DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 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) 1-4, 6, 8-9, 11-12, 21-22, and 24 is/are rejected under 35 U.S.C. 103 unpatentable over Kostrzewski et al (US Patent Pub. 20180289432A1) in view of Dimaio et al (US Patent Pub. 20160206384A1) and Crawford et al (US Patent Pub. 20210077206A1).
Kostrzewski recites robotic surgical system. Specifically in regards to claim 1, Kostrzewski recites a robotic arm (5302) (Fig. 4 and 51; and Para. [0103], [0107], [0118], [0121], [0131]); a surgical instrument (5502 in 5510) operably attached to the robotic arm, wherein the surgical instrument comprises: an elongate body (body of 5502) extending between a proximal end and a distal end (end with 5502), the distal end being configured to retain an implement to penetratingly contact hard tissue (Fig. 55; and Para. [0111]-[0112],[0131]); an interior channel (channel/space for 5504) formed in at least a portion of the elongate body coaxial to a longitudinal axis of the elongate body (Fig. 55; Para. [0114]); and a sensor (5504) at least partially disposed in the channel (The reference recites wherein the sensor 5504 can be used to measure forces on the drill shaft that can be used to detect deflection.) (Fig. 55; Para. [0112]-[0113],[0114],[0116]); and a controller (5312/5308) configured to receive data from the sensor (5504) and use the data to determine whether deflection of the elongate body is occurring during use of the surgical instrument (5502/5510) (Fig. 53; and Para. [0123]-[0124],[0108],[0127]). However, the reference is silent as to the channel extending for greater than half the length of the body or wherein the sensor data alerts to skiving exceeding a threshold.
Dimaio recites a surgical system. Specifically in regards to claim 1, Dimaio recites a surgical instrument (22) comprises: an elongate body (body of 22) extending between a proximal end and a distal end (end with 22b, Fig. 1), the distal end being configured to retain an implement to penetratingly contact hard tissue; and a sensor at least partially disposed in a channel (channel for 20, Fig. 1) wherein the channel extends for greater than half of a longitudinal length of the elongate body (Fig. 1 and 4; and Para. [0030]-[0031],[0039]-[0040]). It would have been obvious to one having ordinary skill in the art at the time the invention was file to modify the instrument channel (channel for 5504) of Kostrzewski to be more than the length of half the body as taught in Dimaio in order to improve the tracking of interventional instruments in surgical environments (Para. [002]) and Dimaio also recites that the channel can extend entirely within or along the interventional instrument or may extend only partially within or along the interventional instrument as needed (Para. [0031]). However, the reference is still silent as to wherein the sensor data alerts to skiving exceeding a threshold.
Crawford recites a surgical system. Specifically in regards to claim 1, Crawford recites a surgical system wherein if deflection is occurring, sensor data is used to determine whether a level of skiving that exceeds a predetermined threshold is occurring (Crawford recites that if the monitored forces and moments do not fall within an expected range or predetermined threshold, an alert or notification is provided by the robot system to indicate the presence of skiving.) (Fig. 15; Para. [0089]). It would have been obvious to one having ordinary skill in the art at the time the invention was file to modify the sensor data of Kostrzewski to alert to a skiving threshold as taught in Crawford in order to alert the user to the exceeding a threshold (Para. [0089]).
In regards to claim 2, Kostrzewski recites wherein the controller is further configured to use the data to determine a magnitude of deflection of the elongate body (Para. [0123]-[0124],[0127],[0177],[0180])
In regards to claim 3, Kostrzewski recites wherein the controller (5312/5308) is further configured to use the data to determine a direction of deflection of the elongate body (Para. [0123]-[0124],[0127],[0177],[0180])
In regards to claim 4, Kostrzewski recites wherein the sensor (5504) is at least one of a strain gauge, a fiber optic cable, or a resistance-based element that changes electrical resistance with bending (Kostrzewski recites wherein the sensor can be a strain gauge.) (Fig. 56b; and Para. [0115]).
In regards to claim 6, Kostrzewski recites wherein the sensor (5504) is a resistance-based element (Kostrzewski recites wherein the sensor can be a strain gauge.) (Fig. 56b; and Para. [0115]).
