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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 3/27/26 is acknowledged.
Applicant's election with traverse of Species B, figs. 10-14, in the reply filed on 3/27/26 is acknowledged. The traversal is on the ground(s) that there is no undue burden posed on the Examiner by examining all the species. This is not found persuasive because the species have mutually exclusive structures and components. For example, the species of figs. 1-9 features the housing assembly 30 and all its interior components at the anterior of the mouthpiece 20. The species of figs. 10-14 features an electronic assembly at the rear of the device. The species of figs. 15A-H features a very specific cannula embodiment on a mouthpiece different from the full dental mouthpieces of previous embodiments. The species of figs. 30-33 features an appendage/box 304 at the side of the appliance, and the species of fig. 34 features sensors directly secured to a lingual surface of the appliance. The mutually exclusive features would require a variety of text searches that pose an undue burden.
The requirement is still deemed proper and is therefore made FINAL.
Applicant identifies claim 2 as not being drawn to Species B, but [0038] describes stimulation as part of the embodiment of mouthpiece 102 of Species B. Thus, claim 2 is examined below. However, claim 10 has been identified by the Examiner as not being drawn to Species B but rather to Species C, figs. 15A-H. Thus, claim 10 is withdrawn.
Claims 10, 19, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group and Species, there being no allowable generic or linking claim. Election was made without traverse for the Group and with traverse for the Species in the reply filed on 3/27/26.
Claims 1-9 and 11-18 are examined below.
Claim Objections
Claims 1 and 16 are objected to because of the following informalities:
“a user” in claim 1, line 4 should be amended to recite --the user--
“a user” in claim 16, line 2 should be amended to recite --the user--
Appropriate correction is required.
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: “inertial measurement unit” in claim claims 1 and 15; “sound measurement device” in claims 1 and 15.
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 (please see [00117] and [0075]).
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.
Claim 14 is 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 14, the claim recites the limitation “about 10 kHz” in line 2. The term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 8 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 8, the claim positively recites “an upper second molar region of the user” in lines 3-4. Language such as “configured” or “adapted” is suggested to avoid claiming a human organism.
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.
Claim(s) 1, 3-7, 11-13, 15, 17, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelly et al. US 2020/0197655 A1.
Regarding claim 1, Shelly discloses an oral appliance 10 (fig. 2 and [0026], system 10 includes mouthpiece 13), comprising:
a mouthpiece 13 configured to be positioned in an oral cavity of a user (fig. 2 and [0029], mouthpiece 13 is worn on the lower and upper jaws);
an inertial measurement unit (IMU) 14 coupled to the mouthpiece 13, the IMU 14 configured to generate data based on movement of a user (fig. 2 and [0030], posture sensor 1 may include an accelerometer to convey information related to acceleration, orientation, movement, etc.);
a sound measuring device 20 coupled to the mouthpiece 13, the sound measuring device 20 configured to generate data based on noises of the user (fig. 2 and [0031], physiological sensor 20 may include a microphone 38 to generate an output based on sounds made by the user); and
a processor 18 coupled to the mouthpiece 13, the processor 18 configured to detect a condition of the user based on analysis of the data generated by the IMU 14 or the data generated by the sound measuring device 20 (fig. 2 and [0037], [0040], controller 18 comprises processing units and determines whether the user experiences a sleep disordered breathing event based on the posture sensor 14 and/or physiological sensor 20).
Regarding claim 3, Shelly discloses the condition of the user includes at least one of normal breathing, abnormal breathing, awake periods, breath intensity, changes in breath sound intensity, snore sound quality, upper airway collapse, obstructive sleep apnea, sleep disordered breathing ([0040], controller 18 determines whether the user experiences a sleep disordered breathing event), total sleep time, sleep disturbances followed by arousal, jaw clenching, grinding, swallowing, a respiratory disease, or a neurodegenerative disorder.
Regarding claim 4, Shelly discloses the mouthpiece 13 comprising an upper mouthpiece 32 configured to be positioned on an upper jaw of the user and a lower mouthpiece 34 configured to be positioned on a lower jaw of the user (fig. 2 and [0029]), and wherein the sound measuring device 20 is coupled to the upper mouthpiece 32 and the IMU 14 is coupled to the lower mouthpiece 34 (fig. 2, all components 14, 20, 32, and 34 being coupled to each other when the device is assembled).
