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 Objections
Claim 1 lines 4-5 recite “the pulse”, this language lacks antecedent basis and should read “a pulse”. Line 10 recites “the greater”, this language lacks antecedent basis and should read “a greater”. This language is also found in independent claims 12 (lines 5-6 and line 11) and 20 (lines 5-6 and 11).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 5 and 16 recite “wherein the first duration is determined according to a vital sign parameter of a user; and wherein the vital sign parameter includes any one or any combination of a respiration beat, a heartbeat rate, and a blood pressure value.” The language in claim 5 is directed towards signal processing and is considered to be computer implemented, stated another way this language is considered to be computer implemented functional language. In order to comply with the enablement requirement, with respect to computer implemented claim language, the specification must teach how to make and use the full scope of the claimed invention without undue experimentation. Below is the Wands factor analysis for the claim 5 limitations.
Breadth
The breadth of the claim language in claims 5 and 16 is considered to be expansive. The first duration is determined based on respiration beat, heartbeat rate, blood pressure or a combination of these sensed signals. Therefore there are likely multiple ways that this can be determined which increases the breadth of the claim.
Nature of the invention
The nature of the invention is complex.
State of the prior art
The state of the prior art is developing
Level of skill of one or ordinary skill in the art
The level of skill for one of ordinary skill in the art is high and likely PhD level.
Level of predictability in the art
The level of predictability in the art is low.
Amount of direction provided by the inventors and Existence of working examples
In this case there is no direction provided by the inventors. Paragraph 0046, which is the only paragraph which discusses the limitations of claim 5 states:
“In another example, the accumulated duration of pulse generation periods in which the evoked compound action potential is sensed by the neural stimulation device, i.e., the first duration, is determined according to vital sign parameters of the user, and the vital sign parameters include any one or any combination of a respiration beat, a heartbeat rate, and a blood pressure value. The first duration for sensing the evoked compound action potential by the neural stimulation device is set based on the vital sign parameters of the user, and the overall energy consumption of the neural stimulation device is reduced as much as possible while ensuring the sensing effectiveness”.
Paragraph 0046 does not provide any teaching as to how applicant intends to determine the first duration for sensing the ECAP based on a vital sign. This is a broad statement without providing any additional teachings as to how applicant intends for this to be done.
Furthermore, there are no working examples as to how the vital signs can or are used to set the durations. This results in missing information within the specification and thus undue experimentation is needed to determine the durations based on vital signs.
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 1-20 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. Any claim not specifically addressed below is considered rejected because the independent claims are rejected and they depend from the rejected independent claims.
Claims 1, 12 and 20 each recite “wherein the sensing delay time is the greater of a total duration of the pulse and a predetermined time.” This language is indefinite in that it is not clear what a greater of a total duration of the pulse and a predetermined time is. This is considered to mean that the sensing delay time is greater than the total pulse duration (i.e. the stimulation pulse) and also greater than a predetermined time. However, this it is not clear if this is an accurate assumption, these claims are therefore indefinite.
Claims 2 and 13 recite “evoked compound action potential needs to be sensed” and “instruct the ECAP sensor to turn on for sensing the evoked compound action potential in response to that the evoked compound action potential needs to be sensed”. This language is not understood and is therefore indefinite. It is unclear what applicant intends “needs to be sensed” to mean, it is further not clear how the processor determines this need. Further the language “to that the evoked” should likely not contain the word “that” and should read “to the evoked”.
Claim 2-3 and 13-14 recites “the evoked compound action potential needs to be sensed”. It is unclear what applicant intends “needs to be sensed” to mean, it is further not clear how the processor determines a need.
Claims 3 and 14 further recites “obtaining an accumulated duration of pulse generation periods”. It is unclear what applicant intends “an accumulated duration of pulse generation periods” to be. This could be an amount of time or it could be a count of pulses, this is unclear and therefore indefinite.
Claims 3-4 and 14-15 recite “accumulated duration”. It is unclear what applicant intends “an accumulated duration of pulse generation periods” to be. This could be an amount of time or it could be a count of pulses, this is unclear and therefore indefinite.
