DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Terminal Disclaimer
The terminal disclaimer does not comply with 37 CFR 1.321 because: See Terminal Disclaimer Review Decision mailed 10/17/2025.
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 claims at issue 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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Claims 1-17 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 8, and 11 of US Patent 10,556,086 in view of Stenzler (7,516,742).
Regarding claim 1, the instant claims is a broader version of the patented claim. (i.e. The instant claim does not include the limitation of a treatment time of 72 hours. In the instant claims, all elements are included in the patented claims except for the NO from a cylinder. However, Stenzler teaches NO from a cylinder (24) (col. 9 lines 40-50). It would have been obvious to one of ordinary skill in the art at the time the invention was made to deliver the NO concentration from a cylinder as taught by Stenzler to provide the advantage of an efficient means of storing and delivering gas.
Thus any infringement over the patented claims would also infringe the instant claims. Hence the instant claims do not differ in scope over the patented claims
Application 18/136,522
US Patent 10,556,086
1. A method of administering nitric oxide (NO), the method comprising administering a gas comprising NO from a cylinder having a NO concentration greater than 2,000 ppm NO, wherein the gas comprising NO is administered at a dosing rate less than or equal to 166 ug NO per second.
10. The method of claim 1, wherein the NO is administered in undiluted form such that a delivery concentration is the same as the NO concentration in the cylinder.
2. The method of claim 1, wherein the cylinder has a NO concentration of greater than 2,000 ppm to 20,000 ppm NO.
3. The method of claim 1, wherein the cylinder has a NO concentration of greater than 2,000 ppm to 5,000 ppm NO.
4. The method of claim 1, wherein the cylinder has a NO concentration of greater than 2,200 ppm NO.
5. The method of claim 1 wherein the NO is administered at a delivery concentration of greater than 2,000 ppm NO.
6. The method of claim 5, wherein the delivery concentration is in the range from greater than 2,000 ppm to 20,000 ppm NO.
7. The method of claim 5, wherein the delivery concentration is in the range from greater than 2,000 ppm to 5,000 ppm NO.
8. The method of claim 5, wherein the delivery concentration is in the range from 2,200 ppm to 5,000 ppm NO.
9. The method of claim 5, wherein the delivery concentration is greater than 2,200 ppm NO.
16. The method of claim 1, wherein the dosing rate is less than or equal to 100 ug NO per second.
17. The method of claim 1, wherein the dosing rate is less than or equal to 83 ug NO per second.
11. The method of claim 1, wherein the NO is administered at a dose in the range from 0.001 to 4.5 mg NO/kg/hr.
12. The method of claim 1, wherein the NO is administered at a dose in the range from 0.001 to 0.5 mg NO/kg/hr.
13. The method of claim 1, wherein the NO is administered in the inspiratory gas of a patient.
14. The method of claim 1, wherein the NO is administered to a patient every breath.
15. The method of claim 1, wherein the NO is administered intermittently.
20. The method of claim 1, wherein the gas comprising NO is delivered via a
nasal cannula and the delivery concentration exiting the nasal cannula is the same as the
NO concentration in the cylinder.
1. A method of treating pulmonary hypertension, the method comprising: administering a plurality of pulses of therapeutic gas comprising nitric oxide (NO) to a patient in need thereof for a treatment time of at least 72 hours, wherein at least one pulse: i. comprises a NO delivery concentration of greater than or equal to 4,600 ppm NO, ii. is administered at a dosing rate of less than or equal to 83 μg NO per second, iii. is administered at a therapeutic gas flow rate of less than or equal to 0.8 L/min, iv. has a pulse volume of less than or equal to 1 mL, and v. comprises less than 420 nmol of NO; and diluting the pulses of therapeutic gas in the patient's trachea and/or lungs to an alveolar concentration less than the delivery concentration.
2. The method of claim 1, wherein the delivery concentration is in a range from 4,600 ppm NO to 30,000 ppm NO.
7. The method of claim 1, wherein the administration of the therapeutic gas provides less nasal irritation than administration of the therapeutic gas with a dosing rate above 83 μg NO per second and/or with more than 420 nmol NO per breath.
8. The method of claim 1, wherein the plurality of pulses are administered to the patient at a dose in a range from 0.001 to 0.5 mg NO/kg/hr.
3. The method of claim 1, wherein the therapeutic gas is administered to the patient every breath.
4. The method of claim 1, wherein the therapeutic gas is administered to the patient intermittently.
11. A method of delivering nitric oxide to a patient, the method comprising: providing a therapeutic gas source comprising therapeutic gas having a nitric oxide (NO) concentration greater than or equal to 4,600 ppm NO; introducing the therapeutic gas into a patient delivery tube having a control valve; opening the control valve to provide a pulse of therapeutic gas; delivering the pulse of therapeutic gas to the patient via a nasal cannula or breathing mask; and diluting the pulse of therapeutic gas in the patient's trachea and/or lungs, wherein the pulse of therapeutic gas: i. comprises a NO delivery concentration of greater than or equal to 4,600 ppm NO, ii. is delivered at a dosing rate of less than or equal to 83 μg NO per second, iii. is delivered at a therapeutic gas flow rate of less than or equal to 0.8 L/min, iv. has a pulse volume of less than or equal to 1 mL, and v. comprises less than 420 nmol of NO.
