`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`AddIESSI COMLHSSIOIVER FOR PATENTS
`PO Box I450
`Alexandria, Vilgim'z 22313-1450
`www.usplo.gov
`
`APPLICATION NUMBER
`
`F'L'NSAOTIESH (Cl GRP ART UNIT
`
`FIL FEE REC'D
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`ATTY.DOCKET.NO
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`TOT CLAIMS
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`IND CLAIMS
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`60/970,780
`
`09/07/2007
`
`100
`
`52874.0001
`
`20322
`
`SNELL & WILMER L.L.P. (Main)
`400 EAST VAN BUREN
`ONE ARIZONA CENTER
`PHOENIX, A285004-2202
`
`CONFIRMATION NO. 1414
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`FILING RECEIPT
`
`Date Mailed: 09/20/2007
`
`It will not be examined for patentability and
`Receipt is acknowledged of this provisional patent application.
`will become abandoned not later than twelve months after its filing date. Any correspondence concerning the
`application must include the following identification information: the US. APPLICATION NUMBER, FILING
`DATE, NAME OF APPLICANT, and TITLE OF INVENTION. Fees transmitted by check or draft are subject to
`collection. Please verify the accuracy of the data presented on this receipt.
`If an error is noted on this
`Filing Receipt, please write to the Office of Initial Patent Examination's Filing Receipt Corrections.
`Please provide a copy of this Filing Receipt with the changes noted thereon. If you received a "Notice
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`Applicant(s)
`
`Robert Tofe, Denver, CO;
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`Power of Attorney:
`Thomas Dougherty--51214
`
`If Required, Foreign Filing License Granted: 09/19/2007
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`The country code and number of your priority application, to be used for filing abroad under the Paris Convention, is
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`Projected Publication Date: None, application is not eligible for pre-grant publication
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`Non-Publication Request: No
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`Early Publication Request: No
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`** SMALL ENTITY **
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`Title
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`COMBINATION OF A BIOLOGICALLY COMPATIBLE SCAFFOLD AND HUMAN
`AMNION TISSUE FOR TISSUE REGENERATION
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`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
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`Since the rights granted by a US. patent extend only throughout the territory of the United States and have
`no effect in a foreign country, an inventor who wishes patent protection in another country must apply for a
`patent in a specific country or in regional patent offices. Applicants may wish to consider the filing of an
`international application under the Patent Cooperation Treaty (PCT). An international (PCT) application
`
`MTF Ex. 1036. pg. 1
`
`MTF Ex. 1036, pg. 1
`
`
`
`generally has the same effect as a regular national patent application in each PCT-member country. The
`PCT process simplifies the filing of patent applications on the same invention in member countries, but
`does not result in a grant of "an international patent" and does not eliminate the need of applicants to file
`additional documents and fees in countries where patent protection is desired.
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`Almost every country has its own patent law, and a person desiring a patent in a particular country must
`make an application for patent in that country in accordance with its particular laws. Since the laws of many
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`Applicants also are advised that in the case of inventions made in the United States, the Director of the
`USPTO must issue a license before applicants can apply for a patent in a foreign country. The filing of a US.
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`further information and guidance as to the status of applicant's license for foreign filing.
`
`Applicants may wish to consult the USPTO booklet, "General Information Concerning Patents" (specifically,
`the section entitled "Treaties and Foreign Patents") for more information on timeframes and deadlines for
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`800-786-9199, or it can be viewed on the USPTO website at
`http://www.uspto.gov/web/offices/pac/doc/generaI/index.html.
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`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you
`may wish to consult the US. Government website, http://www.stopfakes.gov. Part of a Department of
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`LICENSE FOR FOREIGN FILING UNDER
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`Title 35, United States Code, Section 184
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`Title 37, Code of Federal Regulations, 5.11 & 5.15
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`m T
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`if the phrase "IF REQUIRED, FOREIGN
`he applicant has been granted a license under 35 U.S.C. 184,
`FILING LICENSE GRANTED" followed by a date appears on this form. Such licenses are issued in all
`applications where the conditions for issuance of a license have been met, regardless of whether or not a
`license may be required as set forth in 37 CFR 5.15. The scope and limitations of this license are set forth in
`37 CFR 5.15(a) unless an earlier license has been issued under 37 CFR 5.15(b). The license is subject to
`revocation upon written notification. The date indicated is the effective date of the license, unless an earlier
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`This license is to be retained by the licensee and may be used at any time on or after the effective date
`thereof unless it is revoked. This license is automatically transferred to any related applications(s) filed under
`37 CFR 1.53(d). This license is not retroactive.
