`
`Trials@uspto.gov Paper No. 49
`571.272.7822 Filed: August 16, 2016
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`
`MUSCULOSKELETAL TRANSPLANT FOUNDATION,
`Petitioner,
`
`v.
`
`MIMEDX GROUP, INC.,
`Patent Owner.
`____________________
`
`Case IPR2015-00664
`Patent 8,372,437 B2
`____________
`
`Before LORA M. GREEN, CHRISTOPHER G. PAULRAJ, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`GREEN, Administrative Patent Judge.
`
`
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`

`

`IPR2015-00664
`Patent 8,372,437 B2
`
`
`INTRODUCTION
`I.
`Musculoskeletal Transplant Foundation (“Petitioner”) filed a
`Corrected Petition requesting an inter partes review of claims 1 and 2 of
`U.S. Patent No. 8,372,437 B2 (Ex. 1001, “the ’437 patent”). Paper 11
`(“Pet.”). MiMedx Group, Inc. (“Patent Owner”) filed a Corrected
`Preliminary Response to the Petition. Paper 10 (“Prelim. Resp.”). We
`determined that the information presented in the Petition and the Preliminary
`Response demonstrated that there was a reasonable likelihood that Petitioner
`would prevail in challenging claims 1 and 2 as unpatentable under 35 U.S.C.
`§ 103(a). Pursuant to 35 U.S.C. § 314, the Board instituted trial on August
`18, 2015, as to the challenged claims of the ’437 patent. Paper 13
`(“Institution Decision” or “Dec. Inst.”).
`Patent Owner filed a Response (Paper 27, “PO Resp.”), but did not
`file a motion to amend. Petitioner subsequently filed a Reply. Paper 31
`(“Reply”). An oral hearing was held on April 26, 2016, and a transcript of
`the hearing has been entered into the record (Paper 47). Patent Owner filed
`a Motion to Exclude (Paper 38), to which Patent Owner filed an Opposition
`(Paper 40), and Patent Owner filed a Reply (Paper 42).
`We have jurisdiction under 35 U.S.C. § 6(c). This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`Based on the record before us, we conclude that Petitioner has demonstrated
`by a preponderance of the evidence that claims 1 and 2 of the ’437 patent are
`unpatentable.
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`IPR2015-00664
`Patent 8,372,437 B2
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`
`Related Proceedings
`A.
`Petitioner states that the ’437 patent is the subject of a copending
`district court case, MiMedx Group, Inc. v. Liventa Bioscience Inc. et. al.,
`Case No. 1:14-CV-01178-MHC (N.D. Ga.). Pet. 1; Paper 7, 1.
`Petitioner also filed a petition for inter partes review of U.S. Patent
`No. 8,323,701 B2 against Patent Owner in IPR2015-00669, in which we
`denied institution. IPR2015-00669, Paper 13, 30.
`The ’437 Patent (Ex. 1001)
`B.
`The ’437 patent issued on February 12, 2013, with John Daniel listed
`
`as the sole inventor. Ex. 1001. The ’437 patent relates to tissue allografts,
`and more particularly “to placental membrane tissue grafts (amnion and
`chorion) and methods of preparing, preserving, and medical uses for the
`same.” Id. at 1:15–17.
`
`As taught by the ’437 patent:
`The placenta has two primary layers of tissue including amniotic
`membrane and chorion. The amniotic membrane is a non-
`vascular tissue that is the innermost layer of the placenta, and
`consists of a single layer, which is attached to a basement
`membrane. Histological evaluation indicates that the membrane
`layers of the amniotic membrane consist of epithelium cells, thin
`reticular fibers (basement membrane), a thick compact layer, and
`fibroblast layer. The fibrous layer of amnion (i.e., the basement
`membrane) contains cell anchoring collagen types IV, V, and
`VII. The chorion is also considered as part of the fetal
`membrane; however, the amniotic layer and chorion layer are
`separate and separable entities.
`Id. at 1:32–45. Placental membrane has been used for various types of
`reconstructive surgery since the early 1900s, and has also been widely used
`in ophthalmic procedures. Id. at 1:22–28. The ’437 patent teaches that
`
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`IPR2015-00664
`Patent 8,372,437 B2
`
`“[t]ypically, such membrane is either frozen or dried for preservation and
`storage until need for surgery.” Id. at 1:28–30.
