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 § 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 11-13 and 24 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 11 is dependent on claim 1 and as both claims refer to “the cage body” (see lines 3 and 10 of claim 11) and “the first contact surface” and “the second contact surface” (see claim 11 lines 9-11 and 13-15) it is not clear which of these elements is being referred to (e.g., introduced in claim 1 or in claim 11). Also, are there two sets of cages and associated bodies and contact surfaces? Please note that claims 12 and 13 contain similar antecedent basis issues as they are each dependent from claim 11 and recite the same elements. Please amend these claims to assign specific contact surfaces to specific structure (e.g., the body of the implant on whole or to the cage body specifically) and specifying the body of the implant as a whole versus a body of the cage structure, as appropriately intended.
Regarding claims 12 and 24, the phrase "type" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "type"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Please remove “type” or amend with specific structure to clarify the scope of these claims.
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.
Claim(s) 1-8, 11, 12, 16-21 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (US 20080058939) in view of Eisermann (US 20040158328), and further in view of McConnell (US 20140074241). *Note that the claims are presented below by group, then numerical order.
With respect to claims 1, 3-6, 18 and 19, Hughes teaches a cage (e.g., 30) for vertebral arthrodesis operations (e.g., see abstract) a body (see fig. 2 below) having a first contact surface (e.g., 38) for contact with a first vertebral endplate (see para. 20) and a second contact surface (e.g., 48) for contact with a second vertebral endplate (see para. 21), the first contact surface and the second contact surface being arranged opposite each other in a coronal heightwise direction of the cage (see fig. 2-3 below), an entry side (e.g., insertion side) for entry into an intervertebral disc space and a pushing side opposite to the entry side in a direction of insertion into the intervertebral disc space (see para. 18-19, also see para. 29 which refers to para. 52 of incorporated application 11/101,685- note that anterior, transverse and posterior approaches are discussed), wherein the cage has at least one directional guide relief (44) formed on at least one of two opposite surface contact surfaces being the first contact surface and the second contact surface for contact with a vertebral endplate (see fig. 2-3 below); wherein said at least one directional guide relief is configured and arranged to guide the cage along a predefined movement trajectory for insertion of the cage between the first vertebral endplate and the second vertebral endplate from an entry point as far as a predefined correct end position between the first vertebral endplate and the second vertebral endplate (see fig. 2-3 below and para. 21, 27, 29), as a result of insertion of the cage between the vertebral endplates from the entry side by means of action on the pushing side (see para. 27); and wherein said at least one directional guide relief comprises a continuous relief which has an inclined rectilinear development or mixed development with at least one inclined rectilinear section (see fig. 2-3 below).
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Hughes teaches a variety of directional guide reliefs (e.g., 44, 80, 108, 108+120, 108+122, 108+124- see fig. 2-10) and the direction guiding relief is uninterrupted, extending over the whole surface from the entry side to the pushing side (see fig. 2-3 above). Hughes does not appear to explicitly teach wherein said at least one directional guide relief comprises a rectangular development acutely angled in a plane of the at least one of two opposite contact surfaces or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces, configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory; and said at least one directional guide relief projects from the contact surface of the cage with a height on the vertical-coronal direction of between 0.5mm and 4 mm; wherein the at least one directional guide relief projects from the contact surface of the cage or from the first contact surface of the plate with a height in the vertical-coronal direction less than or equal to 2 mm, preferably of between 1 and 2 mm; and further comprising a directional guide relief which has a mixed development with at least one rectilinear section and at least one curvilinear section; and the relief with mixed development comprises a first rectilinear section, preferably proximal to the entry side, and a second curvilinear section connected to the rectilinear section; or in that the directional guide relief extends over a partial section from the entry side to the pushing side.