Claims 6 and 17 recite “the composite action potential that is sensed”. It is unclear if the composite action potential is the same as the ECAP or some other signal entirely. This language is therefore indefinite.
Claim 9 recites:
wherein the neural stimulation device includes a first timer, a fourth timer, and a fifth timer; wherein:
the first timer is configured to be in a first timing mode having a first timing duration, wherein the first timing duration is a duration of the pulse generation periods;
the fourth timer is configured to be in a fourth timing mode having a fourth timing duration, wherein the fourth timing duration is a duration of the current cycle period;
and the fifth timer is configured to be in a fifth timing mode having a fifth timing duration, wherein the fifth timing duration is the first duration;
and wherein the neural stimulation controller instructs the ECAP sensor to turn on in response to the fourth timer and the fifth timer not overflowing and the first timer overflowing
The language underlined indicates that the first timing duration and the fifth timing duration are the same duration. It is further unclear what applicant intends the language “overflowing” to be. This could be when the timer has expired but that is not clear from the claim language or from the specification.
Claim 5 is rejected under 35 U.S.C § 112, the specification does not provide enablement or discussion of the meaning of the claim limitations, therefore it is improper to rely on speculative assumptions regarding the meaning of a claim limitations and then base a rejection under 35 U.S.C. 103 on these assumptions. (In re Steele 305 F.2d 859,134 USPQ 292 (CCPA 1962)). These claims are not considered to be allowable in that the meaning cannot be determined.
Claims 9 and 16 are rejected under 35 U.S.C § 112, and the meaning is not understood and is indefinite, therefore it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions. (In re Steele 305 F.2d 859,134 USPQ 292 (CCPA 1962)). These claims are not considered to be allowable in that the meaning cannot be determined.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 6-7, 10, 12-13, 17-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weijand US 5,792,212.
Regarding claim 1: Weijand discloses a neural stimulator (figure 2, “nerve stimulation system”, column 2, lines 15-16) which includes a controller 47 (“processor”, figure 2; this is a neural stimulation controller in that stimulation to nerves is applied) a pulse generator 30 (“stimulation generator”, figure 2) and an ECAP sensor 41/42/43 (figure 2, column 3, lines 44-50); the controller is configured to:
instruct the ECAP sensor to turn on while instructing the pulse generator to generate the pulse a pulse (column 4, lines 50-62);
instruct the ECAP sensor to sense an ECAP after instructing the pulse generator to generate the pulse, the ECAP is sensed after delay 57 (figure 3, “the timing window W, initiated after delay ΔtD, commences at a time Tc and ends at time TDW”, column 3, lines 20-24);
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instruct the ECAP sensor to turn off after instructing the ECAP sensor to sense the ECAP signal after elapsing of the window (abstract, column 2, lines 11-33; “The delayed signal initiates a window circuit which enables the sense circuitry for a predetermined window duration which is timed to encompass the evoked response pattern.”);
wherein the sensing delay time (delay ΔtD) is greater than the stimulation pulse duration and a predetermined time (column 2, lines 11-33; the delay is shown in figure 1B and is greater than the stimulation pulse t0 time and includes the latency abstract).
Regarding claim 2: Weijand disclose that the controller 47 (“processor”, figure 2) determines whether the ECAP needs to be sensed before instructing the ECAP sensor to turn on (column 3, lines 50-63; the ECAP is only sensed if a stimulation is applied and this is considered to be the controller determining that the ECAP needs to be sensed); and instructing the ECAP sensor to turn on for sensing the ECAP signal in response to the ECAP needing to be sensed (column 3, lines 50-63).
Regarding claim 6: Weijand discloses that the controller 47 (“processor”, figure 2) updates a parameter of the pulse according using the ECAP in a feedback manner (column 4, lines 25-34; “stimulus parameters are optimally adjusted.”).
Regarding claim 7: Weijand discloses spinal cord stimulation (column 5, lines 53-55).
Regarding claim 10: Weijand figure 1B demonstrates a tonic spike at t0, this is considered to be a tonic spike and is the only stimulation shown therefore the device is constantly in the tonic spike mode.