`According to the ’437 patent, in order to prepare the implant,
`placental tissue is collected from a hospital. Id. at 4:65–66. The placenta is
`removed from the sterile shipment bag and transferred to a sterile processing
`basin preferably containing hyperisotonic saline (18% NaCl) solution at
`close to room temperature. Id. at 5:65–6:2. The placenta is gently massaged
`to help separate blood clots, allowed to reach room temperature to ease the
`separation of the amnion from the chorion, and then placed on a processing
`tray with the amniotic membrane layer facing down. Id. at 6:2–10.
`
`With the placental tissue in the processing tray, the chorion layer is
`lifted gently off the amniotic membrane layer, and blood clots are removed
`from the layers using a blunt instrument, a finger, or a sterile, non-
`particulating gauze. Id. at 6:27–62. In particular, the ’437 patent teaches:
`Care is then taken to remove blood clots and other
`extraneous tissue from each layer of tissue until the amniotic
`membrane tissue and the chorion are clean and ready for further
`processing. More specifically, the amnion and chorion tissues
`are placed on the processing tray and blood clots are carefully
`removed using a blunt instrument, a finger, or a sterile non-
`particulating gauze, by gently rubbing the blood until it is free
`from the stromal tissue of the amnion and from the trophoblast
`tissue of the chorion. The stromal layer of the amnion is the side
`of the amniotic membrane that faces the mother. In contrast, the
`basement membrane layer is the side of the amnion that faces the
`baby.
`
`Using a blunt instrument, a cell scraper or sterile gauze,
`any residual debris or contamination is also removed. This step
`must be done with adequate care, again, so as not to tear the
`amnion or chorion tissues. The cleaning of the amnion is
`complete once the amnion tissue is smooth and opaque-white in
`appearance. If the amnion tissue is cleaned too much, the opaque
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`IPR2015-00664
`Patent 8,372,437 B2
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`
`layer can be removed. Any areas of the amnion cleaned too
`aggressively and appear clear will be unacceptable and will
`ultimately be discarded.
`Id. at 6:42–62 (emphasis added).
`The tissue is chemically decontaminated, and then dehydrated on a
`drying fixture. Id. at 6:63–8:64. The drying fixture may have grooves,
`which may be arranged in a grid, and may also have a design in the empty
`spaces of the grid, such as a logo or name. Id. at 7:61–8:11. The drying
`fixture is placed in a dehydration bag, sealed, and placed into a drying oven
`at 35 to 50 degrees Celsius for 30 to 120 minutes. Id. at 8:38–8:61. The
`ideal drying conditions, however, appear to be at 45 degrees Celsius for 45
`minutes. Id. at 8:51–55. Once the tissue is dehydrated, it can be cut into
`specific product sizes, and each cut allograft is placed into its own pouch.
`Id. at 8:65–9:8; 9:22–29.
`The ’437 patent states:
`Accordingly, while the present invention has been described
`herein in detail in relation to preferred embodiments, it is to be
`understood that this disclosure is only illustrative and exemplary
`of the present invention and is made merely for purposes of
`providing a full and enabling disclosure of the invention. The
`foregoing disclosure is not intended nor is to be construed to limit
`the present invention or otherwise to exclude any such other
`embodiments, adaptations, variations, modifications and
`equivalent arrangements, the present invention being limited
`only by the claims appended hereto and the equivalents thereof.
`Id. at 10:59–11:3.
`
`Illustrative Claim
`C.
`Petitioner challenges claims 1 and 2 of the ’437 patent. Claim 1 is the
`only independent claim and is reproduced below:
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`IPR2015-00664
`Patent 8,372,437 B2
`
`
`1. A dehydrated, laminated tissue graft, wherein the tissue graft is
`produced by a process consisting of:
`isolating an intact amnion layer;
`isolating a chorion layer;
`washing and substantially cleaning the amnion layer and the chorion
`layer;
`laminating the amnion and chorion layer together; and
`dehydrating the laminated graft to produce the dehydrated,
`laminated tissue graft.
`Ex. 1001, 11:6–12:6.
`
`Dependent claim 2 specifies that the washing is carried out in an
`antibiotic solution. Id. at 12:7–8.
`
`Instituted Challenges
`D.
`We instituted trial based on the following grounds of unpatentability
`(Dec. Inst. 18):
`References
`Klen1 and Sulner2
`
`Claims Challenged
`1
`
`Basis
`§ 103(a)
`
`Klen, Sulner, and Tseng3
`
`§ 103(a)
`
`2
`
`
`Petitioner relies on the Declaration of Helen N. Jones, Ph.D.
