DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/01/2025 has been entered.
Response to Arguments
Applicant's arguments filed 08/01/2025 have been fully considered but they are not persuasive.
Applicant does not provide any particular arguments regarding any particular limitations nor does Applicant address any particular section or sections of the cited art. Applicant’s amendment moves a previously addressed limitation to a dependent claim and therefore the Examiner is relying on the extensive prosecution history of the present application to clearly speak for the issues at hand, particularly noting the Board Decision dated 03/09/2023 and the most recent detailed responses provided in the Final Rejections dated 08/02/2024; 01/17/2024 (responsive to the particular arguments presented in the response dated 12/19/2023); and again on 02/04/2025, which has been reproduced below:
Applicant argues that “Nicolelis does not teach or suggest ‘afferent nerve stimulation’ where the signal ‘is below a motor threshold of 15 mA’ as recited in claims 1 and 21.” Applicant further argues “As discussed throughout the present Specification, the stimulation is ‘below the motor threshold (afferent stimulation), the current intensities are lower, there is no significant muscle contraction and the stimulation is thereby more comfortable and does not produce muscle fatigue.” Applicant then asserts Nicolelis only lists a few side effects of stimulation in par. [0050] (tingling, pain and muscle contraction) and does not disclose avoiding muscle contraction. The Examiner respectfully disagrees. Applicant’s citation of par. [0050] omits the statement clearly indicating muscle contraction is preferably avoided, “The last of these two side effects are preferably avoided”. As noted in the Final Rejection mailed 06/29/2021 (which was affirmed by the Board) and the Examiner’s Answer mailed 05/04/2022, one of ordinary skill in the art would understand that to avoid muscle contraction, stimulation must be applied that does not surpass the motor threshold (the threshold of stimulation which causes muscle contraction when met or crossed).
The Examiner further notes the specific threshold of 15 mA was addressed in the Final Rejection and the Examiner’s Answer and the Board was aware of such when reviewing the case on appeal. Therefore, the rejection is maintained for the same reasons set forth in the Final Rejection and Examiner’s Answer. The response to this threshold from the Examiner’s Answer is therefore incorporated below.
As a matter of background, the Examiner notes “afferent” nerves and fibers are commonly defined and understood to be sensory nerves and fibers. That is, the types of nerves and fibers that carry signals towards the central nervous system. For the sake of clarity, the opposite of afferent nerves are efferent nerves, also called motor nerves, that carry signals from the brain to the peripheral nervous system (see Hernandez et al., “Afferent vs Efferent Neurons). The Examiner notes this reference is purely relied on for informational background for this Examiner’s Answer and has not been utilized in any of the rejections made in the Final Rejection.
In view of the well-understood knowledge of afferent nerve being sensory nerves, the Examiner notes the plain and well-understood meaning of “afferent nerve stimulation” would simply encompass the stimulation of afferent (i.e. sensory) nerves.
The Examiner notes that the disclosure of Nicolelis clearly discloses this feature in par. [0051] as relied upon in the Final Rejection which states “The same general strategy can be used to stimulate the dorsal roots or the sensory branches of spinal nerves in order to obtain a similar motor effect.” (emphasis added). In summary, Nicolelis discloses stimulating the sensory branches of the spinal nerves and therefore discloses afferent nerve stimulation (simply the stimulation of sensory nerves).
Additionally, the Examiner notes Applicant’s claim states the application of afferent nerve stimulation is intended to “disrupt a low-frequency synchronization in corticobasal ganglia circuits”. As also noted in the Final Rejection, Nicolelis discloses, “The objective of the stimulator 12 is to deliver a signal that disrupts aberrant low frequency synchronization in motor related neural circuits to facilitate volitional movement.” (emphasis added). Therefore, not only does Nicolelis disclose targeting afferent (sensory) nerves, the stimulation applied by Nicolelis achieves the same result claimed by Appellant (disrupting aberrant low frequency synchronization in motor related neural circuits). Thus, the Examiner contends Nicolelis discloses “afferent nerve stimulation” when the term is given its plain meaning.
