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 .
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Instant Application 19/022944
Patent 12,257,092
1. A method for identifying an implant in an x-ray image of an anatomy shown on a display screen, the method comprising:
displaying a rendering of the implant on the display screen along with the x-ray image, the rendering sized and shaped to correspond to the implant;
prompting a user to position the
rendering of the implant on an artifact of the implant at an accurate position corresponding to an actual position of the implant in the anatomy;
alerting the user when the rendering is maneuvered by the user to an inaccurate position
that is outside of a predetermined distance from the accurate position;
prompting the user to reposition the rendering from the inaccurate position to the accurate position;
alerting the user when the rendering is maneuvered by the user to the accurate position, or to within the
predetermined distance of the accurate position; and
after the rendering has been maneuvered to the accurate position by the user, reconstructing the x-ray image to replace the artifact with the rendering affixed in the accurate position.
1. A method for identifying an implant in an image of an anatomy shown on
a display screen, the method comprising: receiving, in a processing system, computed tomography (CT) slices of the anatomy;
displaying the image of the anatomy on the display screen based on the CT slices, the image including an artifact portions due to the implant;
prompting a user to enter parameters of the implant into the processing system by way of a user interface;
displaying a rendering of the implant on the display screen along with the image, the rendering sized and shaped to correspond to the implant;
prompting the user to position the rendering of the implant at an accurate position on the artifact portions corresponding to an actual position of the implant in the anatomy
that includes portions of the artifact portions;
and at least one of:
alerting the user when the rendering is positioned by the user at an inaccurate position relative to the artifact portions that is outside of a predetermined distance from the accurate position, and
prompting the user to reposition the rendering from the inaccurate position;
or
alerting the user when the rendering is positioned by the user to the accurate position including within the predetermined distance of the accurate position,
and
after the rendering has been positioned to the accurate position by the user, reconstructing the image to replace the artifact portions with the rendering in the accurate position;
wherein the predetermined distance is +/−2 mm for a rendered screw top from a screw tip of the implant, and +/−10° for a rendered screw head from a screw head of the implant.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 1, 4, 1, 5-12, 9, 13-15 respectively of U.S. Patent No. 12,257,092. Although the claims at issue are not identical, they are not patentably distinct from each other because, the claims of the instant application are obvious variant of the corresponding ones of the US Patent No. 12,257,092. Furthermore, the scopes of the claims on the instant application are also met and encompassed by the corresponding ones of the Patent No. 12,257,092. (See table above where conflicting claims are aligned for similar elements side-by-side)
The apparent difference between the conflicting claims mainly arises from the style of limitation recitation and relative placement of conflicting elements within the claims’ body. Few other apparent differences fall withing obvious variant of the corresponding limitations within Patent 12,257,092.
E.g.,
1. “x-ray” in instant application is as obvious variant of computed tomography (CT) recited in the Patent (In Col. 3, lines 24-34 the Patent discloses X-Ray as CT).
2. Limitation “the rendering sized and shaped to correspond to the implant” in the instant application is met and encompassed in scope as obvious variant of “the image including an artifact portions due to the implant” in the Patent.
3. Limitation “maneuvered” in the instant application is met and encompassed in scope as obvious variant of “positioned” in the Patent
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 of this title, 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.
Claims 1, 2, 9-11, 12, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Helm et al. (US 8,891,847, hereinafter Helm) in view of Marquart et al. (US 20050267354 A1, hereinafter Marquart).
[Examiner’s Note- Citations are primarily given from Helm, unless otherwise expressly mentioned]
Regarding claim 1, Helm discloses a method for identifying an implant in an x-ray image of an anatomy shown on a display screen (abstract, figs. 7-8, claim 1 and dependents. The present teachings provide a computer-implemented method of implant detection includes…, Col. 1, lines 39-40
The present teachings are directed to a method of correcting artifacts caused by hardware, such as screws or other implants, in portions of the anatomy of a subject undergoing imaging by scanning methods using x-ray sources, Col. 3, lines 15-20
Artifacts from implants pose a problem, for example, in x-ray computed tomography (CT), including cone beam CT (CBCT) and in other imaging methods using an x-ray source. Artifacts from implants arise because the attenuation coefficient of materials used for implants, such as, for example, metals, metal alloys, ceramics, etc., is higher than the attenuation coefficient of bones and soft tissue in the range of x-ray intensities used in such CT imaging. Flat panel detectors used to capture the images can also cause scatter that leads to artifacts at implant locations, Col. 3, lines 24-34), the method comprising:
displaying a rendering of the implant on the display screen along with the x-ray image, the rendering sized and shaped to correspond to the implant (An image of the identified implant can be registered and overlaid in the scale of the CT slice on the image of the CT slice in the display 102 of the image processing computing system 100. The image of the implant can be a wire or solid CAD drawing or other digital rendering of the implant, Col. 11, lines 51-56.
