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 Objections
Claim 2 is objected to because of the following informalities: In Line 3, the word --attachment-- should be added after the word “retractor”. Appropriate correction is required.
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.
Claim(s) 1, 3, 7, 16 & 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xia et al. (US PG Pub No. 2011/0184245).
Regarding Claims 1 & 3, Xia et al. discloses a retractor system (100, Fig. 1, Paragraph [0019-0036]) comprising: a retractor (102, Paragraph [0021]); one or more sensors (sensor 150, Fig. 1, “may be used on each blade”, Paragraphs [0026-0028]) configured to identify a location of one or more anatomical landmarks or instruments (“The sensor 150 provides information indicative of one or more parameters of the loading stress, trauma, status, or other parameter of the tissue at the surgical site. For example, the sensor 150 may provide information including mechanical, thermal, chemical fluidity (such as pressure, time, heat, blood flow, lactid acid build-up, or other parameters) determined to be useful in a surgical setting.” “For example only, the sensor 150 may be a strain sensor, a thermocouple, a flow meter such as a Transonic VLF-21 Laser Doppler Flowmeter, other sensors, or a plurality of sensors arranged in a manner known in the art.”, Paragraph [0026]); and a processing unit (103, Fig. 1, Paragraph [0021]) configured to receive and process data from the one or more sensors. (It is noted that in regards to the intended use limitations above, the retractor 102 is fully and structurally capable of being used to retract a ligament/MCL, and each sensor 150 is fully and structurally capable of being used to identify a tibial plateau and/or soft tissue adjacent thereto. Paragraph [0057])
Regarding Claim 7, Xia et al. discloses wherein the retractor comprises the one or more sensors (150 is on blade(s) 110 of retractor 102, Fig. 1, Paragraph [0026]).
Regarding Claims 16 & 18, Xia et al. discloses a retractor system (100, Fig. 1, Paragraph [0019-0036]) comprising: a retractor (102, Paragraph [0021]) comprising one or more sensors (sensor 150, Fig. 1, “may be used on each blade”, Paragraphs [0026-0028]); and a processing unit (103, Fig. 1, Paragraph [0021]) configured to receive and process data from the one or more sensors; wherein the one or more sensors are capable of confirming placement of the retractor during a surgical procedure (“The sensor 150 provides information indicative of one or more parameters of the loading stress, trauma, status, or other parameter of the tissue at the surgical site. For example, the sensor 150 may provide information including mechanical, thermal, chemical fluidity (such as pressure, time, heat, blood flow, lactid acid build-up, or other parameters) determined to be useful in a surgical setting.” “For example only, the sensor 150 may be a strain sensor, a thermocouple, a flow meter such as a Transonic VLF-21 Laser Doppler Flowmeter, other sensors, or a plurality of sensors arranged in a manner known in the art.” Paragraph [0026]). (It is noted that in regards to the intended use limitations above, the retractor 102 is fully and structurally capable of being used to retract a ligament/MCL (Paragraph [0057]).
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.
Claim(s) 2 & 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (US PG Pub No. 2011/0184245) in view of Pimenta et al. (US PG Pub No. 2005/0149035).
Regarding Claim 2, Xia et al. discloses the claimed invention as stated above in claim 1, and further discloses wherein the retractor comprises a plurality of blades (110, 112, Fig. 1), except a patient specific instrument (PSI) retractor attachment configured to be received by and operatively engage the retractor, wherein the PSI retractor attachment comprises the one or more sensors.
Pimenta et al. discloses a surgical access system (10, Fig. 1, Paragraph [0041]) comprising a retractor (Fig. 1) comprising a plurality of blades (12, 16, 18) configured to each engage tissue, wherein one of the blades may be equipped with a shim element (22, Fig. 2-3) removably attached to a distal-most end of the blade (Paragraph [0043]) and configured to help secure the system to the surgical site and form a protective barrier to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor, and the other blades may be equipped with an extender (24/25, Figs. 4-7) removably attached to a distal-most end of the blade (Paragraph [0043]) and configured to form a protective barrier to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor (Paragraph [0042]), wherein the shim and extenders each act as a patient specific retractor attachment since they can be attached as needed based on a patients particular needs during surgery, wherein any or all of the blades, the shim element and/or the extenders may be provided with electrodes (30) for use with a nerve surveillance system (Paragraph [0043]), wherein a “monitoring system 120 is capable of determining nerve direction relative to one or more of the K-wire 42, the dilators 44, 48, 52, 54, the retractor blades 12, 16, 18 and/or the shim elements 22, 24, 25 before, during and/or following the creation of an operative corridor to a surgical target site. Monitoring system 120 accomplishes this by having the control unit 122 and patient module 124 cooperate to send electrical stimulation signals to one or more of the stimulation electrodes provided on these instruments. Depending upon the location of the surgical access system 10 within a patient (and more particularly, to any neural structures), the stimulation signals may cause nerves adjacent to or in the general proximity of the surgical access system 10 to depolarize. This causes muscle groups to innervate and generate EMG responses, which can be sensed via the EMG harness 126. The nerve direction feature of the system 120 is based on assessing the evoked response of the various muscle myotomes monitored by the system 120 via the EMG harness 126.” (Paragraph [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each blade of the retractor of the system of Xia et al. to add an adjustably connected extender or shim to the distalmost end thereof, wherein each blade extender or shim comprises one of the sensors, as taught by Pimenta et al. in order to provide the system with a means for adjusting each blade to better suit the surgical site based on a patient’s particular needs, so that when attached, a protective barrier can be formed to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor.
