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 .
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “neuromodulation device” in claims 1, 17 and 20, equivalent structures of which are described at [0060] of the instant publication.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-16, 19 and 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.
Claim 1 at line 3 recites the limitation "the patient’s current desired arousal state". There is insufficient antecedent basis for this limitation in the claim.
Claim 2 at line 3 recites the limitation "the patient’s desired sleep state". There is insufficient antecedent basis for this limitation in the claim.
Claim 4 at line 3 recites the limitation "the sleep therapy program of the neuromodulation device". There is insufficient antecedent basis for this limitation in the claim. A suggested amendment to this clause is deletion of the phrase “of the neuromodulation device”.
Claim 5 at line 2 recites the limitation "the patient’s wakeup time". There is insufficient antecedent basis for this limitation in the claim.
Claim 6 at line 2 recites the limitation "the patient’s sleep time". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 at line 3 recites the limitation "the patient’s input". There is insufficient antecedent basis for this limitation in the claim.
Claim 19 at line 3 recites the limitation "the sleep therapy program of the neuromodulation device". There is insufficient antecedent basis for this limitation in the claim. A suggested amendment to this clause is deletion of the phrase “of the neuromodulation device”.
Claim 20 at line 5 recites the limitation "the patient’s physiological data. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 at line 18 recites the limitation "the sleep therapy program of the neuromodulation device". There is insufficient antecedent basis for this limitation in the claim. A suggested amendment to this clause is deletion of the phrase “of the neuromodulation device”.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (U.S. Pub. No. 2015/0306391). Regarding claim 1, Wu et al. (hereinafter Wu) teaches a method of operating a neuromodulation device to modify or achieve a desired arousal state in a patient [0157], the method comprising:
determining the patient's current desired arousal state ([0157]: a patient may desire to stay awake during the day and not fall asleep; or a patient may desire to fall asleep and maintain sleep);
detecting one or more signals that are related to the desired arousal state, the one or more signals being sensed from the patient or provided by an external source [0155]-[0158] and Fig. 7; [0136], [0142]-[0143] and Fig. 6);
determining, via a controller circuit, a therapy parameter setting for the neuromodulation device (IMD) based on the one or more signals ([0143]-[0145]; [0147]-[0148]); and
generating, via the controller circuit, a control signal in the neuromodulation device to initiate or adjust a promoted arousal state therapy program in accordance with the therapy parameter setting ([0146]-[0150]; [0155]-[0157]; [0071]).
Regarding claim 2, the arousal state is related to sleep [0157], the arousal state therapy program is a sleep therapy program ([0114], [0146]-[0147]), and determining the patient's desired arousal state includes determining the patient's desired sleep state [0157], [0160], [0150]-[0151]).
Regarding claim 3, the one or more signals are related to REM sleep behavior disorder (RBD), insomnia, sleep fragmentation, or excessive daytime sleepiness ([0155], [0158], [0063], [0093], [0035]).
Regarding claim 4, the recitation of “when the patient's desired sleep state is a state of nighttime sleep and the one or more signals relate to insomnia or sleep fragmentation, the control signal generated via the controller circuit will adjust to or initiate the sleep therapy program of the neuromodulation device to adjust a level of stimulation to promote sleep” is conditional and therefore not construed as required by the claim. However, the method of Wu anticipates such at [0053]-[0059], [0068] and [0157].
Regarding claim 5, determining the patient's desired sleep state includes tracking the patient's wakeup time ([0097] and [0127]) and
generating the control signal includes providing a gradual change (construed as an increase or decrease) in stimulation beginning before the patient's wakeup time and reaching wake promoting stimulation at a desired time preceding or aligning with the patient's wakeup time ([0127]-[0128]; [0147] and [0056]: “DBS system 10 may select a therapy program that helps improve the motor skills of patient 12 upon detecting the patient's awake state (i.e., detecting that patient 12 is not sleeping), such that patient 12 may initiate movement or maintain movement, e.g., to help patient 12 get out of bed”) (also see Table 4).
Regarding claim 6, determining the patient's desired sleep state includes inputting or tracking the patient's sleep time [0127] and
generating the control signal includes providing a gradual change in stimulation beginning before the patient's sleep time and reaching a sleep promoting stimulation setting at the patient's sleep time ([0127]-[0128], [0144], [0147]-[0149], [0151]; also see Table 4).
Regarding claim 7, detecting one or more signals includes detecting one or more signals that are contrary to the desired arousal state (such as detecting movement signals [0054]).
Regarding claim 8, detecting one or more signals includes detecting one or more signals that are aligned with the patient's current desired arousal state or with an upcoming arousal state (such as detecting movement signals [0056]).
Regarding claim 9, the one or more signals are sensed from the patient and include physiological data from sensors or electrodes positioned subcutaneously or on the patient's skin ([0142], [0035], [0063], [0093]).
Regarding claim 10, the one or more signals are sensed from the patient and include kinematic data from a worn motion sensor (Fig. 1, [0120], [0122]-[0123] and [0102]).
