DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 July 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 27 June 2026. As directed by the amendment: Claims 52, 58, and 71 have been amended, and claims 1-51, 54, 55, 57, 60-70, 73, 74, and 76 are cancelled. Claims 52, 53, 56, 58, 59, 71, 72, 75, and 77 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn. Further claim objections as necessitated by the claim amendments are presented below.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112 (pre-AIA ), second paragraph, listed in the previous action, which are accordingly withdrawn. Further rejections under 35 U.S.C. 112 (pre-AIA ), second paragraph, as necessitated by the claim amendments are presented below.
Response to Arguments
Applicant’s arguments, see page 6 of the arguments filed 27 June 2026, with respect to the rejections under 35 U.S.C. 112 (pre-AIA ), first paragraph, have been fully considered and are persuasive. The previous rejections under 35 U.S.C. 112 (pre-AIA ), first paragraph, have been withdrawn. However, further rejections under 35 U.S.C. 112 (pre-AIA ), first paragraph, as necessitated by the claim amendments are presented below.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103(a) have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Of particular note, as to Bertele (US 2011/0190888), Applicant contends that Bertele does not teach detachably coupling together one or more bone fusion devices and one or more spacers to form a bone fusion assembly based on the height of the desired location, because the size and shape of the endplates/core may be altered to suit differently sized and shaped implant sites. Examiner respectfully submits that even if the components can be altered in size and shape, the total combination (the components coupled together) is required to achieve the desired height, e.g. missing one spacer would change the height of the assembly and not meet the height of the desired location.
Applicant further contends that Bertele does not teach a spacer because the assembly 200 of Bertele is not a spacer but forms the endplates of the interbody device. Examiner respectfully submits that Greenhalgh discloses a bone fusion device having an extendable plate, and the modification of Greenhalgh in view of Bertele results in the spacers as taught by Bertele being coupled to the outer, bone-facing surfaces of Greenhalgh’s bone fusion device, including at the plate, to provide a porous layer to encourage bone on-growth and in-growth and promote fusion. The term “spacer” is not distinguished from Bertele in the claim limitations, and the broadest reasonable interpretation of the term “spacer” is a component used to make a space; since the spacers in Bertele are three-dimensional structures, they make a space.
Applicant further contends that the endplates in Bertele do not serve the same function as a spacer. Bertele’s endplates have hollow pores to promote bone growth. Applicant compares this to the present specification where multiple devices can be coupled together through spacers. Examiner respectfully submits that the independent claims require detachably coupling together one or more bone fusion devices and one or more spacers. This is met by coupling together one bone fusion device and one spacer. This does not require multiple devices coupled together through spacers. As to dependent claims 56 and 75, because Jimenez (US 2011/0160861) discloses coupling together two bone fusion devices, each of which bone fusion device has spacers attached to the bone-facing surfaces in view of Bertele, would result in coupling spacers to each other (the inferior spacer of the superior bone fusion device would couple with the superior spacer of the inferior bone fusion device).
Applicant contends that Krueger (US 2010/0125334) does not teach the mounting interface comprises a plurality of slats and the spacers comprise a plurality of rails, and depressing the snap-fit members when the slats are slid under the rails. Examiner respectfully submits that Krueger teaches the spacer (24) has a plurality of rails (rails 50 and 52 protruding downwardly in FIG. 7A) (par. [0095]-[0096]) and the mounting interface of the bone fusion device (14) has a plurality of slats (thin narrow sections 70 on either end of 14, FIGS. 1 and 8A, in one of which the cutout 38 is disposed) (par. [0095]-[0096] and [0098]), wherein the plurality of rails are positioned on a same side (lower side) of the one or more spacers, FIG. 7A, and the bone fusion device and the spacer are detachably coupled by sliding the slats under the rails (since the bone fusion device comprising the slats is underneath the spacer comprising the rails, FIG. 1). Additionally, even if only one dovetail protrusion/recess of Krueger is provided, each protrusion has a plurality of rails (outwardly protruding tips on either side of the dovetail, FIG. 1) and each recess has a plurality of slats (pointed inwardly protruding side walls forming the recess that engage the rails on the dovetail protrusion). Krueger teaches wherein the rail comprises a snap-fit member (62) and the slat comprises a cutout (38) and the detachably coupling comprises depressing the snap-fit member when the slat is slid under the rail (via relative sliding of the spacer and the bone fusion device, the spacer sliding over the bone fusion device could be interpreted as the bone fusion device sliding under the spacer) and springing the snap-fit member into the cutout when the snap-fit member is aligned with the cutout in order to prevent the slat from sliding out from under the rail (par. [0098]).
