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 .
Status of Claims
2. Claims 1-20 are pending and currently under consideration for patentability under 37 CFR 1.104.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the instant case, line 4 of the Abstract states “comprising” which is form/legal phraseology often used in patent claims, and should be avoided.
Drawings
Figures 18-20 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated, as these appear to be identical to Figures 6-8 of US 2013/0331747. See MPEP § 608.02(g).
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1, 10, 15, and 18-19 are objected to because of the following informalities:
Claim 1, line 4 recites “for creating air pulses” and Examiner suggests --for creating the air pulses-- to clarify the antecedent basis, as line 3 already recites “creating air pulses.”
Claim 1, the penultimate line recites “air pulses” and Examiner suggests --the air pulses-- to clarify the antecedent basis.
Claim 10, line 4 recites “for creating air pulses” and Examiner suggests --for creating the air pulses-- to clarify the antecedent basis, as line 3 already recites “creating air pulses.”
Claim 10, line 10 recites “air pulses” and Examiner suggests --the air pulses-- to clarify the antecedent basis.
Claim 15, lines 1-2 recite “wherein the mobile app includes a remote control interface, and” and Examiner suggests deleting this phrase, as this limitation is already recited in claim 14 which claim 15 depends from.
Claim 18, lines 1-2 recite “a user” and Examiner suggests --the user-- to clarify the antecedent basis.
Claim 19, line 2 recites “a user” and Examiner suggests --the user-- to clarify the 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.
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 1-20 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 1, lines 5-6 recite “wherein a user programs a therapy using the touchscreen” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim 2, lines 1-2 recite “wherein the user labels the therapy … via the touchscreen” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim 8, line 3 recites “airflow channel gasketing around” and it is unclear what is meant by “gasketing” as it appears to be used as a verb.
Claim 10, lines 5-6 recite “wherein a user programs a therapy using the touchscreen” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim 17, lines 1-2 recite “wherein a medical professional uses a web app to input data…” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim 20, lines 1-2 recite “wherein the user labels the therapy … via the touchscreen” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim 20, line 3 recites “based on therapy selected for use” and it is unclear what is meant by this. Therapy selected for what use?
The remaining claims are rejected based on their dependence on a rejected base claim.
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.
Claims 1, 3-4, 7-8, 10-12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rock et al. (2017/0007494).
Regarding claim 1, Rock discloses a high frequency chest wall oscillation system (percussive pulsing therapy system 100, Fig. 1; see also para. [0002]), the system comprising:
a therapy garment (patient device 120, Fig. 1, which “may be or include a vest or jacket” see para. [0041]);
a pulsator (therapy device 110, Fig. 1, which includes an airflow generator 12, Fig. 4C) for creating air pulses (“airflow generator 112 may generally be controlled to adjust the amplitude of air pulses transmitted from the therapy device 110 to the patient device 120” see para. [0058]), wherein the pulsator (110) includes:
an air pulse generator (airflow generator 12, Fig. 4C) for creating air pulses having a frequency and a pressure (“airflow generator 112 may generally be controlled to adjust the amplitude of air pulses … airflow generator 12 may be flowably coupled to the pulse frequency control module 14…” see para. [0058]. The airflow amplitude will have an associated pressure); and
a control panel (user interface 130, Fig. 1) comprising a touchscreen having a display (“user interface 130 may include a touch screen or other display and/or one or more selectable buttons, keys, or switches” see para. [0043]), wherein a user programs a therapy using the touchscreen (the user uses the interface 130 “to view, enter, modify, or delete data” see para. [0043], the patient receives therapy by “selecting one or more options via the user interface 130” see the last sentence of [0068], and the user interface may coordinate with a mobile application for “adjusting one or more settings on the therapy device in real time … pulse frequency, pressure setting, and/or therapy timer” see para. [0083]);
a single hose (left airway 60, Fig. 11. It is noted that claim 1 recites “comprising” and thus this limitation does not exclude additional hoses. Furthermore, Rock discloses using “one or more lines or hoses” see para. [0051], and “a single outlet 51” may be used, see the last two sentences of [0065]) coupling the pulsator (110) to the therapy garment (vest or jacket 120, Fig. 11; see the first sentence of [0051]) for communicating air pulses from the pulsator to the therapy garment (see Fig. 11).