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`The grant of a license does not in any way lessen the responsibility of a licensee for the security of the
`subject matter as imposed by any Government contract or the provisions of existing laws relating to
`espionage and the national security or the export of technical data. Licensees should apprise themselves of
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`Defense Trade Controls, Department of State (with respect to Arms, Munitions and Implements of War (22
`CFR 121-128)); the Bureau of Industry and Security, Department of Commerce (15 CFR parts 730-774); the
`Office of Foreign AssetsControl, Department of Treasury (31 CFR Parts 500+) and the Department of
`Energy.
`
`MTF Ex. 1036, pg. 2
`
`MTF Ex. 1036, pg. 2
`
`
`
`W N
`
`if the phrase "IF REQUIRED, FOREIGN
`o license under 35 U.S.C. 184 has been granted at this time,
`FILING LICENSE GRANTED" DOES NOT appear on this form. Applicant may still petition for a license
`under 37 CFR 5.12,
`if a license is desired before the expiration of 6 months from the filing date of the
`application.
`If 6 months has lapsed from the filing date of this application and the licensee has not received
`any indication of a secrecy order under 35 U.S.C. 181, the licensee may foreign file the application pursuant
`to 37 CFR 5.15(b).
`
`MTF Ex. 1036, pg. 3
`
`MTF Ex. 1036, pg. 3
`
`
`
`Electronic Patent Application Fee Transmittal
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`Filing Date:
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`TItIe Of Inventlon:
`
`COMBINATION OF A BIOLOGICALLY COMPATIBLE SCAFFOLD AND
`HUMAN AMNION TISSUE FOR TISSUE REGENERATION
`
`First Named Inventor/Applicant Name:
`
`Provisional Filing Fees
`
`Basic Filing:
`
`_
`
`—--m W3; '"
`
`MTF Ex. 1036, pg. 4
`
`
`
`—--m W '"
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`Total in USD ($)
`
`Miscellaneous:
`
`MTF Ex. 1036, pg. 5
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`MTF Ex. 1036, pg. 5
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`
`
`International Application Number: —
`
`mm M Invent'on:
`
`COMBINATION OF A BIOLOGICALLY COMPATIBLE SCAFFOLD AND
`HUMAN AMNION TISSUE FOR TISSUE REGENERATION
`
`
`
`First Named Inventor/Applicant Name:
`
`Receipt Date:
`
`o7-SEP-2007
`
`Payment information:
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`Payment was successfully received in RAM
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`$100
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`RAM confirmation Number
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`Charge any Additional Fees required under 37 C.F.R. Section 1.16 and 1.17
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`The Director of the USPTO iS hereby authorized to charge indicated fees and credit any overpayment as follows:
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`File Listing:
`
`MTF Ex. 1036, pg. 6
`
`MTF Ex. 1036, pg. 6
`
`
`
`Document
`
`.
`
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`
`FiIeSize(B(ytes)
`875481
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`Multi
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`Pages
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`Application Data Sheet
`
`528740001ADS.pdf
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`I30809000908603235783dbb166019889
`35195163
`
`Warnings:
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`Information:
`
`This'Is not an USPTO supplied ADS fillable form
`
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`
`528740001 USPAProvisional.
`
`2228542
`
`p
`
`23b3409b909041545b603831b9bbd499
`006512837
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`Multipart Description/PDF files in .zip description
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`—“
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`——
`——
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`Warnings:
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`Information:
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`Fee Worksheet (PTO-06)
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`fee-info.pdf
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`7288713633185d662b32501994756348
`5d50e156
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable.
`It serves as evidence of receipt
`similar to a Post Card, as described in MPEP 503.
