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 .
Terminal Disclaimer
The terminal disclaimers filed on 8/5/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 10,307,190 and 12,004,787 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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, 22 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]).
Regarding claim 22, wherein the elongated shaft of the Nitinol rod includes a constant cross-sectional area along its length (see Fig. 16, note cross-sectional area is constant).
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 and 21 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; and regarding claim 21, wherein the Nitinol rod has an austenite finish temperature of greater than about 10° C., such that a temperature differential between the Nitinol rod and a human body in which the arthrodesis device is implanted is less than about 47° C.
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”). Palmer further discloses that austenite finish temperature and the temperature differential between the body and the nitinol compression device are result effective variables, e.g. a smaller temperature differential between the two results in a nitinol compression device that generates a small compressive force, while a larger temperature differential between the two results in the nitinol compression device that generates a larger compressive load (see para. [0345]).
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. And 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 have an austenite finish temperature of greater than about 10° C., such that a temperature differential between the Nitinol rod and a human body in which the arthrodesis device is implanted is less than about 47° C, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 11-12, 14 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. 2014/0228845 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”), and 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]) and further 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) 5-7 is/are allowed.
Claim(s) 16-18 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.
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.
Response to Arguments
Applicant's arguments filed 8/5/2026 have been fully considered but they are not persuasive.
Regarding the rejection of claims 1-4 and 8 under 35 U.S.C. § 103 as allegedly obvious over Kinmon (US 2012/0130370) in view of Gall (US 2011/0004212):
The Applicant asserts that Kinmon does not disclose a "first fixation body" and a "second fixation body" that are structurally separate and distinct from the recited nitinol rod (see Bullet Point A on pages 7-8). The Applicant asserts that claim 1 recites four structurally distinct elements: (i) a sleeve, (ii) "a first fixation body movably received within the proximal portion of the sleeve," (iii) "a second fixation body movably received within the distal portion of the sleeve," and (iv) "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.", and thus requires the Nitinol rod to be a component separate from, and threadedly connected to, two independently existing fixation bodies. The Applicant asserts that elements 45 and 46 in Kinmon are not described as being separate components from the compression member 44, but rather as the two ends of the single, unitary compression member 44 itself (see para. [0065]). The Applicant asserts that Kinmon does not disclose the recited threaded engagement (see Bullet Point B on pages 8-9). The Applicant asserts that claim 1 further requires the Nitinol rod to include "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 that the compression member 44 of Kinmon has no threaded engagement portion and that the apertures 47, 48 of the compression members through which a fastener passes are through a through-hole is not a threaded engagement. The Applicant further asserts Gall fails to remedy Kinmon's deficiencies (see Bullet Point D on pages 10-11). The Applicant asserts that the Examiner relies on Gall solely for the proposition that it would have been obvious to modify Kinmon's compression member 44 to include threaded portions removably connected to the fixation bodies, "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." This stated rationale is drawn directly from Gall's own disclosure, and it is insufficient to establish a prima facie case of obviousness. The Applicant asserts that in Gall, the threaded connection at issue is not a passive attachment feature; rather, it is the very mechanism by which Gall's device generates compression. Gall's contracting element 206 includes a first thread 214 and a second, oppositely-handed thread 215, and Gall discloses that the surgeon turns the contracting element "like a tie-rod" so that rotation simultaneously advances both threaded ends into the proximal anchor element and the distal anchor element, thereby drawing the two anchors toward one another during assembly. Compression in such an
embodiment is generated by this rotational, turnbuckle-style threading action, not solely by post- assembly superelastic recovery of a previously stretched element. Since Kinmon's device generates compression by an entirely different mechanism: the compression element 44 is stretched after the fixation devices are already fixed in bone, and compression arises later from recovery of the stretched element, with no rotation of the rod relative to the fixation bodies contemplated or required. The Examiner's own articulated rationale for combining Gall with Kinmon - "to enable one of the components to rotate relative to the others" - identifies a function that has no benefit within Kinmon's system. Under MPEP § 2143.01, the mere fact that two references can be physically combined does not establish obviousness; there must be some articulated reasoning with rational underpinning for the combination. Where, as here, the very reason given for extracting a feature from one reference (Gall) does not correspond to any function or need in the base reference (Kinmon), the stated rationale does not supply the requisite reasoned basis for the combination, and the combination amounts to impermissible hindsight reconstruction using the claims as a roadmap.