Regarding claim 3, Rock discloses wherein the therapy is either a Program Therapy or a Ramp Therapy (the therapy may at least be a program, such as “quick start” or “multi step” programs listed in Fig. 13, and Rock states “the pulse frequency module 14 may be programmed and controlled electronically to allow for the automatic timed cycling of frequencies” see the last sentence of [0061]).
Regarding claim 4, Rock discloses wherein the system further comprises a mobile app (“user interface 130 may be or include …a mobile application” see para. [0043]), wherein device data is collected during treatment using the high frequency chest wall oscillation system (“recording therapy data for one or more therapy sessions of a patient, the therapy data including air pressure data, air pulse frequency data, therapy session duration data, and at least one of airflow data, inhalation data, exhalation data, cough data, and sputum production data “ see para. [0009] and see the “adherence data” illustrated in Figs. 13-14 and para. [0083]) and wherein the air pulsator (110) communicates the collected device data to the mobile app (“mobile application may provide a user, such as a patient or caregiver, with updated therapy data and/or adherence data. FIGS. 18A-18E illustrate examples of a mobile user interface providing access to detailed therapy data and adherence data for a patient… including any therapy data and/or adherence data discussed above, for individual therapy sessions, and/or data trends over a plurality of sessions” see para. [0083]).
Regarding claim 7, Rock discloses wherein the display is customizable to the user (“a customized application may be used to access, display, and update information” see the penultimate sentence of [0088]).
Regarding claim 8, Rock discloses wherein the pulsator (110) further includes a housing (housing 70, Fig. 2) having an inlet vent (air intake 74, Fig. 3; para. [0053]) and an outlet vent (“vent 53 for releasing air back to the atmosphere” see Fig. 11 and para. [0065]. This vent is part of frequency control module 14, which is connected to the housing as seen in Figs. 4C-4D), the housing (70) encasing the air pulse generator (12, Fig. 4A) provided in a case (the housing provides a case), a circuit board (CPU board 210, Fig. 12), a fan (“airflow generator 12 may be or include a fan or blower” see para. [0058]), and a motor (motor 21, Fig. 9), and airflow channel (plenum 90, Figs. 4A-4F) gasketing (plenum 90 is forming a fluid-tight passage) around a circumference of the case (plenum 90 extends around at least a portion of the circumference of the case, as seen in Fig. 4B), the airflow channel gasketing defining an airflow pathway (see para. [0057]).
Regarding claim 10, Rock discloses a high frequency chest wall oscillation (percussive pulsing therapy system 100, Fig. 1; see also para. [0002]), the system comprising:
a therapy garment (patient device 120, Fig. 1, which “may be or include a vest or jacket” see para. [0041]);
a pulsator (therapy device 110, Fig. 1, which includes an airflow generator 12, Fig. 4C) for creating air pulses (“airflow generator 112 may generally be controlled to adjust the amplitude of air pulses transmitted from the therapy device 110 to the patient device 120” see para. [0058]), wherein the pulsator (110) includes:
an air pulse generator (airflow generator 12, Fig. 4C) for creating air pulses having a frequency and a pressure (“airflow generator 112 may generally be controlled to adjust the amplitude of air pulses … airflow generator 12 may be flowably coupled to the pulse frequency control module 14…” see para. [0058]. The airflow amplitude will have an associated pressure);
a control panel (user interface 130, Fig. 1) comprising a touchscreen having a display (“user interface 130 may include a touch screen or other display and/or one or more selectable buttons, keys, or switches” see para. [0043]), wherein a user programs a therapy using the touchscreen (the user uses the interface 130 “to view, enter, modify, or delete data” see para. [0043], the patient receives therapy by “selecting one or more options via the user interface 130” see the last sentence of [0068], and the user interface may coordinate with a mobile application to “adjust one or more settings on the therapy device in real time … pulse frequency, pressure setting, and/or therapy timer” see para. [0083]);
