Ex Parte McCarthy

Board of Patent Appeals and Interferences

Oct 21, 2009

11345936 (B.P.A.I. Oct. 21, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte PATRICK M. MCCARTHY

Appellant
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Appeal 2009-008856
Application 11/345,936
Technology Center 3700
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Decided: October 22, 2009
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Before RICHARD E. SCHAFER, RICHARD TORCZON, and SALLY
GARDNER LANE, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL
I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134(a), is from a Final Rejection of
Appellant’s claims 1-6 and 8-20. Claim 7 was cancelled.1 (App. Br. 10,
Claims App’x). We have jurisdiction under 35 U.S.C. § 6(b). We affirm-

1 While Appellant indicated that claims 1-20 were pending in the Brief (App.
Br. 2), claim 7 was listed as cancelled in the Claims Appendix (App. Br. 10).
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in-part and enter new grounds of rejection. Appellant’s application is
directed to an annuloplasty ring for the treatment of mitral valve prolapse.
(Spec. 1)
The Examiner rejected claims 1, 3-15, and 20 under 35 U.S.C.
§ 102(e) and claims 2 and 16-19 under 35 U.S.C. § 102(b)2, both rejections
over US 2003/0093148, published May 15, 2003 (“Bolling”). Appellants
argued separately for the patentability of claims 6 and 10. Accordingly, we
focus on claims 1, 6, and 10 in our review. 37 C.F.R. § 41.37(c)(vii).
II. PRINCIPLES OF LAW
“Anticipation requires a showing that each limitation of a claim is
found in a single reference, either expressly or inherently.” Atofina v. Great
Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006).
The elements must be arranged as required by the claim, but this is not
an ipsissimis verbis test, i.e., identity of terminology is not required. In re
Bond, 910 F.2d 831, 832-33 (Fed. Cir. 1990).
III. FINDINGS OF FACT
Claim 1
1. Appellant’s claim 1 recites3:
A mitral annuloplasty ring comprising a ring body
arranged around a flow axis having an upward direction and a
downward direction, the downward direction corresponding to
the direction of blood flow through the mitral valve annulus

2 The Examiner determined that claims 2 and 16-19 are not entitled to the
benefit of the filing date of continuation-in-part application 10/834,556, filed
April 29, 2004, while claims 1, 3-15, and 20 are. 35 U.S.C. § 120.
Appellant has not challenged this determination.
3 Claim 1 has been modified by adding an indentation for clarity. 37 C.F.R.
§ 1.75(i).
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when the annuloplasty ring is implanted, the ring body
comprising:
an anterior segment generally defined between two
trigones and adapted to be implanted against the anterior aspect
of the mitral annulus;
a posterior portion opposite the anterior segment adapted
to be implanted against the posterior aspect of the mitral
annulus, and
wherein the ring body defines a modified D-shape in
atrial plan view with the anterior segment defining a relatively
straight side as compared with the posterior portion, and with a
minor axis extending between and bisecting the anterior
segment and posterior portion and a major axis extending
perpendicularly thereto, the major and minor axes being
generally perpendicular to the flow axis, and
wherein the posterior portion of the ring body has an
outward bow relative to a D-shaped ring and an upward bow
from adjacent sections.

(App. Br. 8, Claims App’x).
2. Figure 3 of Appellant’s specification is reproduced below.

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Figure 3A depicts a top plan view and Figure 3B depicts a posterior
elevational view of a mitral annuloplasty ring (Spec. ¶ [0025]) with an
anterior segment (AS) (Spec. ¶ [0049]), three posterior segments (P1, P2, and
P3) (Spec. ¶ [0039]), a major axis (44) perpendicular to the minor axis (46),
and a central flow axis (42) (Spec. ¶ [0036]).
3. Appellant’s specification provides that “[f]or purposes of
reference, a conventional 3:4 ratio ‘D-shaped’ annuloplasty ring means the
relaxed shape of a Carperier-Edwards Physio annuloplasty ring available
from Edwards Lifesceinces of Irvine, CA (www.edwards.com).” (Spec. ¶
[0040]).
4. Figure 6 of Bolling is reproduced below.