Claim Objections
Claims 52, 53, 56, 58, 59, 71, 72, 75, and 77 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 52 / lines 6-9: “wherein the one or more extending blocks contact the one or more extendable plates at an angle wherein operation of a positioning element causes the one or more extending blocks to slide within the body, causing the one or more extendable plates to move orthogonally from the one or more extending blocks to an extended position,”
Claim 58 / lines 1-4: “wherein the mounting interface of the one of the one or more extendable plates comprises a plurality of slats and the one of the one or more spacers comprises a plurality of rails, wherein the plurality of rails are positioned on a same side of the one of the one or more spacers”
Claim 71 / lines 6-9: “wherein the one or more extending blocks contact the one or more extendable plates at an angle wherein operation of a positioning element causes the one or more extending blocks to slide within the body, causing the one or more extendable plates to move orthogonally from the one or more extending blocks to an extended position,”
Claim 71 / lines 18-19: “and the one or more spacers comprise a plurality of rails”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 52, 53, 56, 58, 59, 71, 72, 75, and 77 are rejected under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 52 and 71, the limitation “causing the extending plates to move orthogonally from the extending blocks to an extended position” (lines 8-9) is not supported by the specification as originally filed. Since the extending blocks contact the extendable plates at an angle of the ramped surfaces (see FIG. 3 in the instant application), the plates move out of the body but not orthogonally from the extending blocks, due to the angle of the ramped surfaces of the extending blocks. The plates do not move orthogonally from these ramped surfaces.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 52, 53, 56, 58, 59, 71, 72, 75, and 77 are rejected under 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.
As to claim 52, the limitation “an extended position” (lines 21-22) renders the claims indefinite because it is unclear if this refers back to the previously recited extended position (claim 52 / lines 8-9) or to a different extended position. For examination purposes, the limitation will be interpreted in the first instance, as the extended position.
As to claim 71, the limitation “the mounting interface” (line 17) renders the claims indefinite because it lacks proper antecedence in the claims. For examination purposes, the limitation will be interpreted as a mounting interface.
Further as to claim 71, the limitation “to extended positions” (line 24) renders the claims indefinite, because it is unclear if this refers back to the previously recited extended position (claim 71 / lines 8-9) or to different extended positions. For examination purposes, the limitation on lines 8-9 will be interpreted as “extended positions” and the limitation on line 24 will be interpreted as “the extended positions.”
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 52 and 53 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. US 2010/0211176 to Greenhalgh, in view of U.S. Patent Application Publication No. US 2011/0190888 to Bertele et al. (hereinafter, “Bertele”).
As to claim 52, Greenhalgh discloses a method of implanting a bone fusion apparatus into a desired location having a height, the method comprising: one or more bone fusion devices (2) forming a bone fusion assembly, the bone fusion devices each having a body (10) (par. [0038]), one or more extendable plates (one plate 6) and one or more extending blocks (96 and 108) (par. [0043]), FIG. 1, wherein the extending blocks contact the extending plates at an angle (angle of complementary ramps on the extending blocks and the plate 6, par. [0043]-[0046]) wherein operation of a positioning element (tool 80) causes the extending blocks to slide within the body (par. [0093]), causing the extending plates to move orthogonally from the extending blocks to an extended position (par. [0076], [0093]) (at least as much as the instant invention; the extendable plate moves orthogonally from the body and the extending blocks); inserting the bone fusion assembly into the desired location, FIG. 41; and continuously extending (compressive force applied to the extending blocks continuously slides them toward each other and thus continuously extends the plate from the body) one or more of the one or more extendable plates of the at least one of the bone fusion devices from a retracted position within the respective body (the plate is retracted within stability bars 102 of the body, par. [0038]), FIGS. 23 and 41, to an extended position at least partially out of the respective body (par. [0076]-[0077], [0093]), FIGS. 24 and 42a, such that a height of the bone fusion assembly is substantially similar to the height of the desired location (par. [0076]).
