UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
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`MUSCULOSKELETAL TRANSPLANT FOUNDATION,
`Petitioner
`
`v.
`
`MIMEDX GROUP, INC.
`Patent Owner
`
`
`
`
`
`Case IPR2015-00669
`U.S. Patent No. 8,323,701
`
`PETTIONER'S EXHIBIT 1044
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
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`
`
`MUSCULOSKELETAL TRANSPLANT FOUNDATION,
`Petitioner
`
`v.
`
`MIMEDX GROUP, INC.
`Patent Owner
`
`
`
`
`
`Case IPR2015-00669
`U.S. Patent No. 8,323,701
`
`PETTIONER'S EXHIBIT 1044
`
`
`
`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MUSCULOSKELETAL TRANSPLANT FOUNDATION,
`Petitioner
`
`v.
`
`MIMEDX GROUP, INC.
`Patent Owner
`
`Case IPR2015-00669
`U.S. Patent No. 8,323,701
`
`PETTIONER'S CORRECTED PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 8,323,701
`
`NJ 228944060v1229191990v2
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`
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Atty. Dock. No. 103248.037101
`
`TO
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`BE
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`::
`
`In re: MIMEDX GROUP, INC.
`
`NO.:
`CASE
`ASSIGNEDIPR2015-00669
`
`I hereby certify that this
`correspondence is being transmitted
`via the U.S. Patent and Trademark
`Office electronic filing system
`(PRPS) to the USPTO on
`FebruaryJuly 2, 2015.
`/John K. Kim/
`
`::
`
`::
`
`:X
`
`Patent No.: 8,323,701 B2
`
`Issued: December 4, 2012
`
`For: Placental Tissue Grafts
`
`MAIL STOP PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`CORRECTED PETITION FOR INTER PARTES
`REVIEW OF U.S. PATENT NO. 8,323,701 B2
`
`Sir:
`
`Pursuant to 35 USC §311 et seq. and 37 CFR §42.1 et seq., Musculoskeletal
`
`Transplant Foundation (“Petitioner”) hereby petitions for an inter partes review of
`
`U.S. Patent No. 8,323,701 B2 (“the ‘701 Pat.”). Petitioner respectfully submits
`
`that Claims 1, 2 and 5-8 of this patent are unpatentable under Pre-AIA 35 USC §§
`
`102 and 103 in view of the prior art references discussed herein. This Petition
`
`clearly demonstrates that there is a reasonable likelihood that Petitioner will
`
`prevail with respect to at least one of these claims. Accordingly, it is respectfully
`
`requested that the Board institute an inter partes review of the ‘701 Pat. pursuant
`
`NJ 228944060v1229191990v2
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`
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`to 37 CFR §42.108.
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`NJ 228944060v1229191990v2
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS
`PETITIONER’S EXHIBIT LIST
`I.
`Introduction
`II. Mandatory Notices And Disclosures
`A. Real Party-In-Interest
`B. Related Matters
`C. Lead/Back-Up Counsel & Service Infomation
`D. Required Fees
`E. Standing Under 37 CRF §42.104(a)
`
`III. Subject Matter Of The ‘701 Pat.
`IV.
`Independent Claim of the ‘701 Pat.
`V. Claim Construction Under 37 CFR §42.104(b)(3)
`VI. Background of The Alleged Invention In The ‘701 Pat
`VII. Prior Art Status Of The References Cited Herein
`VIII. Level and Person of Ordinary Skill in the Art
`IX. Grounds of Unpatentability Of Claims 1, 2 And 5-8 Of The ‘701 Pat.
