IIIIIIlIiI‘iIlIllIIIIIIOld'8“18le
`
`PTO/SBIO5 (09-04)
`Approved for use through 07/31/2006. 0MB 0651-0032
`US. Patent and Trademark Office. US. DEPARTMENT OF COMMERCE
`Under the Pa - rwork Reducb‘on Act of 1995, no 0 rsons are wuired to res- rid to a collection of infonnation unless it dis a
`a valid OMB control number.
`
`John D Corbitt Jr UT'L'TY
`
`
` PATENT APPLICATION
`— Y—
`
`TRANSMITTAL
`(ONLY FOR NEW NONPROVISIONAL APPLICA TIONS UNDER
`
`”film”
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`C31200001/P001-B
`
`Title
`
`TISSUE MARKING IMPLANT
`
`_
`
`“co
`30'?)
`0
`“5\
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`4.
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`Drawing(s) (35 U.S.C. 113)
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`[Total Sheets
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`5. Oath or Declaration
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`[Total Sheets
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`Name of Assignees
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`]
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`]
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`]
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`10'
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`1
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`4
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`a.
`b.
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`
`
`
`
`ADDRESS TO‘ 33135:?2580 for Patents
`Alexandria, VA 22313-1450
`
`Fee Transmittal Form (e.g., PTO/SB/17)
`ACCOMPANYING—PPLICATIONPARTS
`9.D—AssignmentPapers(coversheet8-document(s))
`(Submit an original and a duplicate for fee processing)
`
`Applicant claims small entity status.
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`See 37 CFR 1.27.
`2‘
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`19
`[Total Pages
`3. E] Specification
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`Both the claims and abstract must start on a new page
`(For infon'nation on the preferred arrangement, see MPEP 608.01(a))
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`37 CFR 3.73(b) Statement
`Power of
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`Attorney
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`11. [:1 English Translation Document (if applicable)
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`12. [:1 Information Disclosure Statement (PTO/SBIOB or PTO-1449)
`SomirffaToi/Sfigioii’l’lflg? 5375;;39-33‘”
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`DELETION OF INVENTOR S
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`named in the prior application,
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`see 37 CFR 1.63(d)(2) and 1.33(b).
` 13. |:' Preliminary Amendment
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`6. I: Application Data Sheet. See 37 CFR 1.76
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`'14_ a Return Receipt Postcard (MPEP 503)
`7_ El CD-ROM or CD-R in duplicate, large table or
`Computer Program (Appendix)
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`l:| Landscape Table on CD
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`Nucleotide and/or Amino Acid Sequence Submission
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`(if applicable, items a. —- c. are required)
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`1 0/621718
`3738
`
`The address associated with Customer Number:
`
`
`24998
`
`-
`
`OR B Correspondence address below
`
`
`
`Stephen A. Soffen
`DICKSTEIN SHAPIRO MORIN & OSHINSKY LLP
`
`
`2101 L Street NW
`
`w shington m
`
`
`DC
`ZipCoae
`20037-1526
`
`Fax
`
`(202)887-0689
`
`(202) 785-9700
`W—__— elephone
`
`
`Signature
`Name (Print/Type)
`
`.
`
`Stephen A. Soffen
`
`Date
`April 19, 2005
`{ffiififfiffggm 31,063
`
`, ..
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`DSMDB. 19 I475}. I
`
`Focal Exhibit 1002 Pagei
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`a. l:] Computer Readable Form (CRF)
`b.
`Specification Sequence Listing on:
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`
`
`
`18.
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`15 ‘1 Certified Copy of Priority Document(s)
`'
`(if foreign priority is claimed)
`16
`Nonpublication Request under 35 U.S.C.122 (b)(2)(B)(i).
`Applicant must attach form PTO/$8135 or its equivalent.
`
`'
`
`17. D Other:
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`ii. [:1 Paper
`LI:| CD—ROM or CD—R (2 copies); or
`c.|:| Statements verifying identity of above copies
`If a CONTINUING APPLICATION, check appropriate box, and supply the requisite information below and in the first sentence of the
`specification following the title, or in an Application Data Sheet under 37 CFR 1. 76:
`E' Continuation l:l Divisional - Continuation-in-pan (CIP)
`of prior application No.:
`Pn'or application information: Examiner
`S.J. Jackson
`Art Unit:
`19. CORRESPONDENCE ADDRESS
`
`Focal Exhibit 1002 Page 1
`
`

