-i-
`
`Smith & Nephew Ex. 1022
`IPR Petition - USP 8,657,827
`
`

`

`PROVISIONAL PATENT APPLICATION
`ATTORNEY DOCKET NO.: OA—003.00us
`
`NOVEL DEVICES FOR CARTILAGE REPAIR
`
`Background:
`
`A large number of cartilage repair systems are currently being developed. These cartilage
`
`repair systems include cartilage or cartilage—like material grown out of stem cells, fetal
`
`cells or adult cartilage cells. Other cartilage repair systems include non-human material
`
`with elastic and biomechanical properties similar to cartilage. Again other cartilage repair
`
`systems include a scaffold for ingrowth of cartilage cells.
`
`One of the biggest challenges for all of these cartilage repair systems is the integration of
`
`the cartilage replacement material with the surrounding cartilage of the patient. This
`
`integration can be extremely difficult due to differences in thickness and curvature
`
`between the surrounding cartilage or the underlying subchondral bone and the cartilage
`
`replacement material.
`
`The present invention provides for methods and devices that improve and facilitate the
`
`integration between the cartilage replacement system and the surrounding cartilage.
`
`Definitions:
`
`A cartilage repair system is a system to repair,
`
`to replace or to regenerate articular
`
`cartilage. Cartilage repair systems include autologous chondrocyte transplantation,
`
`osteochondral allografiing, osteochondral autografting, chondral allografting, chondral
`
`autografting tibial corticotomy, femoral or tibial osteotomy. Cartilage repair systems
`
`include also treatment with cartilage or bone tissue grown ex vivo, stem cells, cartilage
`
`material grown with use of stem cells, fetal cells or immature or mature cartilage cells, an
`
`artificial non—human material, an agent that stimulates repair of diseased cartilage tissue,
`
`an agent that protects diseased cartilage tissue and that protects adjacent normal cartilage
`
`tissue. Cartilage repair systems include also treatment with a cartilage tissue transplant, a
`
`cartilage tissue graft, a cartilage tissue implant, a cartilage tissue scaffold, or any other
`
`OA—003.00us
`
`Lang
`3/12/02
`
`- l —
`
`
`
`

`

`cartilage tissue replacement or regenerating material. Cells and tissue can be autogenic,
`
`allogenic, or xenogenic.
`
`A cartilage replacement or regenerating material includes cartilage or bone tissue grown
`
`ex vivo, stem cells, cartilage material grown out of stem cells, fetal cells or immature or
`
`mature cartilage cells, an artificial non-human material, a cartilage tissue transplant, a
`
`cartilage tissue graft, a cartilage tissue implant, a cartilage tissue scaffold, or a cartilage
`
`tissue regenerating material.
`
`An imaging test includes x—ray based techniques such as conventional film based x-ray
`
`films, digital
`
`x—ray images,
`
`single and dual
`
`x—ray absorptiometry,
`
`radiographic
`
`absorptiometry, ultrasound including broadband ultrasound attenuation measurement and
`
`speed of sound measurements, computed tomography (CT), nuclear scintigraphy,
`
`SPECT, positron emission tomography and MRI. The imaging test can be used to obtain
`
`certain morphological information about one or several tissues such as bone including
`
`bone mineral density and curvature of the subchondral bone, cartilage including
`
`biochemical composition of cartilage, cartilage thickness, cartilage volume, cartilage
`
`curvature, marrow including marrow composition,
`
`synovium including synovial
`
`inflammation, lean and fatty tissue, and thickness, dimensions and volume of soft and
`
`hard tissues. The imaging test can be performed with use of a contrast agent, such as Gd-
`
`DTPA in the case of MRI or ionic or non—ionic contrast agents in the case of CT.
`
`
`
`An electronic image includes x—ray based techniques such as digital x-ray images, for
`
`example acquired using computed or digital
`
`radiography, ultrasound, computed
`
`tomography (CT), nuclear scintigraphy, SPECT, positron emission tomography and MRI.
`
`The electronic image can be used to obtain certain morphological information about one
`
`or several tissues such as bone including curvature of the subchondral bone, cartilage
`
`including biochemical composition of cartilage, cartilage thickness, cartilage volume,
`
`cartilage curvature, marrow including marrow composition, synovium including synovial
`
`OA—003.00us
`
`Lang
`3/12/02
`
`- 2 -
`
`

