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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/2025 has been entered.
Response to Arguments
Regarding 35 U.S.C. 112
New 112(a) and 112(b) rejections necessitated by amendment/upon further consideration.
Applicant’s arguments, see REMARKS, filed 12/11/2025, with respect to claims 13 and 14 have been fully considered and are persuasive. The 112(b) of claim 13 regarding “anatomy” and claim 14 regarding bone and nerve has been withdrawn.
Applicant's arguments filed 12/11/2025 with respect to claims 15-21 have been fully considered but they are not persuasive.
For example, applicant argues “applicant confirms that the electrode can be the same or different from the first and second sensors” and “applicant notes that claim 1 recites a distance from a tissue and the trocar, while claim 16 recites a distance between the trocar and the nerve” (REMARKS pg. 8). Examiner respectfully disagrees in that the claim remains unclear as to the relationship between the electrode and the one or more sensors and the distance between the trocar and the nerve. Examiner notes that by reciting that the one or more first/second sensors is each configured to sense at least one of… a distance from the tissue and the trocar and then further introducing an electrode which is used to determine a distance between the trocar and the nerve, the limitation is unclear in light of the specification as applicant’s originally filed specification only provide one example example of a distance between a nerve and a trocar using an electrode without seeming to provide any disclosure of another type of sensor which would be configured to sense a distance from a tissue (other than a nerve) and a trocar. In other words, if the distance and the electrode are different from the previously recited distance and sensor(s), it is unclear what the nature of the sensor is which is configured to sense a distance from a tissue and the trocar and what such tissue this would encompass and the claim remains unclear for not clearly tying to nor distinguishing the distance from the previously recited distance.
Applicant further argues “applicant confirms that the position sensor can be the same or different than the first or second sensor as previously recited” (REMARKS pg. 7). Examiner respectfully disagrees in that claim 1 previously sets forth each configured to sense at least one of a position of the trocar…. Thus in the instance where the one or more first sensos and the one or more second sensors are configured to sense a position of the trocar, it is unclear what such first/second sensors are in an instance where the position sensor is different from the first/second sensors. In other words, the claim is unclear as it does not clearly define the relationship between the position sensor and the first/second sensors which are each configured to sense a position of the trocar in at least one instance. Examiner notes that there is not sufficient support for a different sensor (other than the position sensor) to sense a position of the trocar as recited in claim 1, thus making the claim unclear.
For at least the reasons listed above the 35 U.S.C 112(b) rejections of claims 16-17 are maintained.
Regarding prior art
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
For example, applicant argues “the Office Action has failed to establish that the nerve and bone that is said to be indicative of an anatomical structure (i.e. the head) as alleged to be taught by Algawi is data from each of the first and second sensors” (REMARKS pg. 8). Examiner respectfully disagrees in that applicant’s arguments that the nerve and bone is indicative of an anatomical structure is data from each of the first and second sensors does not accurately represent the claim language nor the rejections. In other words, the claim does not require that the nerve and bone is indicative of an anatomical structure nor that it is data from each of the first and second sensors. Rather, the claim broadly recites that the processor is configured to: overlay, on the display graphical representations of data from each of the first and second sensors indicative of an anatomical structure including nerve and bone. In other words, the claim merely requires that the graphical representations or data thereof are indicative and anatomical structure and that the anatomical structure includes nerve and bone. Examiner notes that Algawi explicitly teaches displaying graphical representations of data from each of the first and second sensors by disclosing video display of images acquired by the camera on the trocar and the position of the position of the distal end of the trocar thereon. Examiner notes that such display of images would indicate an anatomical structure (e.g. the head or other organ and/or a portion/position therein) which includes nerve and bone. Thus this feature is taught by Algawi. If applicant intends for the claim to be more specific as to how the graphical representation/data indicate the anatomical structure or nerves and bones therein, examiner recommends amending the claims to more clearly define such graphical representations. For at least the reasons listed above, applicant’s arguments against the teachings of Algawi are not found persuasive.
Applicant further argues “Scott fails to cure the deficiency of Algawi noted above with respect to claim 1 recitation of “wherein the graphical representations of data from each of the plurality of sensors are highlighted regions of an image captured by the visible light image sensor denoting the presence of any of a type of tissue and the anatomical structure” (REMARKS pg. 9). Examiner respectfully disagrees in that as noted previously, Scott teaches highlighted regions of an image captured by the visible light image sensor denoting the presence of any of a type of tissue and the anatomical structure. Such highlighting is considered a graphical representation of data from each of the plurality of sensors in its broadest reasonable interpretation in that the data of the position of the trocar and the images from the camera are represented by the image data in which the highlighted regions exist. If applicant intends for the highlighted regions to be something other than what is taught by Algawi and Scott in combination, examiner recommends amending the claims to more clearly define the nature of the highlighting and/or use of the data from each of the plurality of sensors.
Claim Rejections - 35 USC § 112(a)
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.