`

` Old'8“19381
`
`PTO/38h 7 (1 2-04v2)
`Approved for use through 7/31/2006. OMB 0651-0032
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Under the Pa- -rwor‘k Reduction Act of 1995, no - rson are r- -uired to res- -nd to a collection of information unless it dis-la
`a valid OMB control number.
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`.
`Com . Iete if Known
`Effective on 12/08/2004.
`Fees pursuant to the Consolidated Appmpnaaons Act. zoos (rm 4818).
`FEE TRANSM ITTAL
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`
`
`For FY 2005
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`Not Yet Assigned
`Concurrently Herewith
`John D. Corbitt. Jr.
`Not Yet Assigned
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`
`
`_OTALAMOUNT OF PAYMENT
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`METHOD OF PAYMENT (check all that apply)
`
`C3120.0001/P001-B
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`'2‘ Credit Card D Money Order [3 None D Other (please identify):
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`E] Deposit Account
`newsmwunmumben 04—1073 Deposnmum Name;
`Dickstein Shapiro Morin & Oshinsky LLP
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`For the above—identified deposit account, the Director is hereby authorized to: (check all that apply)
`I: Charge fee(s) indicated below
`E] Charge fee(s) indicated below, except for the filing fee
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`
`Charge any additional fee(s) or underpayment of
`x Credit an over a ments
`fee(s) under 37 CFR 1.16 and 1.17
`y
`p y
`
`FEE CALCULATION
`
`
`
`
`1. BASIC FILING. SEARCH. AND EXAMINATION FEES
`
`SEARCH FEES
`FILING FEES
`
`M ___ySmallEntlt
`Fee (§)
`Fee
`Fee (5)
`150
`500
`250 .
`100
`100
`50
`100
`300
`150
`
`EXAMINATION FEES
`MM!
`Fee (Q
`100
`65
`80
`
`Fee (§)
`200
`130
`160
`
`Fees Paid (fl
`500.00
`
`Application Type
`Utility
`Design
`Plant
`
`Fee (§)
`300
`200
`200
`
`,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Multiple Dependent Claims
`Total Clalms
`Extra Claims
`Fee (5)
`Fee Paid (5)
`
`
`Fee (g)
`Fee Paid (fl
`24
`< 20 =
`4
`x 25.00
`=
`100.00
`
`
`
`lndep. Claims
`Extra Clalms
`Fee (3)
`Fee Paid (S)
`
`
`4
`-3=
`1
`X 100.00
`100.00
`
`
`
`
`3. APPLICATION SIZE FEE
`If the specification and drawings exceed 100 sheets of paper (excluding electronically filed sequence or computer
`
`
`listings under 37 CFR 1.52(e)), the application size fee due is $250 ($125 for small entity) for each additional 50
`
`
`sheets or fraction thereof. See 35 U.S.C. 41(a)(l)(G) and 37 CFR 1.16(s).
`
`
`Total Sheets
`Extra Sheets
`Number of each additional 50 or fractlon thereof
`- 100 =
`25
`(round up to a whole number) x
`
`
`4. OTHER FEE(S)
`
`
`
`Non-English Specification, $130 fee (no small entity discount)
`
`
`Other (e.g., late filing s . charge)
`
`
`
`
`—"rm.l/_
`
`_-‘Lma'l.f!- fixigiflgajfgem
`31,063
`Telephone
`(202) 828-4879
`
`
`
`Stephen A.
`offen
`Date
`April 19,2005
`
`
`Reissue
`Provisional
`
`'
`
`300
`200
`
`150
`100
`
`500
`O
`
`250
`0
`
`600
`0
`
`300
`0
`
`2. EXCESS CLAIM FEES
`Fee Description
`Each claim over 20 (including Reissues)
`Each independent claim over 3 (including Reissues)
`Multiple dependent claims
`
`mm
`.FB_9I§I m
`50
`25
`200
`100
`360
`180
`
`/50
`
`Fee (fl
`
`Fee Paid (§)
`
`=
`
`Fees Paid (fit
`
`DSMDB.1914750.I
`
`Focal Exhibit 1002 Page 2
`
`Focal Exhibit 1002 Page 2
`
`

