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 .
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-3, 6-8, 11, 15-16, 27, 31, 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allard et al (US Patent Pub. 20080065153A1) in view of Cheney (US Patent Pub. 20170065275A1).
Allard recites an orthopedic compression implant for applying compression between a first and second bone segments. Specifically in regard to claim 1-3, 8, and 35, Allard recites the orthopedic compression implant (100) comprising a bridge (102) having a longitudinal axis, a first end (end connected to 104), and a second end (end connected to 106) opposite the first end, wherein the bridge (102) has a radially outer surface (surface of 102) extending axially relative to the longitudinal axis from the first to the second ends; a first leg (104) extending from the first end of the bridge (102), wherein the first leg (104) has a central axis, a fixed end fixably attached to the bridge (102), a free end (tip of 112) distal the bridge (102), and a radially outer surface (outer surface of 104) extending axially relative to the central axis of the first leg (104) from the fixed end of the first leg (104) to the free end (tip of 112) of the first leg (104); and a second leg (106) extending from the second end of the bridge (102), wherein the second leg (106) has a central axis, a fixed end fixably attached to the bridge (102), a free end (tip of 122) distal the bridge (102), and a radially outer surface (surface of 106) extending axially relative to the central axis of the second leg (106) from the fixed end of the second leg (106) to the free end (tip of 122) of the second leg (106) (Fig. 1-3; and Para. [0080]-[0084]). Wherein the longitudinal axis of the bridge (102), the central axis of the first and second legs (104/106) are disposed in a common reference plane (Fig. 1-3). Wherein the radially outer surface (surface of 102) of the bridge (102) includes a lower surface that extends axially relative to the longitudinal axis from the first end of the bridge (102) to the second end of the bridge (102), intersects the fixed ends of the first and second legs (104/106) (Fig. 1-3). The radially outer surface (surface of 102) of the bridge (102) defines a first outer profile in a cross-section of the bridge (102) taken in a plane oriented perpendicular to the longitudinal axis of the bridge (102), wherein the radially outer surface of the first leg (104) defines a second outer profile (Fig. 1) in a cross-section of the first leg (104) taken in a plane oriented perpendicular to the central axis of the first leg (104), wherein the second outer profile is non-rectangular, and wherein the first outer profile (profile of 102) has a different geometry than the second outer profile (profile seen in Fig. 1) (As seen in Fig. 1 the profile of the tines 112/122 is different than the profile of the bridge 102.) (Fig. 1-3). The orthopedic compression implant (100) has a central axis (axis bisecting staple 100) disposed in the common reference plane, positioned between the central axes of the first and second legs (104/106), and intersecting the longitudinal axis of the bridge (102) (Fig. 2-3). The first and second legs (104/106) are oriented at a leg angle measured in the common reference plane between the central axes of the first and second legs (104/106) and the central axis of the orthopedic compression implant (100); wherein the legs (104/106) have a first position (Fig. 2) with the central axes of the first and second legs (104/106) being substantially parallel to each other and the leg angles equal to approximately to 0o; and a second position (Fig. 3) with each leg angle greater than 0o and the legs (104/106) sloping towards each other and the central axis of the orthopedic compression implant (100) moving axially relative to the central axis of the corresponding leg (104/106) from the fixed end to the corresponding leg (104/106) to the free end (tip of 112/122) of the corresponding leg (104/106), wherein the legs (104/106) are biased to the second position (Fig. 3) (Fig. 2-3; and Para. [0084]). The first and second legs (104/106) are configured to be inserted into first and second holes in the respective first and second bone segments with the legs (104/106) in the first position (Fig. 2); and wherein the longitudinal axis of the bridge (102) is continuously curved in the common reference plane moving axially along the bridge (102) relative to the longitudinal axis of the bridge (102) from the first to the second end of the bridge (102) with the legs in both the first and second positions (Fig. 2-3 and Para. [0084]). Allard also recites wherein the bridge (102) is elastically flexed with the legs (104/106) in the first position (Fig. 2) to bias the legs (104/106) from the first position (Fig. 2) to the second position (Fig. 3) (Fig. 2-3 and Para. [0084]). However, the reference is silent as to the lower bridge surface extending at a greater width than the width of the legs.
