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 .
DETAILED ACTION
Response to Amendment
The present Office Action is in response to the Request for Continued Examination dated 02/23/2026.
In the amendment dated 02/23/2026, the following occurred: Claims 1, 5, 11, 12, 14, 19 and 20 were amended.
Claims 1-20 are currently pending.
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/23/2026 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method and a system for detecting a conflict, which are within a statutory category.
Step 2A1
Regarding claims 1 and 14, the limitation of (claim 1 being representative) receiving a first signal from the local control means, the local control means being disposed at a local location where a medical intervention is being performed and the first signal being related to the medical intervention; receiving a second signal from the remote control means, the second signal being related to the medical intervention and the remote control means being disposed at a remote location, being communicatively coupled at the local location, and receive input from a remote operator; controlling […] to perform the medical intervention based on at least one of the first signals or the second signal checking whether a conflict is present based on the first signal and the second signal; and providing conflict information based on the checking, wherein the conflict information comprises information that the conflict is present and the local control means and the remote control means are configured to jointly perform the medical intervention with the […] as drafted, is are processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to receive remote and local signals related to a medical intervention, control a robotic system to performance of the medical intervention, check for the presence of a conflict and provide the conflict information (see Spec. Para. 0003-0004 describing performing a medical intervention by remote and local staff, Para. 0006 describing the robotic system controlled or operated by remote staff and Para. 0038 describing remote and local staff to carry out particular operating step as a human activity) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “receiving… controlling … checking … and providing” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a computing unit (claim 14) and a computer and processor (claim 1), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. Claim 1 recites the additional elements of a computer and processor. Claim 14 recites the additional element of a computing unit. These additional elements is not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer component for performing generic computer functions, see Spec. Para. 00165) such that they amount to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1 and 14 recites the additional element of a user interface and Claim 14 further recite the additional element of an interface. These additional elements are recited at a high level of generality (i.e. a general means to receive signals or inputs) and amount to mere receiving of data, which is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Claims 1 and 14 further recites the additional elements of a medical device or a local display. These additional elements are recited at a high level of generality (i.e. a general means to display/send data) which is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Claims 1 and 14 further recites the additional element of controlling a robotic system at the local location to perform the medical intervention. This additional element equates to saying “apply it”. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the computing unit, computer and processor to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
As discussed above with respect to integration of the abstract idea into a practical application, the additional element of the interface, a user interface and a medical device or a local display, were considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Moreover, the prior art of record indicates that receiving/sending/displaying data is well-understood, routine, conventional activity (see Lang at [0003], [0156], [0256], [0501]-[0502], [0652] and [0822] and Oliveira at [0007], [0023], [0033] and [0042]). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional element of controlling a robotic system at the local location to perform the medical intervention was determined to be “apply it”. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
The Examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d));
Claims 2-13 and 15-20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 further merely describe(s) receiving the first and the second signal via at least one of a user input, an audio input, a video input, or a system input. Claim(s) 3 further merely describe(s) checking checks using facial recognition or object recognition. Claim(s) 3 includes the additional element of “facial recognition or object recognition” which generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more. Claim(s) 4 further merely describe(s) checking checks using voice recognition. Claim(s) 4 also includes the additional element of “facial recognition” which generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more. Claim(s) 5 further merely describe(s) the first and second time and checking based on a chronological sequence. Claim(s) 6 further merely describe(s) determining and providing a de-escalation signal. Claim(s) 7 further merely describe(s) providing the de-escalation signal. Claim(s) 8 further merely describe(s) the de-escalation signal triggers a blocking. Claim(s) 9 further merely describe(s) determining a reason for the conflict. Claim(s) 10 further merely describe(s) wherein the de-escalation signal comprises at least one of an audio output or a video output. Claim(s) 11 further merely describe(s) determining a frequency of an occurrence of the conflict. Claim(s) 12 further merely describe(s) the first and the second signal are generated in connection with an intervention, and the de-escalation signal is based on a progress of the intervention. Claim(s) 13 further merely describe(s) receiving feedback via a user input, wherein the feedback comprises an evaluation of the de-escalation signal. Claim(s) 15 further merely describe(s) a non-transitory computer program product comprising a computer program having program sections, executed by a conflict detection system. Claim(s) 15 includes the additional element of “a non-transitory computer program product”, “a computer” and “a conflict detection system” which are analyzed similar to the computing unit of claim 14 and the computer in claim 1 and do not provide practical application or significantly more for the same reasons. Claim(s) 16 further merely describe(s) a non-transitory computer-readable storage medium storing program sections, executed by a conflict detection system. Claim(s) 16 includes the additional element of “a non-transitory computer-readable storage medium” and “a conflict detection system” which are analyzed similar to the computing unit of claim 14 and the computer in claim 1 and do not provide practical application or significantly more for the same reasons. Claim(s) 17 further merely describe(s) determining and providing a de-escalation signal. Claim(s) 18 further merely describe(s) determining a reason for the conflict. Claim(s) 19 further merely describe(s) determining a frequency of an occurrence of the conflict. Claim(s) 20 further merely describe(s) the first and the second signal are generated in connection with an intervention, and the de-escalation signal is based on a progress of the intervention. As can be seen, Claims 2-13 and 15-20 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1 and 14.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lang (US 2021/0192759).
