DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 have been presented for examination based on the application filed on 2/1/2023.
Claims 1 & 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NPL by Naddeo, A. et al. "An automatic and patient-specific algorithm to design the optimal insertion direction of pedicle screws for spine surgery templates". Med Biol Eng Comput 55, 1549–1562 (2017). https://doi.org/10.1007/s11517-017-1627-9.
Claim(s) 2-3 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al., further in view of US PGPUB No. US 20150100067 A1 by Cavanagh; Peter R. et al.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al., further in view of US PGPUB No. US 20050267473 A1 by Vaughan, Paul A.
Claim(s) 7-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al., further in view of US PGPUB No. US 20240299095 A1 by Widmer; Jonas et al.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of Hedblom; Anders et al., in view of Widmer; Jonas et al., further in view of US PGPUB No. US 20190336179 A1 by Pak; Shane S. et al.
Claim(s) 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of Widmer; Jonas et al., further in view of US PGPUB No. US 20190336179 A1 by Pak; Shane S. et al.
This action is made Non-Final.
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Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 & 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NPL by Naddeo, A. et al. "An automatic and patient-specific algorithm to design the optimal insertion direction of pedicle screws for spine surgery templates". Med Biol Eng Comput 55, 1549–1562 (2017). https://doi.org/10.1007/s11517-017-1627-9.
Regarding Claims 1 & 20
Naddeo teaches (Claim 1) A method for optimization of spine screw placement in a spine of a patient (Naddeo: Pg.1549, §“Introduction” - "... The procedure presented in this paper allows us to optimize screws’ insertion direction inside the pedicle. The access point is chosen by the surgeon based on his own experience. The optimum insertion direction as well as the length and diameter of the screws are defined using a novel automatic algorithm that follows a patient-specific vertebra computer-aided design (CAD) model obtained through a reverse engineering operation....") , the method comprising:
(Claim 20) A non-transitory computer-readable medium having instructions stored thereon that, when executed by a computer, cause the computer to perform a method for optimization of spine screw placement in a spine of a patient (Naddeo: §3 as CAD/CAM program performing method of §3, which is computer implemented and is understood to computer stored1) , the method comprising:
a) for a first entry point on a surface of a vertebra among a plurality of vertebrae in a spine model representative of the spine of the patient, defining a first plurality of primary rays respectively representing a plurality of screw trajectories for a spine screw within the model entering from the first entry point (Naddeo: Fig.8 Flow loop to delete point & segment;
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Fig.3 – defining entry point P, Fig.4 showing first plurality of rays from point P representing screw trajectories; Pg.1551-1553, § 3.2 “Determination of the optimum insertion direction, as well as length and diameter of pedicle screws by means of an automatic algorithm”, see specifically Pg.1553 Col.2 Items 1-4; Also see Fig.8 flow chart) ; b) eliminating each of the first plurality of primary rays that intersects a boundary of one or more vertebrae of the spine model, representing a surface of an associated vertebra in the patient, thereby establishing a first set of optimized screw trajectories comprising those of the first plurality of primary rays remaining following this step (b) (Naddeo: Pg.1551-1553, § 3.2 , specifically Pg.1553 Col.2 Item 4 – here the line segments are trajectories; here the line segments [eliminating each of the first plurality of primary rays] are deleted [eliminated] that intersect the surface [boundaries]
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c) defining, for each of the first set of optimized screw trajectories, a plurality of parallel rays (Naddeo : Fig.7 parallel projection lines) disposed circumferentially around, and extending parallel to, the associated primary ray at a predetermined radius therefrom, and which represent a surface of a spine screw having the screw trajectory represented by the associated primary ray (Naddeo: Pgs.1553-1555 Items 5-8; Figs.5-7 & specifically Fig.7 showing the parallel rays disposed circumferentially around one of the rays passing through P
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d) iteratively adjusting a length of the plurality of parallel rays associated with each of said first set of optimized screw trajectories until an optimized length is determined at which the associated plurality of parallel rays present a maximum- length trajectory for a spine screw that does not intersect any said boundary of the one or more vertebra of the spine model (Naddeo: Fig.8 flow; Pg.1554 Item 8 "... Sizing of the screws’ diameter “D” using a safety coefficient “k” with the dimensions, taking into account both the size of the projected area referred to in step 7 and bone density (based on the number of Hounsfield);..."; Item 9 " Determination of the maximum length of the pedicle screw:... To select an appropriate safety coefficient h∈[0,1], the length of the screw is defined as Ls=Lh. In this way, there is a guarantee that the screw tip goes into the vertebral body but not beyond the semi-vertebra and, therefore, does not come into contact with other screws...." );
e) presenting a list of the first set of optimized screw trajectories and their associated optimized lengths for said first entry point (Naddeo: Pg.1554 Col.2 "... Generation of the segment end points “P” (identified by the surgeon), the intersection point of the “optimum direction” (defined in step 6), and the closed surface above. The length “L” of this segment represents a reference
for determining the length of the pedicle screw “Ls.”...") ; and
f) implanting a spine screw in a vertebra of the patient corresponding to a selected one of said first set of optimized trajectories (Naddeo: §4.1 “In vivo testing” of implantation of the screws using the surgical guides made from the automated process of Fig.8) .
