Ex Parte Fogarty et al

Board of Patent Appeals and Interferences

Mar 25, 2008

10355429 (B.P.A.I. Mar. 25, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte THOMAS J. FOGARTY, MICHAEL J. DREWS,
NEIL HOLMGREN, and D. BRUCE MODESITT
__________

Appeal 2008-0434
Application 10/355,429
Technology Center 3700
__________

Decided: March 25, 2008
__________

Before DONALD E. ADAMS, ERIC GRIMES, 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
biologically implantable system for a heart valve which the Examiner has
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

Appeal 2008-0434
Application 10/355,429

Background
“Prosthetic heart valves can replace defective human valves in
patients” (Spec. 1). The Specification notes that “[i]n a typical prosthetic
valve implantation procedure, the heart is incised and the defective valve is
removed leaving a surrounding area of locally tougher tissue. Known heart
valve replacement techniques include individually passing sutures through
the tough tissue to form an array of sutures” (Spec. 2). According to the
Specification, “[o]nce all sutures have been run through the ring, all the
sutures are pulled up taught and the prosthetic valve is slid or ‘parachuted’
down into place adjacent the tough tissue” (id.). “Thereafter, the prosthetic
valve is secured in place by traditional knot tying with the sutures” (id.).
Statement of the Case
The Claims
Claims 10-12, 16, 17, 27, 32, 33, and 35-54 are on appeal. We will
focus on claims 10, 27, and 45, which are representative and read as follows:
10. A biologically implantable system for a heart valve,
comprising:
a first prosthesis comprising an annular ring
implantable directly and independently into an annulus of a
heart, the first prosthesis comprising a circumference and a
fabric covering;
a second prosthesis comprising a heart valve crown,
the second prosthesis further comprising a circumference
including a fabric covering thereon, the circumference
defining a shape including a scallop between adjacent lobes;
and
at least one engagement element disposed on the
circumferences of the first and second prostheses that self-
engage one another when the second prosthesis is inserted
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into engagement with the first prosthesis after the first
prosthesis is implanted within an annulus of a heart.

27. A biologically implantable system for a heart valve,
comprising:
a first annular prosthesis implantable within an
annulus of a heart, the first prosthesis comprising a
circumference and a fabric covering;
a second prosthesis separate from the first prosthesis
and comprising a heart valve crown, the second prosthesis
comprising a circumference;
a plurality of engagement elements disposed around
the circumferences of the first and second prostheses that
self-engage one another when the second prosthesis is
inserted into engagement with the first prosthesis; and
cooperating elements on the first and second
prostheses that angularly align the second prosthesis with
the first prosthesis and prevent rotation of the second
prosthesis with respect to the first prosthesis when the
second prosthesis is inserted into engagement with the first
prosthesis after the first prosthesis is implanted within an
annulus of a heart.

45. A biologically implantable system for a heart valve,
comprising:
a first annular prosthesis implantable into an annulus
within a heart, the first prosthesis including a wall defining a
circumference and a central longitudinal axis substantially
perpendicular to the circumference, at least a portion of the
wall being angled away from the longitudinal axis;
a second annular prosthesis comprising a valve; and at
least one engagement element on the first and second
prostheses that engage one another when the second
prosthesis is inserted into engagement with the first
prosthesis after the first prosthesis is implanted within an
annulus of a heart.

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The prior art
The Examiner relies on the following prior art reference to show
unpatentability:
Alonso US 4,680,031 Jul. 14, 1987
Stobie US 6,143,025 Nov. 7, 2000
Shu US 2004/0015232 A1 Jan. 22, 2004
Berreklouw US 6,790,229 B1 Sep. 14, 2004

The issues
The rejections as presented by the Examiner are as follows:
A. Claims 10-12, 16, 17, 27, 32, 33, 35-40, 43, and 45-51 stand rejected
under 35 U.S.C. § 102(b), as being anticipated by Alonso.
B. Claim 54 stands rejected under 35 U.S.C. § 103(a), as being obvious
over Alonso and Stobie.
C. Claims 41, 42, 44, 52, and 53 stand rejected under 35 U.S.C. § 103(a),
as being obvious over Alonso and either Shu or Berreklouw.

