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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/9/26 has been entered.
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 1-3, 7, 13-14, and 40-42, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Landwehr (US 2015/0248290), hereinafter Landwehr in view of Aylsworth et al (US 2006/0169281), hereinafter Aylsworth, and further in view of Lewis et al (US 2007/0175473), hereinafter Lewis.
Regarding claim 1, Landwehr teaches a respiratory therapy system (paragraphs 2 implement on a respiratory device) comprising:
a flow generator for generating a flow of gases (Landwehr teaches devices for providing artificial respiration, paragraph 3);
a processor (Paragraph 2, paragraph 10, control device and software implement in a control device for implement the one or more patient interfaces; ) during a procedure in which the flow of gases is provided to a patient (Paragraph 3, takes over respiration or assists respiration so would provide a flow of gases to a patient), configured to determine a duration of safe apnea from a measured indicator. (Paragraphs 12, derives a value for a maximum tolerated duration of apnea, 20, 21, 22, 57, 62, a value for a maximum tolerated duration of apnea is based on minute volume and time delay based on the median of the minute volume)
Landwehr does not teach a flow generator to generate a flow rate of at least 15L/minute, one or more patient interfaces for delivering the flow.
However, patient interfaces with respiratory devices are well-known. Lewis teaches a respiratory device (Fig. 17) with a patient interface (nasal cannula 100) for delivering the flow. Lewis further teaches the respiratory device supplies at a flow rate of at least 15 L/minute. (Paragraph 104, flow rate of up to about 60 liters per minute)
It would have been obvious to a person of ordinary skill in the art to have provided Landwehr with the patient interface of Lewis in order to provide the respiratory gas to the patient.
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Landwehr with a flow rate of at least 15 L/minutes as taught by Lewis since high flow therapy may provide sufficient airway pressure to minimize the collapse of the upper airway during inspiration and may be more acceptable to children and others who may not tolerate tradition CPAP therapy. (Paragraph 115)
Landwehr teaches that the minute volume is important evidence of the oxygenation and ventilation of the patient (paragraph 15), but does not teach predicting a duration of safe apnea from a measured indicator wherein the indicator comprises measured oxygen.
However, Aylsworth teaches a respiratory device (Abstract, Fig. 1) which teaches using oxygen as an indication of safe apnea. (Paragraph 54, Apnea may be determined by sensing a reduction in measured breath volume in combination with a dop in blood oxygen saturation e.g. falling below 90%)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Landwehr to include a measure indicator that comprises measured oxygen to determine a duration of a safe apnea in order to more accurately determine apnea.
Regarding claim 2, Landwehr in view of Lewis and Aylsworth teaches the system of claim 1, and Landwehr teaches wherein the indicator is one or more of a respiratory indicator and/or a physiological indicator. (Landwehr, Paragraphs 12, 20, 21, 22, 57, 62, lung volume, Aylsworth, volume and blood oxygen saturation)
Regarding claim 3, Landwehr in view of Lewis and Aylsworth teaches the system of claim 1, and Landwehr in view of Lewis and Aylsworth further teaches wherein the indicator further comprises, or is further based on carbon dioxide concentration, carbon dioxide clearance, respiratory rate, oxygen concentration, arterial oxygen (Aylsworth, paragraph 54), arterial carbon dioxide content, lung volume (Landwehr: Paragraph 57 and 62, Aylsworth paragraph 54), lung compliance, lung/airway pressure, airway resistance/patency, V/Q mismatch (ventilation (V) - perfusion (Q)), heart rate, blood pressure, or metabolic rate.
