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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/21/2026 is being considered by the Examiner.
Status of Claims
Claims 1-20 are currently pending and under examination. As per the amendments filed on 01/20/2026, claims 1, 8, 15-16, and 20 are amended.
Priority
The instant application (filed on 06/14/2022) is a national stage of PCT/US2020/064925 filed under 35 USC 371. Acknowledgment is made of Applicant's claim for domestic priority based on provisional applications 62/948,542 (filed 12/16/2019), 62/959,635 (filed 01/10/2020), and 62/986,373 (filed 03/06/2020). Instant claims 1-13, 14-17, and 20 are adequately supported in the earliest application 62/948,542. However, the notification and confirmation request in claim 14 and the determination and correction of an image deficiency in claims 18-19 are not adequately supported in 62/948,542.
Claim 14 is first adequately supported in 62/959,635 and claims 18-19 are first adequately supported in 62/986,373. In summary, the effective filing dates for the instant claims are:
Claims 1-13, 15-17, and 20 with 12/16/2019
Claim 14 with 01/10/2020
Claims 18-19 with 03/06/2020
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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.
Claims 1, 15, and 16: The limitation “the guidance content further including one or more graphical indicators configured to augment an image of the surgical space during a surgical procedure, each graphical indicator included in the one or more graphical indicators […]” renders the claim indefinite because the use of “each graphical indicator” implies more than one graphical indicator is required. However, the “one or more graphical indicators” establishes the scope as encompassing circumstances where only one graphical indicator is present. The clarity of the claim would benefit from all limitations being consistent with respect to the number of graphical indicators when further describing the “one or more graphical indicators.”
Claims 2-14 and 17-20 are rejected for being dependent on a rejected claim.
Response to Arguments
Applicant’s arguments, see Remarks pages 10-14 (Claim Rejections - 35 U.S.C. § 103), filed 01/20/2026, with respect to the 35 U.S.C. § 103 rejections of claims 1-20 have been fully considered. Regarding independent claims 1, 15, and 16, Applicant argues:
In contrast, the combination of Azizian, Salcudean, and Dorman fails to teach or suggest each and every element recited in claim 1. For example, as discussed during the interview, the combination of Azizian, Salcudean, and Dorman fails to disclose "generate, based on at least the one or more parameters of the non-robotic device, guidance content for use by the computer assisted surgical system to facilitate guided teleoperation of the non-robotic device, the guidance content including an instruction configured to be presented to a user of the computer-assisted surgical system to guide the user in moving the non-robotic device in the surgical space, the guidance content further including one or more graphical indicators configured to augment an image of the surgical space during a surgical procedure, each graphical indicator included in the one or more graphical indicators depicting a suggested angle of contact of the non-robotic device with an object in the surgical space, the one or more graphical indicators displayed across the object to facilitate subsurface imaging the object," as recited in amended independent claim 1 (emphasis added).
The Patent Office relies on Dorman as allegedly disclosing the concept of "augmenting an image with a depicted angle of contact during a surgical procedure." Office Action, pg. 4. However, as discussed during the interview, Dorman describes an angle-indicative line that is provided to let a user know when a device is provided at a correct insertion angle with respect to a vertebra for the purpose of inserting a pedicle screw used in spinal fusion. See, e.g., Dorman, FIG. 3B and paras. [0003] and [0008]. In contrast, Applicant's "one or more graphical indicators" are provided to let a user know a suggested angle of contact with respect to a surface of an object to facilitate subsurface imaging the object. As such, the angle-indicative line in Dorman is provided for completely different purpose than the "one or more graphical indicators" recited in claim 1. Accordingly, Dorman, even when combined with Azizian and Salcudean as asserted, does not teach or suggest "generate, based on at least the one or more parameters of the non-robotic device, guidance content for use by the computer-assisted surgical system to facilitate guided teleoperation of the non-robotic device, the guidance content including an instruction configured to be presented to a user of the computer-assisted surgical system to guide the user in moving the non-robotic device in the surgical space, the guidance content further including one or more graphical indicators configured to augment an image of the surgical space during a surgical procedure, each graphical indicator included in the one or more graphical indicators depicting a suggested angle of contact of the non-robotic device with an object in the surgical space, the one or more graphical indicators displayed across the object to facilitate subsurface imaging the object," as recited in amended independent claim 1 (emphasis added).