`A. Clams 1, 2 and 5-8 Are Unpatentable Over Shenaq
`1. Claim 1 Is Anticipated By Shenaq Under §102(b)
`a. Elm. A
`b. Elm. B
`c. Elm. C
`i. “Exposed Jelly-Like”
`ii. “Cellular” Or “An Identifiable Region Of Fibroblast Cells”
`d. Elm. D
`e. Elm. E
`f. The “consisting of” Language
`2. Claims 2 And 5-8 Are Anticipated by Shenaq Under §102(b)
`3. Shenaq In View Of Ishino, Kinoshita-06 Or Kinoshita-07
`a. Ishino
`b. Kinoshita-06
`c. Kinoshita-07
`4. Claim 1, 2 5-8 Are Obvious Over Shenaq In View Of Dua-07 Or
`Shimazaki Under §103(a)
`B. Clams 1, 2 And 5-8 Are Obvious Over Tseng
`1. Claim 1 Is Obvious Over Tseng In View Of Ishino, Kinoshita-06
`Or Kinoshita-07
`
`NJ 228944060v1229191990v2
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` i
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`i
`ii
`1
`1
`1
`1
`1
`2
`2
`
`2
`3
`3
`5
`7
`8
`9
`9
`9
`9
`9
`13
`13
`17
`21
`23
`23
`23
`25
`25
`27
`30
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`32
`34
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`34
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
`
`a. Elm. A (“a tissue graft consisting of”)
`b. Elm. B (“modified amnion . . . having an exposed basement
`membrane”)
`c. Elm. C (the modified amnion having “an exposed jelly-like
`fibroblast layer”)
`d. Elm. D And E
`e. The “Exposed” Limitation of Elm. B
`i. Kinoshita-06
`ii. Kinoshita-07
`iii. Ishino
`f. The “consisting of” Language
`2. Claims 2 And 6-8 Are Obvious Over Tseng/Ishino, Kinoshita-06
`Or -07
`3. Claim 5 Is Obvious Over Tseng In View Of Ishino, Kinoshita-06
`Or Kinoshita-07 In Further View Of Sulner Or Shenaq Under
`§103(a)
`C. Claims 1, 2 And 5-8 Are Obvious Over Wei He Under §103(a)
`1. Claim 1 Is Obvious Over Wei He In View Of
`Tseng/Sulner/Shenaq
`a. Elm. A
`b. Elm. B
`c. Elm. C
`d. Elm. D & E
`e. The “consisting of” Language
`2. Claims 2 And 6-8 Are Obvious Over Wei He In View Of Tseng,
`Sulner or Shenaq Under §103(a)
`D. Claims 1, 2 And 5-8 Are Anticipated By Sulner Under §102(e)
`1. Claim 1 Is Anticipated by Sulner Under §102(e)
`a. Elm. A
`b. Elm. B
`c. Elm. C
`d. Elm. D & E
`e. The “consisting of” Language
`2. Claims 2 And 5
`3. Claim 6
`4. Claims 7 and 8
`5. Prior Art Date Of Sulner
`
`34
`
`35
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`35
`37
`39
`40
`42
`43
`44
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`44
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`45
`48
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`48
`48
`49
`49
`52
`55
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`55
`56
`56
`57
`57
`57
`58
`59
`60
`60
`60
`60
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`NJ 228944060v1229191990v2
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
`
`Exhibit No.
`Ex. 1001
`Ex. 1002
`
`Ex. 1003
`
`Ex. 1004
`
`Ex. 1005
`
`Ex. 1006
`Ex. 1007
`
`Ex. 1008
`Ex. 1009
`
`Ex. 1010
`Ex. 1011
`
`Ex. 1012
`
`Ex. 1013
`
`Ex. 1014
`
`PETITIONER’S EXHIBIT LIST
`
`Exhibit Description
`U.S. Patent No. 8,323,701 to Daniel et al.
`United States Patent and Trademark Office
`(“USPTO”) file wrapper for the ‘701 Patent
`Complaint filed in MiMedx Group Inc. v.
`Liventa Bioscience, Inc. et al., Civil Action
`No. Case 1:14-cv-01178-RWS (“Related
`Litigation”)
`Joint Claim Construction Statement filed in
`the Related Litigation.
`Exhibit A to Joint Claim Construction
`Statement: MiMedx’s Proposed Claim
`Constructions and Supporting Evidence for
`the ‘701 Patent.
`Expert Declaration of Rebecca N. Baergen
`Parry et al., 1998, New England J. Med.,
`338(10) 663-670
`Expert Declaration of Dr. Helen N. Jones
`International Publication No. WO 93/10722
`to Shenaq et al.
`U.S. Patent No. 6,152,142 to Tseng
`Chinese Patent Publication No. CN1757717A
`to Wei He
`English-Language Translation of Chinese
`Patent Publication No. CN1757717A to Wei
`He and corresponding Translation
`Certification
`U.S. Patent Publication No. 2007/0038298
`A1 to Sulner et al.
`Klen, Preparation of chorion and/or amnion
`grafts used in burns, Transactions of the
`Third International Congress on Research in
`Burns, held in Prague, Sept. 20-25, 1970,
`Matter et al., eds., pp. 289-292 (1971)
`
`Abbreviation
`‘701 Pat.
`N/A
`
`N/A
`
`JCCS
`
`N/A
`
`N/A
`Parry
`
`N/A
`Shenaq
`
`Tseng
`Wei
`
`Wei
`
`Sulner
`
`Klen
`
`NJ 228944060v1229191990v2
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`iii
`
`
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
`
`Abbreviation
`Dua-99
`
`Ward
`
`Douglas
`
`Dino
`
`Hanada
`
`Robson
`
`Rinastiti
`
`Kinoshita-06
`
`Kinoshita-07
`
`Exhibit No.
