DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The priority date of this claims 1-14 and 16-20 will be set as April 2, 2020. The earliest filing that provides support for the method and apparatus is the Application 16/838827.
Claim 15 will receive the priority date of January 26, 2011.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1, 2 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Sommers (U.S. Patent No. 8092505).
Sommers discloses a method for fixing a first bone to a second bone, the method comprising: providing an anchor (40) comprising a core (60), extending along an axis (62) defining axial (along axis 62) and radial directions (the anchor has a radial component to the axis) and having a base end (58) and a point end (84), and a plurality of splines (64, 66), each spline extending radially away from and substantially perpendicular to the core (Figure 3) and tapering at the point end (see figure, arrow points to a taper);
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providing access to two bones (Figures 4-8), each presenting a cortical surface to be joined to the other; penetrating, by the anchor, thereby fixing each of the cortical surfaces in at least two degrees of freedom with respect to the other in response to engagement of each by the splines (Figure 6-8).
Regarding claim 2, the core further comprises a lumen (86) that enables guiding the anchor, and wherein the access is provided by at least one of an incision, a dilation, insertion of a guide, reaming, broaching, installing a portal, and inserting tools along a guided path (Figure 4-6).
Claim(s) 1, 2, 4-7, 9 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Trudeau (U.S. Publication No. 2013/0053902).
Trudeau discloses a method for fixing a first bone to a second bone, the method comprising: providing an anchor (200) comprising a core (210), extending along an axis (Figure 3A, axis considered going longitudinally down center of the anchor) defining axial (along the axis) and radial directions (the anchor has a radial component to the axis) and having a base end (208) and a point end (202), and a plurality of splines (as seen, the core 210 is made of 4 concave surfaces, it can be considered that the rounding where the concave surfaces meet are splines), each spline extending radially away from and substantially perpendicular to the core (i.e they have a width that extends out form the core) and tapering at the point end (Figure 3A, 3B);
providing access to two bones (Figures 4A-4B), each presenting a cortical surface to be joined to the other; penetrating, by the anchor, thereby fixing each of the cortical surfaces in at least two degrees of freedom with respect to the other in response to engagement of each by the splines (Figure 4A-4B).
Regarding claim 2, the core further comprises a lumen (214) that enables guiding the anchor, and wherein the access is provided by at least one of an incision, a dilation, insertion of a guide, reaming, broaching, installing a portal, and inserting tools along a guided path (Figure 4A-4B, can be considered at least an incision is made).
Regarding claim 4, the method further comprising installing multiple anchors engaging the two bones, effecting fixation with respect to one another in six degrees of freedom (Figure 4A-4B).
Regarding claim 5, the two bones are a sacrum and an ilium (Figure 4A, 4B)
Regarding claim 6, the core further comprises a lumen (214) that enables guiding the anchor, and wherein the access is provided by at least one of an incision, a dilation, insertion of a guide, reaming, broaching, installing a portal, and inserting tools along a guided path (Figure 4A-4B, can be considered at least an incision is made).
Regarding claim 7, the access is at lease one of a posterior access and a lateral-posterior process. From Figures 9A and 10A it can be seen from the direction of the taper that the anchors are inserted from posterior access.
Regarding claim 9, the anchor crosses the cortical surfaces in a direction principally orthogonal to both cortical surfaces (Figure 4A), and further comprising: providing a second anchor comprising a second core, extending along an axis defining axial and radial directions and having a second base end and a second point end, and a second plurality of splines, each spline extending radially away from and substantially perpendicular to the second core and tapering at the second point end; and penetrating, by the second anchor, along a joint region between the cortical surfaces principally parallel to both cortical surfaces (Figure 4A).
Claim(s) 15-19 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Donner (U.S. Patent No. 8979928).
Although written separately, it is considered that the 102(b) designation is for the combination of claims 15 and 16 together. Claims 17-19 depend from claim 16 and thus are also addressed under 102(b).
Donner discloses an apparatus comprising: a core (7) having a base end (34) and a point end (12); a plurality of splines (14, 15, 26, 27); the base end and the point end each lying along a central axis defining a radial direction, proceeding orthogonally away therefrom (Figure 10); and the splines extending between the base end and the point end, each extending radially away from the central axis (Figure 10).
Regarding claim 16, the point end is selected from a solid point (Figure 10), constituted by a convergence of the splines (Figure 10) at a corresponding narrowing of a diameter of the core (Figure 15, the core at point 12 narrows), and a hollow point (Figure 10, 15, bore 9 allows a guide pin, thus the tip must be hollow, Column 6, lines 53-54), constituted by a tubular core from which the splines extend radially (Figure 10, 15).
Regarding claim 17, the splines further comprise barbs (Column 10, Lines 35-43, the antimigration elements can be considered part of the spline system as a whole, thus the “the splines further comprise barbs”) and the material of the anchor is selected from the group consisting of: a metal, a polymer, a reinforced polymer, and a bone (Column 7, Lines 32-43).
Regarding claim 18, the anchor further comprises at least one grow-through space (32) and the material of the anchor is selected from the group consisting of: an allograft, a homograft, and an autograft (Column 12, Lines 15-67).
Regarding claim 19, the core is tapered, having a circumference that is greater at the base end as compared to the point end (Figure 11, the very tip is tapered).
Claim(s) 15, 16, 20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Donner et al. (U.S. Patent No. 9408715).
