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 .
Withdrawn Rejections
The 35 U.S.C. §103 rejection of claims 1-5, 7-11, 16-20 as over Schoenfisch et al. (US 2009/0214618) in view of Frangakis et al. (US 2013/0053393), made of record in the office action mailed on 06/11/2025, page 2 has been withdrawn due to Applicant’s amendment in the response filed on 12/3/2025.
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, 7-11, 16-20, 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Schoenfisch et al. (US 2009/0214618) in view of Frangakis et al. (US 2013/0053393) and KR 101420257.
Regarding claims 1-5, 7-11 and 13-15, 22-26 Schoenfisch discloses a nitric oxide-releasing particle, the nitric oxide-releasing particle comprising: (a) a nitric oxide donor; (b) an interior region having a volume, the volume of the interior region being at least partially filled by a core selected from the group consisting of: (i) a metallic cluster; (ii) a dendritic network; (iii) a co-condensed silica network; and (iv) a combination thereof; and (c) an exterior region (claim 1, 66, see figures 1-5). The nitric oxide donor is selected from the group consisting of a nitrosothiol, a hydroxylamine, a hydroxyurea, and combinations thereof (claim 3). The core is condensed silica (para 0068). In some embodiments the NO donor is covalently bound to the exterior region, the core (para 0064). A medical device comprising the nitric oxide releasing particle and the medical device includes stents, catheters (claim 66, 68). The core is mesoporous silica (para 0154). Several nitric oxide donors have been reported, the most notable being N-diazeniumdiolates. Generally, N-diazeniumdiolate NO donors are small molecules synthesized by the reaction of amines with NO at elevated pressure and have been used (para 0056). The core is a co-condensed silica network synthesized from the condensation of a silane mixture comprising an alkoxysilane and an aminoalkoxysilanes. The aminoalkoxysilane is selected from the group consisting of: N-(6 aminohexyl) aminomethyltrimethoxysilane, N-(6-aminohexyl) aminopropyltrimethoxysilane and N-(6 aminoethyl) aminopropyltrimethoxysilane (para 0068, 0075-0078).
However, Schoenfisch fails to disclose that nitric oxide donor on the outer surface is S-nitroso-N-acetyl-penicillamine groups and mesoporous silica core consists of rice husk, SBA-15 type mesoporous silica.
Whereas, Frangakis discloses method of treating a peripheral vascular disease or a condition associated with a peripheral vascular disease by administering to a subject an effective amount of at least one phosphodiesterase type 5 inhibitor and at least one nitric oxide donor (abstract). The nitric oxide donor is S-nitrosylated compound (s-nitroso-N-acetyl-peniccillamine) [para 0027].
Whereas, KR’257 discloses method for producing magnetic inorganic composite nanoparticles and magnetic-inorganic composite nanoparticles using a silica template having a one-dimensional mesopore, and a use of the magnetic inorganic composite (abstract). The silica having the one-dimensional mesopores may be MCM-41, SBA-15 or MSU-H, but is not limited thereto. The MCM-41, SBA-15 or MSU-H may be prepared by methods known in the art (page 3).
It would have been obvious to one of ordinary skill in the art at the time the Application was filed to include S-nitrosylated compound (s-nitroso-N-acetyl-peniccillamine) as taught by Frangakis as the nitric oxide donor of Schoenfisch motivated by the desire as a useful tool for its NO releasing properties and as potent vasodilator in vitro and in vivo and is less prone to produce pharmacological tolerance and to include SBA-15 mesoporous silica as taught by KR’257 in the core of Schoenfisch motivated by the desire to have thermal and mechanical properties.
Regarding claims 16-17, As Schoenfisch in view of Frangakis discloses nitric oxide releasing material as presently claimed, it therefore would be obvious that nitric oxide material would intrinsically have a NO content of about 0.025 micr0mil to about 0.05 micro mol per mg of the nitric oxide releasing material and would intrinsically have a half-life of about 20 hours to about 40 hours.
Regarding claim 18, Schoenfisch discloses NO-releasing particle has a diameter of 1000 nm. The particle has a co-condensed silica core has a diameter between 2 nm to about 10 microns (para 0100).
Although, Schoenfisch does not disclose nitric oxide material has an average pore size of about 300 nm to about 600 nm.
It would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges of average pore size through process optimization motivated by the desire to improve the specificity of nitric oxide delivery to targeted cells and tissues, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (MPEP 2144.05).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schoenfisch et al. (US 2009/0214618) in view of Frangakis et al. (US 2013/0053393) and KR 101420257 as applied to claim 1, further in view of Handa et al. (US 2015/0238662).
Regarding claim 6, Schoenfisch fails to disclose that the diazeniumdiolate is dizeniumdiolated dibutylhexanediamine.
Whereas, Handa discloses polymeric composition includes a polymer matrix having a lipophilic discrete nitric oxide adduct and/or a polymeric nitric oxide adduct associated therewith, by covalent attachment to the polymer matrix and/or by dispersion within the polymer matrix, with the discrete nitric oxide adduct and/or the polymeric nitric oxide adduct being capable of releasing nitric oxide (NO) {abstract}. The NO adduct of choice is one capable of spontaneous release of NO when the polymer is exposed to solutions and/or blood under physiological conditions. Some examples of NO adducts include protected and discrete N-diazeniumdiolates, C-based diazeniumdiolates, and/or mixtures thereof. An example of a suitable NO adduct is diazeniumdiolated dibutylhexanediamine (para 0036).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to include diazeniumdiolated dibutylhexanediamine as taught by Handa and coat it on the silica core of Schoenfisch motivated by the desire to exhibits potent antimicrobial/antiviral activities and serves as a natural inhibitor of platelet adhesion and activation.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Schoenfisch et al. (US 2009/0214618) in view of Frangakis et al. (US 2013/0053393) and KR 101420257 as applied to claim 1, further in view of Kennedy et al. (US 2007/0059350) or Jose et al. (US 2016/0095599).
Regarding claims 12-15, Schoenfisch fails to disclose that the silica core is a mesoporous diatomaceous earth core.
Whereas, Kennedy discloses Therapeutic formulations adapted for positive-pressure application for controlling biological fluid at a desired site in a subject, absorbent articles comprising therapeutic formulations, and anti-infective devices coated with therapeutic formulations (abstract). The formulation for the therapeutic agent includes nitric oxide generating agent, colloidal silica, diatomaceous earth (para 0020). Alternatively, Jose discloses bioresorbable drug-eluting biopolymer suture-free blood vessel anastomosis devices can be deployed to join two blood vessels and resorbed by the body over a predetermined time period after the blood vessel has become joined (abstract). The anti-coagulation agent includes silica, diatomaceous earth (para 0099). The diatomaceous earth would intrinsically be mesoporous.
It would have been obvious to one of ordinary skill in the art at the time the Application was filed to form the core of Schoenfisch as diatomaceous earth core as taught by Kennedy or Jose motivated by the desire to cleanse digestive tract, provide body with trace minerals.
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 21 recites, nitric oxide releasing donor has a structure which is not being taught by prior art references as stated above.
Response to Arguments
Applicant’s arguments filed on 12/3/2025 have been fully considered, but they are moot in view of new grounds of rejections as stated above.
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 extension fee 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 date of this final action.
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/RONAK C PATEL/Primary Examiner, Art Unit 1788