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
This office action is responsive to the amendment filed on 6/4/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1, 12, 18 has/have been amended;
Claim(s) 7 is/are cancelled;
Claim(s) 1-6, 8-19 is/are presently pending.
The amendment(s) to the claim(s) is sufficient to overcome the 35 U.S.C. 101 rejection(s) from the previous office action.
Response to Arguments
Applicant’s arguments with respect to the amended claim(s) have been considered and is correct with regard to the reference(s) cited not teaching the amended claim element(s). However, a new ground of rejection necessitated by the amendment is presented which prevents allowance.
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) 1-6, 8-10, 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt (US 20230064552 A1; 3/2/2023; cited in IDS; cited in previous office action) in view of Toth (US 20160029960 A1; 2/4/2016; cited in previous office action as prior art not relied upon)
Regarding claim 1, Moffitt teaches a system for determining an estimate of an anatomy of neural tissue of a subject (Abstract; Fig. 13), said system comprising:
an electrode arrangement comprising a plurality of electrodes (Fig. 1; Fig. 11), wherein different electrodes in the plurality of electrodes are configured to be arranged in different electrode locations adjacent the neural tissue (Fig. 11; [0032]; [0059]), wherein the plurality of electrodes is configured to receive a plurality of stimulation signals, each stimulation signal being associated with a particular stimulation location adjacent the neural tissue (Fig. 8-13; [0032]; [0059]);
a sensor arrangement configured to detect at least one of a neural activity or a physiological activity of the subject, wherein the sensor arrangement is configured to generate indications of changes in at least one of the neural activity or the physiological activity in response to the stimulation signals (Fig. 8-13; [0032]; [0059]); and
a processing unit (Fig. 4; [0042]), configured to receive data representing relations between the plurality of stimulation signals and the indications of changes in the neural activity or physiological activity, wherein the processing unit is configured to generate the estimate of the anatomy of the neural tissue of the subject using the data received by the processing unit (Fig. 8-13; Fig. 14-16; [0060]; [0063]; [0082]).
Moffitt does not teach a data storage comprising a database comprising previously determined nerve anatomy data sets, each previously determined nerve anatomy data set comprising responses to stimulation signals of neural tissue having a known anatomy;
wherein the processing unit is further configured to generate the estimate of the anatomy of the neural tissue of the subject based at least in part on a comparison between the received data representing relations between the plurality of stimulation signals and the indications of changes in the neural activity or physiological activity of the subject and corresponding data stored in the database comprising the previously determined nerve anatomy data sets.
However, Toth teaches in the same field of endeavor (Abstract; Fig. 1c) a data storage comprising a database comprising previously determined nerve anatomy data sets, each previously determined nerve anatomy data set comprising responses to stimulation signals of neural tissue having a known anatomy (Fig. 1c; Fig. 8a; [0299] “memory module”; [0217] “The mapping may be provided by sweeping a sensory tip in accordance with the present disclosure over the anatomical site of interest, inserting and then withdrawing the sensory tip, deploying the sensory tip and then dragging and/or rotating the deployed tip along/around the lumen wall, combinations thereof, and the like. In aspects, the third method 180 may include displaying the mapped physiologic information for a user, constructing an anatomical model therefrom, directing a surgical robot to perform a treatment therefrom, comparing the map with a previously determined map (e.g. as a means for monitoring the outcome of a procedure, tracking a therapy, etc.), combinations thereof, or the like. In aspects, the method may include providing one or more directions to a surgeon and/or a surgical robot to access one or more regions of the mapped anatomy, overlaying the present map with previously generated maps (so as to evaluate changes in functionality, activity, etc.), combinations thereof, and the like.”);
wherein the processing unit is further configured to generate the estimate of the anatomy of the neural tissue of the subject based at least in part on a comparison between the received data representing relations between the plurality of stimulation signals and the indications of changes in the neural activity or physiological activity of the subject and corresponding data stored in the database comprising the previously determined nerve anatomy data sets ([0217] “The mapping may be provided by sweeping a sensory tip in accordance with the present disclosure over the anatomical site of interest, inserting and then withdrawing the sensory tip, deploying the sensory tip and then dragging and/or rotating the deployed tip along/around the lumen wall, combinations thereof, and the like. In aspects, the third method 180 may include displaying the mapped physiologic information for a user, constructing an anatomical model therefrom, directing a surgical robot to perform a treatment therefrom, comparing the map with a previously determined map (e.g. as a means for monitoring the outcome of a procedure, tracking a therapy, etc.), combinations thereof, or the like. In aspects, the method may include providing one or more directions to a surgeon and/or a surgical robot to access one or more regions of the mapped anatomy, overlaying the present map with previously generated maps (so as to evaluate changes in functionality, activity, etc.), combinations thereof, and the like.”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Toth because this enables comparison to evaluate changes in nerve functionality or activity (Fig. 8a; [0217]).