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`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see
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`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions
`of 35 U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptance of the
`application as a national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt,
`in due course.
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`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary
`components for an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the
`International Application Number and of the International Filing Date (Form PCT/RO/105) will be issued in due
`course, subject to prescriptions concerning national security, and the date shown on this Acknowledgement
`Receipt will establish the international filing date of the application.
`
`MTF Ex. 1036, pg. 7
`
`
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`PTO/salto(o7-o7)
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`_ Approved for fuse through OBIJOI2010. OMB 0651-0032
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`us. Patentano Trademark-Cities; US. DEPARTMENT OF COMMERCE
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`Under the Paperwork Reduction Act of 1995. no personsom required to respond to a collection oi information unless it displays a vafio OMB control number.
`PRCMSIONAL A9PLICATION' FOR: PATENT COVER SHEET - Page 1 at 2
`This ise request for filinga PROVISIONAL APPUCATION FOR PATENT under 37'CFR 1.53(c).
`
`Express Mail Label No.
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`Given Name (first and middle [if any»
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`‘tNVENTomsi
`Family Name or Surname
`
`Robert
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`Ci and either State or Fore'. n Count
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`Additional inventors are.béing:nar‘ned on the.
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`separately numbered sheets attached hereto
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`Direct all oorrospondenceto:
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`The 'address'corresponding to Customer Number:
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`OR
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`"
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`mus onus iNVENTION (soocriamc‘térs m'ajgg):
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`COMBINATION'OF.A.BIOLOG!CALLY COMPATIIB'LE'LSCAFFOLDAND HUMAN AMNION
`
`TiSSUE'FOR TiSSUE REGENERATION
`
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`
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`CORRESPONDENCE'ADDRESS
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`I: ¢D(s),-5Nomberlof-Cl§o 5
`ApplicationDataI-Shoet.--Seo 37 CFR 176
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`D 0ther(specif3)
`[2] Drawingts) NumberofSheets 6
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`8
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`Fees Due: Filingfeo oi-szoo (SiOOJtor smaiiientily).
`It the specification and drawings exceed-1.050 sheets ofipaperganapplialion sige tee is
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`also due, which'is 325018125 for small entityiior each additional‘so sheets or traction'thereof.-See'_35 U.S.C. 4t(a)(1)(G) and 37 CFR 1.16(s);
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`ENCLOSED-APPLICATION PARTS (clieck all Méf'apfily)
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`METHODOF PAYMENT OF THE EiLtNGFEEANoAPRlitcAmN suze FEE FOR THIS PROVISIONAL APPLICATION FOR PATENT
`
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`100 00
`., Applicant‘ciaims small entity status.,8ee,37 CPR-1.27.;
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`D A ched< ormo‘ney‘oroer is enclosed to cover'the filing tee ano'applicationsize le'e {ll applicaoie).
`TOTAL FEE AMOUNT (S)
`[:1 Paymentby credit cad-Form PTO-203813 a‘lloched
`Tho'Director-is herebyauthorizedntodiarge the filing fooano application size tee (itappllable) or credit any overpayment to Deposit
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`USE ONLY FOR FILING A PROVISIONAL REPLICA TIONFOR PA TENT,
`_
`This collection oi information isroquirod by 37 CFR-‘1;51. Thointormation is required ic obtain or retain ‘a benefit by the public which is to liloland by thoUSPTO
`toprooess) on appocwoncuntloentialityla governed by 35 tJtS‘c._'1223 oriov‘37 CFR _1.1_t fonds,t._14.; This collocation is estimated to take 8 hours tocompleto';
`inducing gathering, preparing;,and'submiitin9 tho comptetooappticatlonjiorm to‘lho USPJO.‘ Tlrne‘ will vary depending upon the individual case. Any comments
`on the amount of time you require to oomplote this ioim analor suggcctions toneoua'ng thisgburden.vshouid be sent to thoChletrlniormation Officer. US. Patent
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`ADDRESS. SEflD’TO: Commissloner'for Patents; 9.0. Box'1450. Alexandria; VA 2231;4450.’
