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 9/2/2025. Since the previous filing, claims 39, 40, 52, 54, 55, 65 and 66 have been amended and no claims have been added or cancelled. Thus, claims 39-66 are pending in the application.
In regards to the previous Double Patenting Rejections, these rejections are withdrawn with new rejections entered below.
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to the previous 103 Rejections, Applicant has amended to overcome the previous rejections and they are therefore withdrawn with new rejections entered below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 39, 41, 44, 45, 50-53 and 62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/435228, hereafter referred to as Payton-228, in view of Landis (US 2013/0340752).
In regards to claim 39, Payton-228 discloses a method for providing respiratory support to a patient, the method comprising: providing a first gas flow therapy to the patient through a non-sealing patient interface prior to administration of an anesthetic agent; providing a second gas flow therapy to the patient through the non-sealing patient interface during or after administration of the anesthetic agent; and 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 (claim 1), 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 C02 measurement, or a blood glucose measurement (claim 4).
Payton-228 does not disclose wherein the parameter is flow rate.
However, Landis teaches wherein the parameter is flow rate (flow rate may be adjusted, paragraph 115-116).
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 Payton-228 wherein the parameter is flow rate as taught by Landis as this would allow the device to control the delivered gas flow as needed by the patient.
In regards to claim 41, Payton-228 in view of Landis teaches wherein the second gas flow therapy is different than the first gas flow therapy (claim 1).
In regards to claim 44, Payton-228 in view of Landis teaches wherein the characteristic of the patient comprises a blood oxygen concentration (claim 4).
In regards to claim 45, Payton-228 in view of Landis teaches wherein the characteristic of the patient comprises a blood CO2 concentration (claim 4).
In regards to claim 50, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein at least one of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute.
However, Landis teaches wherein at least one of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute (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 Payton-228 wherein at least one of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute as taught by Landis so as to provide sufficient airflow to the patient.
In regards to claim 51, Payton in view of Landis teaches claim 39.
Payton-228 does not disclose wherein each of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute.
However, Landis teaches wherein each of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute (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 Payton-228 wherein each of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute as taught by Landis so as to provide sufficient airflow to the patient.
In regards to claim 52, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein the flow rate of the second gas flow therapy is greater than a flow rate of the first gas flow therapy.
However, Landis teaches wherein the parameter is flow rate (flow rate may be adjusted, paragraph 115-116).
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 Payton-228 wherein the parameter is flow rate as taught by Landis as this would allow the device to control the delivered gas flow as needed by the patient.
In regards to claim 53, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein the flow rate of the first gas flow therapy is about 40 liters per minute (LPM).
However, Landis teaches wherein the 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 Payton-228 wherein the 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 62, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose further comprising placing the non-sealing patient interface on the patient.
However, Landis teaches further comprising placing the non-sealing patient interface on the patient (non-sealing interface 100, Fig 17).
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 Payton-228 further comprising placing the non-sealing patient interface on the patient as taught by Landis as this would provide the patient with the appropriate interface for the therapy required.
Claim 54 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/435228, hereafter referred to as Payton-228, in view of Landis (US 2013/0340752) and in further view of Conner (US 2011/0168177).
In regards to claim 54, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein controlling a 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 a 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 Payton-228 wherein controlling a flow rate of the second gas flow therapy comprises closed loop control of the 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 40, 56-58 and 64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/435228, hereafter referred to as Payton-228, in view of Landis (US 2013/0340752) and in further view of Krebs (US 7861717).
In regards to claim 40, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein the controlling the flow rate of the second gas flow therapy is in response to a determination of the characteristic of the patient.
However, Krebs teaches wherein the controlling the parameter of the second gas flow therapy is in response to a determination of the characteristic of the patient (column 3 line 50-63 and column 7 line 28-35 and 48-50).
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 Payton-228 wherein the controlling the flow rate of the second gas flow therapy is in response to a determination of the characteristic of the patient as taught by Krebs as this would allow the device to accurately control the therapy based on patient needs.
In regards to claim 56, Payton-228 in view of Landis teaches claim 39.
Payton-228 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 Payton-228 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, Payton-228 in view of Landis teaches claim 39.
Payton-228 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 Payton-228 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, Payton-228 in view of Landis teaches claim 39.
Payton-228 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 Payton-228 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 64, Payton-228 in view of Landis teaches claim 39.
Payton-228 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 Pyaton-228 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.
Claim 42, 47, 49, 55 and 59-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/435228, hereafter referred to as Payton-228, in view of Landis (US 2013/0340752) and in further view of Franz (US 2010/0022849).
In regards to claim 42, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein the second gas flow therapy is based on administration of the anesthetic agent.
However, Franz teaches wherein the second gas flow therapy is based on administration of the anesthetic agent (phase 2 includes anesthetic agent delivery, paragraph 39, as opposed to 100 % O2 of initial phase, paragraph 37).
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 Payton-228 wherein the second gas flow therapy is based on administration of the anesthetic agent as taught by Franz as this would allow the device to adjust to suit patient needs.
In regards to claim 47, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose further comprising providing the anesthetic agent to the patient.
