Ex Parte Brown et al

Patent Trial and Appeal Board

Feb 4, 2013

11431171 (P.T.A.B. Feb. 4, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/431,171 05/10/2006 Roderick B. Brown 20060054.ORI 6913
23595 7590 02/04/2013
NIKOLAI & MERSEREAU, P.A.
900 SECOND AVENUE SOUTH
SUITE 820
MINNEAPOLIS, MN 55402
EXAMINER
DORNBUSCH, DIANNE
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
02/04/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte RODERICK B. BROWN and MICHAEL AFREMOV
__________

Appeal 2011-002656
Application 11/431,171
Technology Center 3700
__________

Before FRANCISCO C. PRATS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a hernia
patch for laparoscopic delivery. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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Application 11/431,171

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Statement of the Case
Background
“This invention relates to an apparatus to be used in hernia repair
surgery, and more particularly to a prosthetic hernia repair patch that can be
rolled into a tube for laparoscopic delivery through a trocar and which
deploys to a generally planar form when ejected from the trocar into the
abdominal cavity” (Spec. 1, ll. 4-7).
The Claims
Claims 1-14 are on appeal. Claim 1 is representative and reads as
follows:
1. A hernia patch for laparoscopic delivery comprising:
(a) a frame member comprising a plurality of strands
of a material exhibiting a shape memory property wound
together as a cable and forming a closed loop of a
predetermined shape configuration when unconstrained;
(b) a mesh fabric attached to the frame member and
arranged to be rolled up or folded for insertion through a
tubular cannula into an abdominal space and when ejected
from the cannula will assume the predetermined shape
configuration.

The issue
The Examiner rejected claims 1-14 under 35 U.S.C. § 103(a) as
obvious over Brown
1
and Corcoran
2
(Ans. 3-8).
The Examiner finds that Brown teaches:
A hernia patch (10) for laparoscopic delivery comprising:
(a) a frame member (12) comprising a strand of a material

1
Brown, R., US 5,824,082, issued Oct. 20, 1998.
2
Corcoran et al., US 6,379,368 B1, issued Apr. 30, 2002.
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exhibiting a shape memory property (Col. 1 Lines 62-63 and
Col. 2 Lines 41-44) and forming a closed loop of a
predetermined shape configuration when unconstrained
(Col. 2 Lines 1-6); (b) a mesh fabric (14) attached to the
frame member (Fig. 1) and arranged to be rolled up or
folded for insertion through a tubular cannula into an
abdominal space and when ejected from the cannula will
assume the predetermined shape configuration.

(Ans. 4.) The Examiner finds that “Brown does not disclose that the frame
member comprises a plurality of strands that are wound together as a cable”
(id. at 5). The Examiner finds that “Corcoran discloses a patch (10)
comprising a frame member (14, 28) comprising a plurality of strands (Fig.
3) of a material exhibiting a shape memory property (Col. 5 Lines 33-37)
wound together as a cable” (id.). The Examiner finds that “Corcoran teaches
that the strands are made from Nitinol (Col. 5 Lines 33-37) where each
strand is at least 0.0005 inches in diameter (Col. 6 Lines 60-61), and that the
cable comprises from at least two strands” (id.).
The Examiner finds it obvious to “provide Brown with a plurality of
shape memory strands wound together as a cable in view of the teachings of
Corcoran, in order to provide the frame with good flexibility, fatigue
strength, and greater life cycle” (id.).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner‟s conclusion
that Brown and Corcoran render Claim 1 obvious?
(ii) If so, have Appellants presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness?
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Findings of Fact
1. Brown teaches a hernia patch which “comprises a wire frame
that can be of various designs including, but not limited to, the form of a
closed loop where the wire comprising the frame is a shape memory alloy.”
(Brown, col. 1, ll. 60-63.)
2. Brown teaches that a “synthetic prosthetic material, such as
woven polypropylene or expanded PTFE (Gortex), is attached to and
supported by the wire frame” (Brown, col. 1, ll. 63-66).
3. Brown teaches that the
wire frame supporting the mesh material may be formed
from NiTiNOL or other suitable shape memory alloy and
can be attached to the prosthetic material so that it has an
hour-glass shape when the alloy is in its austenite form and a
rolled, cylindrical shape when in a martensite form