`

`
`
`inflammation, lean and fatty tissue, and thickness, dimensions and volume of soft and
`
`hard tissues. The electronic image can be include a contrast agent, such as Gd—DTPA in
`
`the case of MRI or ionic or non-ionic contrast agents in the case of CT.
`
`Arthritis is a condition that
`
`is characterized by progressive deterioration of joints.
`
`Arthritis encompasses a group of different diseases including osteoarthritis, rheumatoid
`
`arthritis, seronegative spondyloarthropathies and posttraumatic joint deformity.
`
`Detailed Description of the Invention:
`
`The current invention provides for methods and devices that improve the integration of
`
`cartilage replacement or regenerating materials.
`
`In one embodiment of the invention, a probe is used to harvest tissue from a donor site
`
`and to prepare a recipient site. Said donor site can be located in a xenograit, an allograft
`
`or an autograft. The probe is used to achieve a good anatomic match between the donor
`
`tissue sample and the recipient site. The probe is specifically designed to achieve a
`
`seamless or near seamless match between the donor tissue sample and the recipient site.
`
`The probe can, for example, be cylindrical. The distal end of the probe is typically sharp
`
`in order to facilitate tissue penetration. Additionally,
`
`the distal end of the probe is
`
`typically hollow in order to accept the tissue. The probe can have an edge at a defined
`
`distance from its distal end, e.g. at 1 cm distance from the distal end. Said edge can be
`
`used to achieve a defined depth of tissue penetration for harvesting. The edge can be
`
`external or can be inside the hollow portion of the probe. For example, an orthopedic
`
`surgeon can take the probe and advance it with physical pressure into the cartilage, the
`
`subchondral bone and the underlying marrow in the case of a joint such as a knee joint.
`
`The surgeon can advance the probe until the external or internal edge reaches the
`
`cartilage surface. At that point, the edge will prevent further tissue penetration thereby
`
`achieving a constant and reproducible tissue penetration. The distal end of the probe can
`
`include a blade or saw-like structure or tissue cutting mechanism. For example, the distal
`
`0A—003.00us
`
`Lang
`3/12/02
`
`— 3 -
`
`

`

`
`
`end of the probe can include an iris-like mechanism consisting of several small blades.
`
`The at least one or more blades can be moved using a manual, motorized or electrical
`
`mechanism thereby cutting through the tissue and separating the tissue sample from the
`
`underlying tissue. Typically, this will be repeated in the donor and the recipient. In the
`
`case of an iris—shaped blade mechanism, the individual blades can be moved so as to
`
`close the iris thereby separating the tissue sample from the donor site.
`
`In another embodiment of the invention, a laser device or a radiofrequency device can be
`
`integrated inside the distal end of the probe. The laser device or the radiofrequency
`
`device can be used to cut through the tissue and to separate the tissue sample from the
`
`underlying tissue.
`
`In one embodiment of the invention, the same probe can be used in the donor and in the
`
`recipient. In another embodiment, similarly shaped probes of slightly different physical
`
`dimensions can be used. For example, the probe used in the recipient can be slightly
`
`smaller than that used in the donor thereby achieving a tight fit between the tissue sample
`
`or tissue transplant and the recipient site. The probe used in the recipient can also be
`
`slightly shorter than that used in the donor thereby correcting for any tissue lost during
`
`the separation or cutting of the tissue sample from the underlying tissue in the donor
`
`material.
`
`In another embodiment of the invention, a device can be applied to the outer surface of
`
`the articular cartilage in order to match the alignment of the donor tissue and the recipient
`
`site. The device can be round, circular, oval, ellipsoid, curved or irregular in shape. The
`
`shape is typically selected or adjusted to match or enclose an area of diseased cartilage or
`
`an area slightly larger than the area of diseased cartilage. The inner aspect of the circle,
`
`oval, ellipse, curved or irregular shape can be open or hollow. In that manner, a rounded
`
`or curved joint surface such as a femoral condyle, a femoral head or a humeral head can
`
`protrude through the opening or the hollow portion. The device can include a slit through
`
`0A—003.00us
`
`Lang
`3/12/02
`
`- 4 _
`
`