In regards to claims 8-9, Kostrzewski in view of Dimaio and Crawford recites a robotic surgical system as above. Kostrzewski recites wherein the sensor (5504) is in a channel/space in the instrument (Fig. 55). However, the reference is silent as to there being multiple sensors in multiple channels. Dimaio recites a surgical system. Specifically in regards to claim 8-9, Dimaio recites wherein at least three sensors are disposed within the channel (channel for 772/774/776, Fig. 12-13) to communicate a direction of deflection of the elongate body; and wherein the surgical instrument further comprises a plurality of channels, each channel having an associated sensor to communicate a direction of deflection of the elongate body (DiMaio recites that the sensors can be formed as optical fiber sensors 772,774,776 which are in a ribbon configuration that then are passed into the internal bore of 782.) (Fig. 10-13; and Para. [0052]-[0054]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the sensor (5504) of Kostrzewski to be multiple sensors in the channels as taught in Dimaio to get to improved roll measurements and thus improved pose measurements (Para. [0052]).
In regards to claims 11-12, Kostrzewski in view of Dimaio and Crawford recites a robotic surgical system. Kostrzewski recites a controller (5312/5308) (Fig. 53; and Para. [0123]-[0124],[0108],[0127]). However, the reference is silent as to the controller determining if deflection is within a threshold. Crawford recites wherein, if the controller determines the level of skiving that exceeds the predetermined threshold is occurring, the controller is further configured to display an alert (1812/1816; Fig.15); and wherein, if the controller determines the level of skiving that exceeds the predetermined threshold is occurring, the controller is further configured to cease actuation of the surgical instrument (1600) (Fig. 15; and Para. [0086],[0088]-[0089]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the controller (5308/5312) of Kostrzewski adjust the instrument based on the sensor data as taught in Crawford in order to alert the user and allow for modification of the surgical path (Para. [0089]).
In regards to claim 21-22, Kostrzewski in view of Dimaio and Crawford recites a robotic surgical system. Dimaio recites wherein the channel extends along an entire longitudinal length of the elongate body, and wherein the channel extends concentrically to the longitudinal axis (Fig. 1). It would have been obvious to one having ordinary skill in the art at the time the invention was file to modify the instrument channel (channel for 5504) of Kostrzewski to be more than the length of half the body as taught in Dimaio in order to improve the tracking of interventional instruments in surgical environments (Para. [002]) and Dimaio also recites that the channel can extend entirely within or along the interventional instrument or may extend only partially within or along the interventional instrument as needed (Para. [0031]).
In regards to claim 24, Kostrzewski in view of Dimaio and Crawford recites a robotic surgical system. Kostrzewski discloses a channel/space in the surgical instrument in containing an associated sensor (Fig. 55). Kostrzewski however is silent as to at least three sensors in the channel to communicate a direction of deflection of the elongate body. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the channel and sensor of Kostrzewski to be at least three sensors to communicate a direction of deflection of the elongate body, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski in view of Dimaio and Crawford as applied to claim 1 and further in view of McDonell (US Patent Pub. 20190029759A1).
Kostrzewski in view of Dimaio and Crawford recites a robotic surgical system comprising a robotic arm having an end effector at the distal end, a surgical instrument attached to the end effector of the robotic arm wherein the instrument has a channel containing a sensor therein, and a controller configured to receive data from the sensor. In regards to claim 5, Kostrzewski recites wherein the sensor (5504) is a fiber optic cable that is used to communicate the magnitude or direction of deflection of the elongate body (The sensor can be an optical sensor.) (Para. [0112],[0015]). However, the reference is silent as to the sensor having fiber gratings.
McDonell recites a robotic surgical system. Specifically in regards to claim 5, McDonell recites a robotic arm (20) having a surgical instrument (26a) thereon, and wherein the sensor (92) is a fiber optic cable and further includes a plurality of gratings configured to communicate any of magnitude or direction of deflection of the elongate body (Fig. 1; and Para. [0026],[0056]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the sensor (5504) of Kostrzewski to have fiber gratings as taught in McDonell in order to providing strain measurements in multicore optical fibers (Para. [0056]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski in view of Dimaio and Crawford as applied to claim 6 above, and further in view of Lang (US Patent Pub. 20210137634A1).
Kostrzewski in view of Dimaio and Crawford recites a robotic surgical system comprising a robotic arm having an end effector at the distal end, a surgical instrument attached to the end effector of the robotic arm wherein the instrument has a channel containing a sensor therein, and a controller configured to receive data from the sensor. In regards to claim 7, Kostrzewski recites wherein the sensor (5504) is a resistance based element (Para. [0015]). However, the reference is silent as to the sensor being a conductive wire.
