Ex Parte KOOB et al

Patent Trial and Appeal Board

Sep 4, 2018

13967326 (P.T.A.B. Sep. 4, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/967,326 08/14/2013
143139 7590 09/06/2018
MiMedx Group, Inc./ Alston & Bird LLP
Bank of America Plaza
101 S. Tryon Street, Suite 4000
Charlotte, NC 28280-4000
FIRST NAMED INVENTOR
Thomas J. KOOB
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
061435/483363 5807
EXAMINER
DIOP, ROKHAYA
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
09/06/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
usptomail@alston.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS J. KOOB, ROBERT TOPE,
and ELIZABETH CHEN
Appeal2017-008667
Application 13/967 ,326
Technology Center 3700
Before DEMETRA J. MILLS, ERIC B. GRIMES and
JOHN E. SCHNEIDER, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a). The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
Appeal2017-008667
Application 13/967,326
STATEMENT OF CASE
The following claim is representative.
1. A reinforced tissue graft comprising:
a first membrane comprising a placental tissue having a
first side and a second side;
a non-resorbable biocompatible mesh having a first side
and a second side,
wherein the first side of the biocompatible mesh is
adjacent to the second side of the first membrane;
a second membrane comprising a placental tissue having
a first side and a second side, wherein the first side of the
second membrane is adjacent to the second side of the
biocompatible mesh; and
optionally including from one up to nine additional
membranes on either side of the biocompatible mesh,
wherein at least one of the first membrane, the second
membrane, or the additional membranes comprises modified
amnion having an intact epithelial cell layer, an intact fibroblast
cellular layer, or both.
Cited References
Artandi
Hariri et al.
Daniel et al.
Tom et al.
Chung
US 3,272,204 Sept. 13, 1966
US 2004/0048796 Al Mar. 11, 2004
US 2010/0104539 Al Apr. 29, 2010
US 2011/0206776 Al Aug. 25, 2011
KR-2001/100588 A Nov. 14, 2001
ProxyBiomedical, (http://proxybiomedical.com/lmages/ML005- Ol-
Rev002. pdf)
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Application 13/967,326
Grounds of Rejection
1. Claims 1---6, 9, 16, and 24 are rejected under pre-AIA 35 U.S.C.
§ 103 (a) as being unpatentable over Daniel in view of Artandi.
2. Claim 12 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Daniel in view of Artandi, and Hariri.
3. Claims 7 and 8 are rejected under pre-AIA 35 U.S.C. §103(a) as
being unpatentable over Daniel in view of Artandi, and Tom.
4. Claims 13-15 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Daniel in view of Artandi, and
Proxy Biomedical.
5. Claims 18 and 23 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Daniel in view of Artandi, and Chung.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Action at
pages 3-18. The following fact is highlighted.
1. Artandi, Fig. 1, is reproduced below.
Artandi, Fig. 1 shows a reinforced collagen film used for a collagen
prosthetic implant. Col. 1. "[C]ollagen fibrils of the surface coatings 11 and
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Application 13/967,326
12 extend through the openings 13 in the [ reinforcing] fabric 14 and make it
difficult to separate the collagen layer from the fabric." Artandi, col. 3.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Obviousness Rejection 1
We select claim 1 as the representative claim, as Appellants do not
argue individual claims separately. Arguments not made are waived.
The Examiner finds that Daniel teaches each element claimed except
that "Daniel does not disclose a non-resorbable biocompatible mesh made
from tetrafluoroethylene and interposed between the first and second
membranes." Ans. 4. The Examiner relies on Artandi to make up for this
deficiency of Daniel. Artandi discloses "the use [ of] a non-resorbable
biocompatible mesh made from tetrafluoroethylene (column 2, lines 32-37),
and interposed between two collagen membranes, in the same field of
endeavor, for the purpose of providing a reinforced tissue graft with greater
mechanical strength and better tear resistance." Ans. 4. The Examiner
concludes that:
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Application 13/967,326
It would have been obvious, to one having ordinary skill in the
art, at the time the invention was made, to insert a non-
resorbable biocompatible mesh between the first and second
membranes of Daniel, as taught by Artandi, in order to provide
a reinforced tissue graft with greater mechanical strength and
better tear resistance.