Claims 16-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 16 recites the limitation “further comprising an electrode… so as to determine a distance between the trocar and the nerve”. Examiner notes that the limitation includes an interpretation in which the electrode is different from the one or more first sensors and/or the one or more second sensors, where claim 1 sets forth that the one or more first sensors and/or the one or more second sensors are each configured to sense at least one of “a distance from a tissue and the trocar”. Examiner notes that in an instance where the one or more first sensors and the one or more second sensors are each configured to sense a distance from a tissue and the trocar, there is a lack of support for further comprising an electrode so as to determine a distance between the trocar and the nerve which is different form the first/second sensor which senses a distance from a tissue and a trocar. In other words, the originally filed specification discloses the use of an electrode as one of the first or second sensors to determine a distance between the tissue (i.e. a nerve) and the trocar, but fails to disclose any embodiment of a sensor which determines a distance between a tissue other than a nerve and the trocar which is not an electrode. Thus in the instance where the electrode is something other than the first and/or second sensor(s) that detects a distance from a tissue and the trocar the originally filed specification lacks written description such that a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim 17 recites the limitation “further comprising a position sensor configured to detect a position of the trocar”. Examiner notes that the limitation includes an interpretation in which the position sensor is different from the one or more first sensors and/or the one or more second sensors, where claim 1 sets forth that the one or more first sensors and/or the one or more second sensors are each configured to sense at least one of “a position of the trocar”. Examiner notes that in an instance where the one or more first sensors and the one or more second sensors are each configured to sense a position of the trocar, there is a lack of support for further comprising a position sensor which senses a position of the trocar. In other words, the originally filed specification discloses the use of a position sensor as one of the first or second sensors to sense a position of the trocar, but fails to disclose any embodiment of a sensor which senses a position of the trocar which is not a position sensor. Thus in the instance where the position sensor is something other than the first and/or second sensor(s) that detects a position of the trocar, the originally filed specification lacks written description such that a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim Rejections - 35 USC § 112(b)
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 and 5-21 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 “the graphical representations of data from each of the plurality of sensors are highlighted regions of an image captured by the visible light image sensor”. There is insufficient antecedent basis for the limitation the plurality of sensors and the graphical representation from each of the plurality of sensors in the claims. For example, examiner notes that while the claim previously recites graphical representation of data from each of the first and second sensors, such a limitation does not make clear whether the graphical representations of data from each of the plurality of sensors is the same as the graphical representations of data from each of the first and second sensors or since the first and second sensors are one or more first/second sensors if the plurality of sensors refers to a subset of the first and second sensors (e.g. the first sensors when there are more than one or the second sensors when there are more than one). For examination purposes, it has been interpreted that they may be the graphical representations of data from each of the first and second sensors or any other graphical indications of data from any plurality of the first and second sensors.
Claim 13 recites the limitation “wherein one of the one or more first sensors or the one or more second sensors comprises a camera supported by the trocar body”. The limitation is unclear as to whether the camera is the same as the one of the one or more first sensors or one or more second sensors which is a visible light sensor. Examiner notes that [0045] appears to disclose that the camera 51 can be configured as a visible light sensor, however, the claim appears to be introducing a new camera. For examination purposes, it has been interpreted that I may be the same or different from the visible light camera, however, clarification is required.
Claim 16 recites the limitation “further comprising an electrode”. It is unclear if the electrode is one of the previously recited first or second sensors or if this is a different element/sensor. For examination purposes, it has been interpreted to mean it may be the same or different from the previously recited first or second sensor, however, clarification is required.
Claim 16 recites the limitation “a distance between the trocar and the nerve”. It is unclear if this is the same distance recited previously and if the nerve is the tissue recited previously in claim 1 or if these are different tissue/distance. For examination purposes, it has been interpreted that the nerve and the distance may be the same or different from the tissue and the distance recited in claim 1, however, clarification is required.
Claim 17 recites the limitation “further comprising a position sensor configured to detect a position of the trocar”. It is unclear if the position sensor is one of the previously recited first or second sensors or if this is a different/distinct sensor and if the position of the trocar is the same as the position of the trocar recited previously or a different position of the trocar. For examination purposes, it has been interpreted to mean it may be the same or different from the previously recited first or second sensor and the same or different position, however, clarification is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Algawi et al. (US 20210196105 A1), hereinafter Algawi in view of Scott et al. (US 20090270678 A1), hereinafter Scott.
Regarding claim 1,
Algawi teaches a surgical system (at least fig. 1 (20) and corresponding disclosure in at least [0027]), comprising:
A trocar (at least figs. 1 and 2 (38) and corresponding disclosure in at least [0029]) having a trocar body (at least fig. 2 (69) and corresponding disclosure in at least [0048]) and one or more first sensors (at least fig. 2 (48) and corresponding disclosure in at least [0029]) and one or more second sensors (at least fig. 2 (50) and corresponding disclosure in at least [0029]) supported by the trocar body ([0050] disclosing the camera 48 are positioned at the distal most position within cannula and thus supported by the cannula 69 and [0052] which discloses position sensor 50 is fixed to an inner wall of cannula 69), wherein each of the one or more first (48) and one or more second sensors (50) is configured to sense at least one of a position or the trocar ([0036] which discloses position sensor generates position signals in response to sensing the magnetic fields generated by field generators) and a property of tissue proximate to the trocar (Examiner notes that a camera is configured to sense image data of the tissue proximate to (i.e. in front of/near the distal end of) the trocar, thus a property thereof), and wherein one of the one or more first sensors or the one or more second sensors includes a visible light image sensor (see at least fig. 1 (55) depicting a visible light image and a person having ordinary skill in the art would have recognized the camera 48 capturing images with LEDs as disclosed in [0054]-[0055] is or comprises a visible light image sensor))
A display (at least fig. 1 (52) and corresponding disclosure in at least [0042]); and
A processor (at least fig. 1 (34) and corresponding disclosure in at least [0039]) in communication with the one or more first sensors, the one or more second sensors, and the display (52)(see at least fig. 1 depicting the processors in communication with the sensors and display (at least via cables 32 as disclosed in [0039]) and [0043] which discloses the processor is further configured to display on display 52, thus is in communication with the display),
Wherein the processor is configured to overlay, on the display, graphical representations of data from each of the first and second sensors ([0042]-[0043] which disclose the video display configured for displaying an image 55 acquired by camera 48 and processed by processor 34 where the image 55 is considered a graphical representation of data from the camera 48 and the processor is further configured to display on display 52, the position of the distal end of trocar 38 overlaid on image 55, using the position signals received from position sensor 50, where the position of the distal end of trocar is considered a graphical representation of data (i.e. position signals) from the position sensor 50) indicative of an anatomical structure including nerve and bone that are to be avoided of contact by the trocar as the trocar is advanced toward a target anatomical site (Examiner notes that indicative of an anatomical structure including nerve and bone is broad as indicative merely means that the graphical representations indicate such an anatomical structure. It is therefore noted that the images from the camera and/or overlaid position of the distal end of the trocar are necessarily indicative of anatomy (e.g. the portion of the body in which the trocar is inserted or the body overall which include nerve and bone which are to be avoided of contact by the trocar as the trocar is advanced toward a target anatomical site).
Algawi fails to explicitly teach wherein the graphical representations of data from each of the plurality of sensors are highlighted regions of an image captured by the visible light image sensor denoting the presence of any of a type of tissue and the anatomical structure.
Scott, in a similar field of endeavor involving surgical procedures, teaches wherein graphical representations of data from each of a plurality of sensors (at least fig. 5A (531A-531B and 532A-532B) and corresponding disclosure in at least [0188]) are highlighted regions of an image captured by a visible image sensor (531A and/or 532A) denoting the presence of any of a type of tissue and the anatomical structure ([0107] which discloses the stereoscopic video display includes a normal three-dimensional view of tissue 303 augmented with one or more alternate images to highlight regions of interest in the tissue such as diseased portions of tissue 303 and/or a specific tissue, such as a nerve or organ different from that being operated on).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include a plurality of sensors and the graphical representations taught by Scott in order to allow a surgeon in real-time to identify positive tumor margins for diseased tissue excision and/or to identify nerves (i.e. types of tissue) so as to avoid cutting those nerves (Scott [0015]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Algawi and Scott, as applied to claim 1 above, and further in view of Sohlden et al. (US 20180318009 A1), hereinafter Sohlden.
Regarding claim 5,
Algawi, as modified, teaches the elements of claim 1 as previously stated. Algawi further teaches wherein one of one or more first sensors or the one or more second sensors is configured to sense the position of the trocar and the processor is further configured to display a graphical representation of the actual trajectory of the trocar ([0043] In some embodiments, processor 34 is further configured to display on display 52, the position of the distal end of trocar 38 overlaid on image 55, using the position signals received from position sensor 50).
Algawi fails to explicitly teach wherein the processor is configured to provide on the display a graphical indication of alignment between an actual trajectory of the trocar and a desired trajectory of the trocar.
Sohlden, in a similar field of endeavor involving medical procedures, teaches wherein a processor is configured to provide on the display a graphical indication of alignment between an actual trajectory of a trocar and a desired trajectory of the trocar ([0068] which discloses at step S332, the CT images and the path may be displayed side by side to allow the clinician to compare the actual location of surgical instrument 20 inside patient P and the planned location (thus desired trajectory) of surgical instrument, where displaying the actual position (i.e. actual trajectory) and the planned location (i.e. desired trajectory) side-by-side allowing for comparison constitutes a graphical indication of alignment between the actual trajectory of the instrument and a desired trajectory of the instrument and [0038] which discloses surgical instrument 20 may be, for example, a trocar).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include providing on the display a graphical indication of alignment as taught by Sohlden in order to allow for comparison between the actual location and the planned location accordingly (Sohlden [0068]). Such a comparison thus allows a user to determine if the trocar is following the desired trajectory and allowing the user to withdraw the trocar and reposition the trocar as needed (Sohlden [0069]), thereby enhancing the accuracy of the trocar positioning.
