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 office action is in response to the request for continued examination and the amendment filed 1/30/26. As directed by the amendment, claims 28-31 have been added and no claims have been amended nor cancelled. As such, claims 1, 3, 7, and 21-31 are pending in the instant application.
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.
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Claims 1, 3, 7, 21-22, 24-28, and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 17, and 19 of U.S. Patent No. 10,758,703 in view of Montgomery et al. (7,523,752).
Regarding instant claim 1, the practice of method claim 16 includes the presence of a system for providing a pulse of a pharmaceutical gas having a flow profile to deliver to a patient (see patent claim 16, which is a method of providing pulse of pharmaceutical gas with flow profile to a patient and includes structure which makes up the system as explained further) including a first fixed flow rate assembly including a first fixed flow valve in fluid communication with a first fixed flow orifice (see patent claim 16, “a first fixed flow valve” that is downstream from “a first fixed flow orifice”), the first fixed flow valve being (1) a fixed flow valve that rapidly opens and rapidly closes (see patent claim 16, “rapidly opening” col. 18 ln. 66 and “rapidly closing” col. 19 ln. 9), (2) located downstream of the first fixed flow orifice (see patent claim 16, “first fixed flow valve that is located downstream from a first fixed flow orifice” col. 18 ln. 66-67), and (3) at a volumetric offset from the first fixed flow orifice (see col. 19 ln. 6-8). The patent claim 16 includes that the volumetric offset is less than 0.1 mL, but is silent as to it being between 0.0005 mL to 0.08 mL and to including the flow delivery control (note that patent claim 16 is silent as to what is doing/controlling the opening and closing of the valve); however, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to set a lower bound to the volumetric offset, such as 0.0005 mL in order to provide a desired minimum valve instead of an single bound range and furthermore, one would have expected it necessary to include a lower bound as there must be some type of non-zero lower bound in order for the volumetric offset to exists. One of ordinary skill in the art would have found it obvious to choose a volumetric offset upper bound to be 0.08 mL in order to provide an optimized offset value to control the initial flow spike and furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Montgomery teaches a similar system/method for providing pulse of pharmaceutical gas and includes such a flow delivery control that controls opening/closing of a valve to provide a pulse of gas (see Montgomery Fig. 3-4, flow delivery control 40, col. 7 ln. 50-59, col. 8 ln. 18-58). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified patent claim 16 to include a flow delivery controller, as taught by Montgomery, in order to provide the required structural elements to control operation of the valve (see Montgomery col. 7 ln. 50-59 and col. 8 ln. 18-58). The modified patent claim 16 delivers a pulse of gas and thus has a pulse width, but is silent as to the valve providing a pulse having a pulse width of less than 500 milliseconds; however, Montgomery teaches a similar system/method for providing pulse of pharmaceutical gas at a pulse width of less than 500 milliseconds (see Montgomery col. 8 ln. 18-58, in particular lines 49-58 which discloses a pulse width of 280 milliseconds) and one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the modified patent claim 16’s pulse width (i.e. the time between the valve rapidly opening and rapidly closing) to be less than 500 milliseconds, as taught by Montgomery, in order to provide a desired/optimized overall multiple pulse flow profile. Furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claim 3, the modified patent claim 16 is such that the first fixed flow orifice being upstream to the valve to provide at least one of (1) an initial flow spike in volume of transient therapeutic gas substantially equal to the volume in the offset is delivered when the valve is opened rapidly (see patent claim 16, col. 19 ln. 1-7) and (2) a sharp cutoff is provided when the valve is closed rapidly (due to the orifice being upstream to the valve and the rapid closing, the modified patent claim 16 would also provide a sharp cutoff).