Accordingly, because the combination of Azizian, Salcudean, and Dorman fails to disclose, teach, or suggest each and every feature of independent claim 1, the combination of Azizian, Salcudean, and Dorman is not sufficient to establish a prima facie obviousness rejection of claim 1. Moreover, the additional cited art in the Office Action fails to cure the deficiencies of Azizian, Salcudean, and Dorman. Hence, the combination of the additional cited art with Azizian, Salcudean, and Dorman is also not sufficient to establish a prima facie obviousness rejection of claim 1. Although of different scope than claim 1, independent claims 15 and 16 are patentable over the combination of Azizian, Salcudean, and Dorman for at least the same reasons presented with respect to claim 1.
This argument is persuasive. The non-robotic device in the amended claims is interpreted as being a form of imaging which can facilitate subsurface imaging of the object. This interpretation is supported by [0040] in the specification where a non-robotic device is defined as an instrument not being directly attached to a robotic arm during use (e.g. a clinician or a manipulator arm is holding the device) and examples include imaging devices such as ultrasound, OCT, REIMS, etc. The spinal fusion screw insertion assist display does not fully teach on this amendment for the non-robotic device. Therefore, the rejections of independent claims 1, 15, and 16 are withdrawn. However, upon further consideration, a new grounds of rejection is made newly over Djajadiningrat (EP 3,445,249 B1).
Regarding dependent claims 2-14 and 17-20, Applicant argues:
The dependent claims rejected under Section 103 are patentable over the cited art for at least the same reasons presented above with respect to the independent claims. In addition, the dependent claims are further distinguished from the cited art by the additional features recited therein.
This argument is persuasive because the rejections of independent claims 1, 15, and 16 were withdrawn for the reasons discussed. Therefore, the rejections of claims 2-14 and 17-20 are similarly withdrawn. However, upon further consideration, a new ground(s) of rejection is made newly over Djajadiningrat (EP 3,445,249 B1).
Summary: The prior art rejections of claims 1-20 are withdrawn. New 35 U.S.C. § 103 rejections for claims 1-20 newly in view of Djajadiningrat are added.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-4 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Azizian (WO 2018/152183 A1) in view of Salcudean (US 6,425,865 B1) and Djajadiningrat (EP 3,445,249 B1).
Regarding claim 1, Azizian discloses:
A system comprising:
• a memory storing instructions ([0056] - memory); and
• a processor communicatively coupled to the memory and configured to execute the instructions ([0056] - processors) to:
obtain one or more parameters of a non-robotic device in a surgical space ([0052] -force sensor detecting force as parameter), the non-robotic device engaged by a computer-assisted surgical system ([0052] - arm);
provide guidance content to the computer-assisted surgical system ([0053] - guidance to maintain constant contact force).
Azizian fails to disclose that the parameters are used to generate guidance for teleoperation.
Salcudean discloses the system will: generate, based on at least the one or more parameters of the non-robotic device, guidance content for use by the computer-assisted surgical system to facilitate guided teleoperation of the non-robotic device, the guidance content including an instruction configured to be presented to a user of the computer-assisted surgical system to guide the user in moving the non-robotic device in the surgical space (col 14, lines 1-22 – the ultrasound probe and needles are positioned via a guidance system).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify Azizian with the teachings of Salcudean because there is some teaching, suggestion or motivation in the prior art to do so. Salcudean states “the ability to position the ultrasound transducer in response to acquired ultrasound images would also be of benefit to image-guided interventions (e.g., percutaneous pericardial puncture) and registration with past examination records or images obtained with other imaging methods (e.g., MRI). The use of ultrasound imaging together with three-dimensional tracking of the transducer probe has been proposed in U.S. Pat. No. 5,797,849 as a tool for improving medical interventions” (col 2, lines 22-30).
