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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed on 07/12/2023 has been received and fully considered.
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:
“control module” in claim 4.
“sensor module” in claims 10-12.
“switch module” in claim 11.
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. Examiner notes the control module is interpreted to be any controller or processing module capable of controlling a device. Examiner notes the sensor module is taken to be a sensor or equivalents thereof. Examiner notes that the switch module is interpreted to be any processing/control module which governs treatment type given to a user.
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 § 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)(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 1-2, 5, 8, 10, and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2014117179A1 to Goff et al. (hereinafter “Goff”).
Regarding claim 1, Goff discloses a continuous positive pressure system using a 3G sensor mask (Fig. 1 positive airway pressure system 1000), comprising:
a 3G sensor mask which is mounted on a patient's face to sense the patient's sleep position during sleep (Fig. 1 mask 1008; Fig. 1 shows the mask is on the patient’s face; Paragraph 0023 discloses a position sensor attached to a PAP mask which monitors orientation information about the user); and
a positive pressure device which is connected wirelessly or non-wirelessly to the 3G sensor mask and receives sleep position information of the patient sensed through the 3G sensor mask (Paragraph 0028 discloses the position sensor is connected wired or wirelessly to a positive airway pressure device and gives information to the PAP device), detects pressure necessary for airway opening and airway closure pressure in response to changes in the received sleep position of the patient (Paragraph 0047 discloses the position sensor is used to control output pressure of a PAP system to keep the airway unblocked), and immediately corrects the pressure through a blower based on the detected airway closure pressure and corresponding position information (Paragraph 0037 discloses sensed position of the patient’s head is transmitted to the controller of the pressure source to provide suitable gas pressure based on the sensed position of the patient’s head; Examiner notes the controller/compressor responds to the signals of the patient’s current position and thus the compressor is acting immediately in response the sensed information).
Regarding claim 2, Goff discloses the continuous positive pressure system according to claim 1, and Goff further discloses wherein the positive pressure device collects the sleep position information of the patient sensed from the 3G sensor mask through sleep monitoring and airway closure pressure information of the patient during sleep, matches the collected data, and analyzes airway closure pressure changing according to the patient's sleep position (Paragraph 0032 discloses the pressure sensor placed on the device signals when the user in a lateral position; Paragraph 0038 discloses the pressure sensors sense the determine suitable pressure to maintain critical pressure for patency in the patient’s airway passage; See also Paragraph 0050).
Regarding claim 5, Goff discloses the continuous positive pressure system according to claim 1, and Goff further discloses wherein the positive pressure device detects the airway closure pressure when the patient is lying straight and the airway closure pressure when the patient is lying on the side from the collected data (Paragraph 0036 discloses the head position sensor detects the patient’s head position relative to a horizontal plane; Paragraph 0036 further discloses the sensors may be a three-axis accelerometer which represents three-axis orientation with respect to gravity; Examiner notes the device is thus capable of detecting when the patient is lying on their side; Paragraph 0017 discloses that when a patient is on their side, gravity acts upon the system to disturb airflow), sets the detected airway closure pressures as the maximum pressure and the minimum pressure by gravity direction angles (Paragraph 0075 discloses a dangling element 104 which creates airflow signatures interpreted by air pressure sensors; Examiner notes the dangling element detects gravity direction angles based on how it dangles; See also Paragraph 0081), and predicts and extracts the airway closure pressure according to the sleep positions at various angles based on the function varying proportionally to the gravity direction angles within the range between the maximum pressure and the minimum pressure (Paragraph 0032 discloses the pressure sensors may be used to adjust pressure based on a sensed lateral position for PAP pressure of the device; Paragraph 0031 discloses a 3-axis accelerometer to determine absolute position of the user; Paragraph 0038 discloses the pressure readings are used to maintain critical pressure in the patient’s airway passage; Examiner notes the therapeutic pressure is predicted as the machine adjusts to the orientation information of the user; Paragraph 0023 discloses the sensor may have a predetermined keyed orientation and thus inherently has predictive data based on how it is aligned).
Regarding claim 8, Goff discloses the continuous positive pressure system according to claim 1, and Goff further discloses wherein the positive pressure device performs remote monitoring and sleep monitoring for pressure adjustment (Paragraph 0138 discloses the system may be applicable to breathing systems with remote control and/or pressure sources and wherein the head position sensor is secured to the top of the patient’s head), or performs sleep monitoring for patient profiling by storing and recording the collected data in a storage unit.
