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 .
Response to Amendment
This action is responsive to the amendment filed 12/11/2025. Clams 34-36 are newly added thus claims 7, 14-17, 19, 21-23 and 34-36 are pending.
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.
Claims 7, 14-17, 21-23 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Av-Gay (US 2016/0279165 A1) in view of Pelletier (US 2008/0078392 A1), Acker (US 2014/0000596 A1), Form 8-K Bellerophon Therapeutics, as cited by applicant in IDS dated 07/02/2021, AckerJ (EP 2968828 B1) and Potenziano (US 2017/0232166 A1).
Regarding claim 7, Av-Gay discloses a method for improving or maintaining activity levels in a patient in need thereof (abstract, monitoring of parameters/vital signs is seen as activity levels, par 0306 discloses the method leading to improved or maintained activity levels), the method comprising: administering inhaled nitric oxide to the patient (par 0024) by:
(a) detecting a breath pattern in the patient including a total inspiratory time (par 0186-0187 discloses detecting breathing cycle phases including inhalation onset and exhalation onset, and determining duration of inhalation thus disclosing detecting a total inspiratory time);
(b) correlating the breath pattern with an algorithm to determine a timing of administration of a dose of nitric oxide (par 0186-0187 discloses coordinating a pulse delivery when a rate of intake increases, and coordinating the delivery to occur after a delay period on 20% of inhalation time); and
(c) administering the dose of nitric oxide to the patient in a pulsatile manner over a portion of the total inspiratory time (par 0186-0187),
wherein the patient has interstitial lung disease (par 0311 ln 16-17 discloses ILD as a disease treatable by the disclosed method)
wherein the algorithm uses a breath level threshold (par 0403 discloses a patient trigger wherein the trigger “detects a negative pressure Ptrigger from the patient indicating that the patient 18 is initiating inhalation”),
wherein the breath level threshold detects the breath when a negative pressure threshold is exceeded (par 0403 discloses detecting a breath/inhalation upon detection of a negative pressure threshold of Ptrigger),
wherein the dose of nitric oxide is adjusted based on the breath pattern (par 0187 discloses the period of time that NO is delivered is 60% of the inhalation period, as the inhalation period varies it is seen that the delivered dose thus changes dependent on the patients breathing pattern).
It is unclear from the disclosure of Av-Gay if the algorithm uses a threshold sensitivity AND a slope algorithm, wherein the slope algorithm detects a breath when a rate of pressure drop reaches a predetermined threshold. Av-Gay par 0186 discloses recognizing a rate of intake increasing thus disclosing a slope algorithm and par 0187 discloses a threshold set to 20% of the inspiratory time. Av-Gay par 0403 also discloses detecting pressure reaching a threshold of Ptrigger which is seen as a breath level threshold however it is unclear if there is further a threshold of a slope/rate of pressure drop.
Pelletier teaches a breath detection system that utilizes a breath level threshold (par 0029 discloses a detection threshold of a predetermined pressure) and a slope algorithm (par 0029 discloses monitoring pressure change rate), wherein the slope algorithm detects a breath when a rate of pressure drop reaches a predetermined threshold (par 0029 “the detection threshold is generally indicative of a beginning of inhalation”, “the comparator 28 is configured to monitor the pressure change rate signal and to trip at a threshold that is slightly higher than the common mode voltage or detect when the pressure change rate signal fulfills a predetermined requirement” thus disclosing detecting a breath when a rate of pressure drop/pressure change rate reaches a threshold), and wherein the breath level threshold detects the breath when a low pressure threshold is exceeded (par 0029 discloses a pressure threshold indicating inhalation, par 0002 discloses inhalation causing a low pressure in the cannula).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the breath detection system of Pelletier in method of Av-Gay as the system of Pelletier can detect the start of inhalation within 20 milliseconds (Pelletier par 0029) allowing for Av-Gay to administer iNO close to immediately after the start of inspiration and thus avoid a large delay in administration and wasted iNO that is delivered too late after the start of inhalation.