Cheney recites an orthopedic compression implant for applying compression between a first and second bone segments. Specifically in regard to claim 1, Cheney recites the orthopedic compression implant (210) comprising a bridge (205) having first and second ends affixed to first and second legs (201/204), and wherein the bridge (205) has a width (width along 232 in Fig. 16) measured perpendicular to the common reference plane that is greater than a width of each leg (201/204, see Fig. 16) measured perpendicular to the common reference plane such that the lower surface and extends laterally beyond the first and second legs (201/204) (Fig. 11-16; and Para. [0062]-[0064]). In regards to claims 2-3, Cheney recites wherein the first outer profile is non-rectangular; and wherein the first outer profile is D-shaped (As shown in Fig. 16, the cross-section of bridge 205 when viewed appears to be a “D” laying on its side.) (Fig. 16). In regards to claim 8, Cheney recites wherein the lower surface of the radially outer surface (231) of the bridge (205) comprises a plurality of downward facing shoulders (231, Fig. 13-14, 16) at the first and second ends of the bridge, wherein the plurality of tool engagement shoulders at the first and second ends of the bridge (205) are configured to be engaged by an external tool to elastically flex the bridge (As can be seen in Fig. 16, the lower surface 231 creates a curved shoulder between the fixed end of the legs and the upper surface of the bridge 205. The lower surface 231 is fully capable of being grabbed by a tool to flex the bridge as shown in Figures 13-14.) (Fig. 13-14 and 16). In regards to claim 35, Cheney recites wherein each tool engagement shoulder (231) is defined by a planar surface oriented perpendicular to the common reference plane, and wherein the plurality of tool engagement shoulders at the first end of the bridge (205) are positioned laterally adjacent the fixed end of the first and second legs (201/204) (Fig. 13-14 and 16). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the bridge (3702) of Allard to have a wider width than the legs as taught in Cheney in order to flatten the profile of the implant resulting in less protuberance to a patient (Para. [0064]).
In regards to claim 6-7, Allard in view of Cheney disclose an orthopedic implant as recited above. Allard in a separate embodiment further recites in a separate embodiment wherein the radially outer surface of the first leg (3704) and second leg (3706) comprises a plurality of axially spaced serrations (3732/3734) (Fig. 37-41). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the tines (3732/3734/3742/3744) of Allard to face each other, since it has been held that rearranging parts of an invention involves only routine skill in the art.
In regards to claim 11, Allard recites wherein the central axis of the first leg (104) is not parallel to the central axis of the second leg (106) (Fig. 3).
In regards to claim 15, Allard recites an orthopedic compression implant for applying compression between a first and second bone segments. Specifically, Allard recites the orthopedic compression implant (100) comprising a bridge (102) having a longitudinal axis, a first end (end connected to 104), and a second end (end connected to 106) opposite the first end, wherein the bridge (102) has a radially outer surface (surface of 102) extending axially relative to the longitudinal axis from the first to the second ends; a plurality of legs (104/106) extending from the bridge (102), wherein each leg (104/106) has a central axis disposed in a common reference plane as the longitudinal axis of the bridge (102), a fixed end fixably attached to the bridge (102), a free end (tip of 112/122) distal the bridge (102), and a radially outer surface (outer surface of 104/106) extending axially from the fixed end of the first and second legs (104/106) to the free end (tip of 112/122) of the first and second legs (104/106) (Fig. 1-3; and Para. [0080]-[0084]). Wherein the radially outer surface of the bridge (102) comprises an upper surface and a lower surface, wherein the lower surface of the radially outer surface of the bridge (102) is concave between the first and second ends of the bridge (102) in the common reference plane in front view, and wherein the upper surface of the radially outer surface of the bridge (102) is convex in the cross-section of the bridge (102) taken in a plane oriented perpendicular to the longitudinal axis of the bridge (102) (Fig. 2-3). Wherein the lower surface of the radially outer surface (surface of 102) of the bridge (102) extends first end of the bridge (102) to