Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
2. This office action is in response to the filing of the application on 06/20/2023. Since the initial
filing, claims 6-9, 13-28, 31-39, 43-46, 50-53, and 57-60 have been canceled, claims 3-4, 10-12, 29-30, 41, 47-48, and 54-55 have been amended, and claim 61 was added. Thus, claims 1-5, 10-12, 29-30, 40-42, 47-49, 54-56 and 61 are pending in the application.
Priority
3. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/143,743, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim(s) 2, 10, 30, 47, 49, and 55-56 are not supported by the above listed provisional application.
The non-supported limitations in these claims are listed below:
“a type of leak, an amount of leak” (claim 2, lin. 2)
“acoustic volume, acoustic frequency, acoustic energy ratio” (claim 10, lin. 2)
“generating a mel-frequency cepstrum from the at least a portion of the acoustic data; and determining one or more mel-frequency cepstral coefficients from the mel-frequency cepstrum, wherein the leak is detected based at least in part on the one or more mel-frequency cepstral coefficients” (claim 30, lin. 3-8)
“acoustic volume, acoustic frequency, acoustic energy ratio” (claim 47, lin. 2)
“a type of leak, an amount of leak” (claim 49, lin. 2-3)
“generating a mel-frequency cepstrum from the at least a portion of the acoustic data; and determining one or more mel-frequency cepstral coefficients from the mel-frequency cepstrum, wherein the leak is detected based at least in part on the one or more mel-frequency cepstral coefficients.” (claim 55, lin. 4-8)
“analyze the at least a portion of the acoustic data by inputting the one or more mel-frequency cepstral coefficients into a machine learning model configured to detect the leak based at least on values of the one or more mel-frequency cepstral coefficients.” (claim 56, lin. 2-5)
Therefore, the above listed claims 2, 10, 30, 47, 49, and 55-56 are given the effective filing date of the date when the corresponding subject matter and claims were filed with the office:
PCT/371 filing date: 01/28/2022
Claim Interpretation
4. 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.
At present, no claims are interpreted under 35 USC 112(f).
Claim Rejections - 35 USC § 112
5. 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.
Claim(s) 3-5 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.
The limitation “the acoustic data is generated by, and received from, a plurality of microphones communicatively coupled to the respiratory therapy system” (claim 3, lin. 1-3) is indefinite. It is unclear whether “a plurality of microphones” is actual structure claimed in the method steps or simply giving background on a potential source of “acoustic data”. For purposes of examination, this limitation is being interpreted to be non-structural and simply giving background on a potential source of “acoustic data”.
Similarly, the limitation “at least one microphone of the plurality of microphones is coupled externally to a conduit of the respiratory therapy system, positioned at least partially within a respiratory therapy device of the respiratory therapy system, coupled externally to a user interface of the respiratory therapy system, coupled directly or indirectly to a headgear associated with the user interface, coupled to a mobile device that is communicatively coupled to the respiratory therapy system, electrically connected with a. circuit board of a respiratory therapy device within the respiratory therapy system, in acoustic communication with the airflow in the respiratory therapy system, configured to be in direct fluid communication with the airflow, or any combination thereof” (claim 4, lin. 1-9) is indefinite. It is unclear whether “a least one microphone of the plurality of microphones….” is actual structure claimed in the method steps or simply giving background on a potential source of “acoustic data”. For purposes of examination, this limitation is being interpreted to be non-structural and simply giving background on a potential source of “acoustic data”.
Similarly, the limitation “the microphone is positioned at least partially outside of a housing of a respiratory therapy device of the respiratory therapy system, the microphone being at least partially movable relative to the housing of the respiratory therapy device to aid in directing the microphone towards the user.” (claim 5, lin. 1-4) is indefinite. It is unclear whether “the microphone is positioned ….” is actual structure claimed in the method steps or simply giving background on a potential source of “acoustic data”. For purposes of examination, this limitation is being interpreted to be non-structural and simply giving background on a potential source of “acoustic data”.
Additionally, claim 5 recites the limitation "the microphone" (claim 5, lin. 1). claim 3 recites "a plurality of microphones" (clam 3, lin. 2) and that the limitation "the microphone" is unclear as to which of the plurality of microphones the claim is referring.