Figure 6A depicts a top plan view, Figure 6B depicts a front elevational
view, and Figure 6C depicts a side elevational view of an annuloplasty ring
(Bolling ¶ [0027]) with an anterior portion (60), major axis (56) and minor
axis (54) (id. ¶ [0038]). Figure 6A also includes an imaginary extension
(72) of the ring. (Id. ¶ [0042]).
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5. The figure on page 5 of the Examiner’s answer is reproduced
below.

This figure depicts the ring of Bolling with the imaginary extension
redrawn. This imaginary extension is a more shallow D-shape than the one
depicted by the imaginary extension lines in Figure 6 of Bolling.
Claims 6 and 10
6. Appellant’s claim 6 recites:
A method of correcting mitral valve prolapse wherein a
posterior leaflet of the mitral valve is causing mitral
regurgitation, comprising:
providing an annuloplasty ring having:
a rounded ring body arranged in atrial plan view around a
flow axis defining an upward direction and a downward
direction, the downward direction corresponding to the
direction of blood flow through the mitral valve annulus when
the annuloplasty ring is implanted;
an anterior segment extending between two trigones and
adapted to be implanted against the anterior aspect of the mitral
annulus;
a posterior portion opposite the anterior segmented
adapted to be implanted against the posterior aspect of the
mitral annulus, wherein the posterior portion defines an
outward and an upward bow relative to adjacent sections of the
ring,
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wherein the ring body defines a modified D-shape in
atrial plan view with the anterior segment defining a relatively
straight side as compared with the posterior portion, and with a
minor axis extending between and bisecting the anterior
segment and posterior portion and a major axis extending
perpendicularly thereto, the major and minor axes being
generally perpendicular to the flow axis, and wherein the
outward bow of the posterior portion creates a minor axis to
major axis dimension ratio of between about 3.3:4 (82.5%) and
4:4 (100%); and a suture-permeable exterior on the ring body
for securing the annuloplasty ring to the mitral annulus;
delivering the annuloplasty ring to the mitral annulus;
and
securing the annuloplasty ring to the mitral annulus using
the suture-permeable exterior such that the posterior portion
pulls the periphery of the posterior leaflet of the mitral valve
outward and upward and reduces the mitral regurgitation.

(App. Br. 9-10, Claims App’x).
7. Appellant’s claim 10 recites:

A mitral annuloplasty ring comprising a ring body
arranged around a flow axis having an upward direction and a
downward direction, the downward direction corresponding to
the direction of blood flow through the mitral valve annulus
when the annuloplasty ring is implanted, the ring body
comprising:
an anterior segment generally defined between two
trigones and adapted to be implanted against the anterior aspect
of the mitral annulus;
a posterior portion opposite the anterior segment adapted
to be implanted against the posterior aspect of the mitral
annulus, and
wherein the ring body defines a modified D-shape in
atrial plan view with the anterior segment defining a relatively
straight side as compared with the posterior portion which is
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outwardly curved, and with a minor axis extending between and
bisecting the anterior segment and posterior portion and a major
axis extending perpendicularly thereto, the major and minor
axes being generally perpendicular to the flow axis, and
wherein the posterior portion of the ring body has an outward
bulge that is radially
outwardly curved more pronounced than adjacent
sections of the posterior portion and creates a minor axis to
major axis dimension ratio of between about 3.3:4 (82.5%) and
4:4 (100%).