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al. Regarding Claim 2
Teachings of Naddeo are shown in parent claim 1. Naddeo teaches the the method of claim 1, further comprising: g) for a entry point on a surface of a vertebra among the plurality of vertebrae in said spine model, defining a second plurality of primary rays respectively representing a plurality of screw trajectories for a spine screw within the model entering from the second entry point; h) eliminating each of the second plurality of primary rays that intersects a said boundary of one or more vertebrae of the spine model, thereby establishing a second set of optimized screw trajectories comprising those of the second plurality of primary rays remaining following this step (h); i) defining, for each of the second set of optimized screw trajectories, a second plurality of parallel rays disposed circumferentially around, and extending parallel to, the associated primary ray at a predetermined radius therefrom, and which represent a surface of a spine screw having the screw trajectory represented by the associated primary ray; j) iteratively adjusting a length of the second plurality of parallel rays associated with each of said second set of optimized screw trajectories until an optimized length is determined at which the associated second plurality of parallel rays present a maximum-length trajectory for a spine screw that does not intersect any said boundary of the one or more vertebra of the spine model; and k) presenting a list of the second set of optimized screw trajectories and their associated optimized lengths for said second entry point; and I) implanting a spine screw in a vertebra of the patient corresponding to a selected one of said second set of optimized trajectories, as mapped in claim 1. Although it is apparent the Naddeo’s process is repeated for second entry point on a surface of a vertebra (Naddeo: Fig.10 & §3.2-3.3 showing first and second screw guides on same vertebra, formed as a result of the process described previously in Naddeo §3.1)
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Naddeo does not show an explicitly second entry point on a surface of a vertebra.
Hedblom teaches second entry point on a surface of a vertebra (Hedblom: Fig.8A-8B, [0094]-[0096] showing two insertion points P on left and right parts of the pedicle, each projecting rays passing point pedL & pedR to determine the orientation and length of the of screws: )
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Hedblom to Naddeo to show that each pedicle has two insertion points for the screws (Hedblom: Fig.8A-8B, 9A-9B and Naddeo: Fig.10; Also see parallel rays Hedblom [0015]-[0016]; Naddeo: Fig.7) . Additional motivation to combine would have been that Hedblom and Naddeo are analogous art to the instant claim in the field of vertebral screw insertion planning (Hedblom: Abstract and Naddeo: Introduction).
Regarding Claim 3
Hedblom and Naddeo teach method of claim 2, said first and second entry points being disposed on a surface of the same vertebra of said plurality of vertebrae (Hedblom: Fig.8A-8B, 9A-9B showing points P on left and right and Naddeo: Fig.10 -11 showing guides created based on the two points on pedicle/vertebra for two screws) .
Regarding Claim 20 (rejected additionally)
Hedblom teaches A non-transitory computer-readable medium having instructions stored thereon (Hedblom : [0105]) that, when executed by a computer, cause the computer to perform a method for optimization of spine screw placement in a spine of a patient, the method as taught & mapped for claim 1 by Naddeo. The motivation to combine would be similar to claim 2 above.
