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 .
Election/Restrictions
Applicant’s election without traverse of Species B (Fig 14-28) in the reply filed on 2/9/2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/9/2026.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The prior art was reinterpreted in view of applicant’s amendments. If applicant were to claim how the distal sleeve overlaps with the rod (via a notch/groove #36 to accommodate the spinal rod), examiner notes Shoshtaev US 9,247,964 (previously cited by applicant) which have connectors with a notch/groove to accommodate a spinal rod (#324/#326, Fig 9). At present, the examiner does not have any suggestions to overcome the prior art but applicant is welcome to contact the examiner if they have any questions.
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.
Claims 1-5, 7-9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Carruth US 2018/0228518 in view of Saidha US 2010/009445, Morrison US 2002/0029040, and Prevost US 2011/0106179.
Regarding Claim 1, Carruth discloses a spinal construct (Fig 1a-1b) comprising:
a connector comprising:
a first body (see Fig below), the first body defining a central axis (axis A1, Fig 1b) and having a proximal wall (see Fig below) and a side wall (see Fig below) extending from the proximal wall, the proximal wall and the side wall defining a sleeve (see Fig below, Fig 1d), a proximal surface of the proximal wall (see Fig below), the sleeve including an inner surface that defines a cavity (#144, see Fig below), the cavity being configured for disposal of an existing receiver (as seen in Fig 1a, paragraph 68), and
a second body (see Fig below), the second body having a second rod receiver (see Fig below), the side wall being spaced apart from the second rod receiver by the proximal wall (see Fig below, Fig 1d), the second rod receiver having an inner surface (see Fig below) and a pair of spaced apart arms (see Fig below) that define an implant cavity in the form of a U-shaped passageway (#152, paragraph 61, see Fig below, Fig 1d), the inner surface of the second rod receiver including a thread form (paragraph 72 where fastener #134 engages the thread form);
a set screw extending between a proximal end and a distal end thereof (see Fig below), the set screw comprising a first mating surface (see Fig below), a second mating surface (see Fig below), the first mating surface being configured for engagement with the existing receiver (as seen in Fig 1a, paragraph 65);
and a nut (#132, see Fig below) comprising a tool engaging surface (outer surface of the nut #132, see Fig below), a cavity configured for engagement with the second mating surface of the set screw (as seen in Fig 1a, paragraph 61),
wherein the nut is configured to engage the proximal wall to clamp the connector to the existing receiver (paragraph 61, Fig 1a).
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Carruth does not disclose:
the proximal surface of the proximal wall having a planar configuration and extending perpendicular to the central axis,
the cavity having a substantially rectangular cross-section,
the spaced apart arms each extending parallel to the central axis,
a first circumferential flange between the first and second mating surfaces,
the nut having a second circumferential flange, and a break off portion,
wherein the nut is configured to engage the proximal wall to clamp the connector to the existing receiver such that the existing receiver is spaced apart from the proximal wall, wherein the first circumferential flange has a maximum diameter that is greater than maximum diameters of the mating surfaces such that the first circumferential flange engages the proximal wall when the connector is clamped to the existing receiver,
wherein a distal end of the sleeve at least partially overlaps with the rod implant disposed in the existing receiver along a plane that is substantially transverse to the central axis when the connector is disposed in a position of use.
Carruth discloses a screw (#134) configured for engagement with a rod implant (#107) disposed in the second rod receiver (Fig 1a) but does not disclose a protrusion formed on a surface defined around the distal end of the set screw and comprising a semi-spherical configuration, the protrusion configured for engagement with a rod implant disposed in the second rod receiver.
Carruth discloses a similar embodiment of a connector (Fig 6a) having a first body with a proximal wall having a proximal surface with a planar configuration (see Fig below).
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Carruth disclose another similar embodiment of a connector (Fig 9a-9c) having a first body defining a central axis (see Fig below) and a second body defining a second receiver the spaced apart arms each extending non-parallel to the central axis (paragraph 121 “curved or angled”) or parallel to the central axis (see Fig below, paragraph 121 “straight”), the spaced apart arms receiving a rod therebetween (paragraph 121).
