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 .
Status of Claims
This action is in reply to the claims filed on 17 September 2025. Claims 1, 8, and 14 were amended. Claims 2, 9, and 16 were previously canceled. Claims 1, 3-8, 10-15, and 17-23 are pending and have been examined.
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, 3-8, 10-15, and 17-23 are not rejected under 35 USC § 101
Applicant amended independent claims 1, 8, and 14 to include the following language (or similar language):
wherein automatically actuating the one or more controls for the medical robot includes causing an adjustment to be made to a position of the medical robot.
With the addition of this language, the claims can no longer be considered a method of organizing human activity or a mental process, because the instructions are sent specifically to a robot to adjust its position. Therefore, claims 1, 3-8, 10-15, and 17-23 are considered to be eligible under 35 U.S.C. §101.
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:
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.
Claims 1, 3-8, 10-15, and 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al. (U.S. 2022/0384019), hereinafter “Shelton,” in view of Lutzow et al. (U.S. 2018/0353254), hereinafter “Lutzow.”
Regarding Claim 1, Shelton discloses a computer-implemented method for optimizing medical procedure ergonomics, the method comprising:
receiving, from an ergonomic information database, ergonomic data … (See Shelton [0599] the surgical computing system may determine that the posture of the HCP is a neutral or correct posture. This meets the broadest reasonable interpretation of a “baseline.” See as an example [0641] the display may indicate to the OR team that the display is not in the correct position, for example, outside the range of 15 and 40 degrees below the horizontal plane of the eyes of an HCP in laparoscopic procedures.);
determining, based at least in part on the ergonomic data … , an ergonomic safe zone for the medical practitioner (See Shelton [0599] the surgical computing system may determine that the posture of the HCP is a neutral or correct posture. A neutral or correct position is considered to be an “ergonomic safe zone.”);
receiving, during performance of a medical procedure on a patient involving the medical practitioner, ergonomic measurements generated by at least one sensor within a medical suite (See Shelton [0087] The HCPs and the environment surrounding the HCPs may also be monitored by one or more environmental sensing systems including, for example, a set of cameras, a set of microphones, and other sensors, etc. that may be deployed in the operating room. [0590] system may monitor data from the HCP monitoring system described in [0087] for determining parameters associated with ergonomic positioning. See example in [0639] the surveillance system may monitor the position of the HCP and the surgical display. Based on the viewing angle, the surgical computing system may determine whether the HCP is maintaining neutral posture and/or whether the surgical display is properly positioned. modified position and/or orientation such that the viewing angle is ergonomic and/or improves the HCP's posture.);
determining, during the performance of the medical procedure on the patient and involving the medical practitioner, based at least in part on the ergonomic data … and the ergonomic measurements received during the medical procedure (See Shelton [0633] system can perform analysis throughout a surgical procedure.), an ergonomic status of the medical practitioner (See Shelton [0590] system may monitor data from the HCP monitoring system described in [0087] for determining parameters associated with ergonomic positioning. See example in [0639] the surveillance system may monitor the position of the HCP and the surgical display. Based on the viewing angle, the surgical computing system may determine whether the HCP is maintaining neutral posture and/or whether the surgical display is properly positioned. modified position and/or orientation such that the viewing angle is ergonomic and/or improves the HCP's posture.);
determining whether the ergonomic status of the medical practitioner falls outside of the ergonomic safe zone determined for the medical practitioner (See Shelton [0599] the surgical computing system may determine that the posture of the HCP is a neutral or correct posture. The surgical computing system may determine that the posture of the HCP is an improper or poor posture, such as a straining or awkward posture, for example.); and
in response to determining that the ergonomic status of the medical practitioner falls outside of the ergonomic safe zone determined for the medical practitioner, automatically actuating one or more controls for a medical robot within the medical suite to improve the ergonomic status of the medical practitioner (See Shelton [0632] The suggested actions may include instructions for implementing ergonomic positioning within the OR. The suggested actions may include instructions to modify movement and/or posture for HCPs and/or a patient. See also [0600]. [0642] the display may continuously receive parameters associated with ergonomic positioning of the display from the surgical computing system throughout a surgical procedure. The display may continuously modify its operation, for example, its positioning, based on the received parameters throughout the surgical procedure.), wherein automatically actuating the one or more controls for the medical robot includes causing an adjustment to be made to a position of the medical robot (See Shelton [0641] the system may modify a displays position using a multi-axis control arm. See also [0642].).