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`.Ilyou need assistance in completing tho form. can 1-800-PTO-9199 and select option 2;
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`MTF Ex. 1036, pg. 8
`
`MTF Ex. 1036, pg. 8
`
`
`
`PROVISIONAL APPLICATION COVER-SHEET
`Page 2'01r 2
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`PTOISB/ta (07417)
`Approved for use through 0813012010. OMB 0651-0032
`US Patent and TrademarkOffice: U.S. DEPARTMENT OFCOMMERCE
`Under the Paperwork Reduction Act of 1995 no persons are required to respond to a wilc'otion oi intermation unless it displays a validOMB control number.
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`The invention was made by‘an' agency of the.United'States Gove'mment'or undercoontr'act'wnh an'a'gency of the United States Government.
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`No.D Yes. the nameof the _.U8 Government agencyand the Governmentcontract.numberare:
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`WARNING:
`PetitiOnerlapplica_ntIs cautioned to avoid submitting personal information.In documents filed in a patent application that may
`contribute to identity theft Personal information soon as social security numbers, bantt- account numbers, or credit card
`numbers (other than a check or-credit card authorization form PTO—2038submitted for payment purposes)Is neverrequired by
`the USPTO to supporta petition or an application If this type of personal informationIs included'In documents submitted to
`the USPTO petitionerslapplicants should consider redacting such personal information from the documents before submitting
`them to the USPTO. Petitioner/applicant is- advised that the record of a patent application is available to the public after
`publication ofthe application(unless a non~publication reqUestIn Compliancewith37CFR 1213(a)Is madeIn the application)
`or issuance of a patent. Furthermore the record from an abandoned application may also be available to the public if the
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`SIGNATURE rrhomas-A. Dougherjx/
`
`TYPED or PRINTED NAME ThomasA 001191952
`
`Date September 7. 2007
`
`REGISTRATION NO; 51214
`(if appropriate)
`
`TELEPHONE ”303634-2000
`
`-
`
`Docket Number: 528740001
`
`MTF Ex. 1036. pg. 9
`
`MTF Ex. 1036, pg. 9
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`
`
`PrivacyAct-Statement
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`The Privacy ‘Act of 1974 (PL. 93-579)'reouires that you be given certain information in connection
`withyoursubmission of the attached form related to a patent application or patent Accordingly,
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`collection ofthis information is 35 U. S;C. 2(b)(2); (2) furniShing of the information solicitedIs voluntary;
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`process and/or examine your. submission which may resultIn termination of proceedings or
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`The information provided by'you'in thisfo'rm willibe subject to theioilowingvroutlne uses:
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`1; The-information onvithis-form will be treated confidentiaiiytothe extent allowed under the
`Freedom of information Act-4(5i U:S.C.'552) and the Privacy. Act (5' U.S.C 552a). Recordsfrom
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`3; A record inthis system of records may be disclosed as a routine use toa Member of
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`5. A record related toan international ApplicationIfiledunder the Patent Cooperation TreatyIn
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`.A record frOm this system of records may bedisclosed as aroutine use. to the public after
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`pursuant to 35 U. SC 151 Farther a record may be disclosed subject to the limitations of 37
`CFR 1 14 as a routine uSe tothe public. ifthe record W851filed in an application which
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`'8.
`
`MTF Ex. 1036. pg. 10
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`MTF Ex. 1036, pg. 10
`
`
`
`Provisional Patent Application.
`
`Combination of‘a Biologic‘allyXCompatibl'e Scaffo‘ld?‘ and Human Amnion Tissue for
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`' TiSsueRegcheratiéfl
`
`InttOductiom The term afterbirth may usedtodenote all’thes-tissues and cells leftover after
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`.a woman gives birth. This may include butznot limited to, the placenta, umbilical cord and
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`amniotic sac;
`
`'lhe,-amni0dc sac encloses the embryo during pregnancy. The amniotic sac
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`'may be: procured from adorior during the: birthing process following-the methods outlined
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`in Provisional Patent-Application 11/1314356‘, which is incorporated hereinby reference in
`
`its entirety- for. all purposes. The amniotic sac has: two parts, the amnion and chorion.
