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 .
This action is in response to the filing on 5/14/2026. Since the previous filing, claims 39, 45, 46, 49, 55, 61, 65 and 66 have been amended, claims 50 and 51 have been cancelled and no claims have been added. Thus, claims 39-49 and 52-66 are pending in the application.
In regards to the previous Double Patenting Rejections, these rejections are withdrawn.
In regards to the previous 103 Rejections, Applicant has amended to overcome the previous rejections and they are therefore withdrawn with new rejections entered below.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/14/2026 has been entered.
Claim Objections
Claims 40-49 and 52-64 objected to because of the following informalities:
Line 1: “Claim” should be “claim”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 39-44, 47, 49, 52-53, 55-59, 62, 64 and 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2010/0022849) in view of Landis (US 2013/0340752) and Krebs (US 7861717).
In regards to claim 39, Franz discloses a method for providing respiratory support to a patient (paragraph 33), the method comprising: providing a first gas flow therapy to the patient prior to administration of an anesthetic agent (phase 0 provides 100% O2 delivery, paragraph 37); providing a second gas flow therapy to the patient during or after administration of the anesthetic agent, wherein the second gas flow therapy does not comprise any anesthetic agent (washout step phase 7 uses 100% O2 concentration, paragraph 43 and Table 1).
Franz does not disclose gas therapy provided through a non-sealing patient interface, wherein the first gas glow therapy is provided at 15 L/min or greater, wherein the second gas flow therapy is provided at 15 L/min or greater, wherein during the second gas flow therapy, controlling a flow rate of the second gas flow therapy by providing an input related to a characteristic of the patient, wherein the characteristic of the patient comprises at least one of a heart rate, an EEG signal, an EKG/ECG signal, an oxygen measurement, a CO2 measurement, or a blood glucose measurement.
However, Landis teaches gas therapy including anesthetic provided through a non-sealing patient interface (non-sealing interface 100, additional gas such as anesthetic may be delivered to patient, paragraph 125 line 14-17) and wherein the parameter is flow rate (flow rate may be adjusted, paragraph 115-116) and wherein the first and second gas flow therapy are provided at 15 L/min or greater (paragraph 118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein gas therapy provided through a non-sealing patient interface and the parameter is flow rate and wherein the first and second gas flow therapy are provided at 15 L/min or greater as taught by Landis as this would provide the ability to deliver high flow rates of oxygen and deliver anesthetic to meet the needs of the patient (Landis: paragraph 110 and 118 and 125 line 14-17).
Additionally, while Franz discloses a controller (control interface 11) capable of making treatment determinations (paragraph 37-40), it does not disclose during the second gas flow therapy, controlling a parameter of the second gas flow therapy by providing an input related to a characteristic of the patient, wherein the characteristic of the patient comprises at least one of a heart rate, an EEG signal, an EKG/ECG signal, an oxygen measurement, a CO2 measurement, or a blood glucose measurement.
However, Krebs teaches controlling a parameter of the gas flow therapy by providing an input related to a characteristic of the patient, wherein the characteristic of the patient comprises at least one of a heart rate, an oxygen measurement (column 3 line 50-63 and column 7 line 28-35).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein controlling a parameter of the gas flow therapy by providing an input related to a characteristic of the patient, wherein the characteristic of the patient comprises at least one of a heart rate, an oxygen measurement as taught by Krebs as this would allow the device to accurately control the therapy based on patient needs.
In regards to claim 40, Franz in view of Landis and Krebs teaches the method of claim 39 and the combination further teaches wherein the controlling the flow rate of the second gas flow therapy is in response to a determination of the characteristic of the patient (Krebs: column 3 line 50-63 and column 7 line 28-35 and 48-50).
In regards to claim 41, Franz in view of Landis and Krebs teaches the method of claim 39 and the combination further teaches wherein the second gas flow therapy is different than the first gas flow therapy (Franz: phase 2 includes anesthetic agent delivery, paragraph 39, as opposed to 100 % O2 of initial phase, paragraph 37).
In regards to claim 42, Franz in view of Landis and Krebs teaches the method of claim 39 and the combination further teaches wherein the second gas flow therapy is based on administration of the anesthetic agent (Franz: phase 2 includes anesthetic agent delivery, paragraph 39).
