(12) United States Patent
`Corbitt, Jr. et al.
`
`111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US006214045Bl
`US 6,214,045 Bl
`Apr. 10, 2001
`
`(10) Patent No.:
`(45) Date of Patent:
`
`(54) BIOABSORBABLE BREAST IMPLANT
`
`(76)
`
`Inventors: John D. Corbitt, Jr., 2868 Kirkwood
`Village, Palm Springs, FL (US) 33461;
`Lori A. Leonetti, 540 Jefferson Dr.,
`#110, Deerfield Beach, FL (US) 33446
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 09/169,351
`
`(22) Filed:
`
`Oct. 9, 1998
`
`Related U.S. Application Data
`(60) Provisional application No. 60/061,588, filed on Oct. 10,
`1997, provisional application No. 60/077,639, filed on Mar.
`11, 1998, and provisional application No. 60/091,306, filed
`on Jun. 30, 1998.
`
`Int. Cl? .................................. A61F 2/12; A61F 2/02
`(51)
`(52) U.S. Cl. ............................ 623/8; 623/23.75; 424/400
`(58) Field of Search ................................. 623/7, 8, 23.75;
`628/8; 606/77; 424/426
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`Re. 35,391 * 12/1996 Brauman .................................. 623/8
`4,298,998 * 11/1981 Naficy ................ ...................... 623/7
`5,120,802 * 6/1992 Mares eta!. ......................... 525/415
`5,522,896 * 6/1996 Prescott .................................... 623/6
`
`5,626,611 * 5/1997 Liu et a!.
`............................. 606/230
`5,824,081 * 10/1998 Knapp et a!.
`............ .............. 623/11
`5,869,080 * 2/1999 McGregor et a!.
`.................. 424/426
`5,922,024 * 7/1999 Janzen eta!. ............................ 623/8
`6,066,325 * 5!2000 Wallace ........................ ........ 424/400
`
`OTHER PUBLICATIONS
`
`P. Eiselt et al., "Development of Technologies Aiding Lar(cid:173)
`ge-Tissue Engineering"; Biotechnology Progress; 1998;
`vol. 14, No. 1; pp. 134--140.
`* cited by examiner
`
`Primary Examiner-David H. Willse
`Assistant Examiner-Suzette J. Jackson
`(74) Attorney, Agent, or Firm---Ostrolenk, Faber, Gerb &
`Soffen, LLP
`
`(57)
`
`ABSTRACT
`
`A breast implant has at least an outer shell which is com(cid:173)
`posed of a resorbable material. The implant, which can be
`formed entirely of bioresorbable material, is sized and
`shaped to replace excised tissue. The implant supports
`surrounding tissue upon implantation, while allowing for
`in-growth of fibrous tissue to replace the implant. According
`to various alternative embodiments, the implant is elastically
`compressible, or can be formed from self-expanding foam or
`sponges, and can be implanted through a cannula or by
`injection, as well as by open procedures. The implant also is
`capable of carrying therapeutic and diagnostic substances.
`
`24 Claims, 1 Drawing Sheet
`
`12
`
`~
`
`16
`
`10
`
`Focal Exhibit 1015 Page 1
`
`

`
`U.S. Patent
`
`Apr. 10, 2001
`
`US 6,214,045 Bl
`
`FIG. 1
`
`6
`
`FIG. 2
`
`FIG. 4
`
`16
`
`FIG. 3
`
`FIG. 6
`
`FIG. 5
`
`Focal Exhibit 1015 Page 2
`
`

`
`US 6,214,045 Bl
`
`1
`BIOABSORBABLE BREAST IMPLANT
`
`This application claims the benefit of U.S. Provisional
`Application Ser. No. 60/061,588, filed Oct. 10, 1997, U.S.
`Provisional Application Ser. No. 60/077,639, filed Mar. 11, 5
`1998, and U.S. Provisional Application Ser. No. 60/091,306,
`filed Jun. 30, 1998, the disclosures of which are incorporated
`herein by reference.
`
`2
`The implant is sized and shaped to replace the excised tissue.
`The implant supports surrounding tissue while fibrous tissue
`replaces the resorbable portion of the implant.