`
`During processing the amnion, may be bluntly dissected from the chorion.. Theremaining
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`amniontissue may be typically between.i).2 - 0.4. mm thick, however other-thicknesses are
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`possible. The amniontissue can .:bc::cleansed by various agents-including but not limited to
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`saline, ,tsnrfactant solutions, ethanol,_iglutamldehyde, ultrasound and or other mild agitation
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`techniques, The, amnion tissue is processed aseptically andflozen or terminally sterilized
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`and stored in dehydrated suite” freeze dried or ina. liquid‘preservation agent including but
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`not limited to ethanol or saline untiltime of surgery».
`
`..Amnion tissue has been usedns askin graft-temporary biologic dressing forrfull thickness
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`wounds, reconstruct damagedorgans, a netve..tube,eguided tissue regeneration, preventing
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`tissue adhesion, and in ocular procedures. More'recently it was shown tobe an effective
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`graft: for .regenerating.gingival tissne'in alate—clinical rabbit .study'.
`
`MTF Ex. 1036. pg. 11
`
`MTF Ex. 1036, pg. 11
`
`
`
`Although the exact mechanism; of amnion tissue "in wound ..healing may not be fully
`
`understood, it docs possess several properties that make it an attractive option in the
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`treatincn't of gingival teccssion and increasing thccovctagc of gingival tissue around the root
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`of a tooth, to address ssthctic concerns,- hypersensitivity and/ or root -caries,.-among-other
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`pOs'sib‘lc uses. These. "types of procedures are somotimes tcfcrrcd to as pedophstic. or
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`mucogingiital wrgety. Some, but not all, Of theadvantages, of flicvuscvof'ainnion tissue from
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`a Scientific perspective are listedvhelow.
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`1. Contains laminihs 1 ands;- Laminin 5 has been shown to bind gingival cells.
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`'2. Contains Vfibroncctin and'fibtillat collagen typesv'l, III, and 1V
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`3. Contains several growth- factorsjincluding-jbut not'limited to epidermal growth factor,
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`transforming growth factoto, kerationcyte growth factor, hcpotcyte growth factor,
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`basic ‘fibroblast'growth factor, and transforming growth factors, '91, $2 and [53,.
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`4.- The tissue is acclluar.
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`Tho-laminins in amnion tissue are Suspected to incroasc cell attachment";1 which may up.
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`tcgulate, the expressioniof'gtowth“factors toinduce. rapid gingival-cpithclia cell migration and
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`cellular-proliferation and differentiation‘. These ..gtowth,factors-may aidin the formation of
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`granulation tissue by stimulatingfibroblastgrowth andineovasculatizadOns. Amnion‘ tissue
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`suppresscs the migration of polymorphonuclear cells, which mitigates a strong immune
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`response“. These attributes plus amnion tissues inherent quality toself adhere to host tissue
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`should limit- inflamma’ti'on post irnplantation7.
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`,Despites all these-attributes amnion tissue;
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`primary drawback is less than'optimalztlnckncssyof thctissuc;
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`MTF Ex. 1036. pg. 12
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`MTF Ex. 1036, pg. 12
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`
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`One-of the goals ’-of .mucogingiVal surgery maybe to increase attachment level and the
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`thickness ofsoft tissue,- sometimes referred to a5»gingival-soft'ti3511c,-kc1ratinized tissue, and /
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`or keratinizcd mucosa in a patient’s mouth. A, single layer of amnion tissue may not. provide
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`the necessary depth of new kctatihizedmucosa relative to the depth of the surrounding host
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`keratinized- mucosa. The-dental professional may'pr'efe'r to work withasof't tissue substitute
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`that‘is easy to} use in. muc‘ogingival Surgery. This may invoke cutting the tissueto match the
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`morphology of ' the wound, placement, and possibly, stabilizatibn with sutures.
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`If. left
`
`unsupported the tissue may fall ever itself; and may bunch together. Amnion tissue may
`
`have handling limitations. By’itself,jthe material may bei'una'ble'to hold sutures. Sutures may
`
`tear the tisSue during placement, and maybe knocked free by thespatients tongue post
`
`sixtgcry. These r'fact's makeuimming, placement, andseeuring a singlcflayer of‘amnion tissue
`
`is less than ideal fo: the dental professional.