Shelton does not disclose:
[the ergonomic data] including prior procedural data associated with a medical practitioner and gathered during a prior medical procedure.
Lutzow teaches:
[the ergonomic data] including prior procedural data associated with a medical practitioner and gathered during a prior medical procedure (See Lutzow [0059] the system can determine the user preferred ergonomic position during a procedure and then save that for the user for subsequent use. This meets the broadest reasonable interpretation of prior procedural data associated with a medical practitioner and gathered during a prior medical procedure.).
The system of Lutzow is applicable to the disclosure of Shelton as they both share characteristics and capabilities, namely, they are directed to the ergonomic use of surgical equipment. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shelton to include ergonomic history and limits of a user as taught by Lutzow. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Shelton in order to order to address the concern of user comfort over an extended period of use and avoid user fatigue (see Lutzow [0002]).
Regarding claim 3, Shelton in view of Lutzow discloses the method of claim 1 as discussed above. Shelton further discloses a method, wherein:
automatically actuating the one or more controls for the medical robot within the medical suite to improve the ergonomic status of the medical practitioner further includes activating a light on the medical robot (See Shelton [0632] The display may present one or more notifications configured to indicate suggested actions for HCPs to take. The suggested actions may include instructions for implementing ergonomic positioning within the OR.).
Regarding claim 4, Shelton in view of Lutzow discloses the method of claim 1 as discussed above. Shelton further discloses a method, wherein:
the at least one sensor within the medical suite includes one or more of a motion wearable sensor, eye motion glasses, a head mounted display, a biometric sensor, a pressure sensor, a camera, a clock, a timer, a thermometer, a humidity sensor, and a position sensor attached to the medical robot (See Shelton [0087] The HCPs and the environment surrounding the HCPs may also be monitored by one or more environmental sensing systems including, for example, a set of cameras, a set of microphones, and other sensors, etc. that may be deployed in the operating room.).
Regarding claim 5, Shelton in view of Lutzow discloses the method of claim 1 as discussed above. Shelton further discloses a method, wherein:
calculating an ergonomic risk score for the medical practitioner based at least in part on the ergonomic status of the medical practitioner and the ergonomic safe zone determined for the medical practitioner (See Shelton [0536] system may determine ergonomic risk based on the data associated with HCP positioning. For example, the computing system may calculate a high ergonomic risk factor where the monitored data indicated awkward HCP positioning.).
Regarding claim 6, Shelton in view of Lutzow discloses the method of claim 5 as discussed above. Shelton further discloses a method, wherein:
automatically actuating the one or more controls for the medical robot within the medical suite to improve the ergonomic status of the medical practitioner comprises a first actuation of the controls for the medical robot when the ergonomic risk score exceeds a first threshold and a second actuation of the one or more controls for the medical robot when the ergonomic risk score exceeds a second threshold (See Shelton [0536] calculated ergonomic risk factor for the HCPs during a surgical procedure. [0634] the system can display different risk levels, indicating that there are multiple thresholds of risks, at least one for each level.).
Regarding claim 7, Shelton in view of Lutzow discloses the method of claim 1 as discussed above. Shelton further discloses a method, comprising:
calculating an ergonomic risk baseline for the medical practitioner based at least in part on personal characteristics of the medical practitioner stored in the ergonomic information database, and wherein the ergonomic safe zone for the medical practitioner is determined based at least in part on the ergonomic data and the ergonomic risk baseline (See Shelton [0597] the system can obtain HCP characteristics before the surgery, including eight, arm length, hand shape or length, waist width, shoulder width, age, or focal position of an HCP. Based on these characteristics, the system may determine the recommendations for the OR layout prior to surgery. [0548] the system can reduce ergonomic risk factors by adjusting the OR beforehand. Therefore, it is understood that the system can use the personal characteristics of the HCP to determine a ergonomic risk baseline (by reducing the ergonomic risk factors) with OR adjustments based on the personal measurements of the HCP.).