wherein the pulsator (110) has wireless connectivity (“communicably coupled to the therapy device 110 over a wired or wireless network 160” see the last sentence of [0040] and Fig. 1); and
wherein device data is collected during treatment using the high frequency chest wall oscillation system (“recording therapy data for one or more therapy sessions of a patient, the therapy data including air pressure data, air pulse frequency data, therapy session duration data, and at least one of airflow data, inhalation data, exhalation data, cough data, and sputum production data “ see para. [0009] and see the “adherence data” illustrated in Figs. 13-14 and para. [0083]);
a single hose (left airway 60, Fig. 11. It is noted that claim 1 recites “comprising” and thus this limitation does not exclude additional hoses. Furthermore, Rock discloses using “one or more lines or hoses” see para. [0051], and “a single outlet 51” may be used, see the last two sentences of [0065]) coupling the pulsator (110) to the therapy garment (vest or jacket 120, Fig. 11; see the first sentence of [0051]) for communicating air pulses from the pulsator to the therapy garment (see Fig. 11); and
a mobile app (“user interface 130 may be or include …a mobile application” see para. [0043]), wherein the pulsator (110) communicates the collected device data to the mobile app (“mobile application may provide a user, such as a patient or caregiver, with updated therapy data and/or adherence data. FIGS. 18A-18E illustrate examples of a mobile user interface providing access to detailed therapy data and adherence data for a patient… including any therapy data and/or adherence data discussed above, for individual therapy sessions, and/or data trends over a plurality of sessions” see para. [0083]).
Regarding claim 11, Rock discloses wherein the device data is stored in the pulsator, in the mobile app, or on a server (device data may be stored in database 150, Fig. 1, which “may be a remote database such as a cloud storage database” see para. [0050]).
Regarding claim 12, Rock discloses wherein the device data includes compliance data (see the data provided in Figs. 13-15, which includes usage data in Fig. 13, “adherence reports” in Fig. 14, and “compliance trends” in Fig. 15) including at least one of how often the system is being used and what therapy is being used (Figure 13 shows a log of how often the system is being used, such as the “session date,” “start time,” “stop time,” and what therapy is being used such as “start pressure,” “end pressure,” “Avg,” and “Program” type).
Regarding claim 14, Rock discloses wherein the mobile app is provided on a mobile device (such as a personal digital assistant, smartphone or smart watch, see the last sentence of [0072] and see para. [0085]), wherein the mobile app includes a remote control interface and the mobile device may be used as a remote control (the user interface allows the user to “access the controller 140 and/or database” see para. [0043], para. [0045], and the mobile application provides “options for adjusting one or more settings on the therapy device in real time … pulse frequency, pressure setting, and/or therapy timer” see para. [0083]. Adjusting these parameter(s) via the mobile app would use a remote control interface).
Regarding claim 15, Rock discloses wherein the mobile app includes a remote control interface (the user interface allows the user to “access the controller 140 and/or database” see para. [0043], para. [0045], and the mobile application provides “options for adjusting one or more settings on the therapy device in real time … pulse frequency, pressure setting, and/or therapy timer” see para. [0083]) and wherein the remote control interface is specific to a type of user of the mobile app (“user interface 130 may be accessible by various users, such as a patient who may wear the patient device 120 or for whom the therapy may be directed, a healthcare professional, a caretaker, a system administrator, or other users. In some embodiments, the user interface 130 may prompt a user for a username, user identifier, and/or password or other identifying or login information before a user can access the controller 140 and/or database 150. In some embodiments, a user may be prompted for login or identifying information prior to beginning a therapy session” see para. [0043]. Thus, by requiring a username and password, the access of the remote control interface is specific to a certain user).
