DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 14 recites the limitation “attaching a reference sensor to a predetermined vertebra of the patient” which is not adequately supported by the specification. It is unclear what constitutes the selection of a predetermined vertebra.
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 1-9 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 1 recites the limitation “based on one of the received position data from the joint sensor and the instrument sensor,” which renders the claim unclear. It is unclear whether one of each “joint sensor” and “instruments sensor” is required or one of the “joint sensor” or “instrument sensor” is required. For the purposes of this examination it is interpreted that only one of the sensors data is required.
Claim 2 recites the limitation "the instrument motion sensor" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 1-4, 6-7, 10-13, & 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hunter et al (US20100137707A1; hereinafter referred to as Hunter).
Regarding Claim 1, Hunter discloses a surgical navigation system (“A method for use during a procedure on a body. The method generates a display representing relative positions of two structures during the procedure.” [Abstract], “The present invention relates to localization of a position during neurosurgery. The present invention relates more specifically to electromagnetic localization of a position during stereotactic neurosurgery, such as brain surgery and spinal surgery.” [0003]) comprising:
a tracking system having a magnetic field generator for generating a magnetic field (“The system comprises memory for storing an image data set representing the position of the body based on scans of the body, the image data set having a plurality of data points in known relation to a plurality of reference points for the body; a magnetic field generator for generating a magnetic field to be sensed by one or more magnetic field sensors placed in known relation to the reference points of the body for detecting the magnetic field and for generating positional signals in response to the detected magnetic field” [0014]);
a joint sensor detectable within the magnetic field (“the image data set is created prior to placing the patient on the operating table. Once the patient is ready for surgery, the processor 45 can identify the fiducial marker 20 in patient space using signals received from at least one sensor 50, placed in known relation to the fiducial marker(s) 20 placed on the patient's vertebra 610.” [0064], “the computer system dynamically tracks movement of each sensor 50 on the patient's vertebra and on the medical instrument 60. Thus, the system tracks alignment and positioning of the vertebra 610 (e.g., relative movement of the vertebra) as well as movement of the medical instrument 60 relative to the vertebrae.” [0065]);
an instrument sensor detectable within the magnetic field (“The medical instrument 60 includes a handle 62 and a probe 64 having a tip portion 66. The tip portion 66 of the medical instrument 60 includes a sensor having at least one coil 68 that makes up the sensor 50.” [0061], “the computer system dynamically tracks movement of each sensor 50 on the patient's vertebra and on the medical instrument 60. Thus, the system tracks alignment and positioning of the vertebra 610 (e.g., relative movement of the vertebra) as well as movement of the medical instrument 60 relative to the vertebrae.” [0065]);
and a processor configured to: receive patient-specific image data of a joint of a patient (“The magnetic field sensors 50 on the patient's head 30 and in the medical instrument 60 detect the generated magnetic field and send appropriate signals to the processor 45 so that the processor 45 can determine the positions of the magnetic field sensors 50 during the procedure.” [0041], “FIG. 16 schematically illustrates elements of spinal surgery needed to explain the procedures of the present invention. At least one fiducial marker 20 is placed on each vertebra 610 of concern during the procedure. A vertebra “of concern” is a vertebra whose position the user is concerned with during the spinal procedure. Once at least one fiducial marker 20 has been placed on each vertebra of concern, image slices or a three-dimensional scan (e.g., MR, CT, ultrasound, fluoro and PET) are taken of the patient's spine to create a three-dimensional data set having data points corresponding to reference points on each fiducial marker 20.” [0063]),
receive position data from the joint sensor (“Preferably, the image data set is created prior to placing the patient on the operating table. Once the patient is ready for surgery, the processor 45 can identify the fiducial marker 20 in patient space using signals received from at least one sensor 50, placed in known relation to the fiducial marker(s) 20 placed on the patient's vertebra 610. As described above, the system then auto-registers the patient by correlating the reference points to the data points.” [0064]),
receive position data from the instrument sensor (“The medical instrument 60 includes a handle 62 and a probe 64 having a tip portion 66. The tip portion 66 of the medical instrument 60 includes a sensor having at least one coil 68 that makes up the sensor 50.” [0061], “During the procedure, the computer system dynamically tracks movement of each sensor 50 on the patient's vertebra and on the medical instrument 60. Thus, the system tracks alignment and positioning of the vertebra 610 (e.g., relative movement of the vertebra) as well as movement of the medical instrument 60 relative to the vertebrae. In addition, the system can “learn the geometry” of sensors placed on a single to perform geometry checks that help maintain system accuracy as described above.” [0065]),
update the patient-specific image data based on one of the received position data from the joint sensor and the instrument sensor (“a processor for receiving the reference signals and for ascertaining a location of the magnetic field sensors based upon the reference signals, the processor for generating a displaced image data set representing the relative positions of the body elements during the procedure; and a display utilizing the displaced image data set generated by the processor to display the relative position of the body elements during the procedure.” [0014]),
and output the updated patient-specific image data (“As the system tracks relative movement of vertebra 610 and the medical instrument 60, a graphical representation of instrument navigation through the patient's spinous process is displayed on a monitor 48 of the computer system 40 based on reconstructed images of scanned image data.” [0066]).
