DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. See Page 12 of the Specification.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: sheath 44. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 66 (Fig. 6). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The use of the term Wi-FiTM (Page 12 Line 4), BluetoothTM )Page 24 Line 14), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities: minor error in antecedent basis. The claim should be amended to “[…] be at [[the]] a point of care […]” in order to establish proper antecedent basis. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: inertial measurement unit and controlling unit in Claim 1.
The disclosure cites:
The inertial measurement unit may include a magnetometer and an inertial sensor (e.g., an accelerometer and/or gyroscope) (Page 4 Lines 15-16); and
The controlling unit includes a controller comprising one or more processors, such as microprocessors, digital signal processors, or application-specific integrated circuits, associated memory resources (Page 10 Lines 1-4), a wireless communication interface including a radio frequency transmitter and associated antenna (Page 11 Lines 17-18).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the artificial magnetic source" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-3, 6-8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz (US 20190388158) in view of Russell (WO 2018065372) and Turgeman et al. (US 20220175462).
Regarding Claim 1, Mahfouz teaches a surgical system, ([0073] “image guided surgical system 100”), comprising:
a) a device, (0076] “cutting guides 190”), having a movable device body ([0109] “the upper spherical joint 236 allows the guide body 192 to selectively allow the guide body (and cutting slot 200) to be angularly repositioned with respect to the adjuster 224 (and PAM 130) up to 45 degrees with respect to an axis extending parallel to the rotational axis of the revolute joint 234.”);
b) an inertial measurement unit supported by the device body (Fig. 3 and [0084] “inertial measurement unit (IMU) 183”), the inertial measurement unit configured to produce an inertial signal as a function of the movement of the device body, ([0085]-[0086] “the IMU 173, 183 may also include angular momentum sensors measuring rotational changes in space for at least three axes: pitch (up and down), yaw (left and right) and roll (clockwise or counter-clockwise rotation). In this manner, the IMUs 173, 183 generates data indicative of acceleration in three orthogonal axes, magnetic data, and gyroscopic data, which the surgical navigation software application 104 uses to determine changes in position and orientation of each IMU. By having the IMU 183 rigidly mounted to the cutting guide 190, changes in position and orientation of each IMU 173, 183 can be quickly and accurately attributed to changes in position and orientation of the cutting guide with respect to the patient bone. Thus, by knowing how the IMU 183 is being repositioned as a function of time, the surgical navigation software application 104 is also able to determine changes in position and orientation of the cutting guide 190 over the same time period.”), the inertial measurement unit comprising a magnetometer and an inertial sensor ([0085] “each IMU 173, 183 may comprise three gyroscopes, three accelerometers, and three Hall-effect magnetometers (set of three, tri-axial gyroscopes, accelerometers, magnetometers) that may be integrated into a single circuit board or comprised of separate boards of one or more sensors (e.g., gyroscope, accelerometer, magnetometer)”); and
c) a controlling unit, ([0073] “a workstation 102 that includes a computer/controller and associated software 104”), configured determine the location of at least a portion of the movable device body as a function of the inertial signal, ([0081] “by initializing the IMU device 172 of the rigid reference 170 with respect to a second IMU device 182 associated with a cutting guide 190, a relative position of the cutting guide with respect to the patient bone can be determined by the surgical navigation software application 104.”), the controlling unit comprising an output to transmit a position signal having positional information relating to the movable device body ([0085] “each IMU 173, 183 may comprise three gyroscopes, three accelerometers, and three Hall-effect magnetometers (set of three, tri-axial gyroscopes, accelerometers, magnetometers) that may be integrated into a single circuit board or comprised of separate boards of one or more sensors (e.g., gyroscope, accelerometer, magnetometer) in order to output data concerning three directions perpendicular to one another (e.g., X, Y, Z directions). […] the IMUs 173, 183 generates data indicative of acceleration in three orthogonal axes, magnetic data, and gyroscopic data, which the surgical navigation software application 104 uses to determine changes in position and orientation of each IMU” and [0086] “By having the IMU 183 rigidly mounted to the cutting guide 190, changes in position and orientation of each IMU 173, 183 can be quickly and accurately attributed to changes in position and orientation of the cutting guide with respect to the patient bone. Thus, by knowing how the IMU 183 is being repositioned as a function of time, the surgical navigation software application 104 is also able to determine changes in position and orientation of the cutting guide 190 over the same time period. As will be discussed hereafter, by initializing the IMU 173 of the rigid reference 170 with respect to the second IMU 183 associated with the cutting guide 190, a relative position of the cutting guide with respect to the patient bone can be determined by the surgical navigation software application 104.”).