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It would also have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the proximal surface of Carruth to have a planar configuration in view of another embodiment of Carruth above because this provides a known alternate shape for the proximal surface for the connector. The examiner notes that this modification is a change of shape which has been held to be an obvious design choice since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a proximal surface for a connector. In re Dailey and Eilers, 149 USPQ 47 (1966). See also MPEP 2144.04 (IV)(B).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the spaced apart arms of Carruth to be parallel to each other and to the central axis in view of another embodiment of Carruth because this provides a known alternative configuration/shape for the arms to receive a rod therein.
Saidha discloses a set screw (Fig 14) having first mating surface (#116) configured to engage with an existing receiver (#20, Fig 13, paragraph 76), second (#120) mating surface configured to engage a nut (#122, Fig 13, paragraph 77) and a first circumferential flange (#415) therebetween (Fig 14), wherein the first circumferential flange has a maximum diameter that is greater than maximum diameters of the mating surfaces (Fig 13, paragraph 89 where the flange #415 prevents a connector #450 from contacting the existing receiver #20 when the first mating surface #116 is threaded into the existing receiver) such that the first circumferential flange engages a connector (#450) when the connector is clamped to the existing receiver (Fig 13, paragraph 89), the flange (#41) substantially reducing and/or eliminating loading of the connector to the existing receiver such that likelihood of failure is reduced (ends of paragraphs 79 and 89, Fig 13 where the flange maintains separation between the bottom of connector #450 and the top of the existing receiver #20). Saidha further teaches another embodiment (Fig 15-16) with a connector having a sidewall and a proximal wall (see Fig below), a proximal surface of the proximal wall having a planar configuration and extending perpendicular to a central axis (see Fig below), the proximal wall and sidewall defining a cavity to receive an existing fastener (see Fig below), the cavity having a substantially rectangular cross-section (see Fig below),
wherein a distal end of the sleeve at least partially (see Fig below) overlaps with the rod implant disposed in the existing receiver along a plane (see Fig below where the plane is a plane along the longitudinal axis of the rod implant #45) that is substantially transverse to the central axis when the connector is disposed in a position of use (see Fig below).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the set screw of Carruth to include a flange in view of Saidha above because the flange maintains separation between a bottom surface of the connector and the top of the existing receiver such that there is substantial reduction and/or elimination of loading of the connector to the existing receiver such that likelihood of failure is reduced. With the modification to include the flange, Carruth as modified discloses wherein the nut is configured to engage the proximal wall to clamp the connector to the existing receiver such that the existing receiver is spaced apart from the proximal wall (as discussed above, the flange would maintain separation between the top of existing receiver and the bottom of the proximal wall such that the existing receiver is spaced from the proximal wall).
It would also have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the cavity of Carruth to have a substantially rectangular configuration with a distal end of the side-wall partially overlapping the rod implant, respectively in view of Saidha above because this provides a known alternate shape for a cavity to receive an existing receiver. The examiner notes that this modification is a change of shape which has been held to be an obvious design choice since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a cavity for receiving an existing receiver. In re Dailey and Eilers, 149 USPQ 47 (1966). See also MPEP 2144.04 (IV)(B). Examiner notes that with the modification to have the distal end of the side wall partially overlap the implant, one can recognize that there is a more stabile connection between the sleeve and existing receiver as compared to a configuration where the sleeve does not partially overlap.
Morrison discloses of a nut (#44, Fig 6a, 6c) comprising a tool engagement surface (#78), a threaded cavity (#82) to engage a screw (paragraph 71), circumferential flange (see Fig below), and a break off portion (#76) so that when tightening the nut, the break off portion will break off at a certain torque and will prevent over torqueing the nut (paragraph 75).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the nut Carruth as modified with the nut of Morrison with the features discussed above because when tightening the nut, the break off portion will break off at a certain torque and will prevent over torquing the nut.