`
`In one embodiment amnion tissue may form the-bottom and top layers of the composite
`
`graft.
`
`'lhe:graft may: be composed- of only amnion tissue as shown in figure one or amnion
`
`tissue Combined with another biologically compatible material (BOB/I) as shown in figure
`
`two, "111:; amnion-tissue may be Layetedin, such a way that the. basement membrane is facing
`
`outward on’bo'th sides of'the graft, thereby-'cxposingthc laminins to-host cells.
`
`Another embodiment,-shownin figure 3-, the amniOn tissue‘tnay form the bottom and top
`
`layers .of a» composite graft, In this-graft, only'oue side of the graft Will‘havc the basement
`
`the» basement-hyac'facing inward; The basement,*niembranc may be imptinted in such a way
`
`MTF Ex. 1036. pg. 13
`
`MTF Ex. 1036, pg. 13
`
`
`
`to- clearly tell. the dental professiOnal which side of the composite graft is thclcxposed
`
`basement membrane.
`
`Another embodiment, shownin figure 4, :may use amnion tissue; to form, one side of the
`
`.compos'itezgtaft side, with. the basementglayet facing outward exposing the lam‘inins to the
`
`host’scells. The other. side offthe compo'sitegraft may be the BCM. The BCM may provide
`
`an impetmeable battict to impede the ability omens- to attach and-orvmigtate onsutfacc of
`
`the biological scaffdld;
`
`Another embodiment, shown-in figure 5,-may use amnion tissue to fotm one side of the
`
`composite gut; side with the basement Jaye: facing- outward exposing the laminins to the
`
`host’s cells;'71'he=other side of the compositegr'aft may’jbe'formed by a B'CM. The BCM, may-
`
`be able toabsorb fluids, either bysoaking graft in thedesited ifluid‘ cit-addition ofthedcsircd
`
`fluid directly onto graft. _'1'he desired fluid may be retained by: the BCM until implantation.
`
`Uponimplcmentation, the amnion-Esme wiih the BCM' containing the desired fluid may be
`
`delivered'to. the patient.
`
`Cleansed amnion tissue may be: combined with another BCM. The amnion tissue, alone or
`
`in combination with a biological scaffold may be combined using suture materials, tissue
`
`welding, adhesives, detergents, or chemicals to :form multi—layetcd soft tissue graft. The
`
`combined materials-may be treated'as a singleproduct.
`
`Inran embodiinent itwill be supplied
`
`in a variety of. thicknesses based on number of layers, 1-10, ofzamnion tissue usedand the
`
`type andnumber offlziyets, 1410, of.BC‘M used.
`
`In'ranpmbodimcnnthcgraft may equalto
`
`or larger'than 0.2‘mmthink but not morethe 10 min-thick.
`
`In an embodiment the dental
`
`MTF Ex. 1036. pg. 14
`
`MTF Ex. 1036, pg. 14
`
`
`
`professional will be able to easily cut the graft. to meet the requirements of the particular
`
`surgery In an embodiment the product will not require the dental professional: to: fold
`
`amnion 'tissue- 01: combine it with Mother material at the time of surgery to obtain the
`
`desired Q‘gt'a'ft-tlii'ckness. In an embodiment the-graft may be able to hold sutures by’ itself and
`
`with surrounding host tissue. In 'an- preferred embodiment, the product would not fold ovet
`
`itself, and wc'mld be easy to ,place'inthe surgical site.
`
`The various formulations of a multi-layetcd soft tissue graft containing amnion tissue may be
`
`useful in inuc'ogingival surgery due to the Scientific attributes of amnion tissue described
`
`‘ above.- “The‘s'c benefits may also apply toother'tteaunents or procedures thatthuite a soft
`
`tissue substitute: -ot,_ each. of the BCMS- listed below. The less than Optimal handling.