`

`Docket No.: C3120.0001/P001-B
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION FOR US. LETTERS PATENT
`
`Title:
`
`TISSUE MARKING IMPLANT
`
`Inventor:
`
`John D. Corbitt, Jr.
`
`DICKSTEIN SHAPIRO MORIN 8C
`
`OSHINSKY LLP
`
`2101 L Street NW
`
`Washington, DC 20037-1526
`(202) 828—2232
`
`1688009 v1; 106H501LDOC
`DSMDB.1688009.1
`
`Focal Exhibit 1002 Page 3
`
`Focal Exhibit 1002 Page 3
`
`

`

`Docket No.: C3120.0001/P001—B
`
`TISSUE MARKING IMPLANT
`
`[0001]
`
`This application is a continuation in part of U.S. Patent Application Serial No.
`
`10/627,718, filed July 28, 2003, now U.S. Patent No. 6,881,226, which is a continuation
`
`of U.S. Patent Application Serial No. 09/169,351, filed October 9, 1998, now U.S. Patent
`
`No. 6,638,308, which claims the benefit of U.S. Provisional Application Serial No.
`
`60/061,588, filed October 10, 1997, U.S. Provisional Application Serial No. 60/077,639,
`
`filed March 11, 1998, and U.S. Provisional Application Serial No. 60/091,306, filed June
`
`30, 1998, the disclosures of which are incorporated herein by reference.
`
`BACKGROUND OF THE INVENTION
`
`[0002]
`
`The present invention relates to implantable prostheses. More particularly, the
`
`present invention relates to implantable breast prostheses designed to eliminate
`
`encapsulation and reduce scarring, and to replace tissue removed for purposes of biopsy or
`
`lumpectomy.
`
`Description of the Related Art
`
`[0003]
`
`Breast prostheses are utilized for augmentation mammoplasty and in cosmetic
`
`surgery. Prostheses are also indicated in breast cancer surgery, such as lumpectomies,
`
`where a portion of the breast is removed and can leave some disfigurement if not replaced
`
`by a similar amount of tissue and/or augmentation material.
`
`1688009 v1; 106H501LDOC
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`Focal Exhibit 1002 Page 4
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`Focal Exhibit 1002 Page 4
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`[0004]
`
`Similarly, biopsies can leave small dimples or imperfections 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.
`
`Docket No.: C3120.0001/P001~B
`
`[0005]
`
`Known methods of augmentation mammoplasty utilize silicone or saline
`
`implants. These methods have been complicated post-operatively 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 mount beneath the breast
`
`tissue or pectoralis muscle, depending upon the placement of the implant.
`
`[0006]
`
`Moreover, the known implant materials may not be indicated for replacement
`
`of smaller amounts of tissue, as would be required to prevent dimpling after biopsies, for
`
`example. Further, the known implant materials are not amenable to resizing. In addition,
`
`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.
`
`[0007]
`
`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 for implants into
`
`which useful substances, such as beneficial medications, chemical agents, hormonal
`
`1688009 v1: 106H501l.DOC
`DSMDB.1688009.1
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`3
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`Focal Exhibit 1002 Page 5
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`Focal Exhibit 1002 Page 5
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`

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`treatments, stem cells, such as adipocytes, cellular precursors and components, and
`
`radiation media can be instilled to enhance the treatment capabilities of the implant in
`
`cancer and other breast pathology.
`
`Docket No.: C3120.0001/I’001-B
`
`BRIEF SUMMARY OF THE INVENTION
`
`[0008]
`
`The present invention overcomes deficiency 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 as the entire implant, is made of a resorbable material. The implant is sized
`
`and shaped to reduce excised tissue. Preferably, the implant provides a support structure in
`
`the form of a framework or scaffold for the surrounding tissue after implantation. The
`
`support structure preferably is porous to permit the in-growth of fibrous replacement
`
`tissue. Advantageously, replacement tissue in-growth takes place without encapsulation
`
`and with reduced scarring.
`
`[0009]
`
`According to an embodiment of the invention, excised tissue is replaced by
`
`installing an implant having at least an outer shell of resorbable material. 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.
`
`[0010]
`
`In a further development, at least a portion of the implant can be provided in
`
`the form 0 f a compressible or non—compressible sponge or foam, or a self-expanding
`
`sponge or foam. The sponge or foam provides a porous support matrix for surrounding
`
`and in- growing tissue. In the form of a compressible, expandable, or self-expanding
`
`4
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`1688009 v1: 106H501!.DOC
`DSMDB. 16880091
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`Focal Exhibit 1002 Page 6
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`Focal Exhibit 1002 Page 6
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`