the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2. An embodiment of the method to position the overlay is briefly outlined in the flowchart of FIG. 7, Col. 9, lines 30-37
The present disclosure relates to detection and correction of artifacts caused by implants x-ray related imaging, Col. 1, lines 6-7
The present teachings are directed to a method of correcting artifacts caused by hardware, such as screws or other implants, in portions of the anatomy of a subject undergoing imaging by scanning methods using x-ray sources, Col. 3, lines 15-20
Artifacts from implants pose a problem, for example, in x-ray computed tomography (CT), including cone beam CT (CBCT) and in other imaging methods using an x-ray source. Artifacts from implants arise because the attenuation coefficient of materials used for implants, such as, for example, metals, metal alloys, ceramics, etc., is higher than the attenuation coefficient of bones and soft tissue in the range of x-ray intensities used in such CT imaging. Flat panel detectors used to capture the images can also cause scatter that leads to artifacts at implant locations, Col. 3, lines 24-34);
prompting a user to position the rendering of the implant on an artifact of the implant at an accurate position corresponding to an actual position of the implant in the anatomy (The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37);
alerting the user when the rendering is maneuvered by the user to an inaccurate position that is outside of a predetermined distance from the accurate position (The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37.
Assessing FIGS. 5A and 5F, for example, we can determine that (radiological) right pedicle screw has deviated significantly medially away from the right pedicle 92, Col. 9, lines 20-23);
prompting the user to reposition the rendering from the inaccurate position to the accurate position (ibid, The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37.
Assessing FIGS. 5A and 5F, for example, we can determine that (radiological) right pedicle screw has deviated significantly medially away from the right pedicle 92, Col. 9, lines 20-23);
alerting the user when the rendering is maneuvered by the user to the accurate position, The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37.
Assessing FIGS. 5A and 5F, for example, we can determine that (radiological) right pedicle screw has deviated significantly medially away from the right pedicle 92, Col. 9, lines 20-23); and
after the rendering has been maneuvered to the accurate position by the user, reconstructing the x-ray image to replace the artifact with the rendering affixed in the accurate position (The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37.
The present teachings provide a method for identifying an implant associated with an artifact in one or more CT slices (axial planar sections of the 3D image) after the 3D image reconstruction from a comparison database using a best fit and/or reliability method. After the best fit implant is selected from the database, an image of the selected implant is overlaid on the corresponding artifact. This correction is done after processing of the CT images for 3D reconstruction. The correction is performed on the reconstructed CT slices as a post-processing operation, Col. 3, lines 39-48).
Helm is not found disclosing the limitation of, alerting the user when the rendering is maneuvered by the user to within the predetermined distance of the accurate position.
However, Marquart discloses a system and method for providing computer assistance for performing a medical procedure, for example spinal fixation (abstract), wherein, a surgeon may be automatically prompted to perform certain tasks or to define or enter specific data that will permit, for example, the program to determine and display appropriate placement and alignment of instrumentation or implants or provide feedback to the surgeon (¶0022). Marquart further discloses that in step 122, a registration error is calculated. If desired and as shown in the exemplary screen display of FIG. 3F, the registration error may be displayed on display device 12. If the registration error is more than a predefined threshold, then a visual and/or audio warning may be provided. In step 124, a determination is made as to whether the registration error is acceptable to the user. The user is given the option to re-register the image data set with the anatomy of the patient. The user may indicate that the registration error is acceptable by either selecting the next screen icon or by simply picking up a tool to be used in a subsequent step. The user may indicate that the registration error is not acceptable by either selecting a "re-pick" icon 61 or by selecting a previous screen icon 35. If the registration error is not acceptable to the user, then the process starting at step 110 may be executed (¶0043-0044).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the invention of Helm with the teaching of Marquart such that an alert is provided to the user when the rendering maneuvered by the user to be within the predetermined distance of the accurate position, because, the combination improves the precision and/or consistency of surgical procedures by providing real time alerts pertaining to placement of the implant (Marquart: ¶0009).
Regarding claim 2, Helm in view of Marquart discloses the method of claim 1, wherein the implant is a spinal screw (Col. 3, lines 60-63).
