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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-4 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 7-9 and 11 of U.S. Patent No. 10,307,190 B2 in view of Kinmon (U.S. Pub. No. 2012/0130370 A1, hereinafter “Kinmon”).
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. An arthrodesis device, comprising: a sleeve extending along a longitudinal axis between a proximal portion and a distal portion; a first fixation body movably received within the proximal portion of the sleeve; a second fixation body movably received within the distal portion of the sleeve; and a Nitinol rod including an elongated shaft extending between a first threaded portion that is configured to engage the first fixation body and a second threaded portion that is configured to engage the second fixation body.
7. An arthrodesis device, comprising: a nail body extending along a longitudinal axis between a proximal portion and a distal portion; a proximal interlocking fixation body slidably received within a first cannulation located inside the proximal portion; a distal interlocking fixation body slidably received within a second cannulation located inside the distal portion; and a shape memory material connecting member attached to the proximal interlocking fixation body and the distal interlocking fixation body, wherein the shape memory material connecting member includes an elongated shaft extending between a first threaded portion and a second threaded portion.
2. The arthrodesis device as recited in claim 1, wherein the sleeve includes at least one opening configured to receive a fixation device.
8. The device as recited in claim 7, wherein the nail body includes at least one opening configured to receive a fixation device.
3. The arthrodesis device as recited in claim 1, wherein a first opening is located within the proximal portion of the sleeve and is configured to receive a tibial screw, a second opening is located within the distal portion of the sleeve and is configured to receive a talar screw, and a third opening is located within the distal portion of the sleeve and is configured to receive a calcaneal screw.
9. The device as recited in claim 7, wherein a first opening is located within the proximal portion of the nail body and receives a tibial screw, a second opening is located within the distal portion of the nail body and receives a talar screw, and a third opening is located within the distal portion of the nail body and receives a calcaneal screw.
4. The arthrodesis device as recited in claim 1, wherein the Nitinol rod is configured to move between an unstretched position and a stretched position to generate a compressive force across bones of a joint.
11. The device as recited in claim 7, wherein, when the nail body is implanted, the shape memory material connecting member is movable between an unstretched position and a stretched position to generate a compressive force across bones of a joint.
As is evident from the table above, Patent claim 7 discloses all of the features of the claimed invention, except wherein the shape memory material connecting member is a Nitinol rod. While Patent claim 7 uses the term “nail body” instead of “sleeve” it is clear that the nail body is a sleeve, since it is described in Patent claim 7 as having a “cannulation”. In addition, while Patent claim 7 uses the terms “proximal interlocking” and “distal interlocking” instead of “first” and “second” to refer to the fixation bodies, it is clear that a proximal and distal refer to first and second fixation bodies. And, while Patent claim 7 uses the term “slidably” instead of “movably”, it is clear that the fixation bodies being slidably received means that they are movably received. And further, while Patent claim 7 uses the term “connecting member” instead of “rod”, it is clear that the connecting member is a rod, since both Patent claim 7 and application claim 1 recite that it includes a shaft.
Kinmon discloses an intramedullary nail (200), wherein the intramedullary nail includes a shape memory material connecting member(40), that is made of Nitinol (see para. [0058]) in order to make the connecting member out of a material that is biocompatible (see para. [0058]) and provide compression to the fusion or fracture site (see para. [0054]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shape memory material connecting member in Patent claim 7 to be made of Nitinol in view of Kinmon in order to make the connecting member out of a material that is biocompatible and provide compression to the fusion or fracture site.
Claim(s) 1, 5, 11-15 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2 of U.S. Patent No. 10,307,190 B2 in view of Gall et al. (U.S. Pub. No. 2011/0004212 A1, hereinafter “Gall”).
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. An arthrodesis device, comprising: a sleeve extending along a longitudinal axis between a proximal portion and a distal portion; a first fixation body movably received within the proximal portion of the sleeve; a second fixation body movably received within the distal portion of the sleeve; and a Nitinol rod including an elongated shaft extending between a first threaded portion that is configured to engage the first fixation body and a second threaded portion that is configured to engage the second fixation body.
1. An arthrodesis device for performing tibio-talo-calcaneal (TTC) joint fusions, comprising: a nail body extending along a longitudinal axis between a proximal portion and a distal portion; a proximal slider housed inside the proximal portion; a distal slider housed inside the distal portion; a Nitinol rod connected to both the proximal slider and the distal slider; a first opening located within the proximal portion of the nail body and configured to receive a tibial screw; a second opening located within the distal portion of the nail body and configured to receive a talar screw; a third opening located within the distal portion of the nail body and configured to receive a calcaneal screw, wherein at least one of the first opening, the second opening, and the third opening is an elongated slot; and a cable connected to the distal slider; wherein the cable is tensionable to move the distal slider inside the nail body and thereby stretch the Nitinol rod.