Greenhalgh is silent as to detachably coupling together one or more bone fusion devices and one or more spacers to form a bone fusion assembly; wherein each of the one or more spacers is hollow comprising a hollow space within each of the one or more spacers, formed as an internal cavity between a left-most wall of the respective spacer and a right-most wall of the respective spacer, and further wherein each of the one or more spacers is a discrete component separate from the one or more bone fusion devices, the bone fusion assembly including an outer surface of one of the one or more extendable plates of at least one of the bone fusion devices coupled to one of the one or more spacers such that the one of the one or more spacers extends away from the body beyond the outer surface of the one of the one or more extendable plates of the at least one of the one or more bone fusion devices, wherein the outer surface of the one of the one or more extendable plates comprises a mounting interface configured to receive the one of the one or more spacers; wherein the detachably coupling maintains engagement between the one of the one or more spacers and the one of the one or more extendable plates throughout movement of the one or more of the one or more extendable plates between the retracted position and the extended position (claim 52); wherein the number of spacers and bone fusion devices coupled together is based on the height of the desired location (claim 53).
Bertele teaches detachably coupling together a bone fusion device (2004) and spacers (2002, 2006) to form a bone fusion assembly (par. [0126]), FIGS. 45-47, the bone fusion device having a body, each of the spacers is hollow comprising a hollow space (2010, 2012; and/or pores/porosity forming the hollow space, par. [0130]) within each of the spacers, FIG. 47, formed as an internal cavity (a cavity is commonly understood to mean an empty space; 2010 and 2012 are internal cavities because they are empty/negative spaces, and the pores/porosity are also internal cavities because they are empty/negative spaces) between a left-most wall of the respective spacer and a right-most wall of the respective spacer (the hollow spaces 2010, 2012, and/or pores/porosity are each between left- and right-most walls of the respective spacer because they are within the spacer and thus within the exterior perimeter of the spacer, where the exterior perimeter is defined at least in part by the left- and right-most walls), and further wherein each of the one or more spacers is a discrete component separate from the one or more bone fusion devices (par. [0126]), FIG. 47, the bone fusion assembly including an outer surface coupled to the spacers such that the spacers extend away from the body beyond the outer surface, FIG. 45, wherein the outer surface comprises a mounting interface (the outer surface is a mounting interface because it is the location of meeting or interaction with the other component, e.g. the spacer, and comprises part or half of a mechanical attachment such as lock-and-key features such as v-grooves or fasteners such as small screws) configured to receive the spacers (par. [0126]); wherein the detachably coupling maintains engagement between the spacers and the bone fusion device (par. [0126]).
As to claim 53, Bertele teaches the method of claim 52, wherein the number of spacers and bone fusion devices coupled together is based on the height of the desired location (in order to mate with adjacent vertebral surfaces, par. [0074]).
