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 .
Claim Rejections - 35 USC § 112
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.
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 80 is 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.
Regarding claim 80, the phrase "for optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 101
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 70-82 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 70 recite(s) a respiratory therapy system including a user interface and a vent, a control system comprising one or more processors, and a memory storing instructions. The steps of receiving acoustic data, determining and characterizing are all abstract ideas. This judicial exception is not integrated into a practical application because the generically recited computer elements (control system, processors, memory) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more. The generically recited control system/processors, memory and respiratory therapy system are well-understood, routine, and conventional as evidenced by the prior art of Foote and Holley as set forth below.
Similarly, Claims 71-82 only add more abstract ideas and because the generically recited computer elements (control system, processors, memory) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more. The generically recited control system/processors, memory and respiratory therapy system are well-understood, routine, and conventional as evidenced by the prior art of Foote and Holley as set forth below.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 71 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 71 positively recites a breath of a user which includes an inhalation and exhalation portion which encompasses a human organism. The examiner recommends amending the claim to recite the breath and inhalation/exhalation portions functionally.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 70 and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foote (US 20140261427 A1) in view of Ramanan et al. (US 2015/0250963 A1).
Regarding claim 70, Foote discloses: A system (figure 1c) comprising:
a respiratory therapy system (4000, 5000, 4170, 3000) configured to supply pressurized air to a user of the respiratory therapy system and including a user interface (3000) [0079] and a vent (3400) [0051] [0084];
a control system [0105] comprising one or more processors [0105]-[0108]; and
the control system which executes the following steps:
receives acoustic data associated with airflow caused by operation of the respiratory therapy system configured to supply pressurized air to the user [0122];
determines, based at least in part on a portion of the received acoustic data, an acoustic signature associated with the vent [0125]; and
characterizes, based at least in part on the acoustic signature associated with the vent, the vent ([0125]: characterizes the vent in that it is making too much noise).
Foote does not explicitly state a memory having stored thereon machine readable instructions which, when executed by the one or more processors, causes the control system to execute steps.
However Ramanan teaches a respiratory system (abstract) and thus is analogous art. Ramanan teaches it is known to have a control system with one or more processors (4230) and a memory (4260) having stored thereon machine readable instructions which, when executed by the one or more processors, causes the control system to execute steps [0115].
It would have been obvious to have modified Foote to include a memory having stored thereon machine readable instructions which, when executed by the one or more processors, causes the control system to execute steps as this is a well known way of performing steps.
Regarding claim 71, Foote as modified discloses the claimed invention substantially as set forth in claim 70 above. Foote further discloses wherein the portion of the received acoustic data is generated during a breath of the user [0120] [0125], and wherein the breath includes an inhalation portion and an exhalation portion [0120] [0125], wherein the portion of the received acoustic data is generated at least at a first time, a second time, or both, wherein the first time is about a beginning of the inhalation portion of the breath [0120] [0125] (the acoustic data is generated throughout the respiratory cycle and thus would also include the beginning of the inhalation portion of the breath), and wherein the beginning of the inhalation portion of the breath is associated with a minimum flow volume value of the breath (this is inherent as the beginning portion is the transition from exhalation to inhalation and thus flow volume value is at a minimum), the flow volume being associated with the pressurized air supplied to the user of the respiratory therapy system (figure 1c; figure 18).
Claim(s) 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Foote (US 20140261427 A1) in view of Ramanan et al. (US 2015/0250963 A1) in further view of CN 102316919 A (the examiner notes the translation provided is relied upon below).
Regarding claim 72, Foote as modified discloses the claimed invention substantially as set forth in claim 70 above. Foote does not explicitly disclose wherein the determining the acoustic signature includes a cepstral analysis of the portion of the acoustic data, and wherein the acoustic signature is determined based at least in part on the cepstral analysis, wherein the cepstral analysis includes: generating a mel-frequency cepstrum from the portion of the received acoustic data; and determining one or more mel-frequency cepstral coefficients (MFCC) from the generated mel-frequency cepstrum, and wherein the acoustic signature includes the one or more MFCCs.