Av-Gay does not expressly disclose the dose of nitric oxide being adjusted based on an overall dosage amount, and an ideal body weight of the patient.
Acker teaches delivery of iNO in a pulsatile manner (par 0002 discloses NO, par 0018 discloses providing the therapeutic gas in a pulsatile manner), wherein the does delivered in a pulse is dependent/adjusted based on the breath pattern and an overall dosage amount (par 0037 discloses adjusting the amount of gas delivered in a pulse varying in response to a patients breathing rate changing in order to maintain the overall dose delivered in a given period of time, par 0046 “if the patient's breathing rate and the cylinder concentration are known, then the CPU 115 can calculate how much volume of therapeutic gas needs to be administered each breath or set of breaths to provide the desired dosage of nitric oxide”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have the pulse dose of modified Av-gay be dependent on the breathing rate and the overall dosage to be delivered as doing so allows for the iNO to be delivered in a pulsatile manner that distributes the overall dosage dependent on patient breathing ensuring that the pulse dosage accommodates a specific user’s needs.
Modified Av-Gay does not expressly disclose the dose of nitric oxide being adjusted based on an ideal body weight of the patient.
Form 8-K discloses inhaled nitric oxide is administered at an overall dosage that is dependent on the ideal body weight of the patient (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”, IBW= ideal body weight).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the overall dosage amount of modified Av-Gay/Acker be dependent on a patients ideal body weight as taught by Form 8-K, thus having the pulse dose also be dependent on the ideal body weight of the patient, as doing so ensures that the dose delivered to the patient is specific for their body thus preventing over and under dosing.
Modified Av-Gay remains silent to the dose of nitric oxide is delivered in a first third of the total inspiratory time.
AckerJ teaches a therapeutic gas delivery device (see title) for administering iNO (par 0029) wherein the dose of nitric oxide is delivered in a first third of the total inspiratory time (par 0049 “one or more of therapeutic gas are provided in the first half of inspiration or first third of inspiration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the method of modified Av-Gay deliver the iNO during the first third of the inspiration as taught by AckerJ as doing so can allow the method to deliver iNO in a timing or duration critical to the treatment regime (AckerJ: par 0049).
Modified Av-Gay remains silent to wherein a plurality of doses of nitric oxide are administered over a treatment period, and wherein the treatment period is at least 12 hours per day for at least 5 days.
Potenziano teaches the delivery of low doses of nitric oxide for a treatment period of at least 12 hours per day for at least 5 days (par 0125 “at least 12 hours a day for at least 10 days”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a treatment period as claimed on the method of modified Av-Gay as taught by Potenziano as doing so allows for the nitric oxide to provide proper treatment for various conditions.
Regarding claim 14, modified Av-Gay discloses the method of claim 7. Av-Gay is silent to the overall dosage amount is about 25 micrograms (mcg)/kg ideal body weight (IBW)/hr to about 50 mcg/kg IBW/hr.
Form 8-K discloses the overall dosage amount is about 25 micrograms (mcg)/kg ideal body weight (IBW)/hr to about 50 mcg/kg IBW/hr (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize dosage ranges taught by Form 8-K in the method of Av-Gay as this is a range with confirmed efficacy and safety results (Form 8-K pg 2).
Regarding claim 15, modified Av-Gay discloses the method of claim 14. Av-Gay is silent to the overall dosage amount is about 30 mcg/kg IBW/hr to about 45 mcg/kg IBW/hr.
Form 8-K discloses the overall dosage amount is about 30 mcg/kg IBW/hr to about 45 mcg/kg IBW/hr (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize dosage ranges taught by Form 8-K in the method of Av-Gay as this is a range with confirmed efficacy and safety results (Form 8-K pg 2).
Regarding claim 16, modified Av-Gay discloses the method of claim 14. Av-Gay is silent to the overall dosage amount is about 30 mcg/kg IBW/hr.