Regarding claim 9, Helm in view of Marquart discloses the method of claim 1, wherein the implant is a spinal screw configured to mount a spinal rod (The head of the screw 206 is captured by a receiver or seat 204 that is also used for coupling to elongated rods 250 of a spinal fixation system shown in FIG. 4, Col. 8, lines 47-50, fig. 4).
Helm in view of Marquart is not found disclosing expressly the limitation of, wherein the method is performed after the spinal screw has been implanted, and before the spinal rod has been mounted to the spinal screw.
However, disclosure in Helm in Col. 8, lines 47-53, fig. 4, i.e.
[The head of the screw 206 is captured by a receiver or seat 204 that is also used for coupling to elongated rods 250 of a spinal fixation system shown in FIG. 4. As shown in FIG. 4, the elongated rods 250 can be secured in the receivers 204 with corresponding locking plugs 208.]
suggests an indication that the screws need to be placed first since the rods 250 can be secured withing receivers 204 of the screws 206.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to mount the spinal screw first which is configured to mount a spinal rod, to obtain, wherein the method is performed after the spinal screw has been implanted, and before the spinal rod has been mounted to the spinal screw, because, Helm suggests that the screws are configured to mount a spinal rod. Mounting sequence of the spinal screw and spinal rod also can be attained through “obvious to try” rationale of KSR, since selecting a mounting sequence is nothing but, choosing from a finite number of identified, predictable solutions (i.e. which component to place first), with a reasonable expectation of success.
Regarding claim 10, Helm in view of Marquart discloses the method of claim 1, wherein the rendering of the implant is three-dimensional (abstract).
Regarding claim 11, Helm discloses an image processing system for identifying an implant in an x-ray image of an anatomy shown on a display screen (abstract, fig. 1.
The present teachings are directed to a method of correcting artifacts caused by hardware, such as screws or other implants, in portions of the anatomy of a subject undergoing imaging by scanning methods using x-ray sources, Col. 3, lines 15-20
Artifacts from implants pose a problem, for example, in x-ray computed tomography (CT), including cone beam CT (CBCT) and in other imaging methods using an x-ray source. Artifacts from implants arise because the attenuation coefficient of materials used for implants, such as, for example, metals, metal alloys, ceramics, etc., is higher than the attenuation coefficient of bones and soft tissue in the range of x-ray intensities used in such CT imaging. Flat panel detectors used to capture the images can also cause scatter that leads to artifacts at implant locations, Col. 3, lines 24-34), the system comprising:
a computer processor (108, fig. 2), wherein the processor is configured to:
prompt a user to enter parameters of the implant into the processor; select a rendering of the implant from a database (The method includes prompting for user input if an implant candidate is not automatically identified, selecting one of an automatically identified implant candidate and a user identified implant candidate, Col. 1, lines 57-60.
A best-fit implant is selected from the implant database and a graphical image of the best-fit implant is overlaid on the CT slice on a display of the computing system, abstract);
display the rendering of the implant on a display along with the x-ray image (An image of the identified implant can be registered and overlaid in the scale of the CT slice on the image of the CT slice in the display 102 of the image processing computing system 100. The image of the implant can be a wire or solid CAD drawing or other digital rendering of the implant, Col. 11, lines 51-56.
the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2. An embodiment of the method to position the overlay is briefly outlined in the flowchart of FIG. 7, Col. 9, lines 30-37.
The present teachings are directed to a method of correcting artifacts caused by hardware, such as screws or other implants, in portions of the anatomy of a subject undergoing imaging by scanning methods using x-ray sources, Col. 3, lines 15-20
Artifacts from implants pose a problem, for example, in x-ray computed tomography (CT), including cone beam CT (CBCT) and in other imaging methods using an x-ray source. Artifacts from implants arise because the attenuation coefficient of materials used for implants, such as, for example, metals, metal alloys, ceramics, etc., is higher than the attenuation coefficient of bones and soft tissue in the range of x-ray intensities used in such CT imaging. Flat panel detectors used to capture the images can also cause scatter that leads to artifacts at implant locations, Col. 3, lines 24-34);
prompt the user to position the rendering of the implant on an artifact of the implant at an accurate position corresponding to an actual position of the implant in the anatomy (The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37);
alert the user when the rendering is maneuvered by the user to an inaccurate position that is outside of a predetermined distance from the accurate position (The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37.
