Tissue Transplant Technology Ltd. & Human Biologics of Texas, Ltd.,v.MiMedx Group, Inc.

Patent Trial and Appeal Board

Nov 24, 2015

13954974 (P.T.A.B. Nov. 24, 2015)

Trials@uspto.gov Paper No. 20
571-272-7822 Entered: November 24, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

TISSUE TRANSPLANT TECHNOLOGY LTD. &
HUMAN BIOLOGICS OF TEXAS, LTD.,
Petitioner,

v.

MIMEDX GROUP, INC.,
Patent Owner.
____________

Case IPR2015-00320
Patent 8,709,494 B2
____________

Before LORA M. GREEN, SUSAN L. C. MITCHELL, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION
Denying Petitioner’s Request for Rehearing
37 C.F.R. § 42.71

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INTRODUCTION
Tissue Transplant Technology LTD (d/b/a Bone Bank Allografts) and
Human Biologics of Texas, Ltd. (collectively, “Petitioner”) filed a corrected
Petition requesting an inter partes review of claims 1–10 of U.S. Patent No.
8,709,494 B2 (Ex. 1001, “the ’494 patent”). Paper 7 (“Pet.”). The Board
denied the Petition. Paper 13 (“Dec.”). Petitioner filed a Corrected Request
for Rehearing. Paper 16 (“Reh’g Req.”). Patent Owner was authorized to
file an Opposition to Petitioner’s Request for Rehearing (Paper 17 (“Opp.”)),
to which Petitioner filed a Reply (Paper 19 (“Reply”)).
STANDARD OF REVIEW
When rehearing a decision on institution, the Board reviews the
decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
discretion occurs when a decision was based on an erroneous conclusion of
law or clearly erroneous factual findings, or a clear error of judgment. In re
Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). The party requesting
rehearing bears the burden of showing the decision should be modified.
37 C.F.R. § 42.71(d). Specifically, a request for rehearing must identify all
matters the party believes the Board misapprehended or overlooked. Id.
DISCUSSION
In the Decision Denying Institution, we construed the claim term
“laminate” or “laminated” as requiring that the amnion and/or chorion layers
be adhered together. Dec. 6–7. In its Rehearing Request, Petitioner argues
that we erred in requiring a reference to expressly disclose adherence of the
in order to satisfy the claim requirement that the layers be laminated—i.e.,
adhered—together. Reh’g Req. 2.
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Specifically, Petitioner argues that the ’494 patent fails to expressly
disclose adherence, but discloses that the stromal side of the amnion is
tacky. Id. (citing Ex. 1001, 7:61–64; 8:51–55); see also id. at 3–5 (arguing
that the Specification of the ’494 patent does not expressly use the term
“adherence”). Thus, according to Petitioner, “the ’494 Patent inherently
teaches adherence through layering the naturally tacky amnion.” Id.
Petitioner asserts, therefore, that we “erred factually and legally in failing to
apply the inherent tackiness of amnion in comparing Vishwakarma and/or
Tseng to claims 9 and 10 of the ’494 Patent.” Id.
Petitioner argues that while we found that it was a possibility that the
amniotic layers of Vishwakarma may have adhered to one another, because
the ’494 patent fails to expressly teach adherence, it is not just a mere
possibility that the amniotic layers of Vishwakarma adhered together. Id. at
6–7. Petitioner contends that we recognized the tackiness of the amnion in
construing lamination as used by the claims of the ’494 patent, but then
improperly ignore it when applying the Vishwakarma reference to those
claims. Id. at 7. Petitioner argues further that as the layering process of
Vishwakarma and the ’494 patent “is identical, it is illogical for the Patent
Owner or the Board, to claim it is a mere possibility for Vishwakarma’s
layering to create a laminate whereas the exact same layering procedure in
the ’494 Patent actually creates a laminate.” Id. at 8.
Petitioner argues:
Layering inherently tacky amnion is sufficient to create a
laminate in Hariri, Gray, and the ’494 Patent; thus it is clear
error not to acknowledge the creation of a laminate by layering
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as disclosed in Vishwakarma. . . . Grounds 1, 2, 4, and 6
should be instituted.
Id. .
Initially, we note that Petitioner failed to point out in its Request for
Rehearing where it previously argued that the amnion is inherently tacky,
