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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in DE on 03/05/2024. It is noted, however, that applicant has not filed a certified copy of the DE10 2024 202 038.9 application as required by 37 CFR 1.55.
Status of Claims
This Office Action is responsive to the claims filed on 03/04/2025. Claims 1-9 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5, line 2 recites the claim limitation “a magnetic resonance image” which is indefinite because it is unclear if this magnetic resonance image is the same image that is already recited in claim 4, line 10-11; OR a different image. For the purpose of examination, this is understood to mean the same image that is already recited in claim 4, line 10-11; OR a different image.
Claim 5, line 4 recites the claim limitation “a controller of the magnetic tomography system” which is indefinite because it is unclear if this controller is the same controller that is already recited in claim 4, line 12; OR a different controller. For the purpose of examination, this is understood to mean same controller that is already recited in claim 4, line 12; OR a different controller.
Claim 6, line 2-3 recites the claim limitation “the second information”. There is insufficient antecedent basis for this limitation in the claim. It is further indefinite because it is unclear if the second information is a newly recited element; OR if the second information refers to claim 5 and that claim 6 depends on claim 5.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Monfaredi (US 20220346830 A1) in view of Daum (US 20040064148 A1).
Regarding claim 1, Monfaredi teaches a medical instrument (Paragraph [0050]; a needle guidance toolkit) for use in a magnetic resonance tomography system (Paragraph [0045]; an MRI-safe needle guidance toolkit that allows for injection of contrast agent and imaging of the joint space within a single MRI session), the medical instrument comprising:
a spirit level (Paragraph [0053]; comprising inclinometers 106, Fig. 1A; Paragraph [0086]; The needle guide device 705 includes at least one spherical bubble level 706 that can measure the pitch and yaw angles) for determining a spatial location of the medical instrument (Paragraph [0086]; The needle guide device 705 includes at least one spherical bubble level 706 that can measure the pitch and yaw angles (e.g., range −6 to 6 degrees in each direction).; Paragraph [0048]; two inclinometers to measure two orthogonal angles and a needle guide mechanism to hold, guide, and release the needle once the needle is at the desired position.),
wherein the spirit level is arranged in a predetermined position and location relative to the medical instrument (Paragraph [0047]; comprising inclinometers and a needle guide that allows a radiologist or other physician to insert a needle at a pre-planned angle through the needle entry point previously identified).
Monfaredi does not explicitly teach the spirit level contains a liquid that is detectable by the magnetic resonance tomography system.
Daum, however, teaches a medical instrument (Paragraph [0006]; subject invention pertains to a device for inserting medical instruments into the human body) for determining a spatial location of the medical instrument (Paragraph [0022]; When the position of the device 3 is known, the position of the instrument insertion channel 10 will also be known automatically, Fig. 5) containing a liquid that is detectable by the magnetic resonance tomography system (Paragraph [0030]; the orientation of the device 4 can be identified in a similar way as with the navigation system of FIGS. 3 or 2. A gadolinium-containing liquid is filled into a hollow space 18 in this device. This liquid is an active liquid for the MRI device, to be imaged as a white spot in the MR image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the spirit level of Monfaredi to contained a liquid that is detectable by the magnetic resonance tomography system as taught by Daum because it would have allowed the position and orientation of the device to have been known automatically (Paragraph [0022]) and then measure the angle within the MR image to then adjust the device.
Regarding claim 2, together Monfaredi and Daum teach all of the limitations of claim 1 as noted above.
Monfaredi further teaches the spirit level has a first spirit level and a second spirit level that is arranged at an angle to the first spirit level (Paragraph [0048] and [0053]; the handheld device can include two inclinometers to measure two orthogonal angles, Fig. 1A), such that using the first spirit level, a first inclination is detected (Paragraph [0053]; NGTk may include methods for determining a desired position of the reference grid 101 and angles necessary to position the needle; Paragraph [0086]; at least one spherical bubble level 706 that can measure the pitch angle), using the second spirit level, a second inclination is detected (Paragraph [0086]; at least one spherical bubble level 706 that can measure the… yaw angle), and a spatial angle of the first inclination and a spatial angle of the second inclination span a polar coordinate system in space (Paragraph [0088]; needle angulations are calculated using spherical coordinate system).
Regarding claim 3, together Monfaredi and Daum teach all of the limitations of claim 1 as noted above.
Monfaredi does not explicitly teach the liquid contains a contrast agent for magnetic resonance detection.