REGARDING CLAIM 1
Lang discloses a computer-implemented method for detecting a conflict between a local control means and a distantly disposed remote control means, the method comprising: receiving, with a processor of a computer, a first signal from the local control means, the local control means being disposed at a local location where a medical intervention is being performed, and the first signal being related to the medical intervention ([0096] teaches the surgical site (interpreted by Examiner as the local location where the medical intervention is being performed) including live data of the patient (interpreted by Examiner as the first signal from the local control means), and allowing the surgeon to see the live data of the patient, e.g. the surgical field. [0141] teaches the term live data of the patient, as used herein, includes the surgical site, anatomy, anatomic structures or tissues and/or pathology, pathologic structures or tissues of the patient as seen by the surgeon's or viewer's eyes); receiving, with the processor, a second signal from the remote control means, the second signal being related to the medical intervention and the remote control means being disposed at a remote location, being communicatively coupled with at least one of a medical device or a local display at the local location, and including a user interface configured to receive input from a remote operator ([0096] teaches the surgical site including virtual data of the patient. [0951] teaches the virtual data of the patient, e.g. data from the pre-operative or an intra-operative imaging study, an optional virtual surgical plan and any optional graphical representations or 3D representations of one or more virtual tools, virtual instruments, virtual implants, virtual surgical plans and [1067] and Fig. 12 teach that for generating a virtual surgical plan, image data of a patient are acquired, e.g. at a site remote from the operating room. The imaging data can be transferred to a computer or workstation, e.g. via electronic data transfer routines and can be displayed in two or three dimensions on a computer display or OHMD. (interpreted by Examiner as receiving the second signal from a remote control means, the second signal being related to the medical intervention and the remote control means being disposed at a remote location, being communicatively coupled with at least one of a medical device or a local display at the local location, and including a user interface configured to receive input from a remote operator)); controlling a robotic system at the local location to perform the medical intervention based on at least one of the first signal or the second signal ([0220] teaches commands (interpreted by Examiner as commands for controlling) that can direct or steer, for example, a surgical instrument or a robot (Interpreted by Examiner as the robotic instrument). [0223] teaches that head movement can be used to control a surgical instrument. For example, in a robot assisted procedure with haptic feedback from the robot, the surgeon can use his or her hands in controlling the direction of a surgical instrument. [0370] teaches that once the anatomic surface(s) (interpreted by Examiner as the first signal) is (are) exposed, the one or more of virtual surgical tool, a virtual surgical instrument, a virtual surgical guide (all interpreted by Examiner to be the second signal), can be projected, aligned and/or superimposed by one or more OHMDs onto the surface(s) of the one or more anatomic structures and the surgeon or a robot can then, for example, move and/or align and/or superimpose a physical tool, a physical instrument, a physical surgical guide, physical implant component, a physical implant and/or a physical device to align and/or superimpose it with the virtual projection(s) (interpreted by Examiner as controlling a robotic system at the local location to perform the medical intervention based on at least one of the first signal or the second signal)); checking, with the processor, whether a conflict is present based on the first signal and the second signal ([0051] and Fig. 5 teach inaccuracies between the changes induced by a surgical step and the intended, projected or predetermined changes in the virtual data of the patient and [0335] teaches ensuring that the virtual data of the patient is correctly superimposed with the live data of the patient (interpreted by Examiner as checking whether a conflict is present); and providing, with the processor, conflict information based on the checking, wherein the conflict information comprises information that the conflict is present ([0083] teaches determining a desired alignment correction. [0399] teaches displaying a proposed correction for a surgical step. [0500] teaches for example, when a surgeon is operating on a patient to replace the patient's left knee, one or more implant components or an attached holder or packaging label or sterile package can include an optical marker including a QR marker. The QR marker can indicate the laterality, e.g. left femoral component vs. right femoral component. If the scrub technician accidentally hands the surgeon a right femoral component for implantation into the patient's left knee, an image and/or video capture system integrated or attached to the OHMD that the surgeon