Regarding claim 8 and 10-13, Shelton in view of Lutzow discloses the method of claims 1 and 3-6. Claims 8 and 10-13 recite a system that performs a method that is substantially similar to the method of claims 1 and 3-6. Accordingly, claims 8 and 10-13 are rejected based on the same analysis.
Regarding claim 14, Shelton discloses a non-transitory machine-readable medium storing instructions that, when executed by a computing system, causes the computing system to perform a method for optimizing medical procedure ergonomics, the method including:
receiving, from an ergonomic information database, ergonomic data (See Shelton [0599] the surgical computing system may determine that the posture of the HCP is a neutral or correct posture. See as an example [0641] the display may indicate to the OR team that the display is not in the correct position, for example, outside the range of 15 and 40 degrees below the horizontal plane of the eyes of an HCP in laparoscopic procedures.) including at least one general ergonomic limit (See Shelton [0605] the monitored data can be related to the movement of the surgical instruments during a particular procedure. [0606] this data can be used to determine parameters associated with ergonomic positioning of the surgical instruments. Because this is based on the procedure and instruments, and not the characteristics of the health care provider, it is considered to be a “general” ergonomic data.) … and anthropometric data for the medical practitioner (See Shelton [0597] the data can be directly connected to the provider, with characteristics including height, arm length, hand shape or length, waist width, shoulder width, age, or focal position of the practitioner. These are considered to be “personal” to the practitioner.);
determining, based at least in part on the ergonomic data including the at least one general ergonomic limit … and the anthropometric data for the medical practitioner, an ergonomic safe zone for the medical practitioner (See Shelton [0599] the surgical computing system may determine that the posture of the HCP is a neutral or correct posture. A neutral or correct position is considered to be an “ergonomic safe zone.”);
receiving, during performance of a medical procedure on a patient and involving the medical practitioner, ergonomic measurements generated by at least one sensor within a medical suite (See Shelton [0087] The HCPs and the environment surrounding the HCPs may also be monitored by one or more environmental sensing systems including, for example, a set of cameras, a set of microphones, and other sensors, etc. that may be deployed in the operating room. [0590] system may monitor data from the HCP monitoring system described in [0087] for determining parameters associated with ergonomic positioning. See example in [0639] the surveillance system may monitor the position of the HCP and the surgical display. Based on the viewing angle, the surgical computing system may determine whether the HCP is maintaining neutral posture and/or whether the surgical display is properly positioned. modified position and/or orientation such that the viewing angle is ergonomic and/or improves the HCP's posture.);
determining, during the performance of the medical procedure on the patient and involving the medical practitioner, based at least in part on the ergonomic data including the at least one general ergonomic limit … and the anthropometric data for the medical practitioner and at least in part on the ergonomic measurements received during the medical procedure (See Shelton [0633] system can perform analysis throughout a surgical procedure.[0605] the monitored data can be related to the movement of the surgical instruments during a particular procedure. [0606] this data can be used to determine parameters associated with ergonomic positioning of the surgical instruments. Because this is based on the procedure and instruments, and not the characteristics of the health care provider, it is considered to be a “general” ergonomic data. [0597] the data can be directly connected to the provider, with characteristics including height, arm length, hand shape or length, waist width, shoulder width, age, or focal position of the practitioner.), an ergonomic status of the medical practitioner (See Shelton [0590] system may monitor data from the HCP monitoring system described in [0087] for determining parameters associated with ergonomic positioning. See example in [0639] the surveillance system may monitor the position of the HCP and the surgical display. Based on the viewing angle, the surgical computing system may determine whether the HCP is maintaining neutral posture and/or whether the surgical display is properly positioned. modified position and/or orientation such that the viewing angle is ergonomic and/or improves the HCP's posture.);
determining whether the ergonomic status of the medical practitioner falls outside of the ergonomic safe zone determined for the medical practitioner (See Shelton [0599] the surgical computing system may determine that the posture of the HCP is a neutral or correct posture. The surgical computing system may determine that the posture of the HCP is an improper or poor posture, such as a straining or awkward posture, for example.);
in response to determining that the ergonomic status of the medical practitioner falls outside of the ergonomic safe zone determined for the medical practitioner (See Shelton [0632] The suggested actions may include instructions for implementing ergonomic positioning within the OR. The suggested actions may include instructions to modify movement and/or posture for HCPs and/or a patient. See also [0600]. [0642] the display may continuously receive parameters associated with ergonomic positioning of the display from the surgical computing system throughout a surgical procedure. The display may continuously modify its operation, for example, its positioning, based on the received parameters throughout the surgical procedure.), automatically actuating one or more controls for medical equipment within the medical suite to improve the ergonomic status of the medical practitioner (See Shelton [0641] the system may modify a display’s position using a multi-axis control arm. See also [0642].), wherein automatically actuating the one or more controls for the medical equipment includes causing an adjustment to be made to a position of the medical equipment (See Shelton [0641] the system may modify a display’s position using a multi-axis control arm. See also [0642] the display may continuously receive parameters associated with ergonomic positioning of the display from the surgical computing system throughout a surgical procedure. The display may continuously modify its operation, for example, its positioning, based on the received parameters throughout the surgical procedure.).
