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 with traverse of Group I (claims 1-2, 4, 6-7, 9-10, 12-14, 17, 19, 21, 23-24, 26, 28, 32, 37), Species I (Fig. 11A-11B and 6A-6B), and Subspecies 4 (Fig. 5G) in the reply filed on 2/10/2026 is acknowledged. The traversal is on the ground(s) that the previously used reference Rogachevsky does not provide for the special technical features as now amended thus the claims have unity and relate to a single general concept. This is not found persuasive because claim 1 contains the same shared (potentially) special technical features with claims 38 and 41 as well as between the species of the restriction. As now updated in the rejection below, the features of claim 1 are found to not make a contribution over the prior art, thus the shared features therein are not special technical features and unity is broken therein.
The requirement is still deemed proper and is therefore made FINAL.
Claim 38 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/10/2026.
Claim 41 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/10/2026.
Response to Amendment
Applicant’s Amendments, filed 2/10/2026, to claims 1, 38, and 41 acknowledged by Examiner. Additionally, applicant cancelled claim 2.
Claims 1, 4, 6-7, 9-10, 12-14, 17, 19, 21, 23-24, 26, 28, 32, 37-38, 41 are now pending, with claims 38 and 41 withdrawn.
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 4, 6-7, 9-10, 12-14, 17, 19, 21, 23 and 26 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.
Claims 4 and 17 recites “of claim 2”, claim 2 has been cancelled herein, as such the claim is indefinite for having improper indefinite dependency. For interpretation purposes, claims 4 and 17 will be read as depending from claim 1.
Claim 6 recites the limitation "the basis of data". There is insufficient antecedent basis for this limitation in the claim, specifically to “the basis”.
Claims 12 and 13 recites the limitation "of data". There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same data as in claim 6 or different data. Note, claim 9 uses “the data” being dependent on claim 6 having proper antecedent basis to the data.
Claim 26 recites the limitation "a plurality actuators". It is unclear if this is referring to the “one or more actuators” or different actuators therein. For interpretation purposes, will be read as being the one or more actuators being a plurality of actuators.
Claim 26 recites the limitation "at least one of the inflatable systems" and “the plurality of inflatable systems”. Claim 24 (from which 26 depends) recites “an inflatable system” wherein there is insufficient antecedent basis for plural inflatable systems and the plurality of inflatable systems.
Claims 7, 9-10, 14, 19, 21, 23 are rejected as depending on a rejected claim.
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.
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.
Claim(s) 1, 17, 24, 28 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matula (US 20150128956 A1).
Regarding claim 1, Matula discloses a system 200 for use in connection with a patient 100 (Fig. 1-4, see [0028] wherein all the shown embodiments are interchangeable and combinable with one another, [0017-0018] neck extension device 200, patient/subject 100), comprising:
a positioning device 200 (Fig. 2) comprising one or more movable contact members 202/204 to contact the patient 100 (Fig. 2 and [0018, 0024], the surfaces 202 and 204 are contacting the patient and are moveable therein),
one or more actuators 304 (Fig. 3A) in connection with the one or more movable contact members 202/204 (Fig. 3A and [0024] the actuator herein is an inflatable bellows defining the invention between the upper and lower surfaces 202/204, thus being in connection with the movable contact members 202/204), and
at least one source of energy in connection with the one or more actuators 304 (see [0024] wherein the actuators 304 are filled by gas/liquid/fluid being a source of mechanical energy, and also provided with electrical energy for using an internal pump); and
a control system in operative connection with the one or more actuators 304 and with the at least one source of energy to control a state of the one or more actuators 304 via control of energy provided thereto to control a position of the one or more movable contact members and thereby control a position of at least one of the patient's head, chin, or neck a determined manner to maintain airway patency (see [0024] wherein the internal pump of the actuator bellows 304 may be “operated electrically” to increase the pressure within the bellows 304 thereby increasing the separation distance between the chin and chest for opening the airway as discussed in Fig. 4, thus there is implicitly a control system therein controlling the energy being the gas/fluid of the bellows to control the position of the contact members 202/204 being the position of the device on the chin and chest).
Matula does not explicitly provide for a support to which each of the one or more actuators and each of the one or more contact members are operatively connected, the support being configured to be placed in operatively connection with the patient (in the Figures 1-2 and 3A showing the inflatable bladders).
