DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 January 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 09 January 2026. As directed by the amendment: Claims 1, 8, 9, 12, 15-17, and 20 have been amended. Claims 1-20 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn. However, further claim objections as necessitated by the current amendments are presented below.
Response to Arguments
Applicant’s arguments with respect to the rejections under pre-AIA 35 U.S.C. 102(b) and pre-AIA 35 U.S.C. 103(a) have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 09 January 2026 with respect to the rejections of claims 8 and 15 under pre-AIA 35 U.S.C. 103(a), have been fully considered but they are not persuasive. Applicant's arguments 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 1-7, 14, 16, and 17 are objected to because of the following informalities: grammar and punctuation. Appropriate correction is required. The following amendments are suggested:
Claim 1, lines 2-5:
“a first wedging member;
a second wedging member;
a body portion including of the body portion and surrounding the first wedging member, wherein the first wedging member and the second wedging member are movable relative to the top wall and within the body portion;”
Claim 1 / line 12: “the second wing is configured to be adjustable by a user;”
Claim 5 / line 3: “the movable clamp member is adjusted by”
Claim 14 / lines 3-4: “the movable clamp member is adjusted by”
Claim 16 / line 2: “of the first wedging member”
Claim 17 / line 5: “the
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by U.S. Patent Application Publication No. US 2008/0312741 to Lee et al. (hereinafter, “Lee”).
As to claim 1, Lee discloses an adjustable implant (200), shown in FIGS. 1, 2, 8, 11, and 17, comprising: a body portion (210) including a first wedging member (700) (¶85), shown in FIG. 8, a second wedging member (900), and a top wall (wall formed by upward facing surfaces of the body portion, including top surfaces of 240, 440, 460, and the second end), the top wall extending from a first end (end at 220 including portion to the right of 440 in FIG. 1) to a second end (end at 230 including portion to the left of 440 in FIG. 1) (¶80, 86) and surrounding the first wedging member (at least around its edges), FIG. 1, wherein the first wedging member and the second wedging member are movable relative to the top wall and within the body portion (¶74-78, 94), shown in FIGS. 1, 6-8, 15, and 18; a hook (bent hook-shape side of 700 along the posterior side of the first wedging member 700, including 800 and the overhanging portion of 700 over 800, FIGS. 6 and 8) integrally coupled with one of the first wedging member (integrally coupled with the first wedging member as an integral part of the first wedging member) or the second wedging member, the hook including a first hook portion (overhanging portion of 700 over 800) extending from the body portion (extends superiorly away from the body portion at 440) and a second hook portion (800) extending from the first hook portion in an inferior direction away from the top wall, FIG. 6; a first wing (1800) coupled to the body portion (integrally coupled, ¶101), FIG. 1; and a second wing (2000) coupled to the body portion such that a distance between the first wing and the second wing is adjustable by a user (¶101), shown in FIGS. 17-18, wherein the hook includes an L-shaped portion defined by the first hook portion and the second hook portion, FIG. 6, such that the first hook portion and the second hook portion form approximately a 90 degree angle, FIG. 6.
As to claim 2, Lee discloses the adjustable implant of claim 1, wherein the second end includes a bull nose, FIG. 1.
As to claim 3, Lee discloses the adjustable implant of claim 1, wherein the first hook portion is thicker than the second hook portion (where thickness is measured in the anterior-posterior direction).
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.
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. US 2008/0312741 to Lee et al. (hereinafter, “Lee”), in view of U.S. Patent Application Publication No. US 2011/0144692 to Saladin et al. (hereinafter, “Saladin).