Regarding claim 10, Goff discloses a 3G sensor mask, as a mask for a positive pressure device (Fig. 1 system 1000, mask 1008; Paragraphs 0016 and 0072 disclose the PAP system; Paragraph 0023 discloses the position sensor on the mask), comprising:
a supply hose which is mounted on a patient's face to supply air at a predetermined pressure to the throat (Fig. 1 airway tube 1006; Paragraph 0072 discloses the airway tube 1006 connects the pressure source 1002 to mask 1008 worn by the user);
a 3G sensor module which senses the patient's sleep position during sleep (Paragraph 0023 discloses a position sensor attached to a PAP mask which monitors orientation information about the user; Paragraph 0047 discloses the position sensor is used to control output pressure of a PAP system to keep the airway unblocked); and,
a communication unit which transmits sensed sleep position information of the patient through the 3G sensor module to the positive pressure device wirelessly or wirelessly, thereby reflecting the patient's sleep position in real time (Paragraph 0028 discloses the position sensor is connected wired or wirelessly to a positive airway pressure device and gives information to the PAP device; Paragraph 0037 discloses sensed position of the patient’s head is transmitted to the controller of the pressure source to provide suitable gas pressure based on the sensed position of the patient’s head; Examiner notes the wire of the wired communication would serve as the communication unit, and if wireless, Paragraph 0028 discloses the information may be transmitted via Bluetooth or WiFi).
Regarding claim 12, Goff discloses the 3G sensor mask according to claim 10, and Goff further discloses wherein the 3G sensor module is provided to be integrated with a frame which enables the 3G sensor module to be mounted on the patient's face, or is detachably mounted on the frame to be applicable to a mask for the existing positive pressure device (Paragraph 0023 discloses the position sensor may be attached to the PAP mask; Examiner notes the position sensor is capable of being mounted on the frame of the mask (See Annotated Fig. 1 for designation of the mask frame)).
Claim Rejections - 35 USC § 103
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of US20190151585A1 to Troxell et al. (hereinafter “Troxell”).
Regarding claim 3, Goff discloses the continuous positive pressure system according to claim 1, and Goff further discloses a PCPAP (Position CPAP) (Fig. 1 positive airway pressure system 1000), and simultaneously collects the patient's sleep position information sensed through the 3G sensor mask, matches the collected data to analyze the airway closure pressure changing according to the patient's sleep position during sleep, and immediately corrects the pressure based on the airway closure pressure according to the analyzed sleep position (Paragraph 0032 discloses the pressure sensor placed on the device signals when the user in a lateral position; Paragraph 0038 discloses the pressure sensors sense the determine suitable pressure to maintain critical pressure for patency in the patient’s airway passage; See also Paragraph 0050; Paragraph 0037 discloses sensed position of the patient’s head is transmitted to the controller of the pressure source to provide suitable gas pressure based on the sensed position of the patient’s head; Examiner notes the controller/compressor responds to the signals of the patient’s current position and thus the compressor is acting immediately in response the sensed information).
Goff does not disclose an ACPAP (Auto CPAP), which controls pressure by adjusting a blower according to the patient's airway closure pressure during sleep regardless of the patient's sleep position. However, Troxell teaches a respiratory support system which has a ACPAP which controls pressure by adjusting a blower according to the patient’s airway closure pressure during sleep regardless of the patient’s sleep position (Paragraph 0044 discloses the system may administer APAP (auto CPAP) to the user by using control component 58 to control pressure generator 14; Paragraphs 0024 & 0028 disclose sensors 18 which sense pressure in the airway system and uses that data to control the pressure generator 14; Examiner notes Paragraph 0017 discloses APAP is auto CPAP).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Goff to further include an ACPAP which controls pressure by adjusting a blower according to the patient’s airway closure pressure during sleep regardless of the patient’s sleep position, as taught by Troxell, in order to provide an additional mode of treatment based on respiratory events (Paragraph 0028).
Goff as modified by Troxell further discloses a PCPAP which collects the patient's airway closure pressure information measured through the ACPAP for sleep monitoring of the patient (Examiner notes the sensors of Troxell would be collecting information during the ACPAP treatment and thus would be feeding the information to the processor/control components of Goff to monitor the patient; Examiner further notes that “through” is interpreted to mean “during”).
Regarding claim 4, Goff discloses the continuous positive pressure system according to claim 1, and Goff further discloses a control module (Paragraph 0037 discloses a controller) and simultaneously collects the patient's sleep position information sensed through the 3G sensor mask, matches the collected data to analyze the airway closure pressure changing according to the patient's sleep position during sleep, and immediately corrects the pressure based on the airway closure pressure according to the analyzed sleep position (Paragraph 0037 discloses the controller receives position data to determine a suitable pressure output pressure for the particular sensed head position from the received head position signal; Paragraph 0032 discloses the pressure sensor placed on the device signals when the user in a lateral position; Paragraph 0038 discloses the pressure sensors sense the determine suitable pressure to maintain critical pressure for patency in the patient’s airway passage; See also Paragraph 0050; Examiner notes the controller/compressor responds to the signals of the patient’s current position and thus the compressor is acting immediately in response the sensed information). Goff does not disclose an ACPAP (Auto CPAP), which controls pressure by adjusting a blower according to the patient's airway closure pressure during sleep regardless of the patient's sleep position. However, Troxell teaches a respiratory support system which has a ACPAP which controls pressure by adjusting a blower according to the patient’s airway closure pressure during sleep regardless of the patient’s sleep position (Paragraph 0044 discloses the system may administer APAP (auto CPAP) to the user by using control component 58 to control pressure generator 14; Paragraphs 0024 & 0028 disclose sensors 18 which sense pressure in the airway system and uses that data to control the pressure generator 14; Examiner notes Paragraph 0017 discloses APAP is auto CPAP).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Goff to further include an ACPAP which controls pressure by adjusting a blower according to the patient’s airway closure pressure during sleep regardless of the patient’s sleep position, as taught by Troxell, in order to provide an additional mode of treatment based on respiratory events (Paragraph 0028).