Claim Rejections - 35 USC § 101
6. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-5, 10-12, and 29-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception an abstract idea without significantly more.
Step 1:
With respect to step 1, claim 1 is directed to a method which is eligible for step 1.
Step 2A, Prong 1:
With respect to step 2A Prong 1, the following elements are considered to be abstract:
“receiving acoustic data associated with airflow caused by operation of a respiratory therapy system during a sleep session of a user” in claim 1 lines 2-3.
“analyzing at least a portion of the acoustic data to determine a value of a parameter associated with the at least a portion of the acoustic data” in claim 1 lines 4-5.
“determining an occurrence of a leak during the sleep session in response to the determined value of the parameter satisfying a condition” in claim 1 lines 6-7.
These elements are mental processes (i.e., evaluation or judgement) and/or mathematical operations
that can be performed in the human mind, or by hand using pen and paper.
Step 2A, Prong 2
The above-identified abstract idea in independent Claim 1 (and its respective dependent Claims 2-5, 10-12, and 29-30) is not integrated into a practical application under MPEP 2106.04(d) because they provide no additional elements over the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g).
Additionally, for the reasons listed above dependent claims(2-5, 10-12, and 29-30) fail to further distinguish from an abstract idea and are only further limiting mental processes capable of being performed on a computer/by hand or adding additional computational steps.
The limitations listed below fail 2A prong 2 because they do not provide any additional elements that integrate the abstract idea into a practical application:
“determining the occurrence of the leak includes determining a leak, a type of leak, an amount of leak, or any combination thereof.” In claim 2 lines 1-2.
“the acoustic data is generated by, and received from, a plurality of microphone microphones communicatively coupled to the respiratory therapy system” in claim 3 lines 1-3.
“determining, for each of the plurality of microphones, a baseline audio characteristic ,wherein each of the baseline audio characteristics is unique to a respective one of the microphones” in claim 3 lines 4-6.
“analyzing the at least a portion of the acoustic data includes analyzing the at least a portion of the acoustic data from each of the plurality of microphones with respect to each of the baseline audio characteristic” in claim 3 lines 7-9.
“at least one microphone of the plurality of microphones is coupled externally to a conduit of the respiratory therapy system, positioned at least partially within a respiratory therapy device of the respiratory therapy system, coupled externally to a user interface of the respiratory therapy system, coupled directly or indirectly to a headgear associated with the user interface, coupled to a mobile device that is communicatively coupled to the respiratory therapy system, electrically connected with a. circuit board of a respiratory therapy device within the respiratory therapy system, in acoustic communication with the airflow in the respiratory therapy system, configured to be in direct fluid communication with the airflow, or any combination thereof.” in claim 4 lines 1-10.
“the microphone is positioned at least partially outside of a housing of a respiratory therapy device of the respiratory therapy system” in claim 5 lines 1-2.
“the microphone being at least partially movable relative to the housing of the respiratory therapy device to aid in directing the microphone towards the user” in claim 5 lines 3-4.
“the parameter includes acoustic intensity, acoustic volume, acoustic frequency, acoustic energy ratio, or any combination thereof.” In claim 10 lines 2-3.
“the satisfying the condition includes exceeding a threshold value, not exceeding the threshold value, staying within a predetermined range of values, staying outside the predetermined range of values, or any combination thereof” in claim 11 lines 2-4.
“the determining the occurrence of the leak includes determining an intentional leak that is indicative of airflow venting from one or more vents associated with the respiratory therapy system.” In claim 12 lines 2-3.
“the analyzing the at least a portion of the acoustic data includes: generating a frequency spectrum from the acoustic data” in claim 12 lines 1-2.
“identifying one or more features of the frequency spectrum that are indicative of presence of the leak.” In claim 12 lines 2-3.
“the analyzing the at least a portion of the acoustic data includes: generating a frequency spectrum from the acoustic data” in claim 29 lines 1-3.
“identifying one or more features of the frequency spectrum that are indicative of presence of the leak.” In claim 29 lines 4-5.