Regarding the avoidance of muscle contractions, Nicolelis discloses stimulation can have certain side effects such as “the perception of tingling, pain and ultimately muscle contraction” (par. [0050]), wherein the Examiner notes muscle contraction occurs when the motor threshold is exceeded. Nicolelis immediately follows up the list of side effects with the statement “The last two of these side effects are preferably avoided” (par. [0050]). The Examiner notes that to avoid muscle contraction, stimulation can clearly not be applied that surpasses the motor threshold. In summary, the Examiner notes Nicolelis discloses a) targeting afferent nerves (sensory nerves); b) disrupting aberrant low frequency synchronization in motor related neural circuits (which is the same result claimed by Applicant); and c) preferably avoiding muscle contraction (thus attempting to avoid the application of stimulation that surpasses the motor threshold).
The Examiner additionally noted Applicant describes stimulation of below 15mA as sufficient to avoid the motor threshold (see par. [0145] of PPGPUB 2014/0336722). The Examiner relied upon Nicolelis, which discloses applying stimulation amplitudes in the range of 180-450 microamperes (par. [0052]), which is clearly well-below the exemplary disclose amplitude value of 15 mA. Applicant argues that this embodiment of Nicolelis is drawn to the implanted embodiment of Nicolelis and not the embodiment wherein external electrodes are relied upon. Applicant argues the external embodiment relies on a range of 0-100mA (par. [0054]). However, the Examiner notes, given the entire disclosure of Nicolelis and the desire to avoid motor stimulation as previously discussed and in light of the statement of Nicolelis “The range of amplitude or intensity values of the stimulating signal depends on the patient and the effect sought” (par. [0038]), the Examiner contends that the external embodiment of Nicolelis would also clearly avoid or attempt to avoid the side effect of muscle contraction while stimulating afferent nerves. The entirety of the disclosure of Nicolelis describes the avoidance of motor (efferent) pathways in favor of afferent nerves. Lastly, the Examiner notes the 15mA example provided (and now claimed) by Applicant regarding the motor threshold is just that, an example. Lastly, those of ordinary skill in the art know that thresholds vary from patient to patient and there are no hard and fast threshold that apply to everyone, which is clearly set forth in the final sentence of par. [0038] of Nicolelis acknowledging the range of amplitudes and intensities is patient dependent.
Lastly, regarding Applicant’s arguments with respect to the Wei reference, the Examiner notes Wei is not relied upon for DBS and is instead Wei is relied upon to disclose using EEG as a type of control feedback in stimulation. A point acknowledged and upheld by the Board. The board noted that Applicant’s arguments are not commensurate in scope with the prior art as applied by the Examiner (p. 8 of the Board decision).
Therefore the rejection is maintained.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-9, 11-14, 18-21, 23, 24 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Nicolelis et al. (2011/0184489) in view of Boston (7,643,882), further in view of Wei et al. (2009/0105785).
Regarding Claims 1, 5, 13, 21, 23, 24 and 31, Nicolelis discloses a system and method for treating tremor in a patient comprising a non-invasive transcutaneous stimulation system (par. [0054]) that delivers stimulation to sensory (afferent) nerves (par. [0051]) such that aberrant low frequency synchronization is disrupted (par. [0038]). Nicolelis further discloses avoiding muscle contraction (par. [0050]) and using stimulation intensity values in the range of 180-450 microamperes, which is well below the range indicated by Applicant as causing motor stimulation (above approximately 15 mA, see par. [0145] of PGPUB 2014/0336722). Lastly, Nicolelis discloses that the stimulation is emitted at a frequency of 100-300 Hz, the selection of which can be considered Applicant’s second algorithm in a frequency domain that generates the nerve stimulation signal (par. [0038]). Nicolelis is silent regarding the use of the stimulation in a closed loop system driven by sensed physiological sensors and is silent regarding the use of transcutaneous EEG sensors .
However, Boston discloses utilizing closed loop feedback in a system for treating tremor wherein signals such as EMG signals are sensed and an analysis is performed in the time and frequency domain, such as obtaining frequency data and comparing it to a low pass or high pass threshold, in order to distinguish intentional from unintentional movement such that therapy is only applied when unintentional movement is detected (col. 9, line 43-col. 10, line 9). The therapy is then selected by a stabilization algorithm that utilizes a calibration step before and during stimulation to correctly time the stimulation and adjust parameters in the time domain to improve stimulation response (col. 10, line 62-col. 11, line 29), which can also be considered Applicant’s second algorithm for generating nerve stimulation signals in the time domain. This provides the benefit of allowing a patient to move freely without undesirably blocking or altering intentional movement by the application of stimulation.