Regarding claim 2, in the combination of Moffitt and Toth, Moffitt teaches wherein different electrodes in the plurality of electrodes are configured to be arranged in different electrode locations around a circumference of a nerve of neural tissue (Fig. 2; Fig. 11; [0032]).
Regarding claim 3, in the combination of Moffitt and Toth, Moffitt teaches wherein the electrode arrangement is configured to be implanted in the subject, and wherein the electrode arrangement is configured to at least partially surround the nerve of the subject (Fig. 2; Fig. 11; [0032]).
Regarding claim 4, in the combination of Moffitt and Toth, Moffitt teaches wherein the different electrodes in the plurality of electrodes are configured to be arranged in different electrode locations adjacent to the spinal cord or adjacent to brain tissue (Fig. 1-2; [0003]; [0061]). For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The instant claim recitation does not change the structure of the claimed invention and the prior art is capable of meeting the instant limitation(s).
Regarding claim 5, in the combination of Moffitt and Toth, Moffitt teaches wherein the estimate of the anatomy of the nerve represents properties of nerve fibers within the nerve, and wherein the properties of the nerve fibers within the nerve comprises at least one of
the positions of the nerve fibers within the nerve ([0060] “mapped to corresponding locations”),
the spatial trajectories of the nerve fibers ([0060] “mapped to corresponding locations”),
the type of the nerve fibers ([0068]), or
the size of the nerve fibers (Fig. 14 “Fiber Size”; [0011] “determining fiber sizes”; [0069] “fiber size”).
Regarding claim 6, in the combination of Moffitt and Toth, Moffitt teaches wherein the physiological activity of the subject is at least one of:
a physiological activity indicative of heart activity,
a physiological activity indicative of lung activity,
a physiological activity indicative of muscle activity ([0043] “electromyography”),
a physiological activity indicative of gastrointestinal activity,
a physiological activity indicative of urinary activity, or
a physiological activity indicative of genital activity.
Note that the instant claim is further limiting an alternative recitation; claim 1’s “at least one of the neural activity or the physiological activity” and so would be also be inherently met by claim 1 rejection above due to prior art meeting “one of the neural activity”.
Regarding claim 8, in the combination of Moffitt and Toth, Moffitt teaches wherein the processing unit is configured to compute a functional mapping using a relation between indications of changes in the neural activity or the physiological activity and the stimulation locations, wherein the processing unit is configured to generate the estimate of the anatomy of the neural tissue based on the functional mapping (Fig. 8-13; Fig. 14-16; [0060]-[0061]; [0063]; [0081]-[0082]).
Regarding claim 9, in the combination of Moffitt and Toth, Moffitt teaches wherein the plurality of electrodes of the electrode assembly comprises pairs of electrodes, and wherein each pair of electrodes comprises a first electrode and a second electrode configured to be displaced along a longitudinal axis of the nerve of the subject (Fig. 2; Fig. 11; [0009]; [0044]).
Regarding claim 10, in the combination of Moffitt and Toth, Moffitt teaches wherein the first electrode and the second electrode are configured to generate an electrical field therebetween upon receiving the stimulation signals (Fig. 2; Fig. 6D; Fig. 11; [0044]).