Regarding Claims 21-23, Xia et al. discloses a retractor system (100, Fig. 1, Paragraph [0019-0036]) comprising: a retractor (102, Paragraph [0021]) capable of retracting a ligament during a surgical procedure (It is noted that in regards to the intended use limitations above, the retractor 102 is fully and structurally capable of being used to retract a ligament/MCL, and each sensor 150 is fully and structurally capable of being used to identify a tibial plateau and/or soft tissue adjacent thereto. Paragraph [0057]), wherein the retractor comprises a plurality of blades (110, 112, Fig. 1); and one or more sensors (sensor 150, Fig. 1, “may be used on each blade”, Paragraphs [0026-0028]) configured to identify a location of one or more anatomical landmarks or instruments (“The sensor 150 provides information indicative of one or more parameters of the loading stress, trauma, status, or other parameter of the tissue at the surgical site. For example, the sensor 150 may provide information including mechanical, thermal, chemical fluidity (such as pressure, time, heat, blood flow, lactid acid build-up, or other parameters) determined to be useful in a surgical setting.” “For example only, the sensor 150 may be a strain sensor, a thermocouple, a flow meter such as a Transonic VLF-21 Laser Doppler Flowmeter, other sensors, or a plurality of sensors arranged in a manner known in the art.”, Paragraph [0026]).
Xia et al. does not disclose a patient specific instrument (PSI) retractor attachment configured to be received by and operatively engage the retractor, wherein the PSI retractor attachment is configured to engage an anatomical landmark, and wherein the RSI retractor attachment comprises the one or more sensors.
Pimenta et al. discloses a surgical access system (10, Fig. 1, Paragraph [0041]) comprising a retractor (Fig. 1) comprising a plurality of blades (12, 16, 18) configured to each engage tissue, wherein one of the blades may be equipped with a shim element (22, Fig. 2-3) removably attached to a distal-most end of the blade (Paragraph [0043]) and configured to help secure the system to the surgical site and form a protective barrier to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor, and the other blades may be equipped with an extender (24/25, Figs. 4-7) removably attached to a distal-most end of the blade (Paragraph [0043]) and configured to form a protective barrier to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor (Paragraph [0042]), wherein the shim and extenders each act as a patient specific retractor attachment since they can be attached as needed based on a patients particular needs during surgery, wherein any or all of the blades, the shim element and/or the extenders may be provided with electrodes (30) for use with a nerve surveillance system (Paragraph [0043]), wherein a “monitoring system 120 is capable of determining nerve direction relative to one or more of the K-wire 42, the dilators 44, 48, 52, 54, the retractor blades 12, 16, 18 and/or the shim elements 22, 24, 25 before, during and/or following the creation of an operative corridor to a surgical target site. Monitoring system 120 accomplishes this by having the control unit 122 and patient module 124 cooperate to send electrical stimulation signals to one or more of the stimulation electrodes provided on these instruments. Depending upon the location of the surgical access system 10 within a patient (and more particularly, to any neural structures), the stimulation signals may cause nerves adjacent to or in the general proximity of the surgical access system 10 to depolarize. This causes muscle groups to innervate and generate EMG responses, which can be sensed via the EMG harness 126. The nerve direction feature of the system 120 is based on assessing the evoked response of the various muscle myotomes monitored by the system 120 via the EMG harness 126.” (Paragraph [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each blade of the retractor of the system of Xia et al. to add an adjustably connected extender or shim to the distalmost end thereof, wherein each blade extender or shim comprises one of the sensors, as taught by Pimenta et al. in order to provide the system with a means for adjusting each blade to better suit the surgical site based on a patient’s particular needs, so that when attached, a protective barrier can be formed to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor.
Claim(s) 4-6, 8-10, 14, & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (US PG Pub No. 2011/0184245) in view of Charles et al. (US PG Pub No. 2014/0005488).
