DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 April 2026 has been entered. Claims 1-17 and 19-21 are now pending. The Examiner acknowledges the amendments to claims 1, 11 and 17, as well as the addition of claim 21.
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 .
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.
5. Claims 1-17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Lebosse et al. (U.S. Pub. No. 2009/0216067) in view of Fox et al. (U.S. Pub. No. 2003/0050527). Regarding claims 1 and 21, Lebosse et al. (hereinafter Lebosse) discloses an apparatus for facilitating delivery of Transcranial Magnetic Stimulation, TMS [0002], comprising: a controller configured to be functionally connected to a tracking system and to a multi-axis robotic arm having a TMS stimulation device affixed to the robotic arm (Figs. 1-4; [0109]-[0112], [0115], [0119]-[0128], [0084]-[0085]); the controller being configured to: receive anatomical data for a person, said anatomical data defining a shape of at least the cranium of the person and an outer surface of the skin surrounding the cranium ([0110],[0119], [0089]); receive information from the tracking system regarding a real-time position and orientation of the head of the person ([0099], [0109], [0115]); and control the multi-axis robotic arm to maintain the TMS stimulation device at an optimal position and orientation relative to the head based on the anatomical data and the information regarding the real-time position and orientation of the head in order to target a predetermined location within the cranium with the TMS stimulation device [0064], [0089], [0109]-[0128]); wherein the optimal position and orientation is such that a surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin ([0076]-[0077], [0111], [0084]), and the anatomical data is derived from medical imaging ([0118]-[0120] and [0081]).
However, Lebosse fails to disclose that the controller is configured to control the arm to maintain the TMS device at an optimal position and orientation relative to the head during a session of TMS delivery. Fox et al. (hereinafter Fox) likewise discloses an apparatus for delivering TMS to a patient, wherein the apparatus comprises a coil adapted to a robotic arm for computer-aided control and delivery in order to position and orient the coil for precise delivery (see Abstract). Fox further discloses using the robotic arm to direct the robot to aim the coil according to various parameters during TMS delivery ([0086], [0111] and [0116]) in order to avoid collision between the patient head surface and the coil [0110], wherein such collision avoidance would provide a small spacing between the coil and the scalp [0150]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a controller for controlling a multi-axis robotic arm as taught by Lebosse, for use during a session of TMS delivery to hover a predetermined distance from the outer surface of the skin as taught by Fox, as enabling such a configuration during modeling of the head, or delivery of TMS to the head, would prevent an actual collision of the coil with the head of the patient ([0110] of Fox) and Lebosse recognizes prevention of the device from being dropped on the patient [0092].
Regarding claim 2, the controller is further configured to: receive the predetermined location within the cranium; and calculate the optimal position and orientation in which the surface of the TMS stimulation device is at the predetermined distance from the outer surface of the skin, based on the received predetermined location within the cranium ([0120]-[0128] and [0111] of Lebosse).
Regarding claim 3, the controller is further configured to control the robotic arm to maintain the TMS device at a predetermined distance of 0.5 – 5 mm from the outer surface of the skin ([0109]-[0111] and [0089] of Lebosse).
Regarding claim 4, the controller is further configured to control the robotic arm to adjust, based on a current location of the surface of the TMS stimulation device, the predetermined distance from the outer surface of the skin ([0085]-[0090] and [0109]-[0111] of Lebosse).
Regarding claim 5, the controller is further configured to perform the adjustment upon receipt of an update signal ([0069]-[0072] of Lebosse).
Regarding claim 6, the controller is further configured to perform at least one calibration step comprising sending control signals configured to move the TMS stimulation device towards the head until a mechanical pressure or contact against the TMS stimulation device is detected ([0069]-[0072], [0092]-[0093], [0109]-[0111] of Lebosse).
Regarding claim 7, the controller is further configured to: receive an intended dose of TMS to be delivered at the location within the cranium; and calculate a necessary energy to be delivered to the TMS stimulation device such that the dose is delivered, adjusting for the predetermined distance from the outer surface of the skin ([0122]-[0128] of Lebosse).