and thus layering of the amnion as taught by Vishwakarma inherently would
provide a laminate, such that the layers are adhered together. We could not
have overlooked or misapprehended an argument that was not made in the
Petition.
In addition, as noted in the Decision Denying Institution,
“[i]nherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient. In re Oelrich, 666 F.2d 578, 581 (CCPA
1981) (emphasis added) (citation omitted).” Dec. 8. Although
Vishwakarma teaches layering 50 to 60 squares of amnion on a glass mold
the size of a femoral head, which was then dried at ambient temperature (Ex.
1005, 69), Petitioner pointed to no further evidence, nor provided any
scientific reasoning, demonstrating that the layers of amnion necessarily
adhered to each other in the technique employed by Vishwakarma. Dec. 10.
For example, Petitioner did not provide a side-by-side comparison of the
method of processing the amnion and producing the graft of Vishwakarma
with the methods of the ’494 patent to demonstrate that the methods were
identical, or substantially identical, such that the ordinary artisan would have
understood that the products produced by the two methods necessarily
would be the same.
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Petitioner argues further that we erred in noting that the suture utilized
in the implant of Vishwakarma suggests that a laminate was not formed
necessarily when the amnion layers were layered on the glass mold because
Patent Owner did not explain in its Preliminary Response (Paper 11) “how
the use of a suture nullifies the natural lamination created by layering
inherently tacky amnion.” Reh’g Req. 8. According to Petitioner, “[i]t is
reasonable the suture is used to supplement the natural lamination as
Vishwakarma teaches the use of 50 to 60 layers of amnion.” Id.
We did not rely only on the suture applied by Vishwakarma to deny
the challenges over Vishwakarma. As discussed above, the Petition did not
rely on the inherent tackiness of amnion to argue that the 50 to 60 layers of
amnion piled on a glass mold as Vishwakarma would have adhered together,
nor did Petitioner provide a side-by-side comparison of the method of
Vishwakarma with the method of the ’494 patent to demonstrate that the
methods were identical, or substantially identical, such that the ordinary
artisan would have understood that the products produced by the two
methods would necessarily be the same.
Petitioner asserts further that Patent Owner made further
misrepresentations as to the teachings of Vishwakarma. Reh’g Req. 10–13.
As Petitioner notes, however, we did not rely on those arguments made by
Patent Owner in the Decision Denying Institution. Id. at 10. Moreover, as
we have already concluded that Petitioner has not demonstrated a reasonable
likelihood that the layers of Vishwakarma are not adhered necessarily
together, we need not reach these contentions by Petitioner.
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Petitioner argues further that grounds 5 and 7, which rely on Tseng,
also should be instituted. Reh’g Req. 10. Petitioner asserts we erred in
relying on Patent Owner’s representation that Petitioner’s expert, Dr.
Mooradian, admitted that the layers of amnion taught by Tseng are not
adhered together. Id. at 9 (citing Ex. 1002 ¶ 74); see Dec. Inst. 17–19.
According to Petitioner, as “[l]ayering inherently tacky amnion is sufficient
to create a laminate in Hariri, Gray and the ’494 Patent . . . it is clear error
not to acknowledge the creation of a laminate by layering as disclosed in
Tseng.” Reh’g Req. 10.
We do not find Petitioner’s contentions persuasive. Similar to the
challenged based on Vishwakarma, Petitioner does not point us to where in
the Petition it previously relied on the inherent tackiness of amnion in
making the argument that the layers of Tseng were necessarily adhered to
one another. In addition, although Dr. Mooradian states that a person of
ordinary skill in the art may understand that a laminate may be held together
by various means, such as by clips, adhesives, pressure, drying, or heat, Dr.
Mooradian also states that the “action of laying one sheet upon another is the
process of lamination.” Ex. 1002 ¶74. Dr. Mooradian states further that