However, CN ‘919 teaches it is known to determine acoustic signature which includes a cepstral analysis of the portion of the acoustic data [0062], and wherein the acoustic signature is determined based at least in part on the cepstral analysis [0062], wherein the cepstral analysis includes: generating a mel-frequency cepstrum from the portion of the received acoustic data [0062]; and determining one or more mel-frequency cepstral coefficients (MFCC) from the generated mel-frequency cepstrum [0068]-[0089] (MFCCs result from mel-frequency cepstrum analysis), and wherein the acoustic signature includes the one or more MFCCs [0068]-[0089].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Foote such that wherein the determining the acoustic signature includes a cepstral analysis of the portion of the acoustic data, and wherein the acoustic signature is determined based at least in part on the cepstral analysis, wherein the cepstral analysis includes: generating a mel-frequency cepstrum from the portion of the received acoustic data; and determining one or more mel-frequency cepstral coefficients (MFCC) from the generated mel-frequency cepstrum, and wherein the acoustic signature includes the one or more MFCCs as this is a known way of processing sounds [0020] in a respiratory therapy system (abstract).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 70, 74, 77, 78 and 81 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holley et al. (WO 2019/006496 A1)
Regarding claim 70 Holley discloses: A system (figure 1a-1c) comprising:
a respiratory therapy system (Figure 1a-1c) configured to supply pressurized air [0012] to a user of the respiratory therapy system and including a user interface [0011] and a vent [0017];
a control system [0155] comprising one or more processors [0155]; and
a memory having stored thereon machine readable instructions which, when executed by the one or more processors [0158], causes the control system to:
receive acoustic data associated with airflow caused by operation of the respiratory therapy system configured to supply pressurized air to the user [0199];
determine, based at least in part on a portion of the received acoustic data, an acoustic signature associated with the vent (frequency spectral components as per [0199]); and
characterize, based at least in part on the acoustic signature associated with the vent, the vent ([0204] different masks have unique vent flow characteristics; processor identifies the mask as per [0207] and thus knows the unique flow characteristics; [0208]).
Regarding claim 74 Holley further discloses that the patient interface can have an anti-asphyxia valve [0106] and further that the acoustic signal can determine the type of patient interface [0057] [0061]. Therefore, Holley discloses wherein the characterizing includes determining a presence or absence of an anti-asphyxia valve (by determining the type of patient interface).
Regarding claim 77 Holley further discloses wherein the determined acoustic signature is indicative of a volume of air passing through the vent of the respiratory system [0298] [0306] [0277]-[0278]
Regarding claim 78 Holley further discloses wherein the vent is configured to permit escape of gas exhaled by the user of the respiratory therapy system, and wherein the determined acoustic signature is associated with sounds of the exhaled gas escaping from the vent. [0298] [0306] [0277]-[0278]
Regarding claim 81 Holley further discloses wherein the determining the acoustic signature associated with the vent includes determining the acoustic signature associated with a volume of air passing through the vent during a time period [0298] [0306] [0277]-[0278]
Claim(s) 72, 75, 76, 79, 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holley (WO 2019/006496 A1) in further view of CN 102316919 A (the examiner notes the translation provided is relied upon below).
Regarding claim 72, Holley discloses the claimed invention substantially as set forth in claim 70 above. Holley further discloses wherein the determining the acoustic signature includes a cepstral analysis of the portion of the acoustic data [0199], and wherein the acoustic signature is determined based at least in part on the cepstral analysis [0199], but is not explicit in that the cepstral analysis includes: generating a mel-frequency cepstrum from the portion of the received acoustic data; and determining one or more mel-frequency cepstral coefficients (MFCC) from the generated mel-frequency cepstrum, and wherein the acoustic signature includes the one or more MFCCs.