`Advantageously, the implant can be provided in the form
`of a compressible or non-compressible sponge, or a self(cid:173)
`expanding foam. The implant can be instilled with beneficial
`materials, and can be inserted through a cannula, a needle,
`or directly inserted.
`Other features and advantages of the present invention
`10 will become apparent from the following description of the
`invention which refers to the accompanying drawings.
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention relates to implantable prostheses.
`More particularly, the present invention relates to implant(cid:173)
`able breast prostheses designed to eliminate encapsulation
`and reduce scarring, and to replace tissue removed for 15
`purposes of biopsy or lumpectomy.
`2. Description of the Related Art
`Breast prostheses are utilized for augmentation mammo(cid:173)
`plasty and in cosmetic surgery. Prostheses also are indicated
`in breast cancer surgery, such as lumpectomies, where a
`portion of the breast is removed and can leave some disfig(cid:173)
`urement if not replaced by a similar amount of tissue and/or
`augmentation material.
`Similarly, biopsies can leave small dimples or imperfec- 25
`tions if remedial steps are not taken. About 1 million breast
`biopsies are performed in the United States annually. As a
`result, some 200,000 new breast cancers are diagnosed each
`year.
`Known methods of augmentation mammoplasty utilize
`silicone or saline implants. These have been complicated by
`encapsulation of the implants, which can occur to varying
`degrees. Encapsulation produces a hard area of scar tissue
`around the implant, resulting in a rigid, abnormally-shaped
`mound beneath the breast tissue or pectoralis muscle, 35
`depending upon the placement of the implant.
`Moreover, the known implant materials may not be indi(cid:173)
`cated for replacement of smaller amounts of tissue, as would
`be required to prevent dimpling after biopsies, and they are
`not amenable to resizing. Further, the known implants are
`not capable of being implanted through a cannula or needle,
`and are not readily instilled with medicaments or chemical
`agents that would be useful in treating the patient.
`Accordingly, a need exists for implants and methods that
`can be adapted for replacement of small as well as large
`amounts of tissue. A need also exists for implants that can be
`delivered through cannulae or needles, as well as being able
`to significantly reduce or eliminate encapsulation, resulting
`in a prolonged, aesthetically pleasing, soft mound below the
`breast tissue or pectoralis muscle. In addition, a need exists 50
`for implants into which useful substances, such as beneficial
`medications, chemical agents, hormonal treatments, and
`radiation media can be instilled to enhance the treatment
`capabilities of the implant in cancer and other breast pathol(cid:173)
`ogy.
`
`45
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`20
`
`FIG. 1 is a schematic elevation of a breast implant
`according to a preferred embodiment of the present inven(cid:173)
`tion.
`FIG. 2 is a schematic view of a breast after implantation
`of the implant of FIG. 1.
`FIG. 3 is a schematic view of a breast after implantation
`of an alternative embodiment of the implant of the present
`invention.
`FIG. 4 is a cross-sectional schematic view of a breast
`implant according to a second alternative embodiment of the
`present invention.
`FIG. 5 is a schematic view of a breast after implantation
`of the implant of FIG. 4.
`FIG. 6 is a schematic view of a breast implant and a
`30 method of insertion according to further alternative embodi(cid:173)
`ments of the present invention, particularly for cases involv(cid:173)
`ing the removal of smaller pieces of tissue such as by biopsy
`and lumpectomy.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`Referring initially to FIGS. 1 and 2, an implant 2 has an
`outer shell 4 made of a biosorbable material woven into a
`mesh. The inner contents of the implant are fluids such as
`40 saline and autologous blood products.
`Outer shell 4 is made entirely of a biosorbable material,
`such as polyglycolic acid, for example, as set forth below.
`Over a period of approximately three weeks to six months,
`the outer shell will dissolve, leaving the inner contents 6
`present inside the breast. Hard encapsulation will not occur
`because there is not a foreign body contained within the
`prosthetic space.
`Referring to FIG. 3, implantation of an alternative
`embodiment of implant 2 is illustrated in which the outer
`shell 4 includes both biosorbable material, and non(cid:173)
`absorbable material, such as monofilament polypropylene
`fibers. Outer shell 4 is provided as a mesh or weave of the
`mixed material, surrounding contents 6 as described above.