The combination of Azizian and Salcudean fails to teach the guidance content further including one or more graphical indicators configured to augment an image of the surgical space during a surgical procedure, each graphical indicator included in the one or more graphical indicators depicting a suggested angle of contact of the non-robotic device with an object in the surgical space, the one or more graphical indicators displayed across the object to facilitate subsurface imaging the object; and provide the guidance content to the computer-assisted surgical system.
Djajadiningrat, in the same field of endeavor of a non-robotic device guidance system (Abstract), teaches a guidance system for generating ultrasound positioning instructions ([0012-0017]). The guidance system is based on a medical practitioner manually positioning an ultrasound probe where an expert selects a desired ultrasound image and the necessary probe orientation and location to achieve this image is output to the medical practitioner (Fig. 1, [0038-0040]; [0010] – this guidance system allows an expert to guide ultrasound placement with an inexperienced user remotely). The virtual image of the probe in the desired location and orientation is an overlay superimposed over a view of the surgical site to show the correct probe position ([0045]). In this case, the superimposed image may be displayed as part of an augmented reality headset, holographic representation over the surgical site, or on a display such as a tablet or monitor ([0045]). The pose information for the ultrasound probe includes the necessary position and rotation/tilt angle to achieve a designated ultrasound view ([0040]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Azizian and Salcudean by incorporating the graphical overlay guidance system in Djajadiningrat. This would have been obvious because both Azizian/Salcudean, and Djajadiningrat discuss computer-assisted guidance systems for surgery and Djajadiningrat provides a solution/improvement by providing a graphical overlay on an image of the surgical site showing the necessary probe location and orientation to achieve a desired ultrasound image, which is beneficial for directing inexperienced operators. Therefore, a person of ordinary skill in the art would be motivated to improve the guidance system in the combination of Azizian and Salcudean by incorporating the graphical overlay guidance system in Djajadiningrat.
Regarding claim 2, the system in Claim 1 is obvious over Azizian in view of Salcudean and Djajadiningrat, as indicated hereinabove. The combination of Azizian and Salcudean further teaches the non-robotic device is engaged by a robotic instrument attached to the computer-assisted surgical system (Azizian [0034] 450 grasped by laparoscopic tool); and the generating of the guidance content is based on at least one of a procedural context associated with the surgical space (positioning of needles or instruments) (Salcudean col 14 line 14-18).
Regarding claim 3, the system in Claim 1 is obvious over Azizian in view of Salcudean and Djajadiningrat, as indicated hereinabove. Salcudean further teaches the guidance content (ultrasound transducer image) is configured to be provided by way of a user interface (monitor) of the computer-assisted surgical system to facilitate the guided teleoperation (manipulating hand controller) of the non- robotic device (col 2 line 64-67); and the guidance content includes at least one of visual guidance (col 2 line 64-67 image) or haptic feedback guidance (col 8 line 1-5 motions or forces on user’s hand) to facilitate a user of the computer-assisted surgical system teleoperating the non-robotic device in the surgical space.
Regarding claim 4, the system in Claim 1 is obvious over Azizian in view of Salcudean and Djajadiningrat, as indicated hereinabove. The combination of Azizian and Salcudean further teaches the non-robotic device is a non-robotic imaging device configured to capture imagery of an object in the surgical space (Azizian [0034] ultrasound transducer fig 4a,4b); and the guidance content is configured to facilitate teleoperation of the non-robotic imaging device with respect to the object in the surgical space (Salcudean col 2 line 64-67).
