DETAILED ACTION
Response to Amendment
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed July 23, 2025, with respect to claims 1-20 have been fully considered and are persuasive. The USC 102 rejection of June 23, 2025 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-20 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.
Claim Rejections - 35 USC § 102
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-7, 9-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heldman (US Patent No. 10,758,732).
Regarding claim 1, Heldman discloses a system and method for providing stimulation to a patient's brain using an electrode lead that is implantable in the patient's brain and comprises a plurality of electrodes, the system comprising:
a display (Fig. 2: programmer unit 9), control circuitry configured to:
use one or more of the plurality of electrodes to sequentially provide electrical stimulation at different stimulation locations on the electrode lead, for each stimulation location:
use one or more of the plurality of electrodes to record first signals, wherein the first signals are indicative of electric potentials evoked in the patient's brain by the stimulation (Col. 50, lines 20-29: “Another option is to observe and record electrical responses to neuronal activity. Evoked electrical potentials, generated from the occurrence of a specific event or application of a catalyst, can be measured using sensors such as electrodes (implanted or non-invasive, surface electrodes), such as with use of an electroencephalogram (EEG). Multiple types of evoked potentials are known and characterized based on the response-eliciting event, be it sensory (somatosensory), cognitive or motor in origin.”),
receive the first signals (Col. 50, lines 20-29: “Another option is to observe and record electrical responses to neuronal activity. Evoked electrical potentials, generated from the occurrence of a specific event or application of a catalyst, can be measured using sensors such as electrodes (implanted or non-invasive, surface electrodes), such as with use of an electroencephalogram (EEG). Multiple types of evoked potentials are known and characterized based on the response-eliciting event, be it sensory (somatosensory), cognitive or motor in origin.”),
receive one or more second signals that are indicative of motor activity evoked by the stimulation (Col. 7, line 59-Col. 8, line 4: “Sensors used for measuring body movement or motion include gyroscopes and accelerometers, preferably miniaturized, electromagnets, video, a multitude of sensors or system disclosed herein, or other sensors known to those skilled in the art. Additionally, sensors for measuring physiological signals such as electromyogram (EMG)… or other physiological signals which can directly or indirectly measure movement metrics in the subject may be included if such sensors and signals may be used to sense, detect, measure, and/or quantify the subject's external body motion, or related aspects.”),
determine an indication of therapeutic efficacy of the stimulation and an indication of an unwanted side effect of the stimulation (Fig. 12: Calculate with processor at least two optional groups of therapy parameters, each group corresponding to a separate identified or determined motor symptom or side effect 106),
cause the display to display a representation of the indications of the therapeutic efficacy and the unwanted side effects on a graphical user interface (GUI) (FIG. 5. Graphic depiction of display pages displaying test results and scores, one embodiment of a tuning map, as well as one embodiment of a parameter input screen.).
Regarding claim 2 and 13, Heldman discloses the method of claim 1, wherein the recorded first signals are indicative of evoked resonant neural responses evoked by the stimulation (Col. 50, lines 20-26: Another option is to observe and record electrical responses to neuronal activity. Evoked electrical potentials, generated from the occurrence of a specific event or application of a catalyst, can be measured using sensors such as electrodes (implanted or non-invasive, surface electrodes), such as with use of an electroencephalogram (EEG).).
Regarding claims 3 and 14, Heldman discloses the method of claim 1, wherein the second signals are generated using electromyography (EMG), one or more mechanical sensors, speech sensors, and/or electrochemical sensors (Col. 7, line 59-Col. 8, line 4: “Sensors used for measuring body movement or motion include gyroscopes and accelerometers, preferably miniaturized, electromagnets, video, a multitude of sensors or system disclosed herein, or other sensors known to those skilled in the art. Additionally, sensors for measuring physiological signals such as electromyogram (EMG)… or other physiological signals which can directly or indirectly measure movement metrics in the subject may be included if such sensors and signals may be used to sense, detect, measure, and/or quantify the subject's external body motion, or related aspects.”).