`55 After a resorption period, contents 6 remain surrounded by
`a skeletal outer shell made up of non-absorbable fibers 8, as
`shown in FIG. 3.
`Advantageously, the proportions and spacing of the two
`types of materials can be altered to provide the desired
`60 properties of containment using a minimal amount of non(cid:173)
`absorbable material. Accordingly, the non-absorbable fibers
`8 which remain after the biosorbable materials resorb will
`act as a scaffolding to allow the prosthesis to hold its shape;
`however, because of the limited amount of foreign material,
`65 encapsulation and scarring are decreased.
`Referring to FIGS. 4 and 5, a second alternative embodi(cid:173)
`ment of the present invention is shown. A prothesis 10
`
`SUMMARY OF THE INVENTION
`The present invention overcomes deficiencies of the prior
`art, such as those noted above, by providing an implant in
`which at least the outer portion of the implant, and as much
`the entire implant, is made of a resorbable material. The
`implant is sized and shaped to replace excised tissue, sup(cid:173)
`ports the surrounding tissue after implantation, and permits
`the in-growth of fibrous replacement tissue without encap(cid:173)
`sulation or with reduced scarring.
`Accordingly, excised tissue is replaced by implanting an
`implant having at least an outer shell of resorb able material.
`
`Focal Exhibit 1015 Page 3
`
`

`
`US 6,214,045 Bl
`
`3
`features two capsules, a larger, outer capsule 12 made of
`biosorbable materials, and a smaller inner capsule 14 made
`of a non-absorbable material. Inner capsule 14 also can be
`made partially resorb able as in the first alternative embodi(cid:173)
`ment above. Outer capsule 12 and inner capsule 14 can be 5
`separated by a thin layer 16 of saline or autologous fluids
`such as those described above. Inner capsule 14 surrounds a
`more permanent prosthesis 18 made of autologous fluids or
`saline, for example.
`After implantation, outer capsule 12 dissolves, thus pre- 10
`venting hardening by encapsulation of the prosthesis. The
`supply of fluid 16 between the capsules (a few to several
`cc.'s) is absorbed by the body once released by the disso(cid:173)
`lution of outer capsule 12.
`Referring to FIG. 6, a further alternative embodiment of 15
`the present invention includes an implant prosthesis 20
`provided in the form of a matrix framework, such as a
`sponge or foam. The implant, which preferably is entirely
`biodegradable, has a porous structure which supports the
`surrounding tissue and provides a framework for the 20
`in-growth of fibrous tissue material.
`According to a preferred embodiment, the implant is
`provided in the form of a sponge which can be modified by
`a surgeon prior to implantation, such as at a lumpectomy or
`biopsy site, simply by trimming the sponge to the appropri- 25
`ate size and shape. Alternatively, the implant can be a
`pre-shaped prosthesis of appropriate size, or an appropriate
`amount of foam. Advantageously, the implant can be modi(cid:173)
`fied to correspond to the breast tissue that either has been
`removed, requires replacement, or requires augmentation.
`A preferred method of implantation is shown in FIG. 6,
`whereby the implant is elastically compressible, and is
`delivered using a cannula or needle 22 inserted into the
`breast. A single implant 20 is shown being compressed so as 35
`to fit within cannula 22. A force is applied to drive the
`compressed implant distally through and out the distal end
`of the cannula into the implant site, where the resilient
`implant 20 expands to fill the implant site space.
`The force for advancing the sponge through the cannula 40
`can be applied directly to the implant, or indirectly using
`fluids, for example. Advantageously, the implant can be used
`in conjunction with stereotactic biopsy instrumentation,
`such as the ABEl System, the MIB System by USS, or the
`Mammotome System.
`As a further alternative, the sponge implant of the present
`invention can form all or part of a larger implant, such as
`those described above, to form, for example, all or part of the
`outer shell 4 of implant 2. Implantation using open proce(cid:173)
`dures usually would be indicated when the sponge implant 50
`of the present invention is used as all or part of a larger
`implant. Accordingly, the sponge or implant would be
`placed directly into the biopsy or lumpectomy cavity.
