DETAILED ACTION
This Office Action is responsive to the Amendment filed 22 October 2025.
Claims 1-17, 19 and 20 are now pending. The Examiner acknowledges the
amendments to claims 1-14, 16, 17, 19 and 20, as well as the cancellation of claim 18.
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 § 112
3. 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.
4. Claims 1-10, 17 and 19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. Claim 1 at lines 3-4 recites the limitation " a controller configured to be functionally connected to a tracking system and a multi-axis robotic arm having a TMS stimulation device affixed to the robotic arm". It is unclear if the “tracking system and a multi-axis robotic arm having a TMS stimulation device affixed to the robotic arm” are required by the claim or not. This lack of clarity is also supported by the fact that the remainder of the claim (lines 5-18) only appears to be drawn to the controller. To further clarify, while “configured to be functionally connected to a tracking system” could be construed as the tracking system not being positively required (only that the controller is configured to be functionally connected to one), the immediately proceeding recitation of “and a multi-axis robotic arm” leaves the question of whether or not a robotic arm is being required by the claim or not.
6. Claim 17 at lines 3-5 recites the limitation "an apparatus configured to be functionally connected to a tracking system and a multi-axis robotic arm having a TMS stimulation device affixed to the robotic arm…". It is unclear if the “apparatus configured to be functionally connected to a tracking system and a multi-axis robotic arm having a TMS stimulation device affixed to the robotic arm” are required by the claim or not.
Claim Rejections - 35 USC § 102
7. 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lebosse et al. (U.S. Pub. No. 2009/0216067). Regarding claim 1, 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 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]).
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]).
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]).
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]).
Regarding claim 5, the controller is further configured to perform the adjustment upon receipt of an update signal ([0069]-[0072]).
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]).
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]).
Regarding claim 8, 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]).
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]).
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]).
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]).
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]).
Regarding claim 14, the adjusting is performed upon receipt of an update signal ([0069]-[0072]).
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]).
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]).
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 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]).
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]).
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]).
Response to Arguments
9. Applicant’s arguments filed 22 October 2025 with respect to the rejection of claims 1-20 under 35 U.S.C. 112(b) (in light of the amendments) have been fully considered and are persuasive. However, the first rejection to claims 1 and 17 has been maintained. Applicant states being unclear on how claim 1 is indefinite with respect to “configured to” language. To this, the rejection above provides explanation in an attempt to better clarify the indefinite nature of the clause. It is clear that the controller is required, along with the subsequent recitations of how it’s configured, but the indefinite nature surrounds the positive recitation of the other elements recited (tracking system, robotic arm and TMS stimulation device).
10. Applicant’s arguments filed 22 October 2025 with respect to the rejection of claims 1-20 under 35 U.S.C. 102(a)(1) citing Lebosse (‘067) have been fully considered and are not persuasive. Applicant contends that Lebosse does not teaches that “a surface of the TMS stimulation device is at a predetermined distance from the outer surface of the skin” as Lebosse makes clear that the device should be in direct contact with the head, and not kept at a predetermined distance from the outer surface of the skin. However, this argument is not persuasive. Paragraphs [0084], [0089]-[0090] and [0113]-[0115], for example, disclose movement of the locating system in position and orientation with respect to the head of the patient (which would be considered optimal) as the focal point (“PF”) of the patient corresponds to the hypothetical center of the head ([0047] and [0115]). Further, Lebosse discusses that the probe and the head of the patient are tangent during the treatment procedure requiring a controlled scanning movement of the probe [0077], and tangent would be defined as a point of contact between the probe and the head, in which instance Lebosse would still meet the limitations of the claim(s) as a surface of the TMS device, which is not the “point” in contact with the skin, would be at a predetermined distance from the skin. It is of note that the claim does not specify that treatment is being applied at the predetermined distance from the skin; rather it recites targeting of a predetermined location.
Applicant further contends that Lebosse does not disclose “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…the anatomical data…derived from medical imaging”. However, this argument is not persuasive. 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). The ensuing steps in Lebosse, of calculation of the path of the functional center of the probe around the head of the patient and framing/adjustment of the head relative to the focal point and the three-dimensional model [0124] are also indicated as being implemented by the device/apparatus of Lebosse [0118]. In view of the foregoing, the rejection of claims 1-20 under 35 U.S.C. 102(a)(1) citing Lebosse (‘067) has been maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791