Regarding claim 7, Landwehr in view of Lewis and Aylsworth teaches the system of claim 1, and further teaches, wherein the processor is configured to compare or fit a model to the respiratory indicator to determine the duration of safe apnea. (Landwehr: Paragraph 74-75, compares to a chart,)
Regarding claim 13, Landwehr in view of Lewis and Aylsworth teaches the system of claim 1, and Aylsworth further teaches wherein the indicator comprises a measured oxygen concentration. (Paragraph 54)
Regarding claim 14, Landwehr in view of Lewis and Aylsworth teaches the system of claim 13, and Aylsworth further teaches wherein the oxygen concentration is measured based on expired oxygen, transcutaneous oxygen, blood gases, hemoglobin oxygen concentration, blood pressure, arterial partial pressure of oxygen , or arterial oxygen content. (Paragraph 54, blood oxygen saturation)
Regarding claim 40, Landwehr in view of Lewis and Aylsworth teaches the system of claim 1, Lewis further teaches a high flow therapy device with a non-sealing interface. (Paragraph 98)
It would have been obvious to a person of ordinary skill in the art to have provided Landwehr with the non-sealing interface of Lewis in situations where the patient may not tolerate traditional CPAP therapy requiring a sealing interface. (paragraph 115)
Regarding claim 41, Landwehr in view of Lewis and Aylsworth teaches the system of claim 1, and Lewis further teaches wherein at least one of the one or more patient interfaces is a nasal cannula. (Fig. 17: 100)
Regarding claim 42, Landwehr in view of Lewis and Aylsworth teaches the system of claim 1, and Lewis teaches further comprising a humidifier for providing humidified gases. (paragraph 113)
It would have been obvious to a person of ordinary skill in the art to have included a humidifier in the device of Landwehr as doing so may reduce respiratory infections and providing warmed and humidified respiratory gases optimizes the motion of the cilia and further minimizes infections. (Paragraph 113)
Regarding claim 44, Landwehr in view of Lewis and Aylsworth teaches the system of claim 1, and Lewis further teaches a respiratory device (abstract) wherein the system provides high flow respiratory support. (paragraph 115)
It would have been obvious to a person of ordinary skill in the art to have modified the system of Landwehr with the ability to provide high flow therapy since high flow therapy may provide sufficient airway pressure to minimize the collapse of the upper airway during inspiration and may be more acceptable to children and others who may not tolerate tradition CPAP therapy. (Paragraph 115)
Claims 4-6 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Landwehr in view of Lewis, further in view of Aylsworth, and further in view of Farmery et al “A Model to Describe the Rate of Oxyhemoglobin Desaturation”, as cited in Applicant’s IDS, hereinafter Farmery.
Regarding claim 4, Landwehr in view of Lewis and Aylsworth i teaches the system of claim 1, Aylsworth teaches wherein the indicator comprises a plurality of indictors comprising, or based on, measured oxygen (Aylsworth, paragraph 54) and lung volume (paragraph 54)
However, Landwehr in view of Lewis and Aylsworth does not teach two or more of carbon dioxide concentration, carbon dioxide clearance, respiratory rate, oxygen concentration, arterial oxygen, arterial carbon dioxide content, lung volume (Aylsworth, paragraph 54), lung compliance, lung/airway pressure, airway resistance/patency, V/Q mismatch (ventilation (V) - perfusion (Q)), heart rate, blood pressure, or metabolic rate.
However, Farmery teaches a method of predicting safe apnea (Abstract) and predicting based on two or more of the duration of safe apnea based on carbon dioxide concentration (table 1), carbon dioxide clearance, respiratory rate, oxygen concentration, arterial oxygen, arterial carbon dioxide content, lung volume (table 1), lung compliance, lung/airway pressure, airway resistance/patency, V/Q mismatch (ventilation (V) - perfusion (Q)), heart rate, blood pressure, or metabolic rate.
It would have been obvious to a person or ordinary skill in the art prior to the filing date of the invention to modifiy Landwehr to use two or more indicators as taught by Farmery in order to have higher confidence and more accuracy in the determination of the duration of safe apnea.
Regarding claim 5, Landwehr in view of Lewis, Aylsworth and Farmery teaches the system of claim 4, and Farmery further teaches a process to determine the duration of safe apnea from the plurality of indicators (page 1, summary includes FACO2, arterial oxyhemoglobin) and teaches wherein the processor is configured to determine an average duration of safe apnea from the plurality of indicators. (Page 287, col 1, adds in the calculation of FACO2 can be used to facilitate the computation of the time of SaO2.)
It would have been obvious to a person of ordinary skill in the art to have modified the system of Landwehr in view of Lewis and Aylsworth to determine a plurality of safe apneas and select the shortest one since Farmery teaches that different physiological factors can cause faster desaturation (page 290) and selecting the shortest duration would allow the largest margin of error to maintain a patient safety.
Regarding claim 6, Landwehr in view of Lewis, Aylsworth and Farmery teaches the system of claim 4, and Farmery further teaches a process to predict the duration of safe apnea from a plurality of indicators (page 1, summary includes FACO2, arterial oxyhemoglobin) and teaches wherein the processor is configured to determine a plurality of durations of safe apnea from the plurality of indicators and further wherein the processor selects the shortest duration of safe apnea from the plurality of durations of safe apnea. (Fig. 3a, Fig. 4, Fig. 5, Farmery teaches the difference durations based on starting lung volume, weight age etc.)