Ans. 4.
Appellants contend that, "while the fibrotic collagen of Artandi
requires a unitary structure to avoid delamination, Daniel does not teach,
suggest or otherwise disclose any unitary structure such that a person of
ordinary skill in the art ("POSA") is motivated to combine the teachings of
these references." App. Br. 9.
Appellants further argue that:
The solubilized collagen of Artandi is gelatinous. Such gel
would require support prior to use in surgical procedures like
hernia repair, and the "framework or support" is provided by
the non-absorbable fabric. See Artandi, column 1, 11. 48-50. In
contrast, Daniel teaches a multi-layered tissue graft that is
"thicker and stronger than a single layer of base amnion," and
that "can be held in place with sutures." These qualities
indicate that the laminated grafts of Daniel would not require
support in order to be used as tissue grafts, as taught by Daniel.
As such, there would be no motivation to modify the grafts of
Daniel with a support as taught by Artandi.
App. Br. 10.
Appellants argue that Daniel explicitly teaches away from, or at least
cautions against, freezing the tissue grafts, whereas Artandi requires a
freezing process that would cause crystal formation that can damage the
extracellular matrix in the tissues, thereby compromising the healing
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functionality or bioactivity of bioactive polypeptides or biological materials
in the placental membrane. App. Br. 11-12. Appellants argue that:
Artandi, ... is silent with respect to a tissue graft constructed of
two or more placental tissue membranes adjacent to a non-
resorbable biocompatible mesh, as claimed, let alone a collagen
membrane or laminate as alleged by the Office. At the same
time, Artandi is silent with respect to whether the collagen mass
derived from swelling fibrils could eventually form a
membrane as the placental tissue membranes in the claimed
invention.
App. Br. 13.
ANALYSIS
We agree with the Examiner's fact finding, statement of the rejection
and responses to Appellants' arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness for the reasons of record. We provide the following additional
comment to the Examiner's argument set forth in the Final Rejection and
Answer. 1
We agree with the Examiner's responses to Appellants' arguments set
forth in the Answer at pages 12-18. More particularly, the Examiner states
that the proposed modification is to place the non-resorbable mesh of
Artandi between the membranes of Daniel in order to reinforce and provide
tear resistance to the Daniel tissue graft laminate, as suggested by Artandi.
Ans. 4, Artandi, col. 1.
1 The "Answer" referred to in this Decision is the Examiner's Answer dated
March 9, 2017.
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Appellants argue that Artandi teaches a unitary collagen prosthesis
and Daniel does not. App. Br. 9--10. For this reason, Appellants argue that,
"there would be no motivation to modify the grafts of Daniel with a support
as taught by Artandi," and that the graft of Daniel does not require a support
to be used as a graft. App. Br. 10, 14. We are not persuaded. The Examiner
finds that Daniel discloses a tissue graft membrane laminate. Ans. 13. More
particularly,
Daniel discloses [0048] a membrane laminate, in which the
fibroblast layers are used to adhere adjacent membranes together. The
Examiner submits that the membrane layers of Daniel are bound to
one another as a unitary structure. Furthermore, Appellant's assertion
that the fibroblast layer of Daniel cannot extend through the non-
absorbable fabric of Artandi to avoid delamination is not persuasive.
The adjacent membrane layers in the laminate of Daniel can contact
one another given the large openings present in the non-absorbable
mesh of Artandi (Figure 2).
Ans. 13-14. The Examiner additionally finds that
Artandi ... explains ( column 3, lines 72-7 5) that "[T]he
collagen fibrils of the surface coatings 11 and 12 extend
through the openings 13 of the fabric 14 and make it difficult to
separate the collagen layer from the fabric." The Examiner
notes that Artandi refers to the collagen fibrils as a "layer."
