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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 101
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.
Claim(s) 18 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim(s) 18 recites “A computer program product”. Instant specification p. 15 last line states (emphasis added) “the computer program product may be provided as a signal carrying the computer-readable instructions for allowing the computer program product to be loaded into a memory accessible to the processing unit”. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. The above claimed structure is described in non-limiting open-ended language, and the broadest reasonable interpretation is not limited to non-transitory media.
In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable carrier that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation “non-transitory” to the claim.
See MPEP 2106.03 I:
Non-limiting examples of claims that are not directed to any of the statutory categories include:
• Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations;
• Transitory forms of signal transmission (often referred to as "signals per se"), such as a propagating electrical or electromagnetic signal or carrier wave; and
• Subject matter that the statute expressly prohibits from being patented, such as humans per se, which are excluded under The Leahy-Smith America Invents Act (AIA ), Public Law 112-29, sec. 33, 125 Stat. 284 (September 16, 2011).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-10, 12-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moffitt (US 20230064552 A1; 3/2/2023; cited in IDS).
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]).
Regarding claim 2, 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, 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, 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, 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, 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, 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, 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, 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]).
Regarding claim 13, 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, 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, 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, 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, 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, Moffitt teaches a computer program product comprising computer-readable instructions such that when executed on a processing unit the computer program product will cause the processing unit to perform the method according to claim 14 (see claim 14 above; Fig. 4; [0011]; [0042]).
Regarding claim 19, 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 Rejections - 35 USC § 103
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt as applied to claim 1 above, in view of Freeman (US 20180249954 A1; 9/6/2018).
Regarding claim 7, Moffitt does not teach a data storage, wherein the data storage is configured to store nerve anatomy data sets and wherein the processing unit is further configured to generate the estimate of the anatomy of the neural tissue of the subject by comparing the received data with stored nerve anatomy data sets. However, Freeman teaches in the same field of endeavor (Abstract; [0006]) a data storage, wherein the data storage is configured to store nerve anatomy data sets and wherein the processing unit is further configured to generate the estimate of the anatomy of the neural tissue of the subject by comparing the received data with stored nerve anatomy data sets ([0019] “additional data 180 (that can include stored information on nerve paths in the subject tissue/organ)…”). 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 Freeman because this enables mapping relative locations of nerves sensed and using a global coordinate system ([0019]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt as applied to claim 1 above, in view of Offutt (US 20230256251 A1; 8/17/2023).
Regarding claim 11, 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 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.
Toth (US 20160029960 A1) teaches stimulating nerves in order to map and assess renal nerves to prepare for treatment (Fig. 1c; Fig. 8a).
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