“the analyzing the at least a portion of the acoustic data includes: generating a mel-frequency cepstrum from the at least a portion of the acoustic data” in claim 30 lines 1-3.
“determining one or more mel-frequency cepstral coefficients from the mel-frequency cepstrum” in claim 30 lines 4-5.
“the leak is detected based at least in part on the one or more mel-frequency cepstral coefficients.” In claim 30 lines 6-7.
Step 2B
None of Claims 1-5, 10-12, and 29-30 include additional elements over the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, these claims do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Claim Rejections - 35 USC § 102
7. 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.
8. Claim(s) 1-2, 10-12, 29, 40, 47-49, and 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holley et al.(WO 2010091462 A1).
Regarding claim 1, Holley discloses a method for acoustic detection in a respiratory treatment apparatus (abs.), comprising: receiving acoustic data associated with airflow caused by operation of a respiratory therapy system during a sleep session of a user (para. 72, the sound sensor 104 measures sound traversing within a respiratory treatment conduit 108 for analysis by the detection controller 106.); analyzing at least a portion of the acoustic data to determine a value of a parameter associated with the at least a portion of the acoustic data (para. 19, a controller or processor configured to analyze data samples of the measure of sound from the microphone by calculation of a cepstrum with the data samples of the measure of sound); and determining an occurrence of a leak during the sleep session in response to the determined value of the parameter satisfying a condition. (para. 128, the technology may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient).
Regarding claim 2, Holley discloses the method of claim 1, wherein the determining the occurrence of the leak includes determining a leak, a type of leak, an amount of leak, or any combination thereof. (para. 135, the present technology may permit an apparatus to discern the location of a leak in addition to whether a leak has occurred, para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data
Regarding claim 10, Holley discloses the method of claim 1, wherein the parameter includes acoustic intensity, acoustic volume, acoustic frequency, acoustic energy ratio, or any combination thereof (para. 104, the frequency domain may be processed to isolate or emphasize data of interest in detecting a particular condition).
Regarding claim 11, Holley discloses the method of claim 1, wherein the satisfying the condition includes exceeding a threshold value, not exceeding the threshold value, staying within a predetermined range of values, staying outside the predetermined range of values, or any combination thereof (para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data).
Regarding claim 12, Holley discloses the method of claim 1, wherein the determining the occurrence of the leak includes determining an intentional leak that is indicative of airflow venting from one or more vents associated with the respiratory therapy system (para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data). Additionally, the (para. 17, the microphone may be adapted with an endotracheal tube couple, the coupler may further include a vent). The device (para. 128, may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient). This same system would be able to analyze a “intentional leak”.
Regarding claim 29, Holley discloses the method of claim 1, wherein the analyzing the at least a portion of the acoustic data includes: generating a frequency spectrum from the acoustic data (para. 58, A cepstrum may be considered the inverse Fourier Transform of the log spectrum or the forward Fourier Transform of the decibel spectrum, para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data); and identifying one or more features of the frequency spectrum that are indicative of presence of the leak (para. 104, lower frequencies have more information about leaks, the frequency domain may be processed to isolate or emphasize data of interest in detecting a particular condition or system accessory).
Regarding claim 40, Holley discloses a system comprising: a respiratory therapy device configured to generate a flow of pressurized air (Fig. 1, respiratory treatment apparatus 102); a user interface configured to aid in delivery of the flow of pressurized air to a user (Fig. 17, example mask); a conduit configured to connect the respiratory therapy device and the user interface (Fig. 1, Respiratory treatment conduit 108, para. 75 the patient at a patient end of the conduit, para. 71, the treatment apparatus includes conduits such as an endotracheal tube or supple tube and mask); a microphone (Fig. 1, sound sensor 104, para. 71, such as a microphone), a memory storing machine-readable instructions (Fig. 1, detection controller 106); and a control system including one or more processors configured to execute the machine- readable instructions to (para. 73, the controller may include integrated chips, a memory and/or other control instruction, data or information storage medium. For example, programmed instructions encompassing such a detection methodology may be coded on integrated chips in the memory of the device): generate, using the microphone, acoustic data associated with the flow of the pressurized air during a sleep session of the user (para. 19, microphone adapted for coupling with a respiratory treatment conduit to generate a measure of sound of a flow generator.); analyze at least a portion of the generated acoustic data to determine a value of a parameter associated with the generated acoustic data; (para. 19, The apparatus may also include a controller or processor configured to analyze data samples of the measure of sound from the microphone by calculation of a cepstrum with the data samples of the measure of sound); and determine an occurrence of a leak during the sleep session in response to the determined value of the parameter satisfying a condition. (para. 128, the technology may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient).