(Brown, col. 1, l. 66 to col. 2, l. 4).
4. Brown teaches that:
when the patch is cooled, it can be readily formed into a
cylindrical configuration for placement in a delivery trocar.
When ejected out of the trocar into the patient‟s abdominal
cavity, it warms to the point where the alloy is in its
austenite form so that it springs into its functional,
predetermined configuration. The narrowed central portion
of an hour-glass shape patch accommodates the inferior
epigastric vessels and cord structures while the opposed end
lobes will cover the direct and indirect hernia space.
Because the frame is integral to the patch, it does not
migrate and, accordingly, need not be sutured or stapled in
place.

(Brown, col. 2, ll. 6-17.)
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5. Corcoran teaches “an occlusion device for closure of a physical
anomaly” (Corcoran, col. 2, ll. 2-3).
6. Corcoran teaches “the fixation devices and the attached foam
sheets are collapsible so that the entire occlusion device can be moved
through a catheter. The fixation devices hold the occlusion device in place
once it is inserted into an aperture” (Corcoran, col. 2, ll. 24-28).
7. Corcoran teaches that the “fixation devices have a shape
memory, which allows the fixation devices to return to their original shape,
or „remember‟ their shape even after being bent or deformed for passage
through a catheter” (Corcoran, col. 2, ll. 30-33).
8. Corcoran teaches that:
Of particular benefit to the invention is the significant
extension of cycle life the multi-wire strand 34 adds to the
fixation devices. While an individual wire, when subjected
to the repeated pulsings of a human heart, may likely suffer
a fatigue failure and either fracture or break, a multi-wire
strand greatly decreases the chances of such a failure. The
reason being that when formed in a strand or a cable, the
resulting cycle life of the strand or the cable approximates
the cycle life of each individual wire. Small diameter wires
have the greatest resistance to fatigue failure, and thus have
the longest cycle life, because they are extremely elastic.
However, this elasticity also means that the small diameter
wires do not have enough stiffness to perform the function
required of the fixation device, that is to occlude an anomaly
and hold the device in place. When stranded, the small
diameter wires retain the elasticity and resistence [sic] to
fatigue failure, and yet also obtain the necessary stiffness
required to allow the device to function. Thus, the resulting
strand benefits from significantly increasing its cycle life
while not greatly increasing in size. There are several
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options for either strands or cables to be used in the present
invention.
(Corcoran, col. 5, ll. 47-67.)
9. Corcoran teaches that a “cable refers to two or more strands laid
together, and a strand refers to two or more wires laid together” (Corcoran,
col. 6, ll. 1-2).
Principles of Law
“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). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. As noted by the Court in KSR, “[a] person of
ordinary skill is also a person of ordinary creativity, not an automaton.” 550
U.S. at 421.
Analysis
Brown teaches a hernia patch which comprises a frame member
composed of a shape memory nitinol wire which forms a closed loop of a
predetermined shape when unconstrained (FF 1). Brown teaches a mesh
fabric attached to the frame member (FF 2). Brown teaches that the hernia
patch is arranged to be in a rolled, cylindrical form for insertion through a
trocar and when ejected and warmed to body temperature, the patch will
assume the predetermined shape configuration (FF 3-4).
The Examiner finds that “Brown does not disclose that the frame
member comprises a plurality of strands that are wound together as a cable”
(Ans. 5).
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Corcoran teaches a patch for occlusion of a physical anomaly (FF 5)
which can be rolled and moved through a catheter in one form (FF 6) and
return when in place in the body into a second form (FF 7). Corcoran
specifically teaches that multi strand wires, or cables (FF 9) improve the
cycle life of the device since “the small diameter wires retain the elasticity
and resistence [sic] to fatigue failure, and yet also obtain the necessary
stiffness required to allow the device to function. Thus, the resulting strand
benefits from significantly increasing its cycle life while not greatly
increasing in size” (Corcoran, col. 5, ll. 61-66; FF 8).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary creativity would have reasonably
improved Brown‟s hernia patch by forming the wire frame with multi-wire