`Ex. 1015
`
`Ex. 1017
`
`Ex. 1018
`
`Ex. 1019
`
`Exhibit Description
`Dua et al., Amniotic membrane
`transplantation, Br. J. Ophthalmol.,
`83:748-752 (1999)
`Ex. 1016 Ward et al., The healing of chronic venous
`leg ulcers with prepared human amnion,
`British Journal of Plastic Surgery, 42,
`463-467 (1989)
`Douglas, Homografts of Fetal Membranes as
`a Covering for Large Wounds – Especially
`Those from Burns, Journal of Tennessee State
`Medical Association, 45:6, 230-235 (June
`1952)
`Dino et al., Human Amnion: The
`Establishment of an Amnion Bank and its
`Practical Applications in Surgery, The
`Journal of The Philippine Medical
`Association, Vol. 42, No. 7, pp. 357-366
`(July 1966)
`Hanada et al., Multilayered Amniotic
`Membrane Transplantation for Severe
`Ulceration of the Cornea and Sclera,
`American J. of Ophthalmol., Vol. 131, No. 3,
`pp. 324-331 (March 2001)
`Robson et al., Amniotic Membranes as a
`Temporary Wound Dressing, Surgery,
`Gynecology & Obstetrics, Vol. 136, pp.
`904-906 (June 1973)
`Rinastiti et al., Histological evaluation of
`rabbit gingival wound healing transplanted
`with human amniotic membrane, Int. J. Oral
`Maxillogac. Surg., Vol. 35, pp. 247-251
`(September 2005)
`U.S. Patent Publication No. 2006/0153928
`A1 to Kinoshita et al.
`International Publication No.
`WO2007/013331 A1 to Kinoshita et al.
`
`Ex. 1020
`
`Ex. 1021
`
`Ex. 1022
`
`Ex. 1023
`
`NJ 228944060v1229191990v2
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
`
`Exhibit No.
`Ex. 1024
`
`Ex. 1025
`
`Ex. 1026
`
`Ex. 1027
`
`Ex. 1028
`
`Ex. 1029
`
`Ex. 1030
`
`Ex. 1031
`
`Ex. 1032
`
`Ex. 1033
`
`Ex. 1034
`
`Ex. 1035
`
`Ex. 1036
`
`Exhibit Description
`English-Language Translation of
`International Publication No.
`WO2007/013331 A1 to Kinoshita et al. and
`corresponding Translation Certification
`Ishino et al., Amniotic Membrane as a
`Carrier for Cultivated Human Corneal
`Endothelial Cell Transplantation, IOVS, Vol.
`45, No. 3, pp. 800-806 (March 2004)
`Japanese Patent Publication No.
`2001-161353 to Shimazaki, et al.
`English-Language Translation of Japanese
`Patent Publication No. 2001-161353 to
`Shimazaki, et al. and corresponding
`Translation Certification
`International Publication No. WO
`2005/075002 to Taguchi et al.
`English-Language Translation of
`International Publication No. WO
`2005/075002 to Taguchi et al. and
`corresponding Translation Certification
`U.S. Patent Publication No. 2006/0228339 to
`Wang
`Ohno-Matsui, In vitro and in vivo
`characterization of iris pigment epithelial
`cells cultured on amniotic membranes,
`Molecular Vision, Vol. 12, pp. 1022-1032
`(August 2006)
`U.S. Patent Publication No. 2003/0187515
`A1 to Hariri et al.
`U.S. Patent Publication No. 2004/0048796
`A1 to Hariri et al.
`International Publication No. WO
`2007/010305 A2 to Dua et al.
`Vishwakarma et al., Amniotic Arthroplasty
`for Tuberculosis of the Hip, J. Bone & Joint
`Surgery 68-B(1), 68-74 (1986)
`U.S. Provisional Patent Application Serial
`No. 60/970,780 filed September 7, 2007
`
`Abbreviation
`Kinoshita-07
`
`Ishino
`
`Shimazaki
`
`Shimazaki
`
`Taguchi
`
`Taguchi
`
`Wang
`
`Matsui
`
`Hariri-03
`
`Hariri-04
`
`Dua-07
`
`Vishwakarma
`
`N/A
`
`NJ 228944060v1229191990v2
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
`
`Abbreviation
`N/A
`
`N/A
`
`Toda
`
`Lee
`
`Oxlund
`
`Burgos
`
`N/A
`
`N/A
`
`Exhibit No.
`Ex. 1037
`
`Ex. 1038
`
`Ex. 1039
`
`Ex. 1040
`
`Exhibit Description
`U.S. Provisional Patent Application Serial
`No. 60/989,299 filed November 7, 2007
`U.S. Provisional Patent Application Serial
`No. 60/986,665 filed November 9, 2007
`Toda et al., The Potential of Amniotic
`Membrane/Amnion-Derived Cells for
`Regeneration of Various Tissues, J.
