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 .
Response to Arguments
Applicant's amendment and arguments filed 10/23/2025 have been fully considered but they are not persuasive.
With respect to Baker, Applicant argues “At best, Baker discloses administering a therapy sound based on a sleep cycle, but nothing regarding different levels of wakefulness that do not include a sleep state or different arousal states while a recipient is awake” (see page 10 of the Remarks). The Examiner respectfully disagrees. First, the Examiner notes Applicant uses the open-ended transitional phrase “comprising”. Thus the prior art can disclose things not claimed and still anticipate the claim. While Baker does disclose applying therapy while a patient is asleep (which is not precluded by the claim), Baker still allows for monitoring of a patient while they are awake (i.e. determining that a user is awake or asleep, wherein determining they are awake would occur while the recipient is awake, see par. [0093-0095]). Nothing in the claim requires therapy to be delivered only when a user is awake and instead just broadly states “generating tinnitus therapy signals for delivery to the recipient…based on a change in the level of wakefulness of the recipient”. Baker still reads on the claimed invention.
Regarding Lunner, Applicant argues “Indeed, simply enabling or disabling tinnitus therapy does not include adjusting tinnitus therapy signals being delivered to a recipient.” The Examiner respectfully disagrees. The claim states “generating tinnitus therapy signals for delivery to the recipient, wherein one or more attributes of the tinnitus therapy signals being delivered to the recipient are adjusted base don a change in the level of wakefulness of the recipient”. Nothing in the claim states what kind of adjustments are made to the signals and the broadest, reasonable interpretation of adjusting would include terminating the therapy signal. Termination of a therapy signal is an adjustment to that signal. Additionally, Lunner discloses different levels of wakefulness and different associated parameters base don those levels of wakefulness. Specifically, Lunner discloses a relaxation mode having a first therapy setting (par. [0042]) and then an active mode with another therapy setting (par. [0043]). The rejection with respect to Lunner is therefore maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 5, 7, 11-18, 20, 21, 24, 27-33, 35 and 37-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,335,692 in view of Baker et al. (2020/0129760). The Patent and the presently claimed invention both require detecting signals from a user and controlling tinnitus therapy based on the detected signals. The Patent does not require the determination of a wakefulness-state in order to control the tinnitus therapy. However, Baker discloses determining a wakefulness level (such as a level of zero, person is asleep ) and delivering therapy based on the level, such as the level being zero, in order to increase the efficacy of the therapy ()par. [0005]). Therefore, it would have bene obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Patented invention to deliver tinnitus therapy based on a wakefulness level, as taught and suggested by Baker, for the purpose increasing the efficacy of tinnitus therapy.
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 1, 4, 5, 7, 11-15, 17 and 18 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention..
Applicant amended Claim 1 to state “the level of wakefulness is selected from a plurality of levels of wakefulness that do not include a sleep state”. However, Applicant’s specification states the following with the term “wakefulness level”: “For example, in certain embodiments, the control module 272 can be configured to dynamically adjust a level (amplitude) of the tinnitus therapy signals 283 based on the wakefulness level of the recipient (e.g., from a level of zero to a max level)” see par. [0055]. Applicant further indicates the wakefulness-level module can determine when a user awakens and falls asleep (see par. [0069]), which further indicates the wakefulness-level includes a level of zero, e.g. a sleep state.). This contradicts the current claim in that the claim precludes the wakefulness level from including a sleep state. This would work counter to the currently disclosed invention in which a wakefulness-level determination module determines when a user falls asleep or wakes up from sleep (again, see par. [0069]). Therefore, in light of the originally filed disclosure, the current claim amendment appears to interduce new matter.
Claims 4, 5, 7, 11-15, 17 and 18 are rejected due to their dependence on Claim 1.
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, 4, 5, 7, 11-15, 17 and 18 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.
Regarding Claim 1, Applicant amended the claim to state “wherein the level of wakefulness is selected from a plurality of levels that do not include a sleep state”. However, the specification states that the wakefulness level can be from zero to a max value and that the wakefulness-level module can determine when a user falls asleep (par. [0055, 0069]). Therefore, there are contradictory definitions of what wakefulness levels are covered by the term “level of wakefulness” and the scope of the claim is unclear. For the purposes of examination, the Examiner will interpret “level of wakefulness” to be consistent with the originally filed disclosure in which a level of zero (asleep) is included as a wakefulness level.
Claim 16 is also contradictory in light of the current amendment. Claim 1 states the wakefulness-state signals determine a level of wakefulness that does not include a sleep state. However, claim 16 then states the wakefulness-level signals are used to determine a sleep state. The scope of the claim is therefore unclear.
Claims 4, 5, 7, 11-15, 17 and 18 are rejected as being dependent on indefinite claim 1
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 7, 11-13, 15, 20, 21, 24, 27-30, 35, 37 and 38-42 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Van Den Ende et al. (2022/0016386).
Regarding Claims 1, 5, 11-13, 20, 21, 28-30, 35, 37 and 38-42 Van Den Ende discloses capturing signals such as EEG signals, to determine levels of wakefulness, i.e. awake with eyes open; awake with eyes closed, see par. [0112]). Van Den Ende further discloses generating tinnitus therapy, such as white noise (par. [0086]) and dynamically adjusting the sound (such as sound intensity, frequency or type of sound) based on the level of wakefulness (awake but trying to fall asleep, which can be represented by a slope of the EEG signal), see par. [0074-0076; 0109, 0114]; Fig. 3).
In regard to Claims 7 and 27, Van Den Ende discloses also monitoring heart rate (par. [0117]).