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Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al., further in view of US PGPUB No. US 20150100067 A1 by Cavanagh; Peter R. et al.
Regarding Claim 4
Teachings of Naddeo & Hedblom are shown in the parent claim 2.
Naddeo & Hedblom do not explicitly teach wherein a location of the first entry point is restrained to be within a predetermined distance of the second entry point
Cavanagh; Peter R. et al. teaches wherein a location of the first entry point is restrained to be within a predetermined distance of the second entry point (Cavanagh: [0027] "...Other cost functions can be defined to maximize purchase of the bone implant, or to otherwise achieve a desired position of the implant within the target bone. In some embodiments, the optimization algorithm can constrain the position so that the implant does not penetrating the outer cortex of the target bone. In some embodiments, the optimization algorithm can constrain the position so that the implant crosses a fracture line in the target bone. In some embodiments, the insertion point for the implant can be constrained to a particular location on the target bone (for example the dorsal surface of the scaphoid or the accessible regions of the base of the fifth metatarsal..." [0031] "...In some embodiments, the insertion point for the implant can be constrained to a particular location on the target bone (for example the dorsal surface of the scaphoid). In some embodiments, the implant can be constrained so that at least a pre-defined portion (e.g. 25% of the length) lies on either side of the fracture. Any number of constraints can be included in the optimization algorithm depending on the target bone, the type of implant, etc...." – location constraints form a landmark (like dorsal surface) would be applicable to both screws and therefore effectively constrain the distance between both screws).
Motivation to combine Naddeo & Hedblom is incorporated from the parent claim.
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Cavanagh to Hedblom & Naddeo to improv on the manual placement of the screws by providing distance constraints (Cavanagh: [0027][0031]) . Additional motivation to combine would have been that Hedblom and Naddeo are analogous art to the instant claim in the field of vertebral screw insertion planning (Cavanagh: Abstract; Hedblom: Abstract and Naddeo: Introduction).
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Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al., further in view of US PGPUB No. US 20050267473 A1 by Vaughan, Paul A.
Regarding Claim 5 & 6
Teachings of Naddeo & Hedblom are shown in the parent claim 2.
Naddeo & Hedblom do not explicitly teach said first and second entry points being disposed on respective surfaces of different vertebrae of said plurality of vertebrae.
Vaughan teaches claim 5 said first and second entry points being disposed on respective surfaces of different vertebrae of said plurality of vertebrae (Vaughan: Fig.1B) and claim 6 wherein a location of the first entry point is restrained to be within a predetermined distance of the second entry point (Vaughan: [0054] "... The threaded portions 18 and 32 of the first and second pedicle screws 12 and 14 may have threads similar to those on ordinary screws which extend a distance from the shafts 16 and 30 sufficient to promote optimum anchoring of the first and second pedicle screws 12 and 14 within the first and second vertebra 20 and 34, respectively...."; [0139] "... [0139] It will be appreciated that the configuration of the first pedicle screw 12 illustrated having one or more grooves 250 extending a distance along the length of the shaft 16 may also be utilized with respect to the configuration of the first and second connecting screws 40 and 42....") .
Motivation to combine Naddeo & Hedblom is incorporated from the parent claim.
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Vaughan to Hedblom & Naddeo to show that each pedicle has two insertion points for the screws and can be in separate vertebrae to stabilize the spinal column (Vaughan: [0002] [0011] "... technical advantage of the present invention may include the capability to completely eliminate the need for disc replacement and/or spinal fusion by stabilizing vertebrae. ..."; Fig.1B Hedblom: Fig.8A-8B, 9A-9B and Naddeo: Fig.10; Also see parallel rays Hedblom [0015]-[0016]; Naddeo: Fig.7) . Additional motivation to combine would have been that Hedblom and Naddeo are analogous art to the instant claim in the field of vertebral screw insertion planning (Vaughan: [0011]-[0013]; Hedblom: Abstract and Naddeo: Introduction).
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Claim(s) 7-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al., further in view of US PGPUB No. US 20240299095 A1 by Widmer; Jonas et al.Regarding Claim 7
Teachings of Naddeo & Hedblom are shown in parent claim 2.
