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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2025 has been entered.
Response to Amendments
The Amendment filed 8/11/2025 has been entered. Claims 19, 66-67, and 71 were amended, and claims 1-18, 22, 32-65, and 68 were canceled. Thus, claims 19-21, 23-31, 66-67, and 69-71 are pending in the application.
Claim Objections
Claims 19, 21, 23, 67, and 71 are objected to because of the following informalities:
Claim 19 line 4 recites “snore and apnea” and is suggested to read --a snore and an apnea-- in order to be grammatically correct and ensure proper antecedent basis.
Claim 19 line 14 recites “of occurrence” and is suggested to read --of an occurrence-- in order to be grammatically correct and ensure proper antecedent basis.
Claim 19 line 24 recites “the processor” and is suggested to read --the at least one processor-- in order to more clearly reference how the limitation was originally claimed.
Claim 21 line 3 recites “humidifier, and;” and is suggested to read -- humidifier; and-- in order to be grammatically correct.
Claim 23 line 2 recites “actuates the inflator on,” and is suggested to read --actuates the inflator,-- in order to be grammatically correct.
Claim 67 line 2 recites “required pressure and duration” and is suggested to read --a required pressure and a duration-- in order to be grammatically correct and ensure proper antecedent basis.
Claim 71 line 2 recites “sleep apnea” and is suggested to read --the apnea-- in order to more clearly reference how the limitation was originally claimed and ensure proper antecedent basis.
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 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 is: “a control unit…to actuate” in claim 19 line 17.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 limitation 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 to avoid it 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 recites sufficient structure to perform the claimed function so as to avoid it 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 19-21, 23-31, 66-67, and 69-71 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 19 recites the limitations "the use of pressurized air" in line 4 and “the head” in line 6. There is insufficient antecedent basis for these limitations in the claim. Moreover, the limitations “snore and apnea” in line 6, “a snore” in line 10, “an apnea” in line 11, “a snore or apnea” in line 12, and “snore or apnea” in line 14 are confusing, as it is unclear whether these are meant to be the same as or different from the limitation “snore and apnea” in line 4. For the purposes of examination, they will be interpreted as the same respective snore and apnea limitations.
Claim limitation “a control unit…to actuate” in claim 19 line 17 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 24 recites the limitation “the pressure” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation “the pressure” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 28, the limitation “at least one sensor” in line 1 is confusing, as it is unclear whether these are meant to be the same as, part of, or different from the “at least one sensor” of claim 19. Moreover, the limitation “snore and apnea” in line 2 is confusing, as it is unclear whether these are meant to be the same as or different from the “snore and apnea” in claim 19. For the purposes of examination, they will be interpreted as the same respective sensor, snore, and apnea limitations.
Claim 29 recites the limitation “the pressure” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation “the pressure” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation “the presence” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 66, the limitation “pressurized air” in line 4 is confusing, as it is unclear whether these are meant to be the same as or different from the “pressurized air” of claim 19. Moreover, the limitation “snore or apnea” in line 5 is confusing, as it is unclear whether these are meant to be the same as or different from the “snore and apnea” in claim 19. For the purposes of examination, they will be interpreted as the same respective pressurized air, snore, and apnea limitations.
Regarding claim 67, the limitation “pressurized air” in line 4 is confusing, as it is unclear whether these are meant to be the same as or different from the “pressurized air” of claim 19. For the purposes of examination, it will be interpreted as the same limitation. Moreover, the limitations “the use of the inflatable headgear” in line 4 is recited. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the limitation “the partial or complete interruption” in lines 4-5 is confusing, as it is unclear whether this is meant to be the same as or different from the “to interrupt or reduce” limitation of claim 66.
Regarding claim 69, the limitations “an inflatable headgear” in lines 1-2, “an inflation” in line 2, and “a deflation” in line 3 are confusing, as it is unclear whether these are meant to be the same as or different from the “inflatable headgear configured to inflate…deflate” in claim 19. For the purposes of examination, they will be interpreted as the same respective limitations.