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to modify Greenhalgh to include spacers as taught by Bertele, coupled to the outer, bone-facing surfaces of the bone fusion device, including the outer surface of the extendable plate, such that the spacer extends away from the body beyond the outer surface, the spacers encouraging both bone on-growth (onto the porous spacers) and in-growth (into pores of the spacers), therefore promoting bone fusion that stabilizes the implanted assembly and surrounding bone structures (Bertele, par. [0068]). The spacers are detachably coupled to the bone fusion device by mechanical attachment that is fully capable of being detached during revision, for example. Since both Greenhalgh and Bertele require a particular height to maintain the normal height of the disc space, the number of spacers and bone fusion devices as well as their heights would be based on the height of the desired location in order to mate with adjacent vertebral surfaces. Since both Greenhalgh and Bertele require a vertical bone growth aperture through the devices, and Bertele teaches that the spacer has a complementary shape to the device it’s attached to, the spacers would also have a hollow space within to match Greenhalgh’s devices and thus be hollow, where the term hollow is commonly understood to mean having a hole inside, like a hollow tube. As interpreted above, the hollow space in each spacer is formed as an internal cavity between a left-most wall of the spacer and a right-most wall of the spacer because each of the vertical bone growth apertures as well as the pores/porosity are internal cavities because they are empty/negative spaces that are each between left- and right-most walls of the respective spacer because they are within the spacer and thus within the exterior perimeter of the spacer, where the exterior perimeter is defined at least in part by the left- and right-most walls. Each of the spacers is a discrete component separate from the one or more bone fusion devices, as shown in Bertele, and since the spacers are detachably coupled to the bone fusion devices by mechanical attachment as taught by Bertele. The outer surface of the extendable plate in Greenhalgh, coupled to the spacer as taught in Bertele, would comprise a mounting interface configured to receive one of the spacers, as part or half of a mechanical attachment such as lock-and-key features such as v-grooves or fasteners such as small screws (the interface in this case being the screws or apertures which receive the screws), which Bertele teaches is how the spacer is coupled to the outer surface. The spacer that is detachably coupled to the outer surface of the extendable plate in view of Bertele would maintain engagement between the spacer and the extendable plate throughout movement of the plate between the retracted position and the extended position because the spacer is coupled to the plate which is then implanted as part of the bone fusion assembly to be then expanded. In other words, as the plate moves between the retracted and extended positions, the spacer, coupled to the plate, is along for the ride and also moves between the retracted and extended positions since the spacer and the plate are mechanically coupled together.
Claims 58 and 59 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greenhalgh in view of Bertele (hereinafter, “Greenhalgh/Bertele”), as applied to claims 52 and 53 above, and further in view of U.S. Patent Application Publication No. US 2010/0125334 to Krueger.
Greenhalgh/Bertele are silent as to wherein the mounting interface of the bone fusion devices comprises a plurality of slats and the spacers comprise a plurality of rails, wherein the plurality of rails are positioned on a same side of a respective one of the one or more spacers and the detachably coupling comprises sliding the plurality of slats under the plurality of rails (claim 58); wherein the plurality of slats and the plurality of rails comprise one or more snap-fit members and one or more cutouts and the detachably coupling comprises depressing the one or more snap-fit members when the plurality of slats are slid under the plurality of rails and springing the one or more snap-fit members into the one or more cutouts when the one or more snap-fit members are aligned with the one or more cutouts in order to prevent the plurality of slats from sliding out from under the plurality of rails (claim 59).
As to claim 58, Krueger teaches a bone fusion device (14), FIG. 1, in the same field of endeavor, and a spacer (24), FIG. 5, wherein the spacer has a plurality of rails (rails 50 and 52 protruding downwardly in FIG. 7A) (par. [0095]-[0096]) and the bone fusion device has a plurality of slats (thin narrow sections 70 on either end of 14, FIGS. 1 and 8A, in one of which the cutout 38 is disposed) (par. [0095]-[0096] and [0098]), wherein the plurality of rails are positioned on a same side (lower side) of a respective one of the one or more spacers, FIG. 7A, and the bone fusion device and the spacer are detachably coupled by sliding the slats under the rails (since the bone fusion device comprising the slats is underneath the spacer comprising the rails, FIG. 1).