As to claim 8, Lee discloses an adjustable implant (200), shown in FIGS. 1, 2, 8, 11, and 17, comprising: a body portion (210) including a sidewall (walls formed by outer sides including at 440, 460, and the first and second ends of the body portion) extending from a first end (end at 220 including portion to the right of 440 in FIG. 1) to a second end (end at 230 including portion to the left of 440 in FIG. 1) (¶80, 86), the sidewall having an aperture (590) extending through the sidewall, FIG. 11; a first wedging member (700) movable relative to the sidewall, the first wedging member including a first longitudinal side (posterior side/edge of 740), a second longitudinal side (anterior side/edge of 740) opposite the first longitudinal side, a first wedging member surface (740) between the first and second longitudinal sides, a first panel (800) extending from the first longitudinal side (¶85), shown in FIG. 8, and a pair of spaced apart second panels (770, 780) extending from the second longitudinal side (¶91), shown in FIG. 8; and a second wedging member (900) movable relative to the sidewall (¶74-78, 94), shown in FIGS. 1, 6-8, 15, and 18, the second wedging member including a third longitudinal side (anterior side/edge of 940), a fourth longitudinal side (posterior side/edge of 940) opposite the third longitudinal side, a second wedging member surface (940) between the third and fourth longitudinal sides, a third panel (1000) extending from the third longitudinal side (¶85), shown in FIG. 8, and a pair of spaced apart fourth panels (970, 990) extending from the fourth longitudinal side (¶91), shown in FIG. 8, and wherein the first and second wedging members are movable between a collapsed position (FIG. 14) and a position of maximum expansion (position slightly expanded from the collapsed position; fully capable of being a position of maximum expansion based on the patient needs, i.e. the maximum expansion required for the particular surgery), and wherein (i) the first panel maintains direct engagement with the pair of fourth panels (an outer facing surface of the first panel maintains direct engagement with inward facing surfaces of the fourth panels, FIG. 6) and (ii) the third panel maintains direct engagement with the pair of second panels (an outer facing surface of the third panel maintains direct engagement with inward facing surfaces of the second panels, FIG. 6) as the first wedging member and the second wedging member move between the collapsed position and the position of maximum expansion (the respective adjacent outer facing and inward facing surfaces maintain direct engagement as the wedging members move from the collapsed position in FIG. 6 to a position slightly expanded from the collapsed position and in which the surfaces maintain direct engagement, which position can be interpreted as the position of maximum expansion because, depending on the particular patient’s needs, the wedging members may need be expanded only this distance; alternatively, the outer facing and inward facing surfaces maintain direct engagement as the wedging members move from the collapsed position in FIG. 6 to a position slightly expanded from the collapsed position and in which the outer facing and inward facing surfaces maintain direct engagement, which meets the limitation that the surfaces maintain direct engagement as the wedging members move somewhere in the range of movement between the collapsed position and the position of maximum expansion, since the claim does not require that the surfaces maintain direct engagement throughout the entire range of movement), FIG. 6.
Lee is silent as to wherein (i) the first panel is disposed between the pair of fourth panels and (ii) the third panel is disposed between the pair of second panels as the first wedging member and the second wedging member move between the collapsed position and the position of maximum expansion.
Saladin teaches that telescoping parts (345, 335) can be engaged together via a first panel (347) positioned between and adjacent a pair of panels (sides of 335 that receive 347) (¶93), shown in FIG. 7, to guide telescoping movement in a secure way without adding bulk to the device.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to modify Lee’s first and second wedging members such that the first or third panel of each wedging member is positioned between and adjacent the pair of fourth or second panels, respectively, to provide guided telescoping movement between the first and second wedging members in a secure way, helping to reduce possible torqueing or twisting of the wedging members by telescopically engaging them with each other, as taught by Saladin. To modify Lee in view of Saladin, the first and second wedging members would be modified so that the first panel (800) of the first wedging member is nested between portions of the wall (920) of the second wedging member, by reducing the width of the first panel and providing the wall of the second wedging member in the same plane as the first panel and as a pair of fourth panels that slide on either side of the reduced width first panel, therefore providing the telescoping movement taught by Saladin to reduce torqueing or twisting of the wedging members since both sides of the wedging members are disposed inside of the body portion sidewalls. Similarly, the third panel (1000) of the second wedging member would be nested between portions of the wall (720) of the first wedging member, by reducing the width of the third panel and providing the wall of the first wedging member in the same plane as the third panel and as a pair of second panels that slide on either side of the reduced width third panel. By providing each side of each wedging member as a sliding portion within the body portion sidewalls, with the adjacent panels engaged along their respective sides, the alignment of the wedging members is maintained within the sidewall from collapsed to expanded.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee in view of Saladin (hereinafter, “Lee/Saladin”), as applied to claim 8 above, and further in view of U.S. Patent No. 4,057,924 to Joseph.
As to claim 9, Lee/Saladin disclose wherein the body portion further comprises a top wall (wall formed by upward facing surfaces of the body portion, including top surfaces of 240, 440, 460, and the second end) surrounding the first wedging member, FIGS. 1 and 8, the top wall having an aperture (aperture between 440 and 460) extending into the top wall, and wherein the adjustable implant further comprises: a control shaft (1200) received within the body portion and operably coupled to the first wedging member and the second wedging member (¶85).