Eisermann, also drawn to spinal implants with direction guide reliefs (e.g., keels), teaches a variety of alternate equivalent (keel) configurations (see para. 93 and 99, fig. 4a-31b), including, wherein said at least one directional guide relief comprises a rectangular development (e.g., 68) acutely angled in a plane of the at least one of two opposite contact surfaces (e.g., keel contacting surfaces of vertebral endplates 44, 42- see fig. 4b below) or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces (e.g., keel contacting surfaces of 44, 42- see fig. 4b below), configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory (see para. 99 below); the relief with mixed development comprises a first rectilinear section, preferably proximal to the entry side, and a second curvilinear section connected to the rectilinear section; or in that the directional guide relief extends over a partial section from the entry side to the pushing side; including the relief with mixed development comprises a first rectilinear section, preferably proximal to the entry side, and a second curvilinear section connected to the rectilinear section (e.g., see fig. 28, para. 157-158); or in that the directional guide relief extends over a partial section from the entry side to the pushing side (e.g., see para. 195, fig. 39) in order to provide a directional guide relief that is offset, angled, oriented or positioned relative to first and second vertebral endplates for circumvention of veins, arteries, bony portions or other obstacles that may be in place during insertion of the implant (see para. 99 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Hughes wherein said at least one directional guide relief comprises a rectangular development acutely angled in a plane of the at least one of two opposite contact surfaces or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces, configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory; the relief with mixed development comprises a first rectilinear section, preferably proximal to the entry side, and a second curvilinear section connected to the rectilinear section; or in that the directional guide relief extends over a partial section from the entry side to the pushing side, in view of Eisermann, as a matter of engineering design choice, in order to provide an alternate equivalent directional guide relief that is offset, angled, oriented or positioned relative to first and second vertebral endplates for circumvention of veins, arteries, bony portions or other obstacles that may be in place during insertion of the cage.
McConnell, also drawn to cages (see abstract), teaches at least one directional guide relief (e.g., keel) projects from the contact surface of the cage with a height on the vertical-coronal direction of between 0.5mm and 4 mm (see para. 60-61 below); and characterized in that it comprises a directional guide relief which has a mixed development with at least one rectilinear section and at least one curvilinear section (see para. 60-61 below) in order to provide a known dimension and shape that will allow the desired fixation of the directional guide relief (e.g., keel) into bone (see para. 60-61 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hughes wherein the at least one directional guide relief projects from the contact surface of the cage with a height on the vertical-coronal direction of between 0.5mm and 4 mm; wherein the at least one directional guide relief projects from the contact surface of the cage or from the first contact surface of the plate with a height in the vertical-coronal direction less than or equal to 2 mm, preferably of between 1 and 2 mm; and further comprising a directional guide relief which has a mixed development with at least one rectilinear section and at least one curvilinear section, in view of McConnell, in order to provide a known dimension and shape that will allow the desired fixation of the directional guide relief (e.g., keel) into bone.
As for the at least one directional guide relief projecting from the contact surface of the cage with a height in the vertical-coronal direction less than or equal to 2 mm, preferably of between 1 and 2 mm, the combination of Hughes and McConnell contemplates modification of the guide relief (see para. 29 of Hughes) and/or selection of a guide relief from a kit (see para. 60-61 above of McConnell) in order to select or provide the most appropriate guide relief for the patient (see McConnell para. 61 above). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the guide relief of Hughes, as modified by McConnell, in order to select or provide the most appropriate guide relief for the patient, since it has been held that where the general conditions of a claim are disclosed, in the prior art, discovering optimum or workable ranges involves only routine skill in the art (in re Aller, 105 USPQ 233).
As for claim 7, Hughes, as modified by Eisermann and McConnell, further teaches the cage according to Claim 1, wherein the at least one of the two opposite contact surfaces has an inclination increasing from the entry side to the pushing side (see fig. 3 above).
As for claim 8, Hughes, as modified by Eisermann and McConnell, further teaches the cage according to Claim 1, further comprising a plurality of directional guide reliefs (keels on 32 and 34, see para. 21 and fig. 3 above) parallel to each other and/or in that the at least one directional guide relief has a cross-sectional shape along a coronal plane which is generally triangular, preferably in the form of an equilateral triangle or rectangle, or quadrangular, rectangular or trapezoidal (see fig. 3 above).