Regarding Claims 4-6, Xia et al. discloses the claimed invention as stated above in claim 1, except wherein the one or more sensors comprises an inertial measurement unit (IMU) sensor configured to obtain positional data of the retractor; wherein the one or more sensors comprises an optical sensor configured to provide 3D visualization data of an anatomical landmark proximate the retractor; and wherein the one or more sensors comprises a Hall effect sensor configured to detect proximity of a metallic surgical instrument to the retractor. Xia et al. does disclose in Paragraph [0026] that “The sensor 150 provides information indicative of one or more parameters of the loading stress, trauma, status, or other parameter of the tissue at the surgical site. For example, the sensor 150 may provide information including mechanical, thermal, chemical fluidity (such as pressure, time, heat, blood flow, lactid acid build-up, or other parameters) determined to be useful in a surgical setting. In the embodiment in FIG. 1, the sensor 150 is disposed upon the blade 110 of the retractor 102. Accordingly, in addition to sensing the pressure on the blade 110, the sensor may interface directly with the tissue and may provide information relating to either the state of the retractor or directly measure parameters of the tissue. In some examples, a sensor 150 may be used on each blade. In other examples, the sensor 150 may be used only on a single blade. The blade may be the medial blade, responsible for retracting the midline structures from the anterior aspect of the spine. For example only, the sensor 150 may be a strain sensor, a thermocouple, a flow meter such as a Transonic VLF-21 Laser Doppler Flowmeter, other sensors, or a plurality of sensors arranged in a manner known in the art.”
Charles et al. discloses a surgical retractor device (100, Figs. 2A-2C) comprising a plurality of adjustable blades (101) configured to be used to expand a patient’s tissue to provide for an operating pathway or workspace (Paragraph [0202]), wherein each blade comprises a removably attached camera module (105, Fig. 2B), wherein “The camera modules 105 can include sensors or markers for, e.g., electromagnetic or optical tracking or use encoders accelerometers, gyroscopes, or inertial measurement units (IMUs) or combinations thereof or any other orientation and/or position sensors, as described in more detail below. Tracking can provide location and/or orientation of the cameras. The images obtained by the cameras may be stitched together or tiled using image processing techniques to render a composite mosaic image. Tracking or otherwise knowing the relative locations of the sensor can assist in image processing and display formatting. Tracking position of cameras can support the touch screen user interface, such that a user can select, position and size (zoom) an image array on surgeon display. [0206] In various embodiments, pairs of cameras together provide information for creating a stereo effect or 3-dimensional (3D) image. Pairs of cameras, for example, may be included on each of the blades 101 of the retractor 100. In certain embodiments, images from separate cameras on separate blades 101 can be assembled to provide the stereo and three dimensional effect.”, Paragraphs [0205-0206]). Charles et al. further discloses in Paragraphs [0286-0289] that “It is also possible to use optical tracking, where the surgical device includes some kind of identifying markers, and the information is viewed by an overhead camera. The image can then be processed to identify the position and orientation of the surgical tool. The markers, whether shape or color or both, and whether positioned on or within a tool, for example, may provide white balance and intensity information useful for adjusting the sensors or illumination output. In various embodiments, white balancing may be done by inserting the target into the workspace in the field of view of all cameras before surgery. The frame, retractors and assorted cameras could be placed in a holster, whose purpose is multifold, to include but not limited to: authentication, white balance, camera positions with respect to frame, synching camera types to icons in GUI, such as field of view, line of sight, sensor type, stereo pairing, etc. [0287] In various embodiments inertial measurement units may be employed to determine movement and/or orientation of the cameras. Such inertial measurement units may be less expensive than potential alternative tracking options. In certain embodiments, IMUS are used to provide 5-DOF as opposed to 6-DOF. [0289] In some embodiments, actuation of an electrically powered surgical tool can result in electromagnetic interference with the electromagnetic tracking. In such configurations, optical tracking can be used to supplement electromagnetic tracking as an alternative. Alternatively, a notch filter can be employed to reduce interference from the powered surgical tool with the electromagnetic tracking. The notch filter can be selected such that the stop-band corresponds to the electromagnetic noise produced by the powered surgical tool. The electromagnetic signal used by the trackers may fall outside of the stop-band of the notch filter. Another approach to avoiding deleterious interference with the electromagnetic tracking is for electromagnetic tracking to be suspended during operation of the powered surgical tool. Once operation of the powered surgical tool has ceased, electromagnetic tracking may then re-commence. In various embodiments, a controller can automatically cease electromagnetic tracking when the powered surgical tool is initiated, and similarly can automatically resume electromagnetic tracking when use of the tool ends. Yet another approach involves characterizing the electromagnetic interference caused by a given powered surgical tool, and then using that characterization to subtract out the interference from the electromagnetic tracking signal. For example, in some embodiments, the electromagnetic signatures for a surgical tool may be known in advance, and this signal may be accounted for when electromagnetically tracking the positions of the tool and/or cameras. In other embodiments, the electromagnetic noise caused by the surgical tool may be measured on the fly, and this noise may then be subtracted or otherwise compensated for when calculating the position of the surgical tool and/or cameras.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each sensor of the retractor of the system of Xia et al. to be part of a camera module, wherein each sensor comprises an inertial measurement unit (IMU) sensor configured to obtain positional data of the retractor, an optical sensor configured to provide 3D visualization data of an tissue proximate the retractor, or a Hall effect sensor configured to detect proximity of a metallic surgical instrument to the retractor as taught by Charles et al. in order to provide the retractor with a means for directly viewing the surgical site, identifying a location of a powered surgical tool, and facilitating the creation of a 3D image of the site, thus allowing a surgeon to safely and more freely introduce tools within the surgical site and use both hands without the need of holding an endoscope.