Donner discloses an apparatus comprising: a core (102) having a base end (106) and a point end (104); a plurality of splines (see arrow in figure, there is also a spline on the side not shown); the base end and the point end each lying along a central axis defining a radial direction, proceeding orthogonally away therefrom (Figure 9A); and the splines extending between the base end and the point end, each extending radially away from the central axis (Figure 9A, 9B).
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Regarding claim 16, Donner discloses the point end is selected from a solid point, constituted by a convergence of the splines (Figure 9A, 9B) at a corresponding narrowing of a diameter of the core (Figure 9A, 9B).
Regarding claim 20, a frame is provided with anchor apertures capable of receiving and guiding a plurality of the anchors in directions capable of securing multiple bones to the frame and effecting through-growth between the multiple bones through the frame (Figure 10J).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1, 2, 3, 5- 8, 10, 12-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beck (U.S. Publication No. 2014/0012340) in view of Goldhahn et al. (U.S. Patent No. 6645212).
Regarding claims 1 and 10, Beck discloses a method for fixing a first bone to a second bone, the bones each comprising a cortical portion and a medullar portion (Figure 6, S.I joint), the method comprising: selecting an anchor (32) comprising a core (38), hollow inside (Figure 4), the core extending along an axis (a), the axis defining axial and radial directions with respect thereto (has both, but the radial direction is 0), providing access to two bones, wherein the two bones are a sacrum and an ilium (paragraph 57), each presenting a cortical surface to be joined to the cortical surface of the other (paragraph 61); penetrating, by the anchor (paragraph 61), fixing each of the cortical surfaces in at least one degree of freedom with respect to the other (paragraph 61, Figure 13).
Beck fails to disclose the anchor having a plurality of splines that extend radially away from and substantially perpendicular to the core. Goldhahn et al. teaches an anchor for use in bone having a core (1) and a plurality of splines (3) that extend radially and perpendicularly away from the core (Figure 3-5). Such is an improvement over cortical screws because it has superior strip forces and failure strains (Column 1, lines 30-34 indicates a need to improve inferior strip forces and failure strains). It would have been obvious to one skilled in the art to construct the device of Beck with a plurality of splines that extend radially away from and substantially perpendicular to the core in view of Goldhahn et al. in order to improve strip and failure forces.
Regarding claim 2, the core (of Beck) further comprises a lumen (42) that enables guiding the anchor, and wherein the access is provided by at least one of an incision, a dilation, insertion of a guide, reaming, broaching, installing a portal, and inserting tools along a guided path (Figure 6-9).
Regarding claim 3, the access (Beck) is provided by a process including an incision, a dilation, insertion of a guide, installing a portal, and inserting tools through the portal (paragraph 7, 57).
Regarding claim 5 (Beck), the two bones are a sacrum and an ilium (paragraph 57).
Regarding claim 6 (Beck), wherein the core further comprises a lumen (42) that enables guiding the anchor, and wherein the access is provided by at least one of an incision, a dilation, insertion of a guide, reaming, broaching, installing a portal, and inserting tools along a guided path (Figure 6-9).
Regarding claim 7 (Beck), the access is at least one of a posterior access and a lateral-posterior access (Figure 6-9).
Regarding claim 8, the posterior superior iliac spine (PSIS) is used as a landmark Paragraph 54).
Regarding claim 12, the core (of Beck) further comprises (42) a lumen that enables guiding the anchor, and wherein the access is provided by at least one of an incision, a dilation, insertion of a guide, reaming, broaching, installing a portal, and inserting tools along a guided path (paragraph 57).
Regarding claim 13, the access is at least one of a posterior access and a lateral-posterior access (Figure 7, Beck).
Regarding claim 14, the splines are buttressed (Figure 3, Goldhahn) and the material of the anchor is selected from the group consisting of: a metal, a polymer, a reinforced polymer, and a bone (paragraph 40, Beck).
Claim 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beck (U.S. Publication No. 2014/0012340) in view of Goldhahn et al. (U.S. Patent No. 6645212) and further in view of Warren (U.S. Publication No. 2014/0257489).
Beck and Goldhahn et al. disclose the claimed invention except for the method steps of claim 11. Warren et al. teaches accessing a spinal region by inserting a Jamshidi needle into flesh a distance to reach a first bone (paragraph 78); removing a trocar from within the Jamshidi needle (paragraph 78); inserting a guide of k-wire through the Jamshidi needle (paragraph 78); removing the Jamshidi Needle (paragraph 111); inserting through the flesh and along the guide a first dilator (paragraph 78; inserting through the flesh a second dilator having an inner diameter larger than an outer diameter of the first dilator (paragraph 84); inserting through the flesh and anchoring into at least one of the first and second bones a working portal having an inner diameter larger than an outer diameter of the second dilator (abstract); removing the dilators (abstract). This system allows for a minimally invasive approach (paragraph 10). It would have been obvious to one skilled in the art to use the access method of Warren and applied to Beck in view of Goldhahn to provide a minimally invasive approach to the SI joint. Furthermore, the steps of determining a distance into the working portal; creating a path by piloting a selected distance beyond the working portal; and fixing the first bone with respect to the second bone in at least two degrees of freedom by engaging the first and second bones by the splines of the anchor due to inserting the anchor along the path would be made obvious by the combination as such steps are part of the surgery of Beck (paragraphs 54-59 of Beck).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/Primary Examiner, Art Unit 3775