`
`properties associated with a singlezl‘ajmrof amniOn tissue'would be present and inconvenient
`
`for any "medical professional. The embodimentsof an amnion tissue product \vouldrbe both
`
`useful and‘applieablc top-other procedures or-Ettcatrncnts. The following list a few, but not all,
`
`for the product-nnd‘pw'cess described herein:
`
`It
`
`‘Gingival tecessi’on
`
`2. Root caries
`
`3.. Root covetage
`
`4.
`
`Inercasin'gzone of attached gingivgi
`
`.5- Eliminating frenum pull
`
`’6: Patella regeneration
`
`7. Mouth sores/ Oral lesions
`
`8. Guide tisSuevbone regeneration
`
`9. Shawn:-
`
`MTF Ex. 1036. pg. 15
`
`MTF Ex. 1036, pg. 15
`
`
`
`9. Sinalljntcsti‘nal submucosa,
`
`10; "Bladder accllul‘érmatrix,aand /’ or
`
`11. Cadaveric fasia, and / or combinationswhcrcof '
`
`Fluids Which mziy be utilized -t_xmy 'ihclu’de map. or more of the following, and / or
`
`combinations-thereof:
`
`I. Naturally occurring gtbwth factozs. "these could be souxcéd, fromhuman placental
`
`cord blood, amniotic.fluid,~.platclctsvand or bone mmgw.
`
`,2. Platelet-concentrate
`
`3. Wharmn’sjelly
`
`4. Bone marrow aspirate
`
`5.‘ Stem 9911s. Ihesc could,=c_ome from concentrated human placental cord blodd stem
`
`cells, concentrated-amniotic fluidstmn cells and or stem cells grown in a bioreactor.
`
`'6; Antibiofics
`
`'7. Drugs
`
`MTF Ex. 1036. pg. 16
`
`MTF Ex. 1036, pg. 16
`
`
`
`10; 'Dux‘altrepa'ix
`
`11. Herina'rcpztir
`
`12. Plastic suxgciry
`
`13. Cosmetic-surgexy
`
`14. Peripheralarterial-disease (alternative to saphcnousvcin'gmft)
`
`15. Bladder: reconstruction
`
`1'6. Esophagusgrcconstmction
`
`1 7. orbital .floomcpair
`
`18. Foot ulcers
`
`19. Corneal repair
`
`20-. Adhesion bum'er inispinal implant procedures
`
`21. Adhesion barrier injgcncml surgery
`
`22. Vascuhxficonduits
`
`23. Genitourinary reconstruction
`
`Biologitally CompatiblefMaterials (13(3Ms);may include, .bucf’is not-limited to, the following.
`
`1 . Amnion. tissue,
`
`-2. Chotion,
`
`.3.- Allegraft, pericardium,
`
`4.
`
`:i\.llograft:acclluar dermis,
`
`5. Amniotic membxane- (amnion and thori‘ofi)‘,
`
`6. Wharton’sgjclly,
`
`7. Purified 'xenograft Type-1 Icollaggn,
`
`8, Bioccllulosc biocompatiblc synthetic pdlymcr films c.g. PLGA,
`
`MTF Ex. 1036. pg. 17
`
`MTF Ex. 1036, pg. 17
`
`
`
`Datcof Invention: September 6"“, 2007
`
`Inventor: Robert Tot}:
`
`Eachofthe féllowmg publications-is hereby'incpxpoxated"byrcfcxcncc:
`
`‘.. Histolbgical evaluation of rabbit gingiVal wound healing transplanted with human amniotic
`membrane. M'Rinasmi, A l'vlatijadi, e‘t-aL Jutmafimza!Ja'm‘r'zalv qmel r8?Marz’llofiakzl'f103m. 2006;
`Pages 2474251.
`2. Function oflaminins and laminin-binding integrins in gingival ,cpithclial cell-adhcnsion.
`I Virtanmct ’al. journal (y’l’erz'odnntalqu, 2002. Pagcs'709-719.,
`3. Diffcxcnrial distribution of subchmns” of the ‘basmn'ent'mcmbmnc components Type-IV collagen
`and laminin among the amnidtic .membmne,»comea, and conjunctiva. K FukudalT Chikama.
`Comm; 1999,. pages 73-79.
`_
`.