Regarding claim 12, Moffitt teaches a method for determining an estimate of an anatomy of neural tissue of a subject (Abstract; Fig. 13), said method comprising the steps of
stimulating, using an electrode arrangement, a plurality of stimulation locations of the neural tissue of the subject (Fig. 8-13; [0032]; [0059]);
detecting, using a sensor arrangement, indications of changes in at least one of a neural activity or a physiological activity (Fig. 8-13; [0032]; [0059]);
receiving, at a processing unit, data representing relations between the stimulation signals, the stimulation locations and the indications of changes in the neural activity or the physiological activity (Fig. 8-13; [0032]; [0059]); and
generating an estimate of the anatomy of the neural tissue of the subject, based on the received data (Fig. 8-13; Fig. 14-16; [0060]; [0063]; [0082]).
Moffitt does not teach comparing the received data representing relations between the plurality of stimulation signals and the indications of changes in the neural activity or physiological activity of the subject with corresponding data stored in a database comprising previously determined nerve anatomy data sets, each previously determined nerve anatomy data set comprising responses to stimulation signals of neural tissue having a known anatomy; and
generating an estimate of the anatomy of the neural tissue of the subject, based on the received data and at least in part on the comparison between the received data and the corresponding data stored in the database comprising previously determined nerve anatomy data sets.
However, Toth teaches in the same field of endeavor (Abstract; Fig. 1c) comparing the received data representing relations between the plurality of stimulation signals and the indications of changes in the neural activity or physiological activity of the subject with corresponding data stored in a database comprising previously determined nerve anatomy data sets, each previously determined nerve anatomy data set comprising responses to stimulation signals of neural tissue having a known anatomy (Fig. 1c; Fig. 8a; [0299] “memory module”; [0217] “The mapping may be provided by sweeping a sensory tip in accordance with the present disclosure over the anatomical site of interest, inserting and then withdrawing the sensory tip, deploying the sensory tip and then dragging and/or rotating the deployed tip along/around the lumen wall, combinations thereof, and the like. In aspects, the third method 180 may include displaying the mapped physiologic information for a user, constructing an anatomical model therefrom, directing a surgical robot to perform a treatment therefrom, comparing the map with a previously determined map (e.g. as a means for monitoring the outcome of a procedure, tracking a therapy, etc.), combinations thereof, or the like. In aspects, the method may include providing one or more directions to a surgeon and/or a surgical robot to access one or more regions of the mapped anatomy, overlaying the present map with previously generated maps (so as to evaluate changes in functionality, activity, etc.), combinations thereof, and the like.”); and
generating an estimate of the anatomy of the neural tissue of the subject, based on the received data and at least in part on the comparison between the received data and the corresponding data stored in the database comprising previously determined nerve anatomy data sets ([0217] “The mapping may be provided by sweeping a sensory tip in accordance with the present disclosure over the anatomical site of interest, inserting and then withdrawing the sensory tip, deploying the sensory tip and then dragging and/or rotating the deployed tip along/around the lumen wall, combinations thereof, and the like. In aspects, the third method 180 may include displaying the mapped physiologic information for a user, constructing an anatomical model therefrom, directing a surgical robot to perform a treatment therefrom, comparing the map with a previously determined map (e.g. as a means for monitoring the outcome of a procedure, tracking a therapy, etc.), combinations thereof, or the like. In aspects, the method may include providing one or more directions to a surgeon and/or a surgical robot to access one or more regions of the mapped anatomy, overlaying the present map with previously generated maps (so as to evaluate changes in functionality, activity, etc.), combinations thereof, and the like.”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Toth because this enables comparison to evaluate changes in nerve functionality or activity (Fig. 8a; [0217]).
Regarding claim 13, in the combination of Moffitt and Toth, Moffitt teaches wherein the estimate of the anatomy of the neural tissue of the subject represents properties of nerve fibers within the neural tissue in relation to the electrode arrangement and corresponding to the change in the neural activity or physiological activity for each nerve fiber (Fig. 11; Fig. 13-14; [0060] “mapped to corresponding locations”; [0068]).
