DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This Office Action is responsive to the amendment filed on 19 March 2026. As directed by the amendment: Claims 52 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.
Response to Arguments
Applicant’s arguments with respect to the rejections under pre-AIA 35 U.S.C. 103(a) have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The arguments that Jimenez (US 2011/0160861) does not teach detachably coupling together bone fusion devices and spacers to form a bone fusion assembly, the bone fusion devices each having a body, one or more extendable plates, and one or more extending blocks, are not persuasive because the limitations were met by modification of Jimenez in view of Bertele (US 2011/0190888). Similarly, the arguments that Bertele alone does not teach detachably coupling together bone fusion devices and spacers to form a bone fusion assembly, the bone fusion devices each having a body, one or more extendable plates, and one or more extending blocks, are not persuasive because the limitations were met by modification of Jimenez in view of Bertele. Further, the arguments that Krueger (US 2010/0125334) does not alone does not teach detachably coupling together bone fusion devices and spacers to form a bone fusion assembly, the bone fusion devices each having a body, one or more extendable plates, and one or more extending blocks; and that the spacers are hollow, are not persuasive because the limitations were met by modification of Jimenez in view of Bertele and Krueger.
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 Jimenez discloses bone fusion devices having extendable plates, and the modification of Jimenez in view of Bertele results in the spacers as taught by Bertele being coupled to the outer, bone-facing surfaces of Jimenez’s bone fusion devices, 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 contends that Bertele’s assembly 200 is diffusion bonded and is not a spacer but an integral part of the interbody device. Examiner respectfully submits that Bertele discloses the spacers (2002, 2006) may be mechanically attached to device (2004) using lock-and-key features or fasteners (par. [0126]), FIGS. 45-47. Such a mechanical attachment is a detachable coupling – the spacers are thus detachably coupled to the bone fusion devices by mechanical attachment that is fully capable of being detached during revision, for example. The spacers are thus, as above, spacers because they make a space or take up space. The diffusion bonding of the layers to create the spacers does not make them not spacers, rather this is the technique described to make the spacers porous before coupling the spacers to the rest of the apparatus.
Applicant contends that the cited portions of Jimenez, Bertele, and their combination do not teach that the outer surface of the plate comprises a mounting interface to receive one of the spacers. Examiner respectfully submits that Bertele teaches that the outer surface of the bone fusion assembly comprises a mounting interface because it is the location of meeting or interaction with 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. This mounting interface receives the other part or half of the mechanical attachment on the spacer, to complete the mechanical attachment and couple the spacer to the device.
Since Jimenez discloses that the bone fusion devices are coupled together throughout movement between the retracted position and the extended position, since the devices are implanted such that they interface with each other and then can be actuated simultaneously into the extended position (Jimenez, par. [0096]), then all of the coupled together components would maintain engagement throughout movement of the one or more of the one or more extendable plates between the retracted position and the extended position. The spacer that is detachably coupled to the outer surface of the extendable plate in view of Bertele would thus maintain engagement between the spacer and the extendable plate throughout movement of the plate between the retracted position and the extended position. 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.
Applicant contends that Bertele teaches an aperture 2010 in endplate/spacer 2002 and an aperture 2012 in endplate/spacer 2006, but having an aperture or hole does not mean that an element is hollow. Applicant contends that the layers and the formed endplates are solid, not hollow. Examiner respectfully submits that the commonly understood definition of the term hollow is having a hole or empty space inside [Cambridge Dictionary]. An example provided in the Cambridge Dictionary is a hollow tube; a tube has open ends on either end of the hole inside, much like the spacers in Bertele, which are short hollow tubes. Each endplate/spacer thus is hollow because it has a corresponding hole (2010 or 2012) inside. Even the porosity taught by Bertele (pores 2027, par. [0130]) means that the endplates have holes and are thus hollow because they have a hollow space within (even excluding the central hole 2010/2012) that follows the negative space within the endplate created by the pores, and are not "solid." Diffusion bonding of the layers to make the spacers creates this porous matrix, which thus has pores and is hollow, not solid.
In Bertele, 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.
Applicant contends that the combination of Jimenez, Bertele, and Krueger is improper, because the dovetail rails and slats of Krueger are on rigid, non-moving structures, and Krueger does not suggest adapting these features to a dynamic extendable plate that moves relative to a body while maintaining engagement with a spacer. Applicant contends that applying Krueger’s rigid dovetail structures to the extendable plates of Jimenez would prevent the plates from extending and retracting, rendering Jimenez inoperable. Examiner respectfully submits that modification of Jimenez in view of Bertele results in spacers detachably coupled to outer, bone-facing surfaces of the bone fusion devices, including the outer surface of the extendable plate. Coupling a spacer to the outer surface of the extendable plate would not prevent the plate from extending and retracting since the outer surface of the plate is outside of the rest of the device and does not affect the internal actuation mechanism (see Jimenez FIGS. 1A-1B). Coupling a spacer to the outer surface of the extendable plate in effect makes the plate thicker. Thus, where the spacer and plate interact is relatively non-moving, since the spacer and the plate do not move relative to each other. The dovetail rails and slats of Krueger would thus be applied to the interfacing surfaces of the spacer and the plate (e.g. on the top of the plate shown in Jimenez FIG. 1B), and would not affect, or be affected by, the plate moving relative to the underlying body. Since Jimenez discloses that the bone fusion devices are coupled together throughout movement between the retracted position and the extended position, since the devices are implanted such that they interface with each other and then can be actuated simultaneously into the extended position (Jimenez, par. [0096]), then all of the coupled together components would maintain engagement throughout movement of the one or more of the one or more extendable plates between the retracted position and the extended position. The spacer that is detachably coupled to the outer surface of the extendable plate in view of Bertele would thus maintain engagement between the spacer and the extendable plate throughout movement of the plate between the retracted position and the extended position. 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.
