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 .
Claims Status
Applicants’ election without traverse of Group I (pharmaceutical composition) and the species of diazeniumdiolate (nitric oxide releasing species) and aqueous solution in the reply filed on 11/10/2025 is acknowledged. Applicants elected the species of : hydroxypropyl methylcellulose (HPMC) as the mucoadhesive, stearoyl phosphatidylcholine as the excipient and no election for siderophore species with the cancellation of claim 10, thus the composition is interpreted as not having siderophore in the reply filed on 04/28/2026 without traverse is acknowledged.
Claims 13-30, 32-39, and 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the replies filed on 11/10/2025 and 04/28/2026.
Claims 1, 3, 5, 9,11-12, 40 and 76 are being examined as directed to the elected species of diazeniumdiolate in aqueous solution, HPMC mucoadhesive, and stearoyl phosphatidylcholine excipient.
Information Disclosure Statements
No Information Disclosure statement has been filed. Applicants are respectfully reminded of the duty to disclose.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5, 9, 11-12, 40, and 76 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites at least about 25mg/ml. The metes and bounds of “at least about” render claim 1 unclear because the words “at least” conflict with the word “about”. At least 25mg/ml implies 25mg/ml or more, however about 25mg/ml allows for numerical values that are less than 25mg/ml. Thus, the at least portion of the claim conflicts with the about which enables amounts that are lower than 25mg/ml rendering the scope of the claim unclear.
Claim 1 recites physiologically compatible pH. The meets and bounds of the claim are unclear because the specification does not define “compatible” pH ranges rendering the metes and bounds of the pH required unclear. It is unclear if physiologically compatible pH even requires a physiological pH.
Claim 3 recites “normal physiological temperature and pH”. The metes and bounds of “normal phycological temperature and pH” are unclear because the physiological pH and temperature depends on the location and type of living organism. For example, a human comprises a physiological pH of 7.35-7.45 in blood however the range is 4.1-5.8 for a skin surface. The physiological temperature for humans is 97.6-99.6 degrees Fahrenheit, whereas dogs range from 101-102.5 degrees Fahrenheit. Thus, the claim scope for the required temperature and pH is unclear. Dependent claims 3, 5,9,11,12, and 76 do not rectify the issue.
Claims 1 and 40 recite “low molecular weight polyethylene glycol”. The term “low” is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 3, 5,9,11,12, and 76 do not rectify the issue.
Claim 76 recites the pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated as a liposomal formulation comprising stearoyl phosphatidyl ethanolamine, stearoyl phosphatidyl choline, arachadoyl phosphatidyl choline, cholesterol, or a combination thereof. Claim 76 is being interpreted as comprising an open Markush for the liposomal formulation because it is unclear what other alternatives are intended to be encompassed by the claim, see In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022). A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. Here it is suggested that the claim can recite liposomal formulation selected from the group consisting of stearoyl phosphatidyl ethanolamine, stearoyl phosphatidyl choline, arachadoyl phosphatidyl choline, cholesterol, or a combination thereof.
.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 5, 11, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Schoenfisch et al. (United States Patent Publication 20190322770) as evidenced by Maskova et al. (Hypromellose-a traditional pharmaceutical excipient with modern applications in oral and oromucosal drug delivery).
Schoenfisch et al. teach pharmaceutical formulations which administer aerosols by inhalation through an inhaler, see paragraph [0045], [0052] and [0203]. The formulation can be nebulized and comprises functionalized alginates which are functionalized with nitric oxide releasing compounds, see paragraphs [0118] and [0203]. The composition comprises alginate and a nitric oxide donor of diazeniumdiolate, see paragraphs [0013], [0038] and [0118]. The NO-release has a half-life of 0.1-24 hour, rendering obvious a half-life of at least 15 minutes or about 0.1-24 hours, see paragraph [0150]. The composition can comprise one or more pharmaceutically acceptable excipients, see paragraph [0052]. The nitric oxide releasing compositions include aqueous solutions, see paragraph [0196]. The pH of the composition is controllable with a buffer and can comprise about 7.4, see paragraph [0188] and [0257]. The pharmaceutical composition can comprise excipients such as hydroxypropyl methylcellulose (HPMC), see paragraph [0199]. Although Schoenfisch et al. does not expressly state that HPMC is a mucoadhesive, as evidenced by Maskova et al., HPMC necessarily has mucoadhesive properties, see abstract. Schoenfisch et al. teach that the composition which contains the functionalized alginate are soluble at greater than 25mg/ml as the solubility includes 50mg/ml, see paragraphs [0013], [0089] and [0118].
