`
`
`
`ING or
`(c) DATE
`
`11/20/2007
`
`GRP ART
`UNIT
`
`60/989,299
`
`
`
`U\ I'I'IIII) S'I'A'I'IIIS DEPAR'I'M IIN'I' ()II’ (10M VIIIIIUIII
`United States Patent and Trademark Office
`Address COMMISSIONER FOR PATENTS
`11.0. Box 1450
`Alexandn'a, Vngmia 22313-1450
`wwnspmgmr
`
`FIL FEE REC'D
`105
`
`ATTY.DOCKET.NO
`52874.0350
`
`TOT CLAIMS IND CLAHVIS
`
`20322
`SNELL & WILMER L.L.P. (Main)
`400 EAST VAN BUREN
`ONE ARIZONA CENTER
`PHOENIX, AZ 85004-2202
`
`CONFIRMATION NO. 3005
`
`FILING RECEIPT
`
`llullllllIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII
`
`Date Mailed: 12/26/2007
`
`It will not be examined for patentability and will
`Receipt is acknowledged of this provisional patent application.
`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 to File Missing Parts" for this application, please
`submit any corrections to this Filing Receipt with your reply to the Notice. When the USPTO processes the
`reply to the Notice, the USPTO will generate another Filing Receipt incorporating the requested corrections
`
`Applicant(s)
`
`Robert Tofe, Denver, CO;
`Andrew Tofe, Lakewood, CO;
`Power of Attorney: The patent practitioners associated with Customer NumberM
`
`If Required, Foreign Filing License Granted: 12/26/2007
`The country code and number of your priority application, to be used for filing abroad under the Paris Convention,
`is US 60/989,299
`Projected Publication Date: None, application is not eligible for pre-grant publication
`Non-Publication Request: No
`Early Publication Request: No
`** SMALL ENTITY **
`Title
`
`COMBINATION OF BIOLOGICALLY COMPATIBLE SCAFFOLD AND HUMAN AMNION TISSUE
`FOR TISSUE REGENERATION
`
`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
`
`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 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
`page 1 of 3
`
`MTF Ex. 1037, pg. 1
`
`

`

`patent" and does not eliminate the need of applicants to file additional documents and fees in countries where patent
`protection is desired.
`
`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 countries differ
`in various respects from the patent law of the United States, applicants are advised to seek guidance from specific
`foreign countries to ensure that patent rights are not lost prematurely.
`
`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 U.S. patent application
`serves as a request for a foreign filing license. The application's filing receipt contains 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 filing foreign
`patent applications. The guide is available either by contacting the USPTO Contact Center at 800-786-9199, or it
`can be viewed on the USPTO website at http://www.uspto.gov/web/offices/pac/doc/generaI/index.html.
`
`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may wish
`to consult the U.S. Government website, http://www.stopfakes.gov. Part of a Department of Commerce initiative,
`this website includes self—help "toolkits" giving innovators guidance on how to protect intellectual property in specific
`countries such as China, Korea and Mexico. For questions regarding patent enforcement issues, applicants may
`call the U.S. Government hotline at 1-866-999-HALT (1-866-999—4158).
`
`LICENSE FOR FOREIGN FILING UNDER
`
`Title 35, United States Code, Section 184
`
`Title 37, Code of Federal Regulations, 5.11 & 5.15
`
`m T
`
`he applicant has been granted a license under 35 U.S.C. 184, if the phrase ”IF REQUIRED, FOREIGN 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 license of similar scope has been granted under
`37 CFR 5.13 or 5.14.
`
`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.
`
`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 current regulations especially with
`respect to certain countries, of other agencies, particularly the Office of Defense Trade Controls, Department of
`State (with respect to Arms, Munitions and Implements of War (22 CFR 121-128)); the Bureau of Industry and
`page 2 of 3
`
`MTF Ex. 1037, pg. 2
`
`

`

`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.
`
`NOT GRANTED
`
`if the phrase "IF REQUIRED, FOREIGN FILING
`No license under 35 U.S.C. 184 has been granted at this time,
`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).
`
`page 3 of 3
`
`MTF Ex. 1037, pg. 3
`
`