Shelton does not teach:
[the ergonomic data] including at least one personal ergonomic limit of a medical practitioner.
Lutzow teaches:
[the ergonomic data includes] at least one personal ergonomic limit of a medical practitioner (See Lutzow [0050] starts at a predefined height. [0054] then the system determines an ergonomic height specific to the user. [0055]-[0056] the user specific height is then defined using predefined vertical positions that are either too high or too low. A limit is defined to include a level beyond which something may not extend or pass. Therefore, this set ergonomic level is a personal ergonomic limit because if the level is higher or lower than this set level, it is reset to the level saved for that user. See also [0059].).
The system of Lutzow is applicable to the disclosure of Shelton as they both share characteristics and capabilities, namely, they are directed to the ergonomic use of surgical equipment. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shelton to include ergonomic history and limits of a user as taught by Lutzow. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Shelton in order to order to address the concern of user comfort over an extended period of use and avoid user fatigue (see Lutzow [0002]).
Regarding claim 15, Shelton in view of Lutzow discloses the medium of claim 14 as discussed above. Shelton further discloses a medium, wherein:
the method further includes updating the ergonomic data within the ergonomic information database based at least in part on the ergonomic measurements (See Shelton [0172] The computing system may track real-time measurement data from the sensing systems. [0519] The monitored data may be continuously gathered and communicated prior to, during, and/or after a surgical procedure. [0633] system can perform analysis throughout a surgical procedure. [0642] the display may continuously receive parameters associated with ergonomic positioning of the display from the surgical computing system throughout a surgical procedure. The display may continuously modify its operation, for example, its positioning, based on the received parameters throughout the surgical procedure.).
Regarding claim 17, Shelton in view of Lutzow discloses the medium of claim 14 as discussed above. Shelton further discloses a medium, wherein:
the at least one sensor within the medical suite includes one or more of a motion wearable sensor, eye motion glasses, a head mounted display, a sensor, a pressure sensor, a camera, a clock, a timer, a thermometer, a humidity sensor, and a position sensor attached to a robotic surgical instrument (See Shelton [0087] The HCPs and the environment surrounding the HCPs may also be monitored by one or more environmental sensing systems including, for example, a set of cameras, a set of microphones, and other sensors, etc. that may be deployed in the operating room.).
Regarding claim 18, Shelton in view of Lutzow discloses the medium of claim 14 as discussed above. Shelton further discloses a medium, wherein:
calculating an ergonomic risk score for the medical practitioner based at least in part on the ergonomic status of the medical practitioner and the ergonomic safe zone determined for the medical practitioner (See Shelton [0536] system may determine ergonomic risk based on the data associated with HCP positioning. For example, the computing system may calculate a high ergonomic risk factor where the monitored data indicated awkward HCP positioning.); and
automatically actuating the one or more controls for the medical equipment within the medical suite to improve the ergonomic status of the medical practitioner based at least in part on the ergonomic risk score (See Shelton [0641] the system may modify a display’s position using a multi-axis control arm. See also [0642].).
Regarding claim 19, Shelton in view of Lutzow discloses the medium of claim 14 as discussed above. Shelton further discloses a medium, wherein:
automatically actuating the one or more controls for the medical equipment within the medical suite further includes activating a light on the medical equipment (See Shelton [0432] the system can control the lighting system to direct light to an area that is a focus of the healthcare professional. See also [0036].).
