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 .
Response to Amendment
The amendment filed March 9, 2026 has been entered. Claims 1-7, 10, 12, 15-17, 19-20 have been amended. Claims 8-9, 11, 13 are canceled. Claims 21-22 are new. Currently, claims 1-7, 10, 12, 14-22 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed March 9, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Aydemir et al. (WO 2020/251899) and Min et al. (US 2006/0276848).
Additionally, applicant argues on pages 7-8 the Office action’s reliance of the “low-power” mode ([0139]) as the first state in Stolen et al. (US 2019/0351234), stating that this mode does not state “no BP-managing stimulation be delivered”. This argument is unpersuasive as claim 1 only recites, “in the first state, the stimulation circuitry does not cause any of the electrodes to deliver to the patient’s spinal cord any electrical stimulation configured to manage the patient’s blood pressure”. As explained in the previous Office action, a low-power mode while the patient is sleeping, as indicated by the activity parameter is regarded as a dormant operating mode where the normal operating mode (i.e. delivering stimulation) is not occurring. Claim 1 does not currently require the first state to be delivering stimulation, only that the stimulation circuitry “does not cause any of the electrodes to deliver to the patient’s spinal cord any electrical stimulation configured to manage the patient’s blood pressure”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 10, 12, 14-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite, “determining, by comparing the one or more features to one or more posture-correlated threshold values, that a posture change has occurred and thereby that an actual or anticipated hypotensive event is present”. This limitation is different from what was previously recited in original claim 11 and 13, where an indication of an actual or anticipated hypotensive event is determined by comparing the one or more features of evoked electric potentials to one or more threshold values (claim 11) and the indication of an actual or anticipated hypotensive event is indicative of a posture change of the patient (claim 13). Now, the applicant is claiming that the occurrence of a posture change is determined by the comparing the one or more features of the evoked electric potentials to one or more posture-correlated threshold values, and thereby determining that an actual or anticipated hypotensive event is present based on the posture change occurring.
The specification fails to support these claimed limitations. While the specification states, “changes in the morphology of the sensed neural response may be used to indicate a change in posture… the system may be configured to sense the neural responses (e.g., ECAPs) and to extract one or more features of the neural response to monitor as potential indicators of postural changes” ([0087] of the published application) and “using sensed neural responses and/or sensed stimulation artifact features as an indication of postural changes to trigger stimulation for maintaining the patient's blood pressure” ([0089]), a determination of an actual or anticipated hypotensive event being present is not determined from determining a posture change has occurred. Triggering stimulation for maintaining the patient’s blood pressure is not equivalent to determining “an actual or anticipated hypotensive event is present”. Similarly the specification states, “using extracted features of evoked neural responses to indicate postural changes that indicate the need for blood pressure-controlling stimulation” ([0092]) but indicating the need for blood pressure-controlling stimulation is not, “determining, by comparing the one or more features to one or more posture-correlated threshold values, that a posture change has occurred and thereby that an actual or anticipated hypotensive event is present”. The “need for blood pressure-controlling stimulation” is not equivalent to “an actual or anticipated hypotensive event is present”. The specification also states, “the clinician notes which evoked neural features are good indicators of postural changes that may lead to orthostatic hypotensive events” ([0090]) this is directed to a calibration routine where the patient changes postures and the clinician gives opinions and does not actively compare one or more features of the evoked neural potentials to posture-correlated threshold values.
Claims 2-7, 10, 12, 14-22 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
Claim 21 is new and recites steps performed during the first state. These steps include the control circuitry being further configured to operate a closed-loop feedback controller that adjusts one or more parameters of the first electrical stimulation to treat a condition other than orthostatic hypotension, the closed-loop feedback controller being driven by neural response features extracted from evoked neural potentials recorded by the sensing circuitry. This claim lacks written description support because it presents a broad genus claim but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). Here, claim 21 is attempting to claim broad genus conditions that include every treatable condition in existence as long as it is not orthostatic hypotension. The applicant only has support for treating pain as the condition in the first state (“pain relief” [0067]; “pain” [0068]). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Claim 22 is rejected to for being dependent on and for failing to remedy the deficiencies of claim 21.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 1-5, 10, 12, 14, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stolen et al. (US 2019/0351234) in view of Aydemir et al. (WO 2020/251899) and Min et al. (US 2006/0276848).