Daum, however, further teaches the liquid contains a contrast agent for magnetic resonance detection (Paragraph [0030]; A gadolinium-containing liquid is filled into a hollow space 18 in this device. This liquid is an active liquid for the MRI device, to be imaged as a white spot in the MR image.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Monfaredi in view of Daum such that the liquid contains a contrast agent for magnetic resonance detection as further taught by Daum because it would have allowed the orientation of the device to be identified with the navigation system (Paragraph [0030]).
Claims 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Monfaredi (US 20220346830 A1) in view of Daum (US 20040064148 A1), Bryan (US 20020161446 A1), and Gorek (US 20130253599 A1).
Regarding claim 4, Monfaredi teaches a method for positioning a medical instrument (Paragraph [0050]; a needle guidance toolkit) on a patient (Paragraph [0008]; present disclosure further relates to a method for performing arthrography; determining, by the processing circuitry, a trajectory between an entry point identified on the physical grid and a target point identified within the region of interest of the joint) using a magnetic resonance tomography system (Paragraph [0045]; an MRI-safe needle guidance toolkit that allows for injection of contrast agent and imaging of the joint space within a single MRI session), the medical instrument comprising a spirit level (Paragraph [0053]; comprising inclinometers 106, Fig. 1A; Paragraph [0086]; The needle guide device 705 includes at least one spherical bubble level 706 that can measure the pitch and yaw angles) for determining a spatial location of the medical instrument (Paragraph [0086]; The needle guide device 705 includes at least one spherical bubble level 706 that can measure the pitch and yaw angles (e.g., range −6 to 6 degrees in each direction).; Paragraph [0048]; two inclinometers to measure two orthogonal angles and a needle guide mechanism to hold, guide, and release the needle once the needle is at the desired position.), wherein the spirit level is arranged in a predetermined position and location relative to the medical instrument (Paragraph [0047]; comprising inclinometers and a needle guide that allows a radiologist or other physician to insert a needle at a pre-planned angle through the needle entry point previously identified), the method comprising:
determining a trajectory for the medical instrument (Paragraph [0068]; Accordingly, at step 428 of sub process 425, the processing circuitry may determine a trajectory between the identified entry point and the identified target point) for a scheduled intervention (Paragraph [0008]; for performing arthrography);
identifying an entry point on the patient (Paragraph [0069]; the processing circuitry can be configured to identify an entry point,) and an alignment of the medical instrument that enable the medical instrument to move along the trajectory (Paragraph [0086]; spherical bubble level 706 that can measure the pitch and yaw angles);
positioning the medical instrument at the entry point by a user (Paragraph [0092]; An interventional radiologist performed needle placement… using the needle guidance device to orient the needle and deliver the needle to the joint space at an appropriate location and angle);
detecting at least one actual value of a first spatial angle (Paragraph [0087]; needle guidance device, in combination, allow a radiologist to position and angulate the needle properly; Paragraph [0092]; includes moving the table and using the needle guidance device to orient the needle);
determining a target value for the first spatial angle (Paragraph [0092]; which includes… calculating the needle angulation to achieve the trajectory) by a controller of the magnetic resonance tomography system (Paragraph [0074]; hardware elements in order to achieve the image processing device/planning workstation may be realized by various circuitry elements… CPU 580, Fig. 5);
determining first information for achievement of a predetermined alignment as a function of the at least one actual value of the first spatial angle (Paragraph [0092]; performing the needle insertion according to the planned path… using the needle guidance device to orient the needle and deliver the needle to the joint space at an appropriate location and angle; Paragraph [0093]; to calculate the accuracy of the targeting, the normal distance between the needle and the target point was calculated as the targeting error. For this, 10 to 20 points were manually selected along the center of image artifact of the needle and a straight line was fitted to these points); and
outputting the first information to the user (Paragraph [0093]; After each planning and needle insertion, confirmation images were acquired via MRI to confirm the accuracy of the targeting) for.
Monfaredi does not explicitly teach the spirit level contains a liquid that is detectable by the magnetic resonance tomography system;
detecting the spatial angle using a magnetic resonance image of the spirit level; and
the first information includes correction of the alignment of the medical instrument.