is wearing can read the QR code as the surgeon takes the femoral component and as the femoral component with the attached optical marker and QR code enters the surgeon's field of view or enters the proximity of the surgical field. The image and/or video capture system and related system software can read the QR code identifying that the implant component is for a right knee; the system software can then compare the information to the virtual surgical plan of the patient or the templating and/or sizing information which can indicate that a left knee was planned, then triggering an alert that an incorrect femoral component has entered the field of view of the surgeon or has entered into the proximity of the surgical field, as for example demarcated by another optical marker. The alert can assist the surgeon in correcting the error by switching to the correct side component (interpreted by Examiner as providing conflict information based on the checking, wherein the conflict information comprises information that a conflict is present)) and the local control means and the remote control means are configured to jointly perform the medical intervention with the robotic system ([2039] teaches the surgical plan and the virtual anatomical models can be registered and superimposed with the patient's anatomy, for example to enable the surgeon to compare the surgical plan derived from preoperative images with the real intraoperative anatomy of the patient. The surgeon can then make updates to the surgical plan based on the intraoperative assessment and comparison between virtual anatomical model and live physical patient anatomy. Any changes in the surgical plan can then be translated into updated control commands for the robot and updated display of virtual data by one or more OHMDs (interpreted by Examiner as the local control means and the remote control means are configured to jointly perform the medical intervention with the robotic system)).
REGARDING CLAIM 2
Lang discloses the limitation of claim 1.
Lang further discloses:
The method of claim 1, wherein at least one of the receiving, with the processor, the first signal receives the first signal via at least one of a user input, an audio input, a video input, or a system input; or the receiving, with the processor, receives the second signal receives the second signal via at least one of the user input, the audio input, the video input, or the system input (Lang at [0227] teaches eye, lid, facial and head movement commands can be paired or used in conjunction with voice commands, hand commands, gesture commands, keyboard commands, track pad commands, mouse commands, graphical user interface commands and any other command input device known in the art. The OHMD can optionally also include one or more touch sensitive sensors. [0500] teaches an image and/or video capture system and related system software. [0822] teaches the processor can be configured to receive input from a user interface to facilitate assessment of the fit and/or alignment of the two or more virtual implants to the surgical site of the patient. [1068] teaches visual or optical feedback (interpreted by Examiner as receives the first or second signal via at least one of a user input, an audio input, a video input, or a system input)).
REGARDING CLAIM 3
Lang discloses the limitation of claim 1.
Lang further discloses:
The method of claim 1, wherein at least one of the first signal or the second signal comprises a video input, and the checking, with the processor, checks using facial recognition or object recognition (Lang at [0268] teaches object recognition. [0500] teaches an image and/or video capture system integrated or attached to the OHMD that the surgeon is wearing can read the QR code as the surgeon takes the femoral component and as the femoral component with the attached optical marker and QR code enters the surgeon's field of view or enters the proximity of the surgical field. The image and/or video capture system and related system software can read the QR code identifying that the implant component is for a right knee; the system software can then compare the information to the virtual surgical plan of the patient or the templating and/or sizing information which can indicate that a left knee was planned, then triggering an alert that an incorrect femoral component has entered the field of view of the surgeon or has entered into the proximity of the surgical field, as for example demarcated by another optical marker. The alert can assist the surgeon in correcting the error by switching to the correct side component (interpreted by Examiner as wherein at least one of the first signal or the second signal comprises a video input, and the checking checks using object recognition)).
REGARDING CLAIM 4
Lang discloses the limitation of claim 1.
Lang further discloses:
The method of claim 1, wherein at least one of the first signal or the second signal comprises an audio input, and the checking, with the processor, checks using voice recognition (Lang at [0945] teaches using voice recognition and/or voice commands (interpreted by Examiner as wherein at least one of the first signal or the second signal comprises an audio input, and the checking checks using voice recognition)).
REGARDING CLAIM 5
Lang discloses the limitation of claim 1.