Lee/Saladin are silent as to wherein the control shaft is configured to couple a retention member received within the aperture of the top wall to retain the control shaft within the body portion.
Joseph teaches a body portion (8) including a wall having an aperture (44) extending into the wall, FIG. 4, a control shaft (14) received within the body portion, FIG. 2, wherein the control shaft is configured to couple a retention member (40) received within the aperture of the wall to retain the control shaft within the body portion (col. 2 / line 64 – col. 3 / line 3).
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to include in Lee a retention member (a retaining pin) that is received through the body portion to retain the control shaft within the body portion, as taught by Joseph, thereby allowing rotation of the control shaft as required by Lee, while preventing the undesired backout of the control shaft out of the body portion and out of engagement with the wedging members. As taught by Joseph, the control shaft in Lee would be correspondingly modified to have a reduced diameter portion between the tip of the control shaft and the threaded portion of the control shaft, such that the retention member/retaining pin can be positioned under the shoulder of the tip to limit translational movement of the control shaft out of the bore (Lee, 580, ¶87) while remaining rotatively seated in the bore as required by Lee. The body portion in Lee would be correspondingly modified to have an aperture extending into a wall of the body portion, as taught by the aperture in Joseph, to receive the retention member/retaining pin therethrough. Accordingly, the aperture would be positioned in the wall of the body portion so that the retention member/retaining pin extending therethrough would align with the reduced diameter portion on the control shaft so that the retention member/retaining pin is positioned under the shoulder of the tip.
It further would have been obvious to a person having ordinary skill in the art at the time of invention to position the aperture in the top wall of Lee’s body portion, in the section of the top wall at the second end, adjacent the bore (Lee, 580), so as not to interfere with the threaded bore (590) on the sidewall for attaching a wing, and since the top wall is easily accessible.
Claims 10, 11, 13, and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee in view of Saladin (hereinafter, “Lee/Saladin”), as applied to claim 8 above, and further in view of U.S. Patent Application Publication No. US 2009/0018662 to Pasquet et al. (hereinafter, “Pasquet”).
Lee/Saladin are silent as to a hook portion coupled to the body portion, wherein the hook portion includes at least one bend, and wherein the hook portion includes a first end coupled to the body portion and a second end opposite the first end of the hook portion (claim 10); wherein the first end of the hook portion is selectively coupled to the body portion (claim 11); further comprising a movable clamp member coupled to the hook portion, wherein the movable clamp member includes a first end and a second end opposite the first end of the movable clamp member (claim 13); wherein the first end of the movable clamp member is rotatably coupled to the hook portion, such that a distance between the second end of the hook portion and the second end of the movable clamp member may be adjusted by rotating the movable clamp member (claim 14).
Pasquet teaches an adjustable implant, shown in FIG. 9, in the same field of endeavor of intervertebral implants, comprising a body portion (20) (¶59); a hook portion (21) coupled to the body portion (¶48), wherein the hook portion includes at least one bend, and wherein the hook portion includes a first end coupled to the body portion and a second end opposite the first end of the hook portion, shown for exemplary purposes in the embodiment of FIG. 5; a first wing (superior projection on one side of groove 30), shown for exemplary purposes in the embodiment of FIG. 3 (¶35; same body portion 20 for both embodiments); and a second wing (superior projection on other side of groove 30) (¶38), shown in FIG. 9; wherein the first end of the hook portion is selectively coupled to the body portion (the first end is integrally coupled to the body portion at a selected or suitable location); further comprising a movable clamp member (50) coupled to the hook portion (¶60), FIG. 9, wherein the movable clamp member includes a first end and a second end opposite the first end of the movable clamp member; wherein the first end of the movable clamp member is rotatably coupled to the hook portion (the ends of the movable clamp member are rotatably coupled to the hook portion because each end can rotate about the hook portion, i.e. so that the movable clamp member is more or less angled with the hook portion at the center of rotation), such that a distance between the second end of the hook portion and the second end of the movable clamp member may be adjusted by rotating the movable clamp member (the second end of the movable clamp member can be rotated relative to the hook portion so that the second end is closer or further from the second end of the hook portion which extends upwardly).