Regarding Claim 2, Hunter discloses that each of the joint sensor and the instrument motion sensor are configured to emit a signal (“During the procedure, the computer system dynamically tracks movement of each sensor 50 on the patient's vertebra and on the medical instrument 60. Thus, the system tracks alignment and positioning of the vertebra 610 (e.g., relative movement of the vertebra) as well as movement of the medical instrument 60 relative to the vertebrae.” [0065]).
Regarding Claim 3, Hunter discloses that the processor is further configured to: receive the signal emitted from at least one of the joint sensor and the instrument sensor; and convert the received signal emitted from the at least one of the joint sensor and the instrument sensor to position data (“During the procedure, a magnetic field generator (not shown) generates a magnetic field in the area of the patient. For example, coils (not shown) can be embedded into an operating table 42 on which the patient is placed. The magnetic field sensors 50 on the patient's head 30 and in the medical instrument 60 detect the generated magnetic field and send appropriate signals to the processor 45 so that the processor 45 can determine the positions of the magnetic field sensors 50 during the procedure.” [0041], “During the procedure, the computer system dynamically tracks movement of each sensor 50 on the patient's vertebra and on the medical instrument 60. Thus, the system tracks alignment and positioning of the vertebra 610 (e.g., relative movement of the vertebra) as well as movement of the medical instrument 60 relative to the vertebrae.” [0065]).
Regarding Claim 4, Hunter discloses that the joint sensor includes a marker (“At least one fiducial marker 20 is placed on each vertebra 610 of concern during the procedure. A vertebra “of concern” is a vertebra whose position the user is concerned with during the spinal procedure. Once at least one fiducial marker 20 has been placed on each vertebra of concern, image slices or a three-dimensional scan (e.g., MR, CT, ultrasound, fluoro and PET) are taken of the patient's spine to create a three-dimensional data set having data points corresponding to reference points on each fiducial marker 20.” [0063]).
Regarding Claim 6, Hunter discloses that the joint is a vertebrae, a knee joint, a hip joint, an elbow joint, an ankle joint, a shoulder joint, or a wrist joint (“FIG. 16 schematically illustrates elements of spinal surgery needed to explain the procedures of the present invention. At least one fiducial marker 20 is placed on each vertebra 610 of concern during the procedure. A vertebra “of concern” is a vertebra whose position the user is concerned with during the spinal procedure. Once at least one fiducial marker 20 has been placed on each vertebra of concern, image slices or a three-dimensional scan (e.g., MR, CT, ultrasound, fluoro and PET) are taken of the patient's spine to create a three-dimensional data set having data points corresponding to reference points on each fiducial marker 20.” [0063]).
Regarding Claim 7, Hunter discloses further comprising a reference sensor detectable within the magnetic field for registering a frame of reference (“During the procedure, at least one sensor 50 is placed in known relation to the fiducial marker(s) 20 on patient's head to create a dynamic reference frame for the procedure. Preferably, the at least one sensor is integrated with the fiducial marker(s), removably attached to the fiducial marker(s), permanently affixed to the fiducial marker(s) after the patient is scanned, or interchanged with the fiducial marker(s) during the procedure. In a preferred embodiment of the invention in which a single uniquely shaped fiducial marker with ascertainable location and orientation is utilized (see FIGS. 13 and 14), the location and orientation of the sensor with respect to the fiducial marker is determined prior to placement of the fiducial marker-sensor onto the patient and remains constant throughout the procedure.” [0058]).
