Biomedical Engineering Reference
In-Depth Information
16.5.3
METHODS/PROCESSES
Method patents can protect, at a high level, the entire process of creating a 3D bioprinted object, includ-
ing computerized steps for controlling hardware, the physical actions performed by the hardware, and
even manual steps performed before or after the printing occurs. Therefore, method patents can provide
broad IP coverage of the steps involved to prepare the raw materials, construct the tissue, and perform
postprocessing steps, such as treating the printed tissue with nanomaterials to enhance biocompatibility
or drug delivery capabilities. Unlike patents and copyrights only covering software, method patents can
cover computerized steps and also manual steps involved in the creation of printed tissue. Patents that
cover the manufacturing process are usually referred to as “methods of manufacture.” In addition to
patents that broadly cover the entire manufacturing process, method patents can cover portions of the
process, such as an improved method for storing and transporting living cells before 3D bioprinting
occurs, or a particular method of laying and binding living cells, or a method of treating the printed
tissue with nanomaterials.
Tissue engineering methods are ideal for trade secret protection, especially methods involving high-
ly specialized (and also secret) hardware, or manual steps known only to the innovator. Because of the
complex nature of engineered tissue and organs, reverse engineering a printed organ to determine how
the cells structures were formed and to determine how the tissue was processed to increase biocompat-
ibility may be difficult to accomplish. Accordingly, innovators who do not want to divulge any of their
processes to the public in a patent can hold them as trade secrets and fully capitalize on their inventions
until competitors reverse engineer their method or come up with the next best method.
16.5.4
MATERIALS
Tissue engineered with 3D bioprinting and nanotechnology use some entirely new materials to form
the tissue structures and process the tissue for increased biocompatibility or drug delivery properties.
The man-made and artificially modified materials used for 3D bioprinting and nanotechnology are
patentable as “compositions of matter.” Tissue printed from a 3D bioprinter is usually formed using
“bio-ink,” a medium of living cells suspended in liquid that protects the cells and keeps them alive, and
helps the cells adhere to the tissue structure during printing. Some forms of bio-ink use natural materi-
als or natural cells, such as stem cells. While the natural materials and cells themselves may not be
patentable, artificial compounds that happen to include natural materials, as well as artificial modifica-
tions of the natural materials, can be patented. For example, some types of bio-ink use natural gelatins
as the printing medium. Natural gelatin is semisolid in its natural state, but the gelatin used in bio-ink
is modified to remain in liquid form during storage and printing, and only hardens during printing and
post processing of the printed tissue (
Maxey, 2013
). The modified gelatin, which has different chemical
properties, is patentable as a composition of matter. Like the modified gelatin, bio-ink that incorporates
natural living cells is patentable as a composition of matter when the living cells are mixed or treated
with artificial compounds to form combinations that are not found in nature. For example, the living
cells in the bio-ink may be treated or processed to enhance biocompatibility, adhesion to other cells, or
prolong the shelf life of the bio-ink or printed tissue.
Patents on the bio-ink, nanomaterials, and other materials used in 3D bioprinting may also tie into
patents on the reservoirs and hardware that hold the bio-ink and keep the living cells alive, the mecha-
nisms that transport the cells, and the specialized print heads that dispense bio-ink. Specialized patent-
able materials may also be used in these hardware components, to keep the cells alive and intact while
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