Assessing FIGS. 5A and 5F, for example, we can determine that (radiological) right pedicle screw has deviated significantly medially away from the right pedicle 92, Col. 9, lines 20-23);
prompt the user to reposition the rendering from the inaccurate position to the accurate position (ibid, The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37.
Assessing FIGS. 5A and 5F, for example, we can determine that (radiological) right pedicle screw has deviated significantly medially away from the right pedicle 92, Col. 9, lines 20-23);
alert the user when the rendering is maneuvered by the user to the accurate position, The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37.
Assessing FIGS. 5A and 5F, for example, we can determine that (radiological) right pedicle screw has deviated significantly medially away from the right pedicle 92, Col. 9, lines 20-23); and
reconstruct the x-ray image to replace the artifact with the rendering affixed in the accurate position after the rendering has been maneuvered to the accurate position by the user (The present teachings provide a method that can identify the particular implant that causes the artifact 300 and overlay a CAD, graphical or other scaled image 200' in outline over the artifact 300, thereby indicating its actual position and orientation, as shown, for example, in FIG. 6. In FIG. 6, the outline of a pedicle screw is overlaid on the radiological left blooming artifact 300, reliably indicating the actual position of the implanted left pedicle screw 200' as well as the shape, size and or type of implanted pedicle screw 200 on the CT slice displayed on a display of computing system, such as display 102 of FIG. 2., Col. 9, lines 25-37.
The present teachings provide a method for identifying an implant associated with an artifact in one or more CT slices (axial planar sections of the 3D image) after the 3D image reconstruction from a comparison database using a best fit and/or reliability method. After the best fit implant is selected from the database, an image of the selected implant is overlaid on the corresponding artifact. This correction is done after processing of the CT images for 3D reconstruction. The correction is performed on the reconstructed CT slices as a post-processing operation, Col. 3, lines 39-48).
Helm is not found disclosing the limitation of, alert the user when the rendering is maneuvered by the user to within the predetermined distance of the accurate position.
However, Marquart discloses a system and method for providing computer assistance for performing a medical procedure, for example spinal fixation (abstract), wherein, a surgeon may be automatically prompted to perform certain tasks or to define or enter specific data that will permit, for example, the program to determine and display appropriate placement and alignment of instrumentation or implants or provide feedback to the surgeon (¶0022). Marquart further discloses that in step 122, a registration error is calculated. If desired and as shown in the exemplary screen display of FIG. 3F, the registration error may be displayed on display device 12. If the registration error is more than a predefined threshold, then a visual and/or audio warning may be provided. In step 124, a determination is made as to whether the registration error is acceptable to the user. The user is given the option to re-register the image data set with the anatomy of the patient. The user may indicate that the registration error is acceptable by either selecting the next screen icon or by simply picking up a tool to be used in a subsequent step. The user may indicate that the registration error is not acceptable by either selecting a "re-pick" icon 61 or by selecting a previous screen icon 35. If the registration error is not acceptable to the user, then the process starting at step 110 may be executed (¶0043-0044).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the invention of Helm with the teaching of Marquart such that an alert is provided to the user when the rendering maneuvered by the user to be within the predetermined distance of the accurate position, because, the combination improves the precision and/or consistency of surgical procedures by providing real time alerts pertaining to placement of the implant (Marquart: ¶0009).
Regarding claim 12, Helm in view of Marquart discloses the system of claim 11, wherein the implant is a spinal screw (Col. 3, lines 60-63).
Regarding claim 18, Helm in view of Marquart discloses the system of claim 11, wherein the rendering is three-dimensional (abstract).
Claims 3, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helm in view of Marquart and further in view of Rout et al. (US 20220265320, hereinafter Rout).
Regarding claim 3, Helm in view of Marquart discloses the method of claim 2, except, wherein the spinal screw includes a tulip head.
However, Rout discloses wherein the implant is a spinal screw including a tulip head (¶0136).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to implement the spinal screw of Helm having a tulip head, because, combining prior art elements ready to be improved according to known method to yield predictable results is obvious.
Regarding system claim(s) 13 although wording is different, the material is considered substantively equivalent to the method claim(s) 3 as described above.
Claims 4-5, 7, 14, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helm in view of Marquart and further in view of Uhde et al. (US 2021/0177517, hereinafter Uhde).