Regarding claim 6,
Algawi, as modified, teaches the elements of claim 5 as previously stated. Algawi further teaches displaying a first icon representing a first position of a first location of the trocar ([0043] In some embodiments, processor 34 is further configured to display on display 52, the position of the distal end of trocar 38 overlaid on image 55, using the position signals received from position sensor 50, where such overlay of a position of the distal end is considered a first icon representing a position of a first location of the trocar (i.e. actual/measured location)).
Sohlden, as applied to claim 5 above, further teaches wherein the graphical indication of alignment between the position of the trocar and a desired insertion trajectory includes representation of a position of a first location of the trocar ([0068] which discloses the CT images and the path may be displayed side by side to allow the clinician to compare the actual location of surgical instrument inside patient “P” and the planned location of surgical instrument and [0069] which discloses if surgical instrument shown in the intraoperative CT images following the intended path, thus the CT images include a representation of a first position of a first location (i.e. actual location) of the surgical instrument (i.e. trocar)) and a second icon representing a second position of a second location of the trocar (At step S332, the CT images and the path may be displayed side by side to allow the clinician to compare the actual location of surgical instrument 20 inside patient “P” and the planned location of surgical instrument. Where the path is a second icon representing the planned location (i.e. a position of a second location) of the surgical instrument (i.e. trocar))
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Algawi and Scott, as applied to claim 1 above, and further in view of Wybo (US 20150088029 A1 and included in applicant’s IDS filed 12/13/2022), hereinafter Wybo.
Regarding claim 7,
Algawi teaches the elements of claim 1 as previously stated. Algawi fails to explicitly teach wherein the one or more first sensors or the one or more second sensors comprises a plurality of nerve mapping electrodes.
Wybo, in a similar field of endeavor involving medical procedures, teaches a surgical instrument comprising a plurality of nerve mapping electrodes (at least fig. 4B or 6B (98a, 98b, and 98c) and corresponding disclosure in at least [0056] and [0044] which discloses the stimulator 30 may be provided with a plurality of electrodes that may collectively be used to triangulate the position of the nerve) supported thereon (see figs. 5A-6B)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include a nerve mapping electrode as taught by Wybo in order to allow for identification of location of nerve bundles or fibers (Wybo [0037]). Such a modification would enhance the safety/accuracy of the procedure of Algawi by allowing the location/direction of the nerves with respect to the trocar to be displayed which may aid the user in avoiding actions that may jeopardize the integrity of the identified nerve (Wybo [0006]).
Regarding claim 8,
Algawi, as modified, teaches the elements of claim 7 as previously stated. Algawi, as currently modified, fails to explicitly teach wherein the plurality of nerve mapping electrodes are spaced around a distal region of the trocar and the processor is configured to triangulate nerve location based on any of time-of-flight an signal strength detection at two or more of the plurality of nerve mapping electrodes.
Wybo, as applied to claim 7 above, further teaches wherein the plurality of nerve mapping electrodes (98a-98c) are spaced around a distal region of a surgical instrument ([0036] which discloses for example, in one configuration, the elongate medical instrument 30 may include a probe 32 (e.g., a ball-tip probe, k-wire, or needle) that has one or more electrodes 34 disposed on a distal end portion 36) and a processor is configured to triangulate nerve location based on any of time-of-flight and signal strength detection at two or more of the plurality of nerve mapping electrodes ([0050] the processor 20 may then monitor a mechanical sensor 22 that is in mechanical communication with a muscle 116 innervated by the nerve 112 for a response to each of the respective stimuli 114a, 114b, 114c. Using the monitored muscle response, and the known magnitude (thus signal strength detection) of the respective stimuli, the processor may determine a respective distance between each electrode 98a, 98b, 98c and the nerve 112 and the processor 20 may then use these determined distances to triangulate the position of the nerve 112 relative to the stimulator 90 within an approximate statistical margin of error and [0038] which discloses The lookup table may then be employed by the processor 20 to provide an approximate distance 54 between the electrode 34 and the nerve, given a known stimulus magnitude 56 and a measured mechanical muscle response magnitude 52 (i.e. signal strength detection))
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include the plurality of nerve mapping electrodes and triangulating nerve location as taught by Wybo in order to allow for identification of location of nerve bundles or fibers (Wybo [0037]). Such a modification would enhance the safety/accuracy of the procedure of Algawi by allowing the location/direction of the nerves with respect to the trocar to be displayed which may aid the user in avoiding actions that may jeopardize the integrity of the identified nerve (Wybo [0006]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Algawi, Scott, and Wybo as applied to claim 7 above and further in view of Mastri et al. (US 20080086160 A1), hereinafter Mastri.
Regarding claim 9,
Algawi, as modified, teaches the elements of claim 7 as previously stated. Algawi, as currently modified, fails to explicitly teach wherein the plurality of nerve mapping electrodes are embedded in a transparent distal tip of the trocar.
Nonetheless, Wybo further teaches wherein the plurality of nerve mapping electrodes are embedded in the distal tip of the instrument ([0045] which discloses in each embodiment 90, 92, the distal end portion 36 (thus the distal tip including 36 and 96) of the stimulator 94 includes a plurality of electrodes 96 disposed in a spaced relationship).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi, as currently modified to include embedding the nerve mapping electrodes in the distal tip of the trocar as taught by Wybo in order to allow the electrodes to stimulate the surrounding nerves accordingly thereby allowing for the identification of location of nerve bundles or fibers (Wybo [0037]). Such a modification would enhance the safety/accuracy of the procedure of Algawi by allowing the location/direction of the nerves with respect to the trocar to be displayed which may aid the user in avoiding actions that may jeopardize the integrity of the identified nerve (Wybo [0006]).
Algawi, as modified, fails to explicitly teach the distal tip is a transparent distal tip.
Nonetheless, Mastri, in a similar field of endeavor involving trocars, teaches a trocar having a transparent distal tip ([0003] which discloses insertion devices having a transparent tip to allow visualization of the tissue being penetrated and [0012] which discloses The penetrating tips for the surgical trocar each have a generally transparent body having proximal and distal ends.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi, as currently modified to include a transparent distal tip as taught by Mastri in order to allow a surgeon to view the layers of tissue through which the surgeon is penetrate (Mastri [0050]). Furthermore, such a modification would allow the surgeon to view the tissue through which the trocar and tip are passing, therefore allowing the surgeon to determine by the general appearance of the tissue, the point at which the tip has penetrated to a sufficient depth (Mastri [0050]).
Examiner notes that in the modified system the electrodes of Wybo are embedded in the distal tip and thus the transparent distal tip of Mastri accordingly.
Claims 10, 13-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Algawi and Scott, as applied to claim 1 above, and further in view of Shelton et al. (US 20210196383 A1 and included in applicant’s IDS filed 06/27/2024), hereinafter Shelton.
Regarding claim 10,
Algawi, as modified, teaches the elements of claim 1 as previously stated. Algawi further teaches wherein one of the one or more first sensors or the one or more second sensors comprises a camera (48) configured to capture images. Algawi fails to explicitly teach wherein the camera is a non-visible light image sensor configured to capture images, and the processor is further configured to differentiate tissue type based on the images captured by the non-visible light image sensor.
Shelton, in a similar field of endeavor involving surgical systems, teaches a sensor (at least fig. 1 (120) and corresponding disclosure in at least [0138] or fig. 2 (144) and corresponding disclosure in at least [0144]) comprises a non-visible light image sensor ([0139] which discloses the imaging device (120) can include a camera or imaging sensor that is configured to detect visible light, spectral light waves (visible or invisible) and a structured light pattern (visible or invisible), for example. Thus the image sensor 120 is considered a non-visible light image sensor since it is configured to invisible waves or patterns and [0144] which discloses the camera 144 can include one or more image sensors 135 to receive signals from various light sources emitting light at various visible and invisible spectra (e.g. visible light, spectral imagers, three-dimensional lens, among others)) configured to capture images ([0153] which discloses the imaging device 120 can be configured to receive images indicative of the topography of the visible tissue and the identification and position of hidden critical structures, as further described herein), and a processor (at least fig. 2 (600) and corresponding disclosure in at least [0171] which discloses The control system 600 is a conversion system that integrates spectral signature tissue identification and structured light tissue positioning to identify critical structures, especially when those structures are obscured by other tissue, such as fat, connective tissue, blood, and/or other organs, for example. Such technology could also be useful for detecting tissue variability, such as differentiating tumors and/or non-healthy tissue from healthy tissue within an organ) configured to differentiate tissue type based on images captured by the non-visible light image sensor ([0153] which discloses the imaging device 120 can be configured to receive images indicative of the topography of the visible tissue and the identification and position of hidden critical structures, as further described herein [0186] which discloses Different tissue types have different combinations of constituent materials and, therefore, the tissue type(s) being visualized by a surgical visualization system can be identified and differentiated between according to the particular combination of detected constituent materials. Accordingly, a spectral imaging system can be configured to emit EMR at a number of different wavelengths, determine the constituent materials of the tissue based on the detected absorption EMR absorption response (i.e. based on images captured by the non-visible light image sensor 120) at the different wavelengths, and then characterize the tissue type based on the particular detected combination of constituent materials)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include a non-visible light image sensor as taught by Shelton in order to allow for differentiation of tumors/cancerous tissue/unhealthy tissue from healthy tissue, thereby allowing in a surgical procedure the maximization of removal of unhealthy tissue while minimizing the removal of the healthy tissue (Shelton [0223])
Regarding claim 13,
Algawi, as modified, teaches the elements of claim 1 as previously stated. Algawi further teaches wherein one of the one or more first sensors or one or more second sensors comprises a camera (48) supported by the trocar (38), and
Wherein the processor is configured to display a real-time image of the anatomy from the camera as the trocar travels toward the target anatomical site ([0044] which discloses real-time camera image such as image 55 displayed in fig. 1)
While Algawi teaches in [0034] registering the captured image with a reference medial image and in [0044] in some embodiments, processor 34 is configured to register a selected 2D slice of the anatomical image, with a real-time camera image, such as image 55, and to produce a combined image and to display the combined image on display 36 and/or on display 52. The drawings do not appear to show such a combined image therefore it is unclear such a combined image includes a pre-operative image of anatomy onto the real-time image of the anatomy from the camera as the trocar travels toward the target anatomical site.