Naddeo teaches taking into account the density (Naddeo: Pg.1554 Col.1 Item 8 "... Sizing of the screws’ diameter “D” using a safety coefficient “k” with the dimensions, taking into account both the size of the projected area referred to in step 7 and bone density (based on the number of Hounsfield);...").
Hedblom teaches taking into account the density (Hedblom: [0080] "... [0080] Referring to FIG. 3 and FIG. 4, a plurality of points are electronically generated and/or placed with ray casting in a 3D volume of the patient image 11, from any desired (camera) angle of the image data volume in 3D. A ray can be programmed to stop when it encounters or hits dense tissue (such as bone). A visible density of the bone in the 3D image of the patient can be adjusted...").
Naddeo and Hedblom do not teach limitations of this claim explicitly.
Widmer teaches method of claim 2, the spine model including mapping of density of the plurality of vertebrae (Widmer: Fig.1 flow and then Fig. 5-Fig.8 [0076]-[0087]) , wherein the list of the first set of optimized screw trajectories also includes for each optimized screw trajectory thereof a respective first summation of the density of the associated vertebra surrounding or encompassed by the associated plurality of parallel rays (Widmer: [0080] "... Thereafter, in substep 8.3.3 all voxels of the morphed vertebra model 47 (representing bone density) within the intersection region I1-n and normal to the projection plane P1-n are summed to obtain a respective intersection region density projection Idp1-n for each of the discretely distributed projection planes P1-n. The voxels of the intersection region density projection Idp1-n each define the sum of all bone densities projected on the respective projection plane P1-n. According to embodiments disclosed herein, the Hounsfield Unit (HU) values of the CT image are used either directly or after being converted into bone material properties according to Young's modulus for obtaining the intersection region density projections Idp1-n...."; [0081] "... Details of substep 8.4 shall be described with reference to FIG. 8. In a first, iterative substep, for each intersection projection I1-n, the voxels of the intersection region density projection Idp1-n within an area delimited by a possible bone screw diameter D1-m are summed. This is repeated for each possible bone screw diameter D1-m and each possible location L1.1-x.y of the respective bone screw diameter D1-m within the respective intersection region I1-n to obtain a respective projected bone density score Pbds1.1.1.1-Pdbs n.m.x.y....") , and wherein the list of the second set of optimized screw trajectories also includes for each optimized screw trajectory thereof a respective second summation of the density of the associated vertebra surrounding or encompassed by the associated plurality of parallel rays (Widmer: [0080]-[0082] iterative process as in [0084]-[0087], In re Harza duplication of part) ; the method further comprising: m) calculating a first respective fixation for each optimized screw trajectory in each of the first and second sets of optimized screw trajectories based on the first or second density summation associated therewith(Widmer: Fig.5 step 8.4 – 8.5; [0080]-[0082] at least); n) iteratively selecting pairs of the first and second sets of optimized screw trajectories, one from each said set, and calculating an overall fixation for each such pair based on the first respective fixation thereof (Widmer: [0082] "... [0082] Thereafter, in step 8.5, the optimum screw trajectory is determined as having a direction normal to the projection plane P1-n respectively an axis crossing the center of the screw diameter D1-m corresponding to the highest projected bone density score PbdsMAX....") ; and o) presenting a list of said overall fixation and their associated pairs of the first and second sets of optimized screw trajectories (Widmer: [0084]-[0087] & Fig.5, first set would be for one screw and second set for another screw (In re Harza – duplication of part)).
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Hedblom to Naddeo to show that each pedicle has two insertion points for the screws (Hedblom: Fig.8A-8B, 9A-9B and Naddeo: Fig.10; Also see parallel rays Hedblom [0015]-[0016]; Naddeo: Fig.7) . The motivation to combine would have been that Hedblom and Naddeo are analogous art to the instant claim in the field of vertebral screw insertion planning (Hedblom: Abstract and Naddeo: Introduction).