`Pharmacol. Sci., Vol. 105, pp. 215-218 (June
`2007)
`Lee et al., Amniotic Membrane
`Transplantation for Persistent Epithelial
`Defects With Ulceration, Amniotic
`Membrane Transplantation, Vol. 123, No. 3,
`pp. 303-312 (March 1997)
`Oxlund et al., Biomechanical analysis of
`human chorioamniotic membranes, European
`Journal of Obstetrics and Gynecology and
`Reproductive Biology, Vol. 34, No. 3, pp.
`247-255 (March 1990)
`Burgos, H., Angiogenic and growth factors in
`human amnio-chorion and placenta, Eur. J.
`of Clin. Invest., Vol. 13, pp. 289-296
`(December 1982)
`U.S. Provisional Application No. 60/696,167
`by Sulner et al.
`Ex. 1044 Redline version of Petitioner’s Corrected
`Petition for Inter Partes Review of U.S.
`Patent No. 8,323,701
`
`Ex. 1041
`
`Ex. 1042
`
`Ex. 1043
`
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
`
`I.
`
`Introduction: Petitioner petitions for an inter partes review with respect to
`
`Claims 1, 2 and 5-8 of U.S. Patent No. 8,323,701 (“the ‘701 Pat.") (see Ex. 1001 &
`
`its file history at Ex. 1002), which are unpatentable under Pre-AIA 35 USC
`
`§§102(b) and/or 103(a) and should therefore be cancelled. This Petition
`
`demonstrates a reasonable likelihood that Petitioner will prevail with respect to at
`
`least one of these claims. 35 USC § 314(a).
`
`II.
`
`Mandatory Notices And Disclosures
`
`A.
`
`Real Parties-In-Interest: The real parties-in-interest in this Petition are the
`
`Petitioner (i.e., Musculoskeletal Transplant Foundation, “Petitioner”), Liventa
`
`Bioscience, Inc. and Medline Industries, Inc.
`
`B.
`
`Related Matters: The ‘701 Pat. is involved in MiMedx Group Inc. v. Liventa
`
`Bioscience, Inc. et al., Case No. 1:14-cv-01178-MHC (N.D. Ga.) (“Related
`
`Litigation”), filed by MiMedx Group, Inc. (“P. Owner”). Ex. 1003. The ‘701 Pat.
`
`is related to US Pat. Nos. 8357403, 8409626, 8709493, 8642092, 8703207,
`
`8932643, 8372438 and 8372439; and US App. Nos. 14/171511, 14/262590 and
`
`14/323964. Petitioner is also filing an IPR Petition for P. Owner’s US Pat. No.
`
`8372437.
`
`C.
`
`Lead/Back-Up Counsel & Service Information Petitioner appoints Ralph W.
`
`Selitto, Jr., Reg. No. 26,996, as lead counsel, and John K. Kim, Reg. No. 37,002,
`
`and Eric E. Bleich, Reg. No. 47,430, as back-up counsel. A Power of Attorney is
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
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`filed herewith. Petitioner may be served electronically at selittor@gtlaw.com,
`
`kimjo@gtlaw.com and bleiche@gtlaw.com, and by postal mail and hand delivery
`
`at Greenberg Traurig, LLP, Attn: Ralph W. Selitto, Jr., 200 Park Avenue, Florham
`
`Park, NJ 07932. The attorneys of record may be contacted at 973-443-3550, while
`
`their facsimile number is 973-295-1309.
`
`D.
`
`Required Fees: The Board is authorized to charge $23,000, or any
`
`additional fees associated with this Petition, to Deposit Account No. 501561.
`
`E.
`
`Standing Under 37 CFR §42.104(a): Petitioner certifies that the ‘701 Pat.
`
`is available for inter partes review and that Petitioner and the real parties in
`
`interest are not barred or estopped from requesting an inter partes review
`
`challenging the patent claims on the grounds identified in the Petition.
`
`III.
`
`Subject Matter Of The ‘701 Pat.
`
`The ‘701 Pat. discloses a tissue graft derived from placenta (i.e., amnion and
`
`chorion). Ex. 1001, 1:64-65. The graft includes a first membrane of amnion in
`
`which the epithelium layer has been substantially removed to expose the basement
`
`layer. Id.,1:65-67. “By removing the epithelium layer, cells from the host can more
`
`readily interact with the cell-adhesion bio-active factors located onto [sic] top and
`
`within the basement membrane.” Id., 2:1-3. The first amnion membrane also
`
`includes an exposed jelly-like fibroblast cellular layer. Id., 13:13-14. One or more
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
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`additional membranes is/are layered to the exposed fibroblast layer of the first
`
`membrane, such additional membrane(s) being selected from the group consisting
`
`of amnion, chorion, allograft pericardium, allograft acellular dermis, amniotic
`
`membrane, Wharton's jelly, and combinations thereof. Id., 8:19-25, 13:19-23.