Regarding instant claim 7, the modified patent claim 16 is silent as to the volumetric offset being a volume of between 0.0005 mL (note the patent claim 16 was modified in instant claim 1 to have this lower bound) and 0.05 mL; however, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the modified patent claim 16’s offset to be a volume of less than 0.05 mL in order to provide a desired pulse flow profile with optimized control of the initial flow spike. Furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claim 21, patent claim 16 sets forth a method of providing a pulse of pharmaceutical gas to deliver to a patient, including rapidly opening a first fixed flow valve that is located downstream from a first fixed flow orifice to commence delivery of a first dose of the pharmaceutical gas in a pulse to a patient (see col. 18 ln. 66 through col. 19 ln. 2), wherein the first fixed flow valve is at a volumetric offset from the first fixed flow orifice which has a volumetric offset (see col. 19 ln. 6-8); and rapidly closing the first fixed flow valve to end flow, through the first fixed flow valve, of the pharmaceutical gas to complete delivery, to the patient, of the pulse of the pharmaceutical gas (see col. 19 ln. 9-12). The patent claim 16 includes that the volumetric offset is less than 0.1 mL, but is silent as to it being between 0.0005 mL to 0.08 mL; however, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to set a lower bound to the volumetric offset, such as 0.0005 mL in order to provide a desired minimum valve instead of an single bound range and furthermore, one would have expected it necessary to include a lower bound as there must be some type of non-zero lower bound in order for the volumetric offset to exists. One of ordinary skill in the art would have found it obvious to choose a volumetric offset upper bound to be 0.08 mL in order to provide an optimized offset value to control the initial flow spike and furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The patent claim 16 delivers a pulse of gas and thus has a pulse width, but is silent as to the valve providing a pulse having a pulse width of less than 500 milliseconds; however, Montgomery teaches a similar system/method for providing pulse of pharmaceutical gas at a pulse width of less than 500 milliseconds (see Montgomery col. 8 ln. 18-58, in particular lines 49-58 which discloses a pulse width of 280 milliseconds) and one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the modified patent claim 16’s pulse width (i.e. the time between the valve rapidly opening and rapidly closing) to be less than 500 milliseconds, as taught by Montgomery, in order to provide a desired/optimized overall multiple pulse flow profile. Furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claim 22, the modified patent claim 16 is silent as to the pharmaceutical gas includes nitric oxide; however, Montgomery discloses a method of providing pulsed delivery of pharmaceutical gas which includes nitric oxide (see Montgomery col. 3 ln. 21-32 and 45-56 for example). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified patent claim 16 method’s pharmaceutical gas to include nitric oxide, as taught by Montgomery, in order to provide treatment for a particular patient whose condition would benefit from nitric oxide treatment.
Instant claim 24 corresponds to patent claim 17.
Instant claim 25 corresponds to patent claim 19.
Regarding instant claim 26, the modified patent claim 16 is silent as to the volumetric offset being a volume of between 0.0005 mL (note the patent claim 16 was modified in instant claim 1 to have this lower bound) and 0.05 mL; however, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the modified patent claim 16’s offset to be a volume of less than 0.05 mL in order to provide a desired pulse flow profile with optimized control of the initial flow spike. Furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claim 27, the modified patent claim 16’s pulse has a flow profile that abruptly increases flow to a desired initial flow rate including an initial flow spike over negligible time (see patent claim 16, col. 19 ln. 1-7; due to the orifice being upstream to the valve and the rapid closing, the modified patent claim 16 would also provide a sharp cutoff over negligible time).
Note: it appears Applicant may have intended newly added claims 30 and 31 to be dependent on newly added independent claim 28; however, these claims are being examined as currently worded to be dependent on claim 27
Regarding claim 30, the modified patent claim 16 is silent as to the volumetric offset being a volume of between 0.0005 mL (note the patent claim 16 was modified in instant claim 1 to have this lower bound) and 0.05 mL; however, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the modified patent claim 16’s offset to be a volume of less than 0.05 mL in order to provide a desired pulse flow profile with optimized control of the initial flow spike. Furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Instant claim 31 corresponds to patent claim 19.
Regarding claim 28, patent claim 17 sets forth a method of treating pulmonary hypertension (see patent claim 17), including rapidly opening a first fixed flow valve that is located downstream from a first fixed flow orifice to commence delivery of a pharmaceutical gas (see col. 18 ln. 66 through col. 19 ln. 2), wherein the first fixed flow valve is at a volumetric offset from the first fixed flow orifice which has a volumetric offset (see col. 19 ln. 6-8); and rapidly closing the first fixed flow valve to end flow, through the first fixed flow valve, of the pharmaceutical gas to complete delivery, to the patient, to form a pulse of the pharmaceutical gas (see col. 19 ln. 9-12); and delivering the pulse of the pharmaceutical gas to a patient in need of treating pulmonary hypertension (see patent claim 17). The patent claim 17 includes that the volumetric offset is less than 0.1 mL, but is silent as to it being between 0.0005 mL to 0.08 mL; however, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to set a lower bound to the volumetric offset, such as 0.0005 mL in order to provide a desired minimum valve instead of an single bound range and furthermore, one would have expected it necessary to include a lower bound as there must be some type of non-zero lower bound in order for the volumetric offset to exists. One of ordinary skill in the art would have found it obvious to choose a volumetric offset upper bound to be 0.08 mL in order to provide an optimized offset value to control the initial flow spike and furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The patent claim 17 delivers a pulse of gas and thus has a pulse width, but is silent as to the valve providing a pulse having a pulse width of less than 500 milliseconds; however, Montgomery teaches a similar system/method for providing pulse of pharmaceutical gas at a pulse width of less than 500 milliseconds (see Montgomery col. 8 ln. 18-58, in particular lines 49-58 which discloses a pulse width of 280 milliseconds) and one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the modified patent claim 17’s pulse width (i.e. the time between the valve rapidly opening and rapidly closing) to be less than 500 milliseconds, as taught by Montgomery, in order to provide a desired/optimized overall multiple pulse flow profile. Furthermore, it has been held that where the general conditions of the claim are disclosed in the patent reference claims, discovering optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The modified patent claim 17 is silent as to the pharmaceutical gas includes nitric oxide; however, Montgomery discloses a method of providing pulsed delivery of pharmaceutical gas which includes nitric oxide (see Montgomery col. 3 ln. 21-32 and 45-56 for example). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified patent claim 17 method’s pharmaceutical gas to include nitric oxide, as taught by Montgomery, in order to provide treatment for a particular patient whose condition would benefit from nitric oxide treatment.
Claims 23 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 10,758,703 in view of Montgomery and Bathe et al. (5,558,083).
Regarding instant claim 23, the modified patent claim 16 is silent as to the concentration of nitric oxide in the pharmaceutical gas being 100-5,000 ppm; however, Bathe teaches a nitric oxide delivery system/method which discloses delivery of nitric oxide at a concentration of lower than 150 ppm (thus covering the values of 100 ppm up to 150 ppm of the claimed range; see Bathe col. 1 ln. 34-44). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified patent claim 16’s concentration of nitric oxide to be 100 ppm up to 150 ppm, as taught by Bathe, in order to provide a desired level and benefit of nitric oxide to the patient.
Note: it appears Applicant may have intended newly added claim 29 to be dependent on newly added independent claim 28; however, this claim is being examined as currently worded to be dependent on claim 27
Regarding instant claim 29, the modified patent claim 16 is silent as to the concentration of nitric oxide in the pharmaceutical gas being 100-5,000 ppm; however, Bathe teaches a nitric oxide delivery system/method which discloses delivery of nitric oxide at a concentration of lower than 150 ppm (thus covering the values of 100 ppm up to 150 ppm of the claimed range; see Bathe col. 1 ln. 34-44). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified patent claim 16’s concentration of nitric oxide to be 100 ppm up to 150 ppm, as taught by Bathe, in order to provide a desired level and benefit of nitric oxide to the patient.
Response to Arguments
Applicant's arguments filed 1/30/26 have been fully considered but they are not persuasive.
Applicant’s argument that one of ordinary skill in the art would not have combined the US Patent 10,758,703 with Montgomery because Montgomery uses a valve which is upstream of an orifice for pulse delivery whereas the instant claims require the valve to be located downstream from the flow orifice which is disparate arrangement of components (see pg. 6 of the response) is not well-taken. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The modification in view of Montgomery were not based on the location of the valve with respect to the fixed flow orifice as the patent claims already claim the same type of fixed flow valve being located downstream from the first fixed flow orifice (see patent claim 16). Montgomery was relied upon for the explicit teaching of a flow delivery control device and to provide a particular pulse width, i.e. less than 500 ms. One of ordinary skill in the art would not have been dissuaded by the location of the valve with respect to the flow orifice of Montgomery but rather one of ordinary skill in the art would recognize that such a flow control device would have been desired if not necessary to provide for the control of the opening/closing of the valve and such a pulse width is well-known in the art and would have been a desired parameter for pulsed delivery of pharmaceutical gas for a patient.
Applicant’s argument that the office action relies on Montgomery for the teaching regarding the pulse width and cites MPEP 2141 to argue that the office action cannot rely on the portions of Montgomery that allegedly teach certain pulse width and disregard portions of Montgomery that would lead one of ordinary skill int eh art away from the proposed combination of Montgomery and patent claim 16 (see pg. 6-7 of the response) is not well-taken. Applicant has not cited any particular statements or teachings in Montgomery which would lead one of ordinary skill away from the proposed combination of Montgomery and the patent claim. As noted above Montgomery was relied upon for the teaching of a particular pulse width of a pulse of gas to be delivered to a patient (for instant claims 1, 21, and 28) and for the explicit teaching of a flow control structure (for instant claim 1). There does not appear to be any disclosure in Montgomery which would have taught away from the combination of Montgomery and the patent claim.
Conclusion
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/COLIN W STUART/Primary Examiner, Art Unit 3785