A. 35 U.S.C. § 102(b) rejection over Alonso
The Examiner argues regarding the limitation found in claim 10 of
“self engagement” that the “threads of the sewing ring (30) and stent support
ring (34), respectively, are the respective engagement elements that self-
engage each other” (Ans. 6). The Examiner further contends that “‘self-
engage’ does not imply that any particular motion or lack thereof is required.
Moreover, upon review of the specification, it is clear that [there] is no
special definition for this terminology” (id.).
Regarding the limitation in claim 10 requiring a scallop, the Examiner
contends that “Alonso illustrates at least one scallop between adjacent lobes
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in element (36) of Figure 1” (Ans. 7). The Examiner supports this point by
noting that “[m]oreover, a scallop (i.e. scallop shape) is not a well-defined
shape such as that of a geometrical shape; e.g. square or circle. Rather, it has
been used to describe many features including decorative ornamental edges
or thin slices of meat” (id.).
With regard to claim 27, the Examiner argues that “[s]ince Alonso
clearly discloses an operative lock of the two elements, the claim language
requiring rotation prevention is considered at least read on by Alonso's
disclosure” (Ans. 8).
Appellants argue that the
Alonso reference fails to disclose, teach, or suggest ‘at least
one engagement element disposed on the circumferences of
the first and second prostheses that self-engage one another
when the second prosthesis is inserted into engagement with
the first prosthesis after the first prosthesis is implanted
within an annulus of a heart’ as recited in claim 10.

(App. Br. 8).
Appellants further contend that “merely bringing the threaded rings
30, 34 together, without rotation of the stent support ring 34 by a user, will
not engage the stent support ring 34 to the sewing ring 30. As such, the
threaded rings 30 and 34 cannot be ‘self-engaging’” (Rep. Br. 6).
Appellants also argue that it “is also well understood by persons of ordinary
skill in the art that ‘engage’ and ‘self-engage’ are not synonymous since
‘self-engage’ is narrower than the term ‘engage’ given the additional word
‘self’” (Rep. Br. 7).
In addition, Appellants argue that “Alonso reference fails to disclose,
teach, or suggest a second prosthesis having a circumference defining a
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shape including ‘a scallop between adjacent lobes’ as recited in claim 10”
(App. Br. 14). Appellants further note that “the components described in the
[Alonso] reference must necessarily be circular in order to allow the
internally threaded ring 30 and externally threaded stent support ring 34 to
threadedly mate together when the externally threaded stent support ring 34
is rotated” (App. Br. 13).
Appellants contend regarding claim 27 that Alonso does not teach
“that after the first prosthesis or ring is implanted, the second prosthesis
cannot be rotated” (App. Br. 14). Appellants argue that Alonso teaches
“rotation of the stent support ring 34 after the sewing ring 30 has been
implanted and the rings 30 and 34 are threadedly secured together” and that
“the Alonso reference notes the particular advantages that post-surgical
rotation of the stent support ring 34 can provide” (App. Br. 15).
In view of these conflicting positions, we frame the anticipation issues
before us as follows:
(1) Does Alonso teach heart valve prostheses which are “self
engaging”?
(2) Does Alonso teach heart valve prostheses which comprise a
“scallop between adjacent lobes”?
(3) Does Alonso teach prostheses which prevent rotation after the
second prosthetic element is inserted into the first prosthetic element as
required by claim 27?
(4) Does Alonso teach a prosthesis with an angled wall?
(5) Does Alonso teach a prosthesis with cooperating elements
including a rib and groove?
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Findings of Fact
1. Alonso teaches “an artificial heart valve implant which is
designed to maximize the area available for blood flow in the mitral, aortic
or tricuspid annulus where the implant is surgically mounted” (Alonso 3:24-
27).
2. Alonso teaches a first prosthestic element that is the sewing
ring 30, which “embeds the first cloth tube 38 . . . so that the interior threads
40 of the sewing ring 30 are disposed within the interior 44 of the first cloth
tube 38 and the exterior wall 42 of the sewing ring 30 is disposed on the
exterior 46 of the first cloth tube 38” (Alonso 5:53-58, fig. 1).
3. Alonso teaches that the “surgeon . . . first implants the sewing
ring 30 into the mitral, aortic or tricuspid annulus” (Alonso 7:62-63).
4. Alonso discloses a second prosthestic element that is the stent
32 and stent support 34, and that these have fabric coverings:
to assemble the stent 32 to the stent support ring 34 for the
heart valve prostheses . . . the second cloth tube 62 is folded
over the interior wall 60 of the stent support ring 34. In this
manner, the stent support ring 34 is fully enclosed in the
second cloth tube 62 and a cloth pocket 67 is formed
wherein the stent 32 is mounted by sewing and stitches 50