`
`IV.
`
`Independent Claim of the ‘701 Pat.
`
`The sole independent claim of the ‘701 Pat. is reproduced in the following
`
`chart. The claim elements will be referenced below by their corresponding letters
`
`(i.e., “Elms. A-E”), which are provided in the left column of the following chart.
`
`Elements of Claim 1
`
`A A tissue graft consisting of:
`B a first membrane comprising modified amnion wherein the modified amnion
`has a first side which is an exposed basement membrane and
`C [the modified amnion has] a second side which is an exposed jelly-like
`fibroblast cellular layer; and
`D one or more additional membranes sequentially layered such that the first
`additional membrane is layered adjacent to the exposed fibroblast layer of the
`first membrane,
`E wherein the at least one or more additional membranes is selected from the
`group consisting of amnion, chorion, allograft pericardium, allograft acellular
`dermis, amniotic membrane, Wharton's jelly, and combinations thereof.
`
`V.
`
`Claim Construction Under 37 CFR §42.104(b)(3)
`
`Under 37 CFR §42.100(b), the terms of the claims of the ‘701 Pat. are
`
`construed under the “broadest reasonable interpretation” (“BRI”) standard. In the
`
`parties’ Joint Claim Construction Statements (“JCCS”) filed in the Related
`
`Litigation, P. Owner has advanced the following proposed constructions for the
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
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`‘701 Pat. (see Exs. 1003-10051004-1006 including (1) the JCCS; (2) MiMedx’s
`
`(P. Owner) Proposed Claim Constructions and Supporting Evidence for the ‘701
`
`Pat.; and (3) an Expert Declaration of Rebecca N. Baergen, MD, respectively):
`
`
`
`“a first membrane comprising modified amnion” in Claim 1:
`
`Amniotic membrane separated from the chorionic membrane of native placenta
`
`and having at least a first side which is an exposed basement membrane and a
`
`second side which is an exposed jelly like fibroblast cellular layer (see
`
`Ex.1004,1005, 2);
`
`
`
`“exposed jelly-like fibroblast cellular layer” in Claim 1: The sticky
`
`side of the modified amnion, defined above, which includes an identifiable region
`
`of fibroblast cells (see id., 5);
`
`
`
`“such that the first additional membrane is layered adjacent to the
`
`exposed fibroblast layer of the first membrane” in Claim 1: The one or more
`
`additional membranes is layered in close proximity to, which can include having
`
`contact with the exposed fibroblast layer of the first membrane (see id., 8).
`
`Petitioner states that P. Owner’s proposed constructions of the above claim
`
`terms are inconsistent with the principles dictated in Phillips v. AWH Corp., 415
`
`F.3d 1303 (Fed. Cir. 2005), and thus P. Owner’s proposed constructions should
`
`not be adopted in the Related Litigation. However, pursuant to 37 CFR
`
`§42.104(b)(3), Petitioner states that P. Owner’s construction of the claims for
`
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
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`purposes of litigation should be considered as within the scope of the Office’s BRI
`
`standard for purposes of this IPR Petition. See Sap Am., Inc. v. Versata Dev.
`
`Group, Inc., Case CBM2012-00001, Paper 70, at *7 (P.T.A.B. June 11, 2013)
`
`(“There are . . . two claim construction standards: the Office’s [BRI] construction
`
`and the district court standard set forth in Phillips v. AWH. . .”). See also Motorola
`
`Mobility, LLC v. Arnouse, Case IPR2013-00010, Paper 21, at *6 (P.T.A.B. Feb.
`
`12, 2013) (finding that Petitioner’s identification of “the claim constructions made
`
`in the concurrent litigation” satisfied 37 CFR §42.104(b)(3)).
`
`VI.
`
`Background of The Alleged Invention In The ‘701 Pat.
`
`The human placenta includes two membranes: the amnion and the chorion.
`
`See Parry (Ex. 1007, 1). The amnion and chorion are sometimes referred to as the
`
`amniotic and chorionic, respectively, membranes in the art. Ex. 1008, ¶23.
`
`As the innermost membrane of the placenta (see Fig. 1 of Parry, reproduced
`
`herein), the amnion is in contact with the amniotic fluid and the fetus. An
`
`intermediate/spongy layer is located between the amnion and the chorion, which is
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`the outer-most membrane of the placenta in contact with the maternal tissues of
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`the uterus. Id., ¶24. See also Ex. 1007, 1-2.