Daum, however, teaches a medical instrument (Paragraph [0006]; subject invention pertains to a device for inserting medical instruments into the human body) for determining a spatial location of the medical instrument (Paragraph [0022]; When the position of the device 3 is known, the position of the instrument insertion channel 10 will also be known automatically, Fig. 5) containing a liquid that is detectable by the magnetic resonance tomography system (Paragraph [0030]; the orientation of the device 4 can be identified in a similar way as with the navigation system of FIGS. 3 or 2. A gadolinium-containing liquid is filled into a hollow space 18 in this device. This liquid is an active liquid for the MRI device, to be imaged as a white spot in the MR image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the spirit level of Monfaredi to contained a liquid that is detectable by the magnetic resonance tomography system as taught by Daum because it would have allowed the position and orientation of the device to have been known automatically (Paragraph [0022]) and then measure the angle within the MR image to then adjust the device.
Together Monfaredi and Daum do not explicitly teach detecting the spatial angle using a magnetic resonance image of the spirit level; and
the first information includes correction of the alignment of the medical instrument.
Bryan, however, teaches a method for positioning a medical instrument on a patient (Paragraph [0016]; methods and apparatus of the invention satisfy this need by providing a technique for precisely locating a preferred location for positioning a device, such as a joint prosthesis) using a magnetic resonance tomograph system (Paragraph [0117]; radiograph or other image is then taken that includes both the vertical or plumb line image and the area of spine where the implantation will occur (it will be understood that other imaging techniques can be used, provided that the plumb line or pendulum can be imaged by those techniques); Paragraph [0132]; using radiography, MRI, CT scanning, or other appropriate imaging technique) comprising positioning the medical instrument at the entry point by a user (Paragraph [0136]; the approximate center of the prosthesis will be located once it is properly positioned within the disc space. This predetermined point is then used as a reference to precisely position a scaffold, which in turn will serve to properly position a variety of instruments used to prepare the opposing vertebral bodies to receive the prosthesis);
detecting at least one actual value of a first spatial angle (Paragraph [0108]; quantifying the relationship between the orientation of the spine and a gravitational vector) using an image (Paragraph [0107]-[0108]; taking an orientation image of the spine in the area of the target intervertebral disc space with a gravity direction indicator visible in the image field… gravity direction indicator visible on the image) of the spirit level (Paragraph [0108]; gravity direction indicator; Paragraph [0116]; a vertical or plumb line is positioned near the immobilized patient's spine or on the image intensifier of the fluoroscope. The image of the vertebral or plumb line represents a gravitational vector; Paragraph [0118]; The handle of the transverse centering tool is fitted with a bubble level. The bubble is laterally centered by tilting or rotating the centering tool laterally to define a first vertical transverse arc).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Monfaredi and Daum to include detecting the spatial angle using a magnetic resonance image of the spirit level as taught by Bryan because it would have allowed providing a relationship between the patient’s spinal anatomy and the vertical line of the instrument with respect to gravity, thereby improving the ability to determine an exact angle at which to position the instrument by referencing both the patient anatomy and the instrument angle with respect to gravity (Paragraph [0117]).
Together Monfaredi, Daum, and Bryan do not explicitly teach the first information includes correction of the alignment of the medical instrument.
Gorek, however, teaches a method for positioning a medical instrument on a patient (Paragraph [0007]; facilitates the safe and reproducible use of surgical instruments and/or implants by providing the ability to determine the optimal or desired trajectory for surgical instruments and/or implants and monitor the trajectory of surgical instruments and/or implants during surgery) comprising determining first information for achievement of a predetermined alignment (Paragraph [0107]; the system 10 may be configured to correct the angle data output based on the degree of rotation detected) as a function of the at least one actual value of the first spatial angle (Paragraph [0103]; The tilt sensor 14 measures its own angular orientation with respect to a reference axis, such as vertical or gravity. The feedback device 16 displays the angle measurements obtained by the tilt sensor 14 for reference by a practitioner.); and
outputting the first information to the user for correction of the alignment of the medical instrument (Paragraph [0107]; By way of example, the feedback may utilize numeric indicia to indicate the degree of misalignment; Paragraph [0119]; communicatively linked to tilt sensor 14 to provide feedback to the surgeon regarding angle of the tilt sensor 14 and instrument relative to the desired angles (medial-lateral and cranial-caudal)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first information of Monfaredi, Daum, and Bryan to have included correction of the alignment of the medical instrument as taught by Gorek because it would have allowed a user to take steps in realigning the instrument in the event that the instrument is misaligned (Paragraph [0124]), thereby ensuring the medical device is advanced in the proper position.
