DETAILED ACTION
Non-Final Rejection
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Claims Status
Claims 1, 16, and 17 are amended. Claims 1-17 are pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 16, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The objection to claim 1 is withdrawn in view of the amendment to the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hassan et al. (US 2018/0303413) in view of Official Notice by the Office.
Regarding claim 1, Hassan et al. disclose an information generating apparatus (see Abstract reference to a system for monitoring disease) comprising:
an acquirer that is configured to detect respired air from at least one of a mouth and a nose of a subject , and to acquire respiratory waveform data about respiratory pressure of the subject based on the detected respired air ([0050] and [0079] reference to a nasal pressure transducer; [0081] shows an exemplary respiration waveform data that can be captured, recorded, and stored by according to illustrative embodiments);
a display (Fig. 1A #140 and [0051] which notes that 140 includes displays);
a storage configured to store classification criteria information ([0060] discloses a ranking scale that may be used to rank, score, or otherwise quantify a severity of the condition, such ranking data is shown in Fig. 1A as 133 which is stored in storage system 130); and
a controller (Fig., 1A, #105) that is configured to:
compare the respiratory waveform data acquired by the acquirer with preset respiratory reference waveform data (preset respiratory reference waveform data is disclosed at least at [0006] and [0007] as a reference set of respiratory characteristics which may be determined from normal breathing of the user; [0048] – the controller “determines a condition, state, trend, progress and/or improvement or deterioration of the user's medical condition based on the user's medical condition and based on comparing the respiratory characteristics to a reference set of characteristics (or user respiration profile or reference respiration characteristics vector) as further described herein”) thereby generating respiratory depth information representing respiratory depth of the respiratory waveform data with respect to the respiratory reference waveform data (this was interpreted as determining a difference between the acquired respiratory depth data and the reference respiratory depth data; [0061] – “A score as described may be calculated based on a number of parameters, e.g., a score may be calculated based on differences in values of … depth”; thus differences in respiration depth is determined, further verified at [00063]) and including the classification criteria information according to a classified state of the respiratory depth of the subject (in the previous quotation, the score relating to health status is calculated based on this difference, the score being related to the previously mentioned ranking scale, [0068] notes how ranking data may be related to thresholds indicating normal, abnormal, or highs severity), or numerical value information indicating deviation from the preset respiratory reference waveform (this can be the score/rank discussed previously and noted at least in [0063] which is notes how the score is related to the difference between a recorded respiration value and the value in the respiration profile); and
classify a respiratory depth state of the subject based on the numerical value information and the classification criteria information stored in the storage (as noted at least in [0063], the ranking classifies the state of the subject (as previously mentioned, [0063] generates a severity score related to programmed thresholds and [0068] notes that the score can be indicative of normal respiration or regarded as alarm worthy or even high severity; thresholds can be programmed to reflect any particular condition);
wherein the respiratory waveform data is displayed on the display (Fig shows respiratory waveform data),
wherein the numerical value information is based on the respiratory waveform data and the preset respiratory waveform data (the numerical value information indicating deviation from the preset respiratory reference waveform data is derived as noted in Hassan from the score which is related to the computation of the difference in respiratory depth between the reference profile data and the acquired subject data).
Hassan et al. do not expressly disclose that the respiratory depth information is displayed on the display. Hassan discloses the extraction of depth data (see for example [0081]) but does not expressly disclose presenting such data on a display. However, the Office takes Official Notice that displaying medical data on displays was notoriously known in the medical arts. It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Hassan to include the display of the depth information in view of the Official Notice taken by the Office because it amounts to combining prior art elements according to known methods to yield predictable results. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 2, Hassan et al. disclose wherein: the controller is configured to generate the respiratory depth information based on a comparison of a second value representing respiratory pressure based on the respiratory waveform data and a first value representing respiratory pressure based on the respiratory reference waveform data (based on the respiratory reference waveform data (this can be interpreted as a comparison from a real time breathing waveform value to the baseline profile breathing waveform value).
Regarding claim 3, Hassan et al. disclose wherein: the respiratory reference waveform data are set based on respiratory waveform data acquired in advance from the subject (see claim 1 rejection).
Claim 9 further limits claim 1 by reciting wherein: the controller is configured to generate display data for displaying the respiratory waveform data and the respiratory depth information (while not exactly claimed in the same manner, the claim 1 rejection appears to cover these limitations related to the display of respiratory waveform and depth information; the controller shown in Fig. 1A is connected to a display for outputting data and therefore would be configured to generate the display data).
Claim 9 also recites a respiratory waveform based on the respiratory waveform data includes at least one unit respiratory waveform corresponding to one breath taken by the subject (this is inherent in the acquisition of data disclosed in Hassan et al.; Fig. 4 shows more than one breath of acquired waveform data).
Claim 9 also recites the controller is configured to generate the display data so that the respiratory depth information is displayed in the vicinity of the unit respiratory waveform. The location of where to place information on a display would amount to a design choice however. At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to place respiratory depth information in the vicinity of the unit respiratory waveform on the display because Applicant has not disclosed that such location provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, it would have been prima facie obvious to modify Hassan et al. to obtain the invention as specified in claim 9 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Hassan.
The same argument applied above for claim 9 applies to claim 10 (obvious design choice).
Regarding claim 11, Hassan discloses wherein: the respiratory waveform includes a plurality of the unit respiratory waveforms (Fig. 4 shows multiple breaths); and the controller is configured to generate the display data so that the respiratory depth information is displayed in the vicinity of a peak in each of the unit respiratory waveforms (this is rejected using the same obvious design choice argument for claim 9).