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide implant of Lee/Saladin/Dietz/Rhoda with a hook portion and a movable clamp member, as taught by Pasquet, to exert return forces on the body portion (Lee, 210) directed toward the vertebra to prevent the body portion from escaping out from the intervertebral space (Pasquet, ¶51, 66), therefore providing greater securement of the implant when implanted in the intervertebral space. Lee/Saladin/Dietz/Rhoda would be modified to include a hook portion (Pasquet, 21) coupled to a posterior sidewall (Lee, 440) of the body portion, connected to and projecting from the posterior sidewall in a posterior and superior direction, to provide an L-shaped connection in which to retain the movable clamp member (Pasquet, 50, ¶48). The movable clamp member (Pasquet, 50) would be provided with Lee’s implant to be attached to the vertebra via the hooks (Pasquet, 90) and retained under tension in the hook portion (Pasquet, 21), to exert downward and anterior directed forces on the body portion to keep it in place. Pasquet teaches that the hook portion (Pasquet, 21) accommodates the movable clamp member (Pasquet, 50) to further and more securely attach the implant and body portion to the S1 vertebra when the implant is disposed in the L5-S1 intervertebral space (Pasquet, ¶51, FIG. 9), and because Lee contemplates implantation of the implant in the L5-S1 intervertebral space (Lee, ¶103), providing the hook portion and movable clamp member as taught by Pasquet would allow Lee’s device to further and more securely attach the implant and body portion to the S1 vertebra when the implant is disposed in the L5-S1 intervertebral space to prevent the body portion from escaping out from the intervertebral space.
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee/Saladin in view of Pasquet (hereinafter, “Lee/Saladin/Pasquet”), as applied to claims 10, 11, 13, and 14 above, and further in view of U.S. Patent No. 6,126,660 to Dietz, and U.S. Patent No. US 7,674,296 to Rhoda et al. (hereinafter, “Rhoda”).
Lee/Saladin/Pasquet are silent as to wherein at least one of the first panel or the third panel includes a recess extending into the first panel or the third panel, the recess configured to receive a retention pin to maintain an alignment of the first panel or the third panel relative to the sidewall as the first wedging member or the second wedging member moves relative to the sidewall.
Dietz teaches an adjustable implant with members movable relative to each other and a limiting means for limiting maximum expansion, one member (15) including a recess (70) elongated in a direction of movement of the member; and a retention pin (75) slidingly received in the recess such that the retention pin limits the maximum expansion of the member (col. 7 / ll. 1-10), shown in Figs. 2, 7, 8, and 12.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to include in Lee/Saladin/Pasquet a means for limiting the expansion of the wedging member which may also guide the translation, by including a recess and a retention pin received in the recess, as taught by Dietz, in the wedging member and adjacent sidewall as disclosed in Lee, since Lee contemplates that a limit on maximum expansion is desirable (Lee, [0092]) and the pin/recess connection would provide added security to the adjustable relationship between the wedging member and sidewall and maintain alignment. A recess may be included in each of the first and third panels (Lee, 800, 1000) of Lee’s wedging members, elongated in a direction of movement of the wedging member (Lee, FIGS. 6-8), with a retention pin extending inward from each sidewall (Lee, 440, 460) and slidingly received in the respective recess such that the retention pin limits the maximum expansion of the wedging member and maintains an alignment of the panels relative to the sidewall during relative movement, since the sidewall is of a relatively lesser height such that the placement of the expansion-limiting recess on the wedging member panels would allow for greater expansion (as desired by Lee) than if the recess were placed on the sidewall, and since the mere reversal of the essential working parts of a device involves only routine skill in the art (i.e. moving Dietz’s recess to the inner one of the two relatively moving members with the pin correspondingly extending inwardly).
Lee is silent as to the sidewall having an aperture extending through the sidewall; wherein the aperture is configured to receive the retention pin.
Rhoda teaches a retention pin (38) extends through an aperture in a sidewall (14) to be received in a recess (36) in an inner sliding component (12) to maintain alignment (col. 4 / lines 12-28), FIG. 2.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to attach each retention pin to the sidewall by extending the retention pin through a respective aperture through the sidewall so that the retention pin extends through the sidewall and inwardly into reception into the recess in the respective first or third panel of the respective wedging member to guide sliding of the wedging members and maintain alignment of the panels relative to the sidewall, since Rhoda teaches that this is a way to connect a pin to two nested components, and inserting the pin through the thickness of the sidewall so that it extends inwardly into engagement with the interior component provides an ease of assembly and manufacture as opposed to forming the pin integrally with the sidewall.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication No. US 2008/0312741 to Lee et al. (hereinafter, “Lee”), in view of U.S. Patent No. 4,057,924 to Joseph and U.S. Patent Application Publication No. US 2011/0144692 to Saladin et al. (hereinafter, “Saladin”).