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`Docket No: C3120.0001/P001 -B
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`sponge or foam, the implant advantageously can be inserted through a cannula or a needle,
`
`or optionally can be directly inserted. Additionally, the implant can be instilled with
`
`beneficial materials, such as indicated medicaments, therapeutics, or diagnostic agents, as
`
`well as matrix enhancing additives.
`
`[001 1]
`
`Other features and advantages of the present invention will become apparent
`
`from the following description of the invention which refers to the accompanying
`
`drawings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0012]
`
`FIG. 1 is a schematic elevation of a breast implant according to a preferred
`
`embodiment of the present invention.
`
`[0013]
`
`FIG. 2 is a schematic sectional View of a breast after implantation of the
`
`implant of Fig. 1
`
`[0014]
`
`FIG. 3 is a schematic sectional View of a breast after implantation of an
`
`alternative embodiment of the implant of the present invention.
`
`[0015]
`
`FIG. 4- is a schematic sectional view of a breast implant according to a second
`
`alternative embodiment of the present invention.
`
`1688009 v1; 106H501LDOC
`DSMDB. l688009.l
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`Focal Exhibit 1002 Page 7
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`Focal Exhibit 1002 Page 7
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`

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`[0016]
`
`FIG. 5 is a schematic sectional view ofa breast after implementation of the
`
`Docket No.: C3120.0001/P001 -B
`
`implant ofFig. 4.
`
`[0017]
`
`FIG. 6 is a schematic sectional View ofa breast implant and a method of
`
`insertion according to further alternative embodiments of the present invention,
`
`particularly for cases involving the removal of smaller pieces of tissue such as by biopsy and
`
`lumpectomy.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0018]
`
`Referring initially to Figs. 1 and 2, an implant 2 has an outer shell 4 made ofa
`
`biosorbable material woven into a mesh. The inner contents of the implant are fluids such
`
`as saline and autologous blood products.
`
`[0019]
`
`Outer shell 4 is made entirely of biosorbable materials, such as collagens or
`
`polyglycolic acids, for example. Over a period of approximately three weeks to six months,
`
`the outer shell dissolves, 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.
`
`[0020]
`
`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-
`
`absorbable material, such as monofllament polypropylene fibers. Outer shell 4 is provided
`
`as a mesh or weave of the mixed material, surrounding contents 6 as described above.
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`1688009 v1: 106H501LDOC
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`6
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`Focal Exhibit 1002 Page 8
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`Focal Exhibit 1002 Page 8
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`

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`After a resorption period, contents 6 remain surrounded by a skeletal outer shell made up
`
`of non-absorbable fibers 8.
`
`Docket No.: C3120.0001/P001-B
`
`[0021]
`
`Advantageously, the proportions and spacing of the two types of materials can
`
`be altered to provide the desired properties of containment using a minimal amount of
`
`nonabsorbable 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, encapsulation and
`
`scarring are decreased.
`
`[0022]
`
`Referring to Figs 4 and 5, a second alternative embodiment of the present
`
`invention is shown. A prosthesis 10 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 resorbable as in the first alternative
`
`embodiment above. Outer capsule 12 and inner capsule 14 can be 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.
`
`[0023]
`
`After implantation, outer capsule 12 dissolves, thus preventing hardening by
`
`encapsulation of the prosthesis. The supply of fluid 16 between the capsules (a few to
`
`several c.c.’s) is absorbed by the body once released by the dissolution of outer capsule 12.
`
`1688009 v1: 106H501!.DOC
`DSMDB. 1688009. I
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`Focal Exhibit 1002 Page 9
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`Focal Exhibit 1002 Page 9
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`

`

`Docket No.: C3120.0001/P001 -B
`
`[0024]
`
`Referring to Fig. 6, a further alternative embodiment of 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 (resorbable), has a
`
`porous structure which supports the surrounding tissue and provides a framework for the
`
`in—growth of fibrous tissue material. Fig. 6 illustrates tissue portion 24 surrounding
`
`implant 20 into which marker dye included in the implant, and described further below,
`
`has leached over time from the implant, thereby marking the tissue. Accordingly, a
`
`surgeon performing a subsequent procedure easily will recognize the tissue surrounding the
`
`previous excision.
`
`[0025]
`
`According to a preferred embodiment, the implant is provided in the form of a
`
`foam or 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 appropriate size and
`
`shape. Alternatively, the implant can be a pre—shaped prosthesis of appropriate size, or an
`
`appropriate amount of foam or foam-forming materials. Optionally, the foam can be
`
`provided as a self-expanding matrix that either is compressed, or forms in situ.
`
`Advantageously, the implant-can be modified to correspond to he breast tissue that either
`
`has been removed, requires replacement, or requires augmentation. The foam or sponge
`
`matrix is sufficiently resilient to support the surrounding tissue without collapsing.
`
`[0026]
`
`A preferred embodiment of implantation is illustrated schematically 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 to fit
`8
`
`1688009 v1; meusonooc
`W
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`Focal Exhibit 1002 Page 10
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`Focal Exhibit 1002 Page 10
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`

`

`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
`
`Docket No.: C3120.0001/P001-B
`
`expands to fill the implant site space.
`
`[0027]
`
`The force for advancing the sponge or foam material through the cannula 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 ABBI® System, the MIB System by US Surgical, or the Mammotome® System by
`
`Johnson and Johnson.
`
`[0028]
`
`As a further alternative, the sponge or foam implant of the present invention
`
`can form all or part of a larger implant, such as those described above. Accordingly, the
`
`tissue supporting sponge or foam or foam matrix will form, for example, all or part of the
`
`outer shell 4 of implant 2. Implantation using open procedures usually would be indicated
`
`when the sponge implant 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.
`
`[0029]
`
`In addition, the implant 20 can be provided in the form of a self-expanding
`
`foam, which can be injected by the needle or through cannula 22 in a metered amount.
`
`An appropriate amount of foam-forming materials can be inserted through cannula 22 and
`
`allowed to expand or forma matrix within the cavity created by the excised tissue.
`
`Alternatively, a specialized applicator may be used to inject the desired amount of the foam.
`
`9
`
`1688009 v1; 106H501I.DOC
`DSMDB.I688009.1
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`Focal Exhibit 1002 Page 11
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`Focal Exhibit 1002 Page 11
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`

