Ex Parte Michler et al

Patent Trial and Appeal Board

Dec 12, 2014

11315799 (P.T.A.B. Dec. 12, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/315,799 12/22/2005 Robert E. Michler KSI-16285 9198
77096 7590 12/12/2014
WAYNE D PORTER, JR
LAW OFFICES OF WAYNE D. PORTER, JR.
1370 ONTARIO STREET, SUITE 600
CLEVELAND, OH 44113
EXAMINER
MCDERMOTT, CORRINE MARIE
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
12/12/2014 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 ROBERT E. MICHLER and ALBERT N. SANTILLI1
__________

Appeal 2013-005537
Application 11/315,799
Technology Center 3700
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN and
ROBERT A. POLLOCK, Administrative Patent Judges.

POLLOCK, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
rejections of claims 1–3, 6, 8–17 and 21–26. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Appellants’ invention relates to a device that can be applied to the
exterior of the left atrial appendage (LAA) of the heart in order to prevent

1 According to Appellants, the Real Parties in Interest are the inventors and
Kapp Surgical Instrument, Inc. (App. Br. 1).
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the formation of embolisms associated with atrial fibrillation. (Spec.
abstract.)
Representative independent claim 1 reads as follows:
1. A device for excluding the left atrial appendage (LAA),
comprising:
a first member having first and second ends adapted to
extend from one side of the LAA to the other and to
contact the LAA on a selected side thereof adjacent the
heart;
a second member having first and second ends adapted to
extend from one side of the LAA to the other and to
contact the LAA on the other side thereof adjacent the
heart;
a hinge that connects the second ends of the first and
second members;
the first and second members being movable from a first,
open position in which the LAA can fit therebetween
to a second, closed position in which the first and
second members are disposed generally parallel with
each other and are sufficiently close to each other to
compress the LAA between them without causing the
development of necrotic tissue;
an interlock that connects the first ends of the first and
second members to maintain the first and second
members in a fixed position relative to each other
when the first and second members are in the second,
closed position; and
those portions of the first and second members that
contact the LAA being configured to minimize stress
concentrations in the LAA, said portions being
substantially round in cross-section.
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The following grounds of rejection are before us for review:
Claims 1–3, 6, 8–10, 14–15, 22, and 25 are rejected under 35 U.S.C.
§103(a) as unpatentable over the combination of Cosgrove2 and Williams.3
Claims 11–13 and 16–17 are rejected under 35 U.S.C. §103(a) as
unpatentable over the combination of Cosgrove, Williams, and Mandel.4
Claims 21 and 23 are rejected under 35 U.S.C. §103(a) as
unpatentable over the combination of Cosgrove, Williams, and Reger.5
Claims 24 and 26 are rejected under 35 U.S.C. §103(a) as
unpatentable over the combination of Cosgrove, Williams, Mandel, and
Reger.
FINDINGS OF FACT
Specification
FF1. Figure 1 of the Specification is reproduced below.

Figure 1 is a perspective view of the heart illustrating the location of the
left atrial appendage (LAA) as element 2. (Spec. ¶ 0015.) Appellants’

2 Cosgrove et al., US 2005/0277959 A1, published December 15, 2005.
3 Williams, US 4,024,868, issued May 24, 1977.
4 Mandel et al., US 2002/0177863 Al, published November 28, 2002.
5 Reger, US 5,469,868, issued November 28, 1995.
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invention relates to an exclusion device that can be clamped to the
exterior of the heart to isolate LAA appendage 2 and thereby prevent the
formation of embolisms associated with atrial fibrillation. (Id. ¶¶ 0001,
0009.)
FF2. Figures 2, 5, and 6 are reproduced below.

Figure 2 shows a side elevation view of exclusion device 10 showing first
member 12 and second member 14 in an open configuration. (Id.
¶¶ 0016, 0025.) In this embodiment, a substantial length of the first and
second members is covered with flexible cover 18, preferably a
biocompatible polyester mesh. (Id. ¶ 0029.) “The cover 18 can be sewn
to the exclusion device 10 via the opening 20. The cover 18 may also be
further sewn to the heart 1 and/or LAA 2 at points 18a and 18b.” (Id.)
Figure 5 shows device 10 in a closed position, clamped to the heart to
exclude the LAA. (Id. ¶ 0019.) Figure 6 is an enlarged sectional view
showing that portions of the first member 12 and second member 14 that
contact the LAA 2 are rounded. (Id. ¶¶ 0020, 0028.)
FF3. Figures 8 and 9 are reproduced below.