Regarding claim 15, Azizian discloses a system comprising:
• a memory storing instructions ([0056] - memory); and
• a processor communicatively coupled to the memory and configured to execute the instructions to ([0056] - processors):
• obtain one or more parameters of an object in a surgical space ([0051] - visualizing the location of a tumor);
• obtain one or more parameters (force sensor) of a non-robotic imaging device in a surgical space, the non-robotic device engaged by a computer-assisted surgical system ([0052] – robot arm);
• provide the guidance content to the computer-assisted surgical system ([0053] -guidance to maintain constant contact force).
Azizian fails to disclose that the parameters are used to generate guidance for teleoperation.
Salcudean discloses the system will generate, based on the one or more parameters of the object and the one or more parameters of the non-robotic imaging device, guidance content for use by the computer-assisted surgical system to facilitate guided teleoperation of the non-robotic imaging device to capture imagery of the object in the surgical space (subject system guides the surgeon) (col 14, lines 1-22 – the ultrasound probe and needles are positioned via a guidance system).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify Azizian with the teachings of Salcudean because there is some teaching, suggestion or motivation in the prior art to do so. Salcudean states “the ability to position the ultrasound transducer in response to acquired ultrasound images would also be of benefit to image-guided interventions (e.g., percutaneous pericardial puncture) and registration with past examination records or images obtained with other imaging methods (e.g., MRI). The use of ultrasound imaging together with three-dimensional tracking of the transducer probe has been proposed in U.S. Pat. No. 5,797,849 as a tool for improving medical interventions” (col 2, lines 22-30).
The combination of Azizian and Salcudean fails to teach the guidance content including an instruction configured to be presented to a user of the computer-assisted surgical system to guide the user in moving the non-robotic device in the surgical space, the guidance content further including one or more graphical indicators configured to augment an image of the surgical space during a surgical procedure, each graphical indicator included in the one or more graphical indicators depicting a suggested angle of contact of the non-robotic device with an object in the surgical space, the one or more graphical indicators displayed across the object to facilitate subsurface imaging the object; and provide the guidance content to the computer-assisted surgical system.
Djajadiningrat, in the same field of endeavor of a non-robotic device guidance system (Abstract), teaches a guidance system for generating ultrasound positioning instructions ([0012-0017]). The guidance system is based on a medical practitioner manually positioning an ultrasound probe where an expert selects a desired ultrasound image and the necessary probe orientation and location to achieve this image is output to the medical practitioner (Fig. 1, [0038-0040]; [0010] – this guidance system allows an expert to guide ultrasound placement with an inexperienced user remotely). The virtual image of the probe in the desired location and orientation is an overlay superimposed over a view of the surgical site to show the correct probe position ([0045]). In this case, the superimposed image may be displayed as part of an augmented reality headset, holographic representation over the surgical site, or on a display such as a tablet or monitor ([0045]). The pose information for the ultrasound probe includes the necessary position and rotation/tilt angle to achieve a designated ultrasound view ([0040]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Azizian and Salcudean by incorporating the graphical overlay guidance system in Djajadiningrat. This would have been obvious because both Azizian/Salcudean, and Djajadiningrat discuss computer-assisted guidance systems for surgery and Djajadiningrat provides a solution/improvement by providing a graphical overlay on an image of the surgical site showing the necessary probe location and orientation to achieve a desired ultrasound image, which is beneficial for directing inexperienced operators. Therefore, a person of ordinary skill in the art would be motivated to improve the guidance system in the combination of Azizian and Salcudean by incorporating the graphical overlay guidance system in Djajadiningrat.
Regarding claim 16, Azizian teaches a method comprising:
• obtaining, by a processor associated with a computer-assisted surgical system, one or more parameters of a non-robotic device in a surgical space, the non-robotic device engaged by a computer-assisted surgical system ([0052] - force sensor);
• providing, by the processor, the guidance content to the computer-assisted surgical system ([0053] - guidance to maintain constant contact force).