`In addition, the implant 20 can be provided in the form of
`a self-expanding foam, which can be injected by needle or 55
`through cannula 22 in a metered amount. Alternatively, a
`specialized applicator may be used to inject the desired
`amount of the foam. The amount of foam is preselected to
`allow sufficient expansion to fill the void left by the excision
`and support the surrounding tissue to prevent dimpling.
`Following insertion of the implant, such as by an open
`method or one of the stereotactic methods described above,
`the resorbable implant occupies the breast tissue cavity and
`supports the surrounding tissue until such time as it is
`resorbed or biodegrades. After initial implantation, the 65
`patient's own fluids and fibroblast permeate the sponge
`prosthesis. In the case of a small implant, such permeation
`
`4
`would occur naturally, subsequent to implantation. In the
`case of a larger implant, providing the implant at least
`partially filled with fluids prior to implantation may be
`indicated.
`Advantageously, the new prosthesis decreases encapsula(cid:173)
`tion after implantation. Various biosorbable materials can be
`used in the implant of the present invention. Known bio(cid:173)
`sorbable materials include the following:
`polyglycolic acid (Dexon, Davis & Geck);
`polyglactin material (Vicryl, Ethicon);
`poliglecaprone (Monocryl, Ethicon); and
`synthetic absorbable lactomer 9-1 (Polysorb, United
`States Surgical Corporation).
`The examples above are designed to last varying lengths of
`time, after which time they are totally resorbed.
`According to the present invention, these products may be
`mixed with one another or combined to provide various
`resorption times or gradients, and/or may be interrelated
`with non-absorbable materials, such as polypropylene or
`PTFFE (Gortex) material, for example. In an instance where
`a non-absorbable material is utilized, the non-resorbable
`implant section will remain partially intact as a permanent
`structure.
`In each of the embodiments, the resorbable portions of the
`prosthesis ultimately biodegrade, and the patient is left with
`autologous tissue, some of which may have been implanted,
`or a permanent implant such as saline, as a filler for the
`biopsy cavity, thus preserving the contour of the breast and
`preventing indentation of the overlying skin.
`The implants of the present invention further can be
`instilled, before or after implantation, with indicated medi(cid:173)
`cines and other chemical or diagnostic agents. Examples of
`such agents include, but are not limited to, antibiotics,
`chemotherapies, other cancer therapies, brachytherapeutic
`material for local radiation effect, x-ray opaque or metallic
`material for identification of the area, hemostatic material
`for control of bleeding, growth factor hormones, immune
`system factors, gene therapies, biochemical indicators or
`vectors, and other types of therapeutic or diagnostic mate(cid:173)
`rials which may enhance the treatment of the patient.
`The present invention has been described particularly in
`connection with a breast implant, but it will be obvious to
`those of skill in the art that the invention can have applica-
`45 tion to other parts of the body, such as the face, and generally
`to other soft tissue or bone. Accordingly, the invention is
`applicable to replacing missing or damaged soft tissue,
`structural tissue or bone, or for cosmetic tissue or bone
`replacement.
`Although the present invention has been described in
`relation to particular embodiments thereof, many other
`variations and modifications and other uses will become
`apparent to those skilled in the art. It is preferred, therefore,
`that the present invention be limited not by the specific
`disclosure herein, but only by the appended claims.
`What is claimed is:
`1. An implant for implantation in a human body compris(cid:173)
`ing an outer shell of resorbable material and a resorbable
`inner fluid core, the implant being formed to fit the shape and
`60 size of a cavity in the human body, the implant being
`configured to be installed for supporting tissue surrounding
`the cavity and allowing in-growth of fibrous tissue into and
`replacing the outer shell.
`2. The implant of claim 1, wherein the outer shell further
`comprises a non-resorbable material.
`3. The implant of claim 1, wherein the outer shell is
`elastically compressible.
`
`30
`
`Focal Exhibit 1015 Page 4
`
`

`
`US 6,214,045 Bl
`
`5
`4. The implant of claim 1, wherein the core is surrounded
`completely by the outer shell.
`5. The implant of claim 4, wherein the core includes
`autologous material.