Regarding claim 20, Shelton in view of Lutzow discloses the medium of claim 14 as discussed above. Shelton further discloses a medium, wherein:
calculating an ergonomic risk baseline for the medical practitioner based at least in part on personal characteristics of medical practitioner stored in the ergonomic information database, and wherein the ergonomic safe zone for the medical practitioner is based at least in part on the ergonomic data and the ergonomic risk baseline (See Shelton [0597] the system can obtain HCP characteristics before the surgery, including eight, arm length, hand shape or length, waist width, shoulder width, age, or focal position of an HCP. Based on these characteristics, the system may determine the recommendations for the OR layout prior to surgery. [0548] the system can reduce ergonomic risk factors by adjusting the OR beforehand. Therefore, it is understood that the system can use the personal characteristics of the HCP to determine a ergonomic risk baseline (by reducing the ergonomic risk factors) with OR adjustments based on the personal measurements of the HCP.).
Regarding claim 21, Shelton in view of Lutzow discloses the medium of claim 14 as discussed above. Shelton further discloses a medium, wherein:
the medical equipment is a patient bed or a surgical robot (See Shelton [0420] the medical equipment used by the system can includes robotic surgical equipment.).
Regarding claim 22, Shelton in view of Lutzow discloses the medium of claim 14 as discussed above. Shelton further discloses a medium, wherein:
the at least one general ergonomic limit and the at least one personal ergonomic limit are specific to the medical procedure (See Shelton [0590] the monitored data may include data associated with one or more surgical procedures. This is understood to mean that the ergonomic data is specific to a particular surgical procedure.).
Regarding claim 23, Shelton in view of Lutzow discloses the medium of claim 14 as discussed above. Shelton further discloses a medium, wherein:
the anthropometric data for the medical practitioner is estimated based on image capture (See Shelton [0597] the surgical computing system may obtain monitored data identifying HCP characteristics, for example, prior to starting surgery. The surgical computing system may obtain the monitored data from the HCP monitoring system, which may include a video.).
Response to Arguments
Applicant's arguments filed 17 September 2025, with respect to the 35 U.S.C. §103 rejection of the claims, have been fully considered but they are not persuasive. First, Applicant argues that the combination of Shelton and Lutzow does not teach the use of the prior procedural data in claim 1 because it was captured before the performance of a medical procedure (see Applicant Remarks pages 1-3). This is not persuasive. The broadest reasonable interpretation of the broadly recited “medical procedure” in the claims includes the set up and preparation for that procedure. Further, Shelton discusses the use of data collected prior to the surgery to adjust the ergonomics during the surgery (see Shelton [0596]). Therefore, when considered in combination, the claims are shown to be obvious in view of Shelton and Lutzow for using prior procedural data associated with a medical practitioner (Lutzow [0089]) for determining ergonomic adjustments during surgery (see Shelton [0633]).
Finally, Applicant argues that Lutzow fails to teach the use of at least on personal ergonomic limit of a medical practitioner (see Applicant Remarks pages 3-5). This is not persuasive. Lutzow teaches that the system determines an ergonomic height specific to the user (see Lutzow [0054]. Lutzow also teaches that the user specific height is then defined using predefined vertical positions that are either too high or too low (see Lutzow [0055]-[0056]). A limit is defined to include a level beyond which something may not extend or pass. Therefore, this set ergonomic level is a personal ergonomic limit because if the level is higher or lower than this set level, it is reset to the level saved for that user. See also Lutzow [0059]. Accordingly, the claims remain rejected as being obvious in view of Shelton and Lutzow.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Anderson et al. (U.S. 2018/0092706) discloses a system for the ergonomic operation of surgical equipment.
Carbonaro (Carbonaro et al., A Wearable Sensor-Based Platform for Surgeon Posture Monitoring: A Tool to Prevent Musculoskeletal Disorders. Int. J. Environ. Res. Public Health 2021, 18, 3734.) discloses a method for monitoring surgeon posture using wearable sensors, including subject specific habits that are go against ergonomic principles.
Davila (Davila et al., Intraprocedural Ergonomics of Vascular Surgeons, Journal of Vascular Surgery, Volume 73, Issue 1, Pages 301-308, Dec 2020) discloses a system for using wearable sensors to monitor practitioners during surgery.
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.
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/B.L.H./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684