However, Matula does further provide for an embodiment Fig. 3D defining a support 330 comprising analogous contact members 336/338 ([0027] 336 is a first upper surface and 338 is a second upper surface, analogous to the contacts 202/204) defined by analogous actuators 332/334 ([0027] 332 and 334 members actuate with the torsional springs 342 on each side therein connecting the actuator members), the support 330 thus provides connection with each of the actuators and each of the one or more contact members are operatively connected therein, the support 330 being configured to be placed in operatively connection with the patient (see [0027]), wherein Matula provides that the features of the embodiments Fig. 3A, 3B, 3C, and 3D may be combined with each other (see [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the support 330 of Fig. 3D to the actuator 304 of Fig. 3A of Matula in order to provide a neck extension device that both is inflatably adjustable for changing the neck extension of the user ([0024], Fig 3A) and has resistance against lessening the angle ([0027], Fig 3D) and Matula has provides these embodiments to be combinable. Thus, henceforth the surfaces 202/204 of (Fig. 2-3A) would be provided with the members 332/334 and their torsion springs therein, such that there is a support 330 to which each of the one or more actuators 304 and each of the one or more contact members 202/204/332/334 are operatively connected, the support 330 being configured to be placed in operatively connection with the patient.
Regarding claim 17, Matula discloses the invention of claim 1 (see 112b wherein the claim as written is dependent on claim 2 which is cancelled).
Matula as combined discloses wherein at least one of the one or more contact members 202/204 is positioned to be placed in contact with at least one of a lower portion of the jaw line of the patient and the neck of the patient (Fig. 2).
Regarding claim 24, Matula discloses the invention of claim 1.
Matula as combined discloses the source of energy comprises a pneumatic source of energy ([0024] gas/fluid pneumatically filling the bladder 304 using a pump),
the one or more actuators 304 comprising an inflatable system 304 in fluid connection with the pneumatic source of energy and the state of the at least one of the one or more actuators controlled by the control system is a state of inflation (Fig. 3A and [0024] the actuator 304 is an inflatable bladder and the actuator state is a state of inflation).
Regarding claim 28, Matula discloses the invention of claim 24.
Matula as combined discloses wherein the inflatable system comprises a plurality of connected inflatable chambers 304, each of the plurality of connected inflatable chambers 304 being formed at least partially of a flexible material (see [0024] and Fig. 3A, wherein there are one or more bellows 304 being inflatable chambers, Fig. 3A shows five bellows/chambers, which are connected as shown, are implicitly formed of flexible material to be able to deflate and expand therein).
Regarding claim 32, Matula discloses the invention of claim 28.
Matula as combined discloses wherein two or more of the plurality of connected inflatable chambers 304 (Fig. 3A) are connected in a manner to control inflation of the inflatable system (see [0024] and Fig. 3A, wherein the bellows are connected such that the inflation of the system therein is dependent on all of the chambers 304).
Claim(s) 4, 6-7, 9-10, 12-14, 19, 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matula (US 20150128956 A1) in view of Hohenhorst (US 20100294284 A1) and Pinczuk (US 20220273234 A1).
Regarding claim 4, Matula discloses the invention of claim 1 (see 112b wherein the claim as written is dependent on claim 2 which is cancelled).
Matula does not disclose wherein the control system comprises a processor system, a memory system in operative connection with the processor system, and at least one algorithm stored in the memory system and executable by the processor system to control the state of the one or more movable contact members.
However, Hohenhorst teaches an analogous system for opening an airway 10 (abstract, Fig. 18A-18B and 19A-19B) comprising analogous inflatable actuators 28 (Fig. 18A-18B, [0221]) and inflatable actuators 36 (Fig. 19A-19B, [0224-0226]) for increasing a distance between a chin and chest of a user (see [0221, 0224-0226]) comprising an analogous control system 48 having a processor system (see [0229-0230] the bladders can be inflated based on an automatic control system being a monitor element 48 that processes preprogrammed rules thus having a processor system), further the system of Hohenhorst provides for a memory system in operative connection with the processor system ([0230-0232] present monitored data is compared with best/desired benchmarks which would require a memory in place for keeping these benchmarks recorded), and at least one algorithm stored in the memory system and executable by the processor system to control the state of the one or more movable contact members (see [0229-0232] wherein there are “preprogrammed rules” being implicitly an algorithm therein for controlling the state of the analogous bladders for altering the shape of the device thus its contact members therein for opening the airway of the user, this algorithm being implicitly required to be stored in the memory and executable by the processor systems therein).