However, Franz teaches further comprising providing the anesthetic agent to the patient (phase 2 includes anesthetic agent delivery, paragraph 39).
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 Payton-228 further comprising providing the anesthetic agent to the patient as taught by Franz as this would allow the device to deliver anesthetic to the patient as needed.
In regards to claim 49, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein at least one of the first gas flow therapy and the second gas flow therapy comprises delivering a gas comprising 100% O2.
However, Franz teaches wherein at least one of the first gas flow therapy and the second gas flow therapy comprises delivering a gas comprising 100% O2 (phase 0 provides 100% O2 delivery, paragraph 37).
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 Payton-228 wherein at least one of the first gas flow therapy and the second gas flow therapy comprises delivering a gas comprising 100% O2 as taught by Franz as this would allow the device to deliver the gas flow according to the needs of the patient.
In regards to claim 55, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein controlling the parameter of the second gas flow therapy comprises controlling an O2 concentration of the second gas flow therapy.
However, Franz teaches wherein controlling the parameter of the second gas flow therapy comprises controlling an O2 concentration of the second gas flow therapy (phase 2 includes anesthetic agent delivery, paragraph 39).
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 Payton-228 wherein controlling the parameter of the second gas flow therapy comprises controlling an O2 concentration of the second gas flow therapy as taught by Franz as this would allow the device to deliver the gas flow according to the needs of the patient.
In regards to claim 59, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose further comprising inserting a tube into an airway of the patient.
However, Franz teaches further comprising inserting a tube into an airway of the patient (intubation phase wherein the patient is intubated, paragraph 38-39).
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 Payton-228 further comprising inserting a tube into an airway of the patient as taught by Franz as this would allow the patient to receive the required support during a procedure.
In regards to claim 60, Payton-228 in view of Landis and Franz teaches claim 59 and Franz further discloses wherein the tube is inserted during the second gas flow therapy (paragraph 38-39).
In regards to claim 61, Payton-228 in view of Landis and Franz teaches claim 60 and Franz further discloses wherein controlling the parameter of the second gas flow therapy occurs while the tube is inserted into the airway of the patient (intubation phase wherein the patient is intubated, paragraph 38-39).
Claim 43 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/435228, hereafter referred to as Payton-228, in view of Landis (US 2013/0340752) and in further view of Colas (US 2002/0117174).
In regards to claim 43, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein the patient is not anaesthetized during the first gas flow therapy.
However, Colas teaches wherein the patient is not anaesthetized during the first gas flow therapy (paragraph 2 and paragraph 22 line 2-11).
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 Payton-228 wherein the patient is not anaesthetized during the first gas flow therapy as taught by Colas as this would increase the safety of any subsequent intubation and ventilation.
Claim 46 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/435228, hereafter referred to as Payton-228, in view of Landis (US 2013/0340752) and in further view of Barker (US 2016/0082220).
In regards to claim 46, Payton-228 in view of Landis teaches claim 39.
Payton-228 does not disclose wherein the characteristic of the patient comprises an exhaled CO2 concentration.
However, Barker teaches 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 Payton-228 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 a patient during a procedure.
In regards to claim 48, Payton-228 in view of Landis teaches claim 39.
Payton-228 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 Payton-228 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 63 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/435228, hereafter referred to as Payton-228, in view of Landis (US 2013/0340752) and in further view of Martin (US 2006/0042631).
In regards to claim 63, Payton-228 in view of Landis teaches claim 39.
Payton-228 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 Payton-228 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.
This is a provisional nonstatutory double patenting rejection.
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, 49-53, 55-62, 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 (phase 2 includes anesthetic agent delivery, paragraph 39).
Franz does not disclose gas therapy provided through a non-sealing patient interface, 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).
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 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 50, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein at least one of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute.
However, Landis teaches wherein at least one of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute (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 at least one of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute as taught by Landis so as to provide sufficient airflow to the patient.
In regards to claim 51, Franz in view of Landis and Krebs teaches the method of claim 39.
Franz does not disclose wherein each of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute.
However, Landis teaches wherein each of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute (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 each of the first gas flow therapy and the second gas flow therapy comprises a flow rate of at least 15 liters per minute as taught by Landis so as to provide sufficient airflow to the patient.
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 60, Franz in view of Landis and Krebs teaches the method of claim 59 and Franz further discloses wherein the tube is inserted during the second gas flow therapy (paragraph 38-39).
In regards to claim 61, Franz in view of Landis and Krebs teaches the method of claim 60 and Franz further discloses wherein controlling the parameter of the second gas flow therapy occurs while the tube is inserted into the 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 (phase 2 includes anesthetic agent delivery, paragraph 39).
Franz does not disclose gas therapy provided through a non-sealing patient interface, 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).
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 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 (phase 2 includes anesthetic agent delivery, paragraph 39).
Franz does not disclose wherein therapy is delivered through a non-sealing patient interface, 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).
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 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.
Response to Arguments
In regards to the arguments concerning the independent claims, these arguments are primarily in regards to the amendment made to the claims and are addressed in the new rejections entered above.
Arguments concerning dependent claims are in regards to their dependency on argued independent claims and are addressed in the new rejections entered above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785