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 .
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 1-21 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.
Claim 1 recites the limitations "the electric current provided according to first characteristics”, “information indictive of the first characteristics of the electric current” , and “ second characteristics of the electric current” in lines 5, 10, and 19. It is unclear what the applicant is referring to as first characteristics and how they differ from the second characteristics. Characteristic could be defined as parameters of the current, such as amplitude, or time applied, or they could be defined as the physical characteristics of the patient as current is applied. Therefore, the claim, and its dependent claims, are rendered indefinite.
Claim 14 recites the limitations "the electric current provided according to first characteristics”, “information indictive of the first characteristics of the electric current”, and “ second characteristics of the electric current” in lines 5, 10, and 18. It is unclear what the applicant is referring to as first characteristics and how they differ from the second characteristics. Characteristic could be defined as parameters of the current, such as amplitude, or time applied, or they could be defined as the physical characteristics of the patient as current is applied. Therefore the claim, and its dependent claims, are rendered indefinite.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-7, 9-21 are rejected under 35 U.S.C. 103 as being unpatentable over Rocon de Lima(US 20140336722 A1), herein after Rocon, in view of Marnfeldt(US 20140257427 A1) and further in view of Giuffrida(WO 2012166860 A1) (all cited previously).
Regarding claims 1, 6, 14, and 15, Rocon teaches a method for reducing severity of a tremor of a subject (Rocon, [0001]) the method comprising: storing, via a computing system, prior tremulous movement data(Rocon [0029]); transmitting, via a stimulation unit and at least two electrodes, electric current to at least one muscle of the subject that is associated with the tremor (Rocon, [0009], Fig. 4, [0059]); at least one sensor (regarding claim 6) receiving, in the computing system from at least one sensor placed on at least one body part of the subject, data indicating tremulous movements of the at least one body part or the at least one muscle, (Rocon, [0010-11]); storing, via the computing system, the received data (Rocon, [0022], store measurements that are based on acquired signals; the signals would have to be stored at least for a short time in order to process them into measurements); determining, via the computing system from the stored data, measurements associated with the tremulous movements (Rocon, [0022], store measurements that are based on acquired signals; the signals are based on tremulous movements, [0020], [0024], [0029]); determining, via the computing system from the prior tremulous movement data, an average of the prior tremulous movement data; (Rocon, {[0059], {[0030], closed-loop stimulation is responsively changing characteristics of the electric current). Rocon does not teach comparing present and previous body movement measurements and responsively changing characteristics of the electric current if the measurements associated with the latest movement are the same as or greater than the measurements associated with the at least one previous movement. Rocon further fails to disclose information indictive of the first characteristics of the electric current, the electric current provided according to first characteristics; and second characteristics of the electric current.
However, Marnfeldt teaches sending feedback signals when a switch has been detected from a tremor to no-tremor condition or vice versa (Marnfeldt, [0046]), then changing the stimulation based on this signal, wherein the movement algorithm is further configured to compare the amplitude and frequency relative to one or more threshold to determine if the patient movements are indicative of the patient tremor, and wherein the one or more signals are based on the comparison to the one or more thresholds(claim 16). This constitutes movements that are the same or greater (tremor now, versus no tremor in the past) than those previously detected, and adjusting the signal accordingly. Marnfeldt further teaches the device of claim 15, further comprising a memory configured to store information regarding transmissions of the one or more feedback signals(claim 24), If the communication involves adjustment to the therapy the IPG 10 is providing to the patient, the control circuitry 15 communicates relevant instructions to stimulation circuitry 27. As is known, stimulation circuitry 27 includes various current or voltage sources which can be coupled to selected electrodes 16 to provide desired therapy to the patient. Such therapy, typically referred to as a stimulation program, generally specifies various parameters for the stimulation, such as which electrodes 16 are active, whether such electrodes act as anodes (current sources) or cathodes (current sinks), and the duration, frequency, and amplitude of pulses formed at the electrodes[0011].
It would have been obvious to one having ordinary skill in the art to use feedback and comparisons to prior tremor states, that is, comparing measurements associated with a latest tremulous movement to measurements associated with at least one prior tremulous movement, and responsively changing the characteristics of the electrical current if the measures associated with the latest tremulous movement are the same as or greater than the measurements associated with the at least one previous tremulous movement, because controlling the electrical stimulation avoids wasting power and annoying the user through unnecessary stimulation that is applied even after no tremor has been detected, but to start up the stimulation again when tremor reappears, in order to maintain therapeutic effectiveness.