Pinczuk further provides an analogous sleep bladder system 180 (Fig. 1-2 and [0076], inflatable pillow) comprising a control system 110 (see [0038-0039]) comprises a processor system 112 (see [0039]), a memory system 114 in operative connection with the processor system 112 (see [0040]), and at least one algorithm stored in the memory system 114 and executable by the processor system 112 (see [0040] “machine readable instructions” being an algorithm) to control the state of the one or more movable contact members (see [0006, 0083] wherein the control system is used to control the bladder/inflatable pillow therein having contact members in contact with a user therein).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the electrically operated inflatable bladders actuator 304 of Metula with the control systems, memory systems, processing systems, and algorithms as taught by Hohenhorst and Pinczuk in order to dynamically adjust the inflatable bladders for best open airway sleep breathing (Pinczuk [0006-0007] and Hohenhorst [0229]).
Regarding claim 6, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 4.
Hohenhorst further teaches a sensor system 46 comprising one or more sensors 46 in operative connection with the control system, the control system being configured to control the state at least one of the one or more actuators at least in part on the basis of data from the sensor system 46 (see [0230]).
Regarding claim 7, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 6.
Hohenhorst further teaches wherein the sensor system 46 comprises at least one of a sound sensor, an oximeter sensor, a carbon dioxide sensor, a position sensor, a breath flow sensor, accelerometer, inclinometer, tilt sensor or a heart rate sensor (see [0230] sensor 46 may be a microphone being a sound sensor).
Regarding claim 9, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 6.
Hohenhorst further teaches the control system is configured to determine at least one of a state of the patient's breathing and a position of the patient from the data from the sensor system 46 and control at least one of the one or more actuators at least in part on the basis of at least one of the determined state of the patient's breathing and the position of the patient (see [0230-0232] wherein the sensor 46 determines the state of breathing using the microphone and changes the inflation of the bladder/actuator based on the present state of breathing of the patient).
Regarding claim 10, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 6.
Pinczuk further teaches wherein the at least one algorithm is configured to store a maximum state and a minimum state for at least one of the one or more actuators (see [0083] wherein the algorithm stores a maximum state of the inflatable bladder being 100% inflated and a minimum state of the inflatable bladder being 0% inflated).
Regarding claim 12, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 6.
Hohenhorst further teaches wherein the at least one algorithm is configured to implement feedback control of the state of the at least one of the one or more actuators on the basis of data from the sensor system (see [0229-0230] wherein the algorithm relies on sensed data to implement feedback control to the bladders on the basis of sensed data).
Regarding claim 13, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 6.
Pinczuk further teaches wherein the control system comprises at least one machine learning algorithm stored in the memory system and executable by the processor system to alter control of the state of the at least one of the one or more actuators on the basis of data from the sensor system measured over time (see [01031] wherein the analogous bladder 184 can be controlled using machine learning for optimizing the inflated state over time based on sensed data of the user).
Regarding claim 14, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 6.
Pinczuk further teaches wherein the sensor system includes a sound sensor and the machine learning algorithm is configured to differentiate at least one of snoring from other sounds and between sounds coming from more than one person (see [0103] wherein the sensor system as combined can include an acoustic sensor for snoring working with a machine learning algorithm to monitor snore events compared to waking up/arousals).
Regarding claim 19, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 4.
Matula as combined further discloses the support 330 comprises a frame 330 (Fig. 3D, see combination in claim 1 above) comprising
a lower section 334 configured to contact a chest region of the patient (Fig. 3D and [0027]) and an upper section 332 comprising one or more of the one or more movable contact members 336 (Fig. 3D and [0027]),
the upper section 332 being movable relative to the lower section 334 (Fig. 3D and [0027] hinge 340 enables movement therein),
wherein at least one of the one or more actuators 304 is in connection with the upper section 332 and with the lower section 334 to move the upper section 332 relative to the lower section 334 (see combination of embodiments of Fig. 3A and Fig. 3D in claim 1 above, wherein the upper and lower surfaces of the Fig. 3A embodiment comprises the upper and lower sections 332/334 thus the actuator 304 being in connection therein and able to move them therein).
Regarding claim 21, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 19.
Matula as combined further discloses wherein the upper section 332 is connected to the lower section 334 by a first resilient member 342 on a first side of the frame 330 and by a second resilient member 342 on a second side of the frame 330 (Fig. 3D and [0027] there are torsion springs 342 on each side of the frame 330 being resilient members for connecting the upper and lower sections).
Regarding claim 23, Matula in view of Hohenhorst and Pinczuk discloses the invention of claim 19.
Matula as combined provides for the one or more actuators 304, but does not disclose a first actuator on the first side of the frame which is in connection with the upper section and with the lower section and a second actuator on the second side of the frame which is in connection with the upper section and with the lower section, the control system being configured to independently control the first actuator and the second actuator and thereby independently control the amount of flex in each of the first resilient member and the second resilient member.