As to claim 15, Lee discloses an adjustable implant (200), shown in FIGS. 1, 2, 8, 11, and 17, comprising: a body portion (210) including: a sidewall (sides of 440, 460) extending from a first end (end at 220 including portion to the right of 440 in FIG. 1) to a second end (end at 230 including portion to the left of 440 in FIG. 1) (¶80, 86); a first wedging member (700) movable relative to the sidewall, the first wedging member including a first wedging member surface (740), a first panel (800) extending from the first wedging member surface (the first panel 800 extends from a posterior side of the respective surface 740) (¶85), shown in FIG. 8, and a pair of second panels (770, 780) extending from the first wedging member surface (the second panels 770, 780 extend from sides of the anterior side of the respective surface) (¶91), shown in FIG. 8; a second wedging member (900) movable relative to the sidewall (¶74-78, 94), shown in FIGS. 1, 6-8, 15, and 18, the second wedging member including a second wedging member surface (940), a third panel (1000) extending from the second wedging member surface (the third panel extends from an anterior side of the respective surface 940) (¶85), shown in FIG. 8, and a pair of fourth panels (970, 990) extending from the second wedging member surface (the fourth panels extend from sides of the posterior side of the respective surface) (¶91), shown in FIG. 8; and a top wall (wall formed by upward facing surfaces of the body portion, including top surfaces of 240, 440, 460, and the second end) surrounding the first wedging member, FIGS. 1 and 8, the top wall having an aperture (aperture between 440 and 460) extending into the top wall, a control shaft (1200) received within the body portion and operably coupled to the first wedging member and the second wedging member (¶85), wherein the first wedging member and the second wedging member are movable between a collapsed position (FIG. 14) and a fully expanded position (FIG. 15; fully capable of being fully expanded in FIG. 15 based on the patient needs) via movement of the control shaft, FIGS. 6-7, (¶85), and wherein (i) exterior surfaces (surfaces on 800 facing outward, with surface portions adjacent 970 and 990) of the first panel (800) maintain direct engagement with interior surfaces (inward facing surfaces of 970 and 990) of the pair of fourth panels (970, 990) and (ii) exterior surfaces (surfaces on 1000 facing outward, with surface portions adjacent 770 and 780) of the third panel (1000) maintain direct engagement with interior surfaces (inward facing surfaces of 770 and 780) of the pair of second panels (770, 780) as the first wedging member and the second wedging member move between the collapsed position and the fully expanded position (the respective adjacent exterior and interior surfaces maintain direct engagement as the wedging members move from the collapsed position in FIG. 6 to a position slightly expanded from the collapsed position and in which the exterior and interior surfaces maintain direct engagement, which position can be interpreted as the fully expanded position because, depending on the particular patient’s needs, the wedging members may need be expanded only this distance; alternatively, the exterior and interior surfaces maintain direct engagement as the wedging members move from the collapsed position in FIG. 6 to a position slightly expanded from the collapsed position and in which the exterior and interior surfaces maintain direct engagement, which meets the limitation that the surfaces maintain direct engagement as the wedging members move somewhere in the range of movement between the collapsed position and the fully expanded position, since the claim does not require that the surfaces maintain direct engagement throughout the entire range of movement), FIG. 6.
Lee is silent as to wherein the control shaft is configured to couple a member received within the aperture of the top wall to translationally fix the control shaft within the body portion.
Joseph teaches a body portion (8) including a wall having an aperture (44) extending into the wall, FIG. 4, a control shaft (14) received within the body portion, FIG. 2, wherein the control shaft is configured to couple a member (40) received within the aperture of the wall to translationally fix the control shaft within the body portion (col. 2 / line 64 – col. 3 / line 3).