[i.e. the NO is only diluted in the patient such as the concentration leaving the cannula is the same as the cylinder].
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US Patent 11,660,416 in view of Stenzler (7,516,742).
Regarding claim 1, the instant claims is a broader version of the patented claim. (i.e. The instant claim does not include the limitation of a treatment of hypertension). In the instant claims, all elements are included in the patented claims except for the NO from a cylinder. However, Stenzler teaches NO from a cylinder (24) (col. 9 lines 40-50). It would have been obvious to one of ordinary skill in the art at the time the invention was made to deliver the NO concentration from a cylinder as taught by Stenzler to provide the advantage of an efficient means of storing and delivering gas.
Thus any infringement over the patented claims would also infringe the instant claims. Hence the instant claims do not differ in scope over the patented claims
Application 18/136,522
US Patent 11,660,416
1. A method of administering nitric oxide (NO), the method comprising administering a gas comprising NO from a cylinder having a NO concentration greater than 2,000 ppm NO, wherein the gas comprising NO is administered at a dosing rate less than or equal to 166 ug NO per second.
2. The method of claim 1, wherein the cylinder has a NO concentration of greater than 2,000 ppm to 20,000 ppm NO.
3. The method of claim 1, wherein the cylinder has a NO concentration of greater than 2,000 ppm to 5,000 ppm NO.
4. The method of claim 1, wherein the cylinder has a NO concentration of greater than 2,200 ppm NO.
5. The method of claim 1 wherein the NO is administered at a delivery concentration of greater than 2,000 ppm NO.
6. The method of claim 5, wherein the delivery concentration is in the range from greater than 2,000 ppm to 20,000 ppm NO.
7. The method of claim 5, wherein the delivery concentration is in the range from greater than 2,000 ppm to 5,000 ppm NO.
8. The method of claim 5, wherein the delivery concentration is in the range from 2,200 ppm to 5,000 ppm NO.
9. The method of claim 5, wherein the delivery concentration is greater than 2,200 ppm NO.
10. The method of claim 1, wherein the NO is administered in undiluted form such that a delivery concentration is the same as the NO concentration in the cylinder.
11. The method of claim 1, wherein the NO is administered at a dose in the range from 0.001 to 4.5 mg NO/kg/hr.
12. The method of claim 1, wherein the NO is administered at a dose in the range from 0.001 to 0.5 mg NO/kg/hr.
13. The method of claim 1, wherein the NO is administered in the inspiratory gas of a patient.
14. The method of claim 1, wherein the NO is administered to a patient every breath.
15. The method of claim 1, wherein the NO is administered intermittently.
16. The method of claim 1, wherein the dosing rate is less than or equal to 100 ug NO per second.
17. The method of claim 1, wherein the dosing rate is less than or equal to 83 ug NO per second.
1. A method of treating pulmonary hypertension, the method comprising administering a dose of nitric oxide (NO) to a patient in need thereof, the dose comprising a delivery concentration of greater than 2,000 ppm NO and being administered at a dosing rate less than or equal to 166 μg NO per second.
2. The method of claim 1, wherein the delivery concentration is in the range from greater than 2,000 ppm to 20,000 ppm.
3. The method of claim 1, wherein the delivery concentration is in the range from 2,200 ppm to 5,000 ppm.
2. The method of claim 1, wherein the delivery concentration is in the range from greater than 2,000 ppm to 20,000 ppm.
3. The method of claim 1, wherein the delivery concentration is in the range from 2,200 ppm to 5,000 ppm.
2. The method of claim 1, wherein the delivery concentration is in the range from greater than 2,000 ppm to 20,000 ppm.
3. The method of claim 1, wherein the delivery concentration is in the range from 2,200 ppm to 5,000 ppm.
2. The method of claim 1, wherein the delivery concentration is in the range from greater than 2,000 ppm to 20,000 ppm.
3. The method of claim 1, wherein the delivery concentration is in the range from 2,200 ppm to 5,000 ppm.
7. The method of claim 1, wherein the nitric oxide is administered in undiluted form such that the delivery concentration is the same as a storage concentration.
4. The method of claim 1, wherein the dose is in the range from 0.001 to 4.5 mg NO/kg/hr.
4. The method of claim 1, wherein the dose is in the range from 0.001 to 4.5 mg NO/kg/hr.
5. The method of claim 1, wherein the dose is administered every breath.
6. The method of claim 1, wherein the dose is administered intermittently.
8. The method of claim 1, wherein the dosing rate is less than or equal to 100 μg NO per second.
9. The method of claim 1, wherein the dosing rate is less than or equal to 83 μg NO per second.
Allowable Subject Matter
Claims 1-20 are allowed over the prior art.
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive.
No specific arguments have been presented.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/Primary Examiner, Art Unit 3785