Regarding claim 47, Holley discloses the system in claim 40, wherein the parameter includes acoustic intensity, acoustic volume, acoustic frequency, acoustic energy ratio, or any combination thereof (para. 104, the frequency domain may be processed to isolate or emphasize data of interest in detecting a particular condition).
Regarding claim 48, Holley discloses the system in claim 40, wherein the satisfying the condition includes exceeding a threshold value, not exceeding the threshold value, staying within a predetermined range of values, staying outside the predetermined range of values, or any combination thereof (para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data).
Regarding claim 49, Holley discloses the system in claim 40, wherein the control system is further configured to execute the machine-readable instructions to determine the presence or absence of the leak, a type of the leak, an amount of the leak, or any combination thereof. (para. 172, the processor control instructions and data for controlling the above described methodologies may be contained in a computer readable recording medium, para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data).
Regarding claim 54, Holley discloses the system in claim 40, the control system is further configured to execute the machine-readable instructions (para. 172, the processor control instructions and data for controlling the above described methodologies may be contained in a computer readable recording medium) to analyze the at least a portion of the acoustic data by: generating a frequency spectrum from the acoustic data (para. 58, A cepstrum may be considered the inverse Fourier Transform of the log spectrum or the forward Fourier Transform of the decibel spectrum, para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data); and identifying one or more features of the frequency spectrum that are indicative of presence of the leak (para. 104, lower frequencies have more information about leaks, the frequency domain may be processed to isolate or emphasize data of interest in detecting a particular condition or system accessory).
Claim Rejections - 35 USC § 103
9. 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.
10. Claim(s) 3, 5, 42 and 61 is/are rejected under 35 U.S.C. 103 as being obvious in view of Holley et al. (WO 2010091462 A1).
Regarding claim 3, as being interpreted for purposes of examination to include the structure in claim language, Holley discloses the method of claim 1, wherein the acoustic data is generated by, and received from, (para. 17, a microphone coupled with a respiratory treatment conduit to generate a measure of sound of a flow generator within the respiratory treatment conduit), and determining a baseline audio characteristic for said microphone, wherein the analyzing the at least a portion of the acoustic data includes analyzing the at least a portion of the acoustic data from the microphone with respect to the baseline audio characteristic (para. 128, the technology may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient), but is silent on a plurality of microphone microphones communicatively coupled to the respiratory therapy system, and further comprising: determining, for each of the plurality of microphones, a baseline audio characteristic, wherein each of the baseline audio characteristics is unique to a respective one of the microphones, wherein the analyzing the at least a portion of the acoustic data includes analyzing the at least a portion of the acoustic data from each of the plurality of microphones with respect to each of the baseline audio characteristics.
However, Holley teaches that (para. 99, in some embodiments of the technology additional microphones may be implemented).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method as disclosed by Holley to apply a plurality of microphones for audio analysis in order improve product noise analysis for better spatial analysis and background noise reduction. Since the system is based in “comparing cepstrum data of a system from a prior or known baseline of cepstrum data for the system” (Holley, para. 67), and “acoustic reflections may be analyzed to identify particular characteristics of patient interfaces” (Holley, para. 131). This same type of application and analysis would be used once a plurality of microphones were brought in to analyze each microphone’s unique audio characteristics/acoustic data to find particular user interface characteristics.
Regarding claim 5, as being interpreted for purposes of examination to include the structure in claim language, Holley discloses the modified method of claim 3, wherein the microphone is positioned at least partially outside of a housing of a respiratory therapy device of the respiratory therapy system (Fig. 7, the microphone 772 is slightly outside of microphone chamber 774), the microphone being at least partially movable relative to the housing of the respiratory therapy device to aid in directing the microphone towards the user. While, Holley doesn’t explicitly state “partially moveable”. Fig. 7 implies microphone moveability, furthermore, the Federal Circuit held making separable is obvious as seen in MPEP 2144 (V)(C) – “In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose."