Regarding claim 8, Lebosse teaches that the controller is further configured to: calculate at least one path for the multi-axis robotic arm to move the TMS stimulation device to an optimal location and orientation ([0123] and [0126]), wherein the at least one path is calculated so that neither the multi-axis robot arm nor the TMS stimulation device contact the head (the controller is configured to calculate a path such that neither the multi-axis robot arm nor the TMS stimulation device contact the head - [0109]-[0111]); and send control signals configured to move the multi-axis robotic arm along the at least one path ([0123]-[0128]).
Regarding claim 9, the anatomical data is derived from at least one of: magnetic resonance imaging (MRI), computed tomography (CT), X-Ray, and ultrasound ([0119]-[0120] of Lebosse).
Regarding claim 10, the controller is further configured to: define boundary conditions around at least one of: the head and the TMS stimulation device; and prevent activation of the TMS stimulation device if the boundary conditions are violated ([0109]-[0111], [0090], [0092] and [0128] of Lebosse).
Regarding claim 11, Lebosse discloses a method for facilitating delivery of Transcranial Magnetic Stimulation, TMS [0002], by an apparatus comprising: a controller, a tracking system, and a multi-axis robotic arm having an affixed TMS stimulation device (Figs. 1-4; [0109]-[0112], [0115], [0119]-[0128], [0084]-[0085]), the method comprising the steps of: receiving anatomical data for a person, said anatomical data defining a shape of at least the cranium of the person and an outer surface of the skin surrounding the cranium ([0110],[0119], [0089]); receiving information from the tracking system regarding a real-time position and orientation of the head of the person ([0099], [0109], [0115]); and sending control signals to control the multi-axis robotic arm to maintain the TMS stimulation device at an optimal position and orientation relative to the head based on the anatomical data and the information regarding the real-time position and orientation of the head in order to target a predetermined location within the cranium with the TMS stimulation device [0064], [0089], [0109]-[0128]); wherein the optimal position and orientation is such that a surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin ([0076]-[0077], [0111], [0084]), and the anatomical data is derived from medical imaging ([0118]-[0120] and [0081]).
However, Lebosse fails to disclose maintaining the TMS device at an optimal position and orientation relative to the head during a session of TMS delivery. Fox et al. (hereinafter Fox) likewise discloses an apparatus and method for delivering TMS to a patient, wherein the apparatus comprises a coil adapted to a robotic arm for computer-aided control and delivery in order to position and orient the coil for precise delivery (see Abstract). Fox further discloses using the robotic arm to direct the robot to aim the coil according to various parameters during TMS delivery ([0086], [0111] and [0116]) in order to avoid collision between the patient head surface and the coil [0110], wherein such collision avoidance would provide a small spacing between the coil and the scalp [0150]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a control a multi-axis robotic arm as taught by Lebosse, for use during a session of TMS delivery to hover a predetermined distance from the outer surface of the skin as taught by Fox, as enabling such a configuration during modeling of the head, or delivery of TMS to the head, would prevent an actual collision of the coil with the head of the patient during delivery ([0110] of Fox) and Lebosse recognizes prevention of the device from being dropped on the patient [0092].
Regarding claim 12, the method further comprises the steps of: receiving the predetermined location within the cranium; and calculating the optimal position and orientation in which the surface of the TMS stimulation device is at the predetermined distance from the outer surface of the skin, based on the received predetermined location within the cranium ([0120]-[0128] and [0111] of Lebosse).
Regarding claim 13, the method further comprises adjusting, based on a current location of the surface of the TMS stimulation device, the predetermined distance from the outer surface of the skin ([0085]-[0090] and [0109]-[0111] of Lebosse).
Regarding claim 14, the adjusting is performed upon receipt of an update signal ([0069]-[0072] of Lebosse).
Regarding claim 15, the method further comprises the step of performing at least one calibration step comprising sending control signals configured to move the TMS stimulation device towards the head until a mechanical pressure or contact against the TMS stimulation device is detected ([0069]-[0072], [0092]-[0093], [0109]-[0111] of Lebosse).
Regarding claim 16, the method further comprises the steps of: receiving an intended dose of TMS to be delivered at the location within the cranium; and calculating a necessary energy to be delivered to the TMS stimulation device such that the dose is delivered, adjusting for the predetermined distance from the outer surface of the skin ([0122]-[0128] of Lebosse).
