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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/10/2025 has been entered.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1-3, 6, 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Node-Langlois et al (Pub. No.: US 2008/0089566)
Regarding claim 1, Node-Langlois et al disclose a method for imaging an implant implanted in a body, comprising at least one iteration of a characterization phase comprising the following steps:
measuring a positioning of the implant by at least one sensor (electromagnetic sensor 222, 0048), known as the measurement sensor, located outside the body by supplying at least one electrical signal, known as the measured signal (digitized signals), relating to the implant (device 24 such as a surgical implant (e.g., an artificial disk, a bone screw, a shunt, a pedicle screw, a plate, an intramedullary rod, see 0045]) [see 0048, 0079, figs 2-3];
determining by a processing unit at least one item of data relating to the positioning (position and orientation information) of the implant as a function of said measured signal (digitized signals) and of a previously established model (acquired image data previously, see 0059, 0061) linking the at least one measured signal (digitized signals) to the at least one item of data relating to positioning [see 0048-0051, 0054, 0059, 0073, 0078 and fig 3] by disclosing tracker module 356 includes a processor 352 and memory 354 to calculate position and orientation information based on the received digitized signals [see 0054];
said at least one item of data relating to the positioning (position and orientation information) including at least one orientation data of the implant (device 24) [see 0048-0054, 0074];
providing by a processing unit an image, referred to as a measured image, from the at least one item of positioning data and a visual model relating to the implant [see 0055, 0070, 0073, 0078] by disclosing navigation module 366 includes a processor 362 and memory 364 to register the location of the device to acquired patient data stored on a disk 392, and generates image data suitable to visualize the patient image data and a representation of the device (implant, 0045) [see 0055] and an imaging system to track implants (e.g., screws) inserted into a patient. At least two fluoroscopic image shots are taken to confirm the implant positioning [see 0070];
adapting the visual model based on said at least one item of data relating to the positioning of the implant [see 0087-0091].
Regarding claim 2, Node-Langlois et al disclose wherein the visual model relating to the implant is a three-dimensional image of the implant and wherein the measured image is a three-dimensional image [see 0035, 0070, 0078, 0080, 0087]
Regarding claim 3, Node-Langlois et al disclose measuring by at least one inertial sensor, at least one item of inertial data relating to the body [see 0042]
Wherein the step of providing the measured image comprises an adjustment of the orientation of the visual model [see 0087, 0090].
Regarding claim 6, Node-Langlois et al disclose wherein the visual model is stored in a database [see 0078], the method comprising a step of exchanging data between said processing unit and said database to perform the providing step [see 0050-0051, 0059] by disclosing navigation module 260 reads from memory 220 the acquired patient data [see 0051].
Regarding claim 9, Node-Langlois et al disclose a device for imaging an implant implanted in a body comprising means arranged to implement the imaging method according to claim 1 comprising:
at least one sensor known as the measurement sensor, located outside the body and arranged to supply one electrical signal, known as the measured signal (digitized signals), relating to the implant (device 24 such as a surgical implant (e.g., an artificial disk, a bone screw, a shunt, a pedicle screw, a plate, an intramedullary rod, see 0045]) [see 0048, 0079, figs 2-3];
a processing unit arranged to:
determine at least one item of data relating to the positioning of the implant as a function of the measured signal and of a previously established model linking at least one measured signal to the at least one item of data relating to positioning [see 0055, 0070, 0073, 0078] by disclosing navigation module 366 includes a processor 362 and memory 364 to register the location of the device to acquired patient data stored on a disk 392, and generates image data suitable to visualize the patient image data and a representation of the device (implant, 0045) [see 0055] and an imaging system to track implants (e.g., screws) inserted into a patient. At least two fluoroscopic image shots are taken to confirm the implant positioning [see 0070];
providing an image, referred to as the measurement image, from at least one item of positioning and a visual model relating to the implant [see 0055, 0070, 0073, 0078] by disclosing generates image data suitable to visualize the patient image data and a representation of the device (implant, 0045) [see 0055] and an imaging system to track implants (e.g., screws) inserted into a patient. At least two fluoroscopic image shots are taken to confirm the implant positioning [see 0070].
Regarding claim 10 according to claim 9, Node-Langlois et al disclose measuring by at least one inertial sensor, at least one item of inertial data relating to the body [see 0042]
Wherein the step of providing the measured image comprises an adjustment of the orientation of the visual model [see 0087, 0090].
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Node-Langlois et al (Pub. No.: US 2008/0089566) in view of Yu (Pub. No.: US 2019/0183451)
Regarding claim 4, Node-Langlois et al don’t disclose generating a video from said measured images.
Nonetheless, Yu discloses generating a video from said measured images [see 0025, 0064].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Node-Langlois et al and Yu by generating a video from said measured images; it enhances the assessment of a patient's condition. By providing a complete view of the affected area, medical providers can better understand the patient's issue and identify additional symptoms or underlying issues and this visual assessment can lead to more accurate diagnoses and appropriate treatment plans.
Claim(s) 5, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Node-Langlois et al (Pub. No.: US 2008/0089566) in view of Gupta et al (Pub. No.: US 2017/0231709)
Regarding claims 5, 15, Node-Langlois et al don’t disclose an identification step in order to retrieve said visual model relating to said implant,
Said identification step comprising a step of reading, by an electronic reader, an item of identification data stored in an electronic device integrated into said implant.