Lang further discloses:
The method of claim 1, wherein the first signal comprises a first time, the first time indicates when the first signal was generated, the second signal comprises a second time, the second time indicates when the second signal was generated, and the checking, with the processor, is based on a chronological sequence of the first time and the second time (Lang at [0691] teaches registration of Virtual Patient Data and Live Patient Data at Multiple Time Points, for Example at Different Stages of a Surgical Procedure and [0692] teaches registration of virtual patient data and live patient data can occur at multiple time points, for example during different phases of tissue removal or implantation of a medical device. For select or each time point, e.g. for select or all stages of the surgical procedure, the live data of the patient and the virtual data of the patient can be registered in a common coordinate system (interpreted by Examiner as wherein the first signal comprises a first time, the first time indicates when the first signal was generated, the second signal comprises a second time, the second time indicates when the second signal was generated, and the checking is based on a chronological sequence of the first and the second time)).
REGARDING CLAIM 6
Lang discloses the limitation of claim 1.
Lang further discloses:
The method of claim 1, further comprising: determining, with the processor, a de-escalation signal as a function of the conflict; and providing, with the processor, the de-escalation signal for resolving the conflict (Lang at [1462] teaches the software can highlight potential areas that may result in clinical problems. [0475] teaches if any discrepancies are detected, an alert can be triggered, which can, for example, be displayed and [0499] teaches the alert can be visual, e.g. red warning signs or stop signs or alert signs displayed, or acoustic, or a vibration, or combinations thereof. (interpreted by Examiner as determining a de-escalation signal as a function of the conflict and providing the de-escalation signal for resolving the conflict)).
REGARDING CLAIM 7
Lang discloses the limitation of claim 6.
Lang further discloses:
The method of claim 6, wherein the providing, with the processor, provides the de-escalation signal until a confirmation is received, until the conflict is resolved, until a current operating step is completed, or for a predetermined time period (Lang at [0479] teaches the OHMD can optionally turn off the display of any virtual data of the patient when one or more test data indicate that the system is operating outside its clinically acceptable performance range. When test data indicate that the system is operating again inside the clinically acceptable performance range, the OHMD display can turn back on (interpreted by Examiner as wherein the providing provides the de-escalation signal until a confirmation is received, until the conflict is resolved)).
REGARDING CLAIM 8
Lang discloses the limitation of claim 6.
Lang further discloses:
The method of claim 6, wherein the de-escalation signal triggers a blocking of the local control means or the remote control means (Lang at [0479] teaches the OHMD can optionally turn off the display of any virtual data of the patient when one or more test data indicate that the system is operating outside its clinically acceptable performance range (interpreted by Examiner as wherein the de-escalation signal triggers a blocking of the local control means or the remote control means)).
REGARDING CLAIM 9
Lang discloses the limitation of claim 6.
Lang further discloses:
The method of claim 6, further comprising: determining, with the processor, a reason for the conflict based on the checking, wherein the de-escalation signal comprises information about a reason for the conflict (Lang at [5000] teaches the system software can then compare the information to the virtual surgical plan of the patient or the templating and/or sizing information which can indicate that a left knee was planned, then triggering an alert that an incorrect femoral component has entered the field of view of the surgeon or has entered into the proximity of the surgical field, as for example demarcated by another optical marker. The alert can assist the surgeon in correcting the error by switching to the correct side component (interpreted by Examiner as means for determining a reason for the conflict based on the checking, wherein the de-escalation signal comprises information about a reason for the conflict)).
REGARDING CLAIM 10
Lang discloses the limitation of claim 9.
Lang further discloses:
The method of claim 9, wherein the de-escalation signal comprises at least one of an audio output or a video output, and the at least one of the audio output or the video output is based on the conflict (Lang at [0499] teaches alerts can be acoustic and [0479] teaches an acoustic signal that increases in intensity or frequency the further the system operates outside the clinically acceptable range (interpreted by Examiner as wherein the de-escalation signal comprises at least one of an audio output and the at least one of the audio output is based on the conflict)).
REGARDING CLAIM 11
Lang discloses the limitation of claim 9.
Lang further discloses:
The method of claim 9, further comprising: determining, with the processor, a frequency of an occurrence of the conflict having the reason, wherein the de-escalation signal is dependent on the frequency (Lang at [0713] teaches the surgeon can perform a surgical step 80. The surgeon can then assess the actual changes induced in the live patient 81. The surgeon can compare the actual changes induced in the live patient with the predetermined changes in the virtual data of the patient, e.g. in a virtual surgical plan or in a virtual 3D display 82. The magnitude of the difference(s) between the actual and the predetermined changes can be determined 83. If they are acceptable 84, the surgeon can perform the next surgical step 85. Optionally 85, the steps 81, 82, 83 can be repeated for the next surgical step. If the difference(s) between the actual and the predetermined changes are not acceptable 86, the surgeon has several means of addressing the difference(s), modify the last surgical step 87, modify the next surgical step 88, modify the virtual surgical plan 89, modify the registration of the virtual data of the patient in relationship to the live data of the patient 90, or apply registration correction 91. After the last surgical step has been modified b 87, optionally 92, the steps 81, 82, 83 can be repeated for the next surgical step (interpreted by Examiner as means for determining a frequency of an occurrence of the conflict having the reason, wherein the de-escalation signal is dependent on the frequency)).