`

`Doc Code: TR.PROV
`
`Document Description: Provisional Cover Sheet (SB16)
`
`PTO/SBI16 (04-07)
`Approved for use through 06l30l2010 OMB 0651-0032
`US. Patent and Trademark Office: US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number
`
`Provisional Application for Patent Cover Sheet
`This is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c)
`
`lnventor(s)
`
`Inventor 1
`
`Given Name
`
`Middle Name
`
`
`
`
`
`G) No.
`
`Country i
`
`Family Name
`
`City
`
`
`
`Inventor 2
`
`
`Given Name
`
`Middle Name
`
`Family Name
`
`City
`
`State
`
`Country i
`
`Andrew
`
`Tofe, PhD.
`
`Lakewood
`
`CO
`
`US
`
`All Inventors Must Be Listed — Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`COMBINATION OF A BIOLOGICALLY COMPATIBLE SCAFFOLD AND
`HUMAN AMNION TISSUE FOR TISSUE REGENERATION
`
`Title of Invention
`
`Attorney Docket Number (if applicable)
`
`Correspondence Address
`
`528740350
`
`
`
`Direct all correspondence to (select one):
`
`® The address corresponding to Customer Number 0 Firm or Individual Name
`
`
`
`Customer Number 20322
`
`
`
`The invention was made by an agency of the United States Government or under a contract with an agency of the United
`States Government.
`
`0 Yes, the name of the US. Government agency and the Government contract number are:
`
`EFS — Web 1.0
`
`MTF Ex. 1037, pg. 4
`
`

`

`Doc Code: TR.PROV
`
`Document Description: Provisional Cover Sheet (SB16)
`
`PTO/SBI16 (04-07)
`Approved for use through 06l30l2010 OMB 0651-0032
`US. Patent and Trademark Office: US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number
`
`
`Entity Status
`
`Applicant claims small entity status under 37 CFR 1.27
`
`6) Yes. applicant qualifies for small entity status under 37 CFR 1.27
`O No
`
`Warning
`
`Petitioner/applicant is cautioned to avoid submitting personal information in documents filed in a patent application that may
`contribute to identity theft. Personal information such as social security numbers, bank account numbers, or credit card
`numbers (other than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required
`by the USPTO to support a petition or an application.
`If this type of personal information is included in documents submitted
`to the USPTO, petitioners/applicants should consider redacting such personal information from the documents before
`submitting them to USPTO. Petitioner/applicant is advised that the record of a patent application is available to the public
`after publication of the application (unless a non-publication request in compliance with 37 CFR 1.213(3) is made in the
`application) or issuance of a patent. Furthermore, the record from an abandoned application may also be available to the
`public if the application is referenced in a published application or an issued patent (see 37 CFR1.14). Checks and credit
`card authorization forms PTO-2038 submitted for payment purposes are not retained in the application file and therefore are
`
`Please see 37 CFR 1.4(d) for the form of the signature.
`
`Signature
`
`First Name
`
`Date (YYYY-MM-DD)
`
`Registration Number
`(If appropriate)
`
`Nov 20, 2007
`
`51024
`
`not publicly available. Signature
`
`
`
`/J. Damon Ashcraft/
`
`J_ Damon
`
`Last Name
`
`Ashcraft
`
`
`
`This collection of information is required by 37 CFR 1.51. The information is required to obtain or retain a benefit by the public which is to
`file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection
`is estimated to take 8 hours to complete, including gathering, preparing, and submitting the completed application form to the USPTO.
`Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or
`suggestions for reducing this burden, should be sent to the Chief Information Officer, US. Patent and Trademark Office, US. Department
`of Commerce, PO. Box 1450, Alexandria, VA 22313—1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. This
`form can only be used when in conjunction with EFS-Web. If this form is mailed to the USPTO, it may cause delays in handling
`the provisional application.
`
`EFS — Web 1.0
`
`MTF Ex. 1037, pg. 5
`
`

