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 .
Applicant’s election of Group I in the reply filed on May 22, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8-9 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.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 May 22, 2026.
Claims
Claim Rejections - 35 USC § 102 -Anticipation
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liggins et al. (WO 2006002365).
Liggins et al. disclose microparticles with high drug concentration. The drug may be present in the microparticle at a concentration of greater than 55% (weight of drug/weight of microparticle). The polymer may be or comprise a biologically derived polymer, such as hyaluronic acid and derivatives thereof, dextran and derivatives thereof, cellulose and derivatives thereof including methylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, carboxymethylcellulose, chitosan and derivatives thereof, a polypeptide such as poly(L-glutamic acid), collagen, albumin, fibrin and gelatin. Derivatives of hyaluronic acid and salts are incorporated by reference (US 5,128,326, col. 6, lines 42-50), and includes sodium hyaluronate. The drug is an anti-inflammatory agent, such as, aspirin, hydrocortisone, naproxen, indomethacin, ketoprofen, and analogues and derivatives thereof). In certain other embodiments, the drug is a neurologically active agent such as pentoxyfyline, fluphenazine, bupivacaine and lidocaine. The compositions may be delivered to the lungs. The powders are made by spray-drying. A composition is made comprising lidocaine and PLLA (polylactic, biocompatible polymer) and is spray-dried (see examples). The particle size of the solid composition may be reduced using any suitable method, such as grinding and milling. The microparticles produced according to the present invention are generally between about 0.5 μm to about 1000 μm in size. The optimal sizes of the microparticles may be determined by the desired drug release properties and the particular applications. In certain embodiments, the microparticles or microspheres have an average diameter of at least about 0.5 μm or 1 μm or 5 μm. In certain embodiments, the microparticles have a preferred average diameter of no more than about 5 μm, or 10 μm. The microparticles and microspheres of the invention may have an average diameter of between about 1 μm and about 10 μm.
The combination may be spray dried powders. Therefore, this meets the limitation of a dry powder that may be inhaled.
Liggins et al. anticipate the instant claims.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hofmann et al. (2006/0062737) in view of Kaur et al. (Artificial cells, Blood Substitutes, and Biotechnology, 2012).
Hofmann et al. disclose an anti-tussive nebulized solution for targeted delivery of lidocaine into conducting and central airways. The nebulized lidocaine solution administered in daily dose from about 10 mg to 80 mg of lidocaine dissolved in a saline and nebulized into an aerosol having a mass median aerodynamic diameter 3 micrometer to 10 micrometer and a geometric standard deviation less than 1.7 using an electronic nebulizer (Abstract). A formulation of lidocaine dry powder whose particle size distribution has a mass median aerodynamic diameter (MMAD) between about 3.5 micrometers to about 10 micrometers with a substantially monodisperse particle spectrum for efficient deposition of lidocaine dry powder into conducting and central airways (paragraph 0037). The composition comprising a lidocaine may contain other components, such as excipients, diluents, isotonic solutions, buffers, etc. (paragraph 0052). Other local anesthetics that may be used include proparacaine, cocaine, procaine, tetracaine, hexylcaine, bupivacaine, benoxinate, mepivacaine, prilocaine, mexiletine, vadocaine and etidocaine (paragraph 0067).
Hofmann et al. differ from the instant claims insofar as they do not disclose a biocompatible polymer.
Kaur et al. disclose that hyaluronic acid (HA) is a polyanionic nonsulfated polysaccharide that consists of N-acetyl-D-glucosamine and beta-glucuronic acid. One of the chief components of the extracellular matrix, hyaluronan, contributes significantly to cell proliferation and migration. Due to its high biocompatibility, mucoadhesitivity, and its common presence in the extracellular matrix of tissues, hyaluronan is gaining popularity in drug delivery systems. Studies have demonstrated that hyaluronic acid with the lowest molecular weight (202 kD) exhibited better penetration enhancement properties compared with chitosan hydrochloride. In particular, a number of research groups have found hyaluronan's properties useful for cosmetic, medical, and pharmaceutical purposes. Ofloxacin-loaded hyaluronic acid microspheres have been prepared by spray-drying techniques for delivery of ofloxacin to the lung and alveolar macrophages. Studies have suggested that the most efficient delivery of ofloxacin to the lung is feasible via hyaluronic acid. Moreover, in vitro uptake of ofloxacin from hyaluronic acid microspheres by air-surface cultured alveolar macrophages (RAW 264.7) was approx. 2-fold higher than other formulations. It is suggested that porous microparticles may be applied in long-term pulmonary administration of protein or peptide drugs, especially in deeper lung epithelium.
It would have been obvious to one of ordinary skill in the art to have added hyaluronic acid or its salts as an excipient in the dry powder composition of Hofmann et al. because they improve absorption of drugs and may be applied long term as disclosed by Kaur et al.
In regards to the particle size distribution, the particle size would determine absorption and delivery of the active to the lungs. Therefore, it would have taken no more than the relative skill of one of ordinary skill in the art to have a made the powders of Hoffmann et al. and Kaur et al. having the instantly recited particle size in order to optimize delivery of the powders for the desired therapeutic result.
2) Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Liggins et al. (WO 2006002365).
Liggins et al. disclose microparticles with high drug concentration. The drug may be present in the microparticle at a concentration of greater than 55% (weight of drug/weight of microparticle). The polymer may be or comprise a biologically derived polymer, such as hyaluronic acid and derivatives thereof, dextran and derivatives thereof, cellulose and derivatives thereof including methylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, carboxymethylcellulose, chitosan and derivatives thereof, a polypeptide such as poly(L-glutamic acid), collagen, albumin, fibrin and gelatin. Derivatives of hyaluronic acid and salts are incorporated by reference (US 5,128,326, col. 6, lines 42-50), and includes sodium hyaluronate. The drug is an anti-inflammatory agent, such as, aspirin, hydrocortisone, naproxen, indomethacin, ketoprofen, and analogues and derivatives thereof). In certain other embodiments, the drug is a neurologically active agent such as pentoxyfyline, fluphenazine, bupivacaine and lidocaine. The compositions may be delivered to the lungs. The powders are made by spray-drying. A composition is made comprising lidocaine and PLLA (polylactic, biocompatible polymer) and is spray-dried (see examples). The particle size of the solid composition may be reduced using any suitable method, such as grinding and milling. The microparticles produced according to the present invention are generally between about 0.5 μm to about 1000 μm in size. The optimal sizes of the microparticles may be determined by the desired drug release properties and the particular applications. In certain embodiments, the microparticles or microspheres have an average diameter of at least about 0.5 μm or 1 μm or 5 μm. In certain embodiments, the microparticles have a preferred average diameter of no more than about 5 μm, or 10 μm. The microparticles and microspheres of the invention may have an average diameter of between about 1 μm and about 10 μm.
The combination may be spray dried powders. Therefore, this meets the limitation of a dry powder that may be inhaled.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have made a composition comprising a combination of lidocaine and hyaluronic acid/sodium hyaluronate because it is suggested by Liggins et al.
In regards to the particle size distribution, the particle size would determine absorption and delivery of the active to the lungs, making it a result effective variable. Therefore, it would have taken no more than the relative skill of one of ordinary skill in the art to have a made the powders of Liggins et al. having the instantly recited particle size in order to optimize delivery of the powders for the desired therapeutic result.
Claims 1-7 are rejected.
Claims 8-9 and 12 are withdrawn.
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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