However, Mahfouz does not explicitly teach the controlling unit using a detected stationary artificial magnetic field at a prescribed location to determine information relating to the prescribed location, and the controlling unit configured to automatically zero-out the inertial measurement unit during use as a function of the information relating to the prescribed location.
In an analogous position sensing of a toothbrush field of endeavor, Russell teaches a surgical system, (Page 2 Lines 8-10 “It is known that magnetic fields and magnetometers can be used to determine precise positions of the toothbrush during brushing in a lab or dental surgery” and Page 11 Lines 23-24 “tracking system”), comprising: the controlling unit using a detected stationary artificial magnetic field at a prescribed location to determine information relating to the prescribed location (Page 11 Line 23-Page 12 Line 10 “a tracking system for recording the position of a toothbrush […] the system comprising: […] a magnetic field generator; wherein the magnetic sensor detects the absolute position of the toothbrush within the field created by the magnetic field generator.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Mahfouz with the controlling unit of Russell because the modification would provide high resolution tracking of the device, as taught by Russell on Page 12 Lines 12-16.
However, Mahfouz modified by Russell does not explicitly teach the controlling unit configured to automatically zero-out the inertial measurement unit during use as a function of the information relating to the prescribed location.
In an analogous computer assisted surgery field of endeavor, Turgeman teaches a surgical system, (Fig. 1 and [0086] “an exemplary system according to the present disclosure, using an IMU 11 attached to a vertebra of a subject 18 undergoing spinal surgery. A robotic arm 15 is used to carry out a surgical procedure on a vertebra 16 of a patient 18 under the direction of a system control unit 13.”), comprising: the controlling unit, ([0015] “a method of compensating such IMU drifts can be achieved by periodically resetting the IMU to its zero reference point at times when it is determined that the patient is stationary, thus enabling the offsetting of the accumulated drift at those times” and [0086] “system control unit 13”), configured to automatically zero-out the inertial measurement unit during use as a function of the information relating to the prescribed location ([0091] “The lowest trace 207 in FIG. 2 shows drift of the MEMS IMU output signal baseline over time, represented by the upward slant of the trace. At recurring points of time 203a and 203b, the system controller or the monitor analyzer supplies a trigger signal to the IMU controller to reset the output to zero.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the controlling unit of Turgeman because the modification provides improved accuracy of the registration process intraoperatively in real time, as taught by Turgeman in [0008].
Regarding Claim 2, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. Furthermore, Mahfouz teaches wherein the controlling unit is configured to be at the point of care or in a sterile field (Fig. 1).
Regarding Claim 3, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. Furthermore, Mahfouz teaches wherein the prescribed location is on or in a patient’s body (Figs. 1 and 12 and ([0080] “a distal femur 160 of the patient 110 may include a rigid reference 170 attached to a patient bone, either via an existing surgical incision or percutaneously.”).
Regarding Claim 6, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. Furthermore, Turgeman teaches wherein the controlling unit is configured to automatically zero-out the inertial measurement unit on a periodic basis during use (Abstract “The intrinsic drift of the IMU, which would make the IMU position measurements inaccurate, can be reset to zero regularly, at points of time when the subject's body is stationary” and [0015] “a method of compensating such IMU drifts can be achieved by periodically resetting the IMU to its zero reference point at times when it is determined that the patient is stationary”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the controlling unit of Turgeman because the modification offsets the accumulated drift at the period times, as taught by Turgeman in [0015], which occurs naturally from the patient due to breathing and pulse, as taught by Turgeman in [0014].
Regarding Claim 7, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. Furthermore, Mahfouz teaches wherein the body comprises a catheter, guidewire, pointer, syringe, needle, portal, ([0083] “a guide body 192 having at least one cutting slot 200 for guiding a surgical sagittal saw or similar tool 250”), retraction system, trocar, or camera.