As for claim 11, Hughes, as modified by Eisermann and McConnell, further teaches the cage according to Claim 1, further comprising a cage body (body of 36) and an adapter plate (34), wherein the cage body has a first contact surface (to receive retaining wall on inner surface 40 of 32, see para. 21 below) and a second contact surface (e.g., to receive retaining wall 54) arranged opposite each other in a coronal heightwise direction of the cage (see fig. 3 above), an entry side (e.g., insertion end) for entry into the intervertebral disc space and a pushing side opposite to the entry side in a direction of insertion into the intervertebral disc space (see fig. 3 above), wherein at least one of the first contact surface and the second contact surface of the cage body is stably joined together with the second contact surface (e.g., 54) of the at least one adapter plate (e.g., 34), so as to form a single monolithic body for insertion into the intervertebral disc space (see fig. 2-3 above), whereby the first contact surface of the adapter plate forms the at least one contact surface of the cage having formed thereon said at least one directions guide relief (see para. 34 below).
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As for claim 12, Hughes, as modified by Eisermann and McConnell, further teaches the cage according to Claim 11, wherein the at least one adapter plate comprises a means (e.g., 55) for mechanical joining of the at least one adapter plate to the cage body (see para. 21 and 25), the mechanical joining means comprising one or more of the following: one or more edges extending in the coronal direction (see fig. 3 above), from an end edge of the plate body (see fig. 3 above); and one or more fastening systems, utilizing screw or clip type fasteners (see para. 21, 25).
With respect to claims 2, 16, 17, Hughes teaches an adapter plate (e.g., 32) for a cage (36) for vertebral arthrodesis operations (see fig. 2, 3 above) having a body comprising a first contact surface (e.g., 38) and a second contact surface (e.g., retaining wall, see para. 21 above) arranged opposite each other in a coronal heightwise direction of the cage (see fig. 3 above), an entry side (e.g., insertion end) for entry into the intervertebral disc space and a pushing side opposite to the entry side in a direction of insertion into the intervertebral disc space (see para. 18-19, also see para. 29 which refers to para. 52 of incorporated application 11/101,685- note that several approaches are contemplated), the adapter plate comprising a plate body which has: a first contact surface (upper surface 38) for contact with a vertebral endplate and a second surface (lower/inner surface 40) for contact with a contact surface (see para. 21 above, fig. 2, 3 above) of the cage, the first and second contact surfaces of the plate being opposite each other in a vertical-coronal heightwise direction of the plate (see fig. 2, 3 above); an entry side (insertion end) for entry into the intervertebral disc space; and a pushing side opposite to the entry side in a direction of insertion into the intervertebral disc space (see fig. 2, 3 above); wherein the adapter plate has at least one continuous directional guide relief (44) formed on the first contact surface (see fig. 2, 3 above), which has a rectilinear development or mixed development with at least one rectilinear section (see fig. 2, 3 above); wherein the plate is configured for stable joining together with the cage so as to form therewith a single monolithic body before insertion into the intervertebral disc space (see fig. 2 above) and said at least one directional guide relief of the adapter plate is configured and arranged to guide the cage along a predefined movement trajectory suitable for insertion of the cage between the first vertebral endplate and a second vertebral endplate (see para. 27), from an entry point as far as a predefined and correct end position between the first vertebral endplate and the second vertebral endplate (see para. 27), as a result of insertion of the cage between the vertebral endplates from the entry side by means of action on the pushing side (see para. 27).
Hughes teaches a variety of directional guide reliefs (e.g., 44, 80, 108, 108+120, 108+122, 108+124- see fig. 2-10). Hughes does not appear to explicitly teach wherein said at least one directional guide relief comprises a rectangular development acutely angled in a plane of the at least one of two opposite contact surfaces or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces, configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory and said at least one directional guide relief projects from the contact surface of the cage with a height on the vertical-coronal direction of between 0.5mm and 4 mm; wherein the at least one directional guide relief projects from the contact surface of the cage or from the first contact surface of the plate with a height in the vertical-coronal direction less than or equal to 2 mm, preferably of between 1 and 2 mm; and further comprising a directional guide relief which has a mixed development with at least one rectilinear section and at least one curvilinear section.
