DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-20 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/21/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fine et al. (2010/0089392) in view of Miller et al. (2007/0104653).
Regarding claims 1-4, Fine teaches a method of administering nitric oxide ([0004] lines 8-15, [0021] lines 1-10) comprising administering a therapeutic gas comprising a dose of nitric oxide to a patient in need thereof ([0005] lines 1-10, [0021] lines 1-15) from a cylinder ([0028] discloses a Geno cylinder), wherein the dose comprises a delivery concentration of 2000 ppm ([0005] last 2 lines, [0020] lines 1-5 discloses 2000ppm).
Fine teaches delivering nitric oxide at a concentration of 2-2000 ppm every second to several minutes in pulses ([0017] lines 1-15) or pulsed every breath or intermittently, [0018] lines 1-5, [0019] lines 1-15) to deliver an effective concentration of nitric oxide ([0003] lines 1-7) but does not specifically disclose that the dosage rate is less than 166 µg/sec. However, Miller teaches a nitric oxide delivery device which discloses providing a nitric oxide airway concentration of 65-220 ppm in the lungs ([0054] lines 1-6, [0060] line 15) by providing a dosage rate less than 160 µg/sec ([0060] lines 10-15 disclose delivering an airway concentration of 65 ppm by delivering 5000 ppm of nitric oxide at a dosage rate of 1 L/min or 16.6 ml /sec and 16.6 ml/sec at 5,000 ppm equals approximately 3392.6 nmol/sec. Since # moles = mass/molar mass, 3392.6 nmol/sec would equal approximately 101.8 µg/sec which is within the claimed range. In addition [0077], lines 1-10 of Miller discloses 21cc/breath or 4.2 ml/sec for an average 12 breaths/min which would also be less than 166 µg/sec). It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the nitric oxide delivery system of Fine with the ability to deliver appropriate dosage via a dosing rate of less than 160 µg/ sec of nitric oxide as taught by Miller to provide adequate dosing to deliver effective treatment.
The modified Fine substantially teaches the claimed invention except for a cylinder having an NO concentration greater than 2000, 2200ppm. However, Fine discloses delivering from a cylinder 2000ppm ([0005] last 2 lines, [0028]) and the modified Fine disclose the delivered gas can have a delivery concentration of 5000 ppm ([0060] lines 10-15 of Miller). It would have been obvious to one of ordinary skill in the art at the time the invention was made to provide the nitric oxide delivery cylinder of Fine with an NO concentration greater than 2000 ppm as such would be well within an artisan’s skill. In addition, it has been held that where the general conditions of a claim are known, it is not inventive to determine optimum or workable ranges by routine experimentation.
Regarding claims 5-9, the modified method of Fine discloses a delivery concentration of 5000 ppm which is within the claimed range ([0060] lines 10-15 of Miller).
Regarding claim 10, Fine teaches that the nitric oxide is administered in undiluted form such that the delivery concentration is the same as a storage concentration ([0026] lines 15-16).
Regarding claims 11 and 12, the modified method of Fine discloses delivering 21 cc/breath at 5000 ppm ([0077] lines 1-10 of Miller) which is equivalent to 4,291.8 nmol/breath or 1.324 mg/kg/hr which is within the claimed range of 0.001 to 0.5mg/kg/hr for an average 70 kg adult with a typical respiratory rate of 12 breaths/min.
Regarding claim 13, Fine discloses the NO is administered in an inspiratory gas of the patient (i.e. the patient inhales in the NO).
Regarding claim 14, Fine teaches that the dose is administered every second to several minutes in pulses ([0017] lines 1-15) or pulsed every breath ([0018] lines 1-5, [0019] lines 1-15).
Regarding claim 15, Fine teaches that the dose is administered every second to several minutes in pulses ([0017] lines 1-15) or pulsed intermittently ([0018] lines 1-5, [0019] lines 1-15).
Regarding claim 16, the modified method of Fine teaches that the dosing rate is less than or equal to 100 µg/sec ([0061] lines 1-10 of Miller disclose delivering 1000 ml over 100 breaths or 10 ml/breath equivalent to an average of 2 ml/second with an average respiratory rate of 12 breaths/min and 2 ml/sec delivered at a concentration of 10,000 ppm is equivalent to 817.49 nmol/sec having a mass of 24.5 µg/sec which is within the claimed range).
Regarding claim 17, the modified method of Fine teaches that the dosing rate is less than or equal to 83 µg/sec ([0061] lines 1-10 of Miller disclose delivering 1000 ml over 100 breaths or 10 ml/breath equivalent to an average of 2 ml/second with an average respiratory rate of 12 breaths/min and 2 ml/sec delivered at a concentration of 10,000 ppm is equivalent to 817.49 nmol/sec having a mass of 24.5 µg/sec which is within the claimed range).
Regarding claims 18 and 19, Fine discloses the cylinder includes a carrier gas being nitrogen ([0028] discloses Geno nitrogen cylinders).
Regarding claim 20, Fine discloses a nasal cannula ([0008]) and that the nitric oxide is administered in undiluted form such that the delivery concentration is the same as a storage concentration ([0026] lines 15-16).
Conclusion
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 on M-F 10am-2 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LaToya M Louis/Primary Examiner, Art Unit 3785
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