Regarding Claim 8, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. Furthermore, Mahfouz teaches wherein the body comprises a bone shaping tool or cutting tool ([0078] “an exemplary cutting guide may be aligned by sliding over the pins in order to align the cutting guide to make one or more bone cuts” and [0083] “a surgical sagittal saw or similar tool 250”).
Regarding Claim 10, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. Furthermore, Russell teaches an artificial magnetic source configured to produce the stationary artificial magnetic field positioned relative to the prescribed location, the magnetometer configured to detect the stationary artificial magnetic field (Page 11 Line 23-Page 12 Line 10 “a tracking system for recording the position of a toothbrush […] the system comprising: […] a magnetic field generator; wherein the magnetic sensor detects the absolute position of the toothbrush within the field created by the magnetic field generator.”).
Regarding Claim 11, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. Furthermore Mahfouz teaches wherein the body comprises an instrument, ([0073] “surgical instruments 170, 190”), inserter, or guide used in placement of a tertiary body in a patient's body.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz (US 20190388158) in view of Russell (WO 2018065372) and Turgeman et al. (US 20220175462), as applied to Claim 1, further in view of Hendriks et al. (WO 2023104541), cited with paragraph numbers from its respective US Patent Application containing the same information, US 20250025239.
Regarding Claim 4, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. However, the modified system of Mahfouz does not explicitly teach wherein the artificial electromagnetic source comprises an electromagnet.
In an analogous tracking the location of an interventional device, Hendriks teaches a surgical system, ([0139] “surgical navigation system 610”), wherein the artificial electromagnetic source comprises an electromagnet ([0063] “each field generator may be an electromagnetic, in which an electric signal provided to each electrode controls a strength and/or frequency of a magnetic field generated using the electromagnet” and [0145] “The anatomical mapping system comprises 620 an input module 621 configured to receive: one or more electrical responses, each electrical response being a response of a field-sensitive sensor, positioned on or in an interventional device 629, to any electric, magnetic and/or electromagnetic fields generated by the one or more field generators as the interventional device moves within an anatomical cavity of the subject”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the artificial electromagnetic source of Hendriks because the modification provides aid in analysis of the anatomical structure, specifically during the course of a medical procedure or diagnosis, as taught by Hendriks in [0002].
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mahfouz (US 20190388158) in view of Russell (WO 2018065372) and Turgeman et al. (US 20220175462), as applied to Claim 1, further in view of Cappadona et al. (US 20190183589).
Regarding Claim 5, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. However, the modified system of Mahfouz does not explicitly teach wherein the magnetometer is configured to produce a magnetometer signal with the information relating to the prescribed location, the controlling unit configured to produce the position signal using dead reckoning and sensor fusion techniques using both the magnetometer signal and inertial signal.
In an analogous surgical navigation field of endeavor, Cappadona teaches a surgical system, ([0162] “surgical navigation accessory system”), wherein the magnetometer is configured to produce a magnetometer signal with the information relating to the prescribed location, the controlling unit configured to produce the position signal using dead reckoning and sensor fusion techniques using both the magnetometer signal and inertial signal (Fig. 4 and [0161] “These physical constraints provide the basis for the elimination of drift and the accurate use of dead reckoning pose acquisition, as discussed in detail previously and hereinafter. An internal reference array 50 is present in every surgical instrument 34 in the kit 40. The use of a uniform magnetic field, measured or detected through the use of a calibration sensor as described herein, provides an external reference which originates position data used either (1) as a cross-check with computer calculations based on signals from the IRAs 50 of the various instruments 34 or as a basis for registration of the instrument and patient positions.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to further modify with the magnetometer of Cappadona because the modification provides improved safety and enables cross-checks, as taught by Cappadona in [0053] and [0161].
Regarding Claim 9, the modified system of Mahfouz teaches all limitations of Claim 1, as discussed above. Furthermore, Cappadona teaches wherein the magnetometer is configured to provide both magnitude and directional information relating to the artificial magnetic field ([0156] “a calibration sensor for detecting and measuring a magnetic field (magnitude and direction) in a portion of an operating room about an operating table for use as an external reference frame with which to determine the positions of the patient and the instruments relative to one another.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 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, Mike Carey can be reached at (571) 270-7235. 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.
/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights