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 .
Detailed Action
Restriction/Election
Applicant’s election without traverse of group I, claims 1-2 and 4-17 in the reply filed on 02/20/26 is acknowledged. Applicant’s election of species 1. A standard metered dose inhaler; 2. Polyvinyl alcohol; and 3. Cystic fibrosis, which is not caused by a microbe is also acknowledged.
Claims 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 reply filed on 02/20/26.
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 1-2 and 4-14 are rejected under 35 U.S.C. 103 as being unpatentable over Puvvadi et al. ("Role of Tris-CaEDTA as an adjuvant with nebulized tobramycin in cystic fibrosis patients with Pseudomonas aeruginosa lung infections: A randomized controlled trial", Journal of Cystic Fibrosis, 2021, 20, 316-323, presented in IDS) in view of Wring et al. (US PG Pub. 2022/0339099A1).
Puvvadi et al. teaches a double-blind randomized controlled trial using Tris-CaEDTA as an adjuvant with nebulised tobramycin in the treatment of cystic fibrosis. This pilot study demonstrated increased reduction of sputum density of Pseudomonas aeruginosa and increased ppFEV1 in patients treating with Tris-CaEDTA added to inhaled tobramycin compared to patients treated with inhaled tobramycin itself. The study utilized blinded 1.5 mL prefilled syringes, with the active drug containing 75 mg of CaEDTA in Tris-buffered solution (roughly 5 wt% CaEDTA). Administration was accomplished using a PARI LC SPRINT© nebulizer. (see supplemental box). Puvvadi et al. teach under study drug in section 2.4 that the study drug was supplied in blinded 1.5 ml prefilled syringes. The active drug contained CaEDTA 75 mg in Tris-buffered
solution while the placebo consisted of Tris-buffered 0.9% saline. Active drug or placebo, when added to tobramycin (Tobra-Day ® 250 mg in 2.5 ml), resulted in a 4 ml solution at pH 7.1 to be inhaled using a PARI LC SPRINT ® nebulizer (an inhalation device). The dose and concentration of CaEDTA were based on safety and tolerability data obtained from previously published studies using inhaled CaEDTA, see section 2.4.
Puvvadi et al. as discussed above does not teach use of Saline solution.
Puvvadi et al. also does not teach use of EDTA microparticles or nanoparticles and polyvinyl alcohol polymer as claimed.
Wring et al. discloses a pharmaceutical composition a peptide; a buffer; and optionally one or more additional components each selected from the group consisting of a stabilizer and a tonicity modifier, wherein the pharmaceutical composition is adapted for administration via inhalation. Kits and method of using same for treating an inflammatory disorder of lower airways in a human subject are also disclosed, see abstract. Wring et al. teaches that the delivery device for the drug can be a metered dose inhaler or a dry powder inhaler or nebulizers, see [0031]. The reference teaches that for formulations administered to lower airways, the composition can comprise a drug along with suitable carriers such as buffering agents, pH adjusting agents, tonicity adjusting agents, sodium chloride (saline solution) and viscosity adjusting agents as polyvinyl alcohols, see [0201]. The reference teaches use of EDTA microparticles, see table 8.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized EDTA along with the known carriers used in the formulation comprising tonicity agent sodium chloride (reads on saline solution) and buffer for administration to the airways as taught by Wring et al. into the patients treated with inhaled tobramycin and calcium salt of EDTA of Puvvadi et al. One of ordinary skill would have been motivated to do so because Puvvadi et al. teaches treatment of cystic fibrosis by inhalation technique comprising CaEDTA and Wright et al. teaches that for formulations administered to lower airways, the composition can comprise a drug along with suitable carriers such as buffering agents, pH adjusting agents and tonicity adjusting agents sodium chloride (saline solution). Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Since Puvvadi et al. teaches that active drug or placebo, when added to tobramycin (Tobra-Day ® 250 mg in 2.5 ml), resulted in a 4 ml solution at pH 7.1 to be inhaled using a PARI LC SPRINT ® nebulizer, it would have been obvious to one of ordinary skill to have manipulated the pH for inhalation by adjusting the amount of buffer and tonicity saline sodium chloride solution.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized EDTA in the form of microparticles along with the known carriers used in the formulation as polyvinyl alcohol, tonicity agent sodium chloride and buffer for administration to the airways as taught by Wring et al. into the patients treated with inhaled tobramycin and EDTA of Puvvadi et al. One of ordinary skill would have been motivated to do so because Puvvadi et al. teaches treatment of cystic fibrosis by inhalation technique comprising EDTA and Wright et al. teaches that for formulations administered to lower airways, the composition can comprise a drug along with suitable carriers such as buffering agents, pH adjusting agents, tonicity adjusting agents, sodium chloride (saline solution) and viscosity adjusting agents as polyvinyl alcohols and wherein EDTA can be in particulate form. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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