Regarding claim 4, Heldman discloses the method of claim 1, wherein the second signals are generated using a cortical array (Col. 5, lines 7-11: “Numerous neuroimaging methodologies are known and have been used to track brain activity and help to map it, including, but not limited to, cortical stimulation mapping, diffusion magnetic resonance imaging (dMRI), electroencephalogram (EEG), electrocorticography” – Electrocorticography uses cortical arrays to record brain signals).
Regarding claim 5, Heldman discloses the method of claim 1, wherein the electric potentials evoked in the patient's brain are correlated with therapeutic efficacy of the stimulation (Col. 49, line 66-Col. 50, line 50: “Within the scope of the present invention, particularly focusing on movement disorder therapy, monitoring the brain as a subject performs particular movements or experiences particular symptoms can help provide a framework and guide to the functions of the subject's brain as they correlate to such movements or symptoms… Another option is to observe and record electrical responses to neuronal activity. Evoked electrical potentials, generated from the occurrence of a specific event or application of a catalyst, can be measured using sensors such as electrodes (implanted or non-invasive, surface electrodes), such as with use of an electroencephalogram (EEG). Multiple types of evoked potentials are known and characterized based on the response-eliciting event, be it sensory (somatosensory), cognitive or motor in origin… Each of these, and other imaging modalities can be used alone, or in combination with each other, in order to identify portions or structures of the subject's brain that are activated or deactivated by a particular event or occurrence, such as a particular movement or movement disorder symptom.”).
Regarding claims 6 and 15, Heldman discloses the method of claim 1, wherein the motor activity evoked by the stimulation is correlated with an undesirable side effect of the stimulation (Col. 16, lines 25-: “measuring and quantifying motor symptoms of the subject based at least in part on the signal from the at least one physiological or movement sensor(s) during the at least one movement disorder test(s), entering data corresponding to the subject's measured and quantified motor symptoms into an algorithm, determining, with the algorithm, at least two optional groups of DBS parameter”; Col. 9, lines 28-35: “the system may measure both movement (including symptoms and/or side effects of treatment or therapy) and brain activity of the subject. The iterative training process allows the algorithm to be trained in the correlation between such movement and brain activity”).
Regarding claims 7 and 16, Heldman discloses the method of claim 1, further comprising using the control circuitry to determine a therapeutic window for each of the stimulation locations (Col. 15, lines 28-32: “Other secondary constraints or desired results may also be considered when optimizing or determining a second level of therapy parameters or settings such as maximizing the battery life of the therapeutic (e.g., DBS) device, maximizing the therapeutic window, and the like.”; Col. 43, lines 38-44: “A therapeutic window will be defined as the region in which a patient exhibits optimal symptomatic benefits without side effects. This therapeutic window will be valuable at the initial postoperative programming session as well as all future adjustment sessions for determining the current amplitude when side effects begin to occur on each contact.”) and using the control circuitry to cause the external device to display a representation of the therapeutic windows on the GUI (Fig. 5).
Regarding claim 9, Heldman discloses the method of claim 1, wherein the second signals are indicative of recruitment of neural elements in the patient's corticospinal tract by the stimulation (Col. 95, lines 53-60: “The corticospinal tract is the main pathway for control of voluntary movement in humans. There are other motor pathways which originate from subcortical groups of motor neurons (nuclei). These pathways control posture and balance, coarse movements of the proximal muscles, and coordinate head, neck and eye movements in response to visual targets.”).