5. The arthrodesis device as recited in claim 1, comprising a tensioning cable received through a non-threaded opening of the second fixation body.
2. The device as recited in claim 1, wherein the cable is looped through a non-threaded opening of the distal slider.
11. An arthrodesis device, comprising: a sleeve; a first body located within the sleeve; a Nitinol rod removably connected to the first body; and a tensioning cable connected to the first body, wherein the tensioning cable is tensionable to move the first body inside the sleeve, thereby stretching the Nitinol rod, wherein the Nitinol rod is a separate component from either the first body or the sleeve.
12. The arthrodesis device as recited in claim 11, comprising a second body located within the sleeve.
13. The arthrodesis device as recited in claim 12, wherein the Nitinol rod is removably connected to the second body.
1. An arthrodesis device for performing tibio-talo-calcaneal (TTC) joint fusions, comprising: a nail body extending along a longitudinal axis between a proximal portion and a distal portion; a proximal slider housed inside the proximal portion; a distal slider housed inside the distal portion; a Nitinol rod connected to both the proximal slider and the distal slider; a first opening located within the proximal portion of the nail body and configured to receive a tibial screw; a second opening located within the distal portion of the nail body and configured to receive a talar screw; a third opening located within the distal portion of the nail body and configured to receive a calcaneal screw, wherein at least one of the first opening, the second opening, and the third opening is an elongated slot; and a cable connected to the distal slider; wherein the cable is tensionable to move the distal slider inside the nail body and thereby stretch the Nitinol rod.
15. The arthrodesis device as recited in claim 12, wherein the first body and the second body include different lengths.
6. The device as recited in claim 1, wherein the proximal slider includes a first length and the distal slider includes a second length greater than the first length.
As is evident from the table above, Patent claim 1 discloses all of the features of application claim 1, except wherein the Nitinol rod includes an elongated shaft extending between a first threaded portion that is configured to engage the first fixation body and a second threaded portion that is configured to engage the second fixation body; and regarding application claim 11, wherein the Nitinol rod is removably connected to the first body and wherein the Nitinol rod is a separate component from either the first body or the sleeve. While Patent claim 1 uses slightly different terms than application claim 1, for example: “nail body” instead of “sleeve”, “a proximal slider housed inside” instead of “first fixation body movably received within”, and “a distal slider housed inside” instead of “second fixation body movably received within”. It is clear that the nail body is a sleeve, since the nail body receives the sliders inside; and it is clear that the proximal and distal sliders are first and second fixation bodies movably received within, since they slide inside the nail body. In addition, while Patent claim 1 uses slightly different terms than application claim 5, e.g. “cable is tensionable” instead of “a tensioning cable”; however it is clear that a cable that is tensionable is a tensioning cable. And further, while Patent claim 1 uses slightly different terms than application claim 11, for example: “nail body” instead of sleeve, “distal slider housed inside the distal portion” instead of “first body located within the sleeve”; “proximal slider and the distal slider” instead of “second body located within the sleeve”; it is clear that the nail body is a sleeve, since it is clear that the nail body is a sleeve, since the nail body receives the sliders inside; and it is clear that the proximal and distal sliders are first and second fixation bodies are located within the sleeve, since they slide inside the nail body. In addition, while Patent claim 6 uses slightly different terms than application claim 15, for example: “proximal slider includes a first length and the distal slider includes a second length greater than the first length” instead of “first body and the second body include different lengths”; it is clear that the second body having a length greater than the first length means that the first and second bodies have different lengths.
Gall discloses an intramedullary device (200) with a first and second fixation body (202, 204), a sleeve (208, see para. [0039] “proximal anchor element 202 may be separated from the rigid element 208”) and a shape memory rod (206), wherein the fixation bodies are separate components from the shape memory rod and is removably connected from both the fixation bodies (via threads 214 and 215, see Fig. 2C), and wherein the shape memory rod includes an elongated shaft (218) extending between a first threaded portion (214) and second threaded portion (215); wherein the sleeve, the first fixation body, and the second fixation body are each comprised of a different material than the shape memory rod (see para. [0042]) in order to enable the shape memory rod to be removably connected and securely attached to the fixation bodies and to enable one of the components to rotate relative to the others (see para. [0056]) and in order to provide different materials with different properties adapted for holding a screw and interfacing with the bone rather than properties for contracting along an axis (see para. [0042]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Nitinol shaft in Kinmon to be separate from the fixation bodies and removably connected from the fixation bodies with a first threaded portion and a second threaded portion in view of Gall and to modify the sleeve and fixation bodies to be made of a different material than the Nitinol shaft in order to enable the Nitinol shaft to be removably connected and securely attached to the fixation bodies and to enable one of the components to rotate relative to the others and in order to provide different materials with different properties adapted for holding a screw and interfacing with the bone rather than properties for contracting along an axis.
