Ex Parte Ladet

Patent Trial and Appeal Board

Jul 27, 2016

13124163 (P.T.A.B. Jul. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/124, 163 07 /01/2011
50855 7590 07/29/2016
Covidien LP
555 Long Wharf Drive
Mail Stop SN-I, Legal Department
New Haven, CT 06511
FIRST NAMED INVENTOR
Sebastien Ladet
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.
H-SP-00057(1600-83PCTUS) 4364
EXAMINER
BECKHARDT, LYNDSEY MARIE
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
07/29/2016 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):
mail@cdfslaw.com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SEBASTIEN LADET 1
Appeal2014-005637
Application 13/124,163
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and RICHARD J.
SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
multilayer implant. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm the rejection based on double patenting.
1 According to Appellant, the real party in interest is Sofradim Production.
(Appeal Br. 1.)
Appeal2014-005637
Application 13/124,163
STATEMENT OF THE CASE
Claims on Appeal
Claims 22-24, 27, 28, 32, and 45 are on appeal. 2 (Claims Appendix,
Appeal Br. 20-21.) Claim 22, the only independent claim, is illustrative
and reads as follows:
22. An implant comprising:
a porous layer comprising a self-crosslinked compound
comprising oxidized collagen and chitosan,
a first additional layer,
a second additional layer located between said porous
layer and said first additional layer,
a first hydrogel precursor present in said porous layer,
and,
a second hydrogel precursor present in said first
additional layer,
wherein said second additional layer is free of hydro gel
precursor, and the first hydrogel precursor is spatially separated
from the second hydrogel precursor.
(Id. at 20.)
Examiner's Rejections
1. Claims 22-24 and 45 stand rejected under 35 U.S.C. § 103(a) as
2 Claim 45 is dependent on claim 44, which is dependent on claim 22.
However, claim 44 is withdrawn as directed to a non-elected invention.
(Final Act. dated June 16, 2013.)
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Appeal2014-005637
Application 13/124,163
unpatentable over Sawhney,3 Tardy,4 Lee,5 Rhee, 6 and Lovisetto.7 (Ans. 2.)
2. Claims 27 and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Sawhney, Tardy, Lee, Rhee, Lovisetto, and Guillot.8
(Ans. 8.)
3. Claim 32 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Sawhney, Tardy, Lee, Rhee, Lovisetto, and Bakker. 9 (Ans. 9.)
4. Claims 22-24, 27, 28, 32, and 45 are provisionally rejected on the
ground of nonstatutory obviousness-type double patenting over claims 28-
52 of Application No. 13/124,288 10 in view of Lee. (Ans. 11-12.)
DISCUSSION
Rejections 1-3: Obviousness
Issue
Whether the preponderance of evidence of record supports the
Examiner's conclusion of obviousness under 35 U.S.C. § 103(a).
3 Sawhney et al., US 2002/0106409 Al, published Aug. 8, 2002
("Sawhney").
4 Tardy et al., US 4,931,546, issued June 5, 1990.
5 Lee et al., Effects of the controlled-released TGF-/Jl from chitosan
microspheres on chondrocytes cultured in a
collagen/chitosan/glycosaminoglycan scaffold, BIOMATERIALS 25, 4163-73
(2004).
6 Rhee et al., US 2001/0003126 Al, published June 7, 2001 ("Rhee").
7 Lovisetto et al., Use of Human Fibrin Glue (Tissucol) Versus Staples for
Mesh Fixation in Laparoscopic Transabdominal Preperitoneal
Hernioplasty, A Prospective, Randomized Study, 245 ANNALS OF SURGERY
2, 222-31 (2007) ("Lovisetto").
8 Guillot et al., US 2005/0042265 Al, published Feb. 24, 2005.
9 Bakker et al., US 5,480,436, issued Jan. 2, 1996.
10 The '288 application issued as US Patent No. 9,272,073 B2 on Mar. 1,
2016. Thus, the rejection is no longer provisional.
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Appeal2014-005637
Application 13/124,163
Analysis
The obviousness issue turns on whether the prior art teaches or
suggests an implant as claimed wherein "the first hydrogel precursor is
spatially separated from the second hydrogel precursor." (Claim 22, Appeal
Br. 20, emphasis added.)
The Examiner finds that Sawhney teaches compositions for forming
hydrogel precursors (Ans. 3) and that Rhee teaches a composition to coat