Regarding claim 5, together Monfaredi, Daum, Bryan, and Gorek teach all of the limitations of claim 4 as noted above.
Monfaredi further teaches detecting at least one actual value of a second spatial angle (Paragraph [0053]; In an embodiment, the inclinometers 106 may be two inclinometers providing orthogonal measurements; Paragraph [0086]; that can measure the pitch and yaw angles);
determining a target value for the second spatial angle (Paragraph [0092]; which includes… calculating the needle angulation to achieve the trajectory ;Paragraph [0088]; needle angulations are calculated using spherical coordinate system… i.e. θ and φ) by a controller of the magnetic resonance tomography system (Paragraph [0074]; hardware elements in order to achieve the image processing device/planning workstation may be realized by various circuitry elements… CPU 580, Fig. 5);
determining second information for achievement of the predetermined alignment as a function of the at least one actual value of the second spatial angle (Paragraph [0092]; performing the needle insertion according to the planned path… using the needle guidance device to orient the needle and deliver the needle to the joint space at an appropriate location and angle; Paragraph [0093]; to calculate the accuracy of the targeting, the normal distance between the needle and the target point was calculated as the targeting error. For this, 10 to 20 points were manually selected along the center of image artifact of the needle and a straight line was fitted to these points; Paragraph [0086]; can measure the pitch and yaw angles).
Monfaredi does not explicitly teach detecting the second spatial angle using a magnetic resonance image of the spirit level; and
outputting the second information to the user for correction of the alignment of the medical instrument.
The method of Monfaredi in view of Daum, Bryan, and Gorek, however, already teaches using detecting a spatial angle using a magnetic resonance image of the spirit level and outputting the information to the user for correction of the alignment of the medical instrument as noted above in the rejection of claim 4. One of ordinary skill in the art would have realized the steps of detecting the second spatial angle and outputting second information would have been an obvious duplication of steps.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Monfaredi to have included detecting the second spatial angle using a magnetic resonance image of the spirit level; and outputting the second information to the user for correction of the alignment of the medical instrument because it would have been a duplication of the steps of measuring angles and outputting information for correction of the angles based on the measurement. One would have been motivated to perform the step multiple times to ensure both the pitch and yaw angles as described in Monfaredi (paragraph [0086]), or the cranial-caudal and medial-lateral angles as described in Gorek (paragraph [0121]) are aligned correctly, therefore ensuring the medical device is advanced in the proper position.
Regarding claim 6, together Monfaredi, Daum, Bryan, and Gorek teach all of the limitations of claim 4 as noted above.
Monfaredi does not explicitly teach further correcting, by the user, an alignment of the medical instrument in accordance with the first information, the second information, or the first information and the second information.
Gorek, however, further teaches correcting, by the user, an alignment of the medical instrument in accordance with the first information, the second information, or the first information and the second information (Paragraph [0163]; Once the tip of the instrument rests on the pedicle the shaft of the instrument should be adjusted until it is aligned both medial-laterally and cranial-caudally with the axis of the first retractor blade 336; Paragraph [0186]; The instrument may be advanced while making any adjustments necessary to keep the trajectory in line with the pedicle axis.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Monfaredi in view of Daum, Bryan, and Gorek to have included correcting, by the user, an alignment of the medical instrument in accordance with the first information, the second information, or the first information and the second information because it would have enabled the surgeon to position and maintain the instrument along a desired trajectory during entire operation (Paragraph [0007]-[0008]).
Regarding claim 7, together Monfaredi, Daum, Bryan, and Gorek teach all of the limitations of claim 6 as noted above.
Monfaredi does not explicitly teach detecting an actual value of the at least one actual value, determining the target value, determining the first information, outputting the first information, and correcting the alignment are repeated for the first spatial angle, the second spatial angle, or the first spatial angle and the second spatial angle.
Gorek, however, further teaches detecting an actual value of the at least one actual value, determining the target value, determining the first information, outputting the first information, and correcting the alignment are repeated for the first spatial angle, the second spatial angle, or the first spatial angle and the second spatial angle (Paragraph [0125]; the instrument 12, 80 may occasionally be realigned so that the universal clip 26 or orientation shaft 86 is again perpendicular to the long axis of the spine and the angle measurements rechecked. This may be repeated until the pilot hole is complete).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Monfaredi in view of Daum, Bryan, and Gorek to have further included repeating for the first spatial angle, the second spatial angle, or the first spatial angle and the second spatial angle: determining the target value, determining the first information, outputting the first information, and correcting the alignment as further taught by Gorek because it would have ensured the instrument is advanced at the proper trajectory throughout the entire operation (Paragraph [0125]).