Regarding Claim 10, Hunter discloses a method for performing surgical navigation (“A method for use during a procedure on a body. The method generates a display representing relative positions of two structures during the procedure.” [Abstract], “The present invention relates to localization of a position during neurosurgery. The present invention relates more specifically to electromagnetic localization of a position during stereotactic neurosurgery, such as brain surgery and spinal surgery.” [0003]) comprising:
receiving patient-specific image data of a joint of a patient (“The magnetic field sensors 50 on the patient's head 30 and in the medical instrument 60 detect the generated magnetic field and send appropriate signals to the processor 45 so that the processor 45 can determine the positions of the magnetic field sensors 50 during the procedure.” [0041], “FIG. 16 schematically illustrates elements of spinal surgery needed to explain the procedures of the present invention. At least one fiducial marker 20 is placed on each vertebra 610 of concern during the procedure. A vertebra “of concern” is a vertebra whose position the user is concerned with during the spinal procedure. Once at least one fiducial marker 20 has been placed on each vertebra of concern, image slices or a three-dimensional scan (e.g., MR, CT, ultrasound, fluoro and PET) are taken of the patient's spine to create a three-dimensional data set having data points corresponding to reference points on each fiducial marker 20.” [0063])
generating a magnetic field (“The system comprises memory for storing an image data set representing the position of the body based on scans of the body, the image data set having a plurality of data points in known relation to a plurality of reference points for the body; a magnetic field generator for generating a magnetic field to be sensed by one or more magnetic field sensors placed in known relation to the reference points of the body for detecting the magnetic field and for generating positional signals in response to the detected magnetic field” [0014]);
attaching a joint sensor detectable within the magnetic field to a bone of the joint (“the image data set is created prior to placing the patient on the operating table. Once the patient is ready for surgery, the processor 45 can identify the fiducial marker 20 in patient space using signals received from at least one sensor 50, placed in known relation to the fiducial marker(s) 20 placed on the patient's vertebra 610.” [0064], “the computer system dynamically tracks movement of each sensor 50 on the patient's vertebra and on the medical instrument 60. Thus, the system tracks alignment and positioning of the vertebra 610 (e.g., relative movement of the vertebra) as well as movement of the medical instrument 60 relative to the vertebrae.” [0065]);
tracking position data of the joint sensor within the magnetic field (“Preferably, the image data set is created prior to placing the patient on the operating table. Once the patient is ready for surgery, the processor 45 can identify the fiducial marker 20 in patient space using signals received from at least one sensor 50, placed in known relation to the fiducial marker(s) 20 placed on the patient's vertebra 610. As described above, the system then auto-registers the patient by correlating the reference points to the data points.” [0064]),
updating the patient-specific image data based on the tracked position data of the joint sensor (“a processor for receiving the reference signals and for ascertaining a location of the magnetic field sensors based upon the reference signals, the processor for generating a displaced image data set representing the relative positions of the body elements during the procedure; and a display utilizing the displaced image data set generated by the processor to display the relative position of the body elements during the procedure.” [0014]),
and outputting the updated patient-specific image data (“As the system tracks relative movement of vertebra 610 and the medical instrument 60, a graphical representation of instrument navigation through the patient's spinous process is displayed on a monitor 48 of the computer system 40 based on reconstructed images of scanned image data.” [0066]).
Regarding Claim 11, Hunter discloses that the joint is a vertebrae (“FIG. 16 schematically illustrates elements of spinal surgery needed to explain the procedures of the present invention. At least one fiducial marker 20 is placed on each vertebra 610 of concern during the procedure. A vertebra “of concern” is a vertebra whose position the user is concerned with during the spinal procedure. Once at least one fiducial marker 20 has been placed on each vertebra of concern, image slices or a three-dimensional scan (e.g., MR, CT, ultrasound, fluoro and PET) are taken of the patient's spine to create a three-dimensional data set having data points corresponding to reference points on each fiducial marker 20.” [0063]).
Regarding Claim 12, Hunter discloses further comprising attaching a plurality of joint sensors to a plurality of vertebra respectively (“FIG. 16 schematically illustrates elements of spinal surgery needed to explain the procedures of the present invention. At least one fiducial marker 20 is placed on each vertebra 610 of concern during the procedure. A vertebra “of concern” is a vertebra whose position the user is concerned with during the spinal procedure. Once at least one fiducial marker 20 has been placed on each vertebra of concern, image slices or a three-dimensional scan (e.g., MR, CT, ultrasound, fluoro and PET) are taken of the patient's spine to create a three-dimensional data set having data points corresponding to reference points on each fiducial marker 20 [0063], “Once the patient is ready for surgery, the processor 45 can identify the fiducial marker 20 in patient space using signals received from at least one sensor 50, placed in known relation to the fiducial marker(s) 20 placed on the patient's vertebra 610.” [0064]).