Giuffrida further teaches after each stimulation parameter change, the clinician uses the user interface 7 or the improved user interface 10 and guides the subject through motor tasks. The tuning algorithm output provides a suggested parameter direction output after each motor task evaluation by utilizing the movement disorder quantification algorithm. The invention thereby maximizes clinical benefit by minimizing tremor and bradykinesia, minimizes adverse effects of stimulation-induced dyskinesias, and minimizes current consumption to maximize battery life. Thus, one objective function is to minimize the sum of average tremor score (ATS)(col. 21, lines 27-31).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the method for monitoring tremors of Rocon with the method for tuning movement disorder therapy devices of Giuffrida. Doing so would incorporate an averaging of the tremor measurements that is taken after each change to the stimulation to evaluate the effectiveness of the stimulation.
Regarding claim 2, Rocon teaches a filter to remove selected data (Rocon, [0128]). Though Rocon only teaches filters with regard to EMG data, it would have been obvious to one having ordinary skill in the art to apply the filters to movement data as well, to select for removal the artifacts that are the inevitable result of imperfect coupling between sensor and skin.
Regarding claim 3, Rocon teaches that calculations further comprise calculating frequencies and an amplitude of a wave from the filtered data (Rocon, [0033], [0128]).
Regarding claim 5, Rocon teaches that the electric current is delivered to the body region via the at least two electrodes positioned over the at least one muscle on the body region that experience tremor (Rocon, Fig. 4).
Regarding claims 7 and 16, Rocon teaches that the at least one sensor comprises one or more of the following: (i) a motion sensor, and (ii) an electromyogram (Rocon, [0024- 0025]).
Regarding claims 9-10, and 17-18, Rocon teaches that the characteristics of the electric current include a frequency of the electric current (Rocon, [0059-60], stimulate in a range of frequencies aimed at desynchronizing tremor network). Rocon does not specifically teach that the voltage of stimulation is modified before each stimulus; however, based on Rocon’s teaching that the stimulation factors that may be configured include amplitude (Rocon, [0131]), it would have been obvious to one having ordinary skill in the art that the characteristics of the electric current would include amplitude as well as frequency.
Regarding claim 11, Rocon teaches that the subject may have Parkinson’s disease (Rocon, [0003]).
Regarding claim 12, Rocon teaches that the method may be used to monitor treatment of an essential tremor disease or a movement disorder in the subject (Rocon, [0003], treating the subject and recording results constitutes monitoring treatment).
Regarding claim 13, Rocon teaches wherein the at least one sensor includes an array of sensors placed on multiple body parts of the subject(Rocon, Fig. 2, [0115],[0118]).
Regarding claims 19 and 20, Rocon teaches wherein responsively changing the first characteristics: changing frequencies of the electric current(Rocon, [0059-60], stimulate in a range of frequencies aimed at desynchronizing tremor network); but fails to disclose changing a voltage of the electric current when measurements associated with a second latest tremulous movement after the frequencies that have been changed are the same as or greater than the average of the prior tremulous movement data. However, Marnfedlt teaches wherein the therapy to the patient comprises a current or voltage, and wherein the one or more instructions comprise an instruction to increase or decrease an amplitude of the current or voltage(claim 36).
It would have been obvious to one having ordinary skill in the art to use feedback and comparisons to prior tremor states, that is, comparing measurements associated with a latest tremulous movement to measurements associated with at least one prior tremulous movement, and responsively changing the characteristics of the electrical current if the measures associated with the latest tremulous movement are the same as or greater than the measurements associated with the at least one previous tremulous movement, because controlling the electrical stimulation avoids wasting power and annoying the user through unnecessary stimulation that is applied even after no tremor has been detected, but to start up the stimulation again when tremor reappears, in order to maintain therapeutic effectiveness.
Giuffrida further teaches after each stimulation parameter change, the clinician uses the user interface 7 or the improved user interface 10 and guides the subject through motor tasks. The tuning algorithm output provides a suggested parameter direction output after each motor task evaluation by utilizing the movement disorder quantification algorithm. The invention thereby maximizes clinical benefit by minimizing tremor and bradykinesia, minimizes adverse effects of stimulation-induced dyskinesias, and minimizes current consumption to maximize battery life. Thus, one objective function is to minimize the sum of average tremor score (ATS)(col. 21, lines 27-31).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the method for monitoring tremors of Rocon with the method for tuning movement disorder therapy devices of Giuffrida. Doing so would incorporate an averaging of the tremor measurements that is taken after each change to the stimulation to evaluate the effectiveness of the stimulation.