As to claim 59, Krueger teaches wherein the rail comprises a snap-fit member (62) and the slat comprises a cutout (38) and the detachably coupling comprises depressing the snap-fit member when the slat is slid under the rail (via relative sliding of the spacer and the bone fusion device, the spacer sliding over the bone fusion device could be interpreted as the bone fusion device sliding under the spacer) and springing the snap-fit member into the cutout when the snap-fit member is aligned with the cutout in order to prevent the slat from sliding out from under the rail (par. [0098]).
In the interpretation of Greenhalgh in view of Bertele, where spacers are coupled to the outer, bone-facing surfaces of the bone fusion device, it would have been obvious to a person having ordinary skill in the art at the time of invention to modify the facing surfaces of the bone fusion device and the spacer to have complementary rails and slats in the dovetail shape as taught by Krueger, with the top surface of the bone fusion device at the plate provided with slats or thinner sections (thinner cutaway area), and the lower surface of the spacer provided with rails (dovetail shaped protrusions as taught by Krueger that are complementary to and received in the dovetail cutaway slats), for example in the dovetail shape as taught by Krueger, to allow the components to be implanted separately to allow for the use of a smaller access channel for implantation to prevent undue tissue damage, while still providing the necessary desired height of the apparatus as a whole, with the abutting surfaces of the components interfitting via the complementary dovetail shapes to ensure alignment of the components after implantation. As taught by Krueger (par. [0098]), the components are inserted sequentially via the guidance of the dovetails, to allow assembly in situ. Detachably coupling would then comprise sliding the slats under the rails so that the spacer with the rails is superior to the bone fusion device (at the plate) with the slats and the spacer is bone-facing. The slat would slide under the rail, either in the insertion direction as the lower component is inserted second or in the opposite direction as the upper component is inserted second. Further, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide the rails with a snap-fit member and the slats with a cutout, as taught by Krueger, so that as the components are slid into engagement in situ, the snap-fit member is depressed while the slats are sliding under the rails and springs into the cutout when the snap-fit member is aligned with the cutout (with the snap-fit member and cutout placed so that their alignment coincides with alignment or complete insertion of the components), in order to prevent the slats from sliding out from under the rails and to maintain the components of the apparatus in engagement after implantation. The inferior side of the rail of the spacer (superior component) would be provided with a snap-fit member to be received in the cutout provided on the superior side of the slat on the bone fusion device (inferior component), thereby providing locking engagement to prevent backout or disengagement of any components of the apparatus, particularly during movement of the patient. As taught by Krueger, the coupling is detachable based on the shape of the snap-fit member (par. [0099]) so that the components may be removed separately during revision so as to utilize a smaller access channel and prevent undue tissue damage. Bertele contemplates that the bone fusion device and spacers can be mechanically attached to each other, and combining prior art elements (providing the rail/slat and snap-fit/cutout to Greenhalgh/Bertele) according to known methods to yield predictable results (mechanical attachment) is within the ordinary skill in the art.
Claims 71, 72, and 77 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greenhalgh in view of Bertele and U.S. Patent Application Publication No. US 2010/0125334 to Krueger.
As to claim 71, Greenhalgh discloses a method of implanting a bone fusion apparatus into a desired location having a height, the method comprising: one or more bone fusion devices (2) forming a bone fusion assembly, the bone fusion devices each having a body (10) (par. [0038]), one or more extendable plates (one plate 6) and one or more extending blocks (96 and 108) (par. [0043]), FIG. 1, wherein the extending blocks contact the extending plates at an angle (angle of complementary ramps on the extending blocks and the plate 6, par. [0043]-[0046]) wherein operation of a positioning element (tool 80) causes the extending blocks to slide within the body (par. [0093]), causing the extending plates to move orthogonally from the extending blocks to an extended position (par. [0076], [0093]) (at least as much as the instant invention; the extendable plate moves orthogonally from the body and the extending blocks); inserting the bone fusion assembly into the desired location , FIG. 41; and extending one or more of the one or more extendable plates out from the respective body to extended positions (par. [0038], [0076]-[0077], [0093]), FIGS. 23-24, such that a height of the bone fusion assembly is substantially similar to the height of the desired location (par. [0076]).