Regarding claim 11, the one or more signals are sensed from the patient and include behavioral tracking data including eye tracking ([0142]: “eye activity”), drooping eyes, or decreased reaction time ([0122]: sensed muscular activity would result in signal of decreased reaction time; [0123]: “detecting a relatively low activity level” would also indicate decreased reaction time).
Regarding claim 12, the one or more signals are sensed from the patient and include patient feedback ([0073] and [0120]) received through a cellphone or computer application [0070].
Regarding claim 13, the one or more signals are provided by the external source and include a clock, calendar, or schedule [0127].
Regarding claim 14, the recitation of “when the patient's desired sleep state is a state of wakefulness and the one or more signals relate to excessive daytime sleepiness, the control signal generated via the controller circuit will adjust or switch the neuromodulation device to a program providing stimulation to alleviate or avoid daytime sleepiness” is conditional and therefore not construed as required by the claim. However, the method of Wu anticipates such at [0157].
Regarding claim 15, the one or more signals are sensed from the patient and include signals indicative of patient brain activity ([0142], [0035], [0063], [0093]).
Regarding claim 16, after generating the control signal to initiate or adjust the arousal state therapy program, the method further comprises waiting a pre-determined period of time and re-evaluating the one or more signals ([0034]: “The processor may control the stimulation generator to deliver the electrical stimulation to the GPe substantially continuously (e.g., continuously or nearly continuously) or periodically during the sleep state (e.g., according to a predetermined schedule or cycle) and terminate the delivery of the electrical stimulation to the GPe in response to detecting an end of the sleep state (e.g., in response to detecting the awake state).”) and/or requesting the patient's input regarding effectiveness of the arousal state therapy program.
Regarding claim 17, Wu teaches a method of operating a neuromodulation device to promote sleep or wakefulness in a patient, the method comprising:
determining a desired sleep state from a schedule of designated sleep hours ([0127]: “processor 50 may detect the sleep state (80) based on a time schedule…);
detecting one or more signals ([0127]: “In addition to …detecting a sleep state based on patient input or a physiological parameter of patient 12, processor 50 may detect the sleep state (80) based on a time schedule…), related to insomnia, sleep fragmentation, or excessive daytime sleepiness ([0053]-[0059], [0068] and [0157]), the one or more signals being sensed from the patient or provided by an external source ([0142], [0035], [0063], [0093]);
determining, via a controller circuit, a therapy parameter setting for the neuromodulation device (IMD) based on the one or more signals, the therapy parameter setting including a stimulation energy (intensity) ([0143]-[0145]; [0147]-[0148]); and
generating, via the controller circuit, a control signal in the neuromodulation device to initiate or adjust a sleep therapy program and apply the stimulation energy in accordance with the therapy parameter setting ([0146]-[0150]; [0155]-[0157]; [0071]).
Regarding claim 18, the recitation of “when the patient's desired sleep state is a state of wakefulness and the one or more signals relate to excessive daytime sleepiness, the control signal generated via the controller circuit will switch the neuromodulation device to a program providing stimulation to alleviate or avoid daytime sleepiness” is conditional and therefore not construed as required by the claim. However, the method of Wu anticipates such at [0157].
Regarding claim 19, the recitation of “when the patient's desired sleep state is a state of nighttime sleep and the one or more signals relate to insomnia or sleep fragmentation, the control signal generated via the controller circuit will initiate the sleep therapy program of the neuromodulation device to adjust a level of stimulation to promote sleep” is conditional and therefore not construed as required by the claim. However, the method of Wu anticipates such at [0053]-[0059], [0068] and [0157].
Regarding claim 20, Wu teaches a method of operating a neuromodulation device to promote sleep or wakefulness in a patient [0157], the method comprising:
determining a desired sleep state ([0157]: a patient may desire to stay awake during the day and not fall asleep; or a patient may desire to fall asleep and maintain sleep);
detecting one or more signals related to insomnia, sleep fragmentation or daytime sleepiness, the one or more signals being derived from the patient’s physiological data or provided by an external source ([0155]-[0158] and Fig. 7; [0136], [0142]-[0143] and Fig. 6);
determining, via a controller circuit, a therapy parameter setting for the neuromodulation device (IMD) based on the one or more signals ([0143]-[0145]; [0147]-[0148]); and
generating, via the controller circuit, a control signal in the neuromodulation device to initiate or adjust a sleep therapy program in accordance with the therapy parameter setting ([0146]-[0150]; [0155]-[0157]; [0071]),
wherein when the patient's desired sleep state is a state of wakefulness and the one or more signals relate to excessive daytime sleepiness, the control signal generated via the controller circuit will switch the neuromodulation device to a program providing stimulation to alleviate or avoid daytime sleepiness (which is conditional and therefore not construed as required by the claim. However, the method of Wu anticipates such at [0157]);
wherein when the patient's desired sleep state is a state of nighttime sleep and the one or more signals relate to insomnia or sleep fragmentation, the control signal generated via the controller circuit will initiate the sleep therapy program of the neuromodulation device to adjust a level of stimulation to promote sleep (which is conditional and therefore not construed as required by the claim. However, the method of Wu anticipates such at [0053]-[0059], [0068] and [0157]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. Pub. No. 2025/0134451; and U.S. Pub. No. 2023/0173221.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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