DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of invention I (claims 1-12), species 1 (the sensor is a camera) in the reply filed on 08/19/26 is acknowledged. The traversal is on the ground(s) that the Examiner can examine groups I and II without undue burden. This is not found persuasive because the independent claims still have distinct combination/subcombination scopes, as is laid out in the restriction requirement mailed 07/29/26. Additionally, the limitations of claim 21 are not required for claim 1.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/19/26.
Priority Date
Claim 1-12 have a priority date of 08/23/23 for not having support for a sensor configured to detect usage of a surgical object, assigning a pre-defined order of planned steps of a surgical workflow, automatically distinguishing between executed steps of the workflow based on the usage of the surgical object, record a comparison of an actual order of executed steps of the workflow with the pre-defined order of the steps, before the filing date of these claims.
Claims 3-4 have a priority date of 08/23/23 for not having support for automatically generating a recommended change to the surgical workflow and/or to the future surgical workflow, before the filing date of these claims.
Claim 5 has a priority date of 08/23/23 for not having support for generating feedback by automatically generating a recommendation to train a particular person involved in executing the workflow, before the filing date of these claims.
Claim 10 has a priority date of 08/23/23 for not having support for the controller being configured as an artificial intelligence, before the filing date of these claims.
Drawings
The drawings are objected to because item 26 is used to represent both “hospital bed” and “tool table”. Further, item 26 and 28 are both used to represent tool table. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-12 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for claiming the sensor is “configured to detect usage of a surgical object” but it is unclear how a sensor can “detect usage” of an object. The specification does not go into details regarding how a sensor could detect if an object is being used, since “usage” of any object is not discussed in the specification anywhere.
Further, it is unclear how usage of the surgical object could automatically distinguish between the executed steps of the workflow. It is unclear how usage could distinguish between executed steps or non-executed steps. The specification fails to discuss or mention this at all, meaning the Examiner is unclear on how this is happening.
Further, the claim is unclear since it is unknown how distinguishing between executed steps would result in recording a comparison of an actual order of executed steps versus a pre-defined order of the planned steps. Whether or not a step is executed is not understood to have any relation to the order or a step or order of a planned step. The specification is lacking any explanation regarding this, and so the Examiner cannot understand the meaning.
Claim 10 is indefinite for claiming the controller is “configured as an artificial intelligence system” since it is unclear what it means for a controller to be configured as an artificial intelligence system. It is unclear whether this means the controller is an artificial intelligence system, or whether it perhaps is intended to be able to use artificial intelligence technologies, or whether it works similarly to an artificial intelligence system, or some other explanation. The specification does not discuss or mention this at all in any location, so the Examiner cannot understand further from the specification.
Remaining claims are rejected for depending on an indefinite claim.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1, 5-6, 11, 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DiSilvestro et al. (US 20070078678 A1 ) hereinafter known as DiSilvestro in view of Ryan et al. (US 20100167248 A1) hereinafter known as Ryan.
Regarding claim 1, DiSilvestro discloses a surgical system (Abstract: computer assisted surgery system) comprising:
a sensor configured to detect usage of a surgical object (Figure 1 item 14, 16, 18 [0033], [0039], [0061] camera which tracks location of surgical objects) and
a controller configured to assign a predetermined order of planned steps of a surgical workflow ([0004], [0028]), automatically distinguish between executed steps of the workflow based on the usage of the object ([0061]-[0062] the camera records the positions of surgical objects and sends this information to the controller which determines their locations, [0067]-[0068] the controller cooperates with the camera to determine the locations of the surgical objects and the controller determines deviations from the determined workflow plan based on the camera and sensors), and based on distinguishing executed steps of the workflow ([0079] the controller determines if a current step is not completed), record a comparison of an actual order of the executed steps with the pre-defined order of the planned steps ([0076], [0079] the controller determines what steps were skipped or which had deviations from the planned steps),
but is silent with regards to generating feedback based on the comparison.
However, regarding claim 1 Ryan teaches a surgical system that compares executed steps versus planned steps and generates feedback based on the comparison ([0025], [0031]). DiSilvestro and Ryan are involved in the same field of endeavor, namely surgical procedures. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of DiSilvestro by having it give feedback based on the comparison of the executed and planned steps, such as is taught by Ryan in order to allow the system to provide instant feedback and training information for the surgeon performing the procedure, thus enhancing learning.