cables since Corcoran teaches that “the small diameter wires retain the
elasticity and resistence [sic] to fatigue failure, and yet also obtain the
necessary stiffness required to allow the device to function. Thus, the
resulting strand benefits from significantly increasing its cycle life while not
greatly increasing in size” (Corcoran, col. 5, ll. 61-66; FF 8). While the cited
references demonstrate that the claimed combination is a “predictable use of
prior art elements according to their established functions” KSR, 550 U.S. at
417, we also find that Corcoran provides teaching, suggestion, and
motivation to substitute wire cables composed of small diameter wires for
medical frames for the reasons given in Corcoran (FF 8).
Appellants contend that “neither of the references teach or suggest a
frame for a fabric hernia patch in the form of a closed loop of plural strands
of a material exhibiting shape memory properties wound as a cable where
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the assembly can be rolled up in a compressed form for delivery through a
tubular cannula into an abdominal space” (App. Br. 7-8).
We are not persuaded. Brown teaches each element of the hernia
patch, including the closed form with a frame composed of shape memory
material which can be rolled up for delivery into a cannula (FF 1-4). The
only element missing from Brown is the use of a multi strand cable as the
frame, an element expressly taught and suggested by Corcoran for similar
devices which are also composed of shape memory material that may be
rolled up for delivery into a cannula (FF 5-8).
Appellants “submit that there is no teaching, suggestion or motivation
in the references for making the proposed modification to the Brown „082
reference” (App. Br. 8).
While KSR arguably eliminated that rigid requirement for an explicit
teaching, suggestion, or motivation, in this particular case, the Examiner has
provided a strong teaching, suggestion, and motivation to incorporate the
multi-strand cables of Corcoran into the frame of Brown since Corcoran
teaches that “the small diameter wires retain the elasticity and resistence
[sic] to fatigue failure, and yet also obtain the necessary stiffness required to
allow the device to function. Thus, the resulting strand benefits from
significantly increasing its cycle life while not greatly increasing in size”
(Corcoran, col. 5, ll. 61-66; FF 8). The issue of fatigue and elasticity would
be equally relevant to a hernia patch as to a cardiac patch, since a hernia
patch would also be subject to stresses as the patient moves while requiring
some stiffness (see FF 4).
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Appellants also contend that it “was not obvious to Dr. Brown at the
time he conceived the invention of the „082 patent that a cable frame would
have superior properties” (App. Br. 8).
We are not persuaded. Corcoran clearly provides evidence that the
ordinary artisan, aware of Corcoran‟s teaching regarding multi-strand cables,
would have found such cables superior for forming medical devices which
require both stiffness and elasticity (FF 8).
Appellants contend that the “Examiner gave short shrift to appellants'
commercial success evidence” (App. Br. 9).
We are not persuaded by the commercial success evidence. In the
Nuss Declaration,
3
Mr. Nuss states that “[h]ernia patches made in
accordance with the teachings of the above-captioned patent application are
currently being marketed by MMDI under the trademarks, REBOUND HRD
and REBOUND HRD V” (Nuss Dec. 1 ¶ 4). However, none of the exhibits
referenced by the Nuss Declaration demonstrate that the reason the
“Rebound HRD” hernia patches were recognized with awards was due to the
device being composed of a frame with multiple strands, rather than a single
cable strand as in Brown‟s prior art teaching. Consequently, Appellants
have not shown a nexus between the commercial success and the use of
multiple strands. In the case of evidence of commercial success, the Federal
Circuit has acknowledged that the Appellant bears the burden of establishing
that nexus, stating:
In the ex parte process of examining a patent application…
the PTO lacks the means or resources to gather evidence

3
Declaration of Stephen Nuss, filed May 28, 2010.
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which supports or refutes the applicant‟s assertion that the
sales constitute commercial success. Cf. Ex parte Remark,
15 USPQ2d 1498, 1503 (Bd.Pat.App. & Int.1990)
(evidentiary routine of shifting burdens in civil proceedings
inappropriate in ex parte prosecution proceedings because
examiner has no available means for adducing evidence).
Consequently, the PTO must rely upon the applicant to
provide hard evidence of commercial success.