It would have been obvious to a person of ordinary skill in the art to have modified the system of Landwehr in view of Lewis and Aylsworth to determine a plurality of safe apneas and select the shortest one since Farmery teaches that different physiological factors can cause faster desaturation (page 290) and selecting the shortest duration would allow the largest margin of error to maintain a patient safety.
Regarding claim 15, Landwehr in view of Lewis and Aylsworth teaches the system of claim 14, but does not teach predicting the duration of safe apnea based on a threshold arterial partial pressure of oxygen.
However, Farmery teachesa process to determine the duration of safe apnea from a measured oxygen. (page 1, summary arterial oxyhemoglobin, Fig. 3A b, effect of initial FAo2 on the time course of Sao2 in apnea, table 1 examples of data used to predict consequences on the time course of arterial oxyhemoglobin desaturation during apnea, uses initial FAo2) and Farmery teaches predicting the duration of safe apnea based on a threshold arterial partial pressure of oxygen (PaO2). (Fig. 1, pages 285)
It would have been obvious to a person or ordinary skill in the art prior to the filing date of the invention to modifiy Landwehr to use PaO2 as taught by Farmery in order to have higher confidence and more accuracy in the determination of the duration of safe apnea.
Regarding claim 16, Landwehr in view of Lewis, Aylsworth and Farmery teaches the system of claim 15, and Farmery further teaches wherein the threshold arterial oxygen content is determined from a threshold hemoglobin oxygen saturation (SpO2). (page 287, specific clinical scenarios, Fig. 4)
Regarding claim 17, Landwehr in view of Lewis, Aylsworth and Farmery teaches the system of claim 16, and Landwehr further teaches comprising a user interface to enable a user to input the threshold values (paragraphs 20, 23, 25, 74).
Therefore, the combination of Landwehr, Lewis, Aylsworth and Farmery teaches a user interface to input threshold values for hemoglobin oxygen saturation (SpO2) or threshold arterial partial pressure (PaO2).
Regarding claim 18, Landwehr in view of Lewis, Aylsworth and Farmery teaches the system of claim 16, and Farmery teaches wherein threshold hemoglobin saturation (SpO2), or threshold arterial partial pressure of oxygen (PaO2) is a predetermined value. (Figs. 4, 5, Table 2)
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Landwehr in view of Lewis, further in view of Aylsworth and further in view of Lynn et al (US Pat. 6,223,064 as cited on Applicant’s IDS), hereinafter Lynn.
Regarding claim 19, Landwehr in view of Lewis and Aylsworth teaches the system of claim 14, but does not teach wherein the processor is configured to determine the duration of safe apnea based on, a length of time until the arterial partial pressure of oxygen reaches the threshold arterial partial pressure of oxygen.
However, Lynn teaches a microprocessor system for diagnosis of sleep apnea (abstract) wherein the processor is configured to determine the duration of safe apnea based on a length of time until the arterial partial pressure of oxygen reaches the threshold arterial partial pressure of oxygen. (Col. 6: lines 34-43, a desaturation event can be defined as at least a 4% substantially uninterrupted decrement in saturation below the defined baseline mean of oxygen saturation. The desaturation interval is defined as the duration of the uninterrupted decline in saturation of each desaturation event)
It would have been obvious to a person of ordinary skill in the art to have modified the device of Landwehr in view of Lewis and Aylsworth to include a determination of safe apnea based on a length of time until the arterial partial pressure reaches a threshold as this is an alternative way of calculating the length of time of the apnea episode.
Regarding claim 20, Landwehr in view of Lewis and Aylsworth teaches the system of claim 19, and Lynn further teaches wherein the length of time until the arterial partial pressure reaches the threshold arterial partial pressure of oxygen is determined by the processor by measuring or estimating a rate of change of arterial partial pressure of oxygen.(Col. 3: lines 29-36, the slope of the vent is calculated by means for calculating a slope of said desaturation event representing a rate of change per unit time of fall of oxygen saturation. This slope is used by a means for comparing said calculated slope with a value of slope which is determined in advance to be indicative of sleep apnea in determination of diagnosis of sleep apnea.
Response to Arguments
Applicant’s arguments with respect to newly amended claim 1 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.
Applicant argues that using Farmery to modify Landwehr is not obvious because Farmery does not teach using a continued supply of gases to the patient. However, the examiner disagrees since Farmery teaches a model to describe the rate of oxyhemoglobin desaturation during apnea. Farmery teaches that apnea may occur during anesthesia or postoperatively. Therefore, the characteristics that Farmery teaches occur during apnea seem to applicable to patients under anesthesia or other respiratory treatments.
Conclusion
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/MARGARET M LUARCA/Primary Examiner, Art Unit 3785