Regarding claim 12, Hassan et al. disclose wherein: the controller is configured to generate aggregate information about respiratory depths of the subject in a predetermined time based on pieces of the respiratory depth information continuously generated for the predetermined time ([0055] notes that time periods for data acquisition are customizable for different time intervals, [0077] notes that data can be collected periodically to assess changes over time; aggregate interpreted here as collecting breathing cycles over long periods of time).
Regarding claim 13, Hassan et al. as modified in claim 1 disclose wherein:
the controller is configured to generate display data for displaying the respiratory waveform data and the respiratory depth information (similar to the rejection in claim 9 above of the same limitation); and
the controller is configured to generate either first display data or second display data as the display data, the first display data having inspiratory pressure higher than expiratory pressure in a respiratory waveform based on the respiratory waveform data, the second display data having the expiratory pressure higher than the inspiratory pressure in the respiratory waveform (as the controller is configured to display real time data per [0103], the display of the respiratory waveform for either occurrence would occur).
Regarding claim 14, Hassan as modified in claim 1 disclose wherein: the controller is configured to generate display data for displaying the respiratory waveform data and the respiratory depth information on the display (similar to the rejection in claim 9 above of the same limitation).
Regarding claim 15, Hassan et al. disclose wherein: the controller is configured to generate a notification signal for sending notification of the respiratory depth state of the subject (see at least [0062] or [0063] discussion of alarm generations based on scores, which can be related to depth as discussed above).
Claim 16 is the method performed by the apparatus of claim 1 and is rejected using the same argument above.
Claim 17 is a non-transitory computer readable medium that contains programming for execution by a computer to perform the functions of claim 1 and is therefore rejected using the same argument for above.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hassan et al. in view of Official Notice as applied to claim 1 and further in view of Shouldice et al. (US 20200297955, previously cited).
Regarding claim 4, Hassan et al. do not disclose wherein: the respiratory reference waveform data are set based on attribute information about at least one attribute of the subject. Hassan et al. do disclose that parameters such as age and gender may be queried and stored for the user’s profile ([0091] and [0058]), but do not disclose that it is incorporated into the reference respiration characteristics vector (at times referred to by Hassan as a respiration profile, [0082], and identified by the Office as the preset respiratory reference waveform data). However, the importance of relating demographic data to baseline data is discussed in Shouldice at [0144]. Thus, it would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to base the reference waveform data on attribute information such as the already collected age and gender information as taught by Shouldice because it permits more nuanced/relevant comparisons to the baseline data that incorporate factors that also affect respiratory data.
Regarding claim 5, Hassan et al. as modified by Shouldice in the rejection of claim 4 above teach wherein: the attribute information includes at least one of age information, gender information, chronic disease information, and pre-existing disease information (see Claim 4 rejection above). The rationale for modifying remains the same.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hassan et al. in view of Official Notice as applied to claim 1 and further in view of Erickson (US5546952A, previously cited).
Regarding claim 6, Hassan et al. disclose wherein: the respiratory reference waveform data include a first respiratory waveform having a first amplitude; the respiratory waveform data include a second respiratory waveform having a second amplitude (this is inherent in the breathing signal that is acquired during routine monitoring and for establishing a baseline profile). However, Hassan do not expressly disclose that the first amplitude is based on expiratory peak pressure in the first respiratory waveform and inspiratory peak pressure in the first respiratory waveform; the second amplitude is based on expiratory peak pressure in the second respiratory waveform and inspiratory peak pressure in the second respiratory waveform; and the controller is configured to compare the first amplitude and the second amplitude so as to generate the respiratory depth information. However, Erickson discloses the first amplitude is determined based on expiratory peak pressure (PK2, see Col. 9, lines 51-54) in the first respiratory waveform and inspiratory peak pressure in the first respiratory waveform (PK1) (see Col. 12, lines 40-48); the second amplitude is determined based on expiratory peak pressure (PK2) in the second respiratory waveform and inspiratory peak pressure (PK1) in the second respiratory waveform (see Col. 12, lines 40-48, the same parameters which includes the PK1 to PK2 amplitude) in each respiratory cycle (which includes a second respiratory waveform). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Hassan et al. to use the claimed points in the respiratory cycle for measuring depth as taught by Erickson because it amounts to combining prior art elements according to known methods to yield predictable results. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. There would have been a reasonable expectation of success given that this simply amounts to determining points in the signal.
Regarding claim 7, Hassan et al. disclose wherein: the respiratory depth information includes the classification criteria information according to relative magnitude of the second amplitude relative to the first amplitude (as noted in the claim 1 rejection, depth of respiration is determined by finding a difference between the reference profile depth and the acquired respiration data; Hassan et al. discloses that the magnitude of the difference can be compared to thresholds for determining the rank/score, see at least [0060] and [0063]).
Regarding claim 8, Hassan et al. disclose wherein: the respiratory depth information includes numerical value information indicating relative magnitude of the second amplitude relative to the first amplitude (as noted in the claim 1 rejection, the amplitude differences determined from the acquired respiratory data and the reference respiratory data is used to determine a rank or score related to the respiratory condition of the patient).
Conclusion
Claims 1-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tho Q. Tran whose telephone number is (571)270-1892. The examiner can normally be reached 7-5.
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/THO Q TRAN/ Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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