Goff as modified by Troxell further discloses a control module which collects the patient's airway closure pressure information measured through the ACPAP for sleep monitoring of the patient (Examiner notes the sensors of Troxell would be collecting information during the ACPAP treatment and thus would be feeding the information to the processor/control components of Goff to monitor the patient; Examiner further notes that “through” is interpreted to mean “during”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US20190160282A1 to Dieken et al. (hereinafter “Dieken”) and EP3741417B1 to Gerred et al. (hereinafter “Gerred”).
Regarding claim 6, Goff discloses the continuous positive pressure system according to claim 1, and Goff further discloses wherein when the position of the patient getting up is sensed through the 3G sensor mask (Paragraph 0031 discloses the accelerometer may be a 3-axis accelerometer; Examiner notes the 3-axis accelerometer would be capable of sensing if the patient got up (changed their y-axis arrangement)).
Goff does not disclose the positive pressure device recognizes a patient getting up as a non-sleep state. However, Dieken teaches an accelerometer-based sensing system for sleep disordered breathing that recognizes a non-sleep state (Paragraph 0123 discloses sleep onset is detected via tracking posture).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Goff to further include recognizing when a patient gets up as a non-sleep state, as taught by Dieken, in order to provide control over when the therapeutic flow of gas is provided to the user (Paragraph 0123).
Modified Goff does not disclose switches the mode not into a sleep treatment mode but into a non-sleep treatment mode to enable continuous treatment. However, Gerred teaches a positive airway pressure device which switches into a non-sleep treatment mode to enable continuous treatment (Paragraph 0023 discloses the PAP system determines whether the patient is asleep or awake, and provides and awake pressure for use when the patient is determined to be awake).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Goff to switch into a non-sleep treatment mode, as taught by Gerred, in order to provide comfortable therapy to a patient that is awake (Paragraph 0023).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of US20180125743A1 to Aarestad et al. (hereinafter “Aarestad”).
Regarding claim 7, Goff discloses the continuous positive pressure system according to claim 1, and Goff further discloses wherein, in order to set a reference position when sensing the patient's sleep position, the 3G sensor mask senses the position of the basic position and sends the basic position to the positive pressure device (Paragraph 0035 discloses the position sensing elements may determine the position of the patient’s head with respect to a reference plane (e.g. horizontal plane)), and wherein the positive pressure device sets the position received from the 3G sensor mask as the reference position (Examiner notes the sensed horizontal plane is the reference position).
Goff does not disclose outputs a guidance on the completion of setting and sensing operation to the user using one or more of voice, alarm, and light. However, Aarestad teaches a pressure control system for opening an airway which outputs a guidance on the completion of setting and sensing operation to the user using one or more of voice, alarm, and light (Paragraph 0046 discloses the device may turn on a light when the user is sensed to sit up or stand up in a vertical position).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Goff to further include outputting a light upon sensing operation, as taught by Aarestad, in order to provide a means of indicating when the user stands/sits up (Paragraph 0046). Examiner notes this modification would also allow for the machine to illuminate the room and machine if the user gets up in the middle of the night or in a dark room (Paragraph 0046).
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Goff in view of Gerred.
Regarding claim 9, Goff discloses the continuous positive pressure system according to claim 1, but does not disclose wherein when the patient wakes up, the positive pressure device determines whether to resume treatment with the pressure control method according to the sleep position, and if an operation request for resuming treatment is inputted by the user, the positive pressure device performs the operation with the pressure control method. However, Gerred teaches a positive airway pressure device which switches into a non-sleep treatment mode when the patient wakes up to enable continuous treatment (Paragraph 0023 discloses the PAP system determines whether the patient is asleep or awake, and provides and awake pressure for use when the patient is determined to be awake; Paragraphs 0009 & 0013 discloses a user may input values for an awake pressure for therapy).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Goff to switch into a non-sleep treatment mode, as taught by Gerred, in order to provide manual control over comfortable therapy to a patient that is awake (Paragraphs 0013 & 0023).
Modified Goff further discloses performing the operation with the pressure control method according to the profiled sleep position for each patient (Examiner notes the sensors of Goff send information regarding each patient’s position to a controller; Goff as modified by Gerred would use the position sensor data to further inform the treatment pressures needed for each patient).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20120179005-A1 to McCool; US-20130104883-A1 to Lalonde; US-20140102449-A1 to Lalonde; US-20150059750-A1 to Arnott; US-20150122260-A1 to Daly; US-20160121065-A1 to Lee; US-20170151409-A1 to Peacock; US-20170367619-A1 to Zhan; US-20180043122-A1 to Oenning; US-20180098739-A1 to Freeman; and US-20180303412-A1 to Moore.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYLER RAUBENSTRAW whose telephone number is (571)272-0662. The examiner can normally be reached Monday-Friday 7:30-5:30.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799