Regarding claims 10 and 18, Heldman discloses the method of claim 1, further comprising recommending wherein selecting an optimized location on the electrode lead for providing therapeutic stimulation based on the first and second signals, wherein the recommending comprises: for each stimulation location determining a value for a feature of the first signal and a value for a feature of the second signal, selecting a plurality of stimulation locations where the value for the feature of the second signals is less than a threshold value, and selecting a stimulation location from the plurality of stimulation locations where the value for the feature of the first signal is the greatest (Col. 25, lines 12-17: “FIG. 9A-B. Illustration depicting the difference between different DBS lead configurations including (A) monopolar DBS lead configurations which do not allow shaping of the electrical stimulation field, and (B) bipolar DBS lead configurations which are able to shape the electrical stimulation field to avoid activating a side effect region of the brain.”; Col. 43, lines 35-49: “The monopolar survey helps determine the functional anatomy around the DBS lead site and narrows the search space for determining an optimal set of programming parameters. A therapeutic window will be defined as the region in which a patient exhibits optimal symptomatic benefits without side effects… This therapeutic window is then used to define a side effect region. The system includes internal electric field modeling to determine how this side effect region can be avoided, possibly by shaping the electric field with a bi- or tripolar configuration or altering the pulse width.”).
Regarding claims 11 and 19, Heldman discloses the method of claim 1 further comprising recommending an optimized location on the electrode lead for providing therapeutic stimulation based on the first and second signals, wherein the recommending comprises: for each stimulation location determining a ratio comprising a value for a feature of the first signal and a value for a feature of the second signal and comparing the ratio to a threshold value (Col. 67, lines 9-48: “A tuning map 20 is generated for each task that the subject is directed to perform, symptom, or side effect and depicts the severity of the symptoms measured in each sensor that is used for the given task… Further alternatively or in addition, the different tabs may represent combinations of tasks, symptoms (e.g., averaged results of multiple symptoms), and/or combinations of side effects… Some embodiments further allow the condition to use varying or comparative settings within the groupings. For example, it may be decided to combine the settings in such a manner to provide weighted scores where one symptom, task, or side effect is given a greater weight than another, but they are combined to create a single weighted map. Similarly, therapy settings or parameters may be gradually increased or decreased as symptoms are continuously measured, rather than providing measurements or assessments at discrete amplitude levels.”).
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) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heldman (US Patent No. 10,758,732), in view of Parker (WO 2015/070281).
Regarding claim 8, Heldman discloses the method of claim 1. Heldman does not disclose wherein the first signals are indicative of potentials evoked in the patient's subthalamic nucleus (STN). However, Parker, in the same field of endeavor of deep brain stimulation, discloses “Figures 2 - 6 present recordings of evoked action potentials (ECAPs) and Late Responses (LRs) measured intraoperatively in the subthalamic nucleus (STN) of patients undergoing the implantation of deep brain stimulators” (Par. 27). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the first signals are indicative of potentials evoked in the subthalamic nucleus, as taught and suggested by Parker, for the purpose of “utilising measurement of the compound action potential arising from stimulation of the subthalamic nucleus (STN), and a number of applications that these measurements may have such as for improving the therapy” (Par. 23).
Regarding claim 17, Heldman discloses the method of claim 1, wherein the second signals are indicative of recruitment of neural elements in the patient's corticospinal tract by the stimulation (Col. 95, lines 53-60: “The corticospinal tract is the main pathway for control of voluntary movement in humans. There are other motor pathways which originate from subcortical groups of motor neurons (nuclei). These pathways control posture and balance, coarse movements of the proximal muscles, and coordinate head, neck and eye movements in response to visual targets.”). Heldman does not disclose wherein the first signals are indicative of potentials evoked in the patient’s subthalamic nucleus (STN). However, Parker, in the same field of endeavor of deep brain stimulation, discloses “Figures 2 - 6 present recordings of evoked action potentials (ECAPs) and Late Responses (LRs) measured intraoperatively in the subthalamic nucleus (STN) of patients undergoing the implantation of deep brain stimulators” (Par. 27). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the first signals are indicative of potentials evoked in the subthalamic nucleus, as taught and suggested by Parker, for the purpose of “utilising measurement of the compound action potential arising from stimulation of the subthalamic nucleus (STN), and a number of applications that these measurements may have such as for improving the therapy” (Par. 23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARELY A MENDIOLA whose telephone number is (571)272-0447. The examiner can normally be reached Monday - Friday 9am-5pm ET.
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, Niketa Patel can be reached at (571)272-4156. 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.
/A.M./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights