DETAILED ACTION
This Office Action is responsive to the Amendment filed 26 November 2025.
Claims 21-56 are now pending. The Examiner acknowledges the amendments to
claims 39 and 48. While the instant amendment attempts to comply with the issues set
forth in the Non-Compliant Amendment mailed 13 November 2025, claims 39 and 48 at
lines 1-2 contain inconsistences that do not properly show cancelation/deletion/addition
of particular limitations. For instance, claim 39 of the claims filed 31 March 2025 recites
“An implantable neurostimulation system for treating neurological conditions,
comprising:” and instant claim 39 recites “An implantable neurostimulator for treating
neurological conditions:”. Instant claims 39 and 48 does not reflect any
deletions/additions of any of the aforementioned limitations, however it is clear that
“neurostimulation system” has been changed to –neurostimulator— (in both instant
claims 39 and 48); and “conditions, comprising:” (instant claim 39) now reads
“conditions:” which would render the claim indefinite.
.
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 Objections
Claim 39 is objected to because of the following informalities: at line 2, “conditions:” should apparently read –conditions, comprising:--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 39-56 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.
Claims 39 and 48 now directed to an implantable neurostimulator, which further requires an external controller per line 3. It is unclear if Applicant's intention is to recite at line 1 that the claim is directed to an implantable neurostimulation system (per the previous set of claims) as the specification does not appear to support an implantable neurostimulator itself comprising an external controller, rather the neurostimulator being modified via an external controller ([0089] and [0063]-[0066] of the instant publication). Thus, since both claims are directed to an implantable neurostimulator, “an external controller” of an implantable neurostimulator (as recited in claims 39 and 48) would not contain support within the specification as originally filed.
7. Claim 40 at line 2 recites “pulses in each set of pulses” rendering the claim indefinite as it is unclear if “pulses” (in the aforementioned limitation) is the same as or different than “each pulse” recited at lines 1-2.
8. Claim 49 at line 2 recites “pulses in each set of pulses” rendering the claim indefinite as it is unclear if “pulses” (in the aforementioned limitation) is the same as or different than “each pulse” recited at lines 1-2.
9. Claim 52 at line 4 recites “pulses in each three-pulse train” rendering the claim indefinite as it is unclear if “pulses” (in the aforementioned limitation) is the same as or different than “each pulse” recited at line 2.
Claim Rejections - 35 USC § 101
10. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 39-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a generic system (per the inconsistencies outlined above) for treating a neurological condition with a TBS protocol, wherein the protocol comprises a series of parameters (which amounts to an abstract idea). Claims 39 and 48 recite generic computer components (an external controller, comprising: a processor; and a memory, the memory storing an application which configures the processor to control an implantable neurostimulator) and then a series of parameters that define the TBS protocol, which amounts to no more than intended use of the protocol given the recitation of “…to apply accelerated intermittent theta burst stimulation (TBS)…”. This judicial exception is not integrated into a practical application because the claims, as written (lines 8-13 of claim 39 and lines 8-12 of claim 48) simply define the TBS protocol parameters, which could be written instructions, but the claim does not recite that the controller, processor or neurostimulator are particularly configured to apply such parameters of the protocol. Even under the interpretation of intended use of lines 8-13 (claim 39) and lines 8-12 (claim 48), this would amount to no more than the recited neurostimulator merely adding the words “apply it” with the recitation “the implantable neurostimulator…to apply...aiTBS…” (claim 39) or “the implantable neurostimulator…to apply...acTBS…” (claim 48).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. While both claims 39 and 48 recite “an external controller, comprising: a processor; and a memory, the memory storing an application which configures the processor to control an implantable neurostimulator,” these additional elements are not sufficient to amount to significantly more than the judicial exception because the treating of the neurological condition with a TBS protocol is merely being implemented on generic computer elements (“external controller, comprising: a processor; and a memory, the memory storing an application which configures the processor…”) and thus do not add a meaningful limitation to the abstract idea as they simply amount to implementing the abstract idea on a generic computer component (“external controller, comprising: a processor; and a memory…”) containing an application which configures the processor, which is essentially a set of instructions. Claims 39 and 48 do recite the additional element of “an implantable neurostimulator,” however such an implantable neurostimulator in a system for treating neurological conditions is well-understood and conventional in the art as suggested by U.S. Pub. No. 2013/0281890 and U.S. Patent No. 7,747,318.
Dependent claims 40-43 and 49-52 merely further limit the protocol parameters, and dependent claims 44, 45, 53 and 54 merely further limit the type of neurological condition that can be treated, which do not integrate the judicial exception into a practical application as noted above.
Dependent claims 46, 47, 55 and 56 recite the additional “elements” of magnetic neurostimulation and electric neurostimulation, however such methods of stimulation for treating neurological conditions are well-understood and conventional in the art as suggested by U.S. Pub. No. 2013/0281890 and U.S. Patent No. 7,747,318.
Claim Rejections - 35 USC § 103
11. 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.
12. 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.
13. Claims 39-56 are rejected under 35 U.S.C. 103 as being unpatentable over Peng et al. (U.S. Pub. No. 2016/0367804). Regarding claim 39, Peng et al. (hereinafter Peng) discloses an implantable neurostimulation system for treating neurological conditions, comprising: an external controller, comprising: a processor; and a memory, the memory storing an application which configures the processor to control an implantable neurostimulator [0056]; and; and the implantable neurostimulator ([0054] “…electrode sets, which may be positioned or implanted…”) controlled by the controller to apply accelerated intermittent theta burst stimulation (aiTBS) to a target brain structure during a plurality of sessions on a given day in order to treat a neurological condition ([0055]-[0057]; the instant specification at [0055] describes “aTBS” as “iTBS” or “cTBS”), where the aiTBS comprises a plurality of pulse trains that each comprise a set of pulses ([0056], [0057], [0063] and [0064]), where each set of pulses is separated by an intertrain interval [0066]. While Peng does not disclose explicitly that each session in the plurality of sessions is separated by an intersession interval lasting between 25 and 120 minutes during which no neurostimulation is applied, Peng obviates such as the claim is directed to a neurostimulator configured to apply the specified parameters and the computer/controller 110 of the implanted electrodes ([0054]-[0056] and Fig. 1) is configured to stop stimulation for any amount of time (“during which no neurostimulation is applied”) (“…if an applied electrical signal of over saturation-voltage or high impedance is detected….the process would be directed back to step 402…” where stimulation is not being applied; further in Fig 4 the flow chart indicates “Power On” which obviates a system that can likewise be turned off where no stimulation would be applied).
Regarding claim 40, each pulse in each set of pulses is between 20 Hz and 70 Hz, and pulses in each set of pulses are applied at between 3 Hz to 7 Hz ([0031] and [0034]).
Regarding claim 41, the system of Peng is configured such that the intertrain interval lasts between 4 to 10 seconds [0066]. While Peng does not disclose explicitly wherein each session in the plurality of sessions lasts in the particular range between 3 and 15 minutes, Peng does disclose that the TBS is delivered for more than 0 to 60 minutes [0035], or 0 to 30 minutes (claim 10), or more than 60 minutes (claim 9), obviating the session lengths (between 3 and 15 minutes) claimed. Further, the courts have shown that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP 2144.05(11)). Therefore to determine the session length of the treatment would have been obvious to one of ordinary skill since this would amount to merely optimizing the particular parameters or ranges.
Regarding claim 42, the system of Peng is configured such that between 3 and 15 sessions may be applied (Fig 4 discloses “Power On” which indicates a system that is configured to be likewise turned off in between any desired number of sessions).
Regarding claim 43, Peng makes obvious a neurostimulator controlled by a controller to apply aiTBS during a plurality of sessions (see claim 39), wherein each pulse train in the plurality of pulse trains comprises pulses in the form of three [0063], 50 Hz pulses applied at 5 Hz where the intertrain interval is 10 seconds (made obvious as indicated above in paragraphs [0031], [0034] and [0066] as indicated in the rejection of claims 40 and 41). The neurostimulator of Peng is further controlled to apply at least ten, 10-minute sessions (as indicated by claims 41 and 42) at an intersession interval of 50 minutes (as indicated by claim 39 above). While Peng does not disclose explicitly that the neurostimulator is controlled such that each pulse train in the plurality of pulse trains lasts for 2 seconds, Peng does disclose an embodiment of the stimulation signal wherein the system may operate in cTBS or iTBS mode and that exemplary stimulation parameters may be on the order of 1 to 2 seconds given the disclosed pulse width; time gap between pulses of a burst; burst period; number of pulses per burst and the number of bursts per signal ([0057]-[0064], [0031] and [0034]). Further, the courts have shown that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP 2144.05(11)). Therefore to determine the pulse train length of the treatment would have been obvious to one of ordinary skill since this would amount to merely optimizing the particular parameters or ranges.
Regarding claims 44 and 45, the neurostimulator of Peng is capable of treating clinical depression and suicidal ideation [0049].
Regarding claim 46, the aiTBS comprises magnetic neurostimulation [0003].
Regarding claim 47, the aiTBS comprises electric neurostimulation ([0002]-[0003]).
Regarding claim 48, Peng discloses an implantable neurostimulation system for treating neurological conditions, comprising: an external controller, comprising: a processor; and a memory, the memory storing an application which configures the processor to control an implantable neurostimulator [0056]; and; and the implantable neurostimulator ([0054] “…electrode sets, which may be positioned or implanted…”) controlled by the controller to apply accelerated continuous theta burst stimulation (acTBS) to a target brain structure during a plurality of sessions on a given day in order to treat a neurological condition ([0055]-[0057]; the instant specification at [0055] describes “aTBS” as “iTBS” or “cTBS”), where the acTBS comprises a plurality of pulse trains that each comprise a set of pulses ([0056], [0057], [0063] and [0064]). While Peng does not disclose explicitly that each session in the plurality of sessions is separated by an intersession interval lasting between 10 and 50 minutes during which no neurostimulation is applied, Peng obviates such as the claim is directed to a neurostimulator configured to apply the specified parameters and the computer/controller 110 of the implanted electrodes ([0054]-[0056] and Fig. 1) is configured to stop stimulation for any amount of time (“during which no neurostimulation is applied”) (“…if an applied electrical signal of over saturation-voltage or high impedance is detected….the process would be directed back to step 402…” where stimulation is not being applied; further in Fig 4 the flow chart indicates “Power On” which obviates a system that can likewise be turned off where no stimulation would be applied).
Regarding claim 49, each pulse in each set of pulses is between 20 Hz and 70 Hz, and pulses in each set of pulses are applied at between 3 Hz to 7 Hz ([0031] and [0034]). Further regarding claim 49, Peng obviates a neurostimulator configured such that a session may be stopped after any number of seconds (Fig 4 discloses “Power On” which indicates a system that is configured to be likewise turned off in between any desired number of sessions).
Regarding claim 50, the system of Peng is configured such that between 10 and 40 sessions may be applied (Fig 4 discloses “Power On” which indicates a system that is configured to be likewise turned off in between any desired number of sessions).
Regarding claim 51, each session in the plurality of sessions for a given day comprises a set of 3-pulse trains [0063], where each pulse is 50 Hz applied at 5 Hz (made obvious as indicated above in paragraphs [0031], [0034] and [0066] as indicated in the rejection of claim 41). While Peng does not disclose explicitly wherein each session in the plurality of sessions lasts 40 seconds, Peng does disclose that the TBS is delivered for more than 0 to 60 minutes [0035], or 0 to 30 minutes (claim 10), obviating the session length (40 seconds) claimed. Further, the courts have shown that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP 2144.05(11)). Therefore to determine the session length of the treatment would have been obvious to one of ordinary skill since this would amount to merely optimizing the particular parameters or ranges.
Regarding claim 52, Peng makes obvious a neurostimulator controlled to apply acTBS during a plurality of sessions (see claim 48), wherein the plurality of pulse trains comprises three-pulse trains [0063], where each pulse in each three-pulse train is 30 Hz; wherein pulses in each three-pulse train are applied at 6 Hz (made obvious as indicated above in paragraphs [0031], [0034] and [0066] as indicated in the rejection of claim 51). While Peng does not disclose explicitly wherein each session in the plurality of sessions lasts 44 seconds, Peng does disclose that the TBS is delivered for more than 0 to 60 minutes [0035], or 0 to 30 minutes (claim 10), obviating the session length (44 seconds) claimed. Further, the courts have shown that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (MPEP 2144.05(11)). Therefore to determine the session length of the treatment would have been obvious to one of ordinary skill since this would amount to merely optimizing the particular parameters or ranges.
Regarding claims 53 and 54, the neurostimulator of Peng is capable of treating clinical depression and suicidal ideation [0049].
Regarding claim 55, the acTBS comprises magnetic neurostimulation [0003].
Regarding claim 56, the acTBS comprises electric neurostimulation ([0002]-[0003]).
Terminal Disclaimer
14. The terminal disclaimer filed on 27 October 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,595,735 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Allowable Subject Matter
15. Claims 21-38 are allowable over the prior art of record. The following is a statement of reasons for the indication of allowable subject matter: regarding claims 21-29, while the prior art teaches a method for treating neurological conditions, comprising: implanting a neurostimulator over a target structure of a patient's brain; and applying accelerated intermittent theta burst stimulation (aiTBS) to the target structure using the neurostimulator during a plurality of sessions on a given day in order to treat a neurological condition; the prior art of record does not teach or fairly suggest a method for treating neurological conditions as claimed by Applicant, where each session in the plurality of sessions is separated by an intersession interval lasting between 25 and 120 minutes during which no neurostimulation is applied; and during each session in the plurality of sessions, the neurostimulator is configured to provide the aiTBS by generating a plurality of pulse trains that each comprise a set of pulses, where each set of pulses is separated by an intertrain interval.
Regarding claims 30-38, while the prior art teaches a method for treating neurological conditions, comprising: implanting a neurostimulator over a target structure of a patient's brain; and applying accelerated continuous theta burst stimulation (acTBS) to the target structure using the neurostimulator during a plurality of sessions on a given day in order to treat a neurological condition; the prior art of record does not teach or fairly suggest a method for treating neurological conditions as claimed by Applicant, where each session in the plurality of sessions is separated by an intersession interval lasting between 10 and 50 minutes during which no neurostimulation is applied; and during each session in the plurality of sessions, the neurostimulator is configured to provide the acTBS by generating a plurality of pulse trains that each comprise a set of pulses.
Response to Arguments
16. Applicant’s arguments filed 26 November 2025 with respect to the rejection of claims 39-56 under 35 U.S.C. 112(b) have been fully considered and are persuasive with respect to claims 39 and 48, however new grounds of rejection are presented above in light of the amendments.
17. Applicant’s arguments filed 26 November 2025 with respect to the rejection of claims 40-47 and 49-56 under 35 U.S.C. 112(d) have been fully considered and are persuasive in light of the amendments.
18. Applicant’s arguments filed 26 November 2025 with respect to the rejection of claims 39-56 under 35 U.S.C. 103 citing Peng (‘804) have been fully considered and are not persuasive. Regarding claims 39 and 48, Applicant contends the cited paragraphs of Peng do not contemplate a controller that controls the implantable neurostimulator to deliver a multi-session treatment having the claimed intersession interval and that merely powering off a device (or ending a session early) does not provide any indication of success to one of ordinary skill in the art that the claimed intersession interval would provide any benefit. However, this argument is not persuasive. As indicated previously, claims 39 and 48 recite that the controller is an external controller that comprises a processor; and a memory, the memory storing an application which configures the processor to control the implantable neurostimulator, which amounts to a controller which is configured to control an implantable neurostimulator, which is taught at paragraphs [0054]-[0057] as indicated above. Lines 7-13 of claims 39 and 48 (beginning with “to apply…”) are directed to an intended use of the neurostimulator and as described above, the neurostimulator of Peng is capable of being controlled to apply a set of pulses separated by an intertrain interval and further capable of being controlled during an interval during which no neurostimulation is applied by being powered on/off (as likewise indicated above). Therefore, the implantable neurostimulator of claims 39 and 48 is not being interpreted as specifically configured to operate within the claimed intersession interval. As previously noted, this amendment does not additionally disclose how the controller (or neurostimulator) is configured to perform the recited aiTBS protocol as it merely recites an intended use of the controller (or neurostimulator). In view of the foregoing, the rejection of claims 39-56 under 35 U.S.C. 103 citing Peng (‘804) 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