the multiple membranes of Tseng are layered on top of one another “to form
a laminate,” which is then sutured to the eye “to hold the layers of the
laminate together.” Id. Thus, Dr. Mooradian construes “laminating” as
simply requiring “layering,” and we rejected that proposed construction in
the Decision Denying Institution. Dec. 6–7. As we noted in the Decision
Denying Institution,
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Petitioner has provided no evidence or scientific reasoning as to
how layering two or more placental grafts in a deep ulceration
would necessarily result in the layers adhering together to form
a laminate. Nor has Petitioner provided evidence or scientific
reasoning that it would have been obvious based on Tseng’s
and Miljudin’s teachings to create a laminate by adhering the
layers.
Id. at 18–19. Petitioner has not pointed to any evidence that we overlooked
that would demonstrate a reasonable likelihood that the layers of Tseng in
fact adhered to one another to form the laminate as required by the claims of
the ’494 patent.
Petitioner contends further that we erred in failing to “fully
reconcile[ ] the obviousness of removing cellular layers, as recognized by
the USPTO, with its position that retaining those same layers is not
obvious.” Reh’g Req. 13. In particular, Petition asserts, during prosecution,
the decelled laminate of Hariri was rejected, in part, over the grant of Tseng,
which was not decelled. Id. According to Petitioner, “if it is obvious to
decell amnion tissue grafts, it is obvious to not decell amnion tissue grafts.”
Id. Thus, Petitioner argues, we erred in not instituting on Grounds 3, 4, 6,
and 7. Id. at 13–14.
Petitioner argues further that as the amnion naturally contains
fibroblast and epithelial cellular layers and the ’494 patent requires retention
of these layers, the claims of the ’494 patent require the absence of action or
minimal processing of the natural tissue. Reh’g Req. 14. The use of non-
decelled amnion, Petitioner contends, predates the ’494 patent, and is taught
by Vishwakarma, Tseng, Miljudin, and Sackier. Id. Petitioner contends that
the “clear implication of Gray, as would be understood by a [person or
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ordinary skill in the art], is if removal of a cell layer is not necessary, then it
is obvious to not remove that layer in order to shorten and simplify
processing.” Id. at 14–15 (citing Pet. 5–6, 24–25).
We do not find Petitioner’s arguments persuasive. In essence,
Petitioner is rearguing its position from the Petition that it would have been
obvious not to remove the epithelial or fibroblast layers to simplify
processing. As noted in the Decision Denying Institution,
[A] determination of unpatentability on the ground of
obviousness must include “articulated reasoning with some
rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
The obviousness analysis “should be made explicit” and it “can
be important to identify a reason that would have prompted a
person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does.” KSR,
550 U.S. [398,] 418 [2007].
Dec. 8. Although Petitioner pointed out that deleting the additional step of
Hariri of removing the cell layers was insufficient for demonstrating the
patentability of the Hariri claims before the Examiner, the only reason that
Petitioner provided for retaining the epithelial and cellular layers was to
reduce processing complexity and time. Pet. 45–46. That reason was found
to be conclusory, without any articulated reason as to why the ordinary
artisan would have retained the epithelial or fibroblast cellular layers of Gray
or Hariri. Dec. 14, 16, 21.
In sum, in the Petition, Petitioner did not establish a reasonable
likelihood that it would prevail in its challenges of the claims of the ’494
patent. For the reasons given, Petitioner has not shown anything that we
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misapprehended or overlooked in our Final Decision. We deny the Request
for Rehearing.

ORDER
Accordingly, it is
ORDERED that Petitioner’s Request for Rehearing is denied.

PETITIONER:

Robert McRae
rmcrae@gunn-lee.com

Jason McKinnie
jmckinnie@gunn-lee.com

PATENT OWNER:

Keith Broyles
keith.broyles@alston.com

Thomas Parker
Thomas.Parker@alston.com

Christopher Douglas
chris.douglas@alston.com