`

`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of
`the attached form related to a patent application or paten. Accordingly, pursuant to the requirements of the Act, please be
`advised that :
`(1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the
`information solicited is voluntary; and (3) the principal purpose for which the information is used by the US. Patent and
`Trademark Office is to process and/or examine your submission related to a patent application or patent.
`If you do not
`furnish the requested information, the US. Patent and Trademark Office may not be able to process and/or examine your
`submission, which may result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information
`Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records may be disclosed to the
`Department of Justice to determine whether disclosure of these records is required by the Freedom of Information
`Act.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to
`a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance from the
`Member with respect to the subject matter of the record.
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need
`for the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`A record in this system of records may be disclosed, as a routine use, t o a n other federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services,
`or his/her designee, during an inspection of records conducted by GSA as part of that agency's responsibility to
`recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant (i.e., GSA or Commerce) directive. Such disclosure shall not be used to make
`determinations about individuals.
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record
`may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in an
`application which became abandoned or in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspection or an
`issued patent.
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.
`
`MTF Ex. 1037, pg. 6
`
`

`

`PTO/SBI14 (07-07)
`Approved for use through 0630/2010. OMB 0651-0032
`US. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`
`
`Attorney Docket Number 52874.0350
`
`Application Number
`
`COMBINATION OF BIOLOGICALLY COMPATIBLE SCAFFOLD AND HUMAN AMNION TISSUE FOR
`me Of Invent'm TISSUE REGENERATION
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2
`
`|:| Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`
`Applicant Information:
`
`Applicant1
`IOParty of Interest under 35 U.S.C. 118
`Applicant Authority @Inventor OLegal Representative under 35 U.S.C. 117
`
`Prefix Given Name
`Middle Name
`Family Name
`Suffix
`Robert
`Tofe
`
`
`
`Address 2
`
`
`I Denver
`City
`Postal Code
`
`I StatelProvince
`Countryi
`I US
`
`I GO
`
` A- -licant 2
`
`Applicant Authority Olnventor
`
`Prefix Given Name
`Middle Name
`Family Name
`Suffix
`
`
`
`
`
`Andrew
`Tofe, PhD
`
`Residence Information (Select One) 0 US Residency 0 Non US Residency 0 Active US Military Service
`City
`Lakewood
`StatelProvince I CO
`I Country of Residence i
`I US
`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`
`Address 1
`Unknown
`
`
`
`Address 2
`
`City
`
`Lakewood
`
`Postal Code
`
`StatelProvince
`
`CO
`
`Countryi
`
`US
`
`Inventor Information blocks may be
`Inventors Must Be Listed - Additional
`All
`
`generated within this form by selecting the Add button. Add
`
`Correspondence Information:
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`D An Address is being provided for the correspondence Information of this application.
`EFS Web 2.2.1
`
`MTF Ex. 1037, pg. 7
`
`
`
`
`
`
`
`
`Residence Information (Select One) © US Residency 0 Non US Residency 0 Active US Military Service
`
`State/Province
`
`CO
`
`Country of Residence i
`
`US
`
`City
`Denver
`
`Citizenship under 37 CFR 1.41(b) i
`Mailing Address of Applicant:
`Address 1
`Unknown
`
`
`
`

`

`PTO/SB/14 (07-07)
`Approved for use through 0630/2010. OMB 0651-0032
`US Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe PapenNork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`
`
`Attorney Docket Number 52874.0350
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`COMBINATION OF BIOLOGICALLY COMPATIBLE SCAFFOLD AND HUMAN AMNION TISSUE FOR
`we of Inventm” TISSUE REGENERATION
`
`
`
`
`Customer Number
`I 20322
`Email Address
`dashcraft@swlaw.com
`
`Add Email
`
`Application Information:
`
`COMBINATION OF BIOLOGICALLY COMPATIBLE SCAFFOLD AND HUMAN AMNION TISSUE
`Title of the Invention
`FOR TISSUE REGENERATION
`
`
`Application Type
`Provisional
`
`Attorney Docket Number 52874.0350
`
`Small Entity Status Claimed
`
`Subject Matter
`
`Utility
`
`Suggested Class (if any)
`
`Sub Class (if any
`
`
`
`
`
`
`Suggested Technology Center (if any) Total Number of Drawing Sheets (if any)
`
`Suggested Figure for Publication (if any)
`
`Publication Information:
`
`
`D Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`Request Not to Publish. I hereby request that the attached application not be published under 35 US.
`Cl C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of
`an application filed in another country, or under a multilateral international agreement, that requires publication at
`eighteen months after filing.
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`Enter
`either Customer Number
`or
`complete
`the Representative Name
`section
`below.
`If
`both
`are completed the Customer Number will be used for the Representative Information during processing.
`
`
`sections
`
`
`
` Customer Number
`
`0 Limited Recognition (37 CFR 11.9)
`O US Patent Practitioner
`@ Customer Number
`Please Select One:
`20322
`
`Domestic BenefitINationaI Stage Information:
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(0) or indicate National Stage
`entry from a PCT application. Providing this information in the app ication data sheet constitutes the specific reference required by
`35 U.S.C. 119(e) or 120, and 37 CFR 1.78(a)(2) or CFR 1.78(a)(4), and need not otherwise be made part of the specification.
`
`
`
`Prior Application Status
`
`
`
`Filing Date (YYYY-MM-DD)
`
`Application Number
`
`
`
`Continuity Type
`
`Prior Application Number
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`Add
`
`Foreign Priority Information:
`EFS Web 2.2.1
`
`MTF Ex. 1037, pg. 8
`
`