With regard to Claim 15, Van Den Ende discloses allowing user responses to be made and thus therapy adjusted by a user (par. [0084]).
Regarding Claim 24, Van Den Ende discloses body movement can also be assessed (par. [0117]).
Claims 1, 7, 11-13, 15-17, 20, 27-29, 31, 32, 35 and 37-41 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Baker et al. (2020/0129760).
Regarding Claims 1, 20, 35, 37 and 38, Baker discloses a device for providing tinnitus therapy comprising capturing, with sensors, biosignals indicative of a sleep state of a user (par. [0095-0096]) and generating sound, with a stimulation unit, tinnitus therapy based on the sleep state of the user, i.e. a wakefulness level of zero (par. [0100]). Regarding the interpretation of “one or more wakefulness-state signals”, Applicant notes in par. [0043] of the specification (PPGUB 2024/0090828, which is the publication of the present application) states “Wakefulness is produced by a complex interaction between multiple neurotransmitter systems arising in the brainstem and ascending through the midbrain, hypothalamus, thalamus and basal forebrain, which is not present when asleep. In general, the longer the brain has been awake, the greater the synchronous firing rates of cerebral cortex neurons (e.g., the higher the level of wakefulness). After sustained periods of sleep, both the speed and synchronicity of the neurons firing are shown to decrease. As such, and as noted above, being “asleep” is the opposite of being “awake” (i.e., an individual who is asleep has no wakefulness level).” Given this discussion, wakefulness levels (and arousal states) have a range of 0-100, wherein a level or score of zero would equate to a person being asleep and a level of 100 would be some metric indicating a person is “fully” awake/alert. This is consistent with Applicant’s own use of the term “wakefulness level, see par. [0055] “For example, in certain embodiments, the control module 272 can be configured to dynamically adjust a level (amplitude) of the tinnitus therapy signals 283 based on the wakefulness level of the recipient (e.g., from a level of zero to a max level)”. Applicant further indicates the wakefulness-level module can determine when a user awakens and falls asleep (see par. [0069]), which further indicates the wakefulness-level includes a level of zero, e.g. a sleep state. The Examiner contends that Baker discloses detecting a wakefulness level (arousal state) of either zero (asleep) or greater than zero (a person is awake) and the therapy is generated based on the score being zero (asleep), which meets the broadest reasonable interpretation of Claim 1 that requires therapy to be delivered based on a wakefulness level. Additionally, Baker allows for monitoring of a patient while they are awake (i.e. determining that a user is awake or asleep, wherein determining they are awake would occur while the recipient is awake, see par. [0093-0095]).
In regard to Claims 7 and 27, Baker discloses detecting one or more of heart rate, blood pressure or body temperature (par. [0095]).
Regarding Claims 11 and 39, Baker discloses dynamically changing the tinnitus therapy based on the wakefulness level and variances of sensed parameters within that level (par. [0100]).
With regard to Claims 12, 28 and 40, Baker discloses dynamically changing the amplitude (volume) of therapy based on a level of wakefulness (par. [0101]).
In regard to Claims 13, 29 and 41, Baker discloses amplitude modulating the therapy and making adjustments to the modulation (par. [0070]).
Regarding Claim 15, Baker discloses allowing a user to adjust tinnitus therapy via a user interface (par. [0023]).
In regard to Claims 16, 17, 31 and 32, Baker discloses monitoring for specific sleep states. If a specific state is detected, the therapy can be disabled wherein disabling the therapy could comprise incrementally reducing the amplitude/volume of the therapy over time (par. [0101]).
Claims 1, 5, 20, 21 and 37 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lunner (EP 3700229).
Regarding Claims 1, 5, 20, 21 and 37 Lunner discloses detecting EEG signals from a user to determine a wakefulness-state, namely a relaxation state which is different from other states such as a mentally active state, excited state, etc. (par. [0030]). The Examiner contends a relaxation state would be of less “wakefulness” or “arousal” as compared to a state of excitement or mental engagement (an active state, as disclosed in par. [0043]). Lunner discloses delivering Tinnitus therapy when a relaxation mode is entered (claim 9), which is based on the mental state (wakefulness level) of the user, par. [0007, 0014]) and adjusting parameters if an active mode is entered (par. [0043]) or even turning of therapy when a relaxation mode is exited both of which are adjustments to therapy attributes as claimed.
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 (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 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.
Claims 4 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (2020/0129760) in view of Inada et al. (2021/0038459). Baker discloses all of the claimed invention except for capturing at least one or more of sound signals or body noises. However, Inada, concerned with the same problem of quantifying sleep states, discloses detecting breathing sounds for the purpose of accurately quantifying the slepe state of the user (par. [0020, 0065]). 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 Baker reference to include sound sensors for detecting user sounds, as taught and suggested by Inada, for the purpose of accurately quantifying sleep states.
Claims 14, 30 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (2020/0129760) in view of Lim et al. (2017/0353807).
Regarding Claims 14, 30 and 42, Baker discloses treating tinnitus by applying a sound to a user and fails to disclose applying electrical stimulation signals. However, in the same field of endeavor of tinnitus treatment, Lim discloses combining sound signals and electrical stimulation signals with dynamically adjusted current levels (par. [0083]) for the treatment of tinnitus (par. [0035]) for the purpose of helping increase the gain of wanted sound feature and reducing the gain of unwanted sound features within the brain (par. [0007]). 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 Baker reference to include electrical stimulation, as taught and suggested by Lim, for the purpose of helping increase the gain of wanted sound feature and reducing the gain of unwanted sound features within the brain.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
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