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Figures 8 and 9 show a side and top view, respectively, of device 30. (Id.
¶¶ 0022, 0023.) In this embodiment, “first member 32 and the second
member 34 are generally arc-shaped when viewed from above.” (Id.
¶ 0030.) Figure 8 shows device 30 in an open configuration. Figure 9
shows the device in use to isolate a portion of the LAA. As illustrated in
Figure 9 “the shape of first and second members 32, 34 permits first and
second members 32, 34 to be disposed toward or against the outer surface
of the heart 1 while in use. The arc-shaped feature of the members 32, 34
therefore permits clamping of the LAA 2 to occur closer to the heart 1
while permitting hinging and locking to occur at a location somewhat
away from the outer surface of the heart 1.” (Id. ¶ 0031.)
Cosgrove
FF4. Cosgrove discloses implantable surgical clamps suitable for occluding
hollow tissues such as the left atrial appendage of the heart. (Cosgrove
¶¶ 1, 23.) Cosgrove Figure 23 is reproduced below.

The embodiment shown in Cosgrove Figure 23 is “a one piece clamp
1210 which may be moved from an open position as shown in solid lines
to a closed position as shown in dash-dot lines and locked in place by
respective ratchets 1212 at an appropriate clamping position.” (Id.
¶ 0089.)
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FF5. Cosgrove Figures 10 and 11 are reproduced below.

Cosgrove Figures 10 and 11 are cross-sectional views of surgical clamps
applied to the LAA showing circular cross sections of tissue-engaging
arms 81b and 80b. (Id. ¶¶ 0042, 0043, 0080.)
FF6. Cosgrove discloses that “[t]he tissue engaging surfaces are roughened
and preferably adapted to promote tissue ingrowth. The tissue engaging
surfaces may be comprised of a fabric covering on at least one of the first
and second clamping portions.” (Id. ¶ 0014.) “Fabric coverings may be
treated with collagen, albumin, etc., to promote tissue ingrowth 64, 66.
Fabrics such as DACRON polyester or expanded polytetrafluoroethylene
may be used in this regard to promote inflammatory response and tissue
ingrowth.” (Id. ¶ 0077.) “A protective overmold may be provided of,
for example, silicone to assist with traction if tissue ingrowth feature is
not utilized on one or both clamping portions. Alternatively, and if
necessary, silicone overmolding or other protective guards may be used
to prevent irritation of surrounding tissue, while clamping areas of the
device may be designed to promote traction and/or tissue ingrowth.” (Id.
¶ 0014)
Williams
FF7. Williams is directed to a permanent intracranial aneurysm clamp that
occludes a vessel “by uniformly engaging and restricting the tissue of the
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aneurysm neck without exerting substantial pressure sufficient to break
down the involved tissue thereby causing necrosis and potential rupture.”
(Williams 2:37–44, title, abstract; see also 1:40–57; 4:14–19.) Williams
Figures 2 and 5 are reproduced below.

Williams Figure 2 shows a permanent aneurysm clamp comprising three
elongated and parallel clamp members (14, 16, and 18) secured to handle 20.
(Id. col. 2, ll. 48–56.) Williams Figure 5 is a cross-sectional view revealing
the round aspect of clamp members 14, 16, and 18 as they secure vessel 30.
(Id. col. 4. ll. 3–13.)
Mandel
FF8. Mandel is directed to surgical ligating clips for use in a
patient’s body, including aneurysm clips suitable for occlusion of
blood vessels. (See Mandel ¶¶ 0001, 0002, 0007, and 0014.) The
disclosed clips are made of “a metal, a polymeric material or a
bioabsorbable or biodegradable material” (id. ¶ 0020). Mandel further
states that:
Metal ligating clips are known in the art and may be made
from various metals or metal alloys. The most common
metals for the manufacture of ligating clips are tantalum,
titanium or stainless steel, or alloys of these metals. The
most preferred metal for the surgical clips of the present
invention is titanium.
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(Id.)
Reger
FF9. Reger discloses an implantable heart valve comprising a frame
enveloped by a biologically inert cylindrical cover sewn to the frame
using sewing rings to anchor the sutures. (Reger, Abstract; 3:14–19.)
Reger Figures 2, 3, and 5 are reproduced below.