Azizian fails to disclose that the parameters are used to generate guidance for teleoperation.
Salcudean teaches generating, by the processor and based on at least the one or more parameters of the non- robotic device, guidance content for use by the computer-assisted surgical system to facilitate guided teleoperation of the non-robotic device (subject system guides the surgeon) (col 14, lines 1-22 – the ultrasound probe and needles are positioned via a guidance system).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify Azizian with the teachings of Salcudean because there is some teaching, suggestion or motivation in the prior art to do so. Salcudean states “the ability to position the ultrasound transducer in response to acquired ultrasound images would also be of benefit to image-guided interventions (e.g., percutaneous pericardial puncture) and registration with past examination records or images obtained with other imaging methods (e.g., MRI). The use of ultrasound imaging together with three-dimensional tracking of the transducer probe has been proposed in U.S. Pat. No. 5,797,849 as a tool for improving medical interventions” (col 2, lines 22-30).
The combination of Azizian and Salcudean fails to teach the guidance content including an instruction configured to be presented to a user of the computer-assisted surgical system to guide the user in moving the non-robotic device in the surgical space, the guidance content further including one or more graphical indicators configured to augment an image of the surgical space during a surgical procedure, each graphical indicator included in the one or more graphical indicators depicting a suggested angle of contact of the non-robotic device with an object in the surgical space, the one or more graphical indicators displayed across the object to facilitate subsurface imaging the object; and providing, by the processor, the guidance content to the computer-assisted surgical system.
Djajadiningrat, in the same field of endeavor of a non-robotic device guidance system (Abstract), teaches a guidance system for generating ultrasound positioning instructions ([0012-0017]). The guidance system is based on a medical practitioner manually positioning an ultrasound probe where an expert selects a desired ultrasound image and the necessary probe orientation and location to achieve this image is output to the medical practitioner (Fig. 1, [0038-0040]; [0010] – this guidance system allows an expert to guide ultrasound placement with an inexperienced user remotely). The virtual image of the probe in the desired location and orientation is an overlay superimposed over a view of the surgical site to show the correct probe position ([0045]). In this case, the superimposed image may be displayed as part of an augmented reality headset, holographic representation over the surgical site, or on a display such as a tablet or monitor ([0045]). The pose information for the ultrasound probe includes the necessary position and rotation/tilt angle to achieve a designated ultrasound view ([0040]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Azizian and Salcudean by incorporating the graphical overlay guidance system in Djajadiningrat. This would have been obvious because both Azizian/Salcudean, and Djajadiningrat discuss computer-assisted guidance systems for surgery and Djajadiningrat provides a solution/improvement by providing a graphical overlay on an image of the surgical site showing the necessary probe location and orientation to achieve a desired ultrasound image, which is beneficial for directing inexperienced operators. Therefore, a person of ordinary skill in the art would be motivated to improve the method in the combination of Azizian and Salcudean by incorporating the graphical overlay guidance system in Djajadiningrat.
Regarding claim 17, the method in Claim 16 is obvious over Azizian in view of Salcudean and Djajadiningrat, as indicated hereinabove. Azizian further teaches the non-robotic device is a non-robotic imaging device configured to capture imagery of an object in the surgical space ([0034] ultrasound transducer); and Salcudean further teaches the guidance content is configured to facilitate a user of the computer-assisted surgical system maintaining at least one of a position or an orientation of the non-robotic imaging device (corrected robot trajectory) with respect to the object as the non-robotic imaging device moves along a surface of the object (column 11 lines 56-61 and the general concept of visual servoing throughout the disclosure).
Claims 5-6 are rejected under 35 USC 103 as being unpatentable over Azizian (WO 2018/152183 A1) in view of Salcudean (US 6,425,865 B1), Djajadiningrat (EP 3,445,249 B1), and Richmond (US 2017/0095297 A1).