the second end of the bridge (102), intersects the fixed ends of the plurality of legs (104/106) (Fig. 1-3). The orthopedic compression implant (100) has a central axis (axis bisecting staple 100) disposed in the common reference plane, positioned between the first and second ends of the bridge (102), and intersecting the longitudinal axis of the bridge (102) (Fig. 1-3). Wherein the orthopedic compression implant (100) has (i) an elastically flexed position (Fig. 2) with the central axes of the legs (104/106) oriented substantially parallel to each other, and (ii) a relaxed position (Fig. 3) with each leg (104/106) sloping towards the central axis of the orthopedic compression implant (100) moving axially relative to the central axis of the leg (104/106) from the fixed end of the leg (104/106) to the free end (112/122) of the leg (104/106), wherein the orthopedic compression implant (100) is elastically biased to the relaxed position (Fig. 3) (Fig. 2-3; and Para. [0084]). The plurality of legs (104/106) are configured to be inserted into corresponding holes in the respective first and second bone segments with the orthopedic compression implant (100) in the elastically flexed position (Fig. 2); and wherein the longitudinal axis of the bridge (102) is continuously curved in the common reference plane moving axially along the bridge (102) relative to the longitudinal axis of the bridge (102) from the first to the second end of the bridge (102) with the orthopedic compression implant (100) in the elastically flexed position and in the relaxed position (Fig. 2-3 and Para. [0084]). However, the reference is silent as to the lower bridge surface extending at a greater width than the width of the legs.
Cheney recites an orthopedic compression implant for applying compression between a first and second bone segments. Specifically in regard to claim 15, Cheney recites the orthopedic compression implant (210) comprising a bridge (205) having first and second ends affixed to first and second legs (201/204), wherein the radially outer surface of the bridge (205) defines a first outer profile in a cross-section of the bridge (205) taken in a plane oriented perpendicular to the longitudinal axis of the bridge (205), wherein the first outer profile is non-rectangular; and wherein the bridge (205) has a width (width along 232 in Fig. 16) measured perpendicular to the common reference plane that is greater than a width of each leg (201/204, see Fig. 16) measured perpendicular to the common reference plane such that the lower surface and extends laterally beyond the first and second legs (201/204) (As shown in Fig. 16, the cross-section of bridge 205 when viewed appears to be a “D” laying on its side.) (Fig. 11-16; and Para. [0062]-[0064]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the bridge (3702) of Allard to have a wider width than the legs as taught in Cheney in order to flatten the profile of the implant resulting in less protuberance to a patient (Para. [0064]).
In regards to claim 16, Allard recites wherein the radially outer surface of each leg (104/106) defines a second outer profile (Fig. 1) in a cross-section of the leg (104/106) taken in a plane oriented perpendicular to the central axis of the leg (104/106), and wherein the second outer profile of each leg (106/104) is non-rectangular (If the profile is taken along tines as shown in Fig. 1 then the profile would be non-rectangular.) (Fig. 1).
In regards to claim 27, Allard recites wherein the longitudinal axis of the bridge (102) has a radius of curvature that varies moving axially along the central axis of the bridge (102) from the first to the second end of the bridge (102) with the legs (104/106) in the second position (Fig. 3).
In regards to claim 31 and 33, Allard recites wherein the radially outer surface of the bridge (102) includes an upper surface that extends axially relative to the longitudinal axis from the first to the second end of the bridge (102), wherein the upper surface of the radially outer surface of the bridge is convex in side view perpendicular to the common reference plane with the legs (104/106) in the first and second/elastically flexed and relaxed positions (Fig. 2-3 and Para. [0084]).
In regards to claim 34, Allard recites wherein the bridge (102) is elastically flexed to bias the legs (104/106)/orthopedic compression implant (100) to the second/flexed position (Fig. 2-3 and Para. [0084]).
Claim(s) 8-10, 21-23, 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allard in view of Cheney as applied to claim 1 and 15 above, and further in view of Morgan et al (US Patent Pub. 20160199060A1).