implants, such as meshes (id. at 5). The Examiner also finds that Lovisetto
teaches "fixation of prosthetic meshes using glue ... taught as being applied
to both the anterior and posterior sides of the mesh." (Id.) Based on these
findings, the Examiner concludes that
When the composition taught by [Sawhney] is applied to a mesh
as taught by [Rhee] and is coated on both sides of the mesh as
taught by Lovisetto the final product would include a layer
comprising the two precursors and natural[ly] occurring
material, a mesh layer, and a second layer comprising the two
precursors and naturally occurring material. This reads on claim
22. The precursor in the first layer is spatially separated from the
second hydrogel precursor in the second layer.
(Id. at 19, emphasis added.)
The Examiner further states that
(Id.)
the first hydrogel precursor is located in the top coating layer of
the mesh implant, which is separated by a mesh, from the
additional layer which includes the second hydrogel precursor.
Thus despite the layers each including the first and second
hydrogel precursors, the precursor in the top layer is spatially
separated from those located in the bottom coating layer.
Appellant argues that the cited art does not disclose, teach, or suggest
an implant that includes "a second additional layer located between the
porous layer and the first additional layer, wherein the second additional
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Appeal2014-005637
Application 13/124,163
layer is free of hydro gel precursor and the first hydro gel precursor is
spatially separated from the second hydrogel precursor." (Appeal Br. 11.)
In particular, Appellant argues that none of the references disclose "an
implant wherein the first and second hydrogel precursors are spatially
separated by a second additional layer." (Reply Br. 11.) Appellant further
argues that, even if the Examiner's "final product" position (Ans. 19 above)
was accurate, "each alleged layer includes the mixture of both precursors
and thus neither precursor is spatially separated because the first hydrogel
precursor and the second hydrogel precursor are mixed together in each of
the first and second layers." (Id.)
We find that Appellant has the better position. First, we agree with
Appellant that the Examiner's apparent rationale does not support a
conclusion that the first and second hydrogel precursors are spatially
separated. (See Ans. 19.) Second, merely applying a glue to both sides of a
mesh, as taught by Lovisetto, does not mean that the glue on each side is
necessarily "spatially separated." In fact, the use of a mesh indicates some
contact or interaction of the glue (or hydro gel precursors as claimed) present
on both sides of the mesh because a mesh has holes in it.
The Examiner bears the initial burden of establishing a prima facie
case of obviousness and has not done so. See In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992). Lacking on the record before us is a teaching or
suggestion that the first hydrogel precursor is "spatially separated" from the
second hydrogel precursor, as claimed by Appellant, and the Examiner has
not provided "some articulated reasoning with some rational underpinning,"
KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), to show that this
limitation would have been obvious to a person of ordinary skill in the art.
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Application 13/124,163
Conclusion ofLaw
A preponderance of the evidence of record fails to support the
Examiner's conclusion of obviousness under 35 U.S.C. § 103(a).
Rejection No. 4: Obviousness-type Double Patenting
Appellant presents no arguments in response to Rejection No. 4.
Accordingly, that rejection is affirmed. See 37 C.F.R. § 41.37(c)(l)(iv);
Hyatt v. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008).
SUMMARY
We reverse the rejections of claims 22-24, 27, 28, 32, and 45 under
35 U.S.C. § 103(a).
We affirm the rejection of claims 22-24, 27, 28, 32, and 45 on the
ground of nonstatutory obviousness-type double patenting.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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