Regenerative medicine is an upcoming technology field that may be capable of repairing and replacing damaged cells, tissues, and organs by using those that are specially grown. This technology has evolved by the combined efforts of scientists belonging to a diverse range of expertise, including, biology, genetics, physiology, nanotechnology, and pharmacology. Generally, regenerative medicine includes three sub-fields: tissue engineering, cell therapies, and healing therapies. While working in collaboration, tissue engineers focus on growing connective tissues and replacement organs for the body and their work is tested on animals before implementing it into humans, whereas cell therapy scientists try to stimulate reparation from the diseased tissue or organ itself by identifying and optimizing the factors that lead to self-reparation of the organ. Thereafter, healing therapists are involved in studying strategies to restore the functions of an implanted tissue or organ.
The general procedure includes cutting out a piece of the organ that is to be replaced, separating out the cells and placing them in fluid that allows them to multiply. After that, an animal organ is treated with mild detergent to remove all cells, leaving the basic support structure, called a scaffold. Consequently, patient’s cells are poured onto the scaffold, and the new organ is then placed in an incubator that simulates a human body, where the cells can grow and knit together. Finally, the organ is planted inside the patient’s body, and the scaffold slowly immaterializes, leaving only the regenerated organ.
A recent trial of this technology wasreported in The New York Times, which discussed about Sgt. Ron Strang, whose part of a left thigh was blown away by a roadside bomb in Afghanistan. The explosion and subsequent rounds of surgery left Sergeant Strang, 28, a Marine, with a huge divot in his upper thigh where the quadriceps muscle had been. He could move the leg backward, but with so much of the muscle gone he could not kick it forward. He could walk, but only awkwardly. Applying the technology of regenerative medicine, Sergeant Strang has now grown new muscle thanks to a thin sheet of material from a pig. More details about this may be readhere.
In brief, the thin sheet of material is an adipose tissue-derived cell growth scaffold, which, in layman term, is the extracellular matrix. Reconstruction of tissue, in general, includes provision of a matrix which serves as a guide for cells which grow along and between the fibres of the matrix. At present, biologic scaffolds composed of extracellular matrix (ECM) are utilized in numerous regenerative medicine applications to facilitate the constructive remodeling of tissues and organs. The mechanisms by which the host remodeling response occurs are not fully understood, but recent studies suggest that both constituent growth factors and biologically active degradation products derived from ECM play important roles.
This procedure was performed byDr. Peter Rubin, a plastic surgeon at the University of Pittsburgh Medical Center who is a leader of the said study. Dr. Rubin has also filed a patent application titled “DECELLULARIZED ADIPOSE CELL GROWTH SCAFFOLD” that has been allocated a publication numberWO/2011/087743. The details of the patent application can be accessedhere.
As it may be seen, the patent application primarily claims a method of preparing an adipose tissue-derived cell growth scaffold comprising washing a decellularized adipose tissue-derived cell growth scaffold with n-propanol, isopropanol or a mixture thereof. This method is further limited by use of various dependent claims, which includes preparing the decellularized adipose tissue- derived cell growth scaffold by: (a) digesting an adipose tissue sample with a proteinase; (b) washing the sample with a surfactant; (c) washing the sample with an emulsifier; (d) disinfecting the sample; (e) depyrogenating the sample; (f) drying the sample; (g) washing the sample in n-propanol, isopropanol or a mixture thereof; and (h) washing the sample in an aqueous solvent.
With reference to the report published in The New York Times, the claims directed to the referenced procedure would be claims 13-20. In accordance with claim 13, a method of growing cells comprises contacting cells with a cell growth scaffold as claimed in one of claims 1-10 and culturing the cells. This claim is further limited by various specific features of the procedure, such as, culturing the cells in vivo, applying the cell growth scaffold to a wound in a patient, applying the cell growth scaffold to a topical wound, and spraying the cell growth scaffold onto a topical wound.
The patent claims are further characterized to include the scaffold that is contained within a biocompatible cover to produce an implant, and the implant is implanted into a patient. The implant comprises cells, which may be chondrocytes, chondroprogenitor cells, adipose stem cells, mesenchymal stem cells, myocytes, precursor cells, progenitor cells, stem cells, differentiated cells.
With a view to analyze the patent trends in the field of regenerative medicine, it is important to note that the above-mentioned patent application pertains to the major international patent classification (IPC) of C12N 11/16, which generally relates to enzymes or microbial cells being immobilised on or in a biological cell. A quick search at the WIPO patent database reveals that there are 164 WIPO Patent Applications that include C12N 11/16 as primary patent classification. The following graph illustrates major players filing patents in this field.
Generally, the IPC (International Patent Classification) search is one of the most important patent fundamental search tools available to patent attorneys /patent agents and general public at large while conducting a patent search. Moreover, the International Patent Classification retrieves relevant patent specifications in order to establish the novelty of the technology in question and to evaluate the inventive step or non-obviousness of the inventive part of the patent application. The International Patent Classification system classifies patent applications and helps patent attorneys / patent agents to search patent specifications (patent applications, specifications of granted patents, utility models, and the like).
Furthermore, the International Patent Classification serves as an instrument for arrangement of the patent applications in an orderly format and provides an easy retrieval from the patent databases, and further provides a basis for selective dissemination of information to any person searching for patent resources.
The International Patent Classification acts as a very important tool for conducting state of the art patent search for given technical art in question and provides assessment of technological development in numerous technical fields. The state-of-the-art patent search is the broadest search and aims to locate patent publications in the specific technical field of invention and provide a valuable insight into what has been patented in a specific field of invention. Particularly, the state of the art patent search report assist in developing an IP strategy for long-term market advantage.
The International Patent Classification divides the world of technology into eight sections, which as illustrated below:
SECTION A — HUMAN NECESSITIES
SECTION B — PERFORMING OPERATIONS; TRANSPORTING
SECTION C — CHEMISTRY; METALLURGY
SECTION D — TEXTILES; PAPER
SECTION E — FIXED CONSTRUCTIONS
SECTION F — MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
SECTION G — PHYSICS
SECTION H — ELECTRICITY
The above mentioned eight sections of the International Patent Classification has over 70,000 subdivisions. Each subdivision has a symbol consisting of Arabic numerals and letters of the Latin alphabet. For e.g., as discussed above, the IPC C12N11/16 relates to “Enzymes or microbial cells being immobilised on or in a biological cell”.
IPC classification symbols are made up of a letter denoting the IPC section (e.g. C), followed by a number (two digits) denoting the IPC class (e.g. C12), then a letter denoting the IPC subclass (e.g. C12N). A number (variable, 1-3 digits) denotes the IPC main group (e.g. C12N11). This is followed by a forward slash “/” and a number (variable, 1-3 digits) denoting the IPC subgroup (e.g. C12N11/16). To elaborate more on IPC classification symbols the following example can be considered:
C: CHEMISTRY; METALLURGY
C12: BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
C12N: MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF
C12N11: Carrier-bound or immobilised enzymes; Carrier-bound or immobilised microbial cells; Preparation thereof
C12N11/16: Enzymes or microbial cells being immobilised on or in a biological cell
C12N11/18: Multi-enzyme systems
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