`

`which a blade can be introduced. Alternatively, the device can include a blade holding
`
`mechanism or the blade can be integrated in the device. In the recipient, the blade can be
`
`used to remove an area of diseased cartilage and underlying bone or an area slightly
`
`larger than the diseased cartilage and underlying bone. The device can be applied to the
`
`donor, e.g. a cadaveric specimen. The device is typically positioned in the same general
`
`anatomic area in which the tissue was removed in the recipient. The shape of the device
`
`is then used to identify a donor site providing a seamless or near seamless match between
`
`the donor tissue sample and the recipient site. This is achieved by identifying the position
`
`of the device in which the articular surface in the donor, e. g. a cadaveric specimen has a
`
`seamless or near seamless contact with the inner surface of the device when it is applied
`
`to the cartilage.
`
`In another embodiment of the invention, the tissue is first harvested in the donor and the
`
`recipient site is prepared subsequently.
`
`In another embodiment of the invention, the device can be translucent. A translucent
`
`design can help in order to achieve an improved match between the donor tissue and the
`
`recipient site.
`
`The device can be made of a plastic. The device can be re—usable and sterilizable or
`
`disposable.
`
`In another embodiment of the invention an imaging test can be used to select the device
`
`with the best shape for the recipient. The imaging test can provide information on the size
`
`of the area of diseased cartilage. The device can be available in a number of different
`
`sizes and shapes. The imaging test can then be used to select the device with the shape
`
`and size best suited for a particular recipient.
`
`
`
`OA—003.00us
`
`Lang
`3/12/02
`
`- 5 —
`
`

`

`In another embodiment of the invention, an electronic image for example displaying the
`
`cartilage or the subchondral bone can be used to define the shape of the device. The
`
`device can be molded, machined or formed based on the size of the area of diseased
`
`cartilage and based on the curvature of the cartilage or the underlying subchondral bone
`
`or a combination of both. The device can then be applied to the donor, e.g. a cadaveric
`
`specimen and the donor tissue can be obtained with use of a blade or saw or other tissue
`
`cutting device. The device can then be applied to the recipient in the area of the diseased
`
`cartilage and the diseased cartilage and underlying bone can be removed with use of a
`
`blade or saw or other tissue cutting device whereby the size and shape of the removed
`
`tissue containing the diseased cartilage will closely resemble the size and shape of the
`
`donor tissue. The donor tissue can then be attached to the recipient site. For example, said
`
`attachment can be achieved with use of screws or pins or other fixation means including
`
`but not limited to a tissue adhesive. Said screws or pins or fixation means can be metallic
`
`or non—metallic. Said screws or pins or fixation means can be bioresorbable. Said screws
`
`or pins or fixation means can be applied through the cartilage surface. Alternatively, said
`
`screws or pins or fixation means can be applied to the donor tissue through the recipient’s
`
`marrow space.
`
`In another embodiment of the invention, the donor tissue can be sterilized to inactivate
`
`biological contaminants such as bacteria, viruses, yeasts, molds, mycoplasmas and
`
`parasites. Said sterilization can be performed using radiation,
`
`for example gamma
`
`radiation.
`
`In another embodiment of the invention, the donor tissue can be harvested with use of a
`
`robotic device. The robotic device can use information from an electronic image for
`
`tissue harvesting.
`
`
`
`OA—003.00us
`
`Lang
`3/1 2/02
`
`— 6 -
`
`