Schoenfisch et al. teach pharmaceutical compositions having nitric oxide releasing compounds such as diazeniumdiolate with aqueous solutions further containing HPMC wherein the solubility of the nitric oxide releasing composition is at least 25mg/ml, however Schoenfisch does not teach the pharmaceutical composition having diazeniumdiolate with sufficient specificity to anticipate the claimed invention. Nevertheless, it would have been prima facie obvious to formulate a pharmaceutical composition comprising nitric oxide releasing compounds in aqueous solution having HPMC and a solubility of greater than 25mg/ml as Schoenfisch teaches pharmaceutical compositions comprising nitric oxide releasing compounds wherein a further excipient such as HPMC can be present. Regarding instant claim 40, the pH of Schoenfisch is taught to be controlled with the addition of the desired buffer and includes about 7.4 which renders obvious the claimed pH range from about 7-8. The nitric oxide functionalized alginate can be present in aqueous solution thus the mixing of the water with the nitric oxide containing formulation meets a limitation of mixing at any predetermine ratio which is not defined in the claims.
Accordingly, claims 1, 3, 5, 11, and 40 are rendered obvious by the teachings of Schoenfisch et al.
Claim(s) 9 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Schoenfisch et al. (United States Patent Publication 20190322770) as evidenced by Maskova et al. (Hypromellose-a traditional pharmaceutical excipient with modern applications in oral and oromucosal drug delivery) as applied to claims 1, 3, 5, 11, 40 above, and further in view of Lawrence et al. (United States Patent Publication 20060073198).
The teachings of Schoenfisch are discussed above.
Schoenfisch does not teach the presence of distearoyl phosphatidylcholine.
However, Lawrence et al. teach that liposomes are advantageous to be administered via inhalation or nebulized spray powder or aerosol because they protect the active agent and are compatible with lung lining or lung surfactant, ser paragraph [0085]. Examples of lipids include distearoyl phosphatidylcholine which is comprised of stearoyl phosphatidylcholine, see paragraph [0087].
It would have been prima facie obvious to provide a stearoyl phosphatidylcholine with the pharmaceutical formulation of Schoenfisch in order to protect the active agents of Schoenfisch during administration via inhalation and to provide compatibility with lung lining or lung surfactant.
One of ordinary skill in the art would have been motivated to do so because Schoenfisch et al. teach the presence of one or more additional excipients with their NO-releasing alginate formulation. And both Schoenfisch and Lawerence teach compositions which can further include antimicrobial agents including gentamicin.
Claim(s) 9 and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Schoenfisch et al. (United States Patent Publication 20190322770) as evidenced by Maskova et al. (Hypromellose-a traditional pharmaceutical excipient with modern applications in oral and oromucosal drug delivery) as applied to claims 1, 3, 5, 11, 40 above, and further in view of Smith et al. (United States Patent 6261594) and Chrystyn et al. (The dry powder inhaler features of the Easyhaler that benefit the management of patients-2020).
Schoenfisch et al. teach that the composition can be in powdered form and administration routes include inhalation via inhalers, however Schoenfisch does not expressly teach dry powder inhalation with the inhaler.
However, Smith et al. teach the release of nitric oxide under physiological conditions, see abstract. The composition comprises a chitosan based nitric oxide donor composition, see abstract. The NONOATE composition can be incorporated into dry powder inhalers, for inhalation for the site specific delivery and controlled release of nitric oxide (NO) to the pulmonary vasculature, see abstract and column 10, lines 35-42.
Chrystyn et al. teach dry powder inhalers are more environmentally friendly, easy to use and provides a consistent dose emission, see abstract and page 5.
It would have been prima facie obvious to provide the inhalation form of Schoenfisch as a dry powder administered through an inhaler to provide site specific delivery that is environmentally friendly and provides a consistent dose of the NONOATE containing composition of Schoenfisch et al.
There would have been a reasonable expectation of success because Schoenfisch et al. teach administration via inhalers and that the composition can be in a powder form.
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 1, 3, 5, 9,11-12,40 and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-10 and 15-20 of copending Application No 19291596 (reference application) in view of Schoenfisch et al. (United States Patent Publication 20190322770), Lawrence et al. (United States Patent Publication 20060073198), Smith et al. (United States Patent 6261594) and Chrystyn et al. (The dry powder inhaler features of the Easyhaler that benefit the management of patients-2020) and Maskova et al. (Hypromellose-a traditional pharmaceutical excipient with modern applications in oral and oromucosal drug delivery).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and of Application ‘596 claim a composition which comprises diazeniumdiolate having NO release at normal physiological temperature and pH wherein the aqueous solubility is at least about 25mg/ml.
The difference between the instant clams and that of ‘596 is the presence of HPMC mucoadhesive, the pH of 7-8 the presence of a liposomal formulation including stearoyl phosphatidyl choline and the formulation is inhalable powder through an inhaler and nebulized.