Regarding claim 5, the system in Claim 4 is obvious over Azizian in view of Salcudean and Djajadiningrat, as indicated hereinabove. Salcudean further teaches the non-robotic imaging device (ultrasound probe tip) is configured to contact a surface of the object to capture the imagery of the object (patient) (col 9 line 12-14). Salcudean fails to teach that the guidance content indicates a state of contact for the non-robotic imaging device with the surface of the object.
However, adding the feature of indicating the state of contact constitutes the use of a known technique to improve similar devices (methods or products) in the same way (Rationale C MPEP 2143 (I)(C)). The minimally invasive computer-assisted tele-operated surgery base device from Azizian can be improved as outlined in Richmond et al (US 20170095297 A1); hereinafter Richmond to include detecting a change in image content to determine contact state. In order for any teleoperated surgical system to accurately capture imaging data, it must maintain contact with the object of interest and it would be convenient to display that state of contact or non-contact to the user on the user interface. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to improve the surgical system of Azizian with the contact state display of Richmond.
Regarding claim 6, the system in Claim 5 is obvious over Azizian in view of Salcudean, Djajadiningrat, and Richmond, as indicated hereinabove. Richmond teaches that the generating of guidance content includes: detecting a change in image content (reflected luminance from tissue) in an image captured by the non-robotic imaging device (endoscope); and determining that the non-robotic imaging device is in contact (contact occurred) with the object based on the detected change in image content in the image (change of reflected luminance) ([0011]).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify the combination of Azizian, Salcudean, and Djajadiningrat with the teachings of Richmond because there is some teaching, suggestion, or motivation to do so. Richmond teaches that “if a controller detects contact of an endoscope tip with tissue, the controller attenuates output optical power from the endoscope tip. This ensures the tissue is not damaged as a result of the contact” ([0010]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention that detecting changes in contact between the imaging device and the target tissue would prevent damage to the tissue.
Claim 7 is rejected under 35 USC 103 as being unpatentable over Azizian (WO 2018/152183 A1) in view of Salcudean (US 6,425,865 B1), Djajadiningrat (EP 3,445,249 B1), Cheong (WO 2019/132781 A1), and Lavallee (US 2017/0238999 A1).
Regarding claim 7, the system in Claim 1 is obvious over Azizian in view of Salcudean and Djajadiningrat, as indicated hereinabove.
Cheong teaches the non-robotic device (ultrasound probe) is configured to contact a surface of an object (skin surface) in the surgical space. It would have been obvious to modify the combination of Azizian, Salcudean, and Djajadiningrat with Cheong because there is some teaching, suggestion, or motivation to do so. Cheong teaches a real-time ultrasound image 600 of the kidney is obtained by the ultrasound probe and is displayed on an image feedback unit having a display screen and this can only be obtained by maintaining contact with the skin above the target organ. Cheong fails to teach that the guidance content includes contact pressure or contact angle.
Lavallee teaches the guidance content indicates at least one of a contact pressure ([0084] - contact sensor) of the non-robotic device with respect to the surface of the object ([0015]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination with Lavallee because there is some teaching, suggestion, or motivation to do so. Lavallee teaches that their system measures contact pressure in order to automatically detect the time at which the needle guide is contacting the proximal stop of the needle ([0084]).
Claims 8-12 and 20 are rejected under 35 USC 103 as being unpatentable over Azizian (WO 2018/152183 A1) in view of Salcudean (US 6,425,865 B1), Djajadiningrat (EP 3,445,249 B1), and Frimer (WO 2017/098505).
Regarding claim 8, the system in Claim 1 is obvious over Azizian in view of Salcudean and Djajadiningrat, as indicated hereinabove. Salcudean further teaches the non-robotic device is engaged by a robotic instrument attached to the computer-assisted surgical system (col 11 line 21 – col 12 line 10). The combination of Azizian, Salcudean, and Djajadiningrat fails to teach that the guidance content includes a suggested path and that the suggested path is indicated to the user.