(Alonso 6:34-41, fig. 1-3).
5. Alonso teaches “three commissural posts 70” which are
rounded extensions from the stent 32 (Alonso 7:23-25; Fig. 1).
6. Alonso teaches that the “square threads 40 of the sewing ring
30 readily engage the like threads 58 of the stent support ring 34 within
approximately one turn or less” (Alonso 7:66-8:1).
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7. Alonso teaches that the “pressure of the stent support ring 34 on
the lip 78 locks the stent support ring 34 into operative position in the
sewing ring 30” (Alonso 8:1-3).
8. Appellants’ Specification does not define the term “self
engagement”, but states “there is a need for the above prosthesis that can
self-engage a second prosthesis to improve implantation time” (Spec. 4:3-4).
9. Appellants’ Specification teaches in figure 52, one embodiment
for engagement of the first and second prostheses in which in order for the
second prosthesis to be engaged, the “interference beams 198 can be
removed, as shown by arrows 200, allowing the latches 188 to contract, as
shown by arrows 196, against, for example, the second prosthesis, once the
second prosthesis is positioned within the reach of the latches 188” (Spec.
21:5-8, fig. 52).
10. Appellants’ Specification teaches another embodiment for
engagement of the first and second prostheses with a “second prosthesis 68
that can have fixation points 286 that align with fixation points 286 on the
first prosthesis 2 to allow insertion of sutures, grommets, clips 292 or pins
294 through the aligned fixation points 286 to fix the first prosthesis 2 to the
second prosthesis 68” (Spec. 27:23-28:3).
11. Alonso teaches a padded cloth ring 54 which is perpendicular to
the circumference and which is angled away from the longitudinal axis (see
Alonso, fig. 6-7). Figure 6 of Alonso appears to show the padded cloth ring
54 projection is at a 90 degree angle, while figure 7 appears to show the
padded cloth ring 54 at an angle that is greater than 90 degrees and angled
away from the longitudinal axis (see Alonso, fig. 6-7).
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Discussion of 35 U.S.C. § 102(b) over Alonso
We conclude that the Examiner has set forth a prima facie case that
claims 10, 37, and 45 are anticipated by Alonso. Alonso teaches heart valve
prostheses with a first prosthetic ring with a fabric covering, a second
prosthetic element with fabric which comprises an engagement element to
engage the first and second prostheses after implantation into an annulus of a
heart (FF 1-10).
(1) Self-Engagement
The first argued difference between the Alonso prostheses and the
prosthesis of claim 10 is whether Alonso teaches elements which “self
engage” the first and second prostheses.
In analyzing this difference, we first interpret the claim and the term
“self engage”. Claim 10 requires that “at least one engagement element
disposed on the circumferences of the first and second prostheses . . . self-
engage one another when the second prosthesis is inserted into engagement
with the first prosthesis after the first prosthesis is implanted within an
annulus of a heart” (Claim 10).
The Specification does not define the term “self engage” (see Rep. Br.
7). As Appellants note, the term is therefore interpreted using the broadest
reasonable interpretation “in view of the specification” (Rep. Br. 7). See,
e.g., In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[D]uring
examination proceedings, claims are given their broadest reasonable
interpretation consistent with the specification.”). In the current
Specification, several alternative modes of engagement are detailed for the
first and second prosthetic element (FF 8-10). In the mode of engagement
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depicted in figure 52 and discussed at page 21, the engagement requires the
removal of interference beams 198, which “allow[s] the latches 188 to
contract, as shown by arrows 196, against, for example, the second
prosthesis, once the second prosthesis is positioned within the reach of the
latches 188” (Spec. 21:6-8). A different mode of engagement is discussed at
page 28 of the Specification, where the engagement comprises the “insertion
of sutures, grommets, clips 292 or pins 294 through the aligned fixation
points 286 to fix the first prosthesis 2 to the second prosthesis 68” (Spec.
27:23-28:3). Two other modes of engagement, snap fitting and magnet
interaction, are found in claims which the Examiner has indicated as allowed
(see Claims 20-23). These examples demonstrate that “engagement” in the
context of the Specification encompasses initial interactions of the first and
second prostheses, whether by positioning as at page 21 or by aligning as at
page 28 followed by action by the surgeon to ensure that the prostheses
remained in contact with one another.
We therefore interpret the phrase “self engagement” as simply
requiring the first and second prostheses to interact when they are placed in
contact. We conclude that Alonso’s threads are seated and interact when
placed in contact with one another and therefore meet the “self engagement”
requirement of claim 10. We are not persuaded by Appellants’ argument
that “placing threaded components together, without additional manipulation
or rotation, will not connect or engage the components to one another” (App.
Br. 11). This same argument could be made about most of the modes by
which the Specification places two components together. Without pressure