However, CN ‘919 teaches it is known to determine acoustic signature which includes a cepstral analysis of the portion of the acoustic data [0062], and wherein the acoustic signature is determined based at least in part on the cepstral analysis [0062], wherein the cepstral analysis includes: generating a mel-frequency cepstrum from the portion of the received acoustic data [0062]; and determining one or more mel-frequency cepstral coefficients (MFCC) from the generated mel-frequency cepstrum [0068]-[0089] (MFCCs result from mel-frequency cepstrum analysis), and wherein the acoustic signature includes the one or more MFCCs [0068]-[0089].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Holley such that the cepstral analysis includes: generating a mel-frequency cepstrum from the portion of the received acoustic data; and determining one or more mel-frequency cepstral coefficients (MFCC) from the generated mel-frequency cepstrum, and wherein the acoustic signature includes the one or more MFCCs as this is a known way of processing sounds [0020] in a respiratory therapy system (abstract).
Regarding claims 75 and 82, Holley discloses the claimed invention substantially as claimed as set forth in claim 70. Holley discloses determining amount of air through vent [0298] [0306] [0277]-[0278] but does not explicitly disclose wherein the characterizing includes determining an occlusion of a vent, wherein the determined acoustic signature includes changes relative to a baseline signature in one or more frequency bands.
However, CN ‘919 teaches that it is known to analyze acoustic signals to detect an occlusion (abstract, [0003] [0020] [0099] [0101] [0089] [0102]), wherein the determined acoustic signature includes changes relative to a baseline signature in one or more frequency bands [0089] [0102].
It would have been obvious to have modified Holley such that the characterizing includes determining an occlusion of a vent, wherein the determined acoustic signature includes changes relative to a baseline signature in one or more frequency bands for the benefit of ensuring a properly working vent and respiratory system.
Regarding claim 76, Holley discloses the claimed invention substantially as claimed as set forth in claim 70. Holley discloses determining the acoustic signature for each of the plurality of sleep sessions [0006] (abstract) but does not explicitly state determining based at least in part on the determined acoustic signature for each of the plurality of sleep sessions, a condition of the vent.
CN ‘919 discloses comparing a previous cepstrum to current cepstrum [0089], and [0102] indicates this comparison can detect a blockage and thus a condition of a respiratory therapy system component.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Holley to include determining based at least in part on the determined acoustic signature for each of the plurality of sleep sessions, a condition of the vent to ensure safe operation of the respiratory equipment.
Regarding claim 79 Holley does not explicitly disclose wherein the acoustic signature includes an acoustic feature having a value, and wherein the characterizing includes determining whether the value of the acoustic feature satisfies a condition, wherein the satisfying the condition includes exceeding a threshold value, not exceeding the threshold value, staying within a predetermined threshold range of values, or staying outside the predetermined threshold range of values.
However, CN ‘919 teaches wherein the acoustic signature includes an acoustic feature having a value, and wherein the characterizing includes determining whether the value of the acoustic feature satisfies a condition, wherein the satisfying the condition includes exceeding a threshold value, not exceeding the threshold value, staying within a predetermined threshold range of values, or staying outside the predetermined threshold range of values ([0102] describes comparing values to known clean conditions and known blocked conditions).
It would have been obvious to one having ordinary skill in the art to have modified Holley such that the acoustic signature includes an acoustic feature having a value, and wherein the characterizing includes determining whether the value of the acoustic feature satisfies a condition, wherein the satisfying the condition includes exceeding a threshold value, not exceeding the threshold value, staying within a predetermined threshold range of values, or staying outside the predetermined threshold range of values as taught by CN ‘919 for the benefit of ensuring the respiratory equipment is safe to use.
Regarding claim 78 Holley further discloses wherein the determining the acoustic signature associated with the vent includes determining the acoustic signature associated with a volume of air passing through the vent during a time period. [0298] [0306] [0277]-[0278]
Allowable Subject Matter
Claims 73 and 80 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and addressing any 112b clarity issues and 101 rejections.
Analogous prior art does not disclose the normalization as claimed of acoustic data as claimed. The examiner notes the prior art of Delepine (US 3,932,737).
The prior art does not disclose the timing of the acoustic waveform as required in claim 80.
Conclusion
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/VICTORIA MURPHY/ Primary Patent Examiner, Art Unit 3785
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