Schoenfisch et al. teach pharmaceutical formulations which administer aerosols by inhalation through an inhaler, see paragraph [0045], [0052] and [0203]. The formulation can be nebulized and comprises functionalized alginates which are functionalized with nitric oxide releasing compounds, see paragraphs [0118] and [0203]. The composition comprises alginate and a nitric oxide donor of diazeniumdiolate, see paragraphs [0013], [0038] and [0118]. The NO-release has a half-life of 0.1-24 hour, rendering obvious a half-life of at least 15 minutes or about 0.1-24 hours, see paragraph [0150]. The composition can comprise one or more pharmaceutically acceptable excipients, see paragraph [0052]. The nitric oxide releasing compositions include aqueous solutions, see paragraph [0196]. The pH of the composition is controllable with a buffer and can comprise about 7.4, see paragraph [0188] and [0257]. The pharmaceutical composition can comprise excipients such as hydroxypropyl methylcellulose (HPMC), see paragraph [0199]. Although Schoenfisch et al. does not expressly state that HPMC is a mucoadhesive, as evidenced by Maskova et al., HPMC necessarily has mucoadhesive properties, see abstract. Schoenfisch et al. teach that the composition which contains the functionalized alginate are soluble at greater than 25mg/ml as the solubility includes 50mg/ml, see paragraphs [0013], [0089] and [0118].
Lawrence et al. teach that liposomes are advantageous to be administered via inhalation or nebulized spray powder or aerosol because they protect the active agent and are compatible with lung lining or lung surfactant, ser paragraph [0085]. Examples of lipids include distearoyl phosphatidylcholine which is comprised of stearoyl phosphatidylcholine, see paragraph [0087].
Smith et al. teach the release of nitric oxide under physiological conditions, see abstract. The composition comprises a chitosan based nitric oxide donor composition, see abstract. The NONOATE composition can be incorporated into dry powder inhalers, for inhalation for the site specific delivery and controlled release of nitric oxide (NO) to the pulmonary vasculature.
Chrystyn et al. teach dry powder inhalers are more environmentally friendly, easy to use and provides a consistent dose emission, see abstract and page 5.
In view of Schoenfisch et al., it would have been obvious to provide the diazeniumdiolate formulation claimed with HPMC formulated as a nebulizable composition to deliver the NO releasing composition as liquid droplets. One of ordinary skill in the art would have been motivated to incorporate HPMC as it is a known mucoadhesive and a conventional excipient for formulations desiring oral administration as suggested by Schoenfisch et al.
It would have been obvious to provide a stearoyl phosphatidylcholine with the pharmaceutical formulation of Application ‘596 in order to protect the active agents during administration via inhalation and to provide compatibility with lung lining or lung surfactant. It would have been obvious to provide the pH of Application ‘596 with a pH of about 7.4 because Schoenfisch teaches that the pH can be adjusted for nitric oxide containing compositions which buffering agents
Lastly, it would have been obvious to provide the claims of Application ‘596 as a dry powder administered through an inhaler to provide site specific delivery that is environmentally friendly and provides a consistent dose of the nitric oxide releasing composition of Application ‘596.
There would have been a reasonable expectation of success because Schoenfisch et al. teach administration via inhalers and that the composition can be in a powder form.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 9,11-12,40 and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, 11 of copending Application No. 19197332 (reference application) in view of Schoenfisch et al. (United States Patent Publication 20190322770) and Maskova et al. (Hypromellose-a traditional pharmaceutical excipient with modern applications in oral and oromucosal drug delivery) and Lawrence et al. (United States Patent Publication 20060073198).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘332 recite pharmaceutical compositions which can comprise a dry powder inhaler wherein there is a nitric oxide releasing compound of diazeniumdiolate, see claims 1 and 11 of Application ‘332.
The difference between the instant and that of Application ‘332 is the solubility and the pH of the composition and the presence of HPMC mucoadhesive and that the formulation can be nebulized and the presence of a stearoyl phosphatidylcholine.
Schoenfisch et al. teach pharmaceutical formulations which administer aerosols by inhalation through an inhaler, see paragraph [0045], [0052] and [0203]. The formulation can be nebulized and comprises functionalized alginates which are functionalized with nitric oxide releasing compounds, see paragraphs [0118] and [0203]. The compositum comprises alginate and a nitric oxide donor of diazeniumdiolate, see paragraphs [0013], [0038] and [0118]. The NO-release has a half-life of 0.1-24 hour, rendering obvious a half-life of at least 15 minutes or about 0.1-24 hours, see paragraph [0150]. The composition can comprise one or more pharmaceutically acceptable excipients, see paragraph [0052]. The nitric oxide releasing compositions include aqueous solutions, see paragraph ]0196]. The pH of the composition is controllable with a buffer and can comprise about 7.4, see paragraph [0188] and [0257]. The pharmaceutical composition can comprise excipients such as hydroxypropyl methylcellulose (HPMC), see paragraph [0199]. Although Schoenfisch et al. does not expressly state that HPMC is a mucoadhesive, as evidenced by Maskova et al., HPMC has mucoadhesive properties, see abstract. Schoenfisch et al. teach that the composition which contains the functionalized alginate are soluble at greater than 25mg/ml as the solubility includes 50mg/ml, see paragraphs [0013], [0089] and [0118].