`V
`4'. I~Ii3t()logical.§waluatiol_1pfmbbit gingival Woundhealing transplanted with human amniotic
`membrane. M Rimsriti; A Harijadii et‘ a1. InternationaljbumahJOml‘(’9’ Maxi/Imam .S‘mgcgy. 2006.
`Pages 247-251.
`‘
`5. Gmwth-favcthmRNApand pmtcinin. preserved human amnioticmcmbmnc. N Koizumi, ’1‘
`Inatinni, ct a]. (,3th Ijiyg Reanl). 2002,_ pages 173—177.
`6. Identifigation-of-andan’giogcnic and anti—in flammatory protein's inhuman amniotic membrane~ .Y
`Han, D Kang. Comm. 2000,_pag¢s=348-352;
`7. Antibacterial properties of human amnioticmembranes. Y Talmi, L Siglcn Placenta. 1991; pages
`285488.
`
`'1‘, Pakkala,
`
`MTF Ex. 1036. pg. 18
`
`MTF Ex. 1036, pg. 18
`
`
`
`Note: Drawing: are nor-atommle'. Tbé..auerqgc 2 @y 2 m '5'th time-graft zlr 19:: than 2 or 3 mm: tbz'af»;
`
`1171‘de 'or'dept/J fidmm’m 1mm and‘BCWIE'kkrlzg‘g/Jy eijbafldedyfbr illztxtmtz‘onpdkpom any;
`
`Figure One
`
`Amxfion tissue forms all-layers of dlc‘compositc gulf; The-letter“‘.B” indicates—the basement
`
`membrane-is facihgsoutward on b‘oihgsidcs of the, gmftcxposiug the laminins tohost cells.
`
`
`
`Amnion
`
`.Amnion
`
`Amnion
`
`'Amnion
`
`Amnion
`
`(2mm)
`
`(23mm)
`
`(2 mm)
`
`(2 mm)
`
`(2mm)
`
`
`
`Composite SoftTissue Graft-4 inyAmnion Tissue (10mm)
`
`MTF Ex. 1036. pg. 19
`
`MTF Ex. 1036, pg. 19
`
`
`
`Figure Two
`
`Amnion fissuc'will. form the bottom and top layers of the Composite-graft.
`
`'l'helmid'dle Of
`
`thegmft is form'cd'ftom two'layers o‘thCMv
`
`
`
`I'
`
`\
`
`:1Us?
`
`‘
`
`
`
`\‘ i
`
`
`
`_Amni'ori-
`
`(21mm)
`
`.BCM'
`
`'(5 turn)
`
`BCM.
`
`(3mm):
`
`Amnion
`
`(2 mm}
`
`
`
`.mmwm .... m
`
`..
`
`.
`
`\
`
`‘»
`
`
`
`9
`.‘l'
`Q
`i
`\
`(
`’
`>
`?
`' ‘
`5
`
`1 3‘W ‘
`
`'3,
`.2 c
`.
`‘,
`W w».
`?
`I
`
`,
`M
`
`I
`
`.
`
`V
`
`CompositeAmnion Soft Tissue Substitute 1(15 mm thick)
`
`MTF Ex. 1036. P9- 20
`
`MTF Ex. 1036, pg. 20
`
`
`
`Figure Three
`
`Amnion tissucforms the bottom and top layétspf thetorn‘positcgraft. (Only one side of the
`
`graft has the bascmcnt membrane facing-Outward exposing the lamim'ns to the host’s cells.
`
`Thevothc: side has the basemenclaycrafacing- inward.
`
` 5\" .
`
`,
`
`'
`,
`
`2
`3
`
`f. g 3'
`
`a
`
`._
`
`Amnion
`
`(2mm)
`
`BCM
`
`(5‘ mm)
`
`'BCM
`
`(5 mm)
`
`Amnion
`
`(2 mm)
`
`
`
`CompOsitc Soft Tissue Graft (1'4-mmuth'ick)
`
`MTF Ex. 1036. pg. 21
`
`MTF Ex. 1036, pg. 21
`
`
`
`Figurefoux
`
`Amnion tissue form's one Side
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