Regarding claim 16, Rock discloses wherein the type of user of the mobile app is a patient (a patient can use the mobile app by logging in with their username and password, see para. [0043]) and wherein the remote control interface enables the user to start the therapy, stop the therapy, pause the therapy, and review device status (the user interface allows the user to “access the controller 140 and/or database” see para. [0043]. The controller 140 has a device control module 142, which “generally control[s] operation of the therapy device 110… operate the timing, pressure settings, frequency settings, pause or rest settings, and/or other operations of the therapy device 110” see para. [0045]. Adjusting a frequency setting would allow the user to see a device status, such as the current operating frequency).
Regarding claim 17, Rock discloses wherein a medical professional uses a web app to input data including at least one of settings, prescriptions, instructions, and a new therapy (a “caregiver, may adjust the air pressure and/or frequency prior to and/or during a therapy session” see para. [0039], and the user interface 130 is “accessible by various users …[including] a healthcare professional, a caretaker” such as by having a username and password, see para. [0043]. Additionally, alerts may be sent to the user by a caretaker or healthcare professional, which would read on a prescription or instruction, see para. [0049]), and wherein the data is sent to the mobile app (see para. [0049], the alerts module at least would have the alert data related to prescriptions, instructions, sent to the mobile app so the user is alerted).
Regarding claim 18, Rock discloses wherein the mobile app reminds a user to use the high frequency chest wall oscillation system (the alerts module 148, Fig. 1, is used to remind the user to use the system, see para. [0049]. The mobile app provides the user “access to the controller 140” which includes the alerts module, see Fig. 1 and para. [0043]-[0044]).
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 2 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rock et al. (2017/0007494) in view of Peake et al. (2022/0134033).
Regarding claim 2, Rock is silent regarding wherein the user labels the therapy as a Good Day Therapy or a Bad Day Therapy via the touchscreen (user interface 130 has a touchscreen).
Peake teaches a related mobile application (application executed on a mobile device, Fig. 6; see para. [0199]) for a respiratory therapy system (Respiratory Pressure Therapy Device 4000, Fig. 1), wherein the user labels the therapy as a Good Day Therapy or a Bad Day Therapy (screen 606 asks the user to label the therapy as “Great!” [good day] or “Challenging” [bad day], see Fig. 6 and para. [0173]) via the touchscreen (touch input display, see para. [0155]). “If the feedback response is one of “Challenging” or “Getting there” the RPT device may present a follow up question to identify any specific trouble areas” (see para. [0173]). Additionally, the “feedback received from the user and settings of the medical device can be used to improve settings of other medical devices and provide relevant recommendations to other patients” (see the last sentence of [0130] and the last two sentences of [0194]). The computing system may “segment the patient’s data … and use models … to determine what the patient needs and/or what settings on the RPT device 4000 should be modified” (see para. [0160]-[0161]). One of ordinary skill in the art would recognize that asking the user how their therapy is going would be applicable to a wide range of therapies, so the system can collect patient feedback and use the feedback for improvement.
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 mobile application of Rock to ask the user to label the therapy as a Good Day Therapy or a Bad Day Therapy via the touchscreen as taught by Peake so the system can collect patient feedback to be used to identify trouble areas and improve settings of the medical devices.
Regarding claim 20, Rock is silent regarding wherein the user labels the therapy as a Good Day Therapy or a Bad Day Therapy via the touchscreen, and wherein the device data includes occurrences of good days and bad days based on therapy selected for use.
Peake teaches a related mobile application (application executed on a mobile device, Fig. 6; see para. [0199]) for a respiratory therapy system (Respiratory Pressure Therapy Device 4000, Fig. 1), wherein the user labels the therapy as a Good Day Therapy or a Bad Day Therapy (screen 606 asks the user to label the therapy as “Great!” [good day] or “Challenging” [bad day], see Fig. 6 and para. [0173]) via the touchscreen (touch input display, see para. [0155]). “If the feedback response is one of “Challenging” or “Getting there” the RPT device may present a follow up question to identify any specific trouble areas” (see para. [0173]). Additionally, the “feedback received from the user and settings of the medical device can be used to improve settings of other medical devices and provide relevant recommendations to other patients” (see the last sentence of [0130] and the last two sentences of [0194]). The computing system may “segment the patient’s data … and use models … to determine what the patient needs and/or what settings on the RPT device 4000 should be modified” (see para. [0160]-[0161]). One of ordinary skill in the art would recognize that asking the user how their therapy is going would be applicable to a wide range of therapies, so the system can collect patient feedback and use the feedback for improvement.