In regards to claim 43, Franz in view of Landis and Krebs teaches the method of claim 39 and the combination further teaches wherein the patient is not anaesthetized during the first gas flow therapy (Franz: phase 0 provides 100% O2 delivery, paragraph 37).
In regards to claim 44, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the characteristic of the patient comprises a blood oxygen concentration.
However, Krebs teaches wherein the characteristic of the patient comprises a blood oxygen concentration (column 3 line 50-63).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the characteristic of the patient comprises a blood oxygen concentration as taught by Krebs as this is a known method of monitoring a patient status.
In regards to claim 47, Franz in view of Landis and Krebs teaches the method of claim 39 and the combination further teaches further comprising providing the anesthetic agent to the patient (Franz: phase 2 includes anesthetic agent delivery, paragraph 39).
In regards to claim 49, Franz in view of Landis and Krebs teaches the method of claim 39 and the combination further teaches wherein at least one of the first gas flow therapy and the second gas flow therapy comprises delivering a gas comprising 100% O2 (Franz: phase 0 provides 100% O2 delivery, paragraph 37).
In regards to claim 52, Franz in view of Landis and Krebs teaches the method of claim 39 and Landis further teaches wherein a flow rate of the second gas flow therapy is greater than a flow rate of the first gas flow therapy (flow rate adjusted if patient needs higher flow rate, paragraph 116).
In regards to claim 53, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein a flow rate of the first gas flow therapy is about 40 liters per minute (LPM).
However, Landis teaches wherein a flow rate of the first gas flow therapy is about 40 liters per minute (LPM) (paragraph 118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein a flow rate of the first gas flow therapy is about 40 liters per minute (LPM) as taught by Landis so as to provide the user with the appropriate support.
In regards to claim 55, Franz in view of Landis and Krebs teaches the method of claim 39 and Franz further discloses wherein controlling the parameter of the second gas flow therapy comprises controlling an O2 concentration of the second gas flow therapy (O2 concentration changed across phases from 100% to 30%, paragraph 37-40).
In regards to claim 56, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the patient is spontaneously breathing during the first gas flow therapy.
However, Krebs teaches wherein the patient is spontaneously breathing during the first gas flow therapy (abstract, column 4 line 12-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the patient is spontaneously breathing during the first gas flow therapy as taught by Krebs as this is a state that a patient may be in during a procedure and would need to be accounted for.
In regards to claim 57, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the patient is spontaneously breathing during the second gas flow therapy.
However, Krebs teaches wherein the patient is spontaneously breathing during the second gas flow therapy (abstract, column 4 line 12-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the patient is spontaneously breathing during the second gas flow therapy as taught by Krebs as this is a state that a patient may be in during a procedure and would need to be accounted for.
In regards to claim 58, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the patient is not spontaneously breathing during the second gas flow therapy.
However, Krebs teaches wherein the patient is not spontaneously breathing during the second gas flow therapy (abstract, column 4 line 12-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the patient is not spontaneously breathing during the second gas flow therapy as taught by Krebs as this is a state that a patient may be in during a procedure and would need to be accounted for.
In regards to claim 59, Franz in view of Landis and Krebs teaches the method of claim 39 and Franz further discloses further comprising inserting a tube into an airway of the patient (intubation phase wherein the patient is intubated, paragraph 38-39).
In regards to claim 62, Franz in view of Landis and Krebs teaches the method of claim 39 and the combination further teaches further comprising placing the non-sealing patient interface on the patient (Landis: non-sealing interface 100, Fig 17).
In regards to claim 64, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the patient is spontaneously breathing during at least a portion of the first gas flow therapy and during at least a portion of the second gas flow therapy.
However, Krebs teaches wherein the patient is spontaneously breathing during at least a portion of the first gas flow therapy and during at least a portion of the second gas flow therapy (abstract, column 4 line 12-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the patient is spontaneously breathing during at least a portion of the first gas flow therapy and during at least a portion of the second gas flow therapy as taught by Krebs as these are states which the patient may be under during a procedure.