Additionally, Wei discloses utilizing EEG sensors, such as external EEG sensors (par. [0187, 0189, 0194, 0220, 0228, 0241]), in a therapy system for detecting voluntary and involuntary movement for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement (par. [0155, 0164, 0231]). This is particularly beneficial in patients with impaired movement in that the intent to move as indicated by the EEG signal is used and not an actual limb movement, of which the patient may only have minimal ability.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nicolelis reference to include closed loop control, as taught and suggested by Boston, and to include EEG sensors, as taught and suggested by Wei, for the purpose of allowing a patient to move freely without undesirably blocking or altering intentional movement by the application of stimulation and for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement.
In an alternative interpretation of the prior art, Regarding Claims 1, 5, 13, 20, 21, 23 and 24, Nicolelis discloses a system and method for treating tremor in a patient comprising a non-invasive transcutaneous stimulation system (par. [0054]) that delivers stimulation to sensory (afferent) nerves (par. [0051]) such that aberrant low frequency synchronization is disrupted (par. [0038]). Nicolelis discloses that the stimulation is emitted at a frequency of 100-300 Hz, the selection of which can be considered Applicant’s second algorithm in a frequency domain that generates the nerve stimulation signal (par. [0038]). Additionally, Nicolelis broadly discloses utilizing stimulation below 20 mA beginning with the minimum intensity available with the stimulator used (par. [0049]). One exemplary parameter set includes the range of 180-450 microamperes. Nicolelis discloses the stimulation intensity of the afferent nerves is selected to disrupt aberrant low frequency synchronization (par. [0038]) and to avoid pain and muscle contraction (par. [0050]). Applicant discloses that stimulation intensities of approximately 12 mA to 23 mA that cause motor stimulation (par. [0145]) either performs equally with or better than afferent stimulation intensities of approximately 4-13 mA (par. [0145]) and that afferent stimulation can be used to avoid muscle fatigue due to a lack of motor response (par. [0149]). However, the Examiner notes Nicolelis discloses avoiding muscle contraction which would avoid the same issue of muscle fatigue.
Regardless, the Examiner notes the stimulation intensity ranges of afferent fibers disclosed by Nicolelis (0-20 mA) significantly overlaps with those disclosed by Applicant (4-13mA for sub-motor threshold and 12-23 of supra motor threshold) and that both stimulation regimens are designed to specifically disrupt aberrant low frequency synchronization in a patient to reduce tremor and improve volitional movement while avoiding muscle contraction. Therefore, while the stimulation parameters disclosed by Nicolelis and those contemplated by Applicant do not exactly match, the Examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to limit stimulation to below 15mA, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to limit the stimulation range to below 15 mA, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90. Lastly, the Examiner notes it would have been obvious to try values below 13mA since there are a finite number of identified, predictable stimulation values each having a reasonable expectation of success in disrupting aberrant low frequency synchronization, as noted by Nicolelis (utilizing a minimum value that obtains this result in the range of 0-20 mA).
Nicolelis is silent regarding the use of the stimulation in a closed loop system driven by sensed physiological sensors and is silent regarding the use of transcutaneous EEG sensors. However, Boston discloses utilizing closed loop feedback in a system for treating tremor wherein signals such as EMG signals are sensed and an analysis is performed in the time and frequency domain in order to distinguish intentional from unintentional movement such that therapy is only applied when unintentional movement is detected (col. 9, line 43-col. 10, line 9). The therapy is then selected by a stabilization algorithm that utilizes a calibration step before and during stimulation to correctly time the stimulation and adjust parameters in the time domain to improve stimulation response (col. 10, line 62-col. 11, line 29), which can also be considered Applicant’s second algorithm for generating nerve stimulation signals in the time domain. This provides the benefit of allowing a patient to move freely without undesirably blocking or altering intentional movement by the application of stimulation.
Additionally, Wei discloses utilizing EEG sensors, such as external EEG sensors (par. [0187, 0189, 0194, 0220, 0228, 0241]), in a therapy system for detecting voluntary and involuntary movement for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement (par. [0155, 0164, 0231]). This is particularly beneficial in patients with impaired movement in that the intent to move as indicated by the EEG signal is used and not an actual limb movement, of which the patient may only have minimal ability.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nicolelis reference to include closed loop control, as taught and suggested by Boston, and to include EEG sensors, as taught and suggested by Wei, for the purpose of allowing a patient to move freely without undesirably blocking or altering intentional movement by the application of stimulation and for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement.