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`As shown above, the amnion includes: the epithelium or epithelial layer; the
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`basement membrane; the compact layer; the fibroblast layer; and the spongy layer.
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`The epithelium, which is the inner-most layer (nearest the fetus), has epithelial
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`cells forming a continuous monolayer that overlies the basement membrane. The
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`compact layer lies beneath the basement membrane, while the fibroblast layer lies
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`beneath the compact layer and contains various cells, including fibroblast, within
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`an extracellular matrix. The intermediate spongy layer lies between the fibroblast
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`layer of the amnion and the underlying chorion, and absorbs physical stresses by
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`permitting the amnion to slide along the chorion without disrupting the firm
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`adherence of the chorion to the maternal decidua. See id.
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`The chorion also includes various layers. See id., 2. As acknowledged by the
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`‘701 Pat., human placental membranes have been used in various surgical
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`procedures since the early 1900s. Ex. 1001, 1:16-17. Such procedures included the
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`treatment of a variety of conditions, including corneal injuries, burns, peripheral
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`nerve injuries, chronic ulcers of the leg and skin wounds. See, e.g., Exs.
`
`1009-1021.
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`Over the long history of using placental membranes, many tissue-processing
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`techniques have been developed. For instance, methods of removing the epithelial
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`layer from the amnion were well-known in the prior art. See, e.g., Exs. 1022-1033.
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`Removing the epithelial layer exposes the underlying basement membrane, which
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`can more readily interact with cells from the host and thereby facilitate tissue
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`healing. Ex. 1008 ¶29. It was also known in the prior art that the spongy layer can
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`be removed from its associated amnion (see, e.g., Exs. 1010-1012, 1034),
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`exposing the underlying fibroblast layer. Ex. 1008 ¶30. Methods for layering
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`amnion and/or chorion sheets to form multilayered grafts were known. See, e.g.,
`
`Exs.1009-1010. Multi-layering methods provide additional thickness, rigidity, etc.
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`to a single amnion layer for improving handling, efficacy and other properties. Ex.
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`1008 ¶31.
`
`As illustrated below, the tissue graft claimed in the ‘701 Pat. was known in
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`the prior art. Thus, the Challenged Claims are unpatentable over the prior art.
`
`VII.
`
`Prior Art Status Of The References Discussed Herein
`
`All references discussed herein, with the exception of Kinoshita-07, Sulner,
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`Dua-07 and Toda, were published more than one year prior to the filing dates of
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`the prov. applns. to which the ‘701 Pat. claims priority, and constitute prior art
`
`under §102(b). Kinoshita-07, Dua-07 and Sulner (“3 References”) published prior
`
`to the filing dates of these prov. applns. (see Exc. 1036-1038) and thus constitute
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`prior art at least under §102(a) and/or (e). Because at least some features claimed
`
`in the ‘701 Pat. are not supported by the prov. applns., the ‘701 Pat. is not entitled
`
`to the benefit of any of the prov. applns.’ filing dates. Thus, the ‘701 Pat.’s earliest
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`possible effective filing date is the 9/8/2008 filing date of its parent appln. (see Ex.
`
`1001), which is more than one year after the publication dates of the 3 References
`
`and which is also after the publication date of Toda, qualifying the 3 References &
`
`Toda as prior art under §102(b) and (a), respectively.
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`Once a patent challenger comes forward with invalidating prior art, the
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`burden of production shifts to the patentee to show that “it is not prior art because
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`the asserted claim is entitled to the benefit of an earlier filing date”. Research
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`Corp. Technologies v. Microsoft Corp., 627 F.3d 859, 870 (Fed. Cir. 2010). Thus,
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`Petitioner reserves the right to challenge the ‘701 Pat.’s priority claims, should P.
`
`Owner attempt to antedate or otherwise disqualify any of the references as prior
`
`art.
`
`Certified English-language translations of Wei, Kinoshita-07, Shimazaki
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`and Taguchi at Exs. 1011, 1023, 1026 and 1028 are submitted as Exs. 1012, 1024,
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`1027 and 1029, respectively. Citations to the foreign-language references are
`
`being made herein to the English-language translations. Also, citations to the
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`non-patent references are being made herein to the page numbers in the
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`bottom-lower corners in the exhibits, while citations to the patent references are
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`being made herein to the page, column, paragraph and/or line numbers in the
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`published documents.
`
`VIII.