Regarding Claim 13, Hunter discloses further comprising: tracking position data of each of the plurality of vertebra; and updating the patient-specific image data based on the tracked position data of at least two of the plurality of vertebra (“FIG. 16 schematically illustrates elements of spinal surgery needed to explain the procedures of the present invention. At least one fiducial marker 20 is placed on each vertebra 610 of concern during the procedure. A vertebra “of concern” is a vertebra whose position the user is concerned with during the spinal procedure. Once at least one fiducial marker 20 has been placed on each vertebra of concern, image slices or a three-dimensional scan (e.g., MR, CT, ultrasound, fluoro and PET) are taken of the patient's spine to create a three-dimensional data set having data points corresponding to reference points on each fiducial marker 20 [0063],“Once the patient is ready for surgery, the processor 45 can identify the fiducial marker 20 in patient space using signals received from at least one sensor 50, placed in known relation to the fiducial marker(s) 20 placed on the patient's vertebra 610. As described above, the system then auto-registers the patient by correlating the reference points to the data points. According to the present invention, the fiducial marker-sensor devices illustrated with respect to brain surgery are equally acceptable for spinal surgery.” [0064]).
Regarding Claim 16, Hunter discloses further comprising attaching the joint sensor to the joint via a marker (“At least one fiducial marker 20 is placed on each vertebra 610 of concern during the procedure. A vertebra “of concern” is a vertebra whose position the user is concerned with during the spinal procedure. Once at least one fiducial marker 20 has been placed on each vertebra of concern, image slices or a three-dimensional scan (e.g., MR, CT, ultrasound, fluoro and PET) are taken of the patient's spine to create a three-dimensional data set having data points corresponding to reference points on each fiducial marker 20.” [0063]).
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.
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.
Claims 5, 9, 14-15, & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of Finley (US20180092699A1).
Regarding Claim 5, Hunter discloses all limitations noted above except that the marker comprises a pin.
However, in a similar field of endeavor, Finley teaches a system, including various apparatus and methods, for surgical navigation is provided. The system is configured to track the spine of a patient by capturing images via one or more cameras [Abstract].
Finley also teaches that the marker comprises a pin (“the tracker 50 (i.e., the assembly of the array 38 and pin 52) comprises the array 38 having one or more markers 42 disposed thereon. The arrays 38 may securely, or lockingly and releaseably, engage with a spine pin 52. The markers 42 may be variously positioned on the array 38. The markers 42 may be positioned at various points on a first surface 56 of the array 38. The arrays 38 may be scattered over the first surface 56, as shown in FIGS. 4A and 4B. The spine pin 52 may be positioned with or engage one or more anatomical feature 4 (e.g., vertebrae) by use of a spine tracker inserter 54 (FIGS. 9A-9C).” [0084]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Hunter as outlined above with the marker comprises a pin as taught by Finley, because it provides increased tracking of the desired vertebra [0084].
Regarding Claim 9, Hunter discloses all limitations noted above except that the processor is further configured to: receive image data of a surgical instrument; and update the patient-specific image data based on the received image data of the surgical instrument.
However, in a similar field of endeavor, Finley teaches that the processor is further configured to: receive image data of a surgical instrument; and update the patient-specific image data based on the received image data of the surgical instrument (“The method may include releasing the at least one array from the first vertebra; releasably securing the at least one array with a second vertebra of the spine; capturing images of the at least one array with the second vertebra with the optical tracking system; communicating captured images of the at least one array with the second vertebra to the computer system; tracking the insertion of a third screw into the second vertebra with the optical tracking system and communicating images of the tracked third screw to the computer system;” [0014], “The computer executable instructions are configured to calculate and display a dynamic 3D spine model with streaming data of virtual tools overlaid over the displayed dynamic 3D spine model to augment direct anatomy visualization.” [0103]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Hunter as outlined above with the processor is further configured to: receive image data of a surgical instrument; and update the patient-specific image data based on the received image data of the surgical instrument as taught by Finley, because a need continues to exist for systems and methods that: include compensatory changes as part of surgical planning, provide improved surgeon visualization, reduce radiation to patients and OR staff, increase surgical efficiency, and reduce OR equipment footprint [0009].
Regarding Claim 14, Hunter discloses all limitations noted above except further comprising attaching at least three joint sensors respectively to at least three adjacent vertebra.
However, in a similar field of endeavor, Finley teaches further comprising attaching at least three joint sensors respectively to at least three adjacent vertebra (“FIGS. 14A-14C illustrate images of a set of spine pins affixed to the spinous processes of first, second, and third vertebrae.” [0046])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Hunter as outlined above with further comprising attaching at least three joint sensors respectively to at least three adjacent vertebra as taught by Finley, because a need continues to exist for systems and methods that: include compensatory changes as part of surgical planning, provide improved surgeon visualization, reduce radiation to patients and OR staff, increase surgical efficiency, and reduce OR equipment footprint [0009].