Regarding claim 42, Holley discloses the system in claim 40, wherein the microphone is positioned at least partially outside of a housing of a respiratory therapy device of the respiratory therapy system (Fig. 7, the microphone 772 is slightly outside of microphone chamber 774), the microphone being at least partially movable relative to the housing of the respiratory therapy device to aid in directing the microphone towards the user. While, Holley doesn’t explicitly state “partially moveable”. Fig. 7 implies microphone moveability, furthermore, the Federal Circuit held making separable as obvious as seen in MPEP 2144 (V)(C) – “In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose."
Regarding claim 61, Holley discloses the system in claim 40, wherein the acoustic data is generated by, and received from, (para. 17, a microphone coupled with a respiratory treatment conduit to generate a measure of sound of a flow generator within the respiratory treatment conduit), and determining a baseline audio characteristic for said microphone, wherein the analyzing the at least a portion of the acoustic data includes analyzing the at least a portion of the acoustic data from the microphone with respect to the baseline audio characteristic (para. 128, the technology may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient), but is silent on the microphone includes a plurality of microphones, wherein the control system is further configured to: determine, for each of the plurality of microphones, a baseline audio characteristic, wherein each of the baseline audio characteristics is unique to a respective one of the microphones, wherein the control system analyzes the at least a portion of the generated acoustic data by analyzing the at least a portion of the acoustic data from each of the plurality of microphones with respect to each of the baseline audio characteristics.
However, Holley teaches that (para. 99, in some embodiments of the technology additional microphones may be implemented)
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system as disclosed by Holley to apply a plurality of microphones for audio analysis in order improve product noise analysis for better spatial analysis and background noise reduction. Since the system is based in “comparing cepstrum data of a system from a prior or known baseline of cepstrum data for the system” (Holley, para. 67), and “acoustic reflections may be analyzed to identify particular characteristics of patient interfaces” (Holley, para. 131). This same type of application and analysis would be used once a plurality of microphones were brought in to analyze each microphone’s unique audio characteristics/acoustic data to find particular user interface characteristics.
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11. Claim(s) 4 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (WO 2010091462 A1) in view of Bao et al. (WO 2015020536 A1).
Regarding claim 4, as being interpreted for purposes of examination to include the structure in claim language, Holley discloses the modified method of claim 3, wherein at least one microphone of the plurality of microphones is coupled externally to a conduit of the respiratory therapy system (para. 17, a microphone adapted for coupling with a respiratory treatment conduit), positioned at least partially within a respiratory therapy device of the respiratory therapy system (Fig. 7 microphone 772, para. 90, sound sensor integrated into a conduit or coupler), coupled externally to a user interface of the respiratory therapy system (Fig. 17, example mask), coupled directly or indirectly to a headgear associated with the user interface (See annotated Fig. 17 above, headgear strap holes), but is silent on it being coupled to a mobile device that is communicatively coupled to the respiratory therapy system, electrically connected with a circuit board of a respiratory therapy device within the respiratory therapy system, in acoustic communication with the airflow in the respiratory therapy system, configured to be in direct fluid communication with the airflow, or any combination thereof.
However, Bao teaches using mobile computing device for controlling a respiratory device such as positive airway pressure therapy (Bao, para. 2), including (thresholds for responding to mask leaks, Bao para. 82).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date
of the claimed invention to modify the pre-existing user interface/controller system disclosed in Holley with the mobile computing device taught in Bao to offer a respiratory system with increased user accessibility through an easy to move mobile computing controller.