However, Hohenhorst teaches a first actuator 28 on the first side of the analogous frame 20 (Fig. 18A-18B, left side bladder 28 [0221]) which is in connection with analogous upper section (upper region of frame 20) and analogous lower section (lower region of frame 20) and
a second actuator 28 on the second side of the frame 20 (Fig. 18A-18B, right side bladder 28 [0221]) which is in connection with analogous upper section (upper region of frame 20) and analogous lower section (lower region of frame 20),
the control system being configured to independently control the first actuator 28 and the second actuator 28 (see [0221] wherein the bladders may be inflated individually) and thereby independently control the amount of flex in each of the first resilient member and the second resilient member (see [0021] changes the physical properties/shape of the analogous frame 20 being made of resilient material thus therein wherein having analogous first and second resilient members being first and second sides of the frame 20 formed of resilient deformable material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the actuators 304 of Metula to instead have first and second actuators on two sides therein as taught by Hohenhorst for being able to discretely alter the shape of the chin and chest of the user (Hohenhorst [0221]).
Claim(s) 26 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matula (US 20150128956 A1) in view of Hohenhorst (US 20100294284 A1).
Regarding claim 26, Matula discloses the invention of claim 24.
Matula as combined provides for the one or more actuators 304, but does not disclose a plurality actuators, each of the plurality of actuators comprising an inflatable system, wherein the control system is configured to control the state of inflation of at least one of the inflatable systems independently of the control of at least one other of the plurality of inflatable systems.
However, Hohenhorst teaches an analogous system for opening an airway 10 (abstract, Fig. 18A-18B and 19A-19B) comprising analogous inflatable actuators 28 (Fig. 18A-18B, [0221]) and inflatable actuators 36 (Fig. 19A-19B, [0224-0226]) for increasing a distance between a chin and chest of a user (see [0221, 0224-0226]) comprising an analogous control system 48 having a processor system (see [0229-0230] the bladders can be inflated based on an automatic control system being a monitor element 48 that processes preprogrammed rules thus having a processor system), wherein the actuators 28 are a plurality of actuators 28 being a first actuator 28 on the first side of the analogous frame 20 (Fig. 18A-18B, left side bladder 28 [0221]) and a second actuator 28 on the second side of the frame 20 (Fig. 18A-18B, right side bladder 28 [0221]),
wherein the control system is configured to control the state of inflation of at least one of the inflatable systems independently of the control of at least one other of the plurality of inflatable systems (see [0221] wherein the bladders may be inflated individually).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the actuators 304 of Metula to instead have first and second actuators on two sides therein as taught by Hohenhorst for being able to discretely alter the shape of the chin and chest of the user (Hohenhorst [0221]), the two actuators thus being a plurality of actuators and being independently configurable.
Regarding claim 37, Matula in view of Hohenhorst discloses the invention of claim 28.
Matula as combined provides for the one or more actuators 304, but does not disclose a plurality actuators, each of the plurality of actuators comprising an inflatable system, wherein the control system is configured to control the state of inflation of at least one of the inflatable systems independently of the control of at least one other of the plurality of inflatable systems.
However, Hohenhorst teaches an analogous system for opening an airway 10 (abstract, Fig. 18A-18B and 19A-19B) comprising analogous inflatable actuators 28 (Fig. 18A-18B, [0221]) and inflatable actuators 36 (Fig. 19A-19B, [0224-0226]) for increasing a distance between a chin and chest of a user (see [0221, 0224-0226]) comprising an analogous control system 48 having a processor system (see [0229-0230] the bladders can be inflated based on an automatic control system being a monitor element 48 that processes preprogrammed rules thus having a processor system),
wherein the actuators 28 are a plurality of actuators 28 being a first actuator 28 on the first side of the analogous support/frame 20 (Fig. 18A-18B, left side bladder 28 [0221]) and a second actuator 28 on the second side of the support/frame 20 (Fig. 18A-18B, right side bladder 28 [0221]),
wherein two or more of the plurality of actuators 28 are positioned at different circumferential positions on the support 20 (Fig. 18A-18B), wherein the support 20 extends around at least a portion of the circumference of the patient's neck when the positioning device is placed in operative connection with the patient's neck (Fig. 1-18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the actuators 304 of Metula to instead have first and second actuators on two sides therein at different circumferential positions on the support of Metula as taught by Hohenhorst for being able to discretely alter the shape of the chin and chest of the user (Hohenhorst [0221]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786