Claim(s) 6-7 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2 of U.S. Patent No. 10,307,190 B2 in view of Gall, as applied to claims 1 and 5 above, and in further view of Songer et al. (U.S. Patent 5,536,270, hereinafter “Songer”).
Patent claim 1 in view of Gall discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 6, wherein the tensioning cable is a metallic cable; and regarding claim 7, wherein the tensioning cable is a stainless steel cable.
Songer discloses a tensioning cable (42) to be made of metallic / stainless steel (see lines 55-66 of column 4) in order to provide a tensioning cable configuration that is very flexible and strong (see lines 55-66 of column 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tensioning cable in Patent claim 1 in view of Gall to be made of metallic / stainless steel cable in further view of Songer in order to provide a tensioning cable configuration that is very flexible and strong.
Claim(s) 11-12, 16, 18 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 18-19 of U.S. Patent No. 12,004,787 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
11. An arthrodesis device, comprising: a sleeve; a first body located within the sleeve; a Nitinol rod removably connected to the first body; and a tensioning cable connected to the first body, wherein the tensioning cable is tensionable to move the first body inside the sleeve, thereby stretching the Nitinol rod, wherein the Nitinol rod is a separate component from either the first body or the sleeve.
12. The arthrodesis device as recited in claim 11, comprising a second body located within the sleeve.
18. An arthrodesis device, comprising: a sleeve; a first body located within the sleeve; a second body located within the sleeve; a Nitinol rod removably connected to both the first body and the second body; and a tensioning cable connected to the first body or the second body, wherein the tensioning cable is tensionable to move the first body or the second body inside the sleeve, thereby stretching the Nitinol rod, wherein the Nitinol rod is a separate component from either the first body or the second body.
16. The arthrodesis device as recited in claim 11, wherein the tensioning cable is received through a non-threaded opening of the first body, and the Nitinol rod includes a threaded portion that is removably connected to a threaded opening of the first body.
19. The arthrodesis device as recited in claim 18, wherein the tensioning cable is received through a non-threaded opening of the first body or the second body, and the Nitinol rod includes a threaded portion that is removably connected to a threaded opening of the first body or the second body.
18. The arthrodesis device as recited in claim 16, wherein the threaded opening extends along a first axis, and the non-threaded opening extends along a second axis that is transverse to the first axis.
20. The arthrodesis device as recited in claim 19, wherein the threaded opening extends along a first axis and the non-threaded opening extends along a second axis that is transverse to the first axis.
As is evident from the table above, Patent claim 1 discloses all of the required limitations of application claim 11. It is noted that since Patent claim 1 discloses “Nitinol rod is a separate component from either the first body or”, as required by application claim 1, it is not necessary that it includes the limitation or “the sleeve”, since this limitation is optional.
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) 1-4, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kinmon (U.S. Pub. No. 2012/0130370 A1, hereinafter “Kinmon”) in view of Gall et al. (U.S. Pub. No. 2011/0004212 A1, hereinafter “Gall”).
Kinmon discloses, regarding claim 1, an arthrodesis device (10, see Fig. 16), comprising: a sleeve (11, see annotated Fig. 16 below) extending along a longitudinal axis (see annotated Fig. 16 below) between a proximal portion (see annotated Fig. 16 below) and a distal portion (see annotated Fig. 16 below); a first fixation body (45) movably received within the proximal portion of the sleeve (See Fig.16, note 45 is movable within sleeve 11 along aperture 30, see para. [0054); a second fixation body (46) movably received within the distal portion of the sleeve (see Fig. 16, note that 46 is movable within sleeve 11 prior to inserting the fastener into opening 20); and a Nitinol rod (44, see para. [0058] “nitinol”).
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Regarding claim 2, wherein the sleeve includes at least one opening (20, 22 or 30) configured to receive a fixation device (“fastener”, see para. [0053]).