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Widmer to Hedblom & Naddeo to supplement density based constraints to generate optimal trajectory for the screws (Widmer: [0074] "... The optimal screw trajectory and screw dimension resulting from the optimization are the one maximizing the voxel-based bone material properties within the screw volume which is the output of step 9. As mentioned above, the output can also comprise a number of optimum or near-optimum solutions which may have different advantages of handling, screw head connections between different screws etc. ..."; Widmer : Fig.8A-8B, 9A-9B and Naddeo: Fig.10; Also see parallel rays Hedblom [0015]-[0016]; Naddeo: Fig.7) . Further motivation to combine would have been that Widmer, Hedblom and Naddeo are analogous art to the instant claim in the field of vertebral screw insertion & trajectory planning (Widmer: Abstract & Fig.1; Hedblom: Abstract and Naddeo: Introduction).
Regarding Claim 8
Naddeo teaches method of claim 7, wherein the first respective fixation calculated for each of the first and second sets of optimized screw trajectories is based on a user selected fixation device (Naddeo: §3.4) .
Regarding Claim 9
Naddeo & Widmer teaches the method of claim 7, further comprising: p) calculating a second respective fixation for each of the first and second sets of optimized screw trajectories based on the respective first or second density summation (Widmer: Fig.1 & Fig.5-8 discussing summation of density in [0076]-[0082]) and an alternative fixation device (Naddeo: §3.4 & Pg.1554 Col.1 Item 8) .
Regarding Claim 10
Naddeo teaches the method of claim 9, said first and second entry points being disposed on a surface of the same vertebra of said plurality of vertebrae and said alternative fixation device includes a cross-link connecting a first spline screw in the first entry point to a second spline screw in the second entry point (Naddeo: See Figs.10-11) .
Regarding Claim 12
Widmer teaches the method of claim 1, wherein the spine model includes a mapping of density of the plurality of vertebrae (Widmer: [0056] "... The CT image comprises information allowing to determine bone density information which is extracted and stored for the discrete voxels. The step of obtaining 3D computer tomography data can also be realized by accessing a database, where the prerecorded image is stored. Furthermore, the aim of using 3D computer tomography data is twofold....") .
Regarding Claim 13
Naddeo & Widmer teach the method of claim 12, wherein the list of the first set of optimized screw trajectories also includes for each optimized screw trajectory thereof a respective first summation of the density of the associated vertebra encompassed by the associated plurality of parallel rays (Naddeo: Pg.1554 Col.1 §3.1 & Item 8 in context of Fig.7; Widmer: Fig.4A-4B shows the parallel rays as cylindrical volume passing through the vertebrae, wherein the densities are identified as summation in [0080]-[0088]) .
Regarding Claim 14
Naddeo & Widmer teach the method of claim 12, wherein the list of the first set of optimized screw trajectories also includes for each optimized screw trajectory thereof a respective first summation of the density of the associated vertebra surrounding the associated plurality of parallel rays (Naddeo: first set of optimized trajectories so that they are inside the boundaries as in Fig.4 and Item 8, where Widmer: Figs.1, 5-8, [0080]-[0088] shows the iterative process to determine trajectories based on summation of densities).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of Hedblom; Anders et al., in view of Widmer; Jonas et al., further in view of US PGPUB No. US 20190336179 A1 by Pak; Shane S. et al.Regarding Claim 15
Naddeo, Hedblom & Widmer teach the method of claim 2, the model of the vertebrae including a mapping of density of the plurality of vertebrae (Naddeo: §3.1; Widmer: [0056]) , wherein the list of the first set of optimized screw trajectories also includes for each optimized screw trajectory thereof a respective first summation of the density of the associated vertebra surrounding or encompassed by the associated plurality of parallel rays (Widmer: Fig.1 flow and then Fig. 5-Fig.8 [0076]-[0087]) , and wherein the list of the second set of optimized screw trajectories also includes for each optimized screw trajectory thereof a respective second summation of the density of the associated vertebra surrounding or encompassed by the associated plurality of parallel rays (Widmer : Fig.1 flow and then Fig. 5-Fig.8 [0076]-[0087]; iterative process, duplication as shown in the Hedblom Fig.6, 8A-8B for second screw);
The combination of Naddeo, Hedblom and Widmer do not teach the crossed out limitation regarding pullout strength above.