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 mobile application of Rock to ask the user to label the therapy as a Good Day Therapy or a Bad Day Therapy via the touchscreen as taught by Peake so the system can collect patient feedback to be used to identify trouble areas and improve settings of the medical devices.
The modified Rock/Peake device would have the device data include occurrences of good days and bad days based on therapy selected for use (the patient data is segmented, see para. [0160], and the interface can be filtered by the respiratory pressure “therapy mode” as seen in Figure 10A of Peake, see para. [0243], [0262]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rock et al. (2017/0007494) in view of Gusky et al. (2012/0240932).
Regarding claim 5, Rock is silent regarding wherein the pulsator (110) further comprises an accelerometer, wherein the display has an orientation, and wherein the orientation of the display is adjusted based on readings from the accelerometer.
Gusky teaches a related respiratory therapy device (Fig. 6) with a display (display 104, Fig. 6), further comprising an accelerometer, wherein the display has an orientation, and wherein the orientation of the display is adjusted based on readings from the accelerometer (“the contents of display 104 may be oriented based upon, at least in part, an orientation of housing 100, e.g., such that the contents of display 104 may always be oriented "right-side-up … Orientation of the contents of display 104 may be based upon, at least in part, a control signal provided, for example, by a three axis accelerometer” see para. [0052]).
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 pulsator housing of Rock to include an accelerometer and have the orientation of the display adjusted based on readings from the accelerometer as taught by Gusky so the display can always be oriented “right-side-up.”
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rock et al. (2017/0007494) in view of Han et al. (2021/0181932).
Regarding claim 6, Rock is silent regarding wherein the pulsator further comprises an ambient light sensor, wherein the touchscreen has a brightness, and wherein the brightness is automatically adjusted based on sensed ambient light.
Han teaches a related respiratory therapy device (Fig. 1) comprising an ambient light sensor (ambient light sensor 30, Fig. 1), wherein the touchscreen (user interface 14, Fig. 1; “comprising, for example a display and input device(s) such as button(s), a touch screen” see para. [0087]) has a brightness, and wherein the brightness is automatically adjusted based on sensed ambient light (“The ambient light sensor 30 can allow the flow therapy apparatus 10 to automatically alter the brightness of the screen based on the level of ambient light. This can be particularly beneficial as the device may be used at home or in a hospital ward where people are sleeping.” See para. [0095]).
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 pulsator of Rock to include an ambient light sensor to automatically adjust the brightness as taught by Han because this would automatically adjust the brightness to best suit the ambient light, which can be particularly beneficial when used at home or in a hospital ward where people are sleeping.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rock et al. (2017/0007494) in view of Sepke et al. (2020/0306488).
Regarding claim 9, Rock discloses wherein the airflow pathway is through the inlet vent (air intake 74, Fig. 3), over the case along a first side of the airflow channel gasketing, over the case along a second side of the airflow channel gasketing (the plenum 90 extends along at least two directions and thus two sides; see Figs. 4A-4F and para. [0057]-[0058]. It is noted that the claim does not require a sequential order of the airflow pathway), and out the outlet vent (air is ultimately sent to atmosphere via outlet vent 53, Fig. 11). Rock does not specifically state the airflow pathway is along the circuit board and over the motor.
Sepke teaches a related respiratory therapy device (Fig. 1) having an airflow pathway that extends along the circuit board and over the motor (“at least the control unit, the respiratory gas drive and a main circuit board are arranged in the cooling air path, wherein the control unit, the respiratory gas drive and the main circuit board are arranged in the cooling air path in such a way that the component that has the highest heat build-up during operation is arranged at the end of the cooling air path in the direction of flow of the cooling air path” see para. [0038]. The “respiratory gas drive can be a blower” i.e., a motor, see para. [0014]).