`

`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.
`
`Docket No.2 C3120.0001/P001-B
`
`[0030]
`
`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 resorbs or biodegrades.
`
`After initial implantation, the patient’s own fluids, fibroblast, and stem cells, such
`
`adipocytes, vascular stem cells, and others, permeates the sponge prosthesis. In the case of
`
`a small implant, such permeation 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.
`
`[0031]
`
`Advantageously, the new prosthesis decreases encapsulation after implantation.
`
`Various biosorbable materials can be used in the implant of the present invention. Known
`
`biosorbable materials include polyglycolic acid (Dexon, Davis & Geck); polyglactin material
`
`(Vicryl, Ethicon); poliglecaprone (Monocryl, Ethicon); and synthetic absorbable lactomer
`
`9-1 (Polysorb, United States Surgical Corporation).
`
`[0032]
`
`Other foamable materials that can be utilized in the present invention include,
`
`without limitation, proteins such as collagen, fibronectin, laminin and fibrin, most
`
`preferably collagen, and high molecular weight polysaccharides, such as heparan sulphate,
`
`chondroitin sulphate, hyaluronic acid and dermatan sulphate. Mixtures of any of the
`
`aforementioned materials also can be used, as required.
`
`10
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`1688009 v1; 106H501LDOC
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`[0033]
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`The materials can be modified, by cross-linking for example, to control
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`degradation rates over varying lengths of time, after which they are substantially or
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`completely resorbed.
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`Docket No.: C3120.0001/P001vB
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`[0034]
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`Foams can be formed by various means known to those skilled in the art,
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`including injecting an aerosol into a gel, and freeze-drying aqueous dispersions of the
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`foam-forming material. Foaming agents can be included to promote formation of the
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`foam. In addition, stabilizing agents can be included to enhance foam stability. The foams
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`can be extruded or formed in situ.
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`[0035]
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`According to the present invention, these produces may be mixed with one
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`another or combined to provide various resorption times or gradients, and/or may be
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`interrelated with non-absorbable materials, such as polypropylene or PTFE (Gortez)
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`material, for example. In an instance where a non—absorbable material is utilized, the non-
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`resorbable implant section will remain partially intact as a permanent structure.
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`[0036]
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`In each of the embodiment, the resorbable portions of the prosthesis
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`ultimately biodegrades, and the patient is left with autologous tissue, some of which may
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`have been implanted, or a permanent implant such as saline, as a filler for the biopsy cavity,
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`thus preserving the contour of the breast and preventing indentation of the overlying skin.
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`[0037]
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`The implants of the present invention further can be instilled, before or after
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`implantation, with indicated medicines and other chemical or diagnostic agents. Examples
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`Docket No.: C3120.0001/P001-B
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`of such agents include, but are not limited to, antibiotics, chemotherapies, other cancer
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`therapies, brachytherapeutic material for local radiation effect, x-ray opaque or metallic
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`material for identification of the area, hemostatic material for control of bleeding, growth
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`factor hormones, immune system factors, gene therapies, biochemical indicators or vectors,
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`and other types of therapeutic or diagnostic materials which may enhance the treatment of
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`the patient.
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`[0038]
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`The breast implant preferably includes a permanent or temporary dye marker
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`such as, but not limited to, indigo carmine or methylene blue. This marker serves as a
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`visual identification of the area that has been biopsied or a lumpectomy has been performed
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`so that in the future an operating surgeon can identify the surrounding tissue before he
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`violates the previously biopsied cavity. These dyes leach into the breast tissue giving the
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`surgeon an indication when he is nearing the point of interest, that being a previous biopsy
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`site particularly if it is positive for a cancer or if it is a site for which a lumpectomy has been
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`previously performed and the pathologist advises us that there is residual cancer. The
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`surgeon can thus remove any of the surrounding breast tissue that contains dye and
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`depending upon its concentration and the distance that it has traveled from the biopsy site
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`will give us an indication of how much tissue should appropriately be removed.
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`[0039]
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`This dye may be integrated with a bioabsorbable material such as, but not
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`limited to collagen or may be in a separate capsule that is inserted with the bioabsorbable
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`material as well as a metallic device for radiographic identification.
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`[0040]
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`These two dyes are very dark colored dyes and these do leach through the
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`breast tissue but will not stain the overlying skin.
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`Docket No.: C3120.0001/POOl-B
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`[0041]
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`The present invention has been described particularly in connection with a
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`breast implant, but it will be obvious to those of skill in the art that the invention can have
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`application to other parts of the body, such as the face, and generally to other soft tissue or
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`bone. Accordingly, the invention is applicable to replacing missing or damaged soft tissue,
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`structural tissue or bone, or for cosmetic tissue or bone replacement.
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`[0042]
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`Although the present invention has been described in relation to particular
`/
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`embodiments thereof, many other variations and modifications and other uses will become
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`apparent to those skilled in the art. It is preferred, therefore, that the present invention be
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`limited not only by the specific disclosure herein, but only by the appended claims.
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`Docket No.: C3120.0001/P001-B
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`CLAIMS
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`What is claimed as new and desired to be protected by Letters Patent of the United
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`States is:
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`1. An implant for marking an area within a living body
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`comprising a matrix material and a marking material, the implant being
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`formed to fit the shape and size of a cavity in the human body, the implant
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`being installed for supporting tissue surrounding the cavity and allowing in-
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`growth of fibrous tissue into and replacing at least a portion of the matrix
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`material.
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`2. The implant of claim 1, wherein the marking material is a dye.
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`3. The implant of claim 2, wherein the dye is one of indigo
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`carmine and methylene blue.
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`4. The implant of claim 1, wherein the matrix material is
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`elastically compressible.
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`5. The implant of claim 1, wherein the matrix material is formed
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`from one of a self-expanding foam, a compressible foam or sponge, and a