Pak teaches the method further comprising: I) calculating a respective pull-out strength for each optimized screw trajectory in each of the first and second sets of optimized screw trajectories based on the first or second density summation associated therewith (Pak: [0090] "... [0090] In addition, by knowing the diameter, length and type of the implanted pedicle screws 14, and the density coefficient of the vertebral body 16, the controller 400 may calculate the pull-out strength of each screw 14 (e.g., the amount of force that may be required to pull the implanted screw 14 out of the bone)....") ; and m) presenting a list of said pull-out strengths and their associated pairs of the first and second sets of optimized screw trajectories (Pak: [0084] "... [0084] The pre-surgical spinal model 24 may then be used to model, calculate or otherwise determine the desired position, alignment and trajectory of each pedicle screw and each corresponding spinal rod that may be required during the spinal surgery. It is understood that this data may be theoretically based on the pre-surgical spinal model 24. This information may include, but is not be limited to, the entry point, angular orientation, and trajectory of each pedicle screw, the location, orientation and/or position of each associated spinal rod(s), as well as other information and/or any combinations of information thereof...." ; [0090] "... [0090] In addition, by knowing the diameter, length and type of the implanted pedicle screws 14, and the density coefficient of the vertebral body 16, the controller 400 may calculate the pull-out strength of each screw 14 (e.g., the amount of force that may be required to pull the implanted screw 14 out of the bone)....").
Motivation to combine Naddeo, Hedblom & Widmer is incorporated from the parent claim.
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Widmer to Hedblom & Naddeo to supplement density based constraints to generate optimal trajectory for the screws (Widmer: [0074] "... The optimal screw trajectory and screw dimension resulting from the optimization are the one maximizing the voxel-based bone material properties within the screw volume which is the output of step 9. As mentioned above, the output can also comprise a number of optimum or near-optimum solutions which may have different advantages of handling, screw head connections between different screws etc. ..."; Widmer : Fig.8A-8B, 9A-9B and Naddeo: Fig.10; Also see parallel rays Hedblom [0015]-[0016]; Naddeo: Fig.7) . Further motivation to combine would have been that Widmer, Hedblom and Naddeo are analogous art to the instant claim in the field of vertebral screw insertion & trajectory planning (Widmer: Abstract & Fig.1; Hedblom: Abstract and Naddeo: Introduction).
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Pak to Naddeo, Hedblom & Widmer to perform load bearing analysis, stress analysis and failure analysis (Pak: [0020]) so that potential outcome of the surgical procedure can be predicted (Pak: [0088]) thereby complementing the design, manufacturing and use of such spinal screws. Further motivation to combine would have been that Pak, Naddeo, Hedblom & Widmer are analogous art to the instant claim in the field of the of vertebral screw insertion & trajectory planning (Pak: [0088]-[0090], [0115]; Widmer: Abstract & Fig.1; Hedblom: Abstract and Naddeo: Introduction).
Regarding Claim 16
Pak teaches the method of claim 15, wherein said pull-out strengths less than a user predetermined value are removed from said list of said pull-out strengths (Pak: [0084]-[0090][0115] removal as comparison).
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Claim(s) 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over NPL by Naddeo, A. et al., in view of Widmer; Jonas et al., further in view of US PGPUB No. US 20190336179 A1 by Pak; Shane S. et al.