Eisermann, also drawn to spinal implants with direction guide reliefs (e.g., keels), teaches a variety of alternate equivalent (keel) configurations (see para. 93 and 99, fig. 4a-31b), including, wherein said at least one directional guide relief comprises a rectangular development (e.g., 68) acutely angled in a plane of the at least one of two opposite contact surfaces (e.g., keel contacting surfaces of vertebral endplates 44, 42- see fig. 4b above) or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces (e.g., keel contacting surfaces of 44, 42- see fig. 4b above), configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory (see para. 99 above) in order to provide a directional guide relief that is offset, angled, oriented or positioned relative to first and second vertebral endplates for circumvention of veins, arteries, bony portions or other obstacles that may be in place during insertion of the implant (see para. 99 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Hughes wherein said at least one directional guide relief comprises a rectangular development acutely angled in a plane of the at least one of two opposite contact surfaces or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces, configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory, in view of Eisermann, as a matter of engineering design choice, in order to provide an alternate equivalent directional guide relief that is offset, angled, oriented or positioned relative to first and second vertebral endplates for circumvention of veins, arteries, bony portions or other obstacles that may be in place during insertion of the cage.
McConnell, also drawn to cages (see abstract), teaches at least one directional guide relief (e.g., keel) projects from the contact surface of the cage with a height on the vertical-coronal direction of between 0.5mm and 4 mm (see para. 60-61 above); and characterized in that it comprises a directional guide relief which has a mixed development with at least one rectilinear section and at least one curvilinear section (see para. 60-61 above) in order to provide a known dimension and shape that will allow the desired fixation of the directional guide relief (e.g., keel) into bone (see para. 60-61 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hughes wherein the at least one directional guide relief projects from the contact surface of the cage with a height on the vertical-coronal direction of between 0.5mm and 4 mm; wherein the at least one directional guide relief projects from the contact surface of the cage or from the first contact surface of the plate with a height in the vertical-coronal direction less than or equal to 2 mm, preferably of between 1 and 2 mm; and further comprising a directional guide relief which has a mixed development with at least one rectilinear section and at least one curvilinear section, in view of McConnell, in order to provide a known dimension and shape that will allow the desired fixation of the directional guide relief (e.g., keel) into bone.
As for the at least one directional guide relief projecting from the contact surface of the cage with a height in the vertical-coronal direction less than or equal to 2 mm, preferably of between 1 and 2 mm, the combination of Hughes and McConnell contemplates modification of the guide relief (see para. 29 of Hughes) and/or selection of a guide relief from a kit (see para. 60-61 above of McConnell) in order to select or provide the most appropriate guide relief for the patient (see McConnell para. 61 above). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the guide relief of Hughes, as modified by McConnell, in order to select or provide the most appropriate guide relief for the patient, since it has been held that where the general conditions of a claim are disclosed, in the prior art, discovering optimum or workable ranges involves only routine skill in the art (in re Aller, 105 USPQ 233).
As for claim 20, Hughes, as modified by Eisermann and McConnell, further teaches the adapter plate according to Claim 2, wherein at least one of the opposite contact surfaces has an inclination increasing from the entry side to the pushing side (see fig. 3 above).
As for claim 21, Hughes, as modified by Eisermann and McConnell, further teaches the adapter plate according to Claim 2, further comprising a plurality of directional guide reliefs parallel (keels on 32 and 34, see para. 21 and fig. 3 above) to each other and/or in that the at least one directional guide relief has a cross-sectional shape along a coronal plane which is in the form of an equilateral triangle, a rectangle, or a rectangular or trapezoidal quadrangular (see fig. 3 above).
As for claim 24, Hughes, as modified by Eisermann and McConnell, further teaches the adapter plate according to Claim 2, further comprising means (e.g., 55) for mechanical joining of the adapter plate to the cage body the mechanical joining means comprising one or more of the following: one or more edges (see fig. 3 above) extending in a coronal direction, from an end edge of the plate body; one or more fastening systems (e.g., via 55) , utilizing screw or clip type fasteners (see para. 21, 25).
Claim(s) 9 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (US 20080058939), Eisermann (US 20040158328), and McConnell (US 20140074241), as applied to claims 1 and 2 above, in view of Marnay (US 20050021042).
As for claims 9 and 22, Hughes, as modified by Eisermann and McConnell, contemplates modification of the dimensions of the directional guide relief(s) (see para. 29) but does not explicitly teach that the at least one directional relief has a width at the point of joining to the cage of between 1 and 4 mm and a width at the point of contact with the vertebral endplate of between 0.5 and 4 mm.