The Office respectfully disagrees. In response to Applicant's piecemeal analysis of the references, one cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references. As set forth above, Kinmon discloses a first fixation body (45) a second fixation body (46) and a nitinol rod (44). It is noted that the mere fact that a given structure is integral does not preclude its consisting of various elements. Nerwing v. Erlichman, 168 USPQ 177, 179 (PTO Bd. Of Int. 1969). And further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first fixation body, second fixation body and nitinol rod to be separate, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179. As set forth above, Gall is relied upon to teach modifying the nitinol rod in Kinmon to include 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 e.g. be separate. Regarding the Applicant’s argument that the threaded connection in Gall is not a passive attachment feature, but rather the way to generate compression based on the disclosure in para. [0054]), the disclosure of threading the proximal thread and distal thread of the contracting element 206 describes that rotation drives the distal anchor closer to the proximal anchor e.g. the threads of the contracting element are being threaded into the threaded openings of the proximal and distal anchor and as more and more thread is fed into the threaded openings that the distance between the proximal and distal anchors shrinks from the partially assembled starting length to the fully assembled finished length, which appears to be a description of how threaded engagement works to assemble the components. Further Gall discloses in paragraph [0040] that the contracting element may be strained e.g. stretched toward open end 210 through sliding of the distal anchor to create loading, not via the threaded attachment, e.g. stretched / loaded not during the threaded assembly. In addition, paragraph [0040] discloses that the contracting element may be manufactured from a single piece of material with the distal anchor, similar to the nitinol rod and proximal and distal anchors in Kinmon, therefore it is evident that the threaded connection is not required to create loading on the contracting element. Regarding the Applicant’s assertion that the rationale for modifying Kinmon in view of Gall has no benefit within Kinmon's system, the stated rationale does not supply the requisite reasoned basis for the combination, and the combination amounts to impermissible hindsight reconstruction using the claims as a roadmap; it must be recognized that any judgement on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392; 170 USPQ 209 (CCPA 1971). Threaded connections and making a formerly integral structure in various elements involves only routine skill in the art and takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, as evidenced by Gall. In addition, as set forth above, making the proximal and distal anchors separate of the contracting element provides the benefit of enabling the each to be made of a separate material selected for different properties e.g. holding a screw for the proximal and distal anchors and contracting along an axis for the contracting member (see para. [0042]), which would be beneficial to the nitinol rod and first and second fixation bodies in Kinmon, in addition to enabling them to be removably connected and securely attached and to rotate relative to the others.
The Applicant further asserts that Kinmon teaches away from using a shape-memory nitinol element as the compression-generating mechanism (see Bullet Point C on pages 9-10). The Applicant asserts that in Kinmon's paragraph [0058], which lists "nitinol or other memory metal" among a group of possible materials ("stainless steel, nitinol or other memory metal, titanium, biodur, etc.") from which any of Kinmon's disclosed compression member shapes (a compression spring, extension spring, torsional spring, Belleville washer, or elastic band) could optionally be constructed. However, this material list must be read in light of Kinmon's own express teaching regarding shape-memory materials. For example, Kinmon's Background of the Invention states: Nitinol or memory metal nails have been described, but memory metal is also complicated in many cases, requiring the device to be delivered to the OR frozen, or heated with special machinery during implantation in order to activate the compression mechanism. Also, in order for a memory metal nail to compress, it would require that it also expand in thickness or diameter, which is not desirable in this application. Kinmon at paragraph [0012]. This passage is not incidental. Rather, it represents Kinmon's own stated reasons for departing from shape-memory-based compression devices in favor of the mechanical spring-based compression members 40, 44 that form the entire inventive contribution of Kinmon's device. Kinmon's compression mechanism works by ordinary elastic deflection of a spring shape under axial load (see paragraph [0057]), not by stress-induced martensitic phase transformation and superelastic recovery of a stretched Nitinol element, which is the mechanism recited in claim 1 and which Kinmon expressly disparages as complicated and undesirable. A person of ordinary skill in the art, reading Kinmon as a whole, would not have been motivated to construct Kinmon's compression member 44 from Nitinol in the superelastic, stress-recovery sense required by claim 1, because Kinmon itself identifies exactly that class of device as presenting the problems its invention is designed to avoid. The isolated word "nitinol" in a list of generic spring materials in paragraph [0058] cannot be read in isolation to disclose or render obvious the claimed Nitinol rod when Kinmon's own Background of the Invention teaches away from shape-memory-based compression.