In regards to Claims 3, 9-11 and 12, Nicolelis, Boston and Wei disclose an external programmer 14 having a display 98, memory 94, processor 92 and telemetry module 96 for wireless connection, wherein programmer 14 provides the benefit of allowing a clinician to review patient data obtained by the stimulator and alter stimulation parameters based on stored historical data and trends (Wei: Fig. 8, 10; par. [0060-0067, 0072, 0076, 0098, 0099]).
In regards to Claim 6, Nicolelis and Boston disclose accelerometers 93 can also be used for closed loop stimulation control (Boston, Fig. 5).
Regarding Claims 7 and 8, Nicolelis and Boston disclose all of the claimed invention except for the particular material of the sensors and electrodes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the sensors and electrodes of a thin film material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claims 14 and 18, Nicolelis and Boston disclose utilizing EMG sensors or accelerometers to identify tremor but are silent regarding the use of EEG sensors. Wei discloses utilizing EEG sensors in a therapy system for detecting voluntary and involuntary movement for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement (par. [0155, 0164, 0231]). This is particularly beneficial in patients with impaired movement in that the intent to move as indicated by the EEG signal is used and not an actual limb movement, of which the patient may only have minimal ability. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nicolelis and Boston combination to include EEG sensors, as taught and suggested by Wei, for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement.
Regarding Claims 19 and 20, which contains similar language to that in rejected Claim 1 above, Nicolelis discloses a system and method for treating tremor in a patient comprising a non-invasive transcutaneous stimulation system (par. [0054]) that delivers stimulation to sensory (afferent) nerves (par. [0051]) such that aberrant low frequency synchronization is disrupted (par. [0038]). Nicolelis further discloses avoiding muscle contraction (par. [0050]) and using stimulation intensity values in the range of 180-450 microamperes, which is well below the range indicated by Applicant as causing motor stimulation (above approximately 15 mA, see par. [0145] of PGPUB 2014/0336722). Lastly, Nicolelis discloses that the stimulation is emitted at a frequency of 100-300 Hz, the selection of which can be considered Applicant’s second algorithm in a frequency domain that generates the nerve stimulation signal (par. [0038]). Nicolelis is silent regarding the use of the stimulation in a closed loop system driven by sensed physiological sensors and is silent regarding the use of transcutaneous EEG sensors.
However, Boston discloses utilizing closed loop feedback in a system for treating tremor wherein signals such as EMG signals are sensed and an analysis is performed in the time and frequency domain, such as obtaining frequency data and comparing it to a low pass or high pass threshold, in order to distinguish intentional from unintentional movement such that therapy is only applied when unintentional movement is detected (col. 9, line 43-col. 10, line 9). The therapy is then selected by a stabilization algorithm that utilizes a calibration step before and during stimulation to correctly time the stimulation and adjust parameters in the time domain to improve stimulation response (col. 10, line 62-col. 11, line 29), which can also be considered Applicant’s second algorithm for generating nerve stimulation signals in the time domain. This provides the benefit of allowing a patient to move freely without undesirably blocking or altering intentional movement by the application of stimulation.
Additionally, Wei discloses utilizing EEG sensors, such as external EEG sensors (par. [0187, 0189, 0194, 0220, 0228, 0241]), in a therapy system for detecting voluntary and involuntary movement for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement (par. [0155, 0164, 0231]). This is particularly beneficial in patients with impaired movement in that the intent to move as indicated by the EEG signal is used and not an actual limb movement, of which the patient may only have minimal ability.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nicolelis reference to include closed loop control, as taught and suggested by Boston, and to include EEG sensors, as taught and suggested by Wei, for the purpose of allowing a patient to move freely without undesirably blocking or altering intentional movement by the application of stimulation and for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement.
In an alternative interpretation of the prior art, Regarding Claims 19 and 20, Nicolelis discloses a system and method for treating tremor in a patient comprising a non-invasive transcutaneous stimulation system (par. [0054]) that delivers stimulation to sensory (afferent) nerves (par. [0051]) such that aberrant low frequency synchronization is disrupted (par. [0038]). Nicolelis discloses that the stimulation is emitted at a frequency of 100-300 Hz, the selection of which can be considered Applicant’s second algorithm in a frequency domain that generates the nerve stimulation signal (par. [0038]). Additionally, Nicolelis broadly discloses utilizing stimulation below 20 mA beginning with the minimum intensity available with the stimulator used (par. [0049]). One exemplary parameter set includes the range of 180-450 microamperes. Nicolelis discloses the stimulation intensity of the afferent nerves is selected to disrupt aberrant low frequency synchronization (par. [0038]) and to avoid pain and muscle contraction (par. [0050]). Applicant discloses that stimulation intensities of approximately 12 mA to 23 mA that cause motor stimulation (par. [0145]) either performs equally with or better than afferent stimulation intensities of approximately 4-13 mA (par. [0145]) and that afferent stimulation can be used to avoid muscle fatigue due to a lack of motor response (par. [0149]). However, the Examiner notes Nicolelis discloses avoiding muscle contraction which would avoid the same issue of muscle fatigue.