(App. Br. 10-11, Claims App’x).
8. Bolling states that “[a]s with many conventional rings, the ratio
of the minor axis dimension 54 to the major axis dimension 56 is about 3:4.
Although not geometrically precise, such a ring configuration may be
considered oval or elliptical.” (Bolling ¶ [0038]).
IV. ISSUE
With regard to claim 1, does Bolling teach a mitral annuloplasty ring
with a posterior portion of the ring body that bows outwardly relative to a D-
shaped ring?
With regard to claims 6 and 10, does Bolling teach a mitral
annuloplasty ring with a posterior portion of the ring body that bows
outwardly relative to a D-shaped ring at a minor to major axis dimension
ratio of between about 3.3:4 and 4.4?
V. ANALYSIS
Claim 1
The mitral valve prolapse ring of Appellant’s claim 1 is a “modified
D-shape,” having “the anterior segment defining a relatively straight side as
compared with the posterior portion,” and “wherein the posterior portion of
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the ring body has an outward bow relative to a D-shaped ring . . . .” (FF 1).
Claim 1 does not recite any specific dimensions for the portion of the ring
that bows outward from the D-shaped ring, nor does it recite any specific
dimensions of an unmodified D-shape. (FF 1; cf. FFs 6 and 7).
Furthermore, Appellant’s claim 1 recites a ring “comprising” an outward
bow, but does not exclude any other modifications from a D-shape, such as
an inward bow or multiple outward bows. Though Appellant argues that
“[a]nything ‘slightly or formerly d-shaped’ is not what is claimed” (Reply
Br. 2), we find no language in claim 1 that limits the ring beyond having at
least one outward bow.
Bolling teaches a mitral valve prolapse ring that differs from a general
D-shape, which is depicted by dashed lines showing an imaginary extension.
(FF 4). As drawn in Bolling, the ring bows inward from an imaginary
extension. But, if the extension is redrawn into a more shallow D-shape (see
FF 5), the ring taught by Bolling has two portions that bow outward from
this modified D-shape. Thus, Bolling teaches a ring with a posterior portion
that bows outward (in two places) relative to the D-shape, anticipating the
mitral annuloplasty ring of claim 1. Atofina, 441 F.3d at 999.
Appellant argues that the ring taught in Bolling is B-shaped and not
D-shaped. (App. Br. 15). Because Appellant does not limit the claimed ring
to having only one outward bow, and does not exclude the presence of an
inward bow, we are not persuaded that the shape of Bolling’s ring is not
either a modified D-shape or two D-shapes joined by an inward bow.
Appellant also argues that a “conventional” D-shaped ring has a minor
to major axis ratio of 3:4 and that the ring depicted in Bolling would not bow
outwardly from these dimensions. (App. Br. 5, Reply Br. 4). Though
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Appellant’s specification mentions a ratio of 3:4 “[f]or purpose of reference”
(Spec. p. 11, ll. 10-12), we are not persuaded that claim 1 is limited to this
definition. Claim 1 does not recite a specific ratio, as compared with other
claims that recite “a minor axis to major axis dimension ratio of between
about 3.3:4 (82.5%) and 4:4 (100%).” (See FF 6 and 7). Instead, claim 1
defines “modified D-shape” as being “with the anterior segment defining a
relatively straight side as compared with the posterior portion . . . .” (FF 1).
The imaginary extension drawn by the Examiner shows that the ring taught
in Bolling bows outward from a modified D-shape, as claimed.
Appellants argue that Bolling expressly states that its ring has an
“inward bow of the shaped posterior portion” (Bolling ¶ [0043]), not an
outward bow. (App. Br. 4). Even though Bolling describes the bow with
different language, the ring it depicts has the elements recited in Appellant’s
claim 1, as explained above. Bolling need not have used the same
terminology as recited in the claim for it to anticipate. See Bond, 910 F.2d at
832-33. In short, we fail to see why Bolling’s mitral annuloplasty ring is not
“a modified D-shape” as that phrase is used in Appellant’s specification.
Appellant has not persuaded us that the Examiner erred in rejecting
claim 1 under 35 U.S.C. § 102(e) over Bolling.

Claims 6 and 10
Claims 6 and 10 recite a specific ratio between the minor axis and
major axis of “between about 3.3:4 (82.5%) and 4:4 (100%) . . . .” (FFs 6
and 7). Bolling does not disclose this specific ratio, but teaches only “about
3:4.” (FF 8). When construing a claim with the term “about” it is
considered to “avoid[] a strict numerical boundary to the specified
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parameter. Its range must be interpreted in its technologic and stylistic
context.” Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1217 (Fed.
Cir. 1995). Similarly, when interpreting the term “about” in the prior art,
we look to its context. In the context of the language used by Bolling to
describe the prior art ring, “about 3:4” is that it is “considered oval or
elliptical.” (FF 8). “[O]val or elliptical” would encompass many ratios,
including one end of the claimed range of “about 3.3:4 (82.5%)” and up to
the other end of the claimed range “4:4 (100%),” though perhaps not
including 4:4, which is circular. “It is well established that the disclosure of
a genus in the prior art is not necessarily a disclosure of every species that is
a member of that genus.” Atofina, 441 F.3d at 999 (holding that the
disclosure of a broad temperature range of 100 to 500 °C does not anticipate
the claimed temperature range of 330 to 450 °C). A generic disclosure has
been found to anticipate a species when “the generic disclosure in the
reference identified ‘specific preferences,’ which were met by the later-
described species.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1084
(Fed. Cir. 2008). The Examiner has not identified any preferences by which
one of skill in the art would choose the claimed range. Accordingly, the
Examiner erred in rejecting claims 6 and 10 under 35 U.S.C. § 102(e) over
Bolling and those claims that depend from claims 6 and 10 (i.e., claims 8, 9,
and 11-20).
New Grounds of Rejection
Although Bolling does not anticipate the ring recited in Appellant’s
claims 6 and 10, it renders it obvious because the difference between the
claimed dimensions of “between about 3.3:4 . . . to 4:4 . . .” and the
dimension of “about 3:4” taught in Bolling is minor, and Appellant’s
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specification does not provide sufficient evidence that the claimed
dimension is critical. See Haynes Int’l, Inc. v. Jessop Steel Co., 8 F.3d 1573,
1577, n.3 (Fed. Cir. 1993) (“when the difference between the claimed
invention and the prior art is the range or value of a particular variable, then
a prima facie rejection is properly established when the difference in range
or value is minor.”); see also In re Geisler, 116 F.3d 1465, 1469-70 (Fed.
Cir. 1997) (“When an applicant seeks to overcome a prima facie case of
obviousness by showing improved performance in a range that is within or
overlaps with a range disclosed in the prior art, the applicant must ‘show that
the [claimed] range is critical, generally by showing that the claimed range
achieves unexpected results relative to the prior art range.’”) (quoting In re
Woodruff, 919 F.2d 1575 (Fed. Cir. 1990)). Accordingly, we enter a new
grounds of rejection under 35 U.S.C. § 103(a) over Bolling for claims 6 and
8-20.
VI. CONCLUSION
Bolling teaches a mitral annuloplasty ring with a posterior portion of
the ring body that bows outwardly relative to a D-shaped ring.
Bolling renders obvious a mitral annuloplasty ring with a posterior
portion of the ring body that bows outwardly relative to a D-shaped ring at a
minor to major axis dimension ratio of between about 3.3:4 and 4.4.
VII. ORDER
Upon consideration of the record and for the reasons given,
the rejection of claims 1, and 3-5 under 35 U.S.C. § 102(e) over
Bolling is AFFIRMED;
the rejection of claim 2 under 35 U.S.C. § 102(b) over Bolling is
AFFIRMED;
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the rejection of claims 6, 8-15, and 20 under 35 U.S.C. § 102(e) is
REVESRED; and
the rejection of claims 16-19 under 35 U.S.C. § 102(b) is
REVESRED.
FURTHER ORDERED that no time period for taking any subsequent
action in connection with the appeal may be extended under 37 C.F.R.
§ 1.136(a)(1)(iv).
We enter a new grounds of rejection for claims 6 and 8-20 under 35
U.S.C. § 103(a) over Bolling for the reasons set forth herein. 37 C.F.R.
§ 41.50(b).
37 C.F.R. § 41.50(b) provides that, “[a] new grounds of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new grounds of
rejection to avoid termination of proceedings as to the rejected claims:
(1) Submit an appropriate amendment of the claims so rejected or new
evidence relating to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding will be
remanded to the examiner; or
(2) Request that the proceeding be reheard under 37 C.F.R. § 41.52 by
the Board upon the same record.

AFFIRMED-IN-PART; NEW GROUNDS ENTERED
37 C.F.R. § 41.50(b)

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ack

cc:

Debra D. Condino
Edwards Lifesciences LLC
Law Dept.
One Edwards Way
Irvine, CA 92614