Prevost discloses a protrusion (#28, Fig 3-4) formed on a surface (#29) defined around the distal end of a set screw (Fig 3, 5) and comprising a semi-spherical configuration (as seen in Fig 3, 5, paragraph 25), the protrusion configured for engagement with a rod implant (#3) disposed in a rod receiver (#20, Fig 1), the protrusion helping to provide a strong grip when pressed against the rod implant (paragraph 25).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the screw of Carruth to include a protrusion in view of Prevost above because the protrusion provides a strong grip when pressed against the rod implant.
Regarding Claim 2, Carruth as modified discloses a portion of the second surface disposed along the wall defines a recess (see Fig below, where the set screw extends through the recess).
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Regarding Claim 3, Carruth as modified discloses wherein the proximal wall is flush with proximalmost surfaces of the spaced apart arms (with the modification in view of the embodiment of Fig 6a of Carruth, see annotated Fig 6a above in claim 1 where the proximal surface of the proximal wall is flush with the proximal most surfaces of the arms).
Regarding Claim 4, Carruth as modified discloses the claimed invention as discussed above but does not disclose the inner surface has a surface configured to facilitate engagement selected from the group consisting of rough, arcuate, undulating, mesh, semi-porous, dimpled and textured
However, in another embodiment (Fig 6a), Carruth discloses an inner surface configured to facilitate engagement selected from the group consisting of rough, arcuate, undulating, mesh, semi-porous, dimpled and textured (#646, "teeth" texture, paragraph 99) to engage a corresponding surface (#666) on a flange to help resist rotation there between (paragraph 98).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Carruth as modified to have the flange and inner surface to be textured in view of another embodiment of Carruth in order to help resist rotation between the flange and inner surface.
Regarding Claim 5, Carruth as modified discloses a proximalmost surface of the nut is proximal to proximalmost surfaces of the spaced apart arms when the connector is clamped to the existing receiver (as seen in Fig 1a in Carruth).
Regarding Claim 7, Carruth as modified discloses the first mating surface is a first thread (paragraph 65 in Carruth, as seen in annotated Fig 1b above in claim 1) and the second mating surface is a second thread (paragraph 61 in Carruth and as seen in annotated Fig 1b above in claim 1), the first thread having a major diameter greater than a major diameter of the second thread (as seen in Fig 1b in Carruth).
Regarding Claim 8, Carruth as modified discloses the maximum diameter of the first mating surface is greater than the maximum diameter of the second mating surface (as seen in Fig 1b in Carruth, annotated Fig 1b above in claim 1).
Regarding Claim 11, Carruth as modified discloses the spaced apart arms each have an arcuate outer surface (Fig 1d, 9c in Carruth where the outer bottom surfaces of the arms are arcuate).
Regarding Claim 21, Carruth as modified discloses the projection is within the sleeve when the connector and the setscrew are disposed in the position of use (see modification in view of Prevost above, Fig 12 in Prevost where since the protrusion engages the rod implant during use, it would be located within the sleeve).
Regarding Claim 9, Carruth as modified discloses the claimed invention as discussed above where the second mating surface is an upper portion of the set screw (see annotated Fig 1b of Carruth above in claim 1) but does not disclose the set screw includes a break off portion, the second mating surface being positioned between the first mating surface and the break off portion.
Jackson further discloses that a proximal portion of a set screw (#1) includes a break off portion (#20)(Col 7 lines 55-64) which allows a pre-selected torque to be applied to the set screw when tightening and prevent too much torque from being applied which can allow arms of a receiver to spread and could loosen the set screw (Col 1 lines 55-65, Col 8 lines 30-33).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the set screw of Carruth to include a break off portion in view of additional teachings of Jackons which allows a pre-selected torque to be applied to the set screw when tightening and prevent too much torque from being applied which can allow arms of a receiver to spread and could loosen the set screw. Examiner notes that with the modification, the break off portion would be located at the upper portion of the set screw and thus the second mating surface would be positioned between the first mating surface and the break off portion.