Regarding claim 41, Holley discloses the system of claim 40, wherein the microphone is coupled externally to a conduit of the respiratory therapy system (para. 17, a microphone adapted for coupling with a respiratory treatment conduit), positioned at least partially within a respiratory therapy device of the respiratory therapy system (Fig. 7, microphone 772 in microphone chamber 774), coupled externally to a user interface of the respiratory therapy system (para. 94, The device may also include a display interface 1210 to output data for a user interface, Fig. 11, controller, Fig. 12, data being received by controller and sent to output display), coupled directly or indirectly to a headgear associated with the user interface (See annotated Fig. 17 above, headgear strap holes), but is silent on being coupled to a mobile device that is communicatively coupled to the respiratory therapy system, electrically connected with a circuit board of a respiratory therapy device within the respiratory therapy system, in acoustic communication with the airflow in the respiratory therapy system, configured to be in direct fluid communication with the airflow, or any combination thereof.
However, Bao teaches using mobile computing device for controlling a respiratory device such as positive airway pressure therapy (Bao, para. 2), including “thresholds for responding to mask leaks” (Bao, para. 82).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date
of the claimed invention to modify the pre-existing user interface/controller system disclosed in Holley with the mobile computing device taught in Bao to offer a respiratory system with increased user accessibility through an easy to move mobile computing controller.
12. Claim 30 and 55-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al.(WO 2010091462 A1) in view of Zigel et al.(US 20190298271 A1)
Regarding claim 30, Holley discloses the method of claim 1, and emphasizes analyzing the at least a portion of the acoustic data at low frequencies (para. 104, lower frequencies have more information about leaks, the frequency domain may be processed to isolate or emphasize data of interest in detecting a particular condition or system accessory.), but is silent analyzing the at least a portion of the acoustic data includes: generating a mel-frequency cepstrum from the at least a portion of the acoustic data; and determining one or more mel-frequency cepstral coefficients from the mel-frequency cepstrum, wherein the leak is detected based at least in part on the one or more mel-frequency cepstral coefficients.
However, Zigel teaches a system for estimating apnea-hypopnea index (AHI), as an indicator for Obstructive sleep apnea (OSA) (abs.), which teaches working with Mel-frequency analysis for audio frequency analysis (Zigel, para. 33).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date
of the claimed invention to modify the acoustic analysis of Holley with the Mel-frequency as taught by Zigel in order to focus on lower frequency bands that better distinguish leaks, an area of frequency interest previously disclosed by Holley
Regarding claim 55, Holley discloses the system of claim 40, and emphasizes analyzing the at least a portion of the acoustic data at low frequencies (para. 104, lower frequencies have more information about leaks, the frequency domain may be processed to isolate or emphasize data of interest in detecting a particular condition or system accessory.), but is silent on the control system is further configured to execute the machine-readable instructions to analyze the at least a portion of the acoustic data by generating a mel-frequency cepstrum from the at least a portion of the acoustic data; and determining one or more mel-frequency cepstral coefficients from the mel-frequency cepstrum, wherein the leak is detected based at least in part on the one or more mel-frequency cepstral coefficients.
However, Zigel. teaches a system for estimating apnea-hypopnea index (AHI), as an indicator for Obstructive sleep apnea (OSA) (abs.), which teaches working with Mel-frequency analysis for audio frequency analysis (Zigel, para. 33).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date
of the claimed invention to modify the acoustic analysis of Holley with the Mel-frequency as taught by Zigel. in order to focus on lower frequency bands that better distinguish leaks, an area of frequency interest previously disclosed by Holley.
Regarding claim 56, Holley discloses the modified system of claim 55, but is silent on the control system is further configured to execute the machine-readable instructions to analyze the at least a portion of the acoustic data by inputting the one or more mel-frequency cepstral coefficients into a machine learning model configured to detect the leak based at least on values of the one or more mel-frequency cepstral coefficients.
However, Zigel teaches working with Mel-frequency analysis for audio frequency analysis (Zigel, para. 33) in-tandem with machine learning techniques (para. 25) for sound/speech analysis.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date
of the claimed invention to modify the acoustic analysis of Holley with the machine learning techniques of Zigel in order to create a system which more accurately detects leaks through system training.
Conclusion
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Lehrman et al. (US 6666830 B1) and Mansy et al. (US 6443907 B1). The prior art are various respiratory sleep systems that use audio analysis.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEC ROBERT WAHL whose telephone number is (571)272-9880. The examiner can normally be reached Monday - Friday 8:30 a.m. to 6:00 p.m..
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/A.R.W./Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785