Regarding claim 12: Weijand discloses a neural stimulation system (figure 2) which includes a neural stimulator (figure 2, “nerve stimulation system”, column 2, lines 15-16) which includes a controller 47 (“processor”, figure 2; this is a neural stimulation controller in that stimulation to nerves is applied) a pulse generator 30 (“stimulation generator”, figure 2) and an ECAP sensor 41/42/43 (figure 2, column 3, lines 44-50); the controller is configured to:
instruct the ECAP sensor to turn on while instructing the pulse generator to generate the pulse a pulse (column 4, lines 50-62);
instruct the ECAP sensor to sense an ECAP after instructing the pulse generator to generate the pulse, the ECAP is sensed after delay 57 (figure 3, “the timing window W, initiated after delay ΔtD, commences at a time Tc and ends at time TDW”, column 3, lines 20-24);
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instruct the ECAP sensor to turn off after instructing the ECAP sensor to sense the ECAP signal after elapsing of the window (abstract, column 2, lines 11-33; “The delayed signal initiates a window circuit which enables the sense circuitry for a predetermined window duration which is timed to encompass the evoked response pattern.”);
wherein the sensing delay time (delay ΔtD) is greater than the stimulation pulse duration and a predetermined time (column 2, lines 11-33; the delay is shown in figure 1B and is greater than the stimulation pulse t0 time and includes the latency abstract).
Regarding claim 13: Weijand disclose that the controller 47 (“processor”, figure 2) determines whether the ECAP needs to be sensed before instructing the ECAP sensor to turn on (column 3, lines 50-63; the ECAP is only sensed if a stimulation is applied and this is considered to be the controller determining that the ECAP needs to be sensed); and instructing the ECAP sensor to turn on for sensing the ECAP signal in response to the ECAP needing to be sensed (column 3, lines 50-63).
Regarding claim 17: Weijand discloses that the controller 47 (“processor”, figure 2) updates a parameter of the pulse according using the ECAP in a feedback manner (column 4, lines 25-34; “stimulus parameters are optimally adjusted.”).
Regarding claim 18: Weijand figure 1B demonstrates a tonic spike at t0, this is considered to be a tonic spike and is the only stimulation shown therefore the device is constantly in the tonic spike mode.
Regarding claim 20: Weijand discloses a method which uses a neural stimulator (figure 2, “nerve stimulation system”, column 2, lines 15-16) which includes a controller 47 (“processor”, figure 2; this is a neural stimulation controller in that stimulation to nerves is applied) a pulse generator 30 (“stimulation generator”, figure 2) and an ECAP sensor 41/42/43 (figure 2, column 3, lines 44-50); the controller is configured to:
instruct the ECAP sensor to turn on while instructing the pulse generator to generate the pulse a pulse (column 4, lines 50-62);
instruct the ECAP sensor to sense an ECAP after instructing the pulse generator to generate the pulse, the ECAP is sensed after delay 57 (figure 3, “the timing window W, initiated after delay ΔtD, commences at a time Tc and ends at time TDW”, column 3, lines 20-24);
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instruct the ECAP sensor to turn off after instructing the ECAP sensor to sense the ECAP signal after elapsing of the window (abstract, column 2, lines 11-33; “The delayed signal initiates a window circuit which enables the sense circuitry for a predetermined window duration which is timed to encompass the evoked response pattern.”);
wherein the sensing delay time (delay ΔtD) is greater than the stimulation pulse duration and a predetermined time (column 2, lines 11-33; the delay is shown in figure 1B and is greater than the stimulation pulse t0 time and includes the latency abstract).
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.
Claims 3-4, 11, 14-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Weijand US 5,792,212 in view of Dinsmoor et al. US 2021/0121698.