In re Huang, 100 F.3d 135, 139-40 (Fed. Cir. 1996). Thus, “the applicant
must submit some factual evidence that demonstrates the nexus between the
sales and the claimed invention-for example, an affidavit from the purchaser
explaining that the product was purchased due to the claimed features.” Id.
at 140.
No such evidence of a nexus between the multistrands and the success
is present in the instant application. Mr. Nuss does present sales data,
showing increased sales between January 2008 and April 2009, but there is
no evidence that the increased sales were due to the use of multi-strand
cables as in the instant invention rather than increased advertising, marketing
or other expenses using the $150,000 budget (see, e.g., App. Br. 10). See In
re DBC, 545 F.3d 1373, 1384 (Fed. Cir. 2008) (“[E]vidence of commercial
success alone is not sufficient to demonstrate nonobviousness of a claimed
invention. Rather, the proponent must offer proof „that the sales were a
direct result of the unique characteristics of the claimed invention--as
opposed to other economic and commercial factors unrelated to the quality
of the patented subject matter.‟”)
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We have also considered the Brown Declaration,
4
where Dr. Brown
states that based on “feedback I have received from my colleagues” the
commercial success is due to advantages including “delivery of the hernia
patch laparoscopically through a smaller sized incision,” “an improved
ability to secure the mesh to the NiTiNol frame,” and “prevent the shrinkage
or distortion of polypropylene mesh” (Brown Dec. 3-4 ¶ 13). These
statements do not, however, provide specific evidence from actual buyers
regarding their reasons for purchasing the device. They therefore do not
provide adequate evidence of a nexus between the claimed device and the
asserted commercial success. See In re Huang, 100 F.3d at 139-40 (holding
an inventor‟s affidavit stating an opinion as to purchaser‟s reasons for
buying claimed product insufficient to outweigh prima facie obviousness).
We also conclude that even if the commercial success evidence
provides a secondary consideration, the showing is insufficient to overcome
the strong showing of obviousness in this case. See Pfizer, Inc. v. Apotex,
Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) (“[W]e hold that even if Pfizer
showed that amlodipine besylate exhibits unexpectedly superior results, this
secondary consideration does not overcome the strong showing of
obviousness in this case. Although secondary considerations must be taken
into account, they do not necessarily control the obviousness conclusion.
Newell Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed.Cir.1988)”).
Here, the case of obviousness is very strong, wherein the only alteration in
the prior art hernia patch of Brown is the use of multi-wire strands as taught
by Corcoran, who provides a number of specific strong motivations to use

4
Declaration of Dr. Roderick B. Brown, filed May 28, 2010.
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such multi-wire strands in fixation devices such as the hernia patch of
Brown (FF 1-9). We do not find the evidence of commercial success
sufficient to overcome this strong showing of obviousness.
Although Appellants nominally argue the rejection of dependent
claims 2, 3, 7-9 and 14 separately (App. Br. 4), the arguments presented do
not point out with particularity or explain why the limitations of the
dependent claims are separately patentable. A statement which merely points
out what a claim recites will not be considered an argument for separate
patentability of the claim. See 37 C.F.R. § 41.37(c)(1)(vii) (2010).
Conclusion of Law
(i) The evidence of record supports the Examiner‟s conclusion that
Brown and Corcoran render Claim 1 obvious.
(ii) Appellants have not presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness.

SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. §
103(a) as obvious over Brown and Corcoran. Pursuant to 37 C.F.R. §
41.37(c)(1), we also affirm the rejection of claims 2-14 as these claims were
not argued separately.

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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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