`
`Ex. 1010. Patent Owner relies on the Declaration of Rebecca N. Baergen,
`M.D. Ex. 2030.
`
`1 R. KLEN, Preparation of Chorion and Amnion Grafts Used in Burns,
`RESEARCH IN BURNS 289–92 (P. Matter et al., 1971) (Ex. 1013).
`2 Sulner et al. (“Sulner”), Pub. No. US 2007/0038298 A1, published
`Feb. 15, 2007 (Ex. 1015).
`3 Tseng, US Patent No. 6,326,019 B1, issued Dec. 4, 2001 (Ex. 1011).
`
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`IPR2015-00664
`Patent 8,372,437 B2
`
`
`II. ANALYSIS
`Claim Construction
`A.
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`Specification of the patent in which they appear. See 37 C.F.R. §42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–2145 (2016)
`(upholding the use of the broadest reasonable interpretation standard).
`Under the broadest reasonable construction standard, claim terms are
`presumed to have their ordinary and customary meaning, as would be
`understood by one of ordinary skill in the art in the context of the entire
`disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`2007).
`“[T]he specification ‘is always highly relevant to the claim
`construction analysis. Usually it is dispositive; it is the single best guide to
`the meaning of a disputed term.’” In re Abbott Diabetes Care Inc., 696 F.3d
`1142, 1149 (Fed. Cir. 2012) (quoting Phillips v. AWH Corp., 415 F.3d 1303,
`1315 (Fed.Cir.2005) (en banc)). The Court of Appeals for the Federal
`Circuit has cautioned, however, “[t]here is a fine line between construing the
`claims in light of the specification and improperly importing a limitation
`from the specification into the claims.” Retractable Techs., Inc. v. Becton,
`Dickinson, and Co., 653 F.3d 1296, 1305 (Fed. Cir. 2011). Thus, “[e]ven
`when the specification describes only a single embodiment, the claims of the
`patent will not be read restrictively unless the patentee has demonstrated a
`clear intention to limit the claim scope using ‘words or expressions of
`manifest exclusion or restriction.’” Hill-Rom Services, Inc. v. Stryker Corp.,
`755 F.3d 1367, 1372 (Fed. Cir. 2014); see also SuperGuideCorp. v. DirecTV
`
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`
`Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868-69 (Fed. Cir.
`2004) (“Though understanding the claim language may be aided by
`explanations contained in the written description, it is important not to
`import into the claim limitations that are not part of the claim. For example,
`a particular embodiment in the written description may not be read into a
`claim when the claim language is broader than the embodiment.”);
`i.
`“intact amnion”
`Claim 1 is a product-by-process claim drawn to a tissue graft that is
`produced by the recited process. The patentability of a product-by-process
`claim does not depend on the specified method of production, but on the
`product itself. In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985). Stated
`differently, “[i]f the product in a product-by-process claim is the same or
`obvious from a product of the prior art, the claim is unpatentable even
`though the prior product was made by a different process.” Id. If, however,
`the process by which a product is made imparts “structural and functional
`differences” from the product of the prior art, then those differences are
`relevant to the patentability analysis. Greenliant Sys., Inc. v. Xicor, 692 F.3d
`1261, 1268 (Fed. Cir. 2012).
`
`Claim 1 recites the term “intact amnion layer” in the process portion
`of the claim, that is, the step of “isolating an intact amnion layer.” That
`intact amnion layer is then subject to washing and cleaning steps, a
`lamination step, as well as a dehydrating step. But as Patent Owner itself
`notes, “[a]mniotic membrane is a delicate tissue” (Prelim. Resp. 18), and,
`thus, the ordinary artisan would understand that the washing, cleaning,
`laminating, and drying steps would result in changes to the amnion, such
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`IPR2015-00664
`Patent 8,372,437 B2
`
`that the amnion could no longer be considered intact in the final product
`claimed by challenged claim 1.
`
`For purposes of the Decision on Institution, we did not construe the
`claim as requiring that dehydrated, laminated tissue graft contain an intact
`amnion. Dec. Inst. 7. We concluded that the product-by-process of claim 1
`required only that the dehydrated tissue graft that may be produced by a
`process in which intact amnion is subject to the washing, cleaning,
`laminating, and drying steps as set forth in challenged claim 1.