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`Level and Person of Ordinary Skill in the Art
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`Petitioner submits that persons of ordinary skill in the art (“POSA”) of the
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`‘701 Patent during the 2007-2008 time frame covering 9/7/2007 and 9/8/2008
`
`would possess an advanced degree (i.e., a Masters or Doctorate degree) in a
`
`biomedical science such as physiology, biochemistry, biology, cell biology, or a
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`medical science degree in pathology or medicine, and knowledge of tissue
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`processing methods. Ex. 1008 ¶14. A POSA as of the 2007-2008 timeframe would
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`also have at least two years of experience in and/or knowledge of the processing
`
`of tissues for clinical and/or research use. Id.
`
`IX.
`
`Grounds Of Unpatentability Of Claims 1, 2 And 5-8 Of The ‘701 Pat.
`
`A.
`
`Clams 1, 2 And 5-8 Are Unpatentable Over Shenaq
`
`1.
`
`Claim 1 Is Anticipated By Shenaq Under §102(b)
`
`Shenaq (not cited in the ‘701 Patent) discloses a fetal membrane tube for
`
`use as a nerve and vessel graft. Ex. 1009, 1:6-7. The tube of Shenaq is formed,
`
`inter alia, by separating amnion from chorion, removing the cellular monolayer
`
`overlying the basal lamina of the amnion and wrapping the amnion and chorion in
`
`layers to form the finished tube. Id., 4:23-5:2. Shenaq includes all of the elements
`
`recited in Claim 1, as demonstrated below.
`
`a.
`
`Elm. A: Shenaq discloses a fetal membrane tube for use as a nerve
`
`and vessel graft, id., 1:6-7, and teaches the tissue graft of Elm. A (i.e., “a tissue
`
`graft consisting of”). See Sec. IX.A.1.f. below for “consisting of” discussion.
`
`b.
`
`Elm. B: The tube of Shenaq includes Elm. B: “a first membrane
`
`comprising modified amnion . . . [having] an exposed basement membrane”.
`
`Shenaq teaches that after separating the amnion and chorion from each other, the
`
`“cellular monolayer material overlying the basal lamina on the fetal side of the
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`[amnion] membrane is removed”. Id., 4:26-28; 7:9-10. The “cellular monolayer
`
`material” and the “basal lamina” disclosed in Shenaq refer to the epithelial layer
`
`(formed by a single layer of epithelial cells) and the basement membrane,
`
`respectively. Ex. 1008 ¶58. Due to the removal of the epithelial layer, the
`
`basement membrane of the amnion, which had been covered by the epithelial
`
`layer, is exposed. Id. Thus, Shenaq discloses modified amnion having an exposed
`
`basement membrane, as required by Elm. B. Id.
`
`Shenaq does not teach or suggest retaining epithelial cells on its graft. Id.
`
`¶60. Given Shenaq’s objective of exposing various biochemical components in the
`
`basement membrane to cells in the host (see discussion below), a POSA would
`
`understand Shenaq as teaching removal of all, or substantially all, of the epithelial
`
`layer from the amnion.
`
`Id. Moreover, since Shenaq teaches that “cellular
`
`monolayer material overlying the basal lamina . . . is removed” (emphasis added),
`
`Ex. 1009, 4:26-28, a POSA would understand that only the cellular monolayer is
`
`to be removed and the underlying basal lamina is to be retained. Ex. 1008 ¶61.
`
`Shenaq does not require any specific process to remove the epithelium from
`
`the amnion (see Ex. 1009, 4:26-28, 7:9-11 stating “cellular monolayer . . . is
`
`removed, such as by exposure to trypsin” (emphasis added)). Shenaq provides an
`
`exemplary denuding process in which the amnion is “immersed for two hours at
`
`room temperature in 1:1 solution of distilled water and trypsin . . . [and] is rinsed
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`repeatedly, preferably with phosphate buffered saline”. Id, 7:11-16. Because
`
`trypsin is an enzyme that is effective in disassociating epithelial cells from their
`
`underlying basement membranes, it has been in wide use. Ex. 1008 ¶59. See, e.g.,
`
`Exs. 1022-1024, 1030. Given Shenaq’s objective of preserving laminin (a
`
`component of the basement membrane) as a significant component, Ex. 1009,
`
`9:6-11 (see also below discussion), a POSA would understand that trypsin may be
`
`used to remove the epithelial cells, but in a manner to preserve the basement
`
`membrane and its biochemical components, including laminin. Ex. 1008 ¶57.
`
`Thus, the trypsin treatment in Shenaq would loosen the epithelial cells from the
`
`basement membrane, while the subsequent rinsing step would clear all, or
`
`substantially all, of the loosened epithelial cells from the basement membrane. Ex.
`
`1008 ¶59. The trypsin/rinsing steps of Shenaq would thus effectively remove all,
`
`or substantially all, of the epithelial cells, thereby exposing the basement
`
`membrane. Id.