REGARDING CLAIM 12
Lang discloses the limitation of claim 6.
Lang further discloses:
The method of claim 6, wherein the first signal comprises a first time, the first time indicates when the first signal was generated, the second signal comprises a second time, the second time indicates when the second signal was generated, the first signal and the second signal are generated in connection with the medical intervention, and the de-escalation signal is based on a progress of the medical intervention at at least one of the first time or the second time (Lang at [0691] teaches registration of Virtual Patient Data and Live Patient Data at Multiple Time Points, for Example at Different Stages of a Surgical Procedure and [0692] teaches registration of virtual patient data and live patient data can occur at multiple time points, for example during different phases of tissue removal or implantation of a medical device. For select or each time point, e.g. for select or all stages of the surgical procedure, the live data of the patient and the virtual data of the patient can be registered in a common coordinate system (interpreted by Examiner as wherein the first signal comprises a first time, the first time indicates when the first signal was generated, the second signal comprises a second time, the second time indicates when the second signal was generated) [0435] teaches surgical interventions and [1767] teaches input for real-time optical guidance during the intervention (interpreted by Examiner as the first signal and the second signal are generated in connection with the medical intervention, and the de-escalation signal is based on a progress of the medical intervention at least one of the first time or the second time)).
REGARDING CLAIM 13
Lang discloses the limitation of claim 6.
Lang further discloses:
The method of claim 6, wherein the receiving, with the processor, the first signal and the receiving the second signal occur during an intervention, the method further comprises: receiving, with the processor, feedback from at least one of the local control means or the remote control means via a user input, wherein the feedback comprises an evaluation of the de-escalation signal (Lang at [1767] teaches input for real-time optical guidance during the intervention (interpreted by Examiner as wherein the receiving the first signal and the receiving the second signal occur during an intervention) [0254] teaches a display for providing feedback and [1068] teaches that the modified virtual surgical plan can be further modified based on visual or optical feedback or input and [2002] teaches when the percent superimposition of the physical saw blade or cutting tool (e.g. a pin, a drill, a mill, a reamer), e.g. attached to a robotic arm, with the virtual surgical guide, e.g. a virtual plane or a virtual axis, falls below a predefined or predetermined threshold value, an alarm can be generated, which can be visual, acoustic, vibratory or haptic feedback (interpreted by Examiner as receiving feedback from at least one of the local control means or the remote control means via a user input, wherein the feedback comprises an evaluation of the de-escalation signal)).
REGARDING CLAIMS 14-20
Claims 14-20 are analogous to Claims 1-13 thus Claims 14-20 are similarly analyzed and rejected in a manner consistent with the rejection of Claims 1-13.
Response to Arguments
Claim Objections
Regarding the claim objection(s) of claim 2, the Applicant has amended the claim to overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 112(b)
Regarding the indefinite rejection of claims 1-13, the Applicant has amended the claims to overcome the bases of rejection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-20, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
…The Examiner noted that amendments related to controlling a robotic system may help to advance prosecution with respect to the pending rejections under 35 U.S.C. § 101.
Regarding 1, The Examiner notes that upon further consideration of Applicants disclosure, the provided amendments for controlling a robotic system do not render the claims patent eligible, as they do not provide a practical application nor significantly more. Applicants disclosure describes the medical intervention and controlling the robotic system as a human activity. See Para. 0003-0004 describing performing a medical intervention by remote and local staff, Para. 0006 describing the robotic system controlled or operated by remote staff and Para. 0038 describing remote and local staff to carry out particular operating step. The examiner has analyzed controlling a robotic system at the local location to perform the medical intervention as an additional element that equates to saying “apply it”. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application and MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Moreover, the claims recite only the idea of a solution or an outcome and fail to recite details of how a solution to a problem is accomplished, see MPEP 2106.05(f). Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application and do not provide significantly more.
…At least as amended, claim 1 is not directed to managing personal behavior or relationships or interactions between people and is instead directed to a method of detecting a conflict between a local control means and a remote control means where each of the control means are configured to transmit signals for control of a robotic system to perform a medical intervention.