Marnay, also drawn to cages with directional guide reliefs (keels), teaches at least one directional relief has a width at the point of joining to the cage of between 1 and 4 mm and a width at the point of contact with the vertebral endplate of between 0.5 and 4 mm (see para. 66) in order to provide an appropriate amount of contact between the directional guide relief and the vertebral bone (see para. 66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hughes, as modified by Eisermann and McConnell, with the at least one directional relief has a width at the point of joining to the cage of between 1 and 4 mm and a width at the point of contact with the vertebral endplate of between 0.5 and 4 mm, in view of Marnay, in order to provide an appropriate amount of contact between the directional guide relief and the vertebral bone.
Claim(s) 10 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hughes (US 20080058939), Eisermann (US 20040158328) and McConnell (US 20140074241), as applied to claims 1 and 2 above, in view of Gittings (US 20070050032).
As for claims 10 and 23, Hughes, as modified by Eisermann and McConnell, teaches an angle of inclination of the directional guide relief (see fig. 3 above) but does not appear to explicitly state that an angle (a) of inclination of the directional guide relief is between 5° and 45°.
Gittings, also drawn to cages with directional guide reliefs (keels) (see abstract), teaches an angle (a) of inclination of the directional guide relief is between 5° and 45° (e.g., an acute angle- see para. 168) in order to provide the preferred lordosis angle to accommodate the angle between the vertebral bodies (see para. 168).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hughes, as modified by Eisermann and McConnell, with an angle (a) of inclination of the directional guide relief is between 5° and 45°, in view of Gittings, in order to provide the preferred lordosis angle to accommodate the angle between the vertebral bodies.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faulhaber (US 20160051373) in view of Eisermann (US 20040158328).
With respect to claims 13-15, Faulhaber teaches a cage (e.g., 100) for vertebral arthrodesis operations (e.g., see abstract) a body (see fig. 1, 3-4 below) having a first contact surface (e.g., upper surface) for contact with a first vertebral endplate and a second contact surface (e.g., lower surface) for contact with a second vertebral endplate, the first contact surface and the second contact surface being arranged opposite each other in a coronal heightwise direction of the cage (see fig. 1 below), an entry side (e.g., insertion side) for entry into an intervertebral disc space and a pushing side opposite to the entry side in a direction of insertion into the intervertebral disc space (see fig. 1, 3-4 below, para. 8, 26), wherein the cage has at least one directional guide relief (114) formed on at least one of two opposite surface contact surfaces being the first contact surface and the second contact surface for contact with a vertebral endplate (see fig. 1 below); wherein said at least one directional guide relief is configured and arranged to guide the cage along a predefined movement trajectory for insertion of the cage between the first vertebral endplate and the second vertebral endplate from an entry point as far as a predefined correct end position between the first vertebral endplate and the second vertebral endplate (see fig. 1, 3, 4, 9 below), as a result of insertion of the cage between the vertebral endplates from the entry side by means of action on the pushing side (see fig. 1, 3, 4, 9 below); and wherein said at least one directional guide relief comprises a continuous relief which has an inclined rectilinear development or mixed development with at least one inclined rectilinear section (see fig. 1, 3, 4, 9 below); further comprising a cage body (108, 110) and an adapter plate (106), wherein the cage body has a first contact surface (e.g., 163) and a second contact surface (e.g., 143) arranged opposite each other in a coronal heightwise direction of the cage (see fig. 1, 4, 9 below and fig. 5, 6), an entry side (e.g., see fig. 4-6) for entry into the intervertebral disc space and a pushing side opposite to the entry side in a direction of insertion into the intervertebral disc space (see fig. 4-6), wherein at least one of the first contact surface and the second contact surface of the cage body is stably joined together with the second contact surface (e.g., 199 or 198) of the at least one adapter plate (e.g., 106), so as to form a single monolithic body for insertion into the intervertebral disc space (see fig. 9 below), whereby the first contact surface of the adapter plate forms the at least one contact surface of the cage having formed thereon said at least one directions guide relief (see fig. 1 below); wherein the at least one adapter plate covers the whole of the cage surface with which it is in contact or wherein the adapter plate covers only a part of said cage surface (see fig. 1 below); wherein preferably, the plate body is in the form of a strip having a smaller width then the corresponding width of the cage body (see fig. 1 below); further comprising a transverse dimension greater than the sagittal dimension for latero-lateral insertion (see fig. 1, 3, 4 and 9 below); and further comprising a transverse dimension congruous with the sagittal dimension for antero-posterior insertion (see fig. 1, 3, 4 and 9 below).