`In its Response, Patent Owner argues that we erred in our
`construction, as claim 1 requires only a dehydrating step, not a freeze-drying
`step. PO Resp. 8. We acknowledge that while we referred to freeze-drying
`in the portion on claim construction (Dec. Inst. 7), in summarizing the
`teaching of the ’437 patent, we explicitly observed that the disclosure
`teaches that the graft is preferably dehydrated on a drying fixture which is
`placed in a dehydration bag, sealed, and placed in a drying oven at 35 to 50
`degrees Celsius for 30 to 120 minutes (id. at 4). Thus, our reference to
`“freeze-drying,” rather than simply “dehydrating,” was a typographical
`error. Moreover, although claim 1 does not require the use freeze-drying as
`the dehydration step, it does not exclude the use of freeze-drying as the
`dehydration step.
`Patent Owner argues further that our construction “leaves unanswered
`the question of exactly how different the claimed amnion layer is” after
`undergoing the claimed steps. PO Resp. 8. Patent Owner contends that “the
`plain language of the claims and file history of the ’437 Patent show that the
`amnion layer in the final product must, at a minimum, not have undergone
`substantial decellularization (i.e. removal of more than 90% of cells from the
`
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`IPR2015-00664
`Patent 8,372,437 B2
`
`amnion layer of the graft).” Id. at 8–9. Stated differently, Patent Owner
`proposes a construction in which the amnion layer may have only 10% of
`the cells of the amnion layer of the graft, and still be encompassed by the
`claim.
`Patent Owner points to the language of the claims themselves,
`asserting that claim 1 uses the transition phrase “consisting of,” but does not
`recite a decellularization step. Id. at 9. Patent Owner avers that, given this
`claim formulation, “the final graft cannot include a substantial
`decellularizing step.” Id. According to Patent Owner, Petitioner’s expert,
`Dr. Jones, agrees that the graft could not have undergone a substantial
`decellularization step, as Dr. Jones distinguishes the possible loss of a small
`number of cells during performance of the steps of the ’437 patent from “the
`substantial decellularization of Sulner and Hariri.” Id. at 9 n.1 (citing Ex.
`2027, 259:20–263:21 (“a relatively small number of the cells could be
`removed” during a washing step), 265:4–269:5 (the number of cells lost is
`not quantifiable because it “could change with each –– with each time you
`wash that tissue”); see also id. at 11 (citing Ex. 2027, 191:23–195:25 (some
`cells may be removed during the washing, cleaning, dehydrating, and/or
`laminating steps of the ’437 patent ); Ex. 2025 ¶¶ 131–133, 139, 142–143).
`In particular, Patent Owner notes that Dr. Jones testified that “the final,
`claimed graft of the ’437 Patent has not undergone any treatment that would
`constitute substantial decellularization of the graft (e.g., removal of 90% or
`more of the cells).” Id. at 11 (citing Ex. 2027, 191:23–195:25; Ex. 2025
`¶¶ 131–133, 139, 142–143).
`Patent Owner argues further that the prosecution history supports its
`construction. Id. at 10. In particular, Patent Owner asserts that “the file
`
`10
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`IPR2015-00664
`Patent 8,372,437 B2
`
`history explicitly distinguishes the claimed graft of the ’437 Patent from
`prior art grafts (namely, Hariri) on the basis that the prior art grafts
`substantially decellularized the amnion layer (i.e. at least 90% of cells
`removed).” Id. (citing Ex. 1002, 38, 52; Ex. 2025 ¶¶ 131–132).
`Patent Owner quotes the Notice of Allowability, which states that
`[w]ith regards to the “washing and substantially cleaning” step,
`it is submitted that the specification makes it clear that this
`washing and cleaning only achieves removal of blood and the
`spongy/connective layer, not actual cellular layers of either of the
`amnion or chorion layers.
`Id. at 11 (quoting Ex. 1002, 28–29; citing Ex. 2025 ¶ 104; Ex. 1010 ¶¶ 75,
`161).
`Petitioner responds that Patent Owner’s “attempt to rewrite the claims
`
`to allow for up to 90% decellularization is . . . at odds with its
`representations to the Patent Office.” Reply 7. Specifically, Petitioner
`contends that Patent Owner represented during prosecution that the claims
`did not include a decellularization step, and the “fact that the terms
`‘consisting of’ and ‘intact’ were added to the claims to distinguish over the
`prior art’s disclosure of more than 90% decellularized amnion does not
`entitle PO to claim a range of decellularization up to 90%.” Id. at 7–8.
