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 .
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 8-13 and 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Darren et al. WO 2023028664 A1.
Darren teaches an injectable composition comprising cellulosic nanofibers and hyaluronic acid. See Abstract; and paragraphs 0007-0010 and 0041-44. The cellulosic fibers (or nanofibers) derived from a plant source is found in paragraph 0020. The composition may be suitable for injection into a person (human) or animal (horse and dog) for the purpose of a cosmetic or therapeutic such as for the treatment of arthritis including osteoarthritis. See paragraphs 0021 and 0061-0063. The composition may comprise any suitable solvent for injection. In one embodiment, the solvent is an aqueous solvent. The solvent may be saline, especially sterile saline. The solvent may be an aqueous buffer solution. The solvent may be Phosphate Buffered Saline (PBS). The aqueous buffer solution may be for maintaining the composition at close to physiological pH or at least within a range of about pH 6.0 to 9.0. See paragraph 0037. Method of treating, preventing or ameliorating the symptoms of arthritis in a subject, comprising injecting the composition into the joint of the subject is found in paragraphs 0064-0066.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. US 2018/0050130 A1, in view of Ryan et al. US 2022/0105232 A1.
Jiang teaches an injectable nanofiber-hydrogel composite material can include a gel and at least one nanostructure disposed within the gel. A method for healing a soft tissue defect can include applying a composite material to a soft tissue defect, wherein the composite material includes a gel and a nanostructure disposed within the gel. A method for manufacturing a composite material for use in healing soft tissue defects can include providing a gel and disposing nanofibers within the gel. See Abstract and paragraph 0030 and Figures. Paragraph 0042 discloses composite material that includes a gel and at least one nanostructure disposed within the gel. The gel can be hydrogel or any other suitable gel. The nanostructure can be a nanofiber or any other suitable nanostructure. The nanostructure can be covalently bonded to the gel. The nanostructure can be made of polycaprolactone (PCL) or any other suitable material. Hydrogel includes hyaluronic acid. See paragraph 0132. In one application, the hydrogel/nanostructure composite compositions of the invention can be used to repair cartilage tissue. Current biologically-based surgical procedures for cartilage repair include autologous chondrocyte implantation, drilling, abrasion chondroplasty, microfracture, and mosaic arthroplasty. All these procedures treat only focal articular cartilage injuries, and not cartilage denuded joint surfaces such as seen in severe osteoarthritis and rheumatoid arthritis. Also, they use either cartilage tissue plugs or expanded chondrocytes harvested from the patient to fill cartilage defects. These tissues or chondrocytes are expected to fill the defect by synthesizing entirely de novo material, such as newly synthesized hyaline cartilage, that has integrated with existing cartilage matrices and has the biomechanical properties of normal cartilage. However, such procedures all promote the formation of a reparative tissue (fibrocartilage) rather than true hyaline cartilage with further mechanical damage to fibrocartilage thought to predispose the joint to osteoarthritis. Furthermore, the availability of endogenous cartilage as a repair material is quite limited with its acquisition presenting its own risks and morbidity to the patient. As evident from the foregoing discussion, the resulting hydrogel/nanostructure compositions disclosed herein present practical materials for promising new therapies in patients suffering from cartilage degenerative diseases. See paragraph 0215. As described herein, the present hydrogel/nanostructure compositions can be prepared having widely varying properties that are suitable for any number of synthetic tissue implantation or augmentation, as well as other clinical applications. As already described, the present materials can be used to repair cartilage defects produced as a result of either injury or disease. Defects due to injury that can be so repaired can be sports- or accident-related, and may involve only the superficial cartilage layer, or may include the underlying subchondral bone. Defects due to disease which can be repaired using the compositions described herein include those resulting from osteoarthritis and rheumatoid arthritis. Whether from injury or disease, such defects may be in either mature or growth plate cartilage. Formulations for hydrogels for synthetic growth plate cartilage may require the inclusion of unsubstituted scaffold material to allow for controlled bioresorption of the biomaterial during growth. See paragraph 0216. Referring generally to FIGS. 1A-1D, the biodegradable composite 100 can include a nanofiber 101 reinforced gel 103 that combines the advantages of both gel 103 and nanofibers 101. The gel 103 can include any suitable material, such as, but not limited to, hydrogel. The nanofibers 101 can be made of any suitable nanomaterial, e.g., polycaprolactone (PCL) or any other suitable material, and can take any suitable shape and/or size. The composite 100 includes high porosity (e.g., to mediate cell adhesion and migration) while maintaining sufficient mechanical properties (e.g., to maintain integrity and tissue support). In at least some embodiments, the nanofibers 101 are covalently conjugated to the hydrogel 103 forming one or more polymer chains. Covalent attachment of hydrogels 103 to the nanofibers 101 can result in a material with a combined set of ideal properties superior to the constituent materials used alone or as a simple blend. See paragraphs 0235-0236.
While Jiang teaches hydrogel includes buffer solution, Jiang is silent as to buffered saline.
Ryan teaches an injectable viscoelastic hydrogel composite comprising hyaluronan gel. See Abstract and paragraph 0167. Hyaluronan includes hyaluronic acid and sodium salt thereof, and from any course including bacterial sources. See paragraph 0168. Compositions of’ hyaluronan with high elasticity and uses thereof. This document describes a material, Elastovisc™, comprised of high concentration and molecular weight hyaluronic acid. Its intended use is for injection into joints to relieve pain and treat osteoarthritis. See paragraph 0169. In any embodiment the composite viscoelastic hydrogel composition can be provided in a physiological buffer, e.g., a phosphate buffer or a bicarbonate buffer. In some embodiments, the pH of the composition is between pH 5 and pH 9 or between pH 7.5 and pH 8.5. In some embodiments, the pH of the composition is 8.0. In some embodiments, the pH of the composition is 7.5. In some embodiments, the pH of the composition is 8.5. If needed, acid (such as HCL) or base (such as NaOH) can be added to the composition to attain the desired pH. In a specific embodiment, the hyaluronic acid hydrogel described herein consists essentially of hyaluronic acid present at a concentration of 50 mg/ml (or about 5% W/V, and having an average molecular weight of between 1-2 Mda. Ranges intermediate to the recited values are also intended to be part of this invention. For example, hyaluronan content in the compositions described herein may be between about 0.5% and about 6% (weight/volume). It should further be appreciated that the amount of hyaluronan in a particular volume may also be expressed by alternative means (e.g., mg/ml, gram/litre or mol/litre). A person of ordinary skill in the art would know how to convert the various means of expressing the amount of hyaluronan in a particular volume. See paragraph 0176. The composite further comprising different polymeric materials with thermo-responsive, shear-thinning, shape memory and biological properties can be combined to yield composite hydrogels with improved properties for this application. Improvements can include enhanced biocompatibility, injectability, viscosity, altered biodegradation, drug attachment, tissue adhesion, cohesiveness, sealing ability stability, hydrophilicity. Gelatin and hyaluronic acid are two examples. Substances which can be combined with these polymers include methylcellulose, oxidized cellulose, carboxylmethyl cellulose, and carboxylic acid. See paragraph 0180.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to optimize the teaching in Jiang to include buffered saline solution in view of the teaching in Ryan with the expectation to obtain an injectable composition useful for injecting hydrogel hyaluronic acid and nanofiber for the treatment of arthritis. This is because Ryan teaches the use of hyaluronic acid in a buffered saline solution composition is known in the art, and this is because Jiang teaches the desirability for using buffered solution in a composition comprising hyaluronic acid suitable for delivery to a subject through injection route.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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