The Office respectfully disagrees. Kinmon explicitly discloses that the compression member within the nail body can be made of nitinol or other memory metal (see para. [0058]). In response to applicant’s argument that “Kinmon's paragraph [0058], which lists "nitinol or other memory metal" among a group of possible materials ("stainless steel, nitinol or other memory metal, titanium, biodur, etc.") from which any of Kinmon's disclosed compression member shapes (a compression spring, extension spring, torsional spring, Belleville washer, or elastic band) could optionally be constructed”, it is noted that all of the disclosures in a reference must be evaluated for what they fairly teach one of ordinary skill in the art. In re Boe, 148 USPQ 507 (CCPA 1966); In re Smith, 32 CCPA 959, 148 F. d. 351, 65 USPQ 167; In re Nehrenberg, 47 CCPA 1159, 280 F.2d 161, 126 USPQ 383; and In re Watanable, 50 CCPA 1175, 315 F.2d 924, 137 USPQ 350. In response to the applicant’s argument that the Kinmon's Background of the Invention (para. [0012]) teaches away from the compression member being made of nitinol. The background of the invention describes a Nitinol nail (see para. [0012]), not a nitinol compression member which is described in paragraph [0058] and therefore does not teach away from the compression member being made of nitinol, especially since the detailed description of the invention of Kinmon explicitly discloses that the compression member within the nail body can be made of nitinol or other memory metal (see para. [0058]).
Regarding the rejection of claims 11-15 and 19 are rejected under 35 U.S.C. § 103 as allegedly obvious over Gall (US 2011/0004212) in view of Kinmon (US 2012/0130370) and further in view of Gorsline (US 2011/0228845):
The Applicant asserts that Kinmon is relied upon solely to supply "Nitinol," and the same teaching-away problem thus applies with equal force (see Bullet Point A on Page 12). The Applicant asserts that Kinmon (again citing para. [0058]) reference to "nitinol or other memory metal" is one option in a generic materials list for a mechanical spring, offered against the backdrop of Kinmon's express statement at paragraph [0012] that shape-memory/memory-metal compression mechanisms are undesirably complicated and were deliberately avoided in Kinmon's design. For the same reasons set forth above, a person of ordinary skill would not have looked to Kinmon for a teaching that its own Background of the Invention disparages, and Kinmon does not supply a proper basis for modifying Gall's shape memory alloy rod to be made of Nitinol within the meaning of claim 11.
The Office respectfully disagrees. Kinmon explicitly discloses that the compression member within the nail body can be made of nitinol or other memory metal (see para. [0058]). In response to the applicant’s argument that the Kinmon's Background of the Invention (para. [0012]) teaches away from the compression member being made of nitinol. The background of the invention describes a Nitinol nail (see para. [0012]), not a nitinol compression member which is described in paragraph [0058] and therefore does not teach away from the compression member being made of nitinol. And, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the rod in Gall that is formed of a shape memory alloy to be formed of Nitinol, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Nitinol is a well-known shape memory alloy that is both biocompatible and suitable for contracting along an axis, e.g. suitable for the intended use.
The Applicant asserts that Gorsline is directed to a different purpose and fails to cure the Gall/Kinmon deficiency (see Bullet Point B on pages 12-13). The Applicant asserts that the cable 224 of Gorsline and its attachment to distal member (226), citing Gorsline's disclosure that the cable "provide[s] a device that can extend from and be
removably attached to the distal member for allowing engagement with a tensioning device to impart tension." This general-purpose disclosure of a cable usable for temporary compression or support is not directed to, and does not supply any teaching regarding, the specific combination of a superelastic Nitinol rod stretched by a tensioning cable to generate sustained post-recovery compression, which is the mechanism actually recited in claim 11, as opposed to Kinmon's patent disclosure, which affirmatively avoids shape-memory materials. Gorsline therefore does not remedy the deficiency in the Kinmon citation, and the combination of Gall, Kinmon, and Gorsline fails to render claim 11 obvious.
The Office respectfully disagrees. Gall discloses in paragraph [0040] that the contracting element e.g. shape memory rod may be strained e.g. stretched toward open end 210 through sliding of the distal anchor to create loading and generate sustained post-recovery compression (see para. [0062]). While Gorsline fails to disclose a contracting element that generates sustained post-recovery compression, Gorsline discloses a cable (224, see Fig. 13) that is attached to a distal anchor (226 in 206) in an intramedullary nail (202) to create loading (see para. [0055]) and is therefore relevant to Gall and Kinmon by providing a suitable means to engage the distal anchor and stretch it toward the open end of the nail to create the loading required to compress joints for fusion.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/M.C.G/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