Regarding claim 21, Rocon teaches a filter to remove selected data (Rocon, [0128]) and that calculations further comprise calculating frequencies and an amplitude of a wave from the filtered data (Rocon, [0033], [0128)). Though Rocon only teaches filters with regard to EMG data, it would have been obvious to one having ordinary skill in the art to apply the filters to movement data as well, to select for removal the artifacts that are the inevitable result of imperfect coupling between sensor and skin.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rocon in view of Marnfeldt and Giuffrida, further in view of Toth et al. (US Patent Application Publication 2015/0351690), hereinafter Toth (cited previously).
Regarding claim 4, the modified Rocon invention does not teach its buffering processes in detail. However, in the art of collecting data, it is common to have data management systems set up to deal with disposal of prior data to make room for new data, because storage media are generally of finite size. Toth teaches a body-worn sensing system in which a FIFO (First in, first out) buffer is used, meaning that the oldest data is discarded as new data arrives. It would therefore have been obvious to one having ordinary skill in the art to remove a quantity of the prior tremulous movement data with a longest storage time (that is, the data that was “first in’) after a predetermined data capacity, that is, a buffer size, is reached.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rocon in view of Marnfeldt and Giuffrida, further in view of Hamilton et al. (US Patent Application Publication 2013/0123568), hereinafter Hamilton (cited previously).
Regarding claim 8, the modified Rocon invention teaches using waveform-based sensed data to come up with a stimulation signal (Rocon, [0043-0045], [0060]) and to transmit electrical current via the at least one electrode to the at least one muscle (Rocon, Fig. 4). However, Rocon does not specifically teach that the transmission of electrical current is done by a continuous wave train. Hamilton teaches that a closed-loop electrical stimulation system using electrodes to stimulate the muscles of a peripheral nervous system may use a pulse waveform that is biphasic and charge balanced (Hamilton, [0042]); this waveform maybe in the form of a sinusoidal, square, or triangular wave shape (Hamilton, [0058]), which indicates the use of a continuous wave train. Since Rocon does not clearly teach the form of the stimulation wave, it would have been obvious to one having ordinary skill in the art to utilize a continuous wave train, as taught in the Hamilton reference, which describes a related invention.
Response to Arguments
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive. Applicant argues that Rocon in view of Marnfeldt and Giuffrida fails to disclose “ electric current is provided according to first characteristics. Data is then received from at least one sensor that indicates tremulous movements of at least one body part or at least one muscle. The received data is stored in conjunction with information indictive of the first characteristics of the electric current. When measurements associated with the latest tremulous movement are the same as or greater than an average of prior tremulous movement data, the first characteristics of the electric current are changed to second characteristics of the electric current”. However, Marnfeldt teaches “Feedback signal FB can comprise different pieces of information, such as: the tremor values A and f, or merely one of these values; an instruction to make a specific adjustment to the therapy, such as increasing or decreasing the current amplitude I either by set or variable amounts; or an entire stimulation program, specifying all stimulation parameters to be used by the stimulation circuitry 27[0045]”, “For example, the fitting/adjustment module 180 can provide a first stimulation program (SP1) to the stimulation circuitry 27, prescribing the current amplitude (a1), pulse duration (d1), pulse frequency (f1), active electrodes (E1), and electrode polarity (+). Tremor 102 can then be monitored, and a feedback signal transmitted from the ring 110 to the IPG 111 in any of the manners mentioned earlier. The fitting/adjustment algorithm 180 upon receipt of this feedback signal can issue another simulation program (SP2) to see if it reduces tremor 102 even further by varying one of the parameters comprising the simulation program[0062]”, “The device of claim 15, further comprising a memory configured to store information regarding transmissions of the one or more feedback signals[claim 24]”. Marnfeldt describes starting with initial parameters for current and stimulation and then adjusting to secondary values based on the patient response, and storing the information obtained in a memory unit. Therefore, Rocon in combination with Marnfeldt, Giuffrida, and the other previously stated reference disclose all claims, therefore the 103 rejections stand.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796