Regarding claim 8, together Monfaredi, Daum, Bryan, and Gorek teach all of the limitations of claim 7 as noted above.
Monfaredi does not explicitly teach determining, by the controller of the magnetic resonance tomography system, a deviation between the target value and the actual value and signals to the user when the deviation falls below a predetermined threshold value.
Gorek, however, further teaches determining, by the controller of the magnetic resonance tomography system, a deviation between the target value and the actual value and signals to the user when the deviation falls below a predetermined threshold value (Paragraph [0121]; One such color code scheme will display the color red when the angles of the tilt sensor 14 fall outside an acceptable range from the correct orientation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Monfaredi in view of Gorek to have included determining, by the controller of the magnetic resonance tomography system, a deviation between the target value and the actual value and signals to the user when the deviation falls below a predetermined threshold value as further taught by Gorek because it would have allowed a user to clearly see when the instrument is too far from the correct orientation and thereby allowed the user to know when further correction is needed (Paragraph [0119] and [0121]).
Regarding claim 9, Monfaredi teaches a magnetic resonance tomography system (Paragraph [0042]; magnetic resonance imaging (MRI) unit; Paragraph [0045]; an MRI-safe needle guidance toolkit that allows for injection of contrast agent and imaging of the joint space within a single MRI session) for positioning a medical instrument (Paragraph [0050]; a needle guidance toolkit), the medical instrument comprising a spirit level (Paragraph [0053]; comprising inclinometers 106, Fig. 1A; Paragraph [0086]; The needle guide device 705 includes at least one spherical bubble level 706 that can measure the pitch and yaw angles) for determining a spatial location of the medical instrument (Paragraph [0086]; The needle guide device 705 includes at least one spherical bubble level 706 that can measure the pitch and yaw angles (e.g., range −6 to 6 degrees in each direction).; Paragraph [0048]; two inclinometers to measure two orthogonal angles and a needle guide mechanism to hold, guide, and release the needle once the needle is at the desired position.), wherein the spirit level is arranged in a predetermined position and location relative to the medical instrument (Paragraph [0047]; comprising inclinometers and a needle guide that allows a radiologist or other physician to insert a needle at a pre-planned angle through the needle entry point previously identified), the magnetic resonance tomography system comprising:
a controller (Paragraph [0074]; hardware elements in order to achieve the image processing device/planning workstation may be realized by various circuitry elements… CPU 580, Fig. 5) configured to:
capture a target value for the first spatial angle (Paragraph [0074]; hardware elements in order to achieve the image processing device/planning workstation may be realized by various circuitry elements… CPU 580, Fig. 5);
determine information for achievement of a predetermined alignment as a function of the at least one actual value of the first spatial angle (Paragraph [0092]; performing the needle insertion according to the planned path… using the needle guidance device to orient the needle and deliver the needle to the joint space at an appropriate location and angle; Paragraph [0093]; to calculate the accuracy of the targeting, the normal distance between the needle and the target point was calculated as the targeting error. For this, 10 to 20 points were manually selected along the center of image artifact of the needle and a straight line was fitted to these points); and
output the information to the user (Paragraph [0093]; After each planning and needle insertion, confirmation images were acquired via MRI to confirm the accuracy of the targeting) for correction of an alignment of the medical instrument.
Monfaredi does not explicitly teach the spirit level contains a liquid that is detectable by the magnetic resonance tomography system;
the system is configured to detect at least one actual value of a first spatial angle of the medical instrument positioned at an entry point on a patient using a magnetic resonance image of the spirit level; and
the first information includes correction of the alignment of the medical instrument.
Daum, however, teaches a medical instrument (Paragraph [0006]; subject invention pertains to a device for inserting medical instruments into the human body) for determining a spatial location of the medical instrument (Paragraph [0022]; When the position of the device 3 is known, the position of the instrument insertion channel 10 will also be known automatically, Fig. 5) containing a liquid that is detectable by the magnetic resonance tomography system (Paragraph [0030]; the orientation of the device 4 can be identified in a similar way as with the navigation system of FIGS. 3 or 2. A gadolinium-containing liquid is filled into a hollow space 18 in this device. This liquid is an active liquid for the MRI device, to be imaged as a white spot in the MR image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the spirit level of Monfaredi to contained a liquid that is detectable by the magnetic resonance tomography system as taught by Daum because it would have allowed the position and orientation of the device to have been known automatically (Paragraph [0022]) and then measure the angle within the MR image to then adjust the device.