Allard in view of Cheney recite a shape-memory alloy orthopedic implant comprising a curved bridge with a leg at each end of the bridge wherein the outer surface of the bridge defines a first non-rectangular profile and each leg defines an outer radial surface that is different from the bridge,. However, the reference is silent as to tool engagement features.
Morgan recites an orthopedic compression implant for applying compression between a first and second bone segments. Specifically in regard to claim 8, Morgan recites the orthopedic compression implant (5) comprising a bridge (10) and legs (15); and wherein the lower surface of the radially outer surface of the bridge (20) comprises a plurality of downward facing shoulders at the first and second ends of the bridge (10) (As can be seen in Fig. 20-22, the lower surface of ends 20 creates a curved shoulder between the fixed end of the legs and the upper surface of the bridge 10.) (Fig. 20-22). In regards to claim 9-10, Morgan recites wherein the lower surface of the radially outer surface of the bridge (10) includes a plurality of tool engagement recesses (openings in 20 and curved juncture between 20 and 15) at the first and second ends (20) of the bridge (10), and wherein each tool engagement recess of the bridge is at least partially cylindrical (Fig. 20). In regards to claim 21-26, Morgan recites wherein the lower surface of the radially outer surface of the bridge (10) includes first and second plurality of tool engagement recesses (openings in 20 and curved juncture between 20 and 15) that are axially spaced relative to the longitudinal axis of the bridge (10) from each other; wherein the plurality of first and second tool engagement recesses are positioned proximal the fixed ends of the first and second legs (15), and wherein each tool engagement recess of the bridge is at least partially cylindrical (Fig. 20). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the combination by modifying the bridge (3702) of Allard to have tool engagement features as taught in Morgan in order to have a secure means to grasp and flex the staple.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allard in view of Cheney as applied to claim 1 above, and further in view of Taylor et al (US Patent Pub. 20130231667A1).
Allard in view of Cheney recite a shape-memory alloy orthopedic implant comprising a curved bridge with a leg at each end of the bridge wherein the outer surface of the bridge defines a first non-rectangular profile and each leg defines an outer radial surface that is different from the bridge,. In regards to claim 13, Allard recites wherein the orthopedic implant (100) has a central axis disposed in the common reference plane, positioned between the central axes of the first and second legs (104/106), and intersecting the curved longitudinal axis of the bridge (102), wherein the first leg (104) is oriented at a leg angle α measured in the common reference plane between the central axis of the first leg (104) and the central axis of the orthopedic implant (Fig. 1-3). However, the reference is silent as to the degree of angle alpha being between 0-20 degrees.
Taylor recites a shape-memory alloy orthopedic implant. Specifically in regards to claim 13, Taylor discloses the implant (314) having a bridge (318) and legs (320) and wherein the orthopedic implant (314) has a central axis (axis bisecting implant 314) disposed in the common reference plane, positioned between the central axes of the first and second legs (320), and intersecting the longitudinal axis of the bridge (318), wherein the first leg (320a) is oriented at a leg angle α (half of angle 350) measured in the common reference plane between the central axis of the first leg (320a) and the central axis of the orthopedic implant (314), wherein the leg angle α is between approximately 0° and approximately 20° (Taylor recites that the flex angle 350 that shows the angle of one side section 320A relative to the other side section 320B. can be between approximately 15.0 and 25.0 degrees. Therefore, the angle alpha would be half the angle recited making the alpha angle 7.5-12.5 degrees.) (Fig. 3b; and Para. [0056]-[0061]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the combination by modifying the angle of the legs (3704/3706) of Allard to be between 15-25 degrees in relation to the central axis as taught in Taylor since it has been held that where the general conditions of a claim are 'disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art.
Claim(s) 16-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allard in view of Cheney as applied to claim 15-16 above, and further in view of Weiner et al (US Patent Pub. 20170065276A1).