Applicant contends that neither Jimenez, Bertele, nor Krueger teach the bone fusion devices and the spacers comprise a plurality of rails and a plurality of slats, wherein the plurality of rails are positioned on a same side of the one or more spacers and the detachably coupling comprises sliding the one or more slats under the one or more 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 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).
The response to the arguments as to claim 71 are substantially the same as above. Applicant's arguments as to claim 71 (see pages 12-13) fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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 / line 8: “wall of the respective spacer and a right-most wall of the respective spacer,”
Claim 52 / line 15: “configured to receive the one of the one or more spacers;”
Claim 52 / lines 21-22: “engagement between the one of the one or more spacers and the one of the one or more extendable plates”
Claim 71 / line 8: “wall of the respective spacer and a right-most wall of the respective spacer,”
Claim 71 / lines 21-22: “engagement between the one of the one or more spacers and the one of the one or more extendable plates”
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, and 59 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 claim 52, the limitation “wherein the outer surface of the one of the one or more extendable plates comprises a mounting interface configured to receive one of the spacers” (lines 13-15) is not supported by the specification as originally filed, which does not recite “a mounting interface”.
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 58 and 59 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 claims 58 and 59, the claims are rendered indefinite because it is unclear if the plurality of rails and the plurality of slats (claim 58) are included in or refer back to the mounting interface of claim 52, or if the mounting interface is separate and distinct from the rails and slats. For examination purposes, the limitations will be interpreted in the first instance, as the rails and slats included in the mounting interface.
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, 53, and 56 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. US 2011/0160861 to Jimenez et al. (hereinafter, “Jimenez”), in view of U.S. Patent Application Publication No. US 2011/0190888 to Bertele et al. (hereinafter, “Bertele”).
As to claim 52, Jimenez discloses a method of implanting a bone fusion apparatus into a desired location having a height, the method comprising: detachably coupling together one or more bone fusion devices (100) to form a bone fusion assembly, FIG. 15, the bone fusion devices each having a body (150) (par. [0064]), FIG. 1B, one or more extendable plates (110 including 111, 112) and one or more extending blocks (120, 130) used to extend the one or more extendable plates from the body (par. [0065]-[0067]; the plate extends from the body since portions 111, 112 extend out from the body), FIG. 1C, the bone fusion assembly including an outer surface (upward facing surface) of one of the one or more extendable plates of at least one of the bone fusion devices, wherein the outer surface of the one of the one or more extendable plates comprises a mounting interface (the outer surface of the plate is a mounting interface because it is the location of meeting or interaction with the other component, e.g. the other bone fusion device body, FIG. 15); inserting the bone fusion assembly into the desired location (par. [0005], [0076]); and continuously extending 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 (portions 111, 112 of the plate are retracted within the body, FIG. 1A) to an extended position at least partially out of the respective body (portions 111, 112 extend at least partially out of the body, FIG. 1B) such that a height of the bone fusion assembly is substantially similar to the height of the desired location (par. [0007]).
Jimenez fails to disclose detachably coupling together one or more spacers, 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 spacer and a right-most wall of the 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 outer surface of one of the one or more extendable plates 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 one of the spacers; wherein the detachably coupling maintains engagement between the one or more spacers and 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.
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 spacer and a right-most wall of the 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 one of the spacers (par. [0126]); wherein the detachably coupling maintains engagement between the one or more 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 Jimenez to include spacers as taught by Bertele, coupled to the outer, bone-facing surfaces of the bone fusion devices, 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 devices by mechanical attachment that is fully capable of being detached during revision, for example. Since both Jimenez 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 Jimenez 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 Jimenez’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 Jimenez, 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. Since Jimenez discloses that the bone fusion devices are coupled together throughout movement between the retracted position and the extended position, since the devices are implanted such that they interface with each other and then can be actuated simultaneously into the extended position (Jimenez, par. [0096]), then all of the coupled together components would maintain engagement throughout movement of the one or more of the one or more extendable plates between the retracted position and the extended position. The spacer that is detachably coupled to the outer surface of the extendable plate in view of Bertele would thus maintain engagement between the spacer and the extendable plate throughout movement of the plate between the retracted position and the extended position. 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.