In regards to claim 65, Franz discloses a method for providing respiratory support to a patient (paragraph 33), the method comprising: providing a first gas flow therapy to the patient prior to administration of an anesthetic agent (phase 0 provides 100% O2 delivery, paragraph 37); providing a second gas flow therapy to the patient during or after administration of the anesthetic agent, wherein the second gas flow therapy does not comprise any anesthetic agent (washout step phase 7 uses 100% O2 concentration, paragraph 43 and Table 1).
Franz does not disclose gas therapy provided through a non-sealing patient interface, wherein the first gas glow therapy is provided at 15 L/min or greater, wherein the second gas flow therapy is provided at 15 L/min or greater, wherein during the second gas flow therapy, wherein during the second gas flow therapy, controlling a flow rate of the second gas flow therapy by providing an input related to a characteristic of the patient, wherein during the second gas flow therapy the patient is sedated but spontaneously breathing.
However, Landis teaches gas therapy including anesthetic provided through a non-sealing patient interface (non-sealing interface 100, additional gas such as anesthetic may be delivered to patient, paragraph 125 line 14-17) and wherein the parameter is flow rate (flow rate may be adjusted, paragraph 115-116) and wherein the first and second gas flow therapy are provided at 15 L/min or greater (paragraph 118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein gas therapy provided through a non-sealing patient interface and wherein the parameter is flow rate and wherein the first and second gas flow therapy are provided at 15 L/min or greater as taught by Landis as this would provide the ability to deliver high flow rates of oxygen and deliver anesthetic to meet the needs of the patient (Landis: paragraph 110 and 118 and 125 line 14-17).
Additionally, while Franz discloses a controller (control interface 11) capable of making treatment determinations (paragraph 37-40), it does not disclose wherein during the second gas flow therapy, controlling a parameter of the second gas flow therapy by providing an input related to a characteristic of the patient, wherein during the second gas flow therapy the patient is sedated but spontaneously breathing.
However, Krebs teaches controlling a parameter of the second gas flow therapy by providing an input related to a characteristic of the patient (column 3 line 50-63), wherein during the second gas flow therapy the patient is sedated but spontaneously breathing (abstract, column 4 line 12-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein during the second gas flow therapy, controlling a parameter of the second gas flow therapy by providing an input related to a characteristic of the patient, wherein during the second gas flow therapy the patient is sedated but spontaneously breathing as taught by Krebs as this would allow the treatment to be controlled at the need of the patient during the procedure.
Claim(s) 45-46 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2010/0022849) in view of Landis (US 2013/0340752) and Krebs (US 7861717) as applied above and in further view of Barker (US 2016/0082220).
In regards to claim 45, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the characteristic of the patient comprises a blood CO2 concentration.
However, Barker teaches a respiratory therapy device wherein the characteristic of the patient comprises a blood CO2 concentration (paragraph 74).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the characteristic of the patient comprises a blood CO2 concentration as taught by Barker as this is a known method by which to monitor the patient during a procedure.
In regards to claim 46, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the characteristic of the patient comprises an exhaled CO2 concentration.
However, Barker teaches a respiratory therapy device wherein the characteristic of the patient comprises an exhaled CO2 concentration (paragraph 74).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the characteristic of the patient comprises an exhaled CO2 concentration as taught by Barker as this is a known method by which to monitor the patient during a procedure.
In regards to claim 48, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the characteristic of the patient is determined based on an output of a physiological sensor.
However, Barker teaches a respiratory therapy device wherein the characteristic of the patient is determined based on an output of a physiological sensor (paragraph 74).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the characteristic of the patient is determined based on an output of a physiological sensor as taught by Barker as this is a known method by which to monitor the patient during a procedure.
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2010/0022849) in view of Landis (US 2013/0340752) and Krebs (US 7861717) as applied above and in further view of Conner (US 2011/0168177).
In regards to claim 54, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein controlling the flow rate of the second gas flow therapy comprises closed loop control of the flow rate of the second gas flow therapy.
However, Conner teaches wherein controlling the flow rate of the second gas flow therapy comprises closed loop control of the flow rate of the second gas flow therapy (paragraph 29 and 43).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein controlling the parameter of the second gas flow therapy comprises controlling a flow rate of the second gas flow therapy as taught by Conner so as to provide sufficient and controlled support for the patient at their need.