`

`In another embodiment of the invention, the recipient site can be prepared with use of a
`
`robotic device. The robotic device can use information from an electronic image for
`
`preparing the recipient site.-
`
`In one embodiment of the invention, the thickness of the normal or only mildly diseased
`
`cartilage surrounding a cartilage defect can be measured with use of an imaging test. This
`
`thickness measurement can be obtained at a single point, more preferably two points,
`
`even more preferably 4 or 6 points, and even more preferably all around the defect.
`
`Similarly,
`
`the curvature of the articular surface can be measured. This curvature
`
`measurement can be obtained in one direction, preferably in two directions, and, even
`
`more preferably, in three dimensions.
`
`In another embodiment of the invention, an existing cartilage replacement or regenerating
`
`material can be shaped to fit into a cartilage defect. Said shaping is achieved with use of
`
`at least one or more of said measurements obtained in and around the cartilage defect.
`
`Said shaping can be performed with mechanical means, for example by abrading portions
`
`of the cartilage replacement or regenerating material that are thicker than the cartilage
`
`surrounding the defect. Said shaping can also be achieved with use of laser ablation or
`
`radiofrequency ablation. Said shaping can also be achieved with use of enzymatic
`
`digestion. If enzymatic digestion is used, certain sections of the cartilage replacement or
`
`regenerating material can be exposed to higher doses of the enzyme or can be exposed
`
`longer as a means of achieving different thicknesses and curvatures of the cartilage
`
`replacement or regenerating material in different sections of said material.
`
`
`
`OA-003.00us
`
`Lang
`3/12/02
`
`— 7 -
`
`

`

`A method to achieve seamless or near seamless integration between a tissue
`
`sample or tissue graft and a recipient site
`
`a.
`
`removing
`
`said tissue sample or tissue graft using an open or hollow
`
`device
`
`b. preparing the recipient site using said open or hollow device,
`
`whereby said device includes a tissue cutting mechanism at its distal end.
`
`A device to achieve seamless or near seamless alignment between a tissue
`
`sample or tissue graft and a recipient site
`
`a.
`
`b.
`
`0.
`
`applying said device to the donor and harvesting the donor tissue
`
`applying said device to the recipient and preparing said recipient site,
`
`attaching said tissue sample or tissue graft to said recipient site,
`
`whereby the outer margin of the tissue sample is closely aligned with the outer
`
`margin of the recipient site.
`
`I claim:
`
`
`
`OA-003.00us
`
`Lang
`3/1 2/02
`
`- 8 -
`
`

`

`Provisional Patent
`
`OA—003.00us
`
`DECLARATION AND CORRESPONDENCE ADDRESS
`
`As a below named inventor, I hereby declare that:
`
`My residence, post office address and citizenship are as stated next to my name.
`
`I believe I am the original, first and sole inventor (if only one name is listed
`below) or an original inventor (if plural names are listed below) of the subject matter
`which is claimed and for which a provisional patent is sought on the invention entitled:
`
`NOVEL DEVICES FOR CARTILAGE REPAIR
`
`the specification of which:
`[] is attached hereto.
`[X] was filed on March 12th, 2002, and identified as Docket No. OA-003.00us.
`[] was filed on , as Application Serial number
`
`I hereby state that I reviewed and understand the contents of the above-identified
`specification, including the claims, as amended by any amendment referred to above.
`I acknowledge the duty to disclose information which is material to the
`examination of this application in accordance with Title 37, Code of Federal Regulations,
`Section l.56(a).
`I hereby claim foreign priority benefits under Title 35, United States Code,
`Section 119 of any foreign application(s) for patent or inventor’s certificate listed below
`and have also identified below any foreign application for patent or inventor’s certificate
`having a filing date before that of the application on which priority is claimed:
`
`Prior Foreigp Application! s) (Country) (Number) (Day/Month/Year Filed) Priority Claimed
`
`I hereby claim the benefit under Title 35, United States Code, Section 120 of any
`United States Application(s) listed below and, insofar as the subject matter of each of the
`claims of this application is not disclosed in the prior United States application in the
`manner provided by the first paragraph of Title 35, United States Code, Section 112, I
`acknowledge the duty to disclose material information as defined in Title 37, Code of
`Federal Regulations, Section l.56(a) which occurred between the filing date of the prior
`application and the national or PCT international filing date of this application.
`
`Application Serial No.
`
`Filing Date
`
`Status Pending
`
`
`
`
`
`OA—003.00us
`
`Lang
`
`l
`-9-
`_9_
`
`