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to include in Lee a member (a retaining pin) that is received through the body portion to translationally fix the control shaft within the body portion, as taught by Joseph, thereby allowing rotation of the control shaft as required by Lee, while preventing the undesired backout of the control shaft out of the body portion and out of engagement with the wedging members. As taught by Joseph, the control shaft in Lee would be correspondingly modified to have a reduced diameter portion between the tip of the control shaft and the threaded portion of the control shaft, such that the member/retaining pin can be positioned under the shoulder of the tip to limit translational movement of the control shaft out of the bore (Lee, 580, ¶87) while remaining rotatively seated in the bore as required by Lee. The body portion in Lee would be correspondingly modified to have an aperture extending into a wall of the body portion, as taught by the aperture in Joseph, to receive the member/retaining pin therethrough. Accordingly, the aperture would be positioned in the wall of the body portion so that the member/retaining pin extending therethrough would align with the reduced diameter portion on the control shaft so that the member/retaining pin is positioned under the shoulder of the tip.
It further would have been obvious to a person having ordinary skill in the art at the time of invention to position the aperture in the top wall of Lee’s body portion, in the section of the top wall at the second end, adjacent the bore (Lee, 580), so as not to interfere with the threaded bore (590) on the sidewall for attaching a wing, and since the top wall is easily accessible.
Assuming arguendo, Lee is silent as to wherein (i) exterior surfaces of the first panel maintain direct engagement with interior surfaces of the pair of fourth panels and (ii) exterior surfaces of the third panel maintain direct engagement with interior surfaces of the pair of second panels as the first wedging member and the second wedging member move between the collapsed position and the fully expanded position.
Saladin teaches that telescoping parts (345, 335) can be engaged together via a first panel (347) positioned between and adjacent a pair of panels (sides of 335 that receive 347) (¶93), shown in FIG. 7, to guide telescoping movement in a secure way without adding bulk to the device. Exterior surfaces of the first panel maintain direct engagement with interior surfaces of the pair of panels during the telescoping movement.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to modify Lee’s first and second wedging members such that the first or third panel of each wedging member is positioned between and adjacent the pair of fourth or second panels, respectively, to provide guided telescoping movement between the first and second wedging members in a secure way, helping to reduce possible torqueing or twisting of the wedging members by telescopically engaging them with each other, as taught by Saladin. To modify Lee in view of Saladin, the first and second wedging members would be modified so that the first panel (800) of the first wedging member is nested between portions of the wall (920) of the second wedging member, by reducing the width of the first panel and providing the wall of the second wedging member in the same plane as the first panel and as a pair of fourth panels that slide on either side of the reduced width first panel so that exterior side surfaces of the first panel maintain direct engagement with interior side surfaces of the pair of fourth panels, therefore providing the telescoping movement taught by Saladin to reduce torqueing or twisting of the wedging members since both sides of the wedging members are disposed inside of the body portion sidewalls. Similarly, the third panel (1000) of the second wedging member would be nested between portions of the wall (720) of the first wedging member, by reducing the width of the third panel and providing the wall of the first wedging member in the same plane as the third panel and as a pair of second panels that slide on either side of the reduced width third panel so that exterior side surfaces of the third panel maintain direct engagement with interior side surfaces of the pair of second panels. The surface engagement would be maintained as the first wedging member and the second wedging member move between the collapsed position and the fully expanded position, as interpreted above. By providing each side of each wedging member as a sliding portion within the body portion sidewalls, with the adjacent panels engaged along their respective sides, the alignment of the wedging members is maintained within the sidewall from collapsed to expanded.
Claims 16 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee in view of Joseph and Saladin (hereinafter, “Lee/Joseph/Saladin”), as applied to claim 15 above, and further in view of U.S. Patent No. 6,126,660 to Dietz.
Lee/Joseph/Saladin are silent as to wherein the first panel of the wedging member includes a first recess and the third panel of the second wedging member includes a second recess (claim 16); wherein the first recess is configured to receive a first retention member and the second recess is configured to receive a second retention member to maintain an alignment of the first wedging member and the second wedging member relative to the body portion as the first wedging member and the second wedging member move between the fully collapsed position and the fully expanded position (claim 17).