Lawrence et al. teach that liposomes are advantageous to be administered via inhalation or nebulized spray powder or aerosol because they protect the active agent and are compatible with lung lining or lung surfactant, ser paragraph [0085]. Examples of lipids include distearoyl phosphatidylcholine which is comprised of stearoyl phosphatidylcholine, see paragraph [0087].
It would have been obvious to provide the nitric oxide composition of Application ‘332 with a solubility of greater than 25mg/ml and a pH of about 7.4 because Schoenfisch teaches that the pH can be adjusted for nitric oxide containing compositions which buffering agents and that the nitric oxide containing compositions can be added to functionalize alginates with solubilities of greater than 50mg/ml. Furthermore, it would have been obvious to provide hydroxypropyl methylcellulose as Schoenfisch teaches it as a conventional excipient for oral formulations and it is known in the art that HPMC has mucoadhesive properties. It would have been obvious to provide the composition of Application ‘332 as a nebulized formulation or a dry powder for inhalation because Schoenfisch et al. teach that in the alternative to inhalation, nitric oxide releasing compositions can be nebulized to deliver the active agent as liquid droplets.
It would have additionally been obvious to add distearoyl phosphatidylcholine to the formulation of ‘841 to provide protection to the active agent being administered via inhalation given such liposomal preparations provide enhanced protection for inhalation route of administration.
Claims 1, 3, 5, 9,11-12,40 and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 24,32-36,and 37 of copending Application No. 18856841 (reference application) in view of Schoenfisch et al. (United States Patent Publication 20190322770) and Maskova et al. (Hypromellose-a traditional pharmaceutical excipient with modern applications in oral and oromucosal drug delivery) and Lawrence et al. (United States Patent Publication 20060073198).
Both the instant claims and that of Application ‘841 recite pharmaceutical compositions which can comprise a diazeniumdiolate, aqueous composition and a pH of overlapping ranges. Both compositions have an overlapping half-life and releasable storage. Both the instant claims and that of Application ‘841 can be administered via a dry powder inhaler via inhalation or by a nebulizer.
The difference between the instant claims and that of Application ‘841 is the addition of HPMC excipient and the solubility of the diazeniumdiolate.
Schoenfisch et al. teach pharmaceutical formulations which administer aerosols by inhalation through an inhaler, see paragraph [0045], [0052] and [0203]. The formulation can be nebulized and comprises functionalized alginates which are functionalized with nitric oxide releasing compounds, see paragraphs [0118] and [0203]. The compositum comprises alginate and a nitric oxide donor of diazeniumdiolate, see paragraphs [0013], [0038] and [0118]. The NO-release has a half-life of 0.1-24 hour, rendering obvious a half-life of at least 15 minutes or about 0.1-24 hours, see paragraph [0150]. The composition can comprise one or more pharmaceutically acceptable excipients, see paragraph [0052]. The nitric oxide releasing compositions include aqueous solutions, see paragraph ]0196]. The pH of the composition is controllable with a buffer and can comprise about 7.4, see paragraph [0188] and [0257]. The pharmaceutical composition can comprise excipients such as hydroxypropyl methylcellulose (HPMC), see paragraph [0199]. Although Schoenfisch et al. does not expressly state that HPMC is a mucoadhesive, as evidenced by Maskova et al., HPMC has mucoadhesive properties, see abstract. Schoenfisch et al. teach that the composition which contains the functionalized alginate are soluble at greater than 25mg/ml as the solubility includes 50mg/ml, see paragraphs [0013], [0089] and [0118].
Lawrence et al. teach that liposomes are advantageous to be administered via inhalation or nebulized spray powder or aerosol because they protect the active agent and are compatible with lung lining or lung surfactant, ser paragraph [0085]. Examples of lipids include distearoyl phosphatidylcholine which is comprised of stearoyl phosphatidylcholine, see paragraph [0087].
It would have been obvious to add HPMC to the composition of Application ‘841 in order to provide mucoadhesive binding properties. It would have been obvious to provide a water solubility for the nitric oxide at greater than 25mg/ml because Schoenfisch teaches that functionalized alginates with nitric oxide can have a water solubility of 50mg/ml.
It would have additionally been obvious to add distearoyl phosphatidylcholine to the formulation of ‘841 to provide protection to the active agent being administered via inhalation given such liposomal preparations provide enhanced protection for inhalation route of administration.
Conclusion
Claims 1, 3, 5, 9,11-12,40 and 76 are rejected and no claims are allowed.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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