Form 8-K discloses the overall dosage amount is about 30 mcg/kg IBW/hr (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize dosage taught by Form 8-K in the method of Av-Gay as this is a dosage with confirmed efficacy and safety results (Form 8-K pg 2).
Regarding claim 17, modified Av-Gay discloses the method of claim 14. Av-Gay is silent to the overall dosage amount is about 45 mcg/kg IBW/hr.
Form 8-K discloses the overall dosage amount is about 45 mcg/kg IBW/hr (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize dosage taught by Form 8-K in the method of Av-Gay as this is a dosage with confirmed efficacy and safety results (Form 8-K pg 2).
Regarding claim 21, modified Av-Gay discloses the method of claim 7. Av-Gay further discloses the interstitial lung disease comprises one or more subtypes selected from idiopathic interstitial pneumonia (IIP) (par 0311 ln 12-13), chronic hypersensitivity pneumonia (par 0311 ln 18-19), occupational or environmental lung disease, idiopathic pulmonary fibrosis (IPF) (par 0311 ln 12 and 26), non-IPF IIPs, granulomatous, and connective tissue disease related ILD (par 0311 ln 20-21).
Regarding claim 22, modified Av-Gay discloses the method of claim 7. Av-Gay further discloses the interstitial lung disease comprises idiopathic pulmonary fibrosis (IPF) (par 0311 ln 12 and 26).
Regarding claim 23, modified Av-Gay discloses the method of claim 7. Av-Gay further discloses the patient is at high risk of developing pulmonary hypertension (par 0006 discloses the method being used to prevent pulmonary hypertension thus disclosing the patient being at high risk).
Regarding claim 34, modified Av-Gay discloses the method of claim 7. Potenziano further teaches the treatment period is at least 16 hours per day for at least 5 days (par 0126 disclosing 16 hours a day and par 0125 disclosing at least 5 days).
Regarding claim 35, modified Av-Gay discloses the method of claim 7. Potenziano further teaches the treatment period is at least 12 hours per day for at least 8 weeks (par 0125 disclosing 12 hours a day and 2 months).
Regarding claim 34, modified Av-Gay discloses the method of claim 7. Potenziano further teaches the treatment period is at least 12 hours per day for at least 16 weeks (par 0125 disclosing 12 hours a day and 4 months).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over modified Av-Gay as applied to claim 7 above, and further in view of Freitag (WO 2008/019102 A2).
Regarding claim 19, modified Av-Gay discloses the method of claim 7. Av-Gay further discloses measuring changes in activity levels using noninvasive measures (par 0246-0247, 0274, 0303).
Av-Gay does not expressly disclose the noninvasive measures to be actigraphy.
Freitag teaches a method of providing respiratory support to a patient (abstract) involving measuring changes in activity levels using actigraphy (pg 32 ln 9-11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize actigraphy as taught by Freitag to measure activity levels in the method of Av-Gay as actigraphy is a well-known noninvasive way to evaluate a person’s activity levels.
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.
Claims 7, 14-17, 21-23 and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 12-13 of copending Application No. 17/055,365 in view of Av-Gay, Acker and Form 8-K Bellerophon Therapeutics, and Potenziano.