Greenhalgh is silent as to detachably coupling together one or more bone fusion devices and one or more spacers thereby forming a bone fusion assembly; wherein each of the one or more spacers is hollow comprising a hollow space within each of the one or more spacers formed as an internal cavity between a left-most wall of the respective spacer and a right-most wall of the respective spacer, and further wherein each of the one or more spacers is a discrete component separate from the one or more bone fusion devices, the bone fusion assembly including an outer surface of one of the one or more extendable plates of at least one of the bone fusion devices coupled to one of the one or more spacers such that the one of the one or more spacers extends away from the body beyond the outer surface of the one of the one or more extendable plates of the at least one of the bone fusion devices; wherein the detachably coupling maintains engagement between the one of the one or more spacers and the one of the one or more extendable plates throughout movement of the one or more of the one or more extendable plates from the respective body to the extended positions (claim 71); wherein the number of spacers and bone fusion devices coupled together is based on the height of the desired location (claim 72).
Bertele teaches detachably coupling together a bone fusion device (2004) and spacers (2002, 2006) thereby forming a bone fusion assembly (par. [0126]), FIGS. 45-47, the bone fusion device having a body, each of the spacers is hollow comprising a hollow space (2010, 2012; and/or pores/porosity forming the hollow space, par. [0130]) within each of the spacers, FIG. 47, formed as an internal cavity (a cavity is commonly understood to mean an empty space; 2010 and 2012 are internal cavities because they are empty/negative spaces, and the pores/porosity are also internal cavities because they are empty/negative spaces) between a left-most wall of the respective spacer and a right-most wall of the respective spacer (the hollow spaces 2010, 2012, and/or pores/porosity are each between left- and right-most walls of the respective spacer because they are within the spacer and thus within the exterior perimeter of the spacer, where the exterior perimeter is defined at least in part by the left- and right-most walls), and further wherein each of the one or more spacers is a discrete component separate from the one or more bone fusion devices (par. [0126]), FIG. 47, the bone fusion assembly including an outer surface coupled to the spacers such that the spacers extend away from the body beyond the outer surface, FIG. 45, wherein the outer surface comprises a mounting interface (the outer surface is a mounting interface because it is the location of meeting or interaction with the other component, e.g. the spacer, and comprises part or half of a mechanical attachment such as lock-and-key features such as v-grooves or fasteners such as small screws) configured to receive the spacers (par. [0126]); wherein the detachably coupling maintains engagement between the spacers and the bone fusion device (par. [0126]).
As to claim 72, Bertele teaches the method of claim 52, wherein the number of spacers and bone fusion devices coupled together is based on the height of the desired location (in order to mate with adjacent vertebral surfaces, par. [0074]).
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to modify Greenhalgh to include spacers as taught by Bertele, coupled to the outer, bone-facing surfaces of the bone fusion device, including the outer surface of the extendable plate, such that the spacer extends away from the body beyond the outer surface, the spacers encouraging both bone on-growth (onto the porous spacers) and in-growth (into pores of the spacers), therefore promoting bone fusion that stabilizes the implanted assembly and surrounding bone structures (Bertele, par. [0068]). The spacers are detachably coupled to the bone fusion device by mechanical attachment that is fully capable of being detached during revision, for example. Since both Greenhalgh and Bertele require a particular height to maintain the normal height of the disc space, the number of spacers and bone fusion devices as well as their heights would be based on the height of the desired location in order to mate with adjacent vertebral surfaces. Since both Greenhalgh and Bertele require a vertical bone growth