Regarding claim 5, Shelly discloses the IMU 14 being coupled to an anterior portion of the lower mouthpiece 34 (fig. 2, the sensor 14 being coupled at the anterior forward portion of the lower mouthpiece 34).
Regarding claim 6, Shelly discloses the sound measuring device 20 being coupled to a posterior portion of the upper mouthpiece 20 (fig. 2, the sensor 20 being coupled to the upper mouthpiece 20 and thus coupled to all its portions, including its posterior portion).
Regarding claim 7, Shelly discloses a storage chip 26 configured to store and record the data generated by the IMU 14 or the data generated by the sound measuring device 20 (fig. 2 and [0050], electronic storage 26 stores information received from sensors 14/20); and a battery 28 configured to provide power to at least one of the IMU 14, the sound measuring device 20, the processor 18, or the storage chip 26 ([0051], power supply 28 powers the sensors 14/20, controller (which comprises processors) 18, and storage 26).
Regarding claim 11, Shelly discloses the IMU 14 comprising at least one of a gyroscope and an accelerometer ([0030], posture sensor 14 may include an accelerometer or gyroscope).
Regarding claim 12, Shelly discloses the processor 18 being configured to detect movement of an upper or lower jaw of the user based on the data generated by the IMU 14 (fig. 2 and [0030], posture sensor 1 may include an accelerometer to convey information related to acceleration, orientation, movement, etc., which is capable of capturing movement of the upper and lower jaw).
Regarding claim 13, Shelly discloses the processor 18 being configured to determine awake periods or arousal during sleep of the user based on detection of at least one of jaw clenching, grinding, or swallowing ([0047], the controller 18 (which comprises the processors) may use airflow along with accelerometer information to detect arousals that follow sleep disordered breathing events; the accelerometer would be capable of detecting movement during clenching, grinding, or swallowing).
Regarding claim 15, Shelly discloses system 10 (fig. 2 and [0026], system 10), comprising:
an inertial measurement unit (IMU) 14, the IMU 14 configured to generate data based on movement of a user (fig. 2 and [0030], posture sensor 1 may include an accelerometer to convey information related to acceleration, orientation, movement, etc.);
a sound measuring device 20, the sound measuring device 20 configured to generate data based on noises of the user (fig. 2 and [0031], physiological sensor 20 may include a microphone 38 to generate an output based on sounds made by the user); and
a processor 18 configured to detect a condition of the user based on analysis of the data generated by the IMU 14 or the data generated by the sound measuring device 20 (fig. 2 and [0037], [0040], controller 18 comprises processing units and determines whether the user experiences a sleep disordered breathing event based on the posture sensor 14 and/or physiological sensor 20).
Regarding claim 17, Shelly discloses the condition of the user includes at least one of normal breathing, abnormal breathing, awake periods, breath intensity, changes in breath sound intensity, snore sound quality, upper airway collapse, obstructive sleep apnea, sleep disordered breathing ([0040], controller 18 determines whether the user experiences a sleep disordered breathing event), total sleep time, sleep disturbances followed by arousal, jaw clenching, grinding, swallowing, a respiratory disease, or a neurodegenerative disorder.
Regarding claim 18, Shelly discloses a storage chip 26 configured to store and record the data generated by the IMU 14 or the data generated by the sound measuring device 20 (fig. 2 and [0050], electronic storage 26 stores information received from sensors 14/20); and a battery 28 configured to provide power to at least one of the IMU 14, the sound measuring device 20, the processor 18, or the storage chip 26 ([0051], power supply 28 powers the sensors 14/20, controller (which comprises processors) 18, and storage 26).
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.
Claim(s) 2 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al. US 2020/0197655 A1 in view of Bashyam US 2014/0135868 A1.
Regarding claim 2, Shelly discloses the claimed invention as discussed above.
Shelly is silent on a stimulator to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user.