Regarding claim 7, ‘365 discloses a method for improving or maintaining activity levels in a patient in need thereof (cl 1 ln 1-2, cl 12 ln 1-2), the method comprising: administering inhaled nitric oxide to the patient (cl 1 ln 11, cl 12 ln 11) by:
(a) detecting a breath pattern in the patient including a total inspiratory time (cl 1 ln 3, cl 12 ln 3);
(b) correlating the breath pattern with an algorithm to calculate a timing of administration of a dose of nitric oxide (cl 1 ln 7-8, cl 12 ln 7-8); and
(c) administering the dose of nitric oxide to the patient in a pulsatile manner over a portion of the total inspiratory time (cl 1 ln 11-12, cl 12 ln 11-12)
wherein the algorithm uses a breath level threshold and a slope algorithm (cl 1 ln 16-19, cl 12 ln 15-18),
wherein the slope algorithm detects a breath when a rate of pressure drop reaches a predetermined threshold (cl 1 ln 18-19, cl 12 ln 17-18), and
wherein the breath level threshold detects the breath when a pressure threshold is exceeded (cl 1 ln 16-18, cl 12 ln 15-17), and
wherein the dose of nitric oxide is delivered in a first third of the total inspiratory time (cl 1 ln 23-24, cl 12 ln 22-23).
‘365 is silent to wherein the patient has interstitial lung disease (cl 1 ln 2-3, cl 2 ln 2-3, cl 4 ln 2-3), the pressure threshold being negative and the dose of nitric oxide is adjusted based on the breath pattern, an overall dosage amount, and an ideal body weight of the patient.
Av-Gay teaches a method for improving or maintaining activity levels in a patient in need thereof (abstract, monitoring of parameters/vital signs is seen as activity levels, par 0306 discloses the method leading to improved or maintained activity levels), the method comprising administering inhaled nitric oxide to the patient (par 0024), wherein the patient has interstitial lung disease (par 0311 ln 16-17 discloses ILD as a disease treatable by the disclosed method), utilizing a negative pressure threshold for determining inspiration (par 0403 discloses detecting a breath/inhalation upon detection of a negative pressure threshold of Ptrigger), wherein the dose of nitric oxide is adjusted based on the breath pattern (par 0187 discloses the period of time that NO is delivered is 60% of the inhalation period, as the inhalation period varies it is seen that the delivered dose thus changes dependent on the patients breathing pattern).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of ‘365 on a patient with interstitial lung disease as disclosed by Av-Gay as doing so can help to improve or maintain vital signs in patients with ILD (Av-Gay par 0213, 0306).
Acker teaches delivery of iNO in a pulsatile manner (par 0002 discloses NO, par 0018 discloses providing the therapeutic gas in a pulsatile manner), wherein the does delivered in a pulse is dependent/adjusted based on the breath pattern and an overall dosage amount (par 0037 discloses adjusting the amount of gas delivered in a pulse varying in response to a patients breathing rate changing in order to maintain the overall dose delivered in a given period of time, par 0046 “if the patient's breathing rate and the cylinder concentration are known, then the CPU 115 can calculate how much volume of therapeutic gas needs to be administered each breath or set of breaths to provide the desired dosage of nitric oxide”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have the pulse dose of modified ‘365 be dependent on the breathing rate and the overall dosage to be delivered as doing so allows for the iNO to be delivered in a pulsatile manner that distributes the overall dosage dependent on patient breathing ensuring that the pulse dosage accommodates a specific user’s needs.
Form 8-K discloses inhaled nitric oxide is administered at an overall dosage that is dependent on the ideal body weight of the patient (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”, IBW= ideal body weight).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the overall dosage amount of modified ‘365/Acker be dependent on a patients ideal body weight as taught by Form 8-K, thus having the pulse dose also be dependent on the ideal body weight of the patient, as doing so ensures that the dose delivered to the patient is specific for their body thus preventing over and under dosing.
Potenziano teaches the delivery of low doses of nitric oxide for a treatment period of at least 12 hours per day for at least 5 days (par 0125 “at least 12 hours a day for at least 10 days”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a treatment period as claimed as taught by Potenziano as doing so allows for the nitric oxide to provide proper treatment for various conditions.
Regarding claim 14, modified ‘365 discloses the method of claim 7. Form 8-K discloses the overall dosage amount is about 25 micrograms (mcg)/kg ideal body weight (IBW)/hr to about 50 mcg/kg IBW/hr (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize dosage ranges taught by Form 8-K in the method of ‘365 as this is a range with confirmed efficacy and safety results (Form 8-K pg 2).