`
`Shenaq recognizes that laminin, which is a known component of the
`
`basement membrane (see id. ¶63 and the table in Sec. VI above), has been shown
`
`to promote axon extension and teaches preserving a significant laminin amount in
`
`the amnion. Ex. 1009, 9:6-11. Shenaq teaches that the fetal surface of the amnion
`
`(i.e., the exposed basement membrane) is directed toward the inner surface of the
`
`finished tube, id., 4:35-5:2; 7:34-36, through which axon growth is expected, id.,
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`4:20-22. Thus, one reason for removing the epithelium (i.e, the epithelial layer) in
`
`Shenaq is to expose and make readily available the biochemical components of the
`
`basement membrane, including laminin, to the host cells. Id. ¶63. This reason is
`
`identical to the reason described in the ‘701 Pat. for exposing its basement
`
`membrane. Id. See Ex. 1001, 2:1-3. Thus, even if Shenaq were to expose less than
`
`all of the basement membrane, whatever amount of basement membrane exposure
`
`is achieved in Shenaq should be within the scope of Elm. B. Ex. 1008, ¶63.
`
`The ‘701 Pat. teaches de-epithelializing the amnion (i.e., removing the
`
`epithelium) by, inter alia, “exposing the epithelial cells to nonionic detergents,
`
`anionic detergents, and nucleases”. Ex. 1001, 5:45-46. Since these chemical
`
`processes of the ‘701 Pat. are similar to the trypsin example disclosed in Shenaq,
`
`the extent of epithelium removal and basement membrane exposure in Shenaq
`
`would be comparable to that of the ‘701 Pat. Ex. 1008 ¶64. Thus, the amnion of
`
`Shenaq includes “an exposed basement membrane” as required by Claim 1. Id.
`
`Because Shenaq contemplates removal of all, or substantially all, of the
`
`epithelial cells, the extent of such removal would be greater than 90% (see Ex.
`
`1001, 5:28-31 stating “[t]he term ‘substantially removed’ with respect to the
`
`amount of epithelium removed is defined herein as removing greater than 90%”).
`
`Ex. 1008, ¶65. Should the Board determine that Elm. B requires removal of greater
`
`than 90% of the epithelium and that Shenaq does not achieve such removal,
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
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`Petitioner submits that Claim 1 is obvious over Shenaq under §103(a) because it
`
`would have been obvious to achieve greater than 90% removal in order to
`
`maximize the exposure of the biochemical components in the basement membrane
`
`to cells in the host, as taught or suggested by Shenaq. Ex. 1008, ¶65.
`
`c.
`
`Elm. C: The modified amnion of Shenaq has an “exposed jelly-like
`
`fibroblast cellular layer” (construed by P. Owner as (1) “the sticky side of the
`
`modified amnion” (2) “which includes an identifiable region of fibroblast cells”).
`
`i.
`
`“Exposed Jelly-Like”: The modified amnion of Shenaq includes
`
`a fibroblast layer that is “exposed” and “jelly-like”, and therefore contains a
`
`“sticky side”, as proposed by P. Owner. The tube in Shenaq is formed by
`
`separating amnion and chorion from each other and then wrapping them together
`
`in layers. Ex. 1009, 4:23-36. The amnion and chorion are separated by “finger
`
`dissection”, Id., 7:1-2, which is performed by grasping amnion and/or chorion
`
`with fingers and then pulling same away from the other. Ex. 1008 ¶66. Because
`
`Shenaq does not disclose or suggest removing any tissue layers from the amnion
`
`or chorion during “finger dissection”, all of the tissue layers naturally present in
`
`the placenta (including the fibroblast layer) must necessarily remain in the amnion
`
`and chorion after their separation. Id. Since Shenaq does not teach or suggest any
`
`subsequent processing steps which would cause the fibroblast layer to be removed
`
`from the amnion, the fibroblast layer must remain in the final amnion. Id.
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`Corrected Petition for Inter Partes Review of U.S. Patent No. 8,323,701
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`When the amnion and chorion are separated by “finger dissection”, they
`
`separate from each other along/through the spongy layer located between the
`
`amnion and chorion. Id. ¶67. Because the spongy layer is formed by loosely
`
`arranged bundles of collagen fibers, it separates unevenly between the amnion and
`
`chorion. Id. That is, some of the spongy layer separates from the amnion together
`
`with the chorion, while the rest of the spongy layer separates from the chorion
`
`together with the amnion. Id. See also Ex. 1006 ¶118, in which P. Owner’s expert
`
`confirms this uneven separation. The spongy layer portions that separate together
`
`with the chorion would thereby expose the portions of the fibroblast layer of the
`
`amnion that had been underneath those spongy layer por
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