Shelton, in a similar field of endeavor involving surgical procedures, teaches wherein a processor is configured to overlay on a display a pre-operative image of anatomy onto a real-time image of the anatomy from a camera ([0181] which discloses preoperative data 650 (i.e. a pre-operative image sinc e it is from CT or MRI scan) can be provided to the integration module 643 and ultimately to the image overlay controller 610 so that such information can be overlaid with the views from the camera 612 and provided to the monitors)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include overlaying on the display the pre-operative image of anatomy onto the real-time image of the anatomy as taught by Shelton in order to allow a user to visualize the pre-operative image and the real-time image with ease by providing the data overlaid. Such a modification would further allow for comparison of the pre-operative scans against real time measurement to help enable a surgeon to follow a particular pre-surgical plan (Shelton [0429]), thereby enhancing the accuracy of the trocar procedure of Algawi.
Regarding claim 14,
Algawi, as modified, teaches the elements of claim 13. Examiner notes that the anatomy including any of a bone or a nerve is considered an intended use of the system, where a limitation directed towards intended use must result in a structural difference between the prior art and the claimed invention. In this case, it is noted that the processor of the modified system is configured to overlay on the display a pre-operative image of the anatomy onto a real-time image of the anatomy from the camera as the trocar travels toward the target anatomical site, where the processor is configured to overlay the images regardless of the anatomy and therefore would be capable of overlaying on the display a pre-operative image of the anatomy including any of bone or nerve onto a real-time image of the anatomy including any of the bone or nerve accordingly. Thus the system of Algawi, as modified, teaches wherein the anatomy including any of the bone or nerve.
Alternatively, Shelton further teaches wherein anatomy visualized by the cameras includes critical structures such as nerves ([0136]-[0137]).
It would have alternatively been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi, as currently modified, to include nerve as taught by Shelton in order to allow for visualization of critical structures thereby allowing for prevention of inadvertent damage thereto during a procedure.
Regarding claim 20,
Algawi, as modified, teaches the elements of claim 13 as previously stated. Algawi, as currently modified, fails to explicitly teach wherein the camera comprises a non-visible light image sensor.
Nonetheless, Shelton teaches a camera comprising a non-visible light image sensor (0144] which discloses the camera 144 can include one or more image sensors 135 to receive signals from various light sources emitting light at various visible and invisible spectra (e.g. visible light, spectral imagers, three-dimensional lens, among others)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include a non-visible light image sensor as taught by Shelton in order to allow for differentiation of tumors/cancerous tissue/unhealthy tissue from healthy tissue, thereby allowing in a surgical procedure the maximization of removal of unhealthy tissue while minimizing the removal of the healthy tissue (Shelton [0223])
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Algawi, and Scott, as applied to claim 1 above, and further in view of Syverson et al. (US 20180199999 A1), hereinafter Syverson.
Regarding claim 11,
Algawi, as modified, teaches the elements of claim 1 as previously stated. Algawi fails to explicitly teach wherein the trocar is configured to deliver haptic feedback to a user based on input from the one or more first sensors or the one or more second sensors.
Syverson, in a similar field of endeavor involving surgical procedures, teaches wherein a surgical instrument is configured to deliver haptic feedback to a user based on a position and/or orientation of the instrument with respect to an identified anatomical features ([0081] which discloses a haptic feedback mechanism on the handheld instrument 204 may be actuated based on the position and/or orientation of the instrument with respect to the identified anatomical features)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include delivering haptic feedback to a user as taught by Syverson in order to provide an easily perceptible tactile feedback to a user holding the instrument (i.e. the trocar of Algawi) that the instrument is at a position and orientation that defines a trajectory into an anatomic feature of interest, such as a feature requiring surgical intervention and/or a feature to be avoided during surgical intervention (Syverson [0081]). Such a modification would therefore enhance at least the insertion of the trocar of Algawi by allowing a user to readily understand whether it is at the desired position and orientation.
Examiner notes that in the modified system since the position and orientation of the trocar is known via the plurality of sensors of Algawi, that the haptic feedback is therefore based on input from the plurality of sensors accordingly.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Algawi and Scott, as applied to claim 1 above, and further in view of Ortiz (US 20070038224 A1), hereinafter Ortiz.
Regarding claim 12
Algawi, as modified, teaches the elements of claim 1 as previously stated. Algawi, as modified, fails to explicitly teach further comprising a flexible access port having a lumen, wherein the trocar is received in the lumen.
Ortiz, in a similar field of endeavor involving surgical procedures, teaches a flexible access port having a lumen ([0010] which discloses a flexible access port and [0026] which discloses the access port 310 can be in the form of a flexible elongate tube or cannula with an inner lumen), wherein a trocar is received in the lumen ([0041] which discloses a trocar 360 can be inserted through the access port 310)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi, as currently modified, to include an access port as taught by Ortiz in order to provide a working channel to a surgical site (Ortiz [0010]). Such a modification would allow for withdrawal of the trocar while still providing a pathway through tissue to a body cavity or other region (Ortiz [0041]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Algawi, Scott, and Shelton as applied to claim 13 above and further in view of Mastri et al. (US 20080086160 A1), hereinafter Mastri.
