Notice of Pre-AIA or AIA Status
DETAILED ACTION
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,363,860. Although the claims at issue are not identical, they are not patentably distinct from each other because the presently claimed instructions executable by a processor are obvious in view of the method steps as claimed in claims 1-28 of U.S. Patent No. 10,363,860.
Claims 9-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11, 11,185,697. Although the claims at issue are not identical, they are not patentably distinct from each other because the presently claimed instructions executable by a processor are obvious in view of the method steps as claimed in claims 1-23 of U.S. Patent No. 11, 11,185,697.
Regarding claim 1, a non-transitory computer readable medium storing instructions executable by a processor is obvious over the method of claim 1 of U.S. Patent No. 10,363,860 because the method steps of claim 1 of U.S. Patent No. 10,363,860 achieve a similar effect:
a. cause a stimulus to be applied to one or more of at least one electrode implanted in a target neural structure of a brain;
b. detect a resonant response from the target neural structure evoked by the stimulus at one or more of the at least one electrode in or near the target neural structure of the brain;
c. determine one or more waveform characteristics of the detected resonant response; and
d. cause the stimulus to be adapted based on the one or more determined waveform characteristics of the resonant response, wherein the stimulus is adapted based on the time elapsed between adjacent peaks in the resonant response.
Regarding claim 2, the instructions include instructions which are obvious over the method steps of claim 2 of U.S. Patent No. 10,363,860 to determine the one or more waveform characteristics based on at least part of a second or subsequent cycle in the detected resonant response.
Regarding claim 3, the instructions include instructions which are obvious over the method steps of claim 3 of U.S. Patent No. 10,363,860 for one or more waveform characteristics comprises one or more of the following:
a) a frequency of the resonant response;
b) a temporal envelope of the resonant response;
c) an amplitude of the resonant response;
d) a fine structure of the resonant response;
e) a rate of decay of the resonant response;
f) a delay between the onset of the stimulus and the onset of a temporal feature of the resonant response.
Regarding claim 4, the instructions include instructions which are obvious over the method steps of claim 4 of U.S. Patent No. 10,363,860 to cause the stimulus to be adapted if the time elapsed between two adjacent peaks in the resonant response is less than a first predetermined time period associated with alleviation of movement symptoms in the patient, and
wherein the predetermined time period associated with alleviation of movement symptoms in the patient is less than about 3.5 ms.
Regarding claim 5, the instructions include instructions which are obvious over the method steps of claim 5 of U.S. Patent No. 10,363,860 to cause the stimulus to be adapted if the time elapsed between the stimulus and a peak in the resonant response is between first and second predetermined time periods associated with alleviation of movement symptoms in the patient, and
wherein the peak is a first peak, wherein the first predetermined time period is about 6.5 ms, and wherein the second predetermined time period is about 7.5 ms.
Regarding claim 6, the instructions include instructions which are obvious over the method steps of claim 10 of U.S. Patent No. 10,363,860 to: determine whether one or more of the at least one electrode is positioned in the target neural network based on the detected resonant response.
Regarding claim 7, the instructions include instructions which are obvious over the method steps of claim 13 of U.S. Patent No. 10,363,860 to:
select one or more of the at least one electrode to use for therapeutic stimulation of the target neural structure based on the one or more waveform characteristics; and
apply a therapeutic stimulus to the target neural structure via the selected one or more of the at least one electrode.
Regarding claim 8, the instructions include instructions which are obvious over the method steps of claim 17 of U.S. Patent No. 10,363,860 to:
repeat the steps of applying the stimulus, detecting a resonant response and determining one or more waveform characteristics of the detected resonant response; and
compare a common waveform characteristic between two or more detected resonant responses.
Claims 9, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11, 11,185,697. Although the claims at issue are not identical, they are not patentably distinct from each other because the presently claimed instructions executable by a processor are obvious in view of the method steps as claimed in claims 1-23 of U.S. Patent No. 11,185,697.
Regarding claim 9, the instructions include instructions which are obvious over the method steps of claims 1 and 12 of U.S. Patent No. 11, 11,185,697 to:
a. cause a stimulus to be applied to one or more of at least one electrode implanted in or near a target neural structure of the brain;
b. detect a resonant response from the target neural structure evoked by the stimulus at one or more of the at least one electrode in or near the target neural structure of the brain, the resonant response having a frequency of between 200 Hz and 500 Hz; and
c. determine one or more waveform characteristics of the detected resonant response.
Regarding claim 10, the instructions include instructions which are obvious over the method steps of claims 1 and 12 of U.S. Patent No. 11, 11,185,697 to determine the one or more waveform characteristics based on at least part of a second or subsequent cycle in the detected resonant response.
Regarding claim 11, the instructions include instructions which are obvious over the method steps of claims 1 and 12 of U.S. Patent No. 11, 11,185,697 where the one or more waveform characteristics comprises one or more of the following:
a) a frequency of the resonant response;
b) a temporal envelope of the resonant response;
c) an amplitude of the resonant response;
d) a fine structure of the resonant response;
e) a rate of decay of the resonant response;
f) a delay between the onset of the stimulus and the onset of a temporal feature of the resonant response;
g) a rate of change of the resonant response.
Regarding claim 12, the instructions include instructions which are obvious over the method steps of claims 1, 12 and 14 of U.S. Patent No. 11, 11,185,697 for the instructions to further comprise instructions to:
adapt the stimulus based on the one or more determined waveform characteristics of the resonant response.