`6. The implant of claim 1, further comprising at least one 5
`of radiation material, antibiotics, chemotherapies, cancer
`therapies, hemostatic material, hormone therapies, and
`radiographic markers.
`7. The implant of claim 1, further comprising at least one
`medicinal, therapeutic or diagnostic substance.
`8. The implant of claim 7, wherein the at least one
`substance is selected from the group consisting of radiation
`material, antibiotics, chemotherapies, cancer therapies,
`hemostatic material, hormone therapies, and radiographic
`markers. and the step of implanting is performed by injec- 15
`tion of the self-expanding foam.
`9. A method for replacing excised human breast tissue
`with an implant comprising the steps of:
`forming a cavity having surrounding tissue within a
`breast;
`forming the implant entirely of resorbable material and
`sizing the implant to occupy the cavity; and
`implanting the implant in the cavity, the implant support(cid:173)
`ing the surrounding tissue and allowing for in-growth 25
`of fibrous tissue into and replacing the resorbable
`material wherein the resorbable material is elastically
`compressible, and the step of implanting includes the
`step of compressing the resorbable material.
`10. The method of claim 9, further comprising the step of 30
`introducing into the implant at least one of a medicinal,
`therapeutic or diagnostic substance.
`11. The method of claim 9, wherein the at least one
`substance is selected from the group consisting of radiation
`material, antibiotics, chemotherapies, cancer therapies, 35
`hemostatic material, hormone therapies, and radiographic
`markers.
`12. The implant of claim 1, wherein the core includes a
`saline solution.
`13. The implant of claim 1, further comprising a resorb- 40
`able inner shell surrounding the inner core, and a supply of
`fluid disposed between the inner shell and the outer shell.
`14. An implant for implantation in a human body com(cid:173)
`prising an outer shell of a resorbable material, the implant
`being formed to fit the shape and size of a cavity in the
`human body, the implant supporting tissue surrounding the
`cavity upon implantation and allowing for in-growth of
`
`6
`fibrous tissue into and replacing the outer shell, and a
`resorbable core provided inside and surrounded by the outer
`shell and containing autologous material.
`15. The implant of claim 14, wherein the core is partially
`enclosed by a nonabsorbable material.
`16. The method of claim 9, wherein the step of implanting
`the implant in the cavity comprises expanding the implant
`within the cavity.
`17. A breast implant comprising a self-expanding matrix
`10 of biocompatible material, the expanded matrix having a
`porous structure for supporting surrounding tissue of a
`breast and configured to provide a framework for the
`in-growth of fibrous tissue into the matrix.
`18. The breast implant of claim 17, wherein the biocom(cid:173)
`patible material is resorbable.
`19. The breast implant of claim 17, wherein the self(cid:173)
`expanding matrix comprises a foam.
`20. The breast implant of claim 17, wherein the self-
`20 expanding matrix comprises a resilient framework for
`implantation by compressing the matrix into a smaller
`volume, the matrix expanding resiliently within the breast.
`21. The implant of claim 1, wherein the outer shell is
`adjacent the inner core.
`22. A method for replacing excised human breast tissue
`with an implant comprising the steps of:
`forming a cavity having surrounding tissue within a
`breast;
`forming the implant entirely of resorbable material and
`sizing the implant to occupy the cavity; and
`implanting the implant in the cavity, the implant support-
`ing the surrounding tissue and allowing for in-growth
`of fibrous tissue into and replacing the resorbable
`material, wherein the resorbable material is formed
`from a self-expanding foam and the step of implanting
`is performed by injection of the self-expanding foam.
`23. The method of claim 22, further comprising the step
`of introducing into the implant at least one of a medicinal,
`therapeutic or diagnostic substance.
`24. The method of claim 23, wherein the at least one
`substance is selected from the group consisting of radiation
`material, antibiotics, chemotherapies, cancer therapies,
`hemostatic material, hormone therapies, and radiographic
`45 markers.
`
`* * * * *
`
`Focal Exhibit 1015 Page 5
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`.
`CERTIFICATE OF CORRECTION
`
`PA1ENT NO.