Regarding claim 3, wherein a first opening (30) is located within the proximal portion of the sleeve (see annotated Fig. 16 above) and is configured to receive a tibial screw (see annotated Fig. 16 above), a second opening (20) is located within the distal portion of the sleeve (see annotated Fig. 16 above) and is configured to receive a talar screw (see annotated Fig. 16 above), and a third opening (22) is located within the distal portion of the sleeve (see annotated Fig. 16 above) and is configured to receive a calcaneal screw (see annotated Fig. 16 above).
Regarding claim 4, wherein the Nitinol rod is configured to move between an unstretched position and a stretched position to generate a compressive force across bones of a joint (see Fig. 16, see para. [0069]).
Kinmon fails to explicitly disclose, regarding claim 1, wherein the Nitinol rod includes an elongated shaft extending between a first threaded portion that is configured to engage the first fixation body and a second threaded portion that is configured to engage the second fixation body; regarding claim 8, wherein the sleeve, the first fixation body, and the second fixation body are each comprised of a different material than the Nitinol rod.
Gall discloses an intramedullary device (200) with a first and second fixation body (202, 204), a sleeve (208, see para. [0039] “proximal anchor element 202 may be separated from the rigid element 208”) and a shape memory rod (206), wherein the fixation bodies are separate components from the shape memory rod and is removably connected from both the fixation bodies (via threads 214 and 215, see Fig. 2C), and wherein the shape memory rod includes an elongated shaft (218) extending between a first threaded portion (214) and second threaded portion (215); wherein the sleeve, the first fixation body, and the second fixation body are each comprised of a different material than the shape memory rod (see para. [0042]) in order to enable the shape memory rod to be removably connected and securely attached to the fixation bodies and to enable one of the components to rotate relative to the others (see para. [0056]) and in order to provide different materials with different properties adapted for holding a screw and interfacing with the bone rather than properties for contracting along an axis (see para. [0042]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Nitinol shaft in Kinmon to be separate from the fixation bodies and removably connected from the fixation bodies with a first threaded portion and a second threaded portion in view of Gall and to modify the sleeve and fixation bodies to be made of a different material than the Nitinol shaft in order to enable the Nitinol shaft to be removably connected and securely attached to the fixation bodies and to enable one of the components to rotate relative to the others and in order to provide different materials with different properties adapted for holding a screw and interfacing with the bone rather than properties for contracting along an axis.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kinmon in view of Gall, as applied to claim 1 above, and in further view of Brigido et al. (U.S. Pub. No. 2010/0010490 A1, hereinafter “Brigido”).
Kinmon in view of Gall discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 9, wherein the sleeve, the first fixation body, and the second fixation body are comprised of a titanium alloy.
Brigido discloses an intramedullary nail (12, see Fig. 4B) that is comprised of a proximal section (14) and distal section (16) that apply compression across the tibio-talo-calcaneal joint (see Fig. 4B), wherein the proximal and distal sections of the intramedullary nail are disclosed as being made of titanium (see para. [0039]) in order to provide a material that is biocompatible, lightweight and capable of withstanding compressive forces being applied across the joint.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sleeve, first and second fixation bodies in Kinmon in view of Gall to be made of titanium in further view of Brigido in order to provide a material that is biocompatible, lightweight, and capable of withstanding compressive forces being applied across the joint.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kinmon in view of Gall, as applied to claim 1 above, and in further view of Palmer et al. (U.S. Pub. No. 2015/0230843 A1, hereinafter “Palmer”).
Kinmon in view of Gall discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 10, wherein the Nitinol rod includes between about 15% and about 55% cold work to control a recovery force of the Nitinol rod.
Palmer discloses a nitinol compression device (4005, see para. [0375]), wherein the nitinol includes between about 15% and about 55% cold work to control a recovery force of the Nitinol rod (see para. [0375]) in order to provide an optimal range for achieving the desired compression force on the bone (see para. [0375] , note “percentage of cold work in the shape memory material … affects the compressive force generated”).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Nitinol rod in Kinmon in view of Gall to include between about 15% and about 55% cold work to control a recovery force in further view of Palmer in order to provide an optimal range for achieving the desired compression force on the bone.
Claim(s) 11-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gall et al. (U.S. Pub. No. 2011/0004212 A1, hereinafter “Gall”) in view of Kinmon (U.S. Pub. No. 2012/0130370 A1, hereinafter “Kinmon”) and in view of Gorsline et al. (U.S. Pub. No. 2011/0228845 A1, hereinafter “Gorsline”).