However, Bashyam teaches an oral appliance (fig. 6A and [0068]) comprising a stimulator 603 to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user (fig. 6A and [0068], stimulator electrodes 603 target the genioglossus muscle; [0074], closed loop operation is implemented whereby the stimulation therapy is modulated according to information conveyed by the sensors, including an accelerometer).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral appliance of Shelly with a stimulator to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user, as taught by Bashyam, to train the tongue to be properly positioned according to the patient’s needs.
Regarding claim 16, Shelly discloses the claimed invention as discussed above.
Shelly is silent on a stimulator to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user.
However, Bashyam teaches an oral appliance (fig. 6A and [0068]) comprising a stimulator 603 to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user (fig. 6A and [0068], stimulator electrodes 603 target the genioglossus muscle; [0074], closed loop operation is implemented whereby the stimulation therapy is modulated according to information conveyed by the sensors, including an accelerometer).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral appliance of Shelly with a stimulator to provide electrical stimulation to a muscle in the oral cavity of the user based on detection of the condition of the user, as taught by Bashyam, to train the tongue to be properly positioned according to the patient’s needs.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al. US 2020/0197655 A1 in view of Bergmann US 2020/0155033 A1.
Regarding claim 8, Shelly discloses the claimed invention as discussed above.
Shelly is silent on the mouthpiece comprising a buccal wall, a lingual wall, and an occlusal wall extending between the buccal wall and the lingual wall and the sound measuring device being secured to or embedded within the occlusal wall, such that the sound measuring device is adjacent to an upper second molar region of the user.
However, Bergmann teaches an analogous mouthpiece 1 for monitoring the user (fig. 1 and [0028]-[0029], mouthguard 1 also having a microphone and accelerometer) comprising a buccal wall, a lingual wall, and an occlusal wall extending between the buccal wall and the lingual wall (fig. 1 shows the mouthguard 1 having a buccal/convex wall, lingual/concave wall, and an occlusal wall (the bottom connecting wall) and the sound measuring device 11 being secured to or embedded within the occlusal wall, such that the sound measuring device 11 is adjacent to an upper second molar region of the user (fig. 1 and [0029], the mic 11 is secured on PCB 10; PCB 10 is secured to the occlusal wall, since all components of the device 1 are secured to each other; therefore, the mic 11 can be considered adjacent/near the upper molar region of the user).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the mouthpiece of Shelly to comprise a buccal wall, a lingual wall, and an occlusal wall extending between the buccal wall and the lingual wall and the sound measuring device being secured to or embedded within the occlusal wall, such that the sound measuring device is adjacent to an upper second molar region of the user, as taught by Bergmann, to be securely held on anterior and posterior surfaces of the teeth.
Regarding claim 9, Shelly discloses the claimed invention as discussed above.
Shelly is silent on the sound measuring device comprising a micro-electromechanical system (MEMS) microphone.
However, Bergmann teaches an analogous mouthpiece 1 for monitoring the user (fig. 1 and [0028]-[0029], mouthguard 1 also having a microphone and accelerometer), wherein the sound measuring device 11 comprises a micro-electromechanical system (MEMS) microphone ([0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sound measuring device of Shelly to be a micro-electromechanical system (MEMS) microphone, as taught by Bergmann, to allow the sound measuring device to remain light and discreet.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelly et al. US 2020/0197655 A1 in view of Wilfong et al. US 5,407,713.
Regarding claim 14, Shelly discloses the claimed invention as discussed above.
Shelly is silent on an amplifier configured to pre-amplify a signal from the sound measuring device, wherein the sound measuring device is configured to record sound at about 10 kHz.
However, Wilfong teaches a noise analysis microphone (col. 37, lines 61-62) and an amplifier configured to pre-amplify a signal from the sound measuring device, wherein the sound measuring device is configured to record sound at about 10 kHz (col. 38, lines 11-13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral appliance of Shelly with an amplifier configured to pre-amplify a signal from the sound measuring device, wherein the sound measuring device is configured to record sound at about 10 kHz, as taught by Wilfong, to pick up the appropriate noise in the relevant bandwidth generated by the wearer during use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Logan et al. US 2012/0172679 A1 discloses a mouthguard for monitoring biometric and environmental data
Smith US 2014/0152464 A1 discloses a compliance monitoring system for a mandibular reposition device
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ALIREZA NIA can be reached at (571)270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
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