Regarding claim 4, Helm in view of Marquart discloses the methos of claim 1, further comprising:
receiving, in a processing system, the x-ray image of the anatomy based on computed tomography (CT) projections of the anatomy (steps 500-502, fig. 7.
receiving a three-dimensional (3D) image of an anatomy portion of a patient from computed tomography (CT) projections of the patient in an image processing computing system. A cluster of voxels forming an implant candidate is identified on a CT slice of the 3D image, Col. 1, lines 41-45);
displaying the x-ray image of the anatomy on the display screen, the x-ray image including an artifact of the implant (Either automatically or by user input, for example, through the input device 106 of FIG. 2, identification of voxels with higher intensity relative to the expected intensity thresholds for bones and tissue of the patient's anatomy is initiated in one or more selected CT slices of the 3D image. A post-processing software module configured to execute image processing commands is incorporated in the image processing module 112 and can identify and locate clusters of voxels that are brighter or have higher contrast than the average brightness of surrounding voxels in a CT slice for the particular range of intensity of the x-ray source 36, at block 502. Isolated voxels of higher than a given threshold intensity may be discarded and adjacent voxels higher than the given threshold intensity may be grouped together for further analysis and identification. To determine whether a cluster of voxels is an artifact of an implant (i.e., an implant candidate), such as a metallic or ceramic screw or other implant, various factors or characteristics of the cluster can be compared with corresponding characteristics of artifacts from a potential implant, at block 504, Col. 9, line 52- Col 10, line 3);
prompting a user to enter parameters of the implant The method includes prompting for user input if an implant candidate is not automatically identified, selecting one of an automatically identified implant candidate and a user identified implant candidate, Col. 1, lines 57-60).
Helm in view of Marquart is not found disclosing expressly prompting a user to enter parameters of the implant into the processing system by way of a user interface.
However, Uhde discloses that requirement of later implant placement includes selecting a parameter of the implant inputted by the user in a user interface (¶0016-0022).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the invention of Helm in view of Marquart with the teaching of Uhde of planning an implant placement into an anatomical structure of a patient, which allows a user to modify the implant placement within a frame defined by predefined requirements that have to be fulfilled for achieving a desired medical outcome (see abstract), such that a user to enter parameters of the implant into the processing system by way of a user interface instead of merely selecting a specific implant to be installed, because, combining prior art elements ready to be improved according to known method to yield predictable results is obvious. Furthermore, such combination would provide the surgeon with a supportive advice when planning the placement of an implant, which however leaves enough space for the surgeon's preferences during said planning process (¶0004).
Regarding claim 5, Helm in view of Marquart and Uhde discloses the method of claim 4, wherein the parameters of the implant include at least one of implant system, implant set, implant type, implant diameter, and implant length (Uhde: ¶0016-0022).
Regarding claim 7, Helm in view of Marquart and Uhde discloses the method of claim 4, further comprising prompting the user to enter parameters of additional implants, and prompting the user to position additional renderings of the additional implants during the reconstructing of the x-ray image (Uhde: …at least one further implant to be placed … ¶0017).
Regarding system claim(s) 14, and 16 although wording is different, the material is considered substantively equivalent to the method claim(s) 5 and 7 respectively as described above.
Claims 8, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helm in view of Marquart and Uhde and further in view of Min et al. (US 11094061 B1, hereinafter Min).
Regarding claim 8, Helm in view of Marquart and Uhde discloses the method of claim 4, except, further comprising prompting the user to toggle between the reconstructed x-ray image and an original x-ray image including the artifact.
However, Min discloses a system which can dynamically be configured to select one or more medical images from prior medical scanning and/or current medical scanning juxtaposed to each other, or for example, showing past images that are superimposed on present images thereby allowing a user to move or fade or toggle between past and present images (Col. 51, lines 31-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the invention of Helm in view Marquart and Uhde such that user is able to toggle between the reconstructed image and the image including the artifact portions, using the teaching of toggling between historical and present medical images of Min, because, the juxtaposition would allow the surgeon to better understand the exact location of implant insertion with respect to existing patient condition. Furthermore, combining prior art elements ready to be improved according to known method to yield predictable results is obvious.
Regarding system claim(s) 17 although wording is different, the material is considered substantively equivalent to the method claim(s) 8 respectively as described above.
Allowable Subject Matter
Claims 6, and 15 is/are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. They also need to overcome any double patenting rejections set forth in this office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6 and 15, prior arts of record taken alone or in combination fails to reasonably disclose or suggest,
wherein the predetermined distance is about +/- 2 mm for a rendered screw tip from a screw tip of the implant, and about +/-10° for a rendered screw head from a screw head of the implant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Crawford et al. (2019/0021800)
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