Regarding Claim 22, Carruth as modified discloses a second set screw (#134 in Carruth, Fig 1a-1b) extending between a proximal end and a distal end thereof (as seen in Fig 1b in Carruth , proximal and distal ends of #134), the second set screw comprising a thread configured for engagement with the thread form of the second rod receiver (paragraph 72 in Carruth).
Carruth as modified does not disclose a second protrusion formed on a surface defined around the distal end of the second set screw and comprising a semi-spherical configuration, the second protrusion extending perpendicularly from the surface defined around the distal end of the second sets screw.
However, as discussed above, Prevost discloses a protrusion (#28) formed on a surface (#29) defined around the distal end of a set screw (Fig 3, 5) and comprising a semi-spherical configuration (as seen in Fig 3, 5, paragraph 25), the second protrusion extending perpendicularly from the surface defined around the distal end of the sets screw (Fig 3, 5), the protrusion helping to provide a strong grip when pressed against the rod implant (paragraph 25).
As such it would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the second set screw to also include a protrusion that is semi-spherical in view of Prevost above because the protrusion helping to provide a strong grip when pressed against the rod placed in the second body.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Carruth US 2018/0228518, Saidha US 2010/009445, Morrison US 2002/0029040, and Jackson US 6,004,349, as applied to claim 1 above, and in further view of Rezach US 2011/0257690.
Carruth as modified discloses the claimed invention as discussed above where the second receiver receives a rod (#907, Fig 9a in Carruth) but does not disclose the second rod receiver includes a saddle and tracks; and the tracks are formed on bottom portions of the spaced apart arms.
Rezach discloses a receiver (#80, Fig 10b) having spaced apart arms (#90, #92), a saddle (#220) and tracks (#201, #203), and the tracks are formed on bottom portions of the spaced apart arms (as seen in Fig 10b, the tracks #201, #203 are at bottom portions of each arm), the spaced apart arms guide the saddle along the tracks
(Fig 10a-10c), the saddle (#220) pivotably moveable to adjust the orientation of the rod (#12) relative to the receiver (abstract, paragraph 39, Fig 2-3).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Carruth as modified to a saddle and tracks at the bottom portions of the arms in view of Rezach above because the saddle and tracks adjust the orientation of the rod relative to the receiver.
Claims 12, 15-16, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Carruth US 2018/0228518 in view of Saidha US 2010/009445, Morrison US 2002/0029040, and Prevost US 2011/0106179.
Regarding Claim 12, Carruth discloses a spinal construct (Fig 1a-1b) comprising:
an existing receiver (#104) comprising a first pair of spaced apart arms (see Fig below) defining a first opening (see Fig below) and a first cavity (see Fig below), inner surfaces of the arms defining a first thread (paragraph 65, see Fig below where threads of set screw #108 engage with the first thread);
a first rod (#106) disposed in the first cavity (Fig 1a);
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a connector (see Fig below) comprising:
a first body (see Fig below), the first body defining a central axis (axis A1, Fig 1b) and having a proximal wall (see Fig below) and a side wall (see Fig below) extending from the proximal wall, the proximal wall and the side wall defining a sleeve (see Fig below), a proximal surface of the proximal wall (see Fig below),
the sleeve including an inner surface that defines a cavity (see Fig below), the cavity being configured for disposal of an existing receiver (Fig 1a, paragraph 68), and
a second body (see Fig below), the second body having a second rod receiver (see Fig below), the side wall being spaced apart from the second rod receiver by the proximal wall (see Fig below, Fig 1d), the second rod receiver having an inner surface (see Fig below) and a second pair of spaced apart arms (see Fig below) that define an implant cavity in the form of a U-shaped passageway (#152, paragraph 61, see Fig below, Fig 1d), the inner surface of the second rod receiver including a thread form (paragraph 72 where fastener #134 engages the thread form);
a second spinal rod (#107, Fig 1a) disposed in the implant cavity (Fig 1a);
a set screw extending between a proximal end and a distal end thereof (see Fig below), the set screw comprising a first mating surface (see Fig below), a second mating surface (see Fig below), the first mating surface being configured for engagement with the first thread (as seen in Fig 1a, paragraph 65);
and a nut (#132, see Fig below) comprising a tool engaging surface (see Fig below), a cavity (see Fig below) configured for engagement with the second mating surface of the set screw (Fig 1a, paragraph 61),
wherein the nut is configured to engage the proximal wall to clamp the connector to the existing receiver (paragraph 61, Fig 1a).
