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 .
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 1, 5, 13, 21-22, 29 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Jafri et al. (USPGPub 2018/0304038) in view of Fine et al. (USPGPub 2014/0127330).
Re Claim 1, Jafri discloses a method of modulating oxygen saturation levels, comprising: a) measuring oxygen saturation levels in a patient (Jafri ¶ 0061); b) determining a first oxygen requirement for the patient based on the measured oxygen saturation level to address an oxygen deficiency (Jafri ¶ 0041-0043 - wherein gas sensor feedback mechanism reduces/increases gaseous mixture dependent upon target cumulative dose); c) administering a gas mixture comprising a first amount of nitric oxide to the patient (Jafri ¶ 0027); wherein the step of administering the gas mixture is by delivering the gas mixture from a receptacle to a delivery conduit; (Jafri ¶ 0038-0043, 0053-0055, 0061, 0071, 0073 "conduit of the application device"); d) adjusting an oxygen dose in real-time from a first oxygen dose to a second oxygen dose based on the first amount of nitric oxide administered to the patient (Jafri ¶ 0041-0043 - wherein gas sensor feedback mechanism reduces/increases gaseous mixture dependent upon target cumulative dose); and e) determining a second oxygen requirement based on the first amount of nitric oxide administered to the patient (Jafri ¶ 0041-0043 - wherein gas sensor feedback mechanism reduces/increases gaseous mixture dependent upon target cumulative dose); wherein step e) occurs after step d) (Jafri ¶ 0041-0043); wherein the gas mixture is formed by mixing a first gas including oxygen and a second gas within a receptacle to form a gas mixture (Jafri ¶ 0027 application device 4) wherein the receptacle includes an inlet and an outlet (Jafri ¶ 0027, 0056; Fig. 1); and wherein the receptacle has an outer surface, an inner surface, a length, a width, and a thickness, wherein the thickness is between the inner surface and the outer surface (Jafri ¶ 0056).
However, Jafri does not disclose the second gas including a nitric oxide-releasing agent wherein the receptacle includes a reducing agent; and contacting the nitric oxide-releasing agent in the gas mixture with the reducing agent to generate nitric oxide. Fine discloses a method of mixing gasses including nitric oxide wherein the method comprises a second gas including a nitric oxide-releasing agent wherein the receptacle includes a reducing agent; and contacting the nitric oxide-releasing agent in the gas mixture with the reducing agent to generate nitric oxide (Fine ¶ 0009-0012, 0016) wherein such a process can be effective at converting a nitric oxide-releasing agent to nitric oxide at ambient temperature (Fine ¶ 0047). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Jafri to comprise a second gas including a nitric oxide-releasing agent wherein the receptacle includes a reducing agent; and contacting the nitric oxide-releasing agent in the gas mixture with the reducing agent to generate nitric oxide as disclosed by Fine wherein such a process can be effective at converting a nitric oxide-releasing agent to nitric oxide at ambient temperature (Fine ¶ 0047).
Jafri further fails to teach wherein a volume of the receptacle is at least 1.5 times greater than a volume of the gas mixture in a pulse or on-period. Fine teaches wherein a volume of the receptacle is at least 1.5 times greater than a volume of the gas mixture in a pulse or on-period wherein a preferable level of mixing can occur when the volume of the receptacle is greater than the volume of the gas mixture in a pulse or on-period prior to delivery (Fine ¶ 0074). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Jafri to comprise wherein a volume of the receptacle is at least 1.5 times greater than a volume of the gas mixture in a pulse or on-period as disclosed by Fine wherein a preferable level of mixing can occur when the volume of the receptacle is greater than the volume of the gas mixture in a pulse or on-period prior to delivery (Fine ¶ 0074).
Re Claim 5, Jafri in view of Fine teach all of the limitations of Claim 1. Jafri further discloses wherein the method includes an incremental reduction of pO2 (Jafri ¶ 0062-0063).
Re Claim 13, Jafri in view of Fine teach all of the limitations of Claim 1. Jafri also discloses wherein the concentration of nitric oxide in the gas mixture is 0.1 ppm (Jafri ¶ 0068).
Re Claim 21, Jafri in view of Fine disclose all of the limitations of Claim 1. Jafri further discloses wherein delivering the gas mixture including nitric oxide from the receptacle to a mammal includes pulsing the gas mixture (Jafri ¶ 0054, 0069, 0101; Claim 12).