Frimer discloses the generating of the guidance content includes generating a suggested path (path calculation) for the non-robotic device to follow in the surgical space while the non-robotic device is engaged by the robotic instrument (movements of one surgical object); and the guidance content indicates the suggested path (path can be overlaid on image).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify the combination of Azizian, Salcudean, and Djajadiningrat with the teachings of Frimer because there is a teaching, suggestion, or motivation to do so. Frimer teaches that “in an automatic procedure (where a robotic system is assisting an operator), path calculation can be advantageous in predicting at least one movement of an operator and thereby increasing efficiency in following the operator's movements. For non-limiting example, knowledge of an expected path can enable the system to configure a robotic arm's movement so as to prevent the arm from later being forced into an awkward or highly non-optimal orientation” (pages 32-33).
Regarding claim 9, the system in Claim 8 is obvious over Azizian in view of Salcudean, Djajadiningrat, and Frimer as indicated hereinabove. Frimer further teaches the generating of the suggested path includes: facilitating a user of the computer-assisted surgical system defining a first virtual pointer indicative of a start position of the suggested path and a second virtual pointer indicative of a stop point of the suggested path (figure 10 - part 1020 all points, page 34 for description of figure); and generating the suggested path (preferred path) for the non-robotic device to follow based on the first virtual pointer and the second virtual pointer (between two fixed points).
Regarding claim 10, the system in Claim 9 is obvious over Azizian in view of Salcudean, Djajadiningrat, and Frimer as indicated hereinabove. Frimer further teaches the guidance content includes the first virtual pointer and the second virtual pointer (critical point) provided for display by way of a display device associated with the computer-assisted surgical system (indication to operator) such that the first virtual pointer and the second virtual pointer are virtually positioned on a surface of an object in the surgical space (visible signal); and the suggested path (path) is a curved path that follows the surface of the object (contours of the organ).
Regarding claim 11, the system in Claim 8 is obvious over Azizian in view of Salcudean, Djajadiningrat, and Frimer as indicated hereinabove. Frimer further teaches the generating of the suggested path includes automatically generating the suggested path based on a procedural context associated with the surgical space (analyze the spatiotemporal 3-dimensional surgical database. The result of the analysis can be determining a path for movement of at least one too).
Regarding claim 12, the system in Claim 8 is obvious over Azizian in view of Salcudean, Djajadiningrat, and Frimer as indicated hereinabove. Frimer further teaches the guidance content includes a graphical depiction of the suggested path provided for display by way of a display device associated with the computer-assisted surgical system (indication to operator, visible signal (e.g., on a display)).
Regarding claim 20, the method in Claim 16 is obvious over Azizian in view of Salcudean, and Djajadiningrat as indicated hereinabove. Azizian further teaches the non-robotic device is engaged by a robotic instrument attached to the computer-assisted surgical system ([0034] - 450 grasped by laparoscopic tool). Azizian fails to teach generating a suggested path and indicating the suggested path on the guidance content.
Frimer discloses the generating of the guidance content includes generating a suggested path (path calculation) for the non-robotic device to follow in the surgical space while the non-robotic device is engaged by the robotic instrument (movements of one surgical object); and the guidance content indicates the suggested path (path can be overlaid on image).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify the combination of Azizian and Salcudean with the teachings of Frimer because there is a teaching, suggestion, or motivation to do so. Frimer teaches that “in an automatic procedure (where a robotic system is assisting an operator), path calculation can be advantageous in predicting at least one movement of an operator and thereby increasing efficiency in following the operator's movements. For non-limiting example, knowledge of an expected path can enable the system to configure a robotic arm's movement so as to prevent the arm from later being forced into an awkward or highly non-optimal orientation” (pages 32-33).
Claims 13 and 14 are rejected under 35 USC 103 as being unpatentable over Azizian (WO 2018/152183 A1) in view of Salcudean (US 6,425,865 B1), Djajadiningrat (EP 3,445,249 B1), Frimer (WO 2017/098505), and VanDyken (EP 3,482,710 A1).