aperture through the devices, and Bertele teaches that the spacer has a complementary shape to the device it’s attached to, the spacers would also have a hollow space within to match Greenhalgh’s devices and thus be hollow, where the term hollow is commonly understood to mean having a hole inside, like a hollow tube. As interpreted above, the hollow space in each spacer is formed as an internal cavity between a left-most wall of the spacer and a right-most wall of the spacer because each of the vertical bone growth apertures as well as the pores/porosity are internal cavities because they are empty/negative spaces that are each between left- and right-most walls of the respective spacer because they are within the spacer and thus within the exterior perimeter of the spacer, where the exterior perimeter is defined at least in part by the left- and right-most walls. Each of the spacers is a discrete component separate from the one or more bone fusion devices, as shown in Bertele, and since the spacers are detachably coupled to the bone fusion devices by mechanical attachment as taught by Bertele. The outer surface of the extendable plate in Greenhalgh, coupled to the spacer as taught in Bertele, would comprise a mounting interface configured to receive one of the spacers, as part or half of a mechanical attachment such as lock-and-key features such as v-grooves or fasteners such as small screws (the interface in this case being the screws or apertures which receive the screws), which Bertele teaches is how the spacer is coupled to the outer surface. The spacer that is detachably coupled to the outer surface of the extendable plate in view of Bertele would maintain engagement between the spacer and the extendable plate throughout movement of the plate into the extended positions because the spacer is coupled to the plate which is then implanted as part of the bone fusion assembly to be then expanded. In other words, as the plate moves from the body into the extended positions, the spacer, coupled to the plate, is along for the ride and also moves between the retracted and extended positions since the spacer and the plate are mechanically coupled together.
Greenhalgh is silent as to wherein the mounting interface of the bone fusion devices comprises a plurality of slats and the spacers comprise a plurality of rails, wherein the plurality of rails are positioned on a same side of a respective one of the one or more spacers and the detachably coupling comprises sliding the plurality of slats under the plurality of rails (claim 71); wherein the plurality of slats and the plurality of rails comprise one or more snap-fit members and one or more cutouts and the detachably coupling comprises depressing the one or more snap-fit members when the plurality of slats are slid under the plurality of rails and springing the one or more snap-fit members into the one or more cutouts when the one or more snap-fit members are aligned with the one or more cutouts in order to prevent the plurality of slats from sliding out from under the plurality of rails (claim 77).
As to claim 71, Krueger teaches a bone fusion device (14), FIG. 1, in the same field of endeavor, and a spacer (24), FIG. 5, wherein the spacer has a plurality of rails (rails 50 and 52 protruding downwardly in FIG. 7A) (par. [0095]-[0096]) and the bone fusion device has a plurality of slats (thin narrow sections 70 on either end of 14, FIGS. 1 and 8A, in one of which the cutout 38 is disposed) (par. [0095]-[0096] and [0098]), wherein the plurality of rails are positioned on a same side (lower side) of the one or more spacers, FIG. 7A, and the bone fusion device and the spacer are detachably coupled by sliding the slats under the rails (since the bone fusion device comprising the slats is underneath the spacer comprising the rails, FIG. 1).
As to claim 77, Krueger teaches wherein the rail comprises a snap-fit member (62) and the slat comprises a cutout (38) and the detachably coupling comprises depressing the snap-fit member when the slat is slid under the rail (via relative sliding of the spacer and the bone fusion device, the spacer sliding over the bone fusion device could be interpreted as the bone fusion device sliding under the spacer) and springing the snap-fit member into the cutout when the snap-fit member is aligned with the cutout in order to prevent the slat from sliding out from under the rail (par. [0098]).