by the surgeon on the two components, the snap fit connection will not be
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formed, as the Specification notes “[o]nce seated on the engagement
element 148, the second prosthesis 68 can then be engaged by the first
prosthesis 2” (Spec. 27:2-3). Similarly, the interactions in which beam 198
is removed or in which pins are inserted into point 286 also require
additional manipulation to complete the interaction after the first and second
prostheses are “self engaged”.
We reject Appellants’ argument that “the term ‘self-engage’ within
the context of the present claims does imply, and necessarily requires, lack
of a particular motion” (Rep. Br. 6). We think that in light of Appellants’
Specification, which does not define the term “self-engage” and which
requires particular motions for most forms of locking engagement, “self-
engage” encompasses the interaction shown in Alonso (see FF 8-10).
Whether a snap-fit connection or a pin 294 is placed into fixation point 286,
the completion of the engagement requires particular motions.
Consequently, we conclude that Alonso teaches a mode of engagement
which, when read in light of the Specification, is reasonably interpreted as a
type of “self engagement”.
(2) Scallop
“Scallop” is another term which is the subject of dispute between the
Examiner and Appellants (see Ans. 7; App. Br. 13). We interpret the term
“scallop” using the broadest reasonable interpretation in light of the
Specification. See, e.g., In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000)
(“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.”). The
Specification discloses two images which are termed “scallops” but no
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definition of this term (see Spec. 29:16, 30:1, 4, fig. 79, 81). However, we
do not read limitations from the Specification into the claims. See In re
American Academy Science Tech Center, 367 F.3d 1359, 1369 (Fed. Cir.
2004)(“We have cautioned against reading limitations into a claim from the
preferred embodiment described in the specification, even if it is the only
embodiment described, absent clear disclaimer in the specification.”).
Therefore, we must determine whether Alonso’s second prosthesis has any
structure which may meet the “scallop” requirement.
The “three commissural posts 70” shown in figure 1 of Alonso, are
rounded extensions from the stent 32 (see Alonso 7:23-25, fig. 1). Between
these posts are rounded edges which are part of the circumference of the
second prosthesis (see Alonso, fig. 1). A scallop is defined as “one of a
continuous series of circle segments or angular projections forming a
border”. Merriam Webster Collegiate Dictionary 1633 (1998). We note that
the claim 10 language “the circumference defining a shape including a
scallop between adjacent lobes” does not require that the scallop be located
in the annular plane. Therefore, the region between the “three comissural
posts 70” shown in figure 1 of Alonso reasonably appear to be scallops.
(3) Claim 27 rotation lock
We agree with the Examiner that Alonso teaches elements which
prevent rotation of the second prosthesis relative to the first prosthesis as
required by claim 27. Alonso states that the “pressure of the stent support
ring 34 on the lip 78 locks the stent support ring 34 into operative position in
the sewing ring 30” (Alonso 8:1-3). This statement expressly indicates that
the two prosthetic elements are locked together (see FF 7). Appellants argue
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that “the Alonso reference explains that if the heart valve prosthesis must be
removed at ‘a later time,’ removal of the stent support ring 34 from the
sewing ring 30 is ‘relatively easy because the square threads readily separate
from one another’” (App. Br. 15). We do not find this argument persuasive
since simply because a later surgeon may remove the valve of Alonso does
not detract from Alonso’s express teaching that the pressure locks the
elements together (see FF 7).
Appellants also conflate the question of whether the prosthetic
elements of Alonso are ever able to rotate with the question of whether,
when fully implanted into a patient, the prosthetic elements rotate (see Rep.
Br. 11). While there is no doubt that during the implantation or during a
removal process, the prostheses of Alonso permit rotation, Alonso expressly
states that after implantation, the “pressure of the stent support ring 34 on
the lip 78 locks the stent support ring 34 into operative position in the
sewing ring 30” (Alonso 8:1-3). While Appellants would discount the word
“lock”, we agree with the Examiner that the term is reasonably interpreted as
preventing movement of the prosthetic parts. As the Examiner noted “[i]f
the two elements were not locked than the valve of Alonso would not be
operative in that it would screw apart and come apart while implanted.
Since US patents are presumed to be operative, this is not a reasonable
interpretation of Alonso's disclosure” (Ans. 8).
(4) Angled wall
Appellants argue that Alonso does not teach the claim 45 limitation of
a “first annular prosthesis including a wall defining a circumference and a
central longitudinal axis substantially perpendicular to the circumference, ‘at
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least a portion of the wall being angled away from the longitudinal axis’
(App. Br. 16). We reproduce figure 7 of Alonso below.