Lang recites a robotic surgical system. Specifically in regards to claim 7, Lang recites a robotic arm having a surgical instrument thereon, and wherein the resistance-based element is at least one of a conductive wire, a conductive rubber, a conductive fiber, a conductive fabric, or a liquid metal microchannel (Lang recites wherein the sensors can be strain gauges. The sensors can also consist of elastic conductive wires that extend through the entire length of the catheter wall.) (Para. [01061]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the sensor (5504) of Kostrzewski be a conductive wire as taught in Lang since they appear to be an equivalent structure in the art.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 unpatentable over Kostrzewski et al (US Patent Pub. 20180289432A1) in view of Carusillo et al (US Patent Pub. 20220241045A1) and Crawford et al (US Patent Pub. 20210077206A1).
Kostrzewski recites a robotic surgical system. Specifically in regards to claim 13, Kostrzewski recites a robotic arm (5302) extending between a base and an end effector (5304) (Fig. 4 and 51; and Para. [0103],[0107],[0118],[0121],[0131],[0139]); an instrument mount (4900/5000) attached to the end effector (5304) and retaining a guide (5000) (Fig. 49-50; and Para. [0139]); a surgical instrument rotatably disposed in the guide, the surgical instrument comprising an elongate body extending between a proximal end and a distal end, the distal end being configured to retain an implement to penetratingly contact hard tissue (Fig. 55; and Para. [0111]-[0112],[0131]); a sensor (5504) disposed within the guide and adapted to detect deflection of the elongate body from a longitudinal axis (axis through center of 5502) of the elongate body (The reference recites wherein the sensor 5504 can be used to measure forces on the drill shaft that can be used to detect deflection, and wherein the sensor can be placed in the guide similar to how its placed in Fig. 56); and a controller (5312/5308) configured to receive data from the sensor (5504) and use the data to determine whether deflection of the elongate body is occurring during use of the surgical instrument (Fig. 53; and Para. [0123]-[0124],[0108],[0127]). However, the reference is silent as to the sensor measuring a radial distance or wherein the sensor data alerts to skiving exceeding a threshold.
Carusillo recites a surgical system. Specifically in regards to claim 13, Carusillo recites a surgical instrument (65/66) and a sensor (201) configured to measure a radial distance to the elongate body (176) of the surgical instrument (65/66) (Carusillo recites a sensor for generating an identification signal responsive to variations in a magnetic field during rotation of the shank about the axis resulting from varying radial distances of the outer surface to the axis for identifying the configuration of the cutting tip portion of the drill bit. (Fig. 6/6c; and Para. [0050],[0193]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the sensor of Kostrzewski to detect a radial distance as taught by Carusillo in order to aid identifying the configuration of the cutting tip portion of the drill bit (Para. [0193]). However, the reference is silent as to wherein the sensor data alerts to skiving exceeding a threshold.
Crawford recites a surgical system. Specifically in regards to claim 13, Crawford recites a surgical system wherein if deflection is occurring, sensor data is used to determine whether a level of skiving that exceeds a predetermined threshold is occurring, (Crawford recites that if the monitored forces and moments do not fall within an expected range or predetermined threshold, an alert or notification is provided by the robot system to indicate the presence of skiving.) (Fig. 15; Para. [0089]). Crawford also recites if the level of skiving exceeds the predetermined threshold, perform at least one of displaying an alert (1812/1816; Fig.15); or causing actuation of the surgical instrument to cease (1600) (Fig. 15; and Para. [0086],[0088]-[0089]). It would have been obvious to one having ordinary skill in the art at the time the invention was file to modify the sensor data of Kostrzewski to alert to a skiving threshold as taught in Crawford in order to alert the user to the exceeding a threshold (Para. [0089]), and order to alert the user and allow for modification of the surgical path (Para. [0089]).
In regards to claim 15, Kostrzewski recites wherein the sensor (5504) is one or more laser distance measuring units, ultrasonic distance measuring units, or optical cable measuring units (The sensor 5504 is disclosed as being able to be an optical sensor.) (Para. [0112],[0115]).