Regarding claim 15,
Algawi, as modified, teaches the elements of claim 13 as previously stated. Algawi further teaches wherein the camera is configured to view the anatomy distal of the trocar (see at least fig. 1 (55) and [00534] which discloses a central distal viewing direction pointing at a center of an opening 78 at the distal end of cannula 69). Algawi, as modified, fails to explicitly teach fails to explicitly teach the distal tip is a transparent distal tip and the camera is configured to view the anatomy distal of the trocar through the transparent tip.
Nonetheless, Mastri, in a similar field of endeavor involving trocars, teaches a trocar having a transparent distal tip ([0003] which discloses insertion devices having a transparent tip to allow visualization of the tissue being penetrated and [0012] which discloses The penetrating tips for the surgical trocar each have a generally transparent body having proximal and distal ends).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi, as currently modified to include a transparent distal tip as taught by Mastri in order to allow a surgeon to view the layers of tissue through which the surgeon is penetrate (Mastri [0050]). Furthermore, such a modification would allow the surgeon to view the tissue through which the trocar and tip are passing, therefore allowing the surgeon to determine by the general appearance of the tissue, the point at which the tip has penetrated to a sufficient depth (Mastri [0050]).
Examiner notes that in the modified system since the camera is configured to view the anatomy distal of the trocar through the cannula, that the camera of Algawi is configured to view the anatomy distal of the trocar through the transparent tip of Mastri.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Algawi, Scott, and Shelton as applied to claim 13 above and further in view of Wybo (US 20150088029 A1 and included in applicant’s IDS filed 06/27/2024), hereinafter Wybo.
Regarding claim 16,
Algawi, as modified, teaches the elements of claim 13 as previously stated. Algawi fails to explicitly teach further comprising an electrode supported by the trocar body and configured to apply an electrical current to a nerve so as to determine a distance between the trocar and the nerve.
Wybo, in a similar field of endeavor involving medical procedures, teaches an instrument comprising a nerve mapping electrode (at least fig. 4B or 6B (98a, 98b, and/or 98c) and corresponding disclosure in at least [0056] and [0044] which discloses the stimulator 30 may be provided with a plurality of electrodes that may collectively be used to triangulate the position of the nerve) supported thereon (see figs. 5A-6B), and configured to apply an electrical current to a nerve so as to determine a distance between the instrument and the nerve ([0050] the processor 20 may then monitor a mechanical sensor 22 that is in mechanical communication with a muscle 116 innervated by the nerve 112 for a response to each of the respective stimuli 114a, 114b, 114c. Using the monitored muscle response, and the known magnitude (thus signal strength detection) of the respective stimuli, the processor may determine a respective distance between each electrode 98a, 98b, 98c and the nerve 112 and the processor 20 may then use these determined distances to triangulate the position of the nerve 112 relative to the stimulator 90 within an approximate statistical margin of error and [0044] which discloses the processor 20 may determine the distance between an electrically stimulating electrode 34 and a nerve by providing an electrical stimulus 38 to the electrode 34 at a known or measurable current magnitude, and by measuring the magnitude of the mechanical muscle response)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include a nerve mapping electrode as taught by Wybo in order to allow for identification of location of nerve bundles or fibers (Wybo [0037]). Such a modification would enhance the safety/accuracy of the procedure of Algawi by allowing the location/direction of the nerves with respect to the trocar to be displayed which may aid the user in avoiding actions that may jeopardize the integrity of the identified nerve (Wybo [0006]).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Algawi, Scott, and Shelton as applied to claim 13 above and further in view of Sohlden et al. (US 20180318009 A1), hereinafter Sohlden.
Regarding claim 17,
Algawi, as modified, teaches the elements of claim 13 as previously stated. Algawi further teaches further comprising a position sensor configured to sense a position of the trocar and the processor is further configured to display a graphical representation of the position of the trocar ([0043] In some embodiments, processor 34 is further configured to display on display 52, the position of the distal end of trocar 38 overlaid on image 55, using the position signals received from position sensor 50).
Algawi fails to explicitly teach wherein the processor is configured to provide on the display a graphical indication of alignment between the position of the trocar and a desired insertion trajectory of the trocar.
Sohlden, in a similar field of endeavor involving medical procedures, teaches wherein a processor is configured to provide on the display a graphical indication of alignment between an actual trajectory of a trocar and a desired trajectory of the trocar ([0068] which discloses at step S332, the CT images and the path may be displayed side by side to allow the clinician to compare the actual location of surgical instrument 20 inside patient P and the planned location (thus desired trajectory) of surgical instrument, where displaying the actual position (i.e. actual trajectory) and the planned location (i.e. desired trajectory) side-by-side allowing for comparison constitutes a graphical indication of alignment between the actual trajectory of the instrument and a desired trajectory of the instrument and [0038] which discloses surgical instrument 20 may be, for example, a trocar).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include providing on the display a graphical indication of alignment as taught by Sohlden in order to allow for comparison between the actual location and the planned location accordingly (Sohlden [0068]). Such a comparison thus allows a user to determine if the trocar is following the desired trajectory and allowing the user to withdraw the trocar and reposition the trocar as needed (Sohlden [0069]), thereby enhancing the accuracy of the trocar positioning.