Regarding claim 15, modified ‘365 discloses the method of claim 14. Form 8-K discloses the overall dosage amount is about 30 mcg/kg IBW/hr to about 45 mcg/kg IBW/hr (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize dosage ranges taught by Form 8-K in the method of ‘365 as this is a range with confirmed efficacy and safety results (Form 8-K pg 2).
Regarding claim 16, modified ‘365 discloses the method of claim 14. Form 8-K discloses the overall dosage amount is about 30 mcg/kg IBW/hr (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize dosage taught by Form 8-K in the method of ‘365 as this is a dosage with confirmed efficacy and safety results (Form 8-K pg 2).
Regarding claim 17, modified ‘365 discloses the method of claim 14. Form 8-K the overall dosage amount is about 45 mcg/kg IBW/hr (pg 2 “INOpulse device doses ranging from 3 to 75 mcg/kg IBW/hr”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize dosage taught by Form 8-K in the method of ‘365 as this is a dosage with confirmed efficacy and safety results (Form 8-K pg 2).
Regarding claim 21, ‘356 discloses the method of claim 7 and further discloses the interstitial lung disease comprises one or more subtypes selected from idiopathic interstitial pneumonia (IIP), chronic hypersensitivity pneumonia, occupational or environmental lung disease, idiopathic pulmonary fibrosis (IPF) (cl 13 ln 2), non-IPF IIPs, granulomatous, and connective tissue disease related ILD.
Regarding claim 22, ‘356 discloses the method of claim 7 and further discloses the interstitial lung disease comprises idiopathic pulmonary fibrosis (IPF) (cl 13 ln 2).
Regarding claim 23, ‘356 discloses the method of claim 7 and further discloses the patient is at high risk of developing pulmonary hypertension (cl 13 ln 2).
Regarding claim 34, ‘356 discloses the method of claim 7. Potenziano further teaches the treatment period is at least 16 hours per day for at least 5 days (par 0126 disclosing 16 hours a day and par 0125 disclosing at least 5 days).
Regarding claim 35, ‘356 discloses the method of claim 7. Potenziano further teaches the treatment period is at least 12 hours per day for at least 8 weeks (par 0125 disclosing 12 hours a day and 2 months).
Regarding claim 34, ‘356 discloses the method of claim 7. Potenziano further teaches the treatment period is at least 12 hours per day for at least 16 weeks (par 0125 disclosing 12 hours a day and 4 months).
Response to Arguments
Applicant’s arguments with respect to claim 7 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. Further as the concentration delivered has been modified from the disclosure of Av-Gay it is not seen that the teachings of Av-Gay of maximum treatment period teach away from a treatment period for the modified concentration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0243528 A1 discloses iNO delivery in a pulsatile manner that utilizes the prescribed dose and patients respiratory parameters to determine pulse duration, flow rate and concentration
US 6,109,260 disclose detecting negative pressure as an inhalation trigger
US 2003/0172929 A1 discloses tidal volume-dependent regulation of gas dosing
US 5,427,797 discloses administering NO to a patient and comparing heart rate and oxygen saturation of a baseline and after an NO inhalation period
US 2006/0147553 A1 discloses administering inhaled nitric oxide upon inspiratory demand
US 6,581,599 B1 discloses a device for delivering NO to a patient comprising a flow profile sensor
US 2012/0107423 A1 discloses a method for using inhaled nitric oxide to treat respiratory distress syndrome
US 8,408,206 B2 discloses a system that delivers a pulse of therapeutic gas to a patient based upon a patient trigger sensor
US 2014/0275901 A1 discloses monitoring oxygenation parameters during treatment/delivery of NO
US 2018/0304038 A1 discloses delivering nitric oxide to a patient that enables higher activity of the patient
US 2018/0071467 A1 discloses a method for portable NO delivery
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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/K.B.D./Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799