Re Claim 22, Jafri in view of Fine disclose all of the limitations of Claim 21. Jafri further discloses wherein the pulsing includes a pulse throughout an inhalation cycle, during every second breathing cycle or during every other natural number of breathing cycles except one (Jafri ¶ 0054, 0069, 0101; Claim 12). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005) (anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of a pulse throughout an inhalation cycle, during every second breathing cycle or during every other natural number of breathing cycles except one substantially overlaps and thus anticipates the claimed range of the pulsing including providing the gas mixture for one or more pulses of 1 to 6 seconds (Jafri ¶ 0054, 0069, 0101; Claim 12).
Re Claim 29, Jafri in view of Fine teach all of the limitations of Claim 1. Jafri further discloses supplying the second gas at the receptacle (Jafri ¶ 0056).
Re Claim 35, Jafri in view of Fine teach all of the limitations of Claim 1. Jafri also discloses wherein the nitric oxide is administered to adults (Jafri ¶ 0057).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jafri et al. (USPGPub 2018/0304038) in view of Fine et al. (USPGPub 2014/0127330) as applied to Claim 1 above, and further in view of Figley et al. (USPGPub 2005/0217668).
Re Claim 3, Jafri in view of Fine teach all of the limitations of Claim 1. Jafri in view of Fine fail to disclose wherein adjusting the dose includes titrating the dose of oxygen in real time. Figley discloses a method and system for managing administration of therapeutic gasses wherein adjusting the dose of therapeutic gas includes titrating a dose of oxygen in real time such that the therapeutic gas concentration can be reduced to a safe level prior to reaching the patient (Figley ¶ 0006, 0011). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Jafri in view of Fine such that dose adjustment includes titrating the dose of oxygen in real time as disclosed by Figley so that a therapeutic gas concentration can be reduced to a safe level prior to reaching the patient (Figley ¶ 0006, 0011).
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jafri et al. (USPGPub 2018/0304038) in view of Fine et al. (USPGPub 2014/0127330) as applied to Claim 1 above, and further in view of Kobayashi et al. (USPGPub 2013/0108715).
Re Claim 14, Jafri in view of Fine teach all of the limitations of Claim 1. Jafri in view of Fine fail to disclose wherein hydrogen is added in the following combinations: (H + 02) or (H + NO) or (H + NO + O2). Kobayashi teaches Kobayashi discloses a therapeutic device for alleviating ischemia-reperfusion injury comprising delivery of a hydrogen gas in the combination of (H + NO + O2) (Kobayashi ¶ 0028-0029) wherein the hydrogen acts to eliminate peroxynitrite, thereby reducing adverse effects of nitric oxide such as tissue injury (Kobayashi ¶ 0005, 0017, and 0048). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Jafri in view of Fine to include delivery of hydrogen in the combination of (H + NO + O2) as disclosed by Kobayashi wherein the hydrogen acts to eliminate peroxynitrite, thereby reducing adverse effects of nitric oxide such as tissue injury (Kobayashi ¶ 0005, 0017, and 0048).
Re Claim 16, Jafri in view of Fine teach all of the limitations of Claim 1. Jafri in view of Fine fail to disclose the method comprising delivering hydrogen, the hydrogen acts to eliminate peroxynitrite, thereby reducing adverse effects of nitric oxide. Kobayashi discloses a therapeutic device for alleviating ischemia-reperfusion injury comprising delivery of a hydrogen gas; and wherein the hydrogen acts to eliminate peroxynitrite, thereby reducing adverse effects of nitric oxide such as tissue injury (Kobayashi ¶ 0005, 0017, and 0048). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the method of Jafri in view of Fine to comprise delivering a hydrogen gas; and wherein the hydrogen acts to eliminate peroxynitrite, thereby reducing adverse effects of nitric oxide as disclosed by Kobayashi to prevent tissue injury associated with formation of peroxynitrite (Kobayashi ¶ 0005, 0017, and 0048).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Jafri et al. (USPGPub 2018/0304038) in view of Fine et al. (USPGPub 2014/0127330) as applied to Claim 1 above, and further in view of Muller et al. (USPGPub 2013/0103127).
Re Claim 44, Jafri in view of Fine above, and further in view of Gellman teach all of the limitations of Claim 36. Jafri further discloses wherein the receptacle has a length, width, and thickness, an outer surface, and an inner surface (Jafri Fig. 1; ¶ 0027). However, Jafri in view of Fine above, and further in view of Gellman fail to teach wherein the receptacle has an aspect ratio of 2:1 to 4:1 of length to width. Muller teaches a receptacle for N20 or CO2 having a length of 4-20 cm and a width of 1-7 cm (Muller ¶ 0023). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005) (anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 4-20 cm and a width of 1-7 cm substantially overlaps and thus anticipates the claimed range of an aspect ratio of 2:1 to 4:1 of length to width (Jafri Fig. 1; ¶ 0027).
Response to Arguments
Applicant’s arguments filed 02/26/2026 with respect to 112 new matter rejection of Claims 1, 3, 5, 13-14, 16, 21-22, 29, 35 and 44 have been fully considered and are persuasive. Due to clarifying amendments of Claim 1, the 112 new matter rejection is hereinafter withdrawn.
Applicant's arguments filed 02/26/2026 have been fully considered but they are not persuasive. Applicant argues primary reference Jafri teaches “a feedback system in which a gas sensor monitors nitric oxide concentration and adjusts the composition of an inhaled gaseous mixture to satisfy a target cumulative NO dose; the control variable in Jafri is cumulative nitric oxide exposure, not discrete oxygen requirements.” Applicant does not use the term ‘control variable’ in the claims. Jafri PGPub paragraphs 0041-0043 and 0061 explicitly teach applicant’s steps (a)-(e). In the last full paragraph of Page 6 of the response, applicant argues in particular primary reference Jafri fails to teach first and second "oxygen requirements" as claimed. Again, Jafri PGPub paragraphs 0041-0043 and 0061 explicitly teach said limitations. Jafri also explicitly teaches adjusting an oxygen dose as a function of the amount of nitric oxide administered at PGPub paragraphs 0041-0043 and 0061. Applicant argues Jafri teaches adjusting “the NO component within a mixed gas stream to meet an NO dose target.” Jafri teaches in PGPub paragraph 0061 “at least one physiological parameter of the patient may be measured such as […] oxygen saturation.” Jafri teaches at PGPub paragraph 0043 that the detection of NO results in the alteration of the gaseous mixture. The gaseous mixture in Jafri, PGPub paragraph 0027, is described as being “a source of air, a source of gaseous nitric oxide, a source of gaseous oxygen.”
At the top of Page 7 of the response, applicant argues secondary reference Fine is directed to reactor design for NO production, not oxygen saturation levels. However, Fine is not relied upon to teach oxygen saturation monitoring. In the first full paragraph of Page 7 of the response, applicant argues the motivation for combining prior art Jafri and Fine “amounts to a conclusory assertion of compatibility rather than an articulated, reasoned basis for combination. Fine was relied upon to teach “the second gas including a nitric oxide-releasing agent wherein the receptacle includes a reducing agent; and contacting the nitric oxide-releasing agent in the gas mixture with the reducing agent to generate nitric oxide” and “wherein a volume of the receptacle is at least 1.5 times greater than a volume of the gas mixture in a pulse or on-period.” It is examiner’s position that the two provided motivations “wherein such a process can be effective at converting a nitric oxide-releasing agent to nitric oxide at ambient temperature” and “wherein a preferable level of mixing can occur when the volume of the receptacle is greater than the volume of the gas mixture in a pulse or on-period prior to delivery” for the above aforementioned limitations respectively are more than conclusory assertions of compatibility, but rather reasoned basis for combination upon which one of ordinary skill would rely.
In the last paragraph of Page 7 of the response, leading into Page 8, applicant argues “neither Jafri nor Fine, individually or together, discloses or suggests the claimed method's integration of structural and functional limitations: a receptacle including an inlet, an outlet, and a reducing agent; generation of nitric oxide by contacting a nitric-oxide releasing agent in the gas mixture with the reducing agent; a receptacle volume at least 1.5 times the gas mixture volume in a pulse or on-period; and the use of this configuration within a control scheme that determines oxygen requirements and titrates oxygen dose in real time based on administered nitric oxide.” This argument fails to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant is reminded that prior art Fine used as a secondary reference in the present case is applicant’s own prior art. Much of the above limitations referenced are taught in applicant’s own prior art word-for-word.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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