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Carruth does not disclose
the proximal surface of the proximal wall having a planar configuration and extending perpendicular to the central axis,
the cavity having a substantially rectangular cross-section,
the proximal wall being flush with proximalmost surfaces of the spaced apart arms of the second rod receiver, the spaced apart arms of the second rod receiver each extending parallel to the central axis
a first circumferential flange between the first and second mating surfaces,
the nut having a second circumferential flange, and a break off portion,
wherein the nut is configured to engage the proximal wall to clamp the connector to the existing receiver such that the existing receiver is spaced apart from the proximal wall, wherein the first circumferential flange has a maximum diameter that is greater than maximum diameters of the mating surfaces such that the first circumferential flange engages the proximal wall when the connector is clamped to the existing receiver,
wherein a distal end of the sleeve at least partially overlaps with the rod implant disposed in the existing receiver along a plane that is substantially transverse to the central axis when the connector is disposed in a position of use.
Carruth discloses a set screw (#134) configured for engagement with a rod implant (#107) disposed in the second rod receiver (Fig 1a) but does not disclose a protrusion formed on a surface defined around the distal end of the set screw and comprising a semi-spherical configuration, the protrusion configured for engagement with a rod implant disposed in the second rod receiver.
Carruth discloses a similar embodiment of a connector (Fig 6a) having a first body with a proximal wall having a proximal surface with a planar configuration (see Fig below), wherein the proximal wall is flush with proximalmost surfaces of the spaced apart arms (see Fig below where the proximal surface of the proximal wall is flush with the proximal most surfaces of the arms).
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Carruth disclose another similar embodiment of a connector (Fig 9a-9c) having a first body defining a central axis (see Fig below) and a second body defining a second receiver the spaced apart arms each extending non-parallel to the central axis (paragraph 121 “curved or angled”) or parallel to the central axis (see Fig below, paragraph 121 “straight”), the spaced apart arms receiving a rod therebetween (paragraph 121).
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It would also have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the proximal surface of Carruth to have a planar configuration and flush with the proximalmost surfaces of the arms in view of another embodiment of Carruth above because this provides a known alternate shape for the proximal surface for the connector. The examiner notes that this modification is a change of shape which has been held to be an obvious design choice since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a proximal surface for a connector. In re Dailey and Eilers, 149 USPQ 47 (1966). See also MPEP 2144.04 (IV)(B).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the spaced apart arms of Carruth to be parallel to each other and to the central axis in view of another embodiment of Carruth because this provides a known alternative configuration/shape for the arms to receive a rod therein.
