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 .
Information Disclosure Statement
The information disclosure statement filed on 05/04/2023 has been received and fully considered.
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 1-7, 9-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over US20200282161A1 to Chamtie et al. (hereinafter “Chamtie”).
Regarding claim 1, Chamtie discloses a method for determining a remaining useful life of an interface of a respiratory therapy system (Fig. 3 patient interface 3000, acoustic generator 8500; Paragraphs 0065 & 0229 discloses using acoustic signals to determine the age of a patient interface and whether the seal is degrading; Paragraph 0232 discloses the method is used to determine the useable life of the patient interface via knowing the length of the blade formation in the mask), the method comprising:
receiving acoustic data associated with an acoustic reflection of an acoustic signal (Paragraph 0137 discloses the sensing system may comprise an acoustic sensor configured to receive a signal from the acoustic generator; Paragraph 0149 discloses the acoustic receiver; the microphone may be placed close to the RPT device, see [0150], with the acoustic generator facing away from the RPT, see Fig. 7g, [0182], which must then reflect back for RPT microphone analysis; more broadly, generation of the acoustic signal involves reflection within the acoustic generator, see [0179]), the acoustic reflection being indicative of a portion of a structural shape of the interface;
analyzing the received acoustic data to identify a physical feature of the portion of the structural shape of the interface (Paragraph 0232 discloses acoustic measurements are used to determine the shape of blade formation 8530; Paragraphs 0215 & 0217 discloses an acoustic processor analyzes the acoustic signals from the acoustic generator);
using the physical feature (Paragraph 0217 discloses the processor may identify the mask type based on a lookup table with characteristic frequency profiles; Paragraph 0232 discloses the blade formation 8530 degrades in a predictable way, and that measuring the degradation over time is used to determine the age of the patient interface); and
determining the remaining useful life of the interface (Paragraph 0232 discloses based on the blade formation measurements, the patient may be alerted the interface has exceeded its recommended useable life).
Chamtie does not explicitly disclose comparing the physical feature to a reference feature and based on the comparison determining the remaining useful life of an interface. However, Chamtie discloses identification of a mask characteristic based on comparing the acoustic signal associated with a physical feature (mask type) to a reference feature (lookup table; see [0217]). 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 processor of Chamtie to compare the physical feature to a reference feature in the determination of useful life, in order to provide an accurate assessment of when the blade formation length is indicative of inadequate therapy efficacy. Examiner further notes that one of ordinary skill in the art would be able to know the absolute magnitude of the blade formation shortening when comparing the used blade formation to the lookup table value. The absolute value of the blade formation’s shrinkage would ensure that variances in manufacturing would be taken into account (i.e. in case one blade comes out longer from the manufacturing process than another blade).
Regarding claim 2, Chamtie discloses the method of claim 1, and Chamtie further discloses wherein the physical feature includes a hole in the interface, and the hole progressively expands over time based on usage (Figs. 7A & 7B vortex outlet 8520; Examiner notes that as blade formation 8530 shrinks due to usage, the cavity of vortex outlet 8520 also expands).
Regarding claim 3, Chamtie in view of Holley discloses the method of claim 1, and Chamtie further discloses wherein the physical feature includes a fin on the interface, and the fin progressively dissolves over time based on usage (Fig. 7A blade formation 8530; Paragraph 0232 discloses the blade formation degrades over time due to usage).
Regarding claim 4, Chamtie discloses the method of claim 3, and Chamtie further discloses wherein the fin is integral with the interface (Paragraph 0070 discloses the acoustic generator may be coupled to the interface or may be integrated with a conduit of the air circuit).
Regarding claim 5, Chamtie discloses the method of claim 3, and Chamtie further discloses wherein the fin is separate and distinct from the interface and coupled thereto (Paragraph 0070 discloses the acoustic generator may be coupled to the interface or may be integrated with a conduit of the air circuit).
Regarding claim 6, Chamtie discloses the method of claim 3, and Chamtie further discloses wherein the fin has a geometrical shape (Fig. 7A blade formation 8530 is a geometrical shape).
Regarding claim 7, Chamtie discloses the method of claim 6, and Chamtie further discloses wherein the shape has an edge that has a dimension that shortens over time indicating the remaining useful life (Paragraph 0232 discloses the blade formation 8530 degrades over time, and the patient may be alerted the interface has exceeded its recommended useable life based on the measurements).
Regarding claim 9, Chamtie discloses the method of claim 1, and Chamtie further discloses wherein the remaining useful life of the interface is a function of usage by a user of the interface (Paragraph 0232 discloses blade formation 8530 degrades over time due to usage in the system; Paragraph 0232 discloses based on the blade formation measurements, the patient may be alerted the interface has exceeded its recommended useable life).