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Faulhaber does not appear to explicitly teach wherein said at least one directional guide relief comprises a rectangular development acutely angled in a plane of the at least one of two opposite contact surfaces or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces, configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory.
Eisermann, also drawn to spinal implants with direction guide reliefs (e.g., keels), teaches a variety of alternate equivalent (keel) configurations (see para. 93 and 99, fig. 4a-31b), including, wherein said at least one directional guide relief comprises a rectangular development (e.g., 68) acutely angled in a plane of the at least one of two opposite contact surfaces (e.g., keel contacting surfaces of vertebral endplates 44, 42- see fig. 4b above) or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces (e.g., keel contacting surfaces of 44, 42- see fig. 4b above), configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory (see para. 99 above) in order to provide a directional guide relief that is offset, angled, oriented or positioned relative to first and second vertebral endplates for circumvention of veins, arteries, bony portions or other obstacles that may be in place during insertion of the implant (see para. 99 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Faulhaber wherein said at least one directional guide relief comprises a rectangular development acutely angled in a plane of the at least one of two opposite contact surfaces or a mixed development with at least one rectangular section acutely angled in the plane of the at least one of two opposite contact surfaces, configured to cause a gradual deviation of the cage from a rectilinear insertion trajectory, in view of Eisermann, as a matter of engineering design choice, in order to provide an alternate equivalent directional guide relief that is offset, angled, oriented or positioned relative to first and second vertebral endplates for circumvention of veins, arteries, bony portions or other obstacles that may be in place during insertion of the cage.
Response to Arguments
The amendment to the claims, entered on 1/30/2026, overcomes the objections made to claims 1, 3-16 and 24 and the USC 112b rejections made to claims 1, 3-10 and 15.
The USC 112b rejection made to claims 12 and 24 is maintained as the word “type” makes the scope of the discussed limitation unclear. Please amend these claims as suggested in the rejection above (e.g., removing the word “type” or adding specific structure to clarify the scope.
A new USC 112b rejection is made to claims 11-13 regarding antecedent basis issues presented by the amendment to claims 1 and 11. Please amend these claims to assign specific contact surfaces to specific structure (e.g., the body of the implant on whole or to the cage body specifically, as suggested in the rejection above).
Applicant’s arguments with respect to claim(s) 1-24 have been considered but are moot because of the new ground of rejection. Eisermann has been added to the USC 103(a) rejections made to claims 1-4, 7-17 and 20-24. Eisermann was previously relied upon in the rejection of claims 5-6 and 18-19. Applicant argues that Eisermann does not appear to teach a “keel or other directional guide relief with a mixed development with at least one rectilinear section acutely angled in the plane of a contact surface” (see Remarks page 14). This is not found to be persuasive as the relied upon embodiment of Eisermann teaches keel/ directional guide relief 68 with a continuous top surface that is acutely angled respective a plane (e.g. rectangular plane, e.g., see fig. 4b below) of the top surface (e.g., contact surface) of 44 in order to avoid certain anatomical obstructions (see para. 99 below).
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Applicant further argues that Eisermann does not teach a keel/ directional guide relief that contains both a rectilinear section and a curved section as Eisermann only teaches a curved or rectilinear keel (not a combination of the two shapes) (see Remarks page 14). This is not found to be persuasive as Eiserman teaches a mixed shape keel/ directional guide relief (450) with a continuous top surface and a rectilinear section and a curved section (see fig. 28 below and also para. 163-164) in order to provide an alternate equivalent mixed shape keel/ directional guide relief shaped so as to allow a surgeon to avoid certain anatomical obstructions (see para. 163-164 below).
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Therefore, claims 1-24 are rejected.
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 Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773