`Moreover, Petitioner asserts, the Specification does not provide any
`disclosure as to decellularization, much less any specific range relating to
`decellularization. Id. at 8.
`
`Petitioner avers that we fully addressed Patent Owner’s arguments in
`the Decision on Institution, where we stated that the claims were written as
`product-by-process claims, and that the claims only required that the amnion
`be intact at the beginning of the process. Id. In addition, we noted that as
`acknowledged by Patent Owner, amniotic tissue is delicate. Id. Thus,
`
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`IPR2015-00664
`Patent 8,372,437 B2
`
`Petitioner contends that the construction adopted in the Decision on
`Institution that the dehydrated tissue graft that is “produced by a process in
`which the intact amnion is subject to the washing, cleaning, laminating, and
`[dehydrating] steps as set forth in challenged claim 1” is correct. Id. at 9
`(citing Dec. Inst. 7).
`
`As we noted in our Decision on Institution (Dec. Inst. 6), and as we
`reiterate above, claim 1 is drawn to a product-by-process claim. Claim 1
`does not specify the characteristics of the product, but requires only that it be
`produced by the steps of 1) isolating an intact amnion layer; 2) isolating a
`chorion layer; 3) washing and substantially cleaning the amnion layer and
`the chorion layer; 4) laminating the amnion layer and the chorion layer
`together; and 5) dehydrating the laminated graft to produce the dehydrated,
`laminated tissue graft.
`
`As noted by Petitioner, the Specification of the ’437 patent neither
`defines “intact amnion,” nor indicates the amount of decellularization that
`takes place during the claimed process, and it unequivocally fails to disclose
`up to 90% decellularization, which Patent Owner would like us to read into
`the claim.
`Patent Owner relies on the testimony of Petitioner’s declarant, Dr.
`Jones, to support its construction. Although the testimony of Dr. Jones in
`this proceeding, as well as in the related district court proceeding, supports
`the proposition that a small amount of cells may be lost during the process of
`forming the graft, it does not support that up to 90% of the cells may be lost.
`
`In particular, we observe that, in response to a question of whether the
`epithelial layer would be removed when the steps of claim 1 of performed on
`an amniotic membrane, Dr. Jones testified that the cellular layer may not be
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`IPR2015-00664
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`
`maintained throughout the process, and that the process would alter the layer
`to some extent. Ex. 2027, 191:23–193:21. Dr. Jones testified also in
`response to questions about the process of Klen that the amount of cells that
`would be lost is not quantifiable, as it would vary. Id. at 266:4–267:8.
`Thus, Dr. Jones’ testimony supports the construction we adopted
`during institution, that is, claim 1 does not require that the dehydrated,
`laminated tissue graft contain an intact amnion. Rather, consistent with our
`Decision on Institution, claim 1 only requires that the dehydrated tissue graft
`product may be produced by a process in which intact amnion is subject to
`the washing, cleaning, laminating, and drying steps recited in the claim.
`Dr. Jones’ testimony does not support adding to that construction that up to
`90% of the cellular layer may be lost, and still fall within the scope of the
`claim.
`
`Patent Owner relies also on the prosecution history of the ’437 patent
`to support its construction. We acknowledge that the prosecution history is
`relevant to the claim constriction analysis. Microsoft Corp. v. Proxyconn,
`Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2016) (“The PTO should also consult
`the patent’s prosecution history in proceedings in which the patent has been
`brought back to the agency for a second review.”). In this case, however, we
`conclude that the prosecution history contradicts other more probative
`evidence of record, including the Specification. Moreover, Patent Owner
`asks us to accept certain parts of the prosecution history, but ignore others as
`a misstatement by the Examiner.
`
`Specifically, in an interview summary, the Examiner stated that
`“[p]oints of note include that the method does not include any
`decellularization steps- thus both the epithelial layer and the fibroblast
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`cellular layer pf the amnion membrane must remain intact.” Ex. 1002, 38.