`DATED
`INVENTOR(S)
`
`:6,214,045 Bl
`: AprillO, 2001
`:John D. Corbitt, Jr. and Lori A. Leonetti
`
`Page 1 of 1
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is
`hereby corrected as shown below:
`
`Claim 8,
`Should read as follows:
`
`8. The implant of claim 7, wherein the at least one substance is selected frQm the group
`consisting of radiation material, antibiotics, chemotherapies, cancer therapies,
`hemostatic material, hormone therapies, and radiographic markers.
`
`Signed and Sealed this
`
`Eighteenth Day of December, 200 I
`
`Arrest:
`
`Attesting Officer
`
`JAMES E. ROGAN
`Director of the United States Patent and Trademark Office
`
`Focal Exhibit 1015 Page 6
`
`

`
`1111111111111111111111111111111111111111111111111111111111111
`US006214045C 1
`c12) EX PARTE REEXAMINATION CERTIFICATE (6465th)
`United States Patent
`US 6,214,045 Cl
`c1o) Number:
`Corbitt, Jr. et al.
`(45) Certificate Issued:
`Oct. 7, 2008
`
`111111
`
`(54) BIOABSORBABLE BREAST IMPLANT
`
`wo
`
`wo 95/07057
`
`3/1995
`
`(75)
`
`Inventors: John D. Corbitt, Jr., Palm Springs, FL
`(US); Lori A. Leonetti, Deerfield Beach,
`FL (US)
`
`(73) Assignee: Whitewater Investments, Inc., Atlantis,
`FL (US)
`
`Reexamination Request:
`No. 90/008,109, Jun. 29, 2006
`
`Reexamination Certificate for:
`6,214,045
`Patent No.:
`Apr. 10, 2001
`Issued:
`09/169,351
`Appl. No.:
`Oct. 9, 1998
`Filed:
`
`Certificate of Correction issued Dec. 18, 2001.
`
`Related U.S. Application Data
`(60) Provisional application No. 60/061,588, filed on Oct. 10,
`1997, provisional application No. 60/077,639, filed on Mar.
`11, 1998, and provisional application No. 60/091,306, filed
`on Jun. 30, 1998.
`
`(51)
`
`Int. Cl.
`A61F 2112
`A61F 2102
`
`(2006.01)
`(2006.01)
`
`OTHER PUBLICATIONS
`
`Order Construing Claims ofU.S. Patent No. 6,214,045, Civil
`Action No. CV 04-81178 (S.D. FL).
`Rebuttal Expert Report of Dr. Pat Whitworth (prepared by
`Edward A. Dauer) filed in Civil Action No. CV 04-81178
`(S.D. FL).
`Letter date Oct. 20, 2004 from EthiconEndo-Surgery to
`John D. Corbitt, MD, with enclosures.
`F. J. O'Brien, et a!. "Influence of Freezing Rate on Pore
`Structure in Freeze-dried Collagen-GAG Scaffolds", Rio(cid:173)
`materials 25 1077-1086, (2004).
`F. J. O'Brien, eta!. "The Effect of Pore Size on Cell Adhe(cid:173)
`in Collagen-GAG Scaffolds", Biomaterials 26
`sion
`433-441, (2005).
`James M. Pachence, "Collagen-based Devices for Soft Tis(cid:173)
`sue Repair", Journal of Biomedical Materials Research
`(Applied Biomaterials) vol. 33, 35-40 (1996).
`Jury Verdict Form, Case No. 04-81178-CIV -Middlebrooks/
`Johnson, White Water Investments, Inc. v. Ethicon Endo(cid:173)
`Surgery, Inc. (2005).
`Case No.
`Jury;
`the
`to
`Court's
`Instructions
`04-81178--CIV -Middlebrooks/ Johnson, White Water
`Investments, Inc. v. Ethicon Endo-Surgery, Inc. (2005).
`
`(Continued)
`
`(52) U.S. Cl. .......................... 623/8; 424/400; 623/23.75
`(58) Field of Classification Search ........................ None
`See application file for complete search history.
`
`Primary Examiner-Beverly M. Flanagan
`
`(57)
`
`ABSTRACT
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,326,350 A
`5,716,404 A
`6,066,325 A
`
`7/1994 Li
`211998 Vacanti . ... .. ... ... ... ... ... .. ... 623/8
`5/2000 Wallace et a!.