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`non-compressible foam or sponge.
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`6. The implant of claim 1, wherein the matrix material is formed
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`of a foamed bioabsorbable protein.
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`7. The implant of claim 1, wherein the matrix material is formed
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`of a foamed collagen.
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`8. The implant of claim 1, further comprising at least one
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`medicinal, therapeutic, or diagnostic substance.
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`9. The implant of claim 8, wherein the at least one substance is
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`selected from the group consisting of radiation materials, antibiotics,
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`chemotherapies, cancer therapeutics, hemostatic materials, hormone
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`therapeutics, and radiographic markers.
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`10.
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`The implant of claim 1, wherein the matrix material is at
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`least partially resorbable.
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`11.
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`The implant of claim 1, fiirther comprising a shell
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`containing the matrix material.
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`12.
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`The implant of claim 11, wherein the shell comprises
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`compressed matrix material.
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`13.
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`The implant of claim 1 1, wherein the shell completely
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`surrounds the matrix material.
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`14.
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`A tissue marking implant comprising a matrix of
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`collagen material, the matrix having a porous structure for supporting
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`Docket No.: C3120.0001/P001-B
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`surrounding tissue of a breast and configured to provide a framework for the
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`in-growth of fibrous tissue into the matrix; and
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`a dye marker supported by the matrix for dispersion
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`into the tissue.
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`15.
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`The tissue implant of claim 14, wherein the matrix
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`comprises a foam.
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`16.
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`The tissue implant of claim 14, wherein the matrix
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`comprises a resilient framework for implantation by compressing the matrix
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`into a smaller volume, the matrix expanding resiliently within the breast.
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`17.
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`The breast implant of claim 14, wherein the matrix is
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`self-expanding.
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`18.
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`A method for marking tissue surrounding excised
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`human tissue with an implant comprising the steps of:
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`forming a cavity having surrounding tissue;
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`forming the implant of a matrix material and sizing the implant to
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`occupy the cavity, the matrix material supporting a dye marker ; and
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`implanting the implant in the cavity, the implant supporting the
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`surrounding tissue and allowing for in— growth of fibrous tissue and replacing
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`Focal Exhibit 1002 Page 18
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`Docket No.: C3 120.0001/P001 -B
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`the matrix material, wherein the matrix material is elastically compressible,
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`and the step of implanting includes the step of compressing the matrix
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`material, whereby the surrounding tissue is visibly marked by the dye marker
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`as the result of the dye marker leaching from the implant into the
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`surrounding tissue.
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`19.
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`The method of claim 18, further comprising the step of
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`introducing into the implant at least one of a medicinal, therapeutic or
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`diagnostic substance.
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`20.
`
`The method of claim 19, wherein the at least one
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`substance is selected from the group consisting of radiation material,
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`antibiotics, chemotherapies, cancer therapies, hemostatic material, hormone
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`therapies, stem cells, cellular precursors, and radiographic markers.
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`21.
`
`The method of claim 19, wherein the step of implanting
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`the implant in the cavity comprises expanding the implant within the cavity.
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`22.
`
`A method for marking tissue surrounding excised
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`human breast tissue with an implant comprising the steps of:
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`forming a cavity having surrounding tissue within a breast;
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`forming an implant entirely of resorbable material and sizing the
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`implant to occupy the cavity, the implant including a dye marker; and
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`Docket No.: C3120.0001/P001-B
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`implanting the implant in the cavity, the implant supporting the
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`surrounding tissue and allowing for in-growth of fibrous tissue into and
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`replacing the resorbable material, wherein the resorbable material is formed
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`from a self—expanding foam and the step of implanting is performed by
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`injection of the self—expanding foam, the dye marker leaching into the breast
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`tissue to mark the tissue surrounding the cavity.
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`23.
`
`The method of claim 22, further comprising the step of
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`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
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`substance is selected from the group consisting of radiation material,
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`antibiotics, chemotherapies, cancer therapies, hemostatic material, hormone
`
`therapies, stem cells, cellular precursors, and radiographic markers.
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`Docket No.: C3120.0001/P001—B
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`ABSTRACT
`
`A tissue marking implant includes a matrix material and a dye marker. The implant,
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`which can be formed entirely of bioresorbable material such as a collagen foam, is sized and
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`shaped to replace excised tissue. The implant supports surrounding tissue upon
`
`implantation, while allowing for in-growth of fibrous tissue to replace the implant.
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`According to various alternative embodiments, the implant is elastically compressible, or
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`can be formed from self-expanding foam or sponges, and can be implanted through a
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`cannula or by injection, as well as by open procedures. The implant can carry therapeutic
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`and diagnostic substances. The dye marker leaches from the implant such that a surgeon,
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`upon subsequent surgical intervention, visibly recognizes the tissue marked by the dye
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`marker.
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`'
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`\
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`App No.: Not Yet Assigned
`Inventor: John D. Corbitt, Jr.
`Title: TISSUE MARKING IMPLANT
`NEW SHEET
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`Docket No.: C3120.0001/P001-B ‘
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`Focal Exhibit 1002 Page 22
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`22
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`'_ FIG. 6
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`Focal Exhibit 1002 Page 22
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`

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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`DECLARATION FOR PATENT APPLICATION
`
`As the below named inventor, I hereby declare that:
`
`My residence, post office address and cit