`

`I further direct that correspondence concerning this application be directed to:
`
`Philipp Lang, MD.
`36 Fairlawn Lane
`
`Lexington, MA 02420
`
`(781)-274-7493
`
`I hereby declare that all statements made herein of my own knowledge are true
`and that all statements made on information and belief are believed to be true; and further
`that these statements were made with the knowledge that willful false statements and the
`like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title
`18 of the United States Code and that such willfiil false statements may jeopardize the
`
`validity the application or any patent issued thereon.
`
`
`
`Full name of sole or first inv
`
`Inventor’s signature
`
`Date: 2"
`
`Residence:
`
`Lexington, '
`
`,
`
`Citizen:
`
`Germany
`
`Post Office Address:
`
`36 Fairlawn Lane
`
`Lexington, MA 02402
`
`OA—003.00us
`
`Lang
`
`2
`-10-
`_10_
`
`
`
`

`

`Filed: March 12th, 2002
`Applicant: Lang
`TITLE: Novel Devices for Cartilage Repair
`
`ATTORNEY DOCKET NO.: OA—003.00us
`
`VERIFIED STATEMENT CLAIMING SMALL ENTITY STATUS
`
`37 CFR 1.27(b) AS AN INDIVIDUAL
`
`I hereby declare that I am Philipp Lang, German Citizen and Resident of 36 Fairlawn Lane, Lexington,
`MA 02420 (herein referred to as “Lang”).
`
`I hereby declare that any and all rights under contract or law have been conveyed to and remain with
`Lang with regard to the invention:
`
`ENTITLED “METHODS TO IMPROVE CARTILAGE REPAIR SYSTEMS”
`
`by inventor Philipp Lang
`
`described in docket no. OA-003.00us, filed March 12th. 2002.
`
`If the rights held by Lang are not exclusive, each individual, concern or organization having rights to
`the invention is listed below* and no rights to the invention are held by any person, other than the
`inventor, who would not qualify as an independent inventor under 37 CFR 1.9(c) if that person made
`the invention, or by any concern which would not qualify as a small business concern under 37 CFR
`1.9(d), or a nonprofit organization under 37 CFR 1.9(e). *NOTE: Separate verified statements are
`required from each named person, concern or organization having rights to the invention averring to
`their status as small entities. (37 CFR 1.27)
`
`Full Name:
`
`
`
`
`
`:2: Address:
`
`
`
`[ ] INDIVIDUAL [ ] SMALL BUSINESS CONCERN [ ] NONPROFIT ORGANIZATION
`
`I acknowledge the duty to file, in this application or patent, notification of any change in status
`resulting in loss of entitlement to small entity status prior to paying, or at the time of paying, the
`earliest of the issue fee or any maintenance fee due after the date on which status as a small entity is no
`longer appropriate. (37 CFR l.28(b))
`
`I hereby declare that all statements made herein of my own knowledge are true and that all statements
`made on information and belief are believed to be true; and further that these statements were made
`with the knowledge that willful false statements and the like so made are punishable by fine or
`imprisonment, or both, under section 1001 of Title 18 of the United States Code, and that such willful
`false statements may jeopardize the validity of the application, any patent issuing thereon, or any patent
`
`OA—003 . OOus
`
`Lang
`
`-11-
`_11_
`
`

`

`on which this verified statement is directed.
`
`26 E‘r/Qm Lea/M.
`
`Lexi/7
`
`m
`
`/\7fl 02%29
`
`Name:
`Address: Signature:
`
`
`
`Date:
`
`"
`
`~07
`
`
`
`OA—003 .OOus
`
`Lang
`
`-12-
`_12_
`
`