`

`Mailing Address Information:
`Address 1
`
`
`Address 2
`
`
`
`
`
`
`
`PTO/SB/14 (07-07)
`Approved for use through 0630/2010. OMB 0651-0032
`US Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe PapenNork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`_
`_
`Applicatlon Data Sheet 37 CFR 1.76
`
`
`Attorney Docket Number
`52874.0350
`
`Application Number
`
`COMBINATION OF BIOLOGICALLY COMPATIBLE SCAFFOLD AND HUMAN AMNION TISSUE FOR
`we of Inventm” TISSUE REGENERATION
`
`
`
`This section allows for the applicant to claim benefit of foreign priority and to identify any prior foreign application for which priority is
`not claimed. Providing this information in the application data sheet constitutes the claim for priority as required by 35 U.S.C. 119(b)
`and 37 CFR 1.55(a).
`Remove
`
`
`
`
`Application Number
`
`Country I
`
`Parent Filing Date (YYYY-MM-DD)
`
`Priority Claimed
`
`@ Yes O No
`
`Add
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`
`Assignee Information:
`Providing this information in the application data sheet does not substitute for compliance with any requirement of part 3 of Title 37
`
`of the CFR to have an assignment recorded in the Office.
`
`
`Assignee 1
`
`If the Assignee is an Organization check here.
`|:|
`
`Prefix
`
`Given Name
`
`Middle Name
`
`Family Name
`
`
`
`Suffix
`
`StatelProvince
`
`
`Postal Code
`
`
`Country I
`Phone Number
`
`Email Address
`
`Additional Assignee Data may be generated within this form by selecting the Add
`button.
`
`Add
`
`
`Signature:
`
`A signature of the applicant or representative is required in accordance with 37 CFR 1.33 and 10.18. Please see 37
`
`CFR 1.4(d) for the form of the signature.
`
`Signature
`
`/J. Damon Ashcraft/
`Date (YYYY- MM- DD)
`
`
`2007— 11—20
`
`This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public which
`is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This
`collection is estimated to take 23 minutes to complete, including gathering, preparing, and submitting the completed application data
`sheet form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to
`complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, PO. Box 1450, Alexandria, VA 22313—1450. DO NOT SEND FEES OR
`
`
`COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`
`EFS Web 2.2.1
`
`MTF Ex. 1037, pg. 9
`
`

`

`Privacy Act Statement
`
`
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the attached form related to
`a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised that: (1) the general authority for the collection
`of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is
`used by the U.S. Patent and Trademark Office is to process and/or examine your submission related to a patent application or patent.
`If you do not
`furnish the requested information, the US. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act (5 U.S.C. 552)
`and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the Department of Justice to determine
`whether the Freedom of Information Act requires disclosure of these records.
`
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`EFS Web 2.2.1
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`MTF EX. 1037, pg. 10
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`