Regarding claim 10, Chamtie discloses the method of claim 9, and Chamtie further discloses wherein the remaining useful life of the interface is further the function of a manufacturing date of the interface (Examiner notes that any interface’s usable life begins once manufactured, and thus Chamtie’s interface 3000 has a usable life that is a function of a manufacturing date of the interface).
Regarding claim 11, Chamtie discloses the method of claim 1, and Chamtie further discloses wherein the comparing includes determining a value associated with the physical feature (Paragraph 0232 discloses the blade formation 8530 degrades in a predictable way, and that measuring the degradation over time is used to determine the age of the patient interface; Examiner notes that value associated with the fin is its length) and comparing the value with a reference value associated with the reference feature (Paragraph 0217 discloses the processor may identify the mask type based on a lookup table with characteristic frequency profiles).
Regarding claim 13, Chamtie discloses the method of claim 1, and Chamtie further discloses a system (See Figs. 3-4B generally for the system) comprising: a control system comprising one or more processors (Paragraphs 0215 & 0217 discloses an acoustic processor analyzes the acoustic signals from the acoustic generator); and a memory having stored thereon machine readable instructions (Paragraph 0118 & 0121 discloses memory 4260 which stores computer program instructions and processor control instructions); wherein the control system is coupled to the memory (Paragraph 0121 discloses the memory and processors are connected), and the method of claim 1 is implemented when the machine executable instructions in the memory are executed by at least one of the one or more processors of the control system (Paragraphs 0215 & 0217 discloses an acoustic processor analyzes the acoustic signals from the acoustic generator).
Regarding claim 14, Chamtie discloses the method of claim 1, and Chamtie further discloses a system for determining a remaining useful life of an interface of a respiratory therapy system, the system comprising a control system configured to implement the method of claim 1 (See Figs. 3-4B generally for the system).
Regarding claim 15, Chamtie discloses the method of claim 1, and Chamtie further discloses a non-transitory computer readable medium comprising instructions which, when executed by a computer, cause the computer to carry out the method of claim 1 (Paragraph 0121 discloses the memory acts as a non-transitory computer readable storage medium).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chamtie as applied to claim 1 above, and further in view of WO2021130681A1 to Coffey et al. (hereinafter “Coffey”).
Regarding claim 8, Chamtie discloses the method of claim 1, and Chamtie further discloses wherein the acoustic signal is generated or emitted by a speaker of the respiratory therapy system (Paragraph 0209 discloses a speaker may be used to conduct acoustic analyses using the acoustic generators). Chamtie does not disclose wherein an acoustic signal is generated or emitted at a predetermined interval. However, Coffey teaches a respiratory therapy system which generates acoustic signals at a predetermined interval (Paragraph 0054 discloses a speaker 142 which emits sound waves at a regular interval).
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 speaker of Chamtie to emit sounds at regular intervals, as taught by Coffey, in order to provide active acoustic sensing at a regular interval (Paragraph 0054). Examiner notes that regular intervals of emitting sound would allow for more data sample points regarding the degradation of the blade formation length over time.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chamtie as applied to claim 1 above, and further in view of US20190358473A1 to Szasz et al. (hereinafter “Szasz”).
Regarding claim 12, Chamtie discloses the method of claim 1, but does not disclose comprising presenting the remaining useful life of the interface on a display device of (i) a user device, (ii) a respiratory pressure therapy device, or (iii) both. However, Szasz teaches a filtering face mask and monitoring system which displays the remaining useful life of an interface on a user device (Paragraph 0115 discloses AQR displays 310, 312, 314 show the remaining percentage of filter life of the mask; Examiner notes the remaining filter life is the equivalent to the remaining useful life of the interface).
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 processor of Chamtie to display the remaining useful life of the interface, as taught by Szasz, in order to provide current measurements regarding the remaining life of the interface (Paragraph 0115). Examiner notes the variable for life of the interface in Chamtie is the length of the blade formation (which is determined by the acoustic signal profile). The modification made via Szasz is merely to display a variable relating to remaining life of the interface on a user device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US-20050076906-A1 to Johnson; US-20130037028-A1 to Farrugia; US-20130047982-A1 to Tobias; US-20130118500-A1 to Stevens; US-20140088373-A1 to Phillips; US-20140190481-A1 to Jam; US-20140190485-A1 to Milne; US-20140260667-A1 to Berkcan; US-20160106941-A1 to Hickey; US-20170239432-A1 to Delangre; US-20170361045-A1 to Fu; US-20180243528-A1 to Zapol; US-20180272081-A1 to Porter; US-20180353717-A1 to Buschke; US-20200001035-A1 to VanPelt; US-20200008709-A1 to Martin; US-20200254201-A1 to Bender; US-20200376218-A1 to Mansfield; US-20200383580-A1 to Shouldice; US-6675797-B1 to Berthon-Jones; US-7798143-B1 to Kirby; and US-8985108-B2 to Ahmad.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BRANDY LEE can be reached at 571-270-3525. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TYLER A RAUBENSTRAW/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799