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2010/0022849) in view of Landis (US 2013/0340752) and Krebs (US 7861717) as applied above and in further view of Martin (US 2006/0042631).
In regards to claim 63, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein the patient is undergoing an endoscopic procedure.
However, Martin teaches a respiratory therapy method wherein the patient is undergoing an endoscopic procedure (paragraph 92 and 109).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the patient is undergoing an endoscopic procedure as taught by Martin as this is a common procedure during which a patient might require respiratory support.
Claim(s) 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franz (US 2010/0022849) in view of Landis (US 2013/0340752) and Barker (US 2016/0082220).
In regards to claim 66, Franz discloses a method for providing respiratory support to a patient (paragraph 33), the method comprising: providing a first gas flow therapy to the patient prior to administration of an anesthetic agent (phase 0 provides 100% O2 delivery, paragraph 37); providing a second gas flow therapy to the patient during or after administration of the anesthetic agent, wherein the second gas flow therapy does not comprise any anesthetic agent (washout step phase 7 uses 100% O2 concentration, paragraph 43 and Table 1).
Franz does not disclose wherein therapy is delivered through a non-sealing patient interface, wherein the first gas glow therapy is provided at 15 L/min or greater, wherein the second gas flow therapy is provided at 15 L/min or greater, wherein during the second gas flow therapy, wherein during the second gas flow therapy, controlling a flow rate of the second gas flow therapy by providing an input related to a characteristic of the patient, wherein the characteristic of the patient comprises a CO2 measurement.
However, Landis teaches gas therapy including anesthetic provided through a non-sealing patient interface (non-sealing interface 100, additional gas such as anesthetic may be delivered to patient, paragraph 125 line 14-17) and wherein the parameter is flow rate (flow rate may be adjusted, paragraph 115-116) and wherein the first and second gas flow therapy are provided at 15 L/min or greater (paragraph 118).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein gas therapy provided through a non-sealing patient interface and wherein the parameter is flow rate and wherein the first and second gas flow therapy are provided at 15 L/min or greater as taught by Landis as this would provide the ability to deliver high flow rates of oxygen and deliver anesthetic to meet the needs of the patient (Landis: paragraph 110 and 118 and 125 line 14-17).
Additionally, while Franz discloses a controller (control interface 11) capable of making treatment determinations (paragraph 37-40), it does not disclose during the second gas flow therapy, controlling a parameter of the second gas flow therapy by providing an input related to a characteristic of the patient, wherein the characteristic of the patient comprises a CO2 measurement.
However, Barker teaches a respiratory therapy device wherein the characteristic of the patient comprises a blood CO2 concentration (paragraph 74).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Franz wherein the characteristic of the patient comprises a blood CO2 concentration as taught by Barker as this is a known method by which to monitor the patient during a procedure.
Allowable Subject Matter
Claims 60 and 61 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record, alone or in combination, fails to disclose all of the structural and functional limitations as described in the claims.
Specifically, the limitation wherein a tube or endoscope is inserted into an airway of the patient during the second gas flow therapy as seen in claim 60 conflicts with the modified rejections based on Franz. The modified Franz teaches multiple phases of gas delivery; however, the modified rejection places the second gas therapy after intubation in order to read on the amended limitations and can therefore not support the further limitations.
For these reasons, claim 60 and its dependent claim 61 are allowable over the prior art of record.
Response to Arguments
In regards to the arguments concerning the independent claims, these arguments are not persuasive. Applicant argues against the use of Landis to teach a non-sealing interface to deliver anesthetic. Specifically, they argue that Landis does not deliver anesthetic within the parameters established by primary reference Franz. Examiner accedes that Landis does not describe the parameters of Franz but argues that Landis is not called to teach the parameters of Franz. Landis is called upon to teach that it is known in the art to use non-sealing interfaces to deliver anesthetic to a patient. No further details are included because no further details are required beyond that linkage and teaching that gas flow may be delivered at or above a specific rate through said interface as also taught by Landis. The particulars of the gas concentrations are not relevant to Landis and are taught by other references.
Arguments concerning dependent claims are in regards to their dependency on argued independent claims and are addressed in the new rejections entered above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785
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