Any remaining claims are rejected based on their dependency on a rejected base 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.
Claims 19-20, 23-27, 29-31, 66-67, and 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Landis (US 5,269,296) in view of Axe et al. (US 5,203,343) and Hariri (US 2016/0270948 A1), or alternatively over Landis in view of Sleeper et al. (US 2005/0028822 A1), Axe, and Hariri.
Regarding claim 19, as best understood, Landis discloses an apparatus (nasal continuous positive airway pressure apparatus) (abstract) comprising:
a breathing mask (nCPAP delivery device 12, which comprises nasal cannulae 16, 18) (Figs. 2, 9; col. 5, lines 6-12; col. 9, lines 9-17);
a positive airway pressure device configured to administrate positive air pressure through the breathing mask to interrupt snore and apnea through the use of pressurized air (air pressure source 170 which provides air at a positive pressure to the nCPAP delivery device to treat sleep apnea, wherein one of ordinary skill in the art would know sleep apnea to be associated with snores) (Fig. 9; col. 5, lines 65-68; col. 6, lines 1-5; col. 9, lines 9-17);
inflatable headgear configured to inflate and expand, and to subsequently deflate and collapse, causing the head of a user to move, wherein the inflatable headgear comprises at least one inflatable strap configured to be worn around the head of the user (air strap or harness 114 with segments 158, 180, 200, 202 can be inflated/expanded by an inflation source 204 and subsequently deflated/collapsed by a deflation control valve 206; as the harness 114 supports the underside of the user’s head while the user is laying down, the inflation/deflation of the harness 114 would also move the user’s head) (Fig. 9; col. 9, lines 9-30);
a tube connecting at least one air inflator to the inflatable headgear (tube between harness inflation source 204 and segment 158, on which deflation control valve 206 sits) (Fig. 9; col. 9, lines 9-30);
at least one release valve configured to deflate the inflatable headgear (deflation control valve 206 used to deflate the harness 114) (Fig. 9; col. 9, lines 9-30);
a flexible hose connecting the breathing mask to the positive airway pressure device (main air supply hose 164 and/or air conduit 122 connects the nCPAP delivery device 12 to the nCPAP air supply 170; main air supply hose and/or air conduit are soft and flexible) (Fig. 9; col. 8, lines 13-20; col. 9, lines 9-30);
a control unit in communication with the air inflator to actuate the air inflator on and off and the control unit further in communication with the release valve to close the release valve during the inflation of the inflatable headgear and open the release valve during the deflation of the inflatable headgear (harness inflation source 204 and deflation control valve 206 can be controlled by an automatic pressure sensitive control circuit to control the harness’ inflation/deflation) (Fig. 9; col. 8, lines 13-20; col. 9, lines 20-30).
Alternatively, if Landis is not seen as disclosing a breathing mask, Sleeper teaches a ventilation interface for sleep apnea (Sleeper; abstract; para. [0036]) including a breathing mask (hybrid nasal cannula body portion 2010 and face mask portion 2020) (Sleeper; Figs. 20-21; para. [0061]).
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 Landis nasal cannula to include a breathing mask, as taught by Sleeper, for the purpose of fitting the patient’s mouth for treatment as well as providing the apparatus with bleeder port and anti-asphycsia valve structures (Sleeper; para. [0063]).
Landis does not disclose causing the head of a user to move to interrupt snore and apnea; at least one sensor for detecting a trigger event, wherein the trigger event comprises at least one of: detection of a snore; detection of an apnea; identification of a snore or apnea; identification of a snore or apnea source; or a prediction of occurrence of snore or apnea; a processing unit in communication with the control unit, wherein the processing unit comprises at least one processor and memory storing instructions which when executed by the at least one processor configures the processor to detect the trigger event and transmit control commands to the control unit to trigger actuation of the air inflator or the positive airway pressure device, wherein actuation of the air inflator is based on a time interval from the detection of the trigger event.