Regarding claim 18,
Algawi, as modified, teaches the elements of claim 5 as previously stated. Algawi further teaches displaying a first icon representing a first position of a first location of the trocar ([0043] In some embodiments, processor 34 is further configured to display on display 52, the position of the distal end of trocar 38 overlaid on image 55, using the position signals received from position sensor 50, where such overlay of a position of the distal end is considered a first icon representing a position of a first location of the trocar (i.e. actual/measured location)).
Sohlden, as applied to claim 5 above, further teaches wherein the graphical indication of alignment between the first position of the trocar and the desired insertion trajectory includes representation of a first position of a first location of the trocar ([0068] which discloses the CT images and the path may be displayed side by side to allow the clinician to compare the actual location of surgical instrument inside patient “P” and the planned location of surgical instrument and [0069] which discloses if surgical instrument shown in the intraoperative CT images following the intended path, thus the CT images include a representation of a position of a first location (i.e. actual location) of the surgical instrument (i.e. trocar)) and a second icon representing a second position of a second location of the trocar (At step S332, the CT images and the path may be displayed side by side to allow the clinician to compare the actual location of surgical instrument 20 inside patient “P” and the planned location of surgical instrument. Where the path is a second icon representing the planned location (i.e. a position of a second location) of the surgical instrument (i.e. trocar)), wherein the first location is spaced from the second location in a distal direction (Examiner notes that in cases where the first location is not the same as the second location such as disclosed in [0069] of Sohlden that the first location is spaced from the second location in a distal direction (where distal is a relative term and any spacing is considered distal depending on the perspective of direction) and further in an instance where the first location has not yet reached the second location and is following the trajectory and the user may advance the surgical instrument as disclosed in [0069], then the first location (i.e. actual location) is to be advanced further into the patient to reach the second location, thus is spaced in a distal direction with respect to the distal position of the trocar).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Algawi, Scott, and Shelton as applied to claim 13 above and further in view of Ortiz (US 20070038224 A1), hereinafter Ortiz.
Regarding claim 19,
Algawi, as modified, teaches the elements of claim 13 as previously stated. Algawi, as modified, fails to explicitly teach further comprising a flexible access port having a lumen, wherein the trocar is received in the lumen.
Ortiz, in a similar field of endeavor involving surgical procedures, teaches a flexible access port having a lumen ([0010] which discloses a flexible access port and [0026] which discloses the access port 310 can be in the form of a flexible elongate tube or cannula with an inner lumen), wherein a trocar is received in the lumen ([0041] which discloses a trocar 360 can be inserted through the access port 310)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi, as currently modified, to include an access port as taught by Ortiz in order to provide a working channel to a surgical site (Ortiz [0010]). Such a modification would allow for withdrawal of the trocar while still providing a pathway through tissue to a body cavity or other region (Ortiz [0041]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Algawi and Scott, as a pplied to claim 1 above, and further in view of NPL Pairaiturkar et al. (“Evaluation of Dimensions of Kambin’s Triangle to Calculate Maximum Permissible Cannula Diameter for Percutaneous Endoscopic Lumbar Discectomy : A 3-Dimensional Magnetic Resonance Imaging Based Study”), hereinafter Pairaiturkar.
Regarding claim 21,
Algawi, as modified, teaches the elements of claim 1 as previously stated. Algawi further teaches wherein during the medical procedure the physician inserts the trocar into the head or any other organ in question of patient in [0061], however, fails to explicitly teach wherein the graphical representations include an identification of a superior articular process and nerves that define Kambin’s triangle.
Nonetheless, Pairaiturkar teaches displaying graphical representations including an identification of a superior articular process and nerves that define Kambin’s triangle (at least figs. 2-3 on page 416 depicting exiting root and dura and lower end plate level and exiting nerve root, the facet i.e. superior articular process and the lower end plate level).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Algawi to include displaying graphical representations including identification of a superior articular process and nerves that define Kambin’s triangle as taught by Pairaiturkar in order to evaluate image data of Kambin’s safe zone to calculate maximum cannula diameter permissible for safe percutaneous endoscopic lumbar procedures. Such a modification would allow for performing procedures on other organs in question of the patient such as the spine/lumbar and would further allow for enhanced safety of such procedures by allowing a user to visualize the superior articular process and nerves that define Kambin’s triangle during the procedure of Algawi when other organs such as the spine/lumbar are being evaluated.
Examiner notes that in the modified system, the anatomical structure including nerve and bone that are to be avoided includes the superior articular process and nerves that define Kambin’s triangle.
Conclusion
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797