Therefore, one can consider the collagen layer of Artandi to be
a membrane or a laminae according to the broadest reasonable
interpretation.
Ans. 17; Artandi, Example 1; column 3, 11. 14--75. Therefore, we agree with
the Examiner that both Daniel and Artandi describe tissue graft laminates,
and one of ordinary skill in the art at the time of the invention would have
had a reason to incorporate the reinforcing material of Artandi into the
layered tissue graft of Daniel to increase mechanical strength and durability
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of the graft. Ans. 14. The Examiner also finds that Appellants' arguments
are misleading because the rejection is based on the embodiment of Fig. 1 of
Artandi, not the embodiment of col. 2 of Artandi. Ans. 16-17.
We agree with the Examiner's rationale, reason or motivation to
combine Daniel and Artandi, and that, "it would have been obvious to one of
ordinary skill to reinforce [the] membrane laminate of Daniel with the non-
resorbable biocompatible mesh of Artandi, for the advantage of providing
greater mechanical strength and better tear resistance to the product." Ans.
1 7. Both Daniel and Artandi disclose multilayer tissue prosthesis/tissue
grafts, and it would have been obvious for one of ordinary skill in the art to
look to available tissue reinforcement technologies, such as those of Artandi,
when the tissue graft product required reinforcement or the benefit of tear
resistance.
Appellants argue that Daniel teaches away from freezing tissue grafts
(Daniel, p. 5, ,r,r 5, 72), whereas Artandi discloses freezing tissue grafts
(Artandi, col. 2, 11. 53-55). The Examiner responds, arguing that the
proposed modification is to place the non-resorbable mesh of Artandi
between the membranes of Daniel in order to reinforce the laminate, as
suggested by Artandi. Ans. 13. In addition, Daniel, paragraph 40, states
that, "[ t ]he epithelium layer can be removed by techniques known in the art.
For example, the epithelium layer can be scraped off of the amnion using a
cell scraper. Other techniques include, but are not limited to, freezing the
membrane ... ". Thus, it would reasonably appear that the materials used to
make the Daniel tissue graft prosthesis can be frozen. Appellants have not
provided evidence that one of ordinary skill in the art would have been
unable to place the non-resorbable mesh of Artandi between the membranes
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of Daniel in order to reinforce the laminate, or evidence that freezing the
laminate of Daniel, as modified by Artandi, would render the laminate of
Daniel unable to be used as a tissue graft prosthesis. Attorney argument
cannot take the place of evidence. (Unsupported attorney argument,
presented for the first time on appeal, is an inadequate substitute for record
evidence). See Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371, 1380
(Fed. Cir. 2009) (emphasizing that "unsworn attorney argument ... is not
evidence"). See Becton, Dickinson and Co. v. Tyco Healthcare Group LP,
616 F.3d 1249, 1260 (Fed. Cir. 2010).
Appellants argue that Artandi is silent with respect to a tissue graft
constructed of two or more placental tissue membranes adjacent to a non-
resorbable biocompatible mesh, however, the Examiner relies on Daniel for
this feature. Ans. 4, 14.
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Here, the Examiner
combines familiar elements known in the cited prior art (the tissue graft
laminate of Daniel, with the reinforcing layer of the collagen prosthetic of
Artandi) to achieve the predictable result of a reinforced tissue graft. The
preponderance of the evidence supports the Examiner's position.
Obviousness rejection 1 is affirmed for the reasons of record.
Obviousness Rejections 2-5
Appellants do not argue rejections 2-5 as set forth in the grounds of
rejection above, separately in the Brief. App. Br. 15. These rejections are
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summarily affirmed for the reasons of record. Arguments not made are
waived.
CONCLUSION OF LAW
The cited references support the Examiner's obviousness rejections,
which are affirmed for the reasons of record. All pending, rejected claims
fall.
AFFIRMED
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