However, Hariri teaches an apparatus and method for snore disrupting (Hariri; abstract) including causing the head of a user to move to interrupt snore and apnea (vertical movement of the bladder assembly moves the user’s head to reduce snoring, which can be related to apnea) (Hariri; para. [0003]; para. [0128]); at least one sensor for detecting a trigger event, wherein the trigger event comprises at least one of: detection of a snore; identification of a snore; or a prediction of occurrence of snore (audio sensing component to determine if a detected sound is a snoring sound; additional sensors to predict snoring) (Hariri; para. [0036]; para. [0165]; para. [0256]); a processing unit in communication with the control unit (audio processor 330 in communication with the controller 130) (Hariri; Fig. 3; para. [0045]; para. [0177]), wherein the processing unit comprises at least one processor and memory storing instructions which when executed by the at least one processor configures the processor to detect the trigger event and transmit control commands to the control unit to trigger actuation of the air inflator (processor 330 with memory 332; audio processor detects the snore trigger event and commands the controller to actuate the air inflator upon the trigger event) (Hariri; Fig. 3; para. [0045]; para. [0176]), wherein actuation of the air inflator is based on a time interval from the detection of the trigger event (the inflation cycle is initiated once the trigger event is detected, and so the time interval would be as soon as possible) (Hariri; para. [0012]; paras. [0136-0137]).
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 Landis to include apparatus to include causing the head of a user to move to interrupt snore and apnea; at least one sensor for detecting a trigger event, wherein the trigger event comprises at least one of: detection of a snore; identification of a snore; or a prediction of occurrence of snore; a processing unit in communication with the control unit, wherein the processing unit comprises at least one processor and memory storing instructions which when executed by the at least one processor configures the processor to detect the trigger event and transmit control commands to the control unit to trigger actuation of the air inflator, wherein actuation of the air inflator is based on a time interval from the detection of the trigger event, as taught by Hariri, for the purpose of helping to prevent or disrupt snoring (Hariri; para. [0045]).
Landis does not disclose the control unit is configured to be in communication with the positive airway pressure device to actuate the positive airway pressure device; wherein actuation of the air inflator is prior to or at a same time as actuation of the positive airway pressure device based on a time interval from the detection of the trigger event.
However, Axe teaches a method and device for controlling sleep disorder breathing (Axe; abstract) wherein the control unit is configured to be in communication with the positive airway pressure device to actuate the positive airway pressure device (microprocessor 23 increases the air pressure of the compressor 15 to the patient’s nostrils when snoring is detected, and further increases the pressure incrementally over time if snoring continues) (Axe; Fig. 1; col. 3, lines 6-16; col. 4, lines 60-68; col. 5, lines 1-7).
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 Landis control unit such that the control unit is configured to be in communication with the positive airway pressure device to actuate the positive airway pressure device, as taught by Axe, for the purpose of help prevent the onset of sleep disorder breathing by helping snores to cease (Axe; col. 2, lines 11-32).
With this modification, the modified Landis apparatus would thus teach wherein actuation of the air inflator is prior to or at a same time as actuation of the positive airway pressure device based on a time interval from the detection of the trigger event (in Hariri, the inflation cycle to move the head is initiated once the trigger event is detected, and so the time interval would be as soon as possible; in Axe, the air pressure from compressor 15 is increased when snoring is detected, i.e. at the same time as Hariri’s inflation cycle initiation, but also afterwards over 30 second time period intervals if snoring continues) (Hariri, para. [0012], paras. [0136-0137]; Axe, col. 3 lines 6-16, col. 4 lines 60-68, col. 5, lines 1-7).
Regarding claim 20, the modified Landis teaches wherein the positive airway pressure device comprises at least one blower (air pressure source can be an electrical compression pump) (Landis; Fig. 9; col. 5, lines 44-48).