The figure shows a cross-section of the sewing ring 30 shown in
Alonso’s figure 4 (Alonso 4:37-38). The longitudinal axis of the prosthetic
element shown in Alonso’s Figure 7 is right-to-left. We conclude that
Alonso shows at least part of the walls of a first prosthetic element which
have an angle that is angled away from the longitudinal axis (see FF 11).
Since the angle of padded wall ring 54 is not on the longitudinal axis, it is
necessarily angled away from that axis to some degree (see FF 11). We
therefore agree with the Examiner that Alonso teaches this element of claim
45.
(5) Rib and groove cooperating elements
We reject Appellants’ argument that Alonso does not teach features
which meet the “cooperating element” and “rib and groove” requirements of
claims 11, 12 and 33 because the threads cannot serve both the
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“engagement” and “cooperating element” functions (see App. Br. 17). We
agree with the Examiner that the thread components function both as
engagement elements and as cooperating elements. The engagement occurs
when the threads meet, and the cooperating occurs when the second
prosthesis is rotated so that the threads align and lock the second prosthesis
into the operative position (see FF 7).
We affirm the rejection of claims 10-12, 27, 33, and 45 as anticipated
by Alonso. Claims 16, 17, 32, 35-40, 43, and 46-51 fall with claims 10-12,
27, 33, and 45 as they were not separately argued.
B. 35 U.S.C. § 103(a) rejection over Alonso and Stobie
We have already concluded that Alonso anticipates claims 10-12, 16,
17, 27, 32, 33, 35-40, 43, and 45-51 as discussed above. Since Appellants
do not separately argue the limitations of claim 54 which depends from
claim 45, we affirm the rejection of claim 54 over Alonso and Stobie.
C. 35 U.S.C. § 103(a) rejection over Alonso and either Shu or
Berreklouw
The Examiner argues that “it would have been obvious to replace the
screw thread attachment of Alonso with a removable snap fit attachment for
the same reasons that the prior art uses the same and so that the valve could
be attached to the ring more quickly” (Ans. 5). The Examiner also contends
that “it is clear that Alonso clearly states that the threaded design merely
enables better attachment of the cloth to the base material . . . it is clear to
the Examiner that it is not required in that the other attachment features
apparently can be used at the same time” (Ans. 9).
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Appellants argue that “the Alonso reference repeatedly refers to a
sewing ring 30 and stent support ring 34 that are threadedly mountable by
rotating the ring and particular advantages that are achieved with these
threaded components” (App. Br. 19). Appellants also contend that “the
Alonso reference criticizes and teaches away from non-threaded
components” (id.). Appellants also argue that “the Alonso reference, as
discussed above, makes it even ‘clearer’ that that threaded engagement is in
fact required, and that threaded components are particularly advantageous”
(Rep. Br. 14).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
Would it have been obvious to substitute a snap fitting connection of
Shu or Berreklouw for the threaded connection of Alonso?