`In the “Reasons for Allowance,” the Examiner stated:
`The instant claims are drawn to a tissue graft which is
`defined by its method of production. In these claims the method
`of production
`imparts
`the
`following unique structural
`characteristics to the claimed tissue graft: (1) the claimed tissue
`graft consists of only two layers: an amnion and a chorion; (2)
`as there are no decellularization steps in the method, the amnion
`retains each of the original cellular layers, i.e. the epithelial
`layer and the cellular fibroblast layer; (3) the tissue graft is
`substantially free of blood and spongy/connective tissue, as per
`the step of “washing and substantially cleaning”. With regards
`to the “washing and substantially cleaning” step, it is submitted
`that the specification makes it clear that this washing and
`cleaning only achieves
`removal of blood and
`the
`spongy/connective layer, not actual cellular layers of either of
`the amnion or chorion layers. Thus, the tissue graft covered by
`the instant claims consists of a fully cellularized amniotic
`membrane (i.e. including the epithelial layer and the cellular
`fibroblast layer), and a fully cellularized chorionic membrane,
`which are laminated together and dehydrated to form a unitary
`graft structure, wherein the tissue graft is substantially free of
`blood and spongy/connective tissue.
`The tissue graft as instantly claimed differs from natural
`full-thickness placenta which has been dehydrated because
`natural full-thickness placenta also contains a spongy/connective
`tissue layer between the amnion and the chorion; the instant
`claim excludes this, as it is limited to “consisting of” only the
`amnion and chorion membranes. The tissue graft as instantly
`claimed differs from the biofabric suggested by Hariri (of
`record), in that the tissue graft of the instant claims are not
`decellularized (i.e. they contain all cells of the amnion and
`chorion), whereas the biofabric of Hariri are fully decellularized.
`Finally, the tissue graft as instantly claimed differs from the
`tissue graft claimed in co-pending application 12/428,908 in that
`the tissue graft as instantly claimed includes the epithelial layer
`of the amnion, whereas the claimed tissue graft of the '908
`application is de-epithelialized.
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`Id. at 28–29 (emphasis added).
`
`Thus, the prosecution history does not support that up to 90% of the
`cells may be lost during performance of the recited process. Rather, the
`prosecution history suggests that the claim requires that the amniotic
`membrane remain fully cellularized, that is, no cells are lost, even during
`washing. Counsel for Patent Owner asks us to treat that as a misstatement
`on the part of the Examiner, arguing what the Examiner actually meant is
`that the claims do not require a decellularization step. Tr. 30. Patent
`Owner’s explanation is unconvincing, however, as the Examiner had already
`discussed that there was no decellularization step in the method, before
`going on to further state that the product contained “a fully cellularized
`amniotic membrane (i.e. including the epithelial layer and the cellular
`fibroblast layer), and a fully cellularized chorionic membrane.” Ex. 1002,
`28–29.
`Although we cannot agree with Patent Owner that the Examiner’s
`remarks that the amnion and chorion must remain “fully cellularized”
`throughout the claimed process was a mere misstatement, we nevertheless
`observe that such a requirement for full cellularization contradicts the
`evidence of record in the instant proceeding, as both parties appear to agree
`that there may be some cell loss in the performance of the steps of claim 1.
`See, e.g., Tr. 28 (Counsel for Patent Owner noting that “you may remove
`some cells via washing, cleaning, delamination.”).
`
`We conclude that Patent Owner has not pointed to any support for its
`proposed construction that “the amnion layer in the final product must, at a
`minimum, not have undergone substantial decellularization (i.e. removal of
`more than 90% of cells from the amnion layer of the graft).” PO Resp. 8–9.
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`Rather, we construe “intact amnion” as we did in the Decision on Institution,
`that is, not as requiring that the amnion be intact in the final product, but that
`as requiring only that the dehydrated tissue graft that may be produced by a
`process in which intact amnion is subject to the washing, cleaning,
`laminating, and drying steps as set forth in challenged claim 1. That would
`encompass any decellularization that would naturally occur in the
`performance of those steps, but the record does not support quantifying that
`decellularization as being no greater than 90%.
`ii.
`“washing and substantially cleaning”
`Petitioner requests that this claim be construed as reducing the amount
`
`of blood clots and other extraneous tissue found in the native amnion and
`chorion layer.” Pet. 4 (citing Ex. 1005).
`
`Patent Owner did not respond to Petitioner’s proposed construction in
`its Preliminary Response, but requests that we construe the claim limitation
`of “washing and substantially cleaning” in its Response. PO Resp. 12–17.