Nonetheless, Gupta et al disclose a step of reading, by an electronic reader, an item of identification data stored in an electronic device integrated into said implant [see 0131-0132] by disclosing a radio frequency identification (RFID) transceiver or optical scanner that is configured to read a unique device identifier (UDI) contained in either an RFID tag or bar code, respectively, on the surgical device [see 0131].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Node-Langlois et al and Gupta et al by using an electronic reader, an item of identification data stored in an electronic device integrated into said implant; to facilitate later reconstruction of the surgery [see 0132].
Claim(s) 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Node-Langlois et al (Pub. No.: US 2008/0089566) in view of Roche (Pub. No.: US 2020/0054215).
Regarding claim 7, Node-Langlois et al don’t disclose prior to the first iteration of the characterization phase, a preliminary phase carried out when the implant is outside the body
said preliminary phase comprising at least one iteration of the following steps of:
in a database of the at least one reference signal in association with said at least one item of position data, referred to as an item of reference positioning data of the implant
Nonetheless, Roche discloses in a database of the at least one reference signal in association with said at least one item of position data, referred to as an item of reference positioning data of the implant [see 0256-0259, 0307] by disclosing the measured data can be collected to a database where it can be stored and analyzed [see 0257] and measured data in conjunction with positioning can be collected before and during surgery to aid the surgeon in ensuring that the implanted device has an equivalent geometry and range of motion [see 0256]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Node-Langlois et al and Roche by disclosing in a database of the at least one reference signal in association with said at least one item of position data, referred to as an item of reference positioning data of the implant; to aid the surgeon in ensuring that the implanted device has an equivalent geometry and range of motion [see 0256, Roche]
Regarding claim 8, Node-Langlois et al don’t disclose a supervised neural network trained with a database and taking as input the at least one measured signal, said database linking an electrical signal with an item of positioning data,
or
a pre-recorded table associating at least one electrical signal with at least one item of data relating to the positioning of said implant,
or
a mathematical relationship between the at least one measured signal and the at least one item of positioning data.
Nonetheless, Roche discloses disclose a pre-recorded table associating at least one electrical signal with at least one item of data relating to the positioning of said implant [see 0256-0259, 0307] by disclosing information can be stored in memory on the sensor or transmitted to a database for long-term storage and processing [see 0307].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Node-Langlois et al and Roche by using a pre-recorded table associating at least one electrical signal with at least one item of data relating to the positioning of said implant; for later use.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Node-Langlois et al (Pub. No.: US 2008/0089566) in view of Yaroshenko et al (Pub. No.: US 2014/0187915).
Regarding claim 11, Node-Langlois et al don’t disclose wherein at least one measurement sensor performing the measurement of said measured signal comprises at least one near field sensor.
Nonetheless, Yaroshenko et al disclose wherein at least one measurement sensor performing the measurement of said measured signal comprises at least one near field sensor [see 0034] by disclosing near-field characteristics of the electromagnetic fields may be used to determine spatial properties, such as position coordinates and/or orientation information [see 0034].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Node-Langlois et al and Yaroshenko et al by using at least one near field sensor; It enables short-range communication between compatible devices.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Node-Langlois et al (Pub. No.: US 2008/0089566) in view of Capote et al (Pub. No.: US 2016/0278865).
Regarding claims 12-13, Node-Langlois et al disclose electromagnetic tracking systems may employ coils as receivers and transmitters; electromagnetic tracking systems may also be configured with a single transmitter coil used with an array of receiver coils or an array of transmitter coils with a single receiver coil and position and orientation information may be determined for the transmitter and/or receiver coil(s) [see 0008].
Node-Langlois et al don’t disclose comprising multiple measurement sensors forming a plurality of arrays of measurement sensors arranged to surround a part of the body comprising said implant, each array comprising:
a measurement sensor used as a transmitter,
a plurality of measurement sensors used as receivers and positioned on the measurement sensor used as a transmitter.
Nonetheless, Capote et al disclose multiple measurement sensors forming a plurality of arrays of measurement sensors (a plurality of tracking elements 116, 0042, figs 1-2, 4-5) arranged to surround a part of the body comprising said implant, each array comprising:
a measurement sensor used as a transmitter [see 0042];
a plurality of measurement sensors used as receivers and positioned on the measurement sensor used as a transmitter [see 0042] by disclosing patient tracking apparatus 110is secured to the patient's back over the area to be operated on with the adhesive layer 114 [see 0031, 0047, 0052]; upon making the incision 140 the optical tracking system 46B will measure the location of the tracking elements 116 and compare their average position both before and after the incision 140 is made [see 0053].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Node-Langlois et al and Capote et al by using multiple measurement sensors forming a plurality of arrays of measurement sensors arranged to surround a part of the body comprising said implant, each array comprising a measurement sensor used as a transmitter and a plurality of measurement sensors used as receivers and positioned on the measurement sensor used as a transmitter; such that movement thereof as detected by a surgical tracking system corresponds to patient's anatomy when the patient tracking apparatus is secured over the surgical site [see claim 14].
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Node-Langlois et al (Pub. No.: US 2008/0089566) in view of Kostrzewski et al (Pub. No.: US 2015/0196365)
Regarding claim 14, Node-Langlois et al don’t disclose wherein at least one measurement sensor measuring said measured signal comprises:
at least one capacitive sensor and/or at least one inductive sensor.
Nonetheless, Kostrzewski et al disclose wherein at least one measurement sensor measuring said measured signal comprises:
at least one capacitive sensor, and/or at least one inductive sensor [see 0020, 0035, 0095].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Node-Langlois et al and Kostrzewski et al by using at least one capacitive sensor, and/or at least one inductive sensor; non-contact sensing; they do not require physical contact with the object being sensed, reducing wear and tear; high accuracy: They provide high accuracy and repeatability in position, motion, and presence detection applications.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798