signal and communicates with a processor to generate data for display of an image from a monitor, the image representing position of the spinal implant relative to the cervical vertebra; wherein the cavities being created along the pathway via surgical navigation, wherein the bone fastener is delivered via surgical navigation; wherein the surgical driver is connected to a guide member having an end effector of a robotic arm in view of Kang in order to in order to enable the surgeon to pre-operatively plan the spinal treatment and to track movement of the drill and precisely align the placement of the pedicle screws in their corresponding pilot holes in order to avoid interacting with or damaging the spinal cord.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer in view of Kang, as applied to claim 31 above, and in further view of Smith (U.S. Pub. No. 2014/0148853 A1, hereinafter “Smith”).
Meyer in view of Kang discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 33, wherein at least one of the bone fasteners is threaded at the proximal portion and the distal portion for fixation with the cortical surfaces and is non-threaded at an intermediate portion.
Smith discloses a spinal implant (see Fig. 2a), wherein the implant includes at least one bone fastener (200), wherein the bone fastener has a threaded proximal portion (225) and a threaded distal portion (215), and further includes a non-threaded intermediate portion (220, see Fig. 2a) in order to minimize potential thread contact with the nerve root or spinal cord (see para. [0035]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify an intermediate portion of the bone fastener in Meyer in view of Kang to be non-threaded in further view of Smith in order to minimize potential thread contact with the nerve root or spinal cord.
Claim(s) 34-35, and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer in view of Kang, as applied to claims 31 and 37 above, and in further view of Brennan (U.S. Pub. No. 2014/0046445 A1, hereinafter “Brennan”).
Meyer in view of Kang discloses all of the features of the claimed invention, as previously set forth above except regarding claim 34, wherein the at least one cephalad bone fastener includes a first bone fastener and a second bone fastener extending from the first end, and the at least one caudal bone fastener includes a first bone fastener and a caudal bone fastener extending from the second end; regarding claim 35, wherein the spinal implant system further comprises a posterior implant connected with the distal portion; and wherein the at least one first bone fastener includes a first cephalad bone fastener and a second cephalad bone fastener extending from the first end, and the at least one fixation bone fastener includes a first caudal bone fastener and a second caudal bone fastener extending from the second end.
Brennan discloses a spinal implant (see Fig. 25) comprising at least one first bone fastener (100) and at least one second bone fastener (100), having proximal portions being fixable with an anterior cortical surface (see Fig. 25) and a distal portion of the first bone fastener being fixable with a cortical surface of a pedicle (see Fig. 25), with at least one bone plate (90), wherein the distal portion connected to a posterior implant (140, see para. [0073]) in order to enable connection of the screws with a spinal rod on the posterior side of the vertebrae (see para. [0077]), and wherein the at least one first bone fastener includes a first and a second cephalad bone fasteners (100, received over wires 86 and 86’, see Figs. 15 and 18) extending from a first end of the plate (e.g. end of 90 that receives 86 and 86’) and wherein the at least one second fastener includes first and second caudal bone fasteners (100, received over wires 88 and 88’, see Figs. 15 and 19) extending from a second end of the plate (e.g. end of 90 that receives 88 and 88’)in order to enable connection of the screws with a spinal rod on the posterior side of the vertebrae (see para. [0077]) and in order to enable connection to screws on both sides of the midline on the anterior side of the vertebrae (see paras. [0072] and [0075]) in order to provide stabilization of the vertebrae on both sides the anterior and posterior sides of the vertebrae, as well as on both sides of the midline of the vertebrae (see paras. [0072] and [0075]) to provide a construct that is mechanically linked and therefore more resistant to failure (see para. [0051]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal end of the bone fasteners in Meyer in view of Kang to connected to a posterior implant and to modify the at least one first and second bone fasteners in Meyer in view of Kang to include first and second bone fasteners extending from the first and second ends in further view of Brennan in order to enable connection of the screws with a spinal rod on the posterior side of the vertebrae and to the plate on the posterior side of the vertebrae in order to provide stabilization of the vertebrae on both sides the anterior and posterior sides of the vertebrae, as well as on both sides of the midline of the vertebrae to provide a construct that is mechanically linked and therefore more resistant to failure.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer in view of Kang, as applied to claim 37 above, and in further view of Cronen (U.S. Pub. No. 2016/0051284 A1, hereinafter “Cronen”).
Meyer in view of Kang discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 40, wherein the spinal implant includes an interbody device configured for engagement with the cervical vertebra and at least one
of the bone fasteners.
Cronen discloses a spinal implant system (see Fig. 1H), with bone fasteners (120) and an interbody device (110) configured for engagement with the vertebrae and at least one of the bone fasteners (see Fig. 1H) in order to provide an anchor point that helps prevent fastener pullout (see para. [0018]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system in Meyer in view of Kang to include an interbody device in further view of Cronen in order to provide an anchor point that helps prevent fastener pullout.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose anterior to posterior placed bone screws:
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773