Regarding claim 14, in the combination of Moffitt and Toth, Moffitt teaches a computer-implemented method for controlling selective neural stimulation, comprising the steps of
receiving a computational anatomical model, wherein the computational anatomical model comprises an estimate of the anatomy of neural tissue of a subject, wherein the estimate is determined according to the method of claim 12 (see regarding claim 12 above; Fig. 8-13; Fig. 14-16; [0060]; [0063]; [0082]),
determining, based on the computational anatomical model and on information of electrode locations of a plurality of electrodes arranged in different electrode locations adjacent the neural tissue, a stimulation parameter set for the plurality of electrodes for stimulation of at least one target fiber, wherein the target fiber is a fiber of the neural tissue of the subject corresponding to a desired change in a physiological activity or neural activity (Fig. 8-16; [0068]-[0069]; [0071]; [0081]-[0082]).
Regarding claim 15, in the combination of Moffitt and Toth, Moffitt teaches outputting the stimulation parameter set to a control unit for triggering output of a stimulation signal using the stimulation parameter set to selected electrodes in the plurality of electrodes for causing stimulation of the at least one target fiber (Fig. 4; Fig. 13; Fig. 14-17; [0071]; [0081]-[0082]).
Regarding claim 16, in the combination of Moffitt and Toth, Moffitt teaches wherein determining the stimulation parameter set comprises calculating the number of off-target fibers and target fibers activated by a candidate stimulation parameter set, and determining the stimulation parameter set for avoiding stimulation of off-target fibers, when stimulating the at least one target fiber ([0068] “preferentially stimulate one of the fascicles over the other if the fascicles contain different sizes of nerve fibers”).
Regarding claim 17, in the combination of Moffitt and Toth, Moffitt teaches wherein the stimulation parameter set comprises at least one of
a pair of selected electrodes (Fig. 14; [0009]; [0079]),
a current amplitude (Fig. 14; [0068]),
a pulse shape ([0071])
a frequency (Fig. 14; [0071]),
a duration time of the stimulation ([0010]; [0093])
a pulse repetition frequency (Fig. 14; [0071]), or
a pulse width (Fig. 14; [0071]).
Regarding claim 18, in the combination of Moffitt and Toth, Moffitt teaches non-transitory computer readable medium, having instructions stored thereon which, when executed on a processing unit will cause the processing unit to perform the method according to claim 14 (see claim 14 above; Fig. 4; [0011]; [0042]).
Regarding claim 19, in the combination of Moffitt and Toth, Moffitt teaches wherein the processing unit is configured to perform a computer-implemented method for controlling selective neural stimulation (Fig. 4; [0042]), comprising the steps of
receiving a computational anatomical model, wherein the computational anatomical model comprises an estimate of the anatomy of neural tissue of a subject,
determining, based on the computational anatomical model and on information of electrode locations of a plurality of electrodes arranged in different electrode locations adjacent the neural tissue, a stimulation parameter set for the plurality of electrodes for stimulation of at least one target fiber, wherein the target fiber is a fiber of the neural tissue of the subject corresponding to a desired change in a physiological activity or neural activity (Fig. 8-16; [0068]-[0069]; [0071]; [0081]-[0082]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt and Toth as applied to claim 1 above, in view of Offutt (US 20230256251 A1; 8/17/2023; cited in previous office action).