Saidha discloses a set screw (Fig 14) having first mating surface (#116) configured to engage with an existing receiver (#20, Fig 13, paragraph 76), second (#120) mating surface configured to engage a nut (#122, Fig 13, paragraph 77) and a first circumferential flange (#415) therebetween (Fig 14), wherein the first circumferential flange has a maximum diameter that is greater than maximum diameters of the mating surfaces (Fig 13, paragraph 89 where the flange #415 prevents a connector #450 from contacting the existing receiver #20 when the first mating surface #116 is threaded into the existing receiver) such that the first circumferential flange engages a connector (#450) when the connector is clamped to the existing receiver (Fig 13, paragraph 89), the flange (#41) substantially reducing and/or eliminating loading of the connector to the existing receiver such that likelihood of failure is reduced (ends of paragraphs 79 and 89, Fig 13 where the flange maintains separation between the bottom of connector #450 and the top of the existing receiver #20). Saidha further teaches another embodiment (Fig 15-16) with a connector having a sidewall and a proximal wall (see Fig below), a proximal surface of the proximal wall having a planar configuration and extending perpendicular to a central axis (see Fig below), the proximal wall and sidewall defining a cavity to receive an existing fastener (see Fig below), the cavity having a substantially rectangular cross-section (see Fig below), wherein a distal end of the sleeve at least partially (see Fig below) overlaps with the rod implant disposed in the existing receiver along a plane (see Fig below where the plane is a plane along the longitudinal axis of the rod implant #45) that is substantially transverse to the central axis when the connector is disposed in a position of use (see Fig below).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the set screw of Carruth to include a flange in view of Saidha above because the flange maintains separation between a bottom surface of the connector and the top of the existing receiver such that there is substantial reduction and/or elimination of loading of the connector to the existing receiver such that likelihood of failure is reduced. With the modification to include the flange, Carruth as modified discloses wherein the nut is configured to engage the proximal wall to clamp the connector to the existing receiver such that the existing receiver is spaced apart from the proximal wall (as discussed above, the flange would maintain separation between the top of existing receiver and the bottom of the proximal wall such that the existing receiver is spaced from the proximal wall).
It would also have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the cavity of Carruth to have a substantially rectangular configuration with a distal end of the side-wall partially overlapping the rod implant, respectively in view of Saidha above because this provides a known alternate shape for a cavity to receive an existing receiver. The examiner notes that this modification is a change of shape which has been held to be an obvious design choice since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a cavity for receiving an existing receiver. In re Dailey and Eilers, 149 USPQ 47 (1966). See also MPEP 2144.04 (IV)(B). Examiner notes that with the modification to have the distal end of the side wall partially overlap the implant, one can recognize that there is a more stabile connection between the sleeve and existing receiver as compared to a configuration where the sleeve does not partially overlap.
Morrison discloses of a nut (#44, Fig 6a, 6c) comprising a tool engagement surface (#78), a threaded cavity (#82) to engage a screw (paragraph 71), circumferential flange (see Fig below), and a break off portion (#76) so that when tightening the nut, the break off portion will break off at a certain torque and will prevent over torqueing the nut (paragraph 75).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the nut Carruth as modified with the nut of Morrison with the features discussed above because when tightening the nut, the break off portion will break off at a certain torque and will prevent over torquing the nut.
Prevost discloses a protrusion (#28, Fig 3-4) formed on a surface (#29) defined around the distal end of a set screw (Fig 3, 5) and comprising a semi-spherical configuration (as seen in Fig 3, 5, paragraph 25), the protrusion configured for engagement with a rod implant (#3) disposed in a rod receiver (#20, Fig 1), the protrusion helping to provide a strong grip when pressed against the rod implant (paragraph 25).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the screw of Carruth to include a protrusion in view of Prevost above because the protrusion provides a strong grip when pressed against the rod implant.
Regarding Claim 18, Carruth as modified discloses the first mating surface is a second thread (paragraph 65 in Carruth, as seen in annotated Fig 1b above in claim 12) and the second mating surface is a third thread (paragraph 61 in Carruth and as seen in annotated Fig 1b above in claim 1), the second thread having a major diameter greater than a major diameter of the third thread (as seen in Fig 1b in Carruth).
Regarding Claim 19, Carruth as modified discloses wherein the maximum diameter of the first mating surface is greater than the maximum diameter of the second mating surface (as seen in Fig 1b in Carruth, see also annotated Figs of Carruth above in claim 12).
Regarding Claim 15-16, Carruth as modified discloses the claimed invention as discussed above but does not disclose a planar bottom surface of the nut directly engages with the proximal surface of the proximal wall.
Regarding Claim 15-16, Carruth as modified discloses the claimed invention as discussed above but does not disclose the inner surface includes gripping elements, the inner surface has a surface configured to facilitate engagement selected from the group consisting of rough, arcuate, undulating, mesh, semi-porous, dimpled and textured
However, in another embodiment (Fig 6a), Carruth discloses an inner surface includes gripping elements configured to facilitate engagement, the gripping elements selected from the group consisting of rough, arcuate, undulating, mesh, semi-porous, dimpled and textured (#646, "teeth" texture, paragraph 99) to engage a corresponding surface (#666) on a flange to help resist rotation there between (paragraph 98).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Carruth as modified to have the flange and inner surface to be include gripping elements in the form of texturing in view of another embodiment of Carruth above in order to help resist rotation between the flange and inner surface.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Carruth US 2018/0228518, Saidha US 2010/009445, Morrison US 2002/0029040, and Jackson US 6,004,349, as applied to claim 12 above, and in further view of Kalfas US 2005/0228326.
Carruth as modified discloses the claimed invention as discussed above a bottom surface of the nut directly engages the proximal surface of the proximal wall (Fig 1a in Carruth) but does not disclose the bottom surface of the nut is planar.
Kalfas discloses a similar device with a connector (#124, Fig 1a) having a proximal surface (#142) that is a bearing surface that engages a bottom bearing surface of a nut (#118)(Fig 1b, paragraph 65), where the bearing surfaces of the nut and connector can be domed or planar (“flat” see the end of paragraph 62, 71, see also Fig 5a-5b where bearing surfaces if flat/planar), the nut coupling to a set screw (#116) to couple the connector and an existing receiver (#114)(Fig 1a-1b, paragraph 65).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the bottom surface of the nut to be planar and for the proximal surface to be entirely flat in view of Kalfas above because this provides a known type of bearing surface for the nut to engage and couple to a connector to help couple an existing receiver to the connector. The examiner notes that this modification is a change of shape which has been held to be an obvious design choice since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a proximal surface for a connector to couple with a nut. In re Dailey and Eilers, 149 USPQ 47 (1966). See also MPEP 2144.04 (IV)(B). [Examiner further notes that the shape of the proximal surface of Carruth is not limiting as Carruth states that “1409 of the connector 130 can have a domed or spherical shape” (paragraph 70)].
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Carruth US 2018/0228518, Saidha US 2010/009445, Morrison US 2002/0029040, and Jackson US 6,004,349, as applied to claim 12 above, and in further view of Haskins US 2012/0130436.
Carruth discloses the claimed invention as discussed above but does not disclose a distal surface of the side wall defines a recess.
Haskins discloses a connector (#210, Fig 2-3) defining a sleeve defining a cavity (as seen in Fig 3) to engage and receive an existing receiver (#140) such that an spinal rod (#110, where the rod #310 is in the receiver #140) is disposed in recess (#242, c- shaped recess, Fig 2-3) to provides a more stable coupling between the connector and existing receiver (Figs 1-3 where the hook is c-shape/arcuate to match the outer contour of the rod).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Carruth as modified to have a distal surface of the side wall define a recess in view of Haskins above because the recess can accommodate the outer contour of the rod (that is in the existing receiver) and thus provide a more stable coupling between the connector and existing receiver.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Carruth US 2018/0228518, Saidha US 2010/009445, Morrison US 2002/0029040, and Jackson US 6,004,349, as applied to claim 12 above, and in further view of Rezach US 2011/0257690.
Carruth as modified discloses the claimed invention as discussed above where the second receiver receives a rod (#907, Fig 9a in Carruth) but does not disclose the second rod receiver includes a saddle and tracks; and the tracks are formed on bottom portions of the second pair of spaced apart arms.
Rezach discloses a receiver (#80, Fig 10b) having spaced apart arms (#90, #92), a saddle (#220) and tracks (#201, #203), and the tracks are formed on bottom portions of the spaced apart arms (as seen in Fig 10b, the tracks #201, #203 are at bottom portions of each arm), the spaced apart arms guide the saddle along the tracks
(Fig 10a-10c), the saddle (#220) pivotably moveable to adjust the orientation of the rod (#12) relative to the receiver (abstract, paragraph 39, Fig 2-3).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Carruth as modified to a saddle and tracks at the bottom portions of the arms in view of Rezach above because the saddle and tracks adjust the orientation of the rod relative to the receiver.
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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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