Allard in view of Cheney recite a shape-memory alloy orthopedic implant comprising a curved bridge with a leg at each end of the bridge wherein the outer surface of the bridge defines a first non-rectangular profile and each leg defines an outer radial surface that is different from the bridge. In regards to claims 17, Allard recites wherein the legs (104/106) radially outer surface defines a second outer profile in a cross-section of the leg (104/106) taken in a plane oriented perpendicular to the central axes of the legs (104/106) (Fig. 1). In regards to claim 18, Cheney recites wherein the lower surface of the radially outer surface of the bridge (205) comprises a plurality of downward facing shoulders position between the legs (201/204) and the upper surface (Fig. 16). However, the references are silent as to the profile of the legs being non-rectangular.
Weiner recites a shape-memory alloy orthopedic implant. Specifically in regards to claim 16-17, Weiner recites the implant (10) having a bridge (12) and legs (14) wherein the radially outer surface of each leg (14) defines a second outer profile in a cross-section of the leg (14) taken in a plane oriented perpendicular to the central axis of the leg (14), and wherein the second outer profile of each leg (14) is non-rectangular or circular (Fig. 1-2; and Para. [0068],[0072]). In regards to claim 18, Weiner recites wherein each of the plurality of legs (14) includes a cylindrical surface proximate the fixed end (end connected to 12) (Fig. 1-2). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the legs (201-204) of Cheney to be circular in shape as taught in Weiner since it has been held that the configuration of the claimed subject matter was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration was significant, and Weiner discloses that other geometries are also acceptable (Para. [0072]).
In regards to claims 20, Allard recites wherein the plurality of shoulders are configured to receive loads that apply a bending moment to the bridge that increases a radius of curvature of the curved central axis in front view and transition the orthopedic compression implant (5) from the relaxed to the flexed positions (This limitation is being interpreted as an intended use recitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, if the staple 3700 of Allard were modified to have the lower surface 231 of Cheney that extends beyond the legs it could be used to apply a load to the staple.)
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allard in view of Cheney and Weiner as applied to claim 18 above, and further in view of Morgan.
Allard in view of Cheney and Weiner recite a shape-memory alloy orthopedic implant comprising a curved bridge with a leg at each end of the bridge wherein the outer surface of the bridge defines a first non-rectangular profile and each leg defines an outer radial surface that is different from the bridge. However, the reference is silent as to tool engagement features.
Morgan recites an orthopedic compression implant for applying compression between a first and second bone segments. Specifically in regard to claim 19, Morgan recites the orthopedic compression implant (5) comprising a bridge (10) and legs (15); and wherein the lower surface of the radially outer surface of the bridge (10) includes a plurality of tool engagement recesses (openings in 20 and curved juncture between 20 and 15) at the first and second ends (20) of the bridge (10), and wherein each tool engagement recess of the bridge is at least partially cylindrical (Fig. 20). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the combination by modifying the bridge (3702) of Allard to have tool engagement features as taught in Morgan in order to have a secure means to grasp and flex the staple.
Allowable Subject Matter
Claims 28-30 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 closest art of record is the Allard reference which discloses the orthopedic compression implant however, it does not recite wherein the cross-sectional area of the bridge in any plane orientated perpendicular to the axis of the bridge is equal to or greater than the cross-sectional area of each leg in any plane oriented perpendicular to the axis of the corresponding leg.
Response to Arguments
Applicant’s amendments filed on 12/18/25 have overcome the 112 rejection of claim 27. In addition, the arguments filed in regards to the 112 rejection of claims 28-30 have been found persuasive and those rejections have been withdrawn.
Applicant’s arguments with respect to the claims have been considered but are not persuasive. Applicant argues that the combination of the Allard and Cheney references does not recite wherein the bridge of the implant flexes to move between a closed and open configuration as required by the claims (Remarks Pg. 14-19). However, as shown in Fig. 2-3, the implant 100 demonstrates a closed implant configuration in Fig. 3 and an open configuration in Fig. 2 and the bridge flexes to allow for the legs to shift from slopping toward from one another to being parallel to one another. Therefore, the continued rejection of the claims is proper.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775