Regarding Claims 8-10 & 14, Xia et al. discloses a retractor system (100, Fig. 1, Paragraph [0019-0036]) comprising: a retractor (102, Paragraph [0021]) comprising one or more sensors (sensor 150, Fig. 1, “may be used on each blade”, Paragraphs [0026-0028]); and a processing unit (103, Fig. 1, Paragraph [0021]) configured to receive and process data from the one or more sensors. (It is noted that in regards to the intended use limitations above, the retractor 102 is fully and structurally capable of being used to retract a ligament/MCL (Paragraph [0057]).
Xia et al. does not disclose wherein the one or more sensors are configured to detect proximity of a cutting device to the one or more sensors, wherein the cutting device comprises a material comprising a magnetic field detectable by the one or more sensors; and wherein the one or more sensors comprise one or more Hall effect sensors. Xia et al. does disclose in Paragraph [0026] that “The sensor 150 provides information indicative of one or more parameters of the loading stress, trauma, status, or other parameter of the tissue at the surgical site. For example, the sensor 150 may provide information including mechanical, thermal, chemical fluidity (such as pressure, time, heat, blood flow, lactid acid build-up, or other parameters) determined to be useful in a surgical setting. In the embodiment in FIG. 1, the sensor 150 is disposed upon the blade 110 of the retractor 102. Accordingly, in addition to sensing the pressure on the blade 110, the sensor may interface directly with the tissue and may provide information relating to either the state of the retractor or directly measure parameters of the tissue. In some examples, a sensor 150 may be used on each blade. In other examples, the sensor 150 may be used only on a single blade. The blade may be the medial blade, responsible for retracting the midline structures from the anterior aspect of the spine. For example only, the sensor 150 may be a strain sensor, a thermocouple, a flow meter such as a Transonic VLF-21 Laser Doppler Flowmeter, other sensors, or a plurality of sensors arranged in a manner known in the art.”
Charles et al. discloses a surgical retractor device (100, Figs. 2A-2C) comprising a plurality of adjustable blades (101) configured to be used to expand a patient’s tissue to provide for an operating pathway or workspace (Paragraph [0202]), wherein each blade comprises a removably attached camera module (105, Fig. 2B), wherein “The camera modules 105 can include sensors or markers for, e.g., electromagnetic or optical tracking or use encoders accelerometers, gyroscopes, or inertial measurement units (IMUs) or combinations thereof or any other orientation and/or position sensors, as described in more detail below. Tracking can provide location and/or orientation of the cameras. The images obtained by the cameras may be stitched together or tiled using image processing techniques to render a composite mosaic image. Tracking or otherwise knowing the relative locations of the sensor can assist in image processing and display formatting. Tracking position of cameras can support the touch screen user interface, such that a user can select, position and size (zoom) an image array on surgeon display. [0206] In various embodiments, pairs of cameras together provide information for creating a stereo effect or 3-dimensional (3D) image. Pairs of cameras, for example, may be included on each of the blades 101 of the retractor 100. In certain embodiments, images from separate cameras on separate blades 101 can be assembled to provide the stereo and three dimensional effect.”, Paragraphs [0205-0206]). Charles et al. further discloses in Paragraphs [0286-0289] that “It is also possible to use optical tracking, where the surgical device includes some kind of identifying markers, and the information is viewed by an overhead camera. The image can then be processed to identify the position and orientation of the surgical tool. The markers, whether shape or color or both, and whether positioned on or within a tool, for example, may provide white balance and intensity information useful for adjusting the sensors or illumination output. In various embodiments, white balancing may be done by inserting the target into the workspace in the field of view of all cameras before surgery. The frame, retractors and assorted cameras could be placed in a holster, whose purpose is multifold, to include but not limited to: authentication, white balance, camera positions with respect to frame, synching camera types to icons in GUI, such as field of view, line of sight, sensor type, stereo pairing, etc. [0287] In various embodiments inertial measurement units may be employed to determine movement and/or orientation of the cameras. Such inertial measurement units may be less expensive than potential alternative tracking options. In certain embodiments, IMUS are used to provide 5-DOF as opposed to 6-DOF. [0289] In some embodiments, actuation of an electrically powered surgical tool can result in electromagnetic interference with the electromagnetic tracking. In such configurations, optical tracking can be used to supplement electromagnetic tracking as an alternative. Alternatively, a notch filter can be employed to reduce interference from the powered surgical tool with the electromagnetic tracking. The notch filter can be selected such that the stop-band corresponds to the electromagnetic noise produced by the powered surgical tool. The electromagnetic signal used by the trackers may fall outside of the stop-band of the notch filter. Another approach to avoiding deleterious interference with the electromagnetic tracking is for electromagnetic tracking to be suspended during operation of the powered surgical tool. Once operation of the powered surgical tool has ceased, electromagnetic tracking may then re-commence. In various embodiments, a controller can automatically cease electromagnetic tracking when the powered surgical tool is initiated, and similarly can automatically resume electromagnetic tracking when use of the tool ends. Yet another approach involves characterizing the electromagnetic interference caused by a given powered surgical tool, and then using that characterization to subtract out the interference from the electromagnetic tracking signal. For example, in some embodiments, the electromagnetic signatures for a surgical tool may be known in advance, and this signal may be accounted for when electromagnetically tracking the positions of the tool and/or cameras. In other embodiments, the electromagnetic noise caused by the surgical tool may be measured on the fly, and this noise may then be subtracted or otherwise compensated for when calculating the position of the surgical tool and/or cameras.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each sensor of the retractor of the system of Xia et al. to be part of a camera module, wherein each sensor comprises a Hall effect sensors capable of detecting proximity of a metallic cutting device to the retractor as taught by Charles et al. in order to provide the retractor with a means for directly viewing the surgical site, identifying a location of a powered surgical tool, and facilitating the creation of a 3D image of the site, thus allowing a surgeon to safely and more freely introduce tools within the surgical site and use both hands without the need of holding an endoscope.
