Ex Parte Casanova

Patent Trial and Appeal Board

Nov 27, 2012

10985491 (P.T.A.B. Nov. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte R. MICHAEL CASANOVA
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Appeal 2010-009199
Application 10/985,491
Technology Center 3700
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Before KEN B. BARRETT, BENJAMIN D. M. WOOD, and
RICHARD E. RICE, Administrative Patent Judges.

RICE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
This is an appeal under 35 U.S.C. § 134 involving claims to an
annuloplasty ring that exhibits a compressed form or an expanded form
depending upon temperature. The Examiner has rejected claims 1-10, 15,
28, 37-39, 42, 44, 45, 47, 48, 50, and 52 as obvious. We have jurisdiction
under 35 U.S.C. § 6.
We affirm.

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CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is representative of the claimed
subject matter on appeal:
1. An annuloplasty ring, comprising:

an elastomeric member;

a shape memory member disposed in the elastomeric
member enabling the annuloplasty ring to exhibit a
compressed form and an expanded form having a
desired flexibility after implantation; and

an outer wrap covering the elastomeric member,

wherein the shape memory member is configured to
change the annuloplasty ring from the compressed
form to the expanded form upon being heated to a
temperature above a transformation temperature
range, the transformation temperature range being
between about 15°C and about 30°C such that heat
from a patient's body can cause the annuloplasty ring
to change from its compressed form to its expanded
form.

REJECTIONS
The following Examiner’s rejections are before us for review:
1. Claims 1-10, 15, 28, 42, 44, 45, and 47 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Quijano (US 2003/0191528 A1,
pub. Oct. 9, 2003) and Navia (2004/0243230 A1, pub. Dec. 2, 2004).
2. Claims 37-39, 48, 50, and 52 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Quijano, Navia and Garrison (US
2002/0183839 A1, pub. Dec. 5, 2002).

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OPINION
Claims 1-10, 15, 28, 42, 44, 45, and 47 as unpatentable over Quijano and
Navia

The Examiner found that “Quijano discloses an annuloplasty ring
comprising a shape memory member disposed within an elastomeric
member (paragraph 016-0019) wherein the elastomeric member is covered
by a knit polyester fabric (paragraph 0021) and the shape memory member
is comprised of Nitinol.” Ans. 3. The Examiner also found that Quijano’s
“annuloplasty ring further comprises a compressed form and an expanded
form wherein the shape memory member is configured to change from the
compressed form to the expanded form upon being heated to a temperature
above a transition temperature range (paragraph 0018).” Id.
While finding that Quijano fails to disclose a transformation
temperature range between about 15°C and about 30°C, the Examiner found
that “Navia et al. discloses annuloplasty rings comprising Nitinol having a
transition temperature range between 15-30°C in order to allow the body
temperature to produce a desired change of shape (see paragraphs 0037,
0038, and 0061).” Id. at 4. The Examiner concluded:
Therefore it would have been obvious to one of ordinary
skill in the art at the time of the invention to combine the
teaching of Nitinol with a transition temperature 15-30°C, as
taught by Navia et al, to the annuloplasty ring of Quijano. The
motivation to combine the Quijano annuloplasty ring with a
Nitinol comprising a transition temperature of about 15-30°C
being that the ring shape could change upon exposure to
internal body temperature without the need for applying
external energy means thus simplifying the surgical procedure.
Id.
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Appellant argues that, in contrast with the subject matter of
independent claims 1, 28 and 42,1 Quitano teaches “controlled expansion” of
an annuloplasty ring through use of an external energy source (an energy
source other than body temperature, such as radiofrequency (RF) energy),
and teaches away from utilizing the temperature of the human body to
provide heat activation to cause a shape change. App. Br. 5-6; see also id.
at 7 (“The use of a controllable, external energy source (whether heating or
cooling means) is fundamental to the operation of the Quijano device. [It
fails] to provide any teaching or suggestion as to how its device could be
used in a manner whereby a relatively uncontrolled heat source, i.e., body
heat, provides the energy for heating the device to above its transformation
temperature range.”) (italics omitted). Appellant further argues that Navia
and Quijano teach “entirely different modes of operation.” Id. at 6. In
particular, Appellant argues that Navia utilizes human body temperature to
contract a device, rather than to expand a device as in Quijano. Id. at 6-7.
Appellant contends that “there is no apparent reason to modify the Quijano
device according to Navia in light of the divergent teachings of the two
references,” and that combining the teachings of Navia with Quitano would
“fundamentally alter the mode of operation of both devices.” Id. at 7 (italics
omitted).
In response to Appellant’s argument that the use of body temperature
would not allow control over the procedure, the Examiner contends that “a
determinable period of time would occur before the Nitinol reached the
transition temperature (for example, the device is not exposed to body