`In particular, Patent Owner contends that Petitioner appears to be construing
`this phrase as requiring the removal of any amount of blood clots and
`spongy/connective tissue, which, Patent Owner asserts, reads “substantially”
`out of the claim. Id. at 13. Patent Owner argues further that Petitioner’s
`construction “is contrary to the plain language of the claims, the prosecution
`history, and the understanding of one of skill in the art, all of which indicate
`that the washing and substantially cleaning step removes a substantial
`portion of the spongy layer.” Id. (citing Ex. 2025 ¶¶ 100, 102–110).
`According to Patent Owner, “[i]n light of the claims, specification, file
`history, and testimony of Petitioner’s own expert, ‘washing and substantially
`cleaning’ requires substantial removal of blood clots and spongy/connective
`
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`IPR2015-00664
`Patent 8,372,437 B2
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`tissue, i.e. the tissue that forms the intermediate layer of a placenta.” Id. at
`11–12.
`
`In particular, Patent Owner points to the declaration of Petitioner’s
`declarant, Dr. Jones, submitted in the related district court proceeding. Id. at
`13–14. Dr. Jones stated that the “plain claim language [] explicitly requires
`that the amnion/chorion be substantially cleaned.” Id. at 13 (quoting Ex.
`2025 ¶ 100). Dr. Jones opined in that declaration that “a construction that
`does not attempt to describe the amount of ‘blood clots and other extraneous
`tissue’ that must be removed to satisfy the claim limitation, fails to account
`for the express requirement that the tissue be ‘substantially cleaned.’” Id. at
`14 (quoting Ex. 2025 ¶ 100). Patent Owner states it agrees with the
`declaration of Dr. Jones submitted in the related district court proceeding,
`asserting that “the requirement of substantial cleaning must thus be more
`than a mere washing step (such as mere submerging in water or saline
`solution) that removes any portion of the spongy layer, no matter how
`insignificant.” Id.
`
`Patent Owner argues that Petitioner and Dr. Jones are now advocating
`a construction that reads “substantially cleaning” out of the claims. In fact,
`Patent Owner asserts, Dr. Jones admitted as much during her deposition,
`stating that she did not think there was a difference between washing and
`substantially cleaning. Id. at 15 (citing Ex. 2027, 119:21–120:2, 150:10–24,
`152:23–153:11, 271:20–272:5).
`
`Patent Owner argues further that the prosecution history supports its
`construction. Id. at 15 (citing Ex. 1002, 51–52, 60). Patent Owner notes
`that the Notice of Allowability explicitly states “that ‘the tissue graft covered
`by the instant claims . . . is substantially free of blood and
`
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`IPR2015-00664
`Patent 8,372,437 B2
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`spongy/connective tissue.’” Id. at 16 (quoting Ex. 1002, 29). In fact, Patent
`Owner asserts, Dr. Jones in her declaration in the district court proceeding
`relied on that prosecution history in asserting that the washing and cleaning
`steps included removal of the spongy/connective tissue. Id. at 15–16 (citing
`Ex. 2025 ¶¶ 103–104).
`
`Petitioner responds that the construction for “washing and
`substantially cleaning” that Patent Owner for the first time advocates in its
`Response “is contrary to the claim construction it previously advanced . . .
`[in] the Federal District Court in the Related Litigation.” Reply 2–3.4
`
`Petitioner argues further that Patent Owner’s proposed construction is
`not consistent with the Specification. Id. at 4–5. Petitioner asserts that the
`Specification does not refer to the “spongy layer,” and never discloses that a
`“substantial” portion of it should be removed during the washing and
`cleaning step. Id. at 4. Although the Specification teaches cleaning the
`layers to remove “extraneous tissue,” Petitioner asserts that Patent Owner
`does not offer any evidence that the ordinary artisan would consider the
`spongy tissue to be extraneous. Id. In fact, Petitioner avers, Patent Owner’s
`declarant, Dr. Baergen, in a declaration submitted in the district court
`proceeding, has stated that the spongy layer is considered to be part of the
`amnion or the chorion. Id. (citing Ex. 1006 ¶ 118). Moreover, Dr. Baergen
`also stated in that declaration that examples of extraneous tissue include
`
`
`4 Petitioner also contends that the claim interpretation is inconsistent with
`the claim interpretation Patent Owner advanced in IPR2015-00320. That
`inter partes review, however, involved a different patent and different claim
`language. Thus, Patent Owner’s proposed construction in that proceeding is
`not relevant to the claim language of “washing and substantially cleaning,”
`and we need not further address Petitioner’s arguments in this regard.
`
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`“‘blood clots, remnants of tissue f