Regarding claim 17, Lebosse discloses a non-transitory computer readable medium having stored thereon a set of computer readable instructions that, when executed by at least one processor, cause an apparatus configured to be functionally connected to a tracking system and to a multi-axis robotic arm having a TMS stimulation device affixed to the robotic arm (Figs. 1-4; [0064], [0109]-[0112], [0115], [0119]-[0128], [0084]-[0085]) to at least: receive anatomical data for a person, said anatomical data defining a shape of at least the cranium of the person and an outer surface of the skin surrounding the cranium ([0110],[0119], [0089]); receive information from the tracking system regarding a real-time position and orientation of the head of the person ([0099], [0109], [0115]); and control the multi-axis robotic arm to maintain the TMS stimulation device at an optimal position and orientation relative to the head based on the anatomical data and the information regarding the real-time position and orientation of the head in order to target a predetermined location within the cranium with the TMS stimulation device [0064], [0089], [0109]-[0128]); wherein the optimal position and orientation is such that a surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin ([0076]-[0077], [0111], [0084]).
However, Lebosse fails to disclose that the apparatus is configured to control the arm to maintain the TMS device at an optimal position and orientation relative to the head during a session of TMS delivery. Fox likewise discloses an apparatus for delivering TMS to a patient, wherein the apparatus comprises a coil adapted to a robotic arm for computer-aided control and delivery in order to position and orient the coil for precise delivery (see Abstract). Fox further discloses using the robotic arm to direct the robot to aim the coil according to various parameters during TMS delivery ([0086], [0111] and [0116]) in order to avoid collision between the patient head surface and the coil [0110], wherein such collision avoidance would provide a small spacing between the coil and the scalp [0150]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure an apparatus for controlling a multi-axis robotic arm as taught by Lebosse, for use during a session of TMS delivery to hover a predetermined distance from the outer surface of the skin as taught by Fox, as enabling such a configuration during modeling of the head, or delivery of TMS to the head, would prevent an actual collision of the coil with the head of the patient ([0110] of Fox) and Lebosse recognizes prevention of the device from being dropped on the patient [0092].
Regarding claim 19, the controller is further configured to control the robotic arm to adjust, based on a current location of the surface of the TMS stimulation device, the predetermined distance from the outer surface of the skin ([0085]-[0090] and [0109]-[0111] of Lebosse).
Regarding claim 20, the anatomical data is derived from medical imaging based on at least one of: magnetic resonance imaging (MRI), computed tomography (CT), X-Ray, and ultrasound ([0119]-[0120] of Lebosse).
Response to Arguments
6. Applicant’s arguments filed 22 April 2026 with respect to the rejection of claims 1-10, 17 and 19 under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments.
7. Applicant’s arguments filed 22 April 2026 with respect to the rejection of claims 1-17, 19 and 20 under 35 U.S.C. 102(a)(1) citing Lebosse (‘067) have been fully considered and are persuasive in light of the amendments, however new grounds of rejection are presented above under 35 U.S.C. 103 citing Lebosse (‘067) in view of Fox (‘527). Applicant contends that Lebosse does not mention skin, and therefore potentially the MRI images do not have data on the skin and thus skin thickness may be neglected or modelled using a default thickness. However, this argument is not persuasive. It is noted that the claim recites “anatomical data defining….an outer surface of the skin”. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., thickness of the outer surface of the skin) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As previously indicated, paragraphs [0118]-[0120] that the aforementioned device [0118] carries out the process described in [0119]-[0125], thus the controller of Lebosse being interpreted as carrying out the manufacture of the model based on MRI images (which would comprise data defining a shape of a cranium and an outer surface of the skin of the cranium, which would be round and shown in any MRI image).
Applicant further contends that Lebosse does not disclose that a surface of the TMS device hovers at a predetermined distance from the outer surface of the skin; or controlling of the arm to maintain the TMS device at an optimal position and orientation relative to the head during a session of TMS delivery. As indicated in the Office action above, the rejection has been amended to incorporate Fox, for the aforementioned teachings.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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