Reger Figure 2 shows a perspective of the frame of the stent showing
windows 142, 144, and 146. (Id. col. 6, l. 29; col. 8, ll. 51–55.) Figure 3
shows “a perspective of the frame and a length of foldable cylindrical
covering material disposed therein as a first step in a stent assembly
process.” (Id. col. 6, ll. 31–33.) Figure 5 shows a partially completed
heart valve stent with the covering trimmed to fit the rising cusps of the
stent frame. (Id. col. 6, ll. 34–43.) Also shown in Figure 5 are sewing
rings 100 and 102. (Id. col. 7, ll. 24–53.) Portions of the covering are
folded over the frame and bound with a plurality of sutures. (E.g., id. col.
11, ll. 2–9.)
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FF10. Reger Figure 7 is reproduced below.

Reger Figure 7 is a close up view of the heart valve and covering
showing sutures 184, 186, 188, and 190 on the interior aspect. With
respect to Figure 7, Reger states:
Additional sutures, represented by sutures 184 and 186 in
FIG. 7, tightly bind sewing ring 100 through windows and
inferiorly disposed openings in frame 110 to outside sidewall
156 along seamless connection line 156’. Similarly, sewing
ring 102 is tightly bound through the windows and inferiorly
disposed openings in frame 110 to exterior inferior sidewall
172 along seamless connection line 174' by sutures,
represented by sutures 188 and 190 in FIG. 7.
(Id. col. 11, ll. 10–17).
ANALYSIS
The rejections appealed from are set forth at pages 3–10 of the Final
Rejection dated February 15, 2012. We have considered Appellants’
arguments that the Examiner errs in rejecting the appealed claims over the
art of record.6 With respect to claims 1–3, 6, 8–12, 14–16, and 21–26, we
disagree with Appellants’ conclusions and adopt as our own the factual