Gall discloses, regarding claim 11, an arthrodesis device (200, see Figs. 2A-B), comprising: a sleeve (208); a first body (204) located within the sleeve (see Fig. 2A); a rod (206, see paras. [0046] and [0029]) removably connected to the first body (via threaded portion 215, see Fig. 2C and para. [0049]); and wherein the rod is a separate component from either the first body or the sleeve (see Figs. 2A and 2C, note that 206 is removably connected to first body 204 e.g. separate, in addition note that 206 is separate from sleeve 208).
Regarding claim 12, comprising a second body (202) located within the sleeve (see Fig. 2A, see para. [0039] “proximal anchor element 202 may be separated from the rigid element 208” and para. [0043] “proximal anchor element 202 attached to a rigid element 208”).
Regarding claim 13, wherein the rod is removably connected to the second body (via threads 214, see Fig. 2C and para. [0049]).
Regarding claim 14, wherein the first body and the second body are comprised of a different material than the rod (see para. [0042]).
Regarding claim 15, wherein the first body and the second body include different lengths (see Fig. 2A, note that the lengths taken perpendicular to the longitudinal axis are different).
Regarding claim 19, wherein a portion of the rod is connected to the sleeve (see Fig. 2A, see para. [0039] “proximal anchor element may be formed with the rigid element as a single piece of material”).
Gall further discloses that the rod (206) is formed of a shape memory alloy (see para. [0046] “SMA”) that is tensioned to move the first body inside the sleeve apply a compressive load across bones of the joint (see paras. [0032] and [0040]); however fails to explicitly disclose regarding claim 11, wherein the rod is a Nitinol rod; and a tensioning cable connected to the first body, wherein the tensioning cable is tensionable to move the first body inside the sleeve, thereby stretching the rod.
Kinmon discloses an intramedullary nail (200), wherein the intramedullary nail includes a shape memory material connecting member(40), that is made of Nitinol (see para. [0058]) in order to make the connecting member out of a material that is biocompatible (see para. [0058]) and provide compression to the fusion or fracture site (see para. [0054]).
Gorsline discloses a cable (224, see Fig. 13) that is attached to a distal member (226 in 206) in an intramedullary nail (202) in order to provide a device that can extend from and be removably attached to the distal member for allowing engagement with a tensioning device to impart tension (see para. [0009]) / temporary compression and/ or support of any of various bone elements (see para. [0055]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shape memory alloy rod in Gall to be made of Nitinol in view of Kinmon in order to make the connecting member out of a material that is biocompatible and provide compression to the fusion or fracture site. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first body in Gall to include a tensioning cable in view of Gorsline in order to provide a device that can extend from and be removably attached to the distal member for allowing engagement with a tensioning device to impart tension / temporary compression and/ or support of any of various bone elements.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gall in view of Kinmon and in view of Gorsline, as applied to claim 11 above, and in further view of Songer et al. (U.S. Patent 5,536,270, hereinafter “Songer”).
Gall in view of Kinmon and in view of Gorsline discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 20, wherein the tensioning cable is a stainless steel cable.
Songer discloses a tensioning cable (42) to be made of stainless steel (see lines 55-66 of column 4) in order to provide a tensioning cable configuration that is very flexible and strong (see lines 55-66 of column 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tensioning cable in Gall in view of Kinmon and in view of Gorsline to be made of stainless steel cable in further view of Songer in order to provide a tensioning cable configuration that is very flexible and strong.
Allowable Subject Matter
Claim(s) 17 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim(s) 5-7 and 16, 18 would be allowable if a terminal disclaimer is filed to overcome the Nonstatutory Double Patenting Rejection, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof could be found which disclose, or suggest:
An arthrodesis device, comprising: a sleeve; a first fixation body movably received within the proximal portion of the sleeve; a second fixation body movably received within the distal portion of the sleeve; and a Nitinol rod including a first threaded portion that is configured to engage the first fixation body and a second threaded portion that is configured to engage the second fixation body; and as per claim 5, a tensioning cable received through a non-threaded opening of the second fixation body.
An arthrodesis device, comprising: a sleeve; a first body; a Nitinol rod removably connected to the first body; and a tensioning cable connected to the first body,
wherein the Nitinol rod is a separate component from either the first body or the sleeve; and as per claim 16, wherein the tensioning cable is received through a non-threaded opening of the first body, and the Nitinol rod includes a threaded portion that is removably connected to a threaded opening of the first body; and as per claim 17 wherein the non-threaded opening is a distal most opening of the first body.
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 intramedullary compression nails:
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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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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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