Regarding Claim 17, Xia et al. discloses the claimed invention as stated above in claim 16, except wherein the one or more sensors comprise one or more inertial measurement unit (IMU) sensors configured to obtain positional data of the retractor. Xia et al. does disclose in Paragraph [0026] that “The sensor 150 provides information indicative of one or more parameters of the loading stress, trauma, status, or other parameter of the tissue at the surgical site. For example, the sensor 150 may provide information including mechanical, thermal, chemical fluidity (such as pressure, time, heat, blood flow, lactid acid build-up, or other parameters) determined to be useful in a surgical setting. In the embodiment in FIG. 1, the sensor 150 is disposed upon the blade 110 of the retractor 102. Accordingly, in addition to sensing the pressure on the blade 110, the sensor may interface directly with the tissue and may provide information relating to either the state of the retractor or directly measure parameters of the tissue. In some examples, a sensor 150 may be used on each blade. In other examples, the sensor 150 may be used only on a single blade. The blade may be the medial blade, responsible for retracting the midline structures from the anterior aspect of the spine. For example only, the sensor 150 may be a strain sensor, a thermocouple, a flow meter such as a Transonic VLF-21 Laser Doppler Flowmeter, other sensors, or a plurality of sensors arranged in a manner known in the art.”
Charles et al. discloses a surgical retractor device (100, Figs. 2A-2C) comprising a plurality of adjustable blades (101) configured to be used to expand a patient’s tissue to provide for an operating pathway or workspace (Paragraph [0202]), wherein each blade comprises a removably attached camera module (105, Fig. 2B), wherein “The camera modules 105 can include sensors or markers for, e.g., electromagnetic or optical tracking or use encoders accelerometers, gyroscopes, or inertial measurement units (IMUs) or combinations thereof or any other orientation and/or position sensors, as described in more detail below. Tracking can provide location and/or orientation of the cameras. The images obtained by the cameras may be stitched together or tiled using image processing techniques to render a composite mosaic image. Tracking or otherwise knowing the relative locations of the sensor can assist in image processing and display formatting. Tracking position of cameras can support the touch screen user interface, such that a user can select, position and size (zoom) an image array on surgeon display. [0206] In various embodiments, pairs of cameras together provide information for creating a stereo effect or 3-dimensional (3D) image. Pairs of cameras, for example, may be included on each of the blades 101 of the retractor 100. In certain embodiments, images from separate cameras on separate blades 101 can be assembled to provide the stereo and three dimensional effect.”, Paragraphs [0205-0206]). Charles et al. further discloses in Paragraphs [0286-0289] that “It is also possible to use optical tracking, where the surgical device includes some kind of identifying markers, and the information is viewed by an overhead camera. The image can then be processed to identify the position and orientation of the surgical tool. The markers, whether shape or color or both, and whether positioned on or within a tool, for example, may provide white balance and intensity information useful for adjusting the sensors or illumination output. In various embodiments, white balancing may be done by inserting the target into the workspace in the field of view of all cameras before surgery. The frame, retractors and assorted cameras could be placed in a holster, whose purpose is multifold, to include but not limited to: authentication, white balance, camera positions with respect to frame, synching camera types to icons in GUI, such as field of view, line of sight, sensor type, stereo pairing, etc. [0287] In various embodiments inertial measurement units may be employed to determine movement and/or orientation of the cameras. Such inertial measurement units may be less expensive than potential alternative tracking options. In certain embodiments, IMUS are used to provide 5-DOF as opposed to 6-DOF. [0289] In some embodiments, actuation of an electrically powered surgical tool can result in electromagnetic interference with the electromagnetic tracking. In such configurations, optical tracking can be used to supplement electromagnetic tracking as an alternative. Alternatively, a notch filter can be employed to reduce interference from the powered surgical tool with the electromagnetic tracking. The notch filter can be selected such that the stop-band corresponds to the electromagnetic noise produced by the powered surgical tool. The electromagnetic signal used by the trackers may fall outside of the stop-band of the notch filter. Another approach to avoiding deleterious interference with the electromagnetic tracking is for electromagnetic tracking to be suspended during operation of the powered surgical tool. Once operation of the powered surgical tool has ceased, electromagnetic tracking may then re-commence. In various embodiments, a controller can automatically cease electromagnetic tracking when the powered surgical tool is initiated, and similarly can automatically resume electromagnetic tracking when use of the tool ends. Yet another approach involves characterizing the electromagnetic interference caused by a given powered surgical tool, and then using that characterization to subtract out the interference from the electromagnetic tracking signal. For example, in some embodiments, the electromagnetic signatures for a surgical tool may be known in advance, and this signal may be accounted for when electromagnetically tracking the positions of the tool and/or cameras. In other embodiments, the electromagnetic noise caused by the surgical tool may be measured on the fly, and this noise may then be subtracted or otherwise compensated for when calculating the position of the surgical tool and/or cameras.