Together Monfaredi and Daum do not explicitly teach the system is configured to detect at least one actual value of a first spatial angle of the medical instrument positioned at an entry point on a patient using a magnetic resonance image of the spirit level; and
the first information includes correction of the alignment of the medical instrument.
Bryan, however, teaches a system for positioning a medical instrument on a patient (Paragraph [0016]; methods and apparatus of the invention satisfy this need by providing a technique for precisely locating a preferred location for positioning a device, such as a joint prosthesis) using a magnetic resonance tomograph system (Paragraph [0117]; radiograph or other image is then taken that includes both the vertical or plumb line image and the area of spine where the implantation will occur (it will be understood that other imaging techniques can be used, provided that the plumb line or pendulum can be imaged by those techniques); Paragraph [0132]; using radiography, MRI, CT scanning, or other appropriate imaging technique) comprising positioning the medical instrument at the entry point by a user (Paragraph [0136]; the approximate center of the prosthesis will be located once it is properly positioned within the disc space. This predetermined point is then used as a reference to precisely position a scaffold, which in turn will serve to properly position a variety of instruments used to prepare the opposing vertebral bodies to receive the prosthesis);
the system is configured to detect at least one actual value of a first spatial angle (Paragraph [0108]; quantifying the relationship between the orientation of the spine and a gravitational vector) of the medical instrument positioned at an entry point on a patient (Paragraph [0136]; the approximate center of the prosthesis will be located once it is properly positioned within the disc space. This predetermined point is then used as a reference to precisely position a scaffold, which in turn will serve to properly position a variety of instruments used to prepare the opposing vertebral bodies to receive the prosthesis) using a magnetic resonance image of the spirit level (Paragraph [0108]; gravity direction indicator; Paragraph [0116]; a vertical or plumb line is positioned near the immobilized patient's spine or on the image intensifier of the fluoroscope. The image of the vertebral or plumb line represents a gravitational vector; Paragraph [0118]; The handle of the transverse centering tool is fitted with a bubble level. The bubble is laterally centered by tilting or rotating the centering tool laterally to define a first vertical transverse arc).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Monfaredi and Daum to detect at least one actual value of a first spatial angle of the medical instrument positioned at an entry point on a patient using a magnetic resonance image of the spirit level as taught by Bryan because it would have allowed providing a relationship between the patient’s spinal anatomy and the vertical line of the instrument with respect to gravity, thereby improving the ability to determine an exact angle at which to position the instrument by referencing both the patient anatomy and the instrument angle with respect to gravity (Paragraph [0117]).
Together Monfaredi, Daum, and Bryan do not explicitly teach the first information includes correction of the alignment of the medical instrument.
Gorek, however, teaches a method for positioning a medical instrument on a patient (Paragraph [0007]; facilitates the safe and reproducible use of surgical instruments and/or implants by providing the ability to determine the optimal or desired trajectory for surgical instruments and/or implants and monitor the trajectory of surgical instruments and/or implants during surgery) comprising determining first information for achievement of a predetermined alignment (Paragraph [0107]; the system 10 may be configured to correct the angle data output based on the degree of rotation detected) as a function of the at least one actual value of the first spatial angle (Paragraph [0103]; The tilt sensor 14 measures its own angular orientation with respect to a reference axis, such as vertical or gravity. The feedback device 16 displays the angle measurements obtained by the tilt sensor 14 for reference by a practitioner.); and
outputting the first information to the user for correction of the alignment of the medical instrument (Paragraph [0107]; By way of example, the feedback may utilize numeric indicia to indicate the degree of misalignment; Paragraph [0119]; communicatively linked to tilt sensor 14 to provide feedback to the surgeon regarding angle of the tilt sensor 14 and instrument relative to the desired angles (medial-lateral and cranial-caudal)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the first information of Monfaredi, Daum, and Bryan to have included correction of the alignment of the medical instrument as taught by Gorek because it would have allowed a user to take steps in realigning the instrument in the event that the instrument is misaligned (Paragraph [0124]), thereby ensuring the medical device is advanced in the proper position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
1/12/26