Regarding 2, The Examiner respectfully disagrees. The claims recite an abstract idea. Detecting a conflict and transmitting signals for the control of a robotic system is an abstract idea. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to receive remote and local signals related to a medical intervention, control a robotic system to performance of the medical intervention, check for the presence of a conflict and provide the conflict information. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas.
Rejection under 35 U.S.C. § 102
Regarding the rejection of claims 1-20, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
As amended, claim 1 clarifies that the local control and the remote control means are configured to jointly perform the medical intervention with the robotic system. Further, claim 1 is amended to recite, in part, "controlling a robotic system at the local location to perform the medical intervention based on at least one of the first signal or the second signal." Lang is not related to control of a robotic system for performing a medical intervention where both a local location and a remote location provide signals for control of the robotic system.
Regarding 1, The Examiner respectfully disagrees. Lang at [0096] teaches that a surgical site includes live data of the patient, and allowing the surgeon to see the live data of the patient, e.g. the surgical field. This is interpreted by the Examiner to be the first signal from the local control means, the local control means being disposed at a local location where a medical intervention is being performed, and the first signal being related to the medical intervention. [0096] also teaches the surgical site including virtual data of the patient and [0951] teaches that the virtual data of the patient can be, e.g. data from the pre-operative or an intra-operative imaging study, an optional virtual surgical plan and any optional graphical representations or 3D representations of one or more virtual tools, virtual instruments, virtual implants, virtual surgical plans (interpreted by Examiner as the second signal). [1067] and Fig. 12 further teach that for generating a virtual surgical plan, image data of a patient are acquired, e.g. at a site remote from the operating room (interpreted by Examiner as the second signal being related to the medical intervention and the remote control means being disposed at a remote location). The imaging data can be transferred to a computer or workstation, e.g. via electronic data transfer routines and can be displayed in two or three dimensions on a computer display or OHMD (interpreted by Examiner as receiving the second signal from a remote control means, being communicatively coupled with at least one of a medical device or a local display at the local location, and including a user interface configured to receive input from a remote operator). Moreover, Lang at [0220] teaches commands (interpreted by Examiner as commands for controlling) that can direct or steer, for example, a surgical instrument or a robot (Interpreted by Examiner as the robotic instrument). [0223] teaches that head movement can be used to control a surgical instrument. For example, in a robot assisted procedure with haptic feedback from the robot, the surgeon can use his or her hands in controlling the direction of a surgical instrument. [0370] teaches that once the anatomic surface(s) (interpreted by Examiner as the first signal, since it refers to the live data of the patient) is (are) exposed, the one or more of virtual surgical tool, a virtual surgical instrument, a virtual surgical guide (all interpreted by Examiner to be the second signal), can be projected, aligned and/or superimposed by one or more OHMDs onto the surface(s) of the one or more anatomic structures and the surgeon or a robot can then, for example, move and/or align and/or superimpose a physical tool, a physical instrument, a physical surgical guide, physical implant component, a physical implant and/or a physical device to align and/or superimpose it with the virtual projection(s) (interpreted by Examiner as controlling a robotic system at the local location to perform the medical intervention based on at least one of the first signal or the second signal). Lang at [2039] also teaches the surgical plan and the virtual anatomical models can be registered and superimposed with the patient's anatomy, for example to enable the surgeon to compare the surgical plan derived from preoperative images with the real intraoperative anatomy of the patient. The surgeon can then make updates to the surgical plan based on the intraoperative assessment and comparison between virtual anatomical model and live physical patient anatomy. Any changes in the surgical plan can then be translated into updated control commands for the robot and updated display of virtual data by one or more OHMDs (interpreted by Examiner as the local control means and the remote control means are configured to jointly perform the medical intervention with the robotic system)).
The Examiner notes that the claim as drafted is broad in regards to what the medical intervention, the first signal and second signal are. As a result they are given the broadest reasonable interpretation. The Examiner suggests that Applicant describe what the first signal and second signal are, and what the medical intervention entails.
Given the broadest reasonable interpretation the cited references teaches the claimed features.
Conclusion
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Oliveira (US 2021/0217503) discloses information conflict identification and characterization in response to data carry-over transitions. Fischer (US 2011/0077504) discloses system and method for robotic surgical intervention. Anvari (US 2013/0296883) discloses automated detection, diagnostic and therapeutic method and system. Cattin (US 2019/0388155) discloses controlling a surgical intervention to a bone.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The Examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683