As to claim 56, Bertele teaches wherein the detachably coupling comprises coupling one of the spacers to another one of the spacers (spacers 2026, 2216, 2028 are coupled together) (par. [0130]), FIG. 47.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide the spacers on both bone-facing sides of each of Jimenez’s bone fusion devices, so that a single device would provide bone fusion on both sides, i.e. with superior and inferior vertebrae. This would provide ease of manufacture since each assembly would be constructed in the same way. Then, as required by Jimenez, when multiple assemblies are connected together as in FIG. 15, the adjacent faces, which as modified now include the inferior spacer of the superior assembly and the superior spacer of the inferior assembly, would be detachably coupled together. Therefore, the adjacent spacers would be detachably coupled to each other.
Claims 58 and 59 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jimenez in view of Bertele (hereinafter, “Jimenez/Bertele”), as applied to claims 52, 53, and 56 above, and further in view of U.S. Patent Application Publication No. US 2010/0125334 to Krueger.
Jimenez is silent as to wherein the bone fusion devices and the spacers comprise a plurality of rails and a plurality of slats, 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 Jimenez in view of Bertele, where spacers are coupled to the outer, bone-facing surfaces of the bone fusion devices, 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 slats and rails in the dovetail shape as taught by Krueger, with the top surface of the bone fusion device 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 (Jimenez, FIG. 15). Regardless of if the upper or lower component in Jimenez is inserted second, 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 Jimenez/Bertele) according to known methods to yield predictable results (mechanical attachment) is within the ordinary skill in the art.
Claims 71, 72, 75, and 77 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jimenez in view of Bertele and Krueger.
As to claim 71, Jimenez discloses a method of implanting a bone fusion apparatus into a desired location having a height, the method comprising: detachably coupling together one or more bone fusion devices (100) thereby forming a bone fusion assembly, FIG. 15, the bone fusion devices each having a body (150) (par. [0064]), FIG. 1B, one or more extendable plates (110 including 111, 112) and one or more extending blocks (120, 130) used to extend the one or more extendable plates from the body (par. [0065]-[0067]; the plate extends from the body since portions 111, 112 extend out from the body), FIG. 1C, the bone fusion assembly including an outer surface (upward facing surface) of one of the one or more extendable plates of at least one of the bone fusion devices; inserting the bone fusion assembly into the desired location (par. [0005], [0076]); and extending one or more of the one or more extendable plates out from the respective body (portions 111, 112 of the plate extend at least partially out of the body, FIG. 1B) to extended positions such that a height of the bone fusion assembly is substantially similar to the height of the desired location (par. [0007]).
Jimenez fails to disclose detachably coupling together one or more spacers, 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 spacer and a right-most wall of the 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 outer surface of one of the one or more extendable plates 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 or more spacers and 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.
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 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 spacer and a right-most wall of the 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 detachably coupling maintains engagement between the one or more spacers and the bone fusion device (par. [0126]).
As to claim 72, Bertele teaches method of claim 71, 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 Jimenez to include spacers as taught by Bertele, coupled to the outer, bone-facing surfaces of the bone fusion devices, 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 devices by mechanical attachment that is fully capable of being detached during revision, for example. Since both Jimenez 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 Jimenez 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 Jimenez’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 Jimenez, 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. Since Jimenez discloses that the bone fusion devices are coupled together throughout movement to the extended positions, since the devices are implanted such that they interface with each other and then can be actuated simultaneously into the extended positions (Jimenez, par. [0096]), then all of the coupled together components would maintain engagement throughout movement of the one or more of the one or more extendable plates from the respective body to the extended positions. The spacer that is detachably coupled to the outer surface of the extendable plate in view of Bertele would thus maintain engagement between the spacer and the extendable plate throughout movement of the plate from the respective body to the extended positions. In other words, as the plate moves to the extended positions, the spacer, coupled to the plate, is along for the ride and also moves to the extended positions since the spacer and the plate are mechanically coupled together.
As to claim 75, Bertele teaches wherein the detachably coupling comprises coupling one of the spacers to another one of the spacers (spacers 2026, 2216, 2028 are coupled together) (par. [0130]), FIG. 47.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide the spacers on both bone-facing sides of each of Jimenez’s bone fusion devices, so that a single device would provide bone fusion on both sides, i.e. with superior and inferior vertebrae. This would provide ease of manufacture since each assembly would be constructed in the same way. Then, as required by Jimenez, when multiple assemblies are connected together as in FIG. 15, the adjacent faces, which as modified now include the inferior spacer of the superior assembly and the superior spacer of the inferior assembly, would be detachably coupled together. Therefore, the adjacent spacers would be detachably coupled to each other.
Jimenez fails to disclose wherein the spacers and the one or more extendable plates of the bone fusion devices comprise a plurality of rails and a plurality of slats, 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 Jimenez in view of Bertele, where spacers are coupled to the outer, bone-facing surfaces of the bone fusion devices, 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 (Jimenez, FIG. 15). Regardless of if the upper or lower component in Jimenez is inserted second, 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 Jimenez/Bertele) according to known methods to yield predictable results (mechanical attachment) is within the ordinary skill in the art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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