Regardless, the Examiner notes the stimulation intensity ranges of afferent fibers disclosed by Nicolelis (0-20 mA) significantly overlaps with those disclosed by Applicant (4-13mA for sub-motor threshold and 12-23 of supra motor threshold) and that both stimulation regimens are designed to specifically disrupt aberrant low frequency synchronization in a patient to reduce tremor and improve volitional movement while avoiding muscle contraction. Therefore, while the stimulation parameters disclosed by Nicolelis and those contemplated by Applicant do not exactly match, the Examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to limit stimulation to below 13 mA, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to limit the stimulation range to below 13 mA, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90. Lastly, the Examiner notes it would have been obvious to try values below 13mA since there are a finite number of identified, predictable stimulation values each having a reasonable expectation of success in disrupting aberrant low frequency synchronization, as noted by Nicolelis (utilizing a minimum value that obtains this result in the range of 0-20 mA).
Nicolelis is silent regarding the use of the stimulation in a closed loop system driven by sensed physiological sensors and is silent regarding the use of transcutaneous EEG sensors. However, Boston discloses utilizing closed loop feedback in a system for treating tremor wherein signals such as EMG signals are sensed and an analysis is performed in the time and frequency domain in order to distinguish intentional from unintentional movement such that therapy is only applied when unintentional movement is detected (col. 9, line 43-col. 10, line 9). The therapy is then selected by a stabilization algorithm that utilizes a calibration step before and during stimulation to correctly time the stimulation and adjust parameters in the time domain to improve stimulation response (col. 10, line 62-col. 11, line 29), which can also be considered Applicant’s second algorithm for generating nerve stimulation signals in the time domain. This provides the benefit of allowing a patient to move freely without undesirably blocking or altering intentional movement by the application of stimulation.
Additionally, Wei discloses utilizing EEG sensors, such as external EEG sensors (par. [0187, 0189, 0194, 0220, 0228, 0241]), in a therapy system for detecting voluntary and involuntary movement for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement (par. [0155, 0164, 0231]). This is particularly beneficial in patients with impaired movement in that the intent to move as indicated by the EEG signal is used and not an actual limb movement, of which the patient may only have minimal ability.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nicolelis reference to include closed loop control, as taught and suggested by Boston, and to include EEG sensors, as taught and suggested by Wei, for the purpose of allowing a patient to move freely without undesirably blocking or altering intentional movement by the application of stimulation and for the purpose of providing feedback for therapy using involuntary movement and controlling therapy with detected voluntary movement.
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Nicolelis et al. (2011/0184489) in view of Boston (7,643,882), further in view of Wei et al. (2009/0105785) and Giuffrida et al. (2013/0123666). Nicolelis, Boston and Wei disclose treating and suppressing tremor using neurostimulation, wherein accelerometers are used to distinguish voluntary from involuntary movement. See rejection of Claim 1 above in this action. Nicolelis, Boston and Wei are silent regarding the use of gyroscopes for quantifying tremor. However, Giuffrida discloses utilizing gyroscope data and comparing the peak power of the data in a frequency domain to a threshold to distinguish voluntary motion from involuntary motion (par. [0110]). Giuffrida further discloses that the gyroscope data can be combined with accelerometer data to track and distinguish tremor from voluntary motion and multiple sensors of each type can be sued to provide further details in three or more axes (par. [0056-0057]). Doing so would provide a more detailed and accurate picture of patient motion thus ensuring more accurate detection of tremor. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Nicolelis, Boston and Wei combination to include multiple gyroscopes, as taught and suggested by Giuffrida, for the purpose of providing a more detailed and accurate detection of tremor in a patient.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Applicant has moved a limitation from Claim 1 into new claim 31 and new claim 31 is word-for-word the same as previously rejected claim 1. Additionally, currently amended claim 1 has been broadened and is patentably indistinct from previously rejected Claim 1. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/ALLEN PORTER/Primary Examiner, Art Unit 3796