Regarding claim 1, Stolen et al. discloses a system for managing orthostatic hypotension in a patient having an implantable medical device comprising an implantable pulse generator (IPG) 444 and one or more electrode leads 454 ([0141-0142]; fig. 4), wherein each of the one or more electrode leads are configured for implantation in the patient’s spinal column and comprise a plurality of electrodes configured to deliver electrical stimulation to the patient’s spinal cord (“At 772, electrodes are placed in the epidural space to target neural tissue in or near the spinal cord” [0151]), the system comprising: stimulation circuitry 320 (fig. 3) within the IPG; sensing circuitry 202 (fig. 2-3) coupled to one or more of the plurality of electrodes, and control circuitry 322 (fig. 3) configured to: receive an indication of an actual or anticipated hypotensive event in the patient (“a change in the one or more physiological parameters exceeding a therapy threshold specified to indicate a need for therapy” [0139]; “it is determined whether an actual or anticipated blood event that is indicated for a blood pressure change has occurred… neurally-mediated hypotension” [0148]); wherein the indication is determined based on an evoked neural response (“a neural sensor to sense a nerve signal indicative of sympathetic tone (which in turn indicates blood pressure), such as electrode(s) incorporated into the distal end of a lead connected to the implantable device to sense local field potentials and/or evoked compound action potentials” [0101]); and respond to the indication by causing stimulation circuitry to change from a first state (“a low-power mode” [0139]) to a second state (“The power management circuit 322 can resume to a normal operation mode in therapy device 320 or system 300 in response to a specified wake-up event… Examples of such wake-up event include… a change in the one or more physiological parameters exceeding a therapy threshold specified to indicate a need for therapy” [0139]), wherein: in the first state, the stimulation circuitry does not cause any of the electrodes to deliver to the patient’s spinal cord any electrical stimulation configured to manage the patient’s blood pressure (“a low-power mode while the patient is sleeping, as indicated by the activity parameter” [0139]; regarded as a dormant operating mode where the normal operating mode (i.e. delivering stimulation) is not occurring), and in the second state, the stimulation circuitry causes one or more of the plurality of electrodes to deliver to the patient’s spinal cord electrical stimulation that is configured to manage the patient’s blood pressure (“At 568, the neuromodulation energy is delivered using a second parameter set to change BP. The second parameter set includes at least one different value for at least one parameter to cause the BP change.” [0149]).
Stolen et al. discloses wherein determining the indication comprises: using the stimulation circuitry to cause a first one or more of the plurality of electrodes to deliver first electrical stimulation configured to evoke one or more neural potentials in the patient’s spinal cord, wherein the first electrical stimulation is not configured to maintain the patient’s blood pressure (“testing stimulation parameters” [0157]), using sensing circuitry of the IPG to cause a second one or more of the plurality of electrodes to record the electric potentials (“a neural sensor to sense a nerve signal indicative of sympathetic tone (which in turn indicates blood pressure), such as electrode(s) incorporated into the distal end of a lead connected to the implantable device to sense local field potentials and/or evoked compound action potentials” [0094]).
Stolen et al. does not expressly disclose the indication is determined based on the evoked neural response that is indicative of a posture change; extracting, by the control circuitry, one or more features of the recorded evoked neural potentials, and determining, by comparing the one or more features to one or more posture-correlated threshold values, that a posture change has occurred and thereby that an actual or anticipated hypotensive event is present. Aydemir et al. teaches it is known in the art for evoked neural responses to be indicative of a posture change ([0019], [0021]) and to extract, by control circuitry 102 (fig. 4a), one or more features of the recorded evoked neural potentials ([0040]); and determine, by comparing the one or more features to one or more posture-correlated threshold values, that a posture change has occurred ([0019-0021], [0052], [0058], [0060]). Stolen et al. acknowledges there is a correlation between a patient’s postural changes and hypotensive events ([0005]), and further teaches a posture change event can indicate a blood pressure change has occurred ([0148]). Min et al. teaches it is known in the art that sensor data indicating a posture changing event has occurred, is used as information to decide that an actual or anticipated hypotensive event (“orthostatic hypotension”) is present ([0062]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stolen et al. to determine the indication of an actual or anticipated hypotensive event in the patient based on the evoked neural response that is indicative of a posture change; extracting, by the control circuitry, one or more features of the recorded evoked neural potentials, and determining, by comparing the one or more features to one or more posture-correlated threshold values, that a posture change has occurred and thereby that an actual or anticipated hypotensive event is present as taught by Aydemir et al., Stolen et al. and Min et al. as these are known techniques in the art to determine postural changes and if an actual or anticipated hypotensive event is present, and the results of such a modification would have been reasonably predictable.
