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.
Claims 10, 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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.
Claim 10 and 20 each recites “a hook” which was not disclosed in the elected species. A hook is shown in non-elected Species C (see hook #640, #644 in Fig 29).
Claim Objections
Claims 12-19 are objected to because of the following informalities:
Claim 12 recites that the existing receiver comprises “spaced apart arms” (see line 2) but also recites that the second receiver also has “a pair of spaced apart arms” (see line 14). Likewise, see claim 17 line 3 where applicant does not specify which “spaced apart arms” applicant is referring to but since line 2 of claim 17 recites the second rod receiver, it is understood that line 3 is referring to the second rod receiver. It is suggested to use different terminology to avoid confusion.
Claim 18 recites the first mating surface is “a first thread”. However, in Claim 12, recites that the arms of the existing receiver defines “a first thread”. It is suggested to use different terminology to avoid confusion. Appropriate correction is required.
Claim 18 recites the first mating surface is “a first thread”. However, in Claim 12, recites that the arms of the existing receiver defines “a first thread”. It is suggested to use different terminology to avoid confusion. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the distal end of the screw" in line 17. There is insufficient antecedent basis for this limitation in the claim. It is not clear if applicant is referring to the distal end of the set screw recited line 14 or a different screw all together. Likewise, the set screw in line 14 is for engagement with the existing receiver where line 18 recites that the screw is for the second receiver. For examination purposes, the examiner will treat this limitation as referring to a different screw.
Claim 2 recites the limitation "the second surface" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the wall" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is not clear if applicant is referring the proximal wall or side wall recited in claim 1 or a different wall all together. The examiner will treat with art as best understood.
Claim 12 recites the limitation "the distal end of the screw" in line 22. There is insufficient antecedent basis for this limitation in the claim. It is not clear if applicant is referring to the distal end of the set screw recited line 19 or a different screw all together. For examination purposes, the examiner will treat this limitation as referring to a different screw.
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 Jackson US 6,004,349.
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.
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 screw, 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),
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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, 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).
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.
Jackson discloses a protrusion (#28, Fig 2-3) formed on a surface (#29) defined around the distal end of the screw (Fig 3), the protrusion configured for engagement with a rod implant (#5) disposed in a second rod receiver (#7, Fig 5), the protrusion helps to secure the rod implant and prevent relative movement of the rod implant with respect to the second receiver (Col 8 lines 34-39).
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 Jackson above because the protrusion helps to secure the rod implant and prevent relative movement of the rod implant with respect to the second receiver.
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 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.
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 Jackson US 6,004,349.
Regarding Claim 12, Carruth discloses a spinal construct (Fig 1a-1b) comprising:
an existing receiver (#104) comprising 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 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.
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 screw, 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),
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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, 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).
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.
Jackson discloses a protrusion (#28, Fig 2-3) formed on a surface (#29) defined around the distal end of the screw (Fig 3), the protrusion configured for engagement with a rod implant (#5) disposed in a second rod receiver (#7, Fig 5), the protrusion helps to secure the rod implant and prevent relative movement of the rod implant with respect to the second receiver (Col 8 lines 34-39).
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 Jackson above because the protrusion helps to secure the rod implant and prevent relative movement of the rod implant with respect to the second receiver.
Regarding Claim 18, 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 12) 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 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 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
Examiner notes the following references already cited which have similar connectors to the invention, Stein US 2017/0348026 and Null US 20080177323.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773