Regarding claim 5 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
wherein Ryan further teaches the feedback is generated by automatically generating a recommendation to train a particular person involved in executing the workflow ([0045]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of the DiSilvestro Ryan Combination by having it give feedback to recommend training as is taught by Ryan in order to provide instant feedback and training information for the surgeon performing the procedure, thus enhancing learning.
Regarding claim 6 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
wherein DiSilvestro further discloses the sensor is a camera (Figure 1 item 14, 16, 18), and the controller is configured to identify motion of the camera ([0021] mobile camera 16; [0030] if the controller could not identify motion of the mobile camera it would be unable to identify the motion and data received thereby to track the bones and tools).
Regarding claim 11 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
wherein DiSilvestro further discloses the sensor is configured to detect the position of the object within an operating room (see Figures 1-2 and 18-19 which show the operating room, [0023], [0055], [0062], [0065] the location the operation takes place is an operating room),
and wherein Ryan further teaches the sensor is configured to detect a position of the surgical object defined in a global coordinate system of a room ([0017]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of the DiSilvestro Ryan Combination so the sensor detects the position of the object in the defined global coordinate system of the room as is taught by Ryan in order to ensure the system can register the locations of the object to the room the user is in.
Regarding claim 21 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
wherein DiSilvestro further discloses the sensor is positionable in an operating room (this does not appear to materially affect the surgical system or sensor in any way).
Claim(s) 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DiSilvestro and Ryan as is applied above, further in view of Ramshaw et al. (US 5791907 A) hereinafter known as Ramshaw.
Regarding claim 2 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
wherein DiSilvestro further discloses identifying a missed step of the planned steps ([0076] the controller determines if the surgeon has skipped a step) and generating an indication of the missed step ([0076] the skipped step is recorded), but is silent with regards to this being how the feedback is generated.
However, regarding claim 2 Ramshaw teaches feedback being provided based on whether or not a step is missed (Column 3 lines 21-39; if the user skips the step of, for example, selecting the proper instrument, and identifies a different instrument, feedback is generated). DiSilvestro and Ramshaw are involved in the same field of endeavor, namely surgical systems. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of the DiSilvestro Ryan Combination so that the feedback is based on whether or not the step is missed as is taught by Ramshaw in order to ensure the user is made aware of the missed step, thus increasing the user’s education during the procedure.
Claim(s) 3-4 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DiSilvestro and Ryan as is applied above, further in view of Lang (US 9861446 B2).
Regarding claim 3 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
but is silent with regards to the feedback automatically generates a recommended change to the workflow.
However, regarding claim 3 Lang teaches differences between predicted and actual changes in a patient automatically generate a recommended change the to the workflow (Figure 6 items 80-83 and 86-87 the intended and actual changes in a patient are compared, and a change to the implant plan is suggested so the last step is modified). DiSilvestro and Lang are involved in the same field of endeavor, namely surgical systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the DiSilvestro Ryan Combination so that the feedback automatically recommends a change to the workflow as is taught by Lang in order to allow the surgical workflow to be updated and adapted based on the surgeon’s best judgement, allowing them to skip unnecessary steps in the future.
Regarding claim 4 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
but is silent with regards to the feedback automatically generates a recommended change to a future workflow.
However, regarding claim 4 Lang teaches differences between predicted and actual changes in a patient automatically generate a recommended change the to a future workflow (Figure 6 items 80-83, 86 and 88-89 the intended and actual changes in a patient are compared, and a change to the future workflow plan and steps are suggested). DiSilvestro and Lang are involved in the same field of endeavor, namely surgical systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the DiSilvestro Ryan Combination so that the feedback automatically recommends a change to the workflow as is taught by Lang in order to allow the surgical workflow to be updated and adapted based on the surgeon’s best judgement, allowing them to skip unnecessary steps in the future.
Claim(s) 7-8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DiSilvestro and Ryan as is applied above, further in view of Razzaque et al. (US 20110137156 A1) hereinafter known as Razzaque.
Regarding claim 7 the DiSilvestro Ryan Combination teaches the surgical system of claim 6 substantially as is claimed,
but is silent with regards to there being an accelerometer coupled to the camera to detect the camera’s movement.