Regarding Claim 17
Naddeo teaches A method for optimization of spine screw placement in a spine of a patient (Naddeo: Pg.1549, §“Introduction” - "... The procedure presented in this paper allows us to optimize screws’ insertion direction inside the pedicle. The access point is chosen by the surgeon based on his own experience. The optimum insertion direction as well as the length and diameter of the screws are defined using a novel automatic algorithm that follows a patient-specific vertebra computer-aided design (CAD) model obtained through a reverse engineering operation...."), the method comprising:
a) for a first entry point on a surface of a vertebra among a plurality of vertebrae in a spine model representative of the spine of the patient, defining a first plurality of primary rays respectively representing a plurality of screw trajectories for a spine screw within the model entering from the first entry point (Naddeo: Fig.8 Flow loop to delete point & segment;
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Fig.3 – defining entry point P, Fig.4 showing first plurality of rays from point P representing screw trajectories; Pg.1551-1553, § 3.2 “Determination of the optimum insertion direction, as well as length and diameter of pedicle screws by means of an automatic algorithm”, see specifically Pg.1553 Col.2 Items 1-4; Also see Fig.8 flow chart);
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b) eliminating each of the first plurality of primary rays that intersects a boundary of one or more vertebrae of the spine model, representing a surface of an associated vertebra in the patient, thereby establishing a first set of optimized screw trajectories comprising those of the first plurality of primary rays remaining following this step (b) (Naddeo: Pg.1551-1553, § 3.2 , specifically Pg.1553 Col.2 Item 4 – here the line segments are trajectories; here the line segments [eliminating each of the first plurality of primary rays] are deleted [eliminated] that intersect the surface [boundaries]);
c) defining, for each of the first set of optimized screw trajectories, a plurality of parallel rays (Naddeo : Fig.7 parallel projection lines) disposed circumferentially around, and extending parallel to, the associated primary ray at a predetermined radius therefrom, and which represent a surface of a spine screw having the screw trajectory represented by the associated primary ray (Naddeo: Pgs.1553-1555 Items 5-8; Figs.5-7 & specifically Fig.7 showing the parallel rays disposed circumferentially around one of the rays passing through P
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);
d) iteratively adjusting a length of the plurality of parallel rays associated with each of said first set of optimized screw trajectories until an optimized length is determined at which the associated plurality of parallel rays present a maximum- length trajectory for a spine screw that does not intersect any said boundary of the one or more vertebra of the spine model (Naddeo: Fig.8 flow; Pg.1554 Item 8 "... Sizing of the screws’ diameter “D” using a safety coefficient “k” with the dimensions, taking into account both the size of the projected area referred to in step 7 and bone density (based on the number of Hounsfield);..."; Item 9 " Determination of the maximum length of the pedicle screw:... To select an appropriate safety coefficient h∈[0,1], the length of the screw is defined as Ls=Lh. In this way, there is a guarantee that the screw tip goes into the vertebral body but not beyond the semi-vertebra and, therefore, does not come into contact with other screws...." );
(Naddeo: §4.1 “In vivo testing” of implantation of the screws using the surgical guides made from the automated process of Fig.8).
Naddeo does not explicitly teach e) calculating a respective first summation of the density of the associated vertebra surrounding or encompassed by the associated plurality of parallel rays based on a mapping of density of the plurality of vertebrae; f) calculating a respective pull-out strength for each optimized screw trajectory in each of the first set of optimized screw trajectories based on the first density summation associated therewith; g) presenting a list of the first set of optimized screw trajectories and their associated optimized lengths for said first entry point and said pull-out strengths; and h) implanting a spine screw in a vertebra of the patient corresponding to a selected one of said first set of optimized trajectories.
Widmer teaches e) calculating a respective first summation of the density of the associated vertebra surrounding or encompassed by the associated plurality of parallel rays based on a mapping of density of the plurality of vertebrae (Widmer: [0080] "... Thereafter, in substep 8.3.3 all voxels of the morphed vertebra model 47 (representing bone density) within the intersection region I1-n and normal to the projection plane P1-n are summed to obtain a respective intersection region density projection Idp1-n for each of the discretely distributed projection planes P1-n. The voxels of the intersection region density projection Idp1-n each define the sum of all bone densities projected on the respective projection plane P1-n. According to embodiments disclosed herein, the Hounsfield Unit (HU) values of the CT image are used either directly or after being converted into bone material properties according to Young's modulus for obtaining the intersection region density projections Idp1-n...."; [0081] "... Details of substep 8.4 shall be described with reference to FIG. 8. In a first, iterative substep, for each intersection projection I1-n, the voxels of the intersection region density projection Idp1-n within an area delimited by a possible bone screw diameter D1-m are summed. This is repeated for each possible bone screw diameter D1-m and each possible location L1.1-x.y of the respective bone screw diameter D1-m within the respective intersection region I1-n to obtain a respective projected bone density score Pbds1.1.1.1-Pdbs n.m.x.y....");
Widmer also does not teach f) calculating a respective pull-out strength for each optimized screw trajectory in each of the first set of optimized screw trajectories based on the first density summation associated therewith; g) presenting a list of the first set of optimized screw trajectories and their associated optimized lengths for said first entry point and said pull-out strengths.