In regards to claim 17, Kostrzewski in view of Dimaio and Crawford recites a robotic surgical system. Kostrzewski recites wherein the sensor (5504) is in a channel in the guide (Fig. 56b/56c). However, the reference is silent as to the sensor determining a radial distance.
Carusillo recites a surgical system. Specifically in regards to claims 17, Carusillo recites wherein the controller is further configured to use the data to determine at least one of a magnitude of deflection of the elongate body or a direction of deflection of the elongate body (Para. [0050], [0061], [0168]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the controller (5308/5312) and sensor (5504) of Kostrzewski to determine the radial distance of the instrument in regards to the guide as taught in Carusillo in order to identify one or more performance features of the cutting tip portion (Para. [0050]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kostrzewski in view of Dimaio and Crawford as applied to claim 24 and further in view of Park (US Patent Pub. 20180125507A1).
Kostrzewski in view of Dimaio and Crawford recites a robotic surgical system comprising a robotic arm having an end effector at the distal end, a surgical instrument attached to the end effector of the robotic arm wherein the instrument has a plurality of channels each containing a sensor therein, and a controller configured to receive data from the sensor. However, the references are silent as to the plurality of sensors being of different modalities from other sensors.
Park in regards to claim 25 recites wherein all the sensors are of a different modality (The various sensors may illustratively include contact sensors, force sensors, proximity sensors, distance measurement sensors, acoustic sensors, electric sensors, position sensors, pressure sensors, or any combination thereof.) (Para. [0023] and claim 6]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the sensors of Kostrzewski to be of different modalities as taught in Parkin order to in order to allow for more parameters to be identified at the same time.
Allowable Subject Matter
Claim 16 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record are the Kostrzewski and Dimaio references which each disclose an elongated instrument with a channel/space within the body housing a sensor. However, none of the references cited herein discloses wherein the body has spaced apart channel aside from the previously disclosed channel that each house their own sensor or wherein a flat is disposed on the body between the proximal and distal ends so that the sensor can measure a variation in radial distance between the flat and inner wall of the guide. Therefore, the claims of the instant application have not been rejected using prior art because none of the references or reasonable combinations thereof could be found which disclose or suggest all of the features of the claims, and there is no reasonable motivation to modify the art of record to have these features. Furthermore, attempting to modify the references to have all the cited limitations would destroy the proposed inventions.
Response to Arguments
Applicant’s amendments filed on 6/1/26 have overcome the previous 112 rejection which is hereby withdrawn.
Applicant in their Remarks filed on 6/1/26 have been considered and are not persuasive. The arguments presented in applicant’s response are arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim 1 (Remarks pg. 6-9):
Applicant argues that the body of drill of 5502 of Kostrzewski does not have a channel as required by the claim limitation to house a sensor (Pg. 6-7). However, as can be seen in Fig. 55 of Kostrzewski the sensor 5504 is housed within the body of the drill 5502 and is recited as such in para. [0112] it states “the force sensor 5504 is located inside the body 5510 of the drill, thereby better protecting the force sensor 5504 from external influences.” This implies that the sensor has been placed in a space within the body of the drill and that space would count as a very small channel only so large as to house the sensor.
Applicant argues that the DiMaio reference as a secondary reference would not be looked to for combination with Kostrzewski since DiMaio’s sensors are for determining relative position between each other and not for skiving as concerns the current application (Pg. 7-8). Applicant’s citation to their own specification without more evidence is not considered evidentiary but merely conclusory statements in support of their position. In addition, the addition of sensors for more accurate and precise monitoring of surgical tools as is recited as the reason for the combination of Kostrzewski and DiMaio would serve as a beneficial purpose in surgery allowing the user more precise measurements as to the location of tools within the surgical site.
Applicant argues that the Crawford reference as a secondary reference since it does not disclose a sensory in the vicinity of a cutting instrument (Remarks Pg. 8-9). The use of the Crawford reference is brought in to demonstrate it is known in the art that deflection of a tool can be determined and measured by means of attached sensors. Therefore, the reference does not need to disclose the sensors on a cutting tool since it is not being bodily incorporated into the Kostrzewski but merely as a means to teach how to modify the sensor usage of Kostrzewski to measure skiving.
Applicant did not present any arguments against any other claims either dependent or independent and therefore, the rejection of the claim 13 and it’s dependents is maintained.
Therefore, the claims continue to be deemed rejectable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
Prosecution Insights