Dietz teaches an adjustable implant with members movable relative to each other and a limiting means for limiting maximum expansion, one member (15) including a recess (70) elongated in a direction of movement of the member; and a retention member (75) slidingly received in the recess such that the retention pin limits the maximum expansion of the member and maintains alignment (col. 7 / ll. 1-10), shown in Figs. 2, 7, 8, and 12.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to include in Lee/Joseph/Saladin a means for limiting the expansion of the wedging member which may also guide the translation and maintain alignment of the wedging members in the body portion, by including a recess and a retention member received in the recess, as taught by Dietz, in the wedging member and adjacent sidewall as disclosed in Lee, since Lee contemplates that a limit on maximum expansion is desirable (Lee, [0092]) and the pin/recess connection would provide added security to the adjustable relationship between the wedging member and sidewall and maintain alignment. A recess may be included in each of the first and third panels (Lee, 800, 1000) of Lee’s wedging members, elongated in a direction of movement of the wedging member (Lee, FIGS. 6-8), with a retention member extending inward from each sidewall (Lee, 440, 460) and slidingly received in the respective recess such that the retention member limits the maximum expansion of the wedging member and maintains an alignment of the panels and wedging members relative to the sidewall and body portion during relative movement, since the sidewall is of a relatively lesser height such that the placement of the expansion-limiting recess on the wedging member panels would allow for greater expansion (as desired by Lee) than if the recess were placed on the sidewall, and since the mere reversal of the essential working parts of a device involves only routine skill in the art (i.e. moving Dietz’s recess to the inner one of the two relatively moving members with the pin correspondingly extending inwardly).
Claims 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee in view of Joseph and Saladin (hereinafter, “Lee/Joseph/Saladin”), as applied to claim 15 above, and further in view of U.S. Patent Application Publication No. US 2009/0018662 to Pasquet et al. (hereinafter, “Pasquet”).
As to claim 20, Lee/Joseph/Saladin disclose wherein the collapsed position is a fully collapsed position, FIG. 14. The collapsed position in FIG. 14 is fully collapsed. Other positions may also be interpreted as fully collapsed based on the patient’s needs in the particular surgery.
Lee/Joseph/Saladin are silent as to a hook portion coupled to the body portion (claim 18); wherein the hook portion includes at least one bend, and wherein the hook portion includes a first end coupled to the body portion and a second end opposite the first end of the hook portion (claim 19).
Pasquet teaches an adjustable implant, shown in FIG. 9, in the same field of endeavor of intervertebral implants, comprising a body portion (20) (¶59); a hook portion (21) coupled to the body portion (¶48), wherein the hook portion includes at least one bend, and wherein the hook portion includes a first end coupled to the body portion and a second end opposite the first end of the hook portion, shown for exemplary purposes in the embodiment of FIG. 5.
Accordingly, at the time of invention, it would have been obvious to a person having ordinary skill in the art to provide the implant of Lee/Joseph/Saladin with a hook portion and a movable clamp member, as taught by Pasquet, to exert return forces on the body portion (Lee, 210) directed toward the vertebra to prevent the body portion from escaping out from the intervertebral space (Pasquet, ¶51, 66), therefore providing greater securement of the implant when implanted in the intervertebral space. Lee/Joseph/Saladin would be modified to include a hook portion (Pasquet, 21) coupled to a posterior sidewall (Lee, 440) of the body portion, connected to and projecting from the posterior sidewall in a posterior and superior direction, to provide an L-shaped connection in which to retain the movable clamp member (Pasquet, 50, ¶48). The movable clamp member (Pasquet, 50) would be provided with Lee’s implant to be attached to the vertebra via the hooks (Pasquet, 90) and retained under tension in the hook portion (Pasquet, 21), to exert downward and anterior directed forces on the body portion to keep it in place. Pasquet teaches that the hook portion (Pasquet, 21) accommodates the movable clamp member (Pasquet, 50) to further and more securely attach the implant and body portion to the S1 vertebra when the implant is disposed in the L5-S1 intervertebral space (Pasquet, ¶51, FIG. 9), and because Lee contemplates implantation of the implant in the L5-S1 intervertebral space (Lee, ¶103), providing the hook portion and movable clamp member as taught by Pasquet would allow Lee’s device to further and more securely attach the implant and body portion to the S1 vertebra when the implant is disposed in the L5-S1 intervertebral space to prevent the body portion from escaping out from the intervertebral space.
Allowable Subject Matter
Claims 4-7 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.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance: None of the searched, pertinent prior art clearly shows by itself, or in combination with each other, an adjustable implant comprising a hook integrally coupled with a wedging member, wherein the hook includes a movable clamp member having first and second ends, as required by claim 4. Although the closest prior art to Lee et al. (US 2008/0312741) discloses an adjustable implant of claim 1, comprising a hook integrally coupled with a wedging member, as recited in the rejections above, Lee is silent as to wherein the hook includes a movable clamp member having first and second ends.
It would not have been obvious in view of the cited art to make modifications to resolve the above deficiencies and arrive at the claimed invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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