1 Separate patentability is not argued for dependent claims 2-10, 15, 44, 45,
and 47. App. Br. 7.
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temperature until released from the delivery catheter).” Id. 5-6. The
Examiner also contends that “Appellant has not shown that selecting body
temperature as the transition temperature would prevent control over the
procedure as desired by Quijano.” Id. at 6.
Appellant has not persuaded us that the Examiner lacked an apparent
reason to combine the teachings of Quijano and Navia. Quijano discloses an
annuloplasty ring made from shape-memory Nitinol having a transition
temperature above human body temperature, in the range of about 39-90°C.
Quijano, paras. [0052], [0062]; see Ans. 3. Navia discloses a form of shape-
memory Nitinol having a transition temperature below human body
temperature, in the range of 75-95°F.2 Navia, paras. [0061], [0070]; see
Ans. 4. An apparent reason for substituting Navia’s Nitinol in Quijano’s
annuloplasty ring would have been to use human body temperature instead
of an external energy source for expanding the ring, as the Examiner
determined. Ans. 4; see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007) (“when a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result”) (citing
United States v. Adams, 383 U.S. 39, 50-51 (1966)).
We do not agree with Appellant’s argument that Quijano teaches
away from utilizing the temperature of the human body to provide heat
activation to cause a shape change.3 App. Br. 5-6. Quijano discloses an

2 We note that 75-95°F is approximately 24-35°C. National Weather
Service, NOAA (found at: http:www.wbuf.noaa.gov/tempfc.htm).
3 A prior art reference is said to teach away from an applicant's invention
“when a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
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embodiment having a shape-transition temperature of “preferably” between
about 39-90°C, which requires use of an external energy source to heat the
shape-memory material above the shape-transition temperature (Quijano,
para. [0020]). But Quijano does not contain language warning against use of
a shape-memory material that changes shape upon exposure to human body
temperature.4 See DyStar Textilfarben GmbH & Co. Deutschland KG v.
C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006) (“[w]e will not read
into a reference a teaching away from a process where no such language
exists”); Para-Ordnance Mfg. v. SGS Importers Int’l Inc., 73 F.3d 1085,
1090 (Fed Cir. 1995) (a warning against use of an element, rather than
omission of mention of the element, is required to find teaching away). We
determine that Quijano would not have discouraged the person of ordinary
skill in the art from using a heat-transition temperature in the range of 75-
95°F as taught by Navia.
We also do not agree with Appellant’s argument that combining the
teachings of Navia and Quijano would “fundamentally alter the mode of
operation of both devices.” App. Br. 7. While Navia discloses heating a
Nitinol annuloplasty ring from an expanded form to a contracted form,
rather than the reverse, the rejection as articulated by the Examiner relies

in a direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
4 Quijano actually incorporates by reference (at para. [0013]) “the entire
contents” of U.S. Patent No. 5,163,952 to Froix, which discloses shape-
memory plastics having a shape-transition temperature at or below human
body temperature and teaches surgical procedures for keeping the
temperature of a stent made from such material below human body
temperature prior to insertion of the stent into the vessel of a patient to
prevent premature shape change. Froix, col. 5, ll. 22-47, col. 10, ll. 38 – col.
11, l. 7.
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only on Navia’s disclosure of a form of shape-memory Nitinol having a
shape-transition temperature of between 15-30°C. Ans. 4-6. Appellant has
not persuaded us that using body heat to activate the shape-memory material
would change the fundamental principle of operation of Quijano’s
annuloplasty ring, which would still be radially expandable in situ by way of
non-mechanical expandable means in keeping with Quijano’s basic teaching.
See Quijano, p. 2, para. [0016]. Further, Appellant has not explained why
measures such as cooling (see Navia, para. [0065]) or insulating (see
Ans. 