Regarding claim 13, the system in Claim 12 is obvious over Azizian in view of Salcudean, Djajadiningrat, and Frimer as indicated hereinabove. This combination fails to teach tool path planning and user confirmation on the accuracy of the tool path.
VanDyken teaches the graphical depiction of the suggested path includes a simulation of the non-robotic device moving along the suggested path ([0072] - planning parameters, path of tool 22).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify the combination of Azizian, Salcudean, Djajadiningrat, and Frimer with the teachings of VanDyken because there is some teaching, suggestion, or motivation to do so. VanDyken teaches that even with surgical navigation, surgeons may have difficulty “perform(ing) unfamiliar procedures or procedures that they have not performed recently” ([0005]). Therefore, it would have been obvious to include tool path planning to address these concerns.
Regarding claim 14, the system in Claim 12 is obvious over Azizian in view of Salcudean, Djajadiningrat, and Frimer as indicated hereinabove. This combination fails to teach tool path planning and user confirmation on the accuracy of the tool path.
VanDyken further teaches the guidance content includes a notification provided by the computer-assisted surgical system to a user of the computer-assisted surgical system, the notification requesting user confirmation that the suggested path indicated by the graphical depiction is acceptable ([0072] - confirm or modify automatically generated planning parameters 306).
Claim 18 is rejected under 35 USC 103 as being unpatentable over Azizian (WO 2018/152183 A1) in view of Salcudean (US 6,425,865 B1), Djajadiningrat (EP 3,445,249 B1), and Border (US 2016/0015470 A1).
Regarding claim 18, the method in Claim 17 is obvious over Azizian in view of Salcudean, and Djajadiningrat as indicated hereinabove.
Border teaches the generating of the guidance content includes: analyzing an image captured by the non-robotic imaging device while the non-robotic imaging device is used to capture the imagery of the object ([0235] - image can be captured and analyzed); and determining, based on the analyzing of the image captured by the non- robotic imaging device, that the image includes an image capture deficiency ([0235] determined to not be sharp); and the method further includes performing, by the processor in response to the determining that the image includes the image capture deficiency, an action to facilitate correcting the image capture deficiency ([0235] - automated adjustment of focus).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify the combination of Azizian, Salcudean, and Djajadiningrat with the teachings of Border because there is some teaching, suggestion, or motivation to do so. Border teaches that “having the ability to measure and automatically adjust the focus of displayed images can be very useful in augmented reality imaging where the focus distance of the displayed image can be varied in response to changes in the environment or changes in the method of use by the wearer” ([0235]).
Claim 19 is rejected under 35 USC 103 as being unpatentable over Azizian (WO 2018/152183 A1) in view of Salcudean (US 6,425,865 B1), Djajadiningrat (EP 3,445,249 B1), Border (US 2016/0015470 A1), and Cheong (WO 2019/132781 A1).
Regarding claim 19, the method in Claim 18 is obvious over Azizian in view of Salcudean, Djajadiningrat, and Border, as indicated hereinabove.
Cheong teaches the performing of the action to facilitate correcting the image capture deficiency includes automatically adjusting (admittance control algorithm) at least one of an amount of contact pressure or a contact angle of the non-robotic imaging device with respect to the object while the user of the computer-assisted surgical system uses the non-robotic imaging device to capture the imagery of the object (maintain appropriate contact force between ultrasound probe and the patient’s body when the operator releases the probe).
It would have been obvious to a person having ordinary skill in the art prior to the filing date of the invention to modify the combination of Azizian, Salcudean, Djajadiningrat, and Border with the teachings of Cheong because there is some teaching, suggestion, or motivation to do so. Cheong teaches that “this not only provides better image quality but also reduces burden on the surgeon so that he can concentrate on the more critical components” (page 22).
Conclusions
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
Prosecution Insights