Findings of Fact
12. Alonso teaches the use of threaded sewing rings as the means
for connecting the stent support ring with the sewing ring (see Alonso 5:52-
60, 7:64-68).
13. Alonso teaches that “prior art valve implants which had
relatively complex mounting mechanisms” (Alonso 3:5-6).
14. Shu teaches that a variety of equivalent means can be used to
connect the ring and valve body, including “[m]ating male and female screw
threads, snaps, fabric hooks, screws, or other interlocking mechanisms” (Shu
2, ¶ 13).
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15. Berreklouw teaches that “[a]ccording to the invention[,] the top
closure can comprise a screw ring or snap-fit ring and/or resilient lips”
(Berreklouw 7:38-39).
Discussion of 35 U.S.C. § 103(a) over Alonso and either Shu or Berreklouw
We agree with the Examiner that Alonso when combined with either
Shu or Berreklouw teach the snap fit elements (see Ans. 9). We are not
persuaded by Appellants’ argument that because Alonso preferred a threaded
engagement, it would have been unobvious to use other known equivalent
means to connect the ring and valve. In KSR, the Supreme Court indicated
that “[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. If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” KSR v. Teleflex Inc., 127 S. Ct.
1727, 1740 (2007). While Alonso teaches threaded engagement
mechanisms (FF 12-13), Shu and Berreklouw teach that in the field of heart
valve prosthestic elements, the art recognizes the equivalence of threaded
engagement and snap fit engagements (see FF 14-15). We conclude that the
substitution of the snap fit for its threaded engagement equivalent is a
predictable variation, which is obvious.
We also reject Appellants’ argument that Alonso teaches away from
the invention because Alonso prefers a threaded engagement mechanism.
This preference does not “teach away” from alternatives, but simply teaches
towards a preferred embodiment (see FF 12-13). Like our appellate
reviewing court, “[w]e will not read into a reference a teaching away from a
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process where no such language exists.” DyStar Textilfarben GmbH & Co.
Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
We affirm the rejection of claims 41, 42, 44, 52, and 53 as obvious
over Alonso with either Shu or Berreklouw.
CONCLUSION
In summary, we affirm the rejection of claims 10-12, 27, 33, 41, 42,
44, 45, 52, and 53 under 35 U.S.C. § 103(a). Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejections of claims 16, 17, 32, 35-
40, 43, 46-51, and 54 as these claims were not argued separately.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED

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