`

`Provisional Patent Application
`
`Title: Combination of a Biologically Compatible Scaffold and Human Amnion
`Tissue for Tissue Regeneration
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`Inventors: Robert Tofe
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`Andrew Tofe, PhD.
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`Reference to Related Application: This application incorporates US. Provisional
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`Application Serial No. 60/970,780 filed on September 7, 2007 and entitled “Combination
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`of a Biologically Compatible Scaffold and Human Amnion Tissue For Tissue
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`Regeneration” by reference in its entirety for all purposes.
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`Introduction: The term afterbirth may used to denote all the tissues and cells left over
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`after a woman gives birth. This may include but not limited to, the placenta, umbilical
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`cord and amniotic sac. The amniotic sac encloses the embryo during pregnancy. The
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`amniotic sac may be procured from a donor during the birthing process following the
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`methods outlined in US. Patent Application Serial No. 11/314,356 entitled “Method of
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`Procuring Birth Tissue” and filed on December 21, 2005, which is incorporated herein by
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`reference in its entirety. The amniotic sac has two parts, the amnion and chorion. During
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`processing the amnion may be bluntly dissected from the chorion. The remaining amnion
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`tissue may be typically between 20—50 um thick, however other thicknesses are possible.
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`The amnion tissue can be cleansed by various agents including but not limited to saline,
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`surfactant solutions, ethanol, glutaraldehyde, ultrasound, mild agitation techniques, and
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`other methods commonly known to one skilled in the art. The epithelium layer covering
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`20737932
`
`MTF Ex. 1037, pg. 11
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`

`

`the basement membrane of the amnion tissue may or may not be removed during the
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`cleansing process using decellularization techniques including but not limited to freezing,
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`physical removal using a cell scraper, nonionic detergents, anionic detergents, nucleases,
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`as a secondary outcome of sterilizing the tissue using the previously described practices,
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`and other methods commonly known to one skilled in the art. The processed amnion
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`tissue is processed aseptically and frozen or terminally sterilized and stored in dehydrated
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`state either by air drying or freeze drying, or in a liquid preservation agent including but
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`not limited to ethanol or saline until time of surgery.
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`Amnion tissue has been used as a skin graft,
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`temporary biologic dressing for full
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`thickness wounds, reconstruct damaged organs, a nerve tube, guided tissue regeneration,
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`preventing tissue adhesion, and in ocular procedures. More recently it was shown to be
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`an effective graft for regenerating gingival tissue in a pre-clinical rabbit studyl.
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`Although the exact mechanism of amnion tissue in wound healing may not be fully
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`understood,
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`it does possess several properties that make it an attractive option in the
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`treatment of gingival recession and increasing the coverage of gingival tissue around the
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`root of a tooth. Amnion tissue is expected to address esthetic concerns, hypersensitivity
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`and / or root caries, among other possible uses. These types of procedures are sometimes
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`refen‘ed to as perioplastic or mucogingival surgery. Another application is its use in oral
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`reconstruction procedures to repair tissue lost by cancer or traumatic injury. Some, but
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`not all, of the advantages of the use of amnion tissue from a scientific perspective are
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`listed below.
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`20737932
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`MTF Ex. 1037, pg. 12
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`

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`1. Contains laminins l and 5. Laminin 5 has been shown to bind gingival cells.
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`2. Contains fibronectin and fibrillar collagen types I, III, and IV
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`3. Contains several growth factors including but not limited to epidermal growth
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`factor,
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`transforming growth factor-0t, kerationcyte growth factor, hepotcyte
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`growth factor, basic fibroblast growth factor, and transforming growth factors, [31,
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`[32 and [33.
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`4. The tissue is acelluar.
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`The laminins in amnion tissue, specifically laminin-S, are suspected to increase cell
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`attachmentz,3 which may up regulate the expression of growth factors to induce rapid
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`gingival epithelia cell migration and cellular proliferation and differentiation4. These
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`growth factors may aid in the formation of granulation tissue by stimulating fibroblast
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`growth and neovascularizations.
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`Amnion tissue
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`suppresses
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`the migration of
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`polymorphonuclear cells, which mitigates a strong immune responseé. These attributes
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`plus amnion tissue’s
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`inherent quality to self adhere to host
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`tissue should limit
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`inflammation post implantati0n7. Despites all these attributes amnion tissue primary
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`drawback is less than opti