However, regarding claim 7 Razzaque teaches accelerometers coupled to a object to detect movement thereof ([0070]). DiSilvestro and Razzaque are involved in the same field of endeavor, namely surgical systems. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of the DiSilvestro Ryan Combination to have an accelerometer determine the mobile camera’s movement as is taught by Razzaque since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the use of an accelerometer to track the movement of an object (e.g. the camera of DiSilvestro) to improve its location tracking would have been obvious.
Regarding claim 8 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
but is silent with regards to the surgical system comprising a radio-frequency identification (RFID) tag coupled to the surgical object.
However, regarding claim 8 Razzaque teaches surgical systems can comprise RFID tags coupled to a moving surgical object ([0069]). DiSilvestro and Razzaque are involved in the same field of endeavor, namely surgical systems. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of the DiSilvestro Ryan Combination to use an RFID tag on the surgical object as is taught by Razzaque since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). In this case, the use of an RFID tag to track the movement of an object to improve its location tracking would have been obvious.
Claim(s) 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DiSilvestro and Ryan as is applied above, further in view of Van Der Lugt et al. (US 20050090733 A1) hereinafter known as Van Der Lugt.
Regarding claim 9 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
wherein DiSilvestro further discloses the sensor is configured to detect positions of the surgical object (Figure 1 item 14, 16, 18 [0033], [0039], [0061] camera which tracks location of surgical objects), and the controller automatically distinguishes between the executed steps of the workflow by observing the positions of the surgical object ([0061]-[0062] the camera records the positions of surgical objects and sends this information to the controller which determines their locations, [0067]-[0068] the controller cooperates with the camera to determine the locations of the surgical objects and the controller determines deviations from the determined workflow plan based on the camera and sensors),
but is silent with regards to whether the observed positions of the object are compared to the planned positions of the object .
However, regarding claim 9 Van Der Lugt teaches a surgical method whose workflow plan includes a planned location of an object ([0017]) so that planned and actual positions of an object are compared when evaluating the workflow plan ([0025]). DiSilvestro and Van Der Lugt are involved in the same field of endeavor, namely surgical methods. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the surgical system of the DiSilvestro Ryan Combination so that the controller compared the planned versus observed positions of the object as is taught by Van Der Lugt, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the choice of any known suitable method in the prior art to determine whether the workflow is executed with to the camera monitoring system of DiSilvestro is considered obvious to try and reasonably expected to succeed.
Claim(s) 10 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DiSilvestro and Ryan as is applied above, further in view of Quistgaard et al. (US 20050193451 A1) hereinafter known as Quistgaard.
Regarding claim 10 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
but is silent with regards to the controller being configured as an artificial intelligence system.
However, regarding claim 10 Quistgaard teaches a controller for use in a surgical system can be configured as an artificial intelligence system ([0074]). DiSilvestro and Quistgaard are involved in the same field of endeavor, namely surgical systems. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of the DiSilvestro Ryan Combination to use a controller that can be configured as an artificial intelligence system as is taught by Quistgaard in order to allow a variety of medical devices to be present in the operating site, and the controller can access a library of procedures based on what tool is being used, thus increasing the amount of procedures the surgical system can be used for and broadening its use as a whole.
Regarding claim 12 the DiSilvestro Ryan Combination teaches the surgical system of claim 1 substantially as is claimed,
but is silent with regards to there being a robot operatively coupled to the controller, where the object is a portion of the robot or a tool held thereby.
However, regarding claim 12 Quistgaard teaches a surgical system that includes a robot operatively coupled to the controller ([0070] robotic articulating arm), wherein a tracked surgical object ([0023]) is a portion of the robot or a tool held by the robot ([0071], [0032]). DiSilvestro and Quistgaard are involved in the same field of endeavor, namely surgical systems. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of the DiSilvestro Ryan Combination to include a robot as is taught by Quistgaard in order to provide the surgical system with a means to perform a surgery according to the desired method but while also allowing at least part of the surgery to be automated with a robot, thereby allowing precise movement and control over various aspects of the surgery, thus cutting down on errors in the final procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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, Jerrah Edwards can be reached on 408-918-7557. 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.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
Prosecution Insights