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 circuit board and motor of Rock to be exposed to the airflow pathway as taught by Sepke so these elements are cooled off to prevent overheating.
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Rock et al. (2017/0007494) in view of Hansen et al. (2009/0306556).
Regarding claim 13, Rock is silent regarding wherein the device data includes fault codes and/or troubleshooting information.
Hansen teaches a related high frequency chest wall oscillation system (Fig. 1, Fig. 3) that has device data including fault codes and/or troubleshooting information (“Data may be collected by the system 10 relating to system use, operation, errors, status … Data may be transferred from system 10 to a remote system via various wired or wireless means … data across multiple systems may be utilized in outcome assessments” see para. [0043]. Error data would be fault codes or could be used for future troubleshooting).
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 device data of Rock to include fault codes and/or troubleshooting information as taught by Hansen so the data can be shared across multiple systems and used for future troubleshooting.
Regarding claim 19, Rock discloses wherein the mobile app coordinates with another device to gather health information about a user of the high frequency chest wall oscillation system (“the system 100 may include other sensors as well. In some embodiments, the system 100 may include leveraging the use of one or more sensors incorporated in another device, such as a smartphone, smart watch, or fitness tracker. For example, the microphone on a smartphone or smart watch may be used to evaluate a user's cough sounds and/or breathing sounds” see the last sentence of [0042]; “mobile application may use a microphone and/or other sensor on a smartphone or smart watch to evaluate the sound of a patient’s cough and/or breathing” see the second sentence of [0084]). Rock does not specifically state the other device measures at least one vital sign including body temperature, pulse rate, respiratory rate, blood pressure, and blood oxygen levels.
Hansen teaches a related high frequency chest wall oscillation system (Fig. 1, Fig. 3) that coordinates with another device (sensor device(s) 6, 8, Fig. 1) which may be a pulse oximeter to measure blood oxygen levels (“System 10 includes a blood oximeter for monitoring the blood oxygen saturation of the patient before, during or after a therapy session … the sensor accessory 6 is attached to a blood-carrying tissue sample of the patient, such as the finger or ear lobe” see para. [0032]). The data collected by the patient may be transferred to a remote system via wired or wireless means (see the last three sentences of [0043]).
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 other device of Rock to include a pulse oximeter to measure blood oxygen levels as taught by Hansen so the sensor feedback can be used to monitor patient progress.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. O’Donnell et al. (2023/0137510) discloses a related respiratory therapy device that asks the patient subjective queries to evaluate how their therapy is going. Chang Guo et al. (2013/0289456) discloses a related high frequency chest wall oscillation device with physiological sensor(s) that can include temperature, blood pressure, heart rate, etc. Chikkanaravangala et al. (2014/0257151) discloses a related high frequency chest wall oscillation device that tracks compliance data. Van Brunt (2004/0097849) discloses a related high frequency chest wall oscillation device that tracks compliance data, and circulates air around the motor to dissipate heat and prevent overheating. Banov et al. (2020/0383875) discloses a related mobile application that asks the patient whether they are feeling worse or feeling better from the therapy. Lee (2019/0274919) discloses a related high frequency chest wall oscillation device that has one or more sensor(s) that detect heart rate, respiration, blood pressure, and may be worn by the subject or disposed in a plurality of locations. Abadi et al. (2023/0065458) discloses a related mobile application that asks the patient whether they are feeling worse or feeling better from the therapy. Vik et al. (2012/0176394) discloses a related medical device with a display screen having an ambient light sensor to adjust brightness. Barilea et al. (2024/0024188) discloses a related high frequency chest wall oscillation device that has a fan directing air through a vent to reduce heat of electronic components. Shockley Jr. et al. (2016/0095793) discloses a related high frequency chest wall oscillation device that monitors compliance.
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
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