Regarding claim 13, the instructions include instructions which are obvious over the stimulus adaptation of claim 22 of U.S. Patent No. 10,363,860 to cause the stimulus to be adapted based on the time elapsed between adjacent peaks in the resonant response, wherein the stimulus is adapted if the time elapsed between two adjacent peaks in the resonant response is less than a first predetermined time period associated with alleviation of movement symptoms in the patient, wherein the predetermined time period associated with alleviation of movement symptoms in the patient is less than about 3.5 ms.
Regarding claim 14, the instructions include instructions which are obvious over the method steps of claims 1, 12 and 14 of U.S. Patent No. 11, 11,185,697 for the instructions to comprise instructions to detect a resonant response at two or more of the at least one electrode, compare the one or more waveform characteristics of the detected resonant response detected at the two or more of the at least one electrode and adapt the stimulus based on the comparison.
Regarding claim 15, the instructions include instructions which are obvious over the method steps of claims 1, 12 and 14 of U.S. Patent No. 11, 11,185,697 for the stimulus to comprises a patterned signal comprising a plurality of bursts separated by a first time period, each burst comprising a plurality of pulses separated by a second time period, wherein the first time period is greater than the second time period and wherein the detecting is performed during one or more of the first time periods.
Regarding claim 16, the instructions include instructions which are obvious over the method steps of claim 1 of U.S. Patent No. 11, 11,185,697 for a non-transitory computer readable medium storing instructions executable by a processor to:
cause a plurality of stimuli to be applied to one or more electrodes implanted in or near a target neural structure of the brain, each of the plurality of stimuli applied at a different location in the brain;
detect a resonant response from the target neural structure evoked by each of the plurality of stimuli at one or more of the electrodes in or near the target neural structure of the brain; and
compare one or more waveform characteristics of each of the detected resonant responses, wherein one or more of the plurality of stimuli comprises a patterned signal comprising a plurality of bursts separated by a first time period, each burst comprising a plurality of pulses separated by a second time period, wherein the first time period is greater than the second time period and wherein the detecting is performed during one or more of the first time periods.
Regarding claim 17, the instructions include instructions which are obvious over the method steps of claims 1 and 4 of U.S. Patent No. 11, 11,185,697 to further comprise instructions to:
determine a location of the target neural structure relative to the one or more electrodes based on the comparison.
Regarding claim 18, the instructions include instructions which are obvious over the method steps of claims 1, 2 and 3 of U.S. Patent No. 11, 11,185,697 to determine a location of one or more electrodes relative to the target neural structure comprise instructions to determine a direction and/or a distance of one or more of the electrodes to the target neural structure.
Regarding claim 19, the instructions include instructions which are obvious over the method steps of claims 1 and 9 of U.S. Patent No. 11, 11,185,697 to comprise instructions to compare one or more of the presence, amplitude, natural frequency, damping, rate of decay, rate of change, envelope, delay between onset of the respective stimulus and the onset of a temporal feature, and fine structure of each of the detected resonant responses.
Regarding claim 20, the instructions include instructions which are obvious over the method steps of claims 1, 2 and 7 of U.S. Patent No. 11, 11,185,697 to further comprise instructions to select one or more stimulation electrodes implanted in the brain for therapeutic stimulation based on the determined location of the target neural structure.
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.
Claims 1-3, 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al (US 2009/0306728).
Regarding claim 1, Wright discloses a non-transitory computer readable medium storing instructions executable
by a processor 80 to:
cause a stimulus (source 60) to be applied to one or more of at least one electrode 30a-b implanted in a target neural structure of a brain.
Wright teaches, “The coil 122 accordingly generates an alternating magnetic field at the selected resonant frequency in response to the excitation energy either by itself or in combination with the capacitor 126.” See paragraph [0066].
In view of this Wright teaching, one of ordinary skill in the art would have found it obvious to detect a resonant response from the target neural structure evoked by the stimulus from source 60 at one or more of the at least one electrode 30a-b in or near the target neural structure of the brain because Wright suggests implanting the electrode 30a-b in the brain, see paragraph [0063].
Wright discloses determining one or more waveform characteristics of the detected resonant response to comprise markers 40, see paragraph [0085]; and
causing the stimulus to be adapted based on the one or more determined waveform characteristics of the resonant response,
wherein the stimulus is adapted based on the time elapsed between adjacent peaks in the resonant response. Each marker 40a, 40b and 40c has a unique resonant frequency, see paragraph [0044] and thus a respective unique time elapsed between adjacent peaks.
Regarding claim 2, one of ordinary skill in the art would have found it obvious to determine the one or more waveform characteristics based on at least part of a second or subsequent cycle in the detected resonant response to distinguish each marker 40a, 40b and 40c.
Regarding claim 3, the one or more waveform characteristics comprises a frequency of the resonant response.
Regarding claim 6, Wright discloses determining whether one or more of the at least one electrode 30a-b is positioned in the target neural network based on the detected resonant response, see paragraph [0061].
Regarding claim 7, Wright discloses selecting one or more of the at least one electrode 30a-b to use for therapeutic stimulation of the target neural structure based on the one or more waveform characteristics of each marker 40a, 40b and 40c; and apply a therapeutic stimulus to the target neural structure via the selected one or more of the at least one electrode 30a-b, see paragraph [0047].
Conclusion
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/George Manuel/
Primary Examiner
Art Unit: 3792
2/3/2026