Regarding claim 23, the modified Landis teaches wherein upon the detection of the trigger event the control unit actuates the air inflator on, inflating the inflatable headgear (Hariri audio processor detects the snore trigger event and commands the controller to actuate the air inflator upon the trigger event, thereby inflating the Landis harness 114 in the modified Landis device) (Landis, Fig. 9, col. 9 lines 9-30; Hariri, Fig. 3, para. [0012], para. [0045], para. [0176]).
Regarding claim 24, as best understood, the modified Landis teaches wherein upon detection of the trigger event, the control unit actuates the positive airway pressure device to at least one of: initiate the administration of positive air pressure; or, increase the pressure of the administrated positive air pressure; wherein the positive air pressure is administered through the breathing mask (Axe microprocessor 23 increases the air pressure of the compressor 15 to the patient’s nostrils when snoring is detected, and further increases the pressure in installments if snoring continues; the positive air pressure would be delivered through the Landis nCPAP delivery device 12/Sleeper face mask portion 2020 in the modified Landis apparatus) (Landis, Figs. 2 and 9, col. 5 lines 6-12, col. 9 lines 9-17; Sleeper, Figs. 20-21, para. [0061]; Axe, Fig. 1, col. 3 lines 6-16, col. 4 lines 60-68, col. 5 lines 1-7).
Regarding claim 25, the modified Landis teaches wherein the control unit is configured to increase the positive air pressure in installments (microprocessor 23 increases the air pressure of the compressor 15 to the patient’s nostrils when snoring is detected, and further increases the pressure in installments if snoring continues) (Axe; Fig. 1; col. 3, lines 6-16; col. 4, lines 60-68; col. 5, lines 1-7).
Regarding claim 26, as best understood, the modified Landis teaches wherein after a predetermined time during which the processing unit does not detect the trigger event, the control unit is configured to reduce the pressure of or stop the administration of positive air pressure administrated by the positive airway pressure device (after a 20 minute time interval with no snoring detected, microprocessor 23 decreases the pressure from compressor 15 administered to the patient) (Axe; Fig. 1; col. 3, lines 6-16; col. 5, lines 8-14).
Regarding claim 27, the modified Landis teaches wherein the control unit is configured to reduce the positive air pressure in installments (pressure from compressor 15 is decreased in a controlled manner of 1 cm of water every 20 minutes) (Axe; Fig. 1; col. 5, lines 8-14).
Regarding claim 29, as best understood, the modified Landis teaches wherein in response to the trigger event, the control unit is configured to actuate the air inflator and the positive airway pressure device (in Hariri, the controller 130 starts the inflation cycle to move the head is initiated once the trigger event is detected; in Axe, the microprocessor 23 has the air pressure from compressor 15 increased when snoring is detected) (Hariri, para. [0012], paras. [0136-0137]; Axe, col. 3 lines 6-16, col. 4 lines 60-68, col. 5, lines 1-7), wherein the air inflator inflates the inflatable headgear and the positive airway pressure device initiates administration of or increases the pressure of positive air pressure (in the modified Landis apparatus, the Landis harness 114 would be inflated as taught by Hariri to move the head to disrupt snoring once the snore trigger event is detected, and the air pressure from the modified Landis air pressure source 170 would be administered and increased as taught by Axe) (Landis, Fig. 9, col. 9 lines 9-30; Hariri, para. [0012], para. [0128], paras. [0136-0137]; Axe, col. 3 lines 6-16, col. 4 lines 60-68, col. 5, lines 1-7).