`
`FOREIGN PATENT DOCUMENTS
`
`JP
`JP
`wo
`
`08-500274
`09-502371
`wo 94/16647
`
`111996
`3/1997
`8/1994
`
`A breast implant has at least an outer shell which is com(cid:173)
`posed of a resorbable material. The implant, which can be
`formed entirely of bioresorbable material, is sized and
`shaped to replace excised tissue. The implant supports sur(cid:173)
`rounding tissue upon implantation, while allowing for
`in-growth of fibrous tissue to replace the implant. According
`to various alternative embodiments, the implant is elastically
`compressible, or can be formed from self-expanding foam or
`sponges, and can be implanted through a cannula or by
`injection, as well as by open procedures. The implant also is
`capable of carrying therapeutic and diagnostic substances.
`
`10
`
`Focal Exhibit 1015 Page 7
`
`

`
`US 6,214,045 Cl
`Page 2
`
`OTHER PUBLICATIONS
`
`Expert Report by Edward A. Dauer, dated Jun. 1, 2005, Case
`No. 04-81178--CIV-Middlebrooks/Johnson, White Water
`Investments, Inc. v. Ethicon Endo-Surgery, Inc.
`
`Defendant's Motion for Summary Judgment, filed Jun. 29,
`2005, Case No. 04-81178-CIV-Middlebrooks/Johnson,
`White Water Investments, Inc. v. Ethicon Endo-Surgery, Inc.
`
`Declaration of Dr. Pat. Whitworth in Support of Defendant's
`Motion for Summary Judgment, filed Jun. 29, 2005, Case
`No. 04-81178--CIV-Middlebrooks/Johnson, White Water
`Investments, Inc. v. Ethicon Endo-Surgery, Inc.
`
`Plaintiff's Response in Opposition to Defendant's Motion
`for Summary Judgment, filed Jul. 18, 2005, Case No.
`04-81178--CIV -Middlebrooks/ Johnson, White Water
`Investments, Inc. v. Ethicon Endo-Surgery, Inc.
`Declaration of Dr, Edward A Dauer in Support of Defen(cid:173)
`dant's Motion for Summary Judgment, filed Jul. 18, 2005,
`Case No. 04-81178-CIV -Middlebrooks/Johnson, White
`Water Investments, Inc. v. Ethicon Endo-Surgery, Inc.
`Defendant's Reply Memorandum in Support of its Motion
`for Summary Judgment, filed Jul. 26, 2005, Case No.
`04-81178--CIV -Middlebrooks/ Johnson, White Water
`Investments, Inc. v. Ethicon Endo-Surgery, Inc.
`John D. Corbitt, Jr., M.D., "Comparison of the '045 Patent
`with the Li Patent," filed Jul. 6, 2007.
`
`Focal Exhibit 1015 Page 8
`
`

`
`US 6,214,045 Cl
`
`1
`EX PARTE
`REEXAMINATION CERTIFICATE
`ISSUED UNDER 35 U.S. C. 307
`
`THE PATENT IS HEREBY AMENDED AS
`INDICATED BELOW.
`
`Matter enclosed in heavy brackets [ ] appeared in the
`patent, but has been deleted and is no longer a part of the
`patent; matter printed in italics indicates additions made
`to the patent.
`
`AS A RESULT OF REEXAMINATION, IT HAS BEEN
`DETERMINED THAT:
`
`The patentability of claims 1-24 is confirmed.
`
`2
`New claims 25-28 are added and determined to be patent(cid:173)
`able.
`
`2 5. The method of claim 9, wherein the implant is sized to
`5 occupy substantially the entirety of the cavity within the
`breast.
`26. The breast implant of claim 17, wherein the implant is
`sized to occupy substantially an entire cavity in the breast.
`2 7. The breast implant of claim 17, wherein the matrix of
`10 the implant is configured, in its expanded state, to support
`the surrounding tissue of the breast.
`28. The method of claim 22, wherein the implant is sized
`to occupy substantially the entirety of the cavity within the
`breast.
`
`15
`
`* * * * *
`
`Focal Exhibit 1015 Page 9