Pak teaches f) calculating a respective pull-out strength for each optimized screw trajectory in each of the first set of optimized screw trajectories based on the first density summation associated therewith(Pak: [0090] "... [0090] In addition, by knowing the diameter, length and type of the implanted pedicle screws 14, and the density coefficient of the vertebral body 16, the controller 400 may calculate the pull-out strength of each screw 14 (e.g., the amount of force that may be required to pull the implanted screw 14 out of the bone)...."; [0084]-[0090][0115]); g) presenting a list of the first set of optimized screw trajectories and their associated optimized lengths for said first entry point and said pull-out strengths (Pak: [0084] "... [0084] The pre-surgical spinal model 24 may then be used to model, calculate or otherwise determine the desired position, alignment and trajectory of each pedicle screw and each corresponding spinal rod that may be required during the spinal surgery. It is understood that this data may be theoretically based on the pre-surgical spinal model 24. This information may include, but is not be limited to, the entry point, angular orientation, and trajectory of each pedicle screw, the location, orientation and/or position of each associated spinal rod(s), as well as other information and/or any combinations of information thereof...." ; [0090] "... [0090] In addition, by knowing the diameter, length and type of the implanted pedicle screws 14, and the density coefficient of the vertebral body 16, the controller 400 may calculate the pull-out strength of each screw 14 (e.g., the amount of force that may be required to pull the implanted screw 14 out of the bone)....").
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Widmer to Naddeo to supplement density based constraints to generate optimal trajectory for the screws (Widmer: [0074] "... The optimal screw trajectory and screw dimension resulting from the optimization are the one maximizing the voxel-based bone material properties within the screw volume which is the output of step 9. As mentioned above, the output can also comprise a number of optimum or near-optimum solutions which may have different advantages of handling, screw head connections between different screws etc. ..."; Widmer : Fig.8A-8B, 9A-9B and Naddeo: Fig.10; Naddeo: Fig.7) . Further motivation to combine would have been that Widmer, Hedblom and Naddeo are analogous art to the instant claim in the field of vertebral screw insertion & trajectory planning (Widmer: Abstract & Fig.1; and Naddeo: Introduction).
It would have been obvious to one (e.g. a designer) of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Pak to Naddeo, & Widmer to perform load bearing analysis, stress analysis and failure analysis (Pak: [0020]) so that potential outcome of the surgical procedure can be predicted (Pak: [0088]) thereby complementing the design, manufacturing and use of such spinal screws. Further motivation to combine would have been that Pak, Naddeo, & Widmer are analogous art to the instant claim in the field of the of vertebral screw insertion & trajectory planning (Pak: [0088]-[0090], [0115]; Widmer: Abstract & Fig.1; and Naddeo: Introduction).
Regarding Claim 18
Naddeo & Widmer teach the method of claim 17, wherein the spine model is derived via a 3- dimensional or volumetric imaging methodology of the patient's spine (Naddeo: §3.1; Widmer: [0016]-[0019] 3D bone image model represented by voxel) .
Regarding Claim 19
Pak teaches the method of claim 17, wherein said pull-out strengths less than a user predetermined value are removed from said list of said pull-out strengths (Pak: [0084]-[0090][0115] removal as comparison).
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Conclusion
All claims are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Examiner’s Note: Examiner has cited particular columns and line numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
In the case of amending the claimed invention, Applicant is respectfully requested to indicate the portion(s) of the specification which dictate(s) the structure relied on for proper interpretation and also to verify and ascertain the metes and bounds of the claimed invention.
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Communication
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AKASH SAXENA
Primary Examiner
Art Unit 2188
/AKASH SAXENA/Primary Examiner, Art Unit 2188 Saturday, June 27, 2026
1 US PGPUB No. US 20190046269 A1 by Hedblom; Anders et al. in ¶[0105] can also be used to show computer-readable memory performing the method. Also see additional references cited on PTO-892 for non-transitory computer-readable medium aspect for performing screw placement simulation.
Prosecution Insights