Regarding claim 30, as best understood, the modified Landis teaches wherein the control unit is configured to: actuate the air inflator on in response to the trigger event; and, actuate the positive airway pressure device to start the administration of, or increase the pressure of, positive air pressure, after a predetermined time interval from the detection of the trigger event (in the modified Landis apparatus, the Landis harness 114 would be inflated as taught by Hariri to move the head to disrupt snoring once the snore trigger event is detected, and the air pressure from the modified Landis air pressure source 170 would be administered and increased over 30 second time intervals from the snoring detection event as taught by Axe) (Landis, Fig. 9, col. 9 lines 9-30; Hariri, para. [0012], para. [0128], paras. [0136-0137]; Axe, col. 3 lines 6-16, col. 4 lines 60-68, col. 5, lines 1-7).
Regarding claim 31, as best understood, the modified Landis teaches wherein the control unit is configured to initiate inflation and deflation cycles of the inflatable headgear at predetermined intervals for a duration that the presence of the trigger event is detected (controller 130 actuates the air inflator 140 cyclically to inflate/deflate a bladder assembly in a pattern of time intervals when triggered, the inflation/deflation cycles occurring until completed) (Hariri; paras. [0136-0137]; paras. [0160-0161]).
Regarding claim 66, as best understood, the modified Landis teaches wherein the movement of the head and pressurized air are initiated at a same time, or with a time delay for the pressurized air, to interrupt or reduce snore or apnea of the user, wherein the time delay is based on a predetermined time interval based on a condition of the user (in Hariri, the inflation cycle is initiated to move the head to disrupt snoring once the snore trigger event is detected, and so the time interval would be as soon as possible; in Axe, the air pressure from compressor 15 is increased when snoring is detected, i.e. at the same time as Hariri’s inflation cycle initiation, but also afterwards over 30 second time period intervals if the patient’s snoring condition continues) (Hariri, para. [0012], para. [0128]; Axe, col. 3 lines 6-16, col. 4 lines 60-68, col. 5, lines 1-7).
Regarding claim 67, as best understood, the modified Landis teaches wherein use of movement of the head caused by the inflatable headgear prior to or at a same time as the use of pressurized air reduces required pressure and duration of air administration compared to a required pressure and duration of air administration of the positive airway pressure device functioning alone and without the use of the inflatable headgear due to the partial or complete interruption of snore or apnea by the movement (in the modified Landis apparatus, the Landis harness 114 would inflate as taught by Hariri to move the head to disrupt snoring once the snore trigger event is detected, and so the time interval would be as soon as possible; as the modified Landis device is used to disrupt snoring, and increased pressure is needed only when snoring occurs, the inflation of the modified Landis harness 114 would thus reduce the required air pressure and duration of the delivered pressurized air to the mask in comparison to an apparatus without the modified Landis harness 114) (Landis, Fig. 9, col. 9 lines 9-30; Hariri, para. [0012], para. [0128]; Axe, col. 3 lines 6-16, col. 4 lines 60-68, col. 5, lines 1-7).
Regarding claim 69, as best understood, the modified Landis teaches wherein the inflatable headgear comprises an inflatable headgear worn around the head of the user, wherein an inflation and deflation cycle comprises an inflation of the inflatable headgear from an initial deflated position, followed by a deflation of the inflatable headgear back to the initial deflated position (in the modified Landis apparatus, the Landis harness 114 worn on the user’s head would first inflate and then deflate cyclically as taught by Hariri to move the head to disrupt snoring once the snore trigger event is detected) (Landis, Fig. 9, col. 9 lines 9-30; Hariri, para. [0012], para. [0128], para. [0137]).
Regarding claim 70, the modified Landis teaches wherein the inflatable headgear is configured to hold the breathing mask in place (air strap or harness 114 with segments 158, 180, 200, 202 can be used with belt 212 and/or loop strap 216 to connect with conduit 122, which in turn holds the nCPAP delivery device 12 in place on the patient) (Landis; Fig. 9; col. 9, lines 30-47).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Landis in view of Sleeper, Axe, and Hariri as applied to claim 19 above, and further in view of Selvarajan et al. (US 2010/0147302 A1).