Regarding claims 3 and 14: Weijand discloses the claimed invention however Weijand does not specifically disclose obtaining an accumulated duration of pulse generation periods (considered to be a count) in which the ECAP has been sensed in a current cycle period and determining that the ECAP’s still need to be sensed according to the accumulated duration being less than a first duration that is predetermined, with the current cycle period including at least two pulse generation periods. Dinsmoor however teaches of delivering a pulse 1002 (figure 10), the number of pulses delivered is then calculated at 1004 (figure 10), if an ECAP is sensed (yes at 1006) then the ECAP is also counted. In this example the number of pulses delivered is M and the number of ECAP’s sensed is N. If no ECAP is sensed at 1006, and a threshold value for M is determined, if there have not been enough pulses delivered (no at 1012) the method continues back to pulse delivery at 1002 (see paragraphs 0136-0137). This is considered to be obtaining an accumulated duration of pulse generated periods in which an ECAP is sensed 1008 (figure 10); determining that the ECAP needs to be sensed in response to the accumulated duration being less than a first duration 1012 (figure 10) and there are at least 2 pulse generation periods (the feedback loop will include the pulse generation periods). It therefore would have been obvious in the art at the time the invention was filed to modify Weijand to include obtaining a count of pulse generation periods in which an ECAP was sensed and determining if more ECAP’s need to be sensed, with more than two pulse generation periods, as taught by Dinsmoor, in order to establish an N/M ratio which is the number of ECAPs sensed per the number of pulses delivered.
Regarding claims 4 and 15: Weijand/Dinsmoor discloses the claimed invention. Dinsmore further discloses a posture sensor as well as an activity sensor (paragraphs 0057 and 0090) which detect a patients posture (paragraph 0057). Dinsmoor further discloses that the sensors are used to initiate control pulses and ECAP sensing. In the example provided the sensing of ECAP’s is either increased or decreased based on the sensor input (paragraph 0090). Once the sensor sends a signal that the activity and/or posture is changed the frequency of ECAP sensing is also changed which is considered to be resetting. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weijand/Dinsmoor to include a posture sensor which changes the frequency of ECAP sensing, as taught by Dinsmoor, in order to dynamically sense ECAP signals to reduce power consumption (Dinsmoor, paragraph 0090).
Regarding claims 11 and 19: Weijand discloses generating a pulse 56 (figure 3) which is considered to be a pulse generation mode and turning the ECAP sensor on after the pulse (figure 1B, the sense window is synchronized, abstract). However Weijand does not disclose an excitation cluster, considered to be a pulse train. Dinsmoor however teaches of delivering a plurality control pulses (paragraph 0029) and the ECAP is sensed based on the delivery of the control pulse (paragraph 0030, “set of control pulses”, paragraph 0067). The control pulse can be the last pulse in a burst (paragraph 0124) and is used to elicit and sense an ECAP. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weijand to include a cluster of pulses or a pulse train with the last pulse used to sense the ECAP, as taught by Dinsmoor, in order to sense signals after the delivery of therapy.
Claim 8 is are rejected under 35 U.S.C. 103 as being unpatentable over Weijand US 5,792,212 in view of Thompson US 6,185,454.
Regarding claim 8: Weijand discloses a duration of a stimulation pulse ST
(figures 1A and 1B), the stimulation pulse is delivered at T0, this is when the pulse generator delivers a stimulation pulse to the tissue 56 (figure 3). Once the stimulation pulse ST is delivered or at the same time the stimulation pulse is delivered the T0 + TD is determined 57 (figure 3), the sensor is turned on at this time, then during the timing window W (figure 1B) is initiated, once the window W has ended TDW the sensor is then turned off to conserve power. Therefore Weijand discloses the timing of the stimulation delivery, timing of when the sensor is turned on, the timing of when the ECAP is sensed and when the timer is turned off. However Weijand does not disclose the use of timers. Thompson however teaches of a clock system 30 (figure 3) which includes a plurality of clocks/timers 34 and a plurality of circuits 32 (figure 3). Each circuit is capable of performing different circuit functions and the clocks provide clock timing signals (column 6, lines 3-15) for when the circuit is to be active. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weijand to include multiple clocks/timers such as a clock/timer to control stimulation, a clock/timer to control when the sensor turns on and a clock/timer to create a sensing window, as taught by the multiple clock/timers of Thompson, in order to time the various functions of the implanted device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796