Regarding Claim 15, Hunter discloses all limitations noted above except further comprising attaching a reference sensor to a predetermined vertebra of the patient, and attaching at least three joint sensors respectively to at least three vertebra adjacent the predetermined vertebra..
However, in a similar field of endeavor, Finley teaches further comprising attaching a reference sensor to a predetermined vertebra of the patient, and attaching at least three joint sensors respectively to at least three vertebra adjacent the predetermined vertebra. (“FIGS. 14A-14C illustrate images of a set of spine pins affixed to the spinous processes of first, second, and third vertebrae.” [0046], “The adjacent vertebrae levels may be displayed in their new locations as solid engineering files, such as 3D.stl or other format files, and all may be tracked relative to the single patient reference array 38 (above operative level)” [0124])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Hunter as outlined above with further comprising attaching a reference sensor to a predetermined vertebra of the patient, and attaching at least three joint sensors respectively to at least three vertebra adjacent the predetermined vertebra as taught by Finley, because a need continues to exist for systems and methods that: include compensatory changes as part of surgical planning, provide improved surgeon visualization, reduce radiation to patients and OR staff, increase surgical efficiency, and reduce OR equipment footprint [0009].
Regarding Claim 17, Hunter discloses further comprising: receiving position data from an instrument sensor (“The medical instrument 60 includes a handle 62 and a probe 64 having a tip portion 66. The tip portion 66 of the medical instrument 60 includes a sensor having at least one coil 68 that makes up the sensor 50.” [0061], “During the procedure, the computer system dynamically tracks movement of each sensor 50 on the patient's vertebra and on the medical instrument 60. Thus, the system tracks alignment and positioning of the vertebra 610 (e.g., relative movement of the vertebra) as well as movement of the medical instrument 60 relative to the vertebrae. In addition, the system can “learn the geometry” of sensors placed on a single to perform geometry checks that help maintain system accuracy as described above.” [0065]),
and updating the patient-specific image data based on the received position data from the instrument sensor (“a processor for receiving the reference signals and for ascertaining a location of the magnetic field sensors based upon the reference signals, the processor for generating a displaced image data set representing the relative positions of the body elements during the procedure; and a display utilizing the displaced image data set generated by the processor to display the relative position of the body elements during the procedure.” [0014]).
Hunter does not specifically disclose receiving image data of a surgical instrument and updating the patient-specific image data based on the received image data of the surgical instrument.
However, in a similar field of endeavor, Finley teaches receiving image data of a surgical instrument and updating the patient-specific image data based on the received image data of the surgical instrument (“The method may include releasing the at least one array from the first vertebra; releasably securing the at least one array with a second vertebra of the spine; capturing images of the at least one array with the second vertebra with the optical tracking system; communicating captured images of the at least one array with the second vertebra to the computer system; tracking the insertion of a third screw into the second vertebra with the optical tracking system and communicating images of the tracked third screw to the computer system;” [0014], “The computer executable instructions are configured to calculate and display a dynamic 3D spine model with streaming data of virtual tools overlaid over the displayed dynamic 3D spine model to augment direct anatomy visualization.” [0103]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Hunter as outlined above with receiving image data of a surgical instrument and updating the patient-specific image data based on the received image data of the surgical instrument as taught by Finley, because a need continues to exist for systems and methods that: include compensatory changes as part of surgical planning, provide improved surgeon visualization, reduce radiation to patients and OR staff, increase surgical efficiency, and reduce OR equipment footprint [0009].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter in view of Inkpen et al (US20140148808A1; hereinafter referred to as Inkpen).
Regarding Claim 8, Hunter discloses all limitations noted above except that the joint sensor and the instrument sensor comprise a non-ferrous metal.
However, in a similar field of endeavor, Inkpen teaches methods and apparatus for integrating an electromagnetic navigation system [Abstract].
Inkpen also teaches the joint sensor and the instrument sensor comprise a non-ferrous metal (“The material of housing 9, including arm portion 30, field generator mounting portion 32, bushing 46, and cover 24, is preferably non-ferrous and of low conductivity… For the exemplary embodiment the material preferably withstands autoclave or other high temperature sterilization processes without deforming. Some examples of suitable materials are titanium, PEEK, or Ultem™.” [0293])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Hunter as outlined above with the joint sensor and the instrument sensor comprise a non-ferrous metal as taught by Inkpen, because it minimizes effects on the electromagnetic navigation system [0293].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached on (571) 272-7230. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Steven Maldonado/
Patent Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
Prosecution Insights