Regarding claim 21, the modified Landis does not teach wherein the positive airway pressure device comprises: at least one air filter; at least one humidifier, and; at least one heater.
However, Selvarajan teaches a CPAP system (Selvarajan; abstract) wherein the positive airway pressure device comprises: at least one air filter (flow generator includes an anti-bacterial filter) (Selvarajan; para. [0054]); at least one humidifier (flow generator used with a humidifier) (Selvarajan; para. [0091]), and; at least one heater (heater to vaporize or evaporate water) (Selvarajan; para. [0151]; claim 31).
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 Landis positive airway pressure device to include at least one air filter, at least one humidifier, and at least one heater, as taught by Selvarajan, for the purpose of helping to reduce the possibility of cross-contamination (Selvarajan; para. [0094]), improving therapy or patient comfort (Selvarajan; para. [0149]), and achieving greater humidity without condensation (Selvarajan; para. [0151]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Landis in view of Sleeper, Axe, and Hariri as applied to claim 19 above, and further in view of Aarts (US 2008/0308112 A1).
Regarding claim 28, as best understood, the modified Landis does not teach wherein at least one sensor is continuously active to detect the occurrence of both snore and apnea.
However, Aarts teaches a system for reducing snoring and sleep apnea (Aarts; abstract) wherein at least one sensor is continuously active to detect the occurrence of both snore and apnea (sensor 4 determines whether snoring and/or sleep apnea occurs; the sensor 4 works continuously as long as the patient is asleep) (Aarts; para. [0024]; para. [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Landis at least one sensor to be continuously active to detect the occurrence of both snore and apnea, as taught by Aarts, for the purpose of enabling the at least one sensor to additionally detect sleep apnea (Aarts; para. [0024]), and thereby allow the apparatus to help treat sleep apnea that occurs without snoring.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Landis in view of Sleeper, Axe, and Hariri as applied to claim 30 above, and further in view of Berthon-Jones et al. (US 2007/0142741 A1).
Regarding claim 71, the modified Landis does not teach wherein the positive air pressure is administered through the mask to in part open a blockage of the respiratory tract or airway causing the snore or sleep apnea.
However, Berthon-Jones teaches an apparatus for treating sleep disordered breathing (Berthon-Jones; abstract) including wherein the positive air pressure is administered through the mask to in part open a blockage of the respiratory tract or airway causing the snore or sleep apnea (detecting snoring can be an indicator of obstruction in the patient’s airway; once a determination that there is a blockage has been made, the CPAP treatment pressure to the mask is increased) (Berthon-Jones; para. [0046]; para. [0048]).
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 Landis positive air pressure such that the positive air pressure is administered through the mask to in part open a blockage of the respiratory tract or airway causing the snore or sleep apnea, as taught by Berthon-Jones, for the purpose of helping to eliminate patient airway obstructions (Berthon-Jones; para. [0046]; para. [0048]), and thereby improve a patient’s sleep.
Response to Arguments
Applicant's arguments filed 8/11/2025 have been fully considered but they are not persuasive.
On page 6 in the “Claim Objections” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the claim objection of the previous office action. The Examiner agrees, and has thus withdrawn that objection. However, new claim objections have been raised for the newly amended claims as detailed above.
On page 6 in the “Claim Rejections - 35 USC 112” section of the Applicant’s remarks, the Applicant argues that claim 71 has been amended to overcome the 35 U.S.C. 112(b) rejection of the previous office action. The Examiner agrees, and has thus withdrawn that rejection. However, new 35 U.S.C. 112(b) rejections have been raised for the newly amended claims as detailed above.
Applicant’s arguments on pages 6-7 in the “Claim Rejections - 35 USC 103” section of the Applicant’s remarks with respect to claims 19-25, 28-29, 66-68, and 71 have been considered but are moot in view of new grounds of rejection with new additional Landis, Sleeper, and Axe references being used in the current rejection as discussed above.
Conclusion
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785