Regarding claim 11, in the combination of Moffitt and Toth, Moffitt does not teach wherein the processing unit is further configured to receive updated data representing relations between the plurality of stimulation signals and the indications of changes in the neural activity or the physiological activity, wherein the processing unit is configured to determine an updated relation between the electrode arrangement and the neural tissue using the estimate of the anatomy of the neural tissue of the subject. As an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143). However, Offutt teaches in the same field of endeavor ([0007]; [0012]; claims 13, 18) wherein the processing unit is further configured to receive updated data representing relations between the plurality of stimulation signals and the indications of changes in the neural activity or the physiological activity, wherein the processing unit is configured to determine an updated relation between the electrode arrangement and the neural tissue using the estimate of the anatomy of the neural tissue of the subject (Fig. 5-6; [0044]-[0045]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt and Toth to include these features as taught by Offutt because this enables flexibility in treatment in response to nerve to electrode distance changes due to movement (Fig. 5; [0007]; [0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
He (US 20170120048 A1; 5/4/2017) teaches electrical stimulation of nerves with identification of nerve sites to apply treatment (Fig. 2A-2E; [0002]) in which a data storage comprising a database comprising previously determined nerve anatomy data sets, each previously determined nerve anatomy data set comprising responses to stimulation signals of neural tissue having a known anatomy ([0039] “As previously mentioned, in some examples, a virtual map of a desired body part may be generated, e.g., by a processor within controller 280, and displayed, e.g., on interface 270. In some examples, the displayed virtual map may be pre-set. For example, interface 280 will display the same body part with the same shape and the number and configuration of electrodes during every use/procedure. In other examples, the displayed virtual map may be based on real-time data/analysis. For example, data analysis may involve pattern recognition in which a particular pattern is recognized as a signature of bladder activity. Each time an electrode senses this pattern (e.g., by finding a match in a previously recorded database of responses/patterns), the active area may be identified/marked. For example, information may be stored on medical device 250, so that, once medical device 250 is connected to controller 270 and/or interface 280, the virtual map may be generated based on the shape of the electrode array, number of electrodes, and/or electrode configuration. Similarly, controller 270 and/or the processor within controller 270 may be able to sense the shape of the electrodes so that, once in an expanded configuration (e.g., contracting an interior wall of a body part), the shape of the electrode array may affect the displayed shape of the body part. For example, electrode array 116 may expand to contact the interior walls of the bladder and based on the expanded shape of electrode array 116, a virtual map may be generated that approximates the size and shape of the patient's bladder.”; [0052] “These measurements may be stored as “vector impedance” values. Once impedance values are measured and/or stored in controller 270 for each vector, a nerve recruitment curve may be acquired by titrating up the current for each of these vectors and measuring the EMG response at other electrodes. An activation threshold (e.g., the current at which an EMG response above a given threshold is measured) may be recorded and/or stored (e.g., in the memory of controller 270) for each vector. The activation threshold may be divided by the determined impedance for each vector (e.g., by the processor within controller 270) to determine the voltage required at each site. The operator and/or processor may determine the sites with lowest voltage required to elicit a response. In some examples, the representative markings associated with these sites in virtual map 200 may be displayed with the third indicator (e.g., markings 25, 26, 29, 30, 33, and 37 may be red).”; [0060] “In some examples, there may be an interim “test ablation” period between the mapping (e.g., generating and/or displaying virtual map 200) and the ablation step (e.g., in examples where the selected treatment is a form of ablation). For example, a medical device (e.g., medical device 250 and/or electrode array 116) may stimulate nerves and/or sense electrical activity in order to map and determine ideal ablation zones”; [0067] “In one example, a method may include measurement of the entire bladder activity, then a ‘rest phase’ (e.g., no measurement), followed by another whole bladder measurement, followed by ‘rest phase’ and so forth. This way the bladder is mapped in different stages and a comprehensive map is created (using an average of activity per electrode for example) to pinpoint the highly active sites. The rest phase may include filling the bladder and/or stimulating (mechanical, electrical, etc.) the bladder, followed by another measurement and subsequent measurement-stimulus cycles from which an average may be obtained for a final bladder activity map.”)
wherein the processing unit is further configured to generate the estimate of the anatomy of the neural tissue of the subject based at least in part on a comparison between the received data representing relations between the plurality of stimulation signals and the indications of changes in the neural activity or physiological activity of the subject and corresponding data stored in the database comprising the previously determined nerve anatomy data sets (see above; [0039; [0052]; [0060]; [0067]).
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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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