In the interpretation of Greenhalgh in view of Bertele, where spacers are coupled to the outer, bone-facing surfaces of the bone fusion device, it would have been obvious to a person having ordinary skill in the art at the time of invention to modify the facing surfaces of the bone fusion device and the spacer to have complementary rails and slats in the dovetail shape as taught by Krueger, with the top surface of the bone fusion device at the plate provided with slats or thinner sections (thinner cutaway area), and the lower surface of the spacer provided with rails (dovetail shaped protrusions as taught by Krueger that are complementary to and received in the dovetail cutaway slats), for example in the dovetail shape as taught by Krueger, to allow the components to be implanted separately to allow for the use of a smaller access channel for implantation to prevent undue tissue damage, while still providing the necessary desired height of the apparatus as a whole, with the abutting surfaces of the components interfitting via the complementary dovetail shapes to ensure alignment of the components after implantation. As taught by Krueger (par. [0098]), the components are inserted sequentially via the guidance of the dovetails, to allow assembly in situ. Detachably coupling would then comprise sliding the slats under the rails so that the spacer with the rails is superior to the bone fusion device (at the plate) with the slats and the spacer is bone-facing. The slat would slide under the rail, either in the insertion direction as the lower component is inserted second or in the opposite direction as the upper component is inserted second. Further, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide the rails with a snap-fit member and the slats with a cutout, as taught by Krueger, so that as the components are slid into engagement in situ, the snap-fit member is depressed while the slats are sliding under the rails and springs into the cutout when the snap-fit member is aligned with the cutout (with the snap-fit member and cutout placed so that their alignment coincides with alignment or complete insertion of the components), in order to prevent the slats from sliding out from under the rails and to maintain the components of the apparatus in engagement after implantation. The inferior side of the rail of the spacer (superior component) would be provided with a snap-fit member to be received in the cutout provided on the superior side of the slat on the bone fusion device (inferior component), thereby providing locking engagement to prevent backout or disengagement of any components of the apparatus, particularly during movement of the patient. As taught by Krueger, the coupling is detachable based on the shape of the snap-fit member (par. [0099]) so that the components may be removed separately during revision so as to utilize a smaller access channel and prevent undue tissue damage. Bertele contemplates that the bone fusion device and spacers can be mechanically attached to each other, and combining prior art elements (providing the rail/slat and snap-fit/cutout to Greenhalgh/Bertele) according to known methods to yield predictable results (mechanical attachment) is within the ordinary skill in the art.
Claim 56 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greenhalgh in view of Bertele (hereinafter, “Greenhalgh/Bertele”), as applied to claims 52 and 53 above, and further in view of U.S. Patent Application Publication No. US 2011/0160861 to Jimenez et al. (hereinafter, “Jimenez”).
Greenhalgh/Bertele are silent as to wherein the detachably coupling comprises coupling one of the spacers to another one of the spacers.
Jimenez teaches detachably coupling together two bone fusion devices (100) to form a bone fusion assembly, FIG. 15.
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of invention to detachably couple together two of the bone fusion devices in Greenhalgh/Bertele, stacked on top of each other, to provide a greater final device height for procedures that require greater correction. The mere duplication of the essential working parts of a device involves only routine skill in the art. Then, in view of the modification in view of Bertele in which spacers are coupled to the outer, bone-facing surfaces of each bone fusion device, coupling together two of such bone fusion devices with spacers attached to each top/bottom bone-facing surface would result in coupling spacers to each other (the inferior spacer of the superior bone fusion device would couple with the superior spacer of the inferior bone fusion device).
Claim 75 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Greenhalgh in view of Bertele and Krueger (hereinafter, “Greenhalgh/Bertele/Krueger”), as applied to claims 71, 72, and 77 above, and further in view of U.S. Patent Application Publication No. US 2011/0160861 to Jimenez et al. (hereinafter, “Jimenez”).
Greenhalgh/Bertele/Krueger are silent as to wherein the detachably coupling comprises coupling one of the spacers to another one of the spacers.
Jimenez teaches detachably coupling together two bone fusion devices (100) to form a bone fusion assembly, FIG. 15.
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of invention to detachably couple together two of the bone fusion devices in Greenhalgh/Bertele/Krueger, stacked on top of each other, to provide a greater final device height for procedures that require greater correction. The mere duplication of the essential working parts of a device involves only routine skill in the art. Then, in view of the modification in view of Bertele in which spacers are coupled to the outer, bone-facing surfaces of each bone fusion device, coupling together two of such bone fusion devices with spacers attached to each top/bottom bone-facing surface would result in coupling spacers to each other (the inferior spacer of the superior bone fusion device would couple with the superior spacer of the inferior bone fusion device).
Conclusion
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