6 The rejection of claims 1–3, 6, 8–13, and 21 under 35 U.S.C. § 112, second
paragraph was withdrawn in light of Appellants’ amendments. (See Ans. 2.)
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findings and analysis set forth in the Final Rejection and Examiner’s
Answer. With respect to claims 13 and 17, we reverse for the reasons set
forth below.
Claims 1–3, 6, 8–10, 14–15, 22, and 25
Appellants contend that the Examiner errs in rejecting claims 1–3, 6,
8–10, 14–15, 22, and 25 over the combination of Cosgrove and Williams.
Claims 1 and 14 require that at least the portions of the clamping members
that contact the LAA are round or substantially round in cross-section and
are configured to minimize stress concentrations in the LAA. Claims 2–3, 6,
and 8–10 depend, directly or indirectly, from claim 1; claims 15, 22, and 25
depend, directly or indirectly, from 14. Appellants set forth no separate
arguments with respect to claims 2–3, 6, 8–10, 15, 22, or 25, which stand or
fall with claims 1 and 14. (See App. Br. 13–14.)
Appellants argue that although Cosgrove Figures 10 and 11 each
disclose one contacting member that is round in cross-section, the reference
fails to teach or suggest that both of the LAA-contacting members could be
substantially round or entirely round––even though “Cosgrove was
presumably aware of [Williams’] teaching that included all tissue-contacting
surfaces being round.” (App. Br. 11.) According to Appellants, Cosgrove’s
omission is evidence of non-obviousness (id.), and an implicit teaching away
(Reply Br. 1) because a hypothetical worker would have taken Cosgrove’s
silence to mean that dual, round or substantially round tissue-contacting
surfaces should be avoided in order to prevent undesired movement of the
exclusion device. (Id.) In response, the Examiner finds that “[i]t does not
matter if Cosgrove was ‘aware’ of the modification,” “Cosgrove never
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teaches away from having a substantially round or round cross-section and
Applicant ignores the teachings of Williams.” (Ans. 2-3.)
We find that the Examiner has the better position. The Examiner has
provided a specific reason to incorporate two, round, tissue-contacting
surfaces into the Williams device, which is “to prevent injury to tissue.”
(Final Rejection at 5.) Such a combination is merely a “predictable use of
prior art elements according to their established functions.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 417 (2007).
Appellants further argue that the Examiner errs because “Cosgrove
does not address the issue of preventing necrosis of LAA tissue.” (App. Br.
12.) In particular, Appellants argue that Cosgrove paragraphs 14 and 18
disclose the use of roughened tissue contacting surfaces, fabric coverings,
and silicone coatings to promote traction, “albeit at the expense of
potentially causing damage to the LAA, such as the development of necrotic
tissue.” (Id. 12-13.) We are not persuaded by Appellants’ argument.
As an initial matter, Appellants’ contention that Cosgrove’s teachings
“potentially” result in tissue damage and necrosis is unsupported by the
present record. “Attorney’s argument in a brief cannot take the place of
evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Mere
lawyer’s arguments and conclusory statements unsupported by factual
evidence are entitled to little probative value. In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997). Moreover, we note that (1) claim 10 on appeal
recites the same fabric covering (“flexible cover. . . made of polyester
fabric”) that Appellants disparage in Cosgrove; (2) Cosgrove paragraph 14
teaches that “silicone overmolding or other protective guards may be used to
prevent irritation of surrounding tissue;” and, (3) Williams, expressly set
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forth in the Examiner’s rejection, is directed to a permanent aneurysm clamp
designed to avoid causing tissue damage and necrosis (FF7; Final Rejection
4–5).
For the above reasons, we do not disturb the Examiner’s rejection of
claims 1–3, 6, 8–10, 14–15, 22, and 25.
Claims 11–13 and 16–17
Appellants contend that the Examiner errs in rejecting claims 11-13,
16, and 17 over the combination of Cosgrove, Williams, and Mandel.
Claims 11, 12, and 16 require that first and second members are made from
material that is “biocompatible with the LAA” (claim 11) and comprising
“titanium, titanium alloys, stainless steel, tantalum, tantalum alloys, [or]
mixtures thereof” (claims 12 and 16). The Examiner finds that, not only
does Mandel disclose a stainless steel ligating clip (Final Rejection at 6; see
also, FF8), but Cosgrove “explicitly discloses applying metal to the clip
(Paragraph 14) and discloses an embodiment (Fig 2C) with ‘leaf spring
members 56, 58’, which are more than likely formed of a metal” (Ans. 3).
Appellants do not address the Examiner’s finding regarding Cosgrove,
but argue that Mandel is “not pertinent to the claimed invention.” (Reply Br.
3) In particular, Appellants state that “although Mandel discloses that metal
ligating clips are known, there is no indication that such clips would be
suitable for use in occluding the LAA” because the LAA is “a part of the
heart and has mechanical and physiological properties that are distinct from
the blood vessels and tissue bundles that Mandel addresses.” (App. Br. 3.)
We interpret Appellants’ argument to be that Mandel is non-
analogous art with respect to the claimed invention. In order for a reference
to be proper for use in an obviousness rejection, it must be analogous art to
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the claimed invention. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
Analogous art need not be from the same field of endeavor as the claimed
invention because “[w]hen a work is available in one field of endeavor,
design incentives and other market forces can prompt variations of it, either
in the same field or a different one.” KSR, 550 U.S. at 417.
“Two separate tests define the scope of analogous prior art: (1)
whether the art is from the same field of endeavor, regardless of the problem
addressed and, (2) if the reference is not within the field of the inventor’s
endeavor, whether the reference still is reasonably pertinent to the particular
problem with which the inventor is involved.” Bigio, 381 F.3d at 1325
(citations omitted). If Mandel is analogous art, “any need or problem known
in the field of endeavor at the time of the invention and addressed by
[Appellant’s disclosure] can provide a reason for combining the elements in
the manner claimed.” KSR, 550 U.S. at 420.
We find that Mandel is analogous art under either test. First, similar
to Appellants’ invention, Mandel is directed to improvements in “[s]urgical
ligating clips like hemostatic clips and aneurysm clips [] often used in
surgery to ligate vessels or tissue bundles to stop the flow of blood.”
(Mandel ¶ 2; see also FF8.) As such, Mandel is within the same general
field of the invention. Second, we find that Mandel’s disclosure of surgical
ligating clips for use in a patient’s body is reasonably pertinent to an
exclusion device that can be clamped to a patient’s heart.
In view of the above, and because Appellants have set forth no
evidence of why the titanium, tantalum, or stainless steel clips set forth in
Mandel would not be biocompatible with the LAA, we sustain the
Examiner’s rejection.
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Claims 13 and 17
Claims 13 and 17 recite that the first and second members are “arc-
shaped when viewed from above.” Appellants argue that the Examiner errs
in finding that it would have been obvious to modify Cosgrove to include the
arc-shape taught by Mandel because Mandel discloses an arc shape “when
viewed from the side.” (App. Br. 14–15; see also Reply Br. 3–4.) In
response to the Examiner’s argument that there is no reference point for the
phrase “when viewed from above” (see Ans. 3–4), Appellants point to
paragraph 23 of the Specification which describes Figure 9 as “a top plan
view of the device of FIG. 8 as used on a heart to exclude the LAA.” (Reply
Br. 3.)
The side view of clamp 30 in Figure 8 of the Specification does not
show the arc shape set forth in Mandel. Because the arc shape is clearly
apparent in the “top plan view” of the same clamp shown in Figure 9, we
agree with Appellants that the claim language “when viewed from above”
pertains to a fixed reference point. Because Mandel fails to teach or suggest
a clamp having an arc shape when viewed from above, we find that the
Examiner has not established a prima facie case of obviousness on this
record.
Claims 21, 23, 24, and 26
Claims 9 and 15 recite “a flexible cover for the first and second
members.” Depending from claims 9 and 15, respectively, claims 21 and 23
further require that “a selected one of the first and second members has an
opening, and the cover is connected to the first and second members by
being sewn to the opening.” Claim 24 and its dependent claim, claim 26,
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likewise encompass a cover connected to first and second members by being
sewn to an opening in one of the members.
Appellants argue that the Examiner errs in rejecting claims 21, 23, 24,
and 26 over the cited art because none of the cited references disclose
sewing a cover to an opening in a clamping member. (App. Br. 16–17.) The
Examiner points to Reger as disclosing “an implant comprising an opening
to which a fabric cover is sutured” (Final Rejection at 10) and finds that
“looking at Fig 2-3 of Reger, one of ordinary skill in the art at the time of
the invention would understand that placing holes through the clip of
Cosgrove would provide a secure, tight fit of the fabric to the clip” (Ans. 4).
In response, Appellants state in a heading that: “Reger is Not Pertinent to the
Claimed Invention.”
As discussed in FF9 and FF10, Reger discloses an implantable heart
valve comprising a frame enveloped by a biologically inert cylindrical cover
sewn to the frame using sewing rings to anchor the sutures. Reger discloses
that “sutures . . . tightly bind sewing ring 100 through windows [142, 144,
and 146] and inferiorly disposed openings in frame 110 to outside sidewall
156 . . . . Similarly, sewing ring 102 is tightly bound through the windows
[142, 144, and 146] and inferiorly disposed openings in frame 110 to
exterior inferior sidewall 172.” (Reger col. 11, ll. 10–17.)
The Examiner bears the burden of establishing an initial case of
unpatentability; once that burden is met the burden of coming forward with
evidence or arguments demonstrating error in the Examiner’s rejection shifts
to the Appellants. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
With respect to Appellants’ argument that none of the cited references
disclose sewing a cover to an opening in a clamping member, we reiterate
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that lawyer’s arguments and conclusory statements unsupported by factual
evidence are entitled to little probative value. In re Geisler, 116 F.3d at
1470. We also find that Reger is analogous art. Applying the tests set forth
in Bigio, Reger’s sewn, fabric-covered heart valve is directed to same
general field of invention as the instant claims, and reasonably pertinent to a
fabric-covered exclusion device that can be clamped to a patient’s heart.
In light of Reger, we do not disturb the Examiner’s finding that one of
ordinary skill would find it obvious to sew a cover to an opening in a
clamping member as required by claims 21, 23, 24, and 26.
SUMMARY
We affirm the rejection of claims 1–3, 6, 8–10, 14–15, 22, and 25
under 35 U.S.C. §103(a) as unpatentable over the combination of Cosgrove
and Williams.
We affirm the rejection of claims 11, 12, and 16 under 35 U.S.C.
§103(a) as unpatentable over the combination of Cosgrove, Williams, and
Mandel.
We reverse the rejection of claims 13 and 17 under 35 U.S.C. §103(a)
as unpatentable over the combination of Cosgrove, Williams, and Mandel.
We affirm the rejection of claims 21 and 23 under 35 U.S.C. §103(a)
as unpatentable over the combination of Cosgrove, Williams, and Reger.
We affirm the rejection of claims 24 and 26 under 35 U.S.C. §103(a)
as unpatentable over the combination of Cosgrove, Williams, Mandel, and
Reger.
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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-IN-PART

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