Regarding claim 2, Stolen et al. discloses wherein the indication of an actual or anticipated hypotensive event comprises a signal from a blood pressure monitor indicating a drop in the patient’s blood pressure ([0075]; [0148]).
Regarding claim 3, Stolen et al. discloses wherein the blood pressure monitor is implantable in the patient (“an invasive arterial pressure sensor” [0094]).
Regarding claim 4, Stolen et al. discloses further comprising an accelerometer wherein the indication of an actual or anticipated hypotensive event comprises a signal from the accelerometer (“an accelerometer or a microphone” [0094]).
Regarding claim 5, Stolen et al. discloses wherein the accelerometer is configured within the IPG (“an accelerometer or a microphone, in an implantable device” [0094]).
Regarding claim 10, Stolen et al. in view of Aydemir et al. disclose wherein the one or more features are selected from the group consisting of an amplitude of any peak, an area under a curve, a curve length, and a difference between amplitudes of any two peaks ([0040]).
Regarding claim 12, Stolen et al. discloses wherein the first stimulation is configured to manage a condition in the patient other than orthostatic hypotension (“testing stimulation parameters” [0157] used to determine the stimulation parameters for “At 774, the first parameter set is optimized. For example, the embodiment that delivers SCS to the T10-T12 region may optimize the first parameter set by modifying parameters until the patient has adequate pain relief or perceives paresthesia in a desired location” [0151]).
Regarding claim 14, Stolen et al. discloses alerting the patient of the actual or anticipated hypotensive event ([0143]).
Regarding claim 19, Stolen et al. discloses the electrical stimulation configured to manage the patient’s blood pressure comprises stimulation having a frequency of 25 – 70 Hz (“between 20 Hz to 200 Hz” [0149]).
Regarding claim 20, Stolen et al. discloses wherein the electrical stimulation that is configured to manage the patient’s blood pressure is delivered to the patient’s T8 – L3 spinal level ([0147]).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stolen et al. (US 2019/0351234) in view of Aydemir et al. (WO 2020/251899) and Min et al. (US 2006/0276848) and further in view of Mokelke et al. (US 2013/0338727).
Regarding claims 6-7, Stolen et al. does not expressly disclose the accelerometer is configured external to the patient. However, Stolen et al. acknowledges that determining actual or anticipated blood pressure demand events include sensing posture ([0078], [0148]). Mokelke et al. teaches external posture sensors such as accelerometers are known in the art for detecting posture changes of a patient ([0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stolen et al. to use an external accelerometer to detect a posture change of the patient as taught by Mokelke et al. as it is a known component in the art for the purpose of providing patient activity information for a neural stimulation therapy device, such a modification being reasonably predictable.
Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stolen et al. (US 2019/0351234) in view of Aydemir et al. (WO 2020/251899) and Min et al. (US 2006/0276848) and further in view of Ramaci (US 2018/0211509).
Regarding claim 15, Stolen et al. does not expressly disclose the control circuitry is configured to receive one or more indications that the patient has fallen. Stolen et al. however does disclose hypotension is accompanied by dizziness, nausea and fainting ([0155]). Ramaci teaches accelerometers are known in the art to detect a free-fall condition of a patient and in response, send an indication to a processor for further steps ([0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stolen et al. to incorporate fall detection with the accelerometer signals as taught by Ramaci in order to provide a device that can better detect a patient fallen posture state in the event hypotension causes fainting.
Regarding claim 16, Stolen et al. in view of Ramaci disclose the one or more indications that the patient has fallen is based on accelerometer signals ([0075]).
Regarding claim 17, Stolen et al. does not expressly disclose the control circuitry is configured to send an alert to the patient based on the one or more indications that the patient has fallen. Ramaci teaches that upon detection of an accelerometer of a free-fall, the device issues an alert (‘verbal communication”) that a free-fall condition was sensed and then asks the patient if an E911 emergency call should be placed ([0105]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stolen et al. to send an alert to the patient based on the indication the patient has fallen as taught by Ramaci in order to better determine if the patient needs additional assistance with the fall.
Regarding claim 18, Stolen et al. in view of Ramaci disclose the control circuitry is configured to monitor for a patient response to the alert, and if no response is received, to send an alert to one or more remote locations ([0105]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796