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each sensor of the retractor of the system of Xia et al. to be part of a camera module and comprise an inertial measurement unit (IMU) sensor configured to obtain positional data of the retractor as taught by Charles et al. in order to provide the retractor with a means for directly viewing the surgical site and facilitating the creation of a 3D image of the site, thus allowing a surgeon to safely and more freely introduce tools within the surgical site and use both hands without the need of holding an endoscope.
Claim(s) 11 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (US PG Pub No. 2011/0184245) in view of Charles et al. (US PG Pub No. 2014/0005488) as applied to claim 8 above and further in view of Douglas (US PG Pub No. 2023/0270428).
Regarding Claim 11, the combination of Xia et al. and Charles et al. discloses the claimed invention as stated above in claim 8, except a cutting guide configured to be coupled to the retractor and receive and guide the cutting device.
Douglas et al. discloses various embodiments of a retractor blade (100, Figs. 1A-7, 9-10, Paragraphs [0087-0098]), wherein the blade can be formed from two or more components coupled together in a suitable manner (Paragraph [0088]), and wherein the blade comprises two guides (first and second paths 150a, 150b, Figs. 2-5D,) defined on opposing lateral sides of each blade and extending from a proximal most end (130) of the blade to a distal most end (140) of the blade (Paragraphs [0087, 0093-0098]), each comprising guide comprising an enclosed channel through the blade and each configured to guide a surgical wire into bone adjacent the distal end of the blade (Figs. 9-10, Paragraphs [0079-0086]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each blade of the retractor of the combination to add two guides on opposing lateral sides thereof and extending between the proximal and distal ends of the blade as taught by Douglas in order to provide each blade with a means for guiding a surgical wire into the surgical site such that the wire does not encroach within the operative space.
Regarding Claims 19-20, the combination of Xia et al. and Charles et al. discloses the claimed invention as stated above in claim 16, except wherein the retractor further comprises a Hall effect sensor and the retractor system further comprises a cutting device comprising a material comprising a magnetic field detectable by the one or more sensors, wherein the Hall effect sensor is configured to detect a proximity of the cutting device to the ligament retractor. Xia et al. does disclose in Paragraph [0026] that “The sensor 150 provides information indicative of one or more parameters of the loading stress, trauma, status, or other parameter of the tissue at the surgical site. For example, the sensor 150 may provide information including mechanical, thermal, chemical fluidity (such as pressure, time, heat, blood flow, lactid acid build-up, or other parameters) determined to be useful in a surgical setting. In the embodiment in FIG. 1, the sensor 150 is disposed upon the blade 110 of the retractor 102. Accordingly, in addition to sensing the pressure on the blade 110, the sensor may interface directly with the tissue and may provide information relating to either the state of the retractor or directly measure parameters of the tissue. In some examples, a sensor 150 may be used on each blade. In other examples, the sensor 150 may be used only on a single blade. The blade may be the medial blade, responsible for retracting the midline structures from the anterior aspect of the spine. For example only, the sensor 150 may be a strain sensor, a thermocouple, a flow meter such as a Transonic VLF-21 Laser Doppler Flowmeter, other sensors, or a plurality of sensors arranged in a manner known in the art.”
Douglas et al. discloses various embodiments of a retractor blade (100, Figs. 1A-7, 9-10, Paragraphs [0087-0098]), wherein the blade can be formed from two or more components coupled together in a suitable manner (Paragraph [0088]), and wherein the blade comprises two guides (first and second paths 150a, 150b, Figs. 2-5D,) defined on opposing lateral sides of each blade and extending from a proximal most end (130) of the blade to a distal most end (140) of the blade (Paragraphs [0087, 0093-0098]), each comprising guide comprising an enclosed channel through the blade and each configured to guide a surgical wire into bone adjacent the distal end of the blade (Figs. 9-10, Paragraphs [0079-0086]).
Charles et al. discloses a surgical retractor device (100, Figs. 2A-2C) comprising a plurality of adjustable blades (101) configured to be used to expand a patient’s tissue to provide for an operating pathway or workspace (Paragraph [0202]), wherein each blade comprises a removably attached camera module (105, Fig. 2B), wherein “The camera modules 105 can include sensors or markers for, e.g., electromagnetic or optical tracking or use encoders accelerometers, gyroscopes, or inertial measurement units (IMUs) or combinations thereof or any other orientation and/or position sensors, as described in more detail below. Tracking can provide location and/or orientation of the cameras. The images obtained by the cameras may be stitched together or tiled using image processing techniques to render a composite mosaic image. Tracking or otherwise knowing the relative locations of the sensor can assist in image processing and display formatting. Tracking position of cameras can support the touch screen user interface, such that a user can select, position and size (zoom) an image array on surgeon display. [0206] In various embodiments, pairs of cameras together provide information for creating a stereo effect or 3-dimensional (3D) image. Pairs of cameras, for example, may be included on each of the blades 101 of the retractor 100. In certain embodiments, images from separate cameras on separate blades 101 can be assembled to provide the stereo and three dimensional effect.”, Paragraphs [0205-0206]). Charles et al. further discloses in Paragraphs [0286-0289] that “It is also possible to use optical tracking, where the surgical device includes some kind of identifying markers, and the information is viewed by an overhead camera. The image can then be processed to identify the position and orientation of the surgical tool. The markers, whether shape or color or both, and whether positioned on or within a tool, for example, may provide white balance and intensity information useful for adjusting the sensors or illumination output. In various embodiments, white balancing may be done by inserting the target into the workspace in the field of view of all cameras before surgery. The frame, retractors and assorted cameras could be placed in a holster, whose purpose is multifold, to include but not limited to: authentication, white balance, camera positions with respect to frame, synching camera types to icons in GUI, such as field of view, line of sight, sensor type, stereo pairing, etc. [0287] In various embodiments inertial measurement units may be employed to determine movement and/or orientation of the cameras. Such inertial measurement units may be less expensive than potential alternative tracking options. In certain embodiments, IMUS are used to provide 5-DOF as opposed to 6-DOF. [0289] In some embodiments, actuation of an electrically powered surgical tool can result in electromagnetic interference with the electromagnetic tracking. In such configurations, optical tracking can be used to supplement electromagnetic tracking as an alternative. Alternatively, a notch filter can be employed to reduce interference from the powered surgical tool with the electromagnetic tracking. The notch filter can be selected such that the stop-band corresponds to the electromagnetic noise produced by the powered surgical tool. The electromagnetic signal used by the trackers may fall outside of the stop-band of the notch filter. Another approach to avoiding deleterious interference with the electromagnetic tracking is for electromagnetic tracking to be suspended during operation of the powered surgical tool. Once operation of the powered surgical tool has ceased, electromagnetic tracking may then re-commence. In various embodiments, a controller can automatically cease electromagnetic tracking when the powered surgical tool is initiated, and similarly can automatically resume electromagnetic tracking when use of the tool ends. Yet another approach involves characterizing the electromagnetic interference caused by a given powered surgical tool, and then using that characterization to subtract out the interference from the electromagnetic tracking signal. For example, in some embodiments, the electromagnetic signatures for a surgical tool may be known in advance, and this signal may be accounted for when electromagnetically tracking the positions of the tool and/or cameras. In other embodiments, the electromagnetic noise caused by the surgical tool may be measured on the fly, and this noise may then be subtracted or otherwise compensated for when calculating the position of the surgical tool and/or cameras. In some embodiments, for example as illustrated in FIG. 13B, the second surgical device can be a surgical tool such as a needle holder 300. In various embodiments, the surgical tool can be, for example, drill, Kerrison, a cutting tool, grasping tool, Ronguer, scalpel, scissors, forceps, etc. The surgical tool 300 may have an camera module 305 integrated therein or attached thereto, whose field of view is determined by the position of the tool.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of the combination to add a metallic cutting tool as taught by Charles et al., and modify each sensor of the retractor of the combination to comprise a Hall effect sensor capable of detecting proximity of the metallic cutting tool to the retractor as taught by Charles et al. in order to provide the system with a tool for preparing the surgical site as needed which can be tracked in order to verify a position thereof during use.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (US PG Pub No. 2011/0184245) in view of Charles et al. (US PG Pub No. 2014/0005488) as applied to claim 8 above and further in view of Pimenta et al. (US PG Pub No. 2005/0149035).
Regarding Claim 12, the combination of Xia et al. and Charles et al. discloses the claimed invention as stated above in claim 8, and further discloses wherein the retractor comprises a plurality of blades (110, 112, Fig. 1). The combination does not disclsoe a patient specific instrument (PSI) retractor attachment configured to be received by and operatively engage the retractor, wherein the PSI retractor attachment comprises the one or more sensors.
Pimenta et al. discloses a surgical access system (10, Fig. 1, Paragraph [0041]) comprising a retractor (Fig. 1) comprising a plurality of blades (12, 16, 18) configured to each engage tissue, wherein one of the blades may be equipped with a shim element (22, Fig. 2-3) removably attached to a distal-most end of the blade (Paragraph [0043]) and configured to help secure the system to the surgical site and form a protective barrier to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor, and the other blades may be equipped with an extender (24/25, Figs. 4-7) removably attached to a distal-most end of the blade (Paragraph [0043]) and configured to form a protective barrier to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor (Paragraph [0042]), wherein the shim and extenders each act as a patient specific retractor attachment since they can be attached as needed based on a patients particular needs during surgery, wherein any or all of the blades, the shim element and/or the extenders may be provided with electrodes (30) for use with a nerve surveillance system (Paragraph [0043]), wherein a “monitoring system 120 is capable of determining nerve direction relative to one or more of the K-wire 42, the dilators 44, 48, 52, 54, the retractor blades 12, 16, 18 and/or the shim elements 22, 24, 25 before, during and/or following the creation of an operative corridor to a surgical target site. Monitoring system 120 accomplishes this by having the control unit 122 and patient module 124 cooperate to send electrical stimulation signals to one or more of the stimulation electrodes provided on these instruments. Depending upon the location of the surgical access system 10 within a patient (and more particularly, to any neural structures), the stimulation signals may cause nerves adjacent to or in the general proximity of the surgical access system 10 to depolarize. This causes muscle groups to innervate and generate EMG responses, which can be sensed via the EMG harness 126. The nerve direction feature of the system 120 is based on assessing the evoked response of the various muscle myotomes monitored by the system 120 via the EMG harness 126.” (Paragraph [0054]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each blade of the retractor of the combination to add an adjustably connected extender or shim to the distalmost end thereof, wherein each blade extender or shim comprises one of the sensors, as taught by Pimenta et al. in order to provide the system with a means for adjusting each blade to better suit the surgical site based on a patient’s particular needs, so that when attached, a protective barrier can be formed to prevent the ingress or egress of instruments or biological structures into or out of the operative corridor.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (US PG Pub No. 2011/0184245) in view of Charles et al. (US PG Pub No. 2014/0005488) and Pimenta et al. (US PG Pub No. 2005/0149035) as applied to claim 12 above and further in view of Douglas (US PG Pub No. 2023/0270428).
Regarding Claim 13, the combination of Xia et al., Charles et al., and Pimenta et al. discloses the claimed invention as stated in claim 12 above, except a cutting guide configured to be coupled to the PSI retractor attachment and receive and guide the cutting device.
Douglas et al. discloses various embodiments of a retractor blade (100, Figs. 1A-7, 9-10, Paragraphs [0087-0098]), wherein the blade can be formed from two or more components coupled together in a suitable manner (Paragraph [0088]), and wherein the blade comprises two guides (first and second paths 150a, 150b, Figs. 2-5D,) defined on opposing lateral sides of each blade and extending from a proximal most end (130) of the blade to a distal most end (140) of the blade (Paragraphs [0087, 0093-0098]), each comprising guide comprising an enclosed channel through the blade and each configured to guide a surgical wire into bone adjacent the distal end of the blade (Figs. 9-10, Paragraphs [0079-0086]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each blade of the retractor of the combination to add two guides on opposing lateral sides thereof and extending between the proximal and distal ends of the blade as taught by Douglas in order to provide each blade with a means for guiding a surgical wire into the surgical site such that the wire does not encroach within the operative space.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al. (US PG Pub No. 2011/0184245) in view of Pimenta et al. (US PG Pub No. 2005/0149035) as applied to claim 21 above and further in view of Douglas (US PG Pub No. 2023/0270428).
Regarding Claim 24, the combination of Xia et al., and Pimenta et al. discloses the claimed invention as stated in claim 21 above, except a cutting guide configured to be coupled to the PSI retractor attachment and receive and guide the cutting device.
Douglas et al. discloses various embodiments of a retractor blade (100, Figs. 1A-7, 9-10, Paragraphs [0087-0098]), wherein the blade can be formed from two or more components coupled together in a suitable manner (Paragraph [0088]), and wherein the blade comprises two guides (first and second paths 150a, 150b, Figs. 2-5D,) defined on opposing lateral sides of each blade and extending from a proximal most end (130) of the blade to a distal most end (140) of the blade (Paragraphs [0087, 0093-0098]), each comprising guide comprising an enclosed channel through the blade and each configured to guide a surgical wire into bone adjacent the distal end of the blade (Figs. 9-10, Paragraphs [0079-0086]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each blade of the retractor of the combination to add two guides on opposing lateral sides thereof and extending between the proximal and distal ends of the blade as taught by Douglas in order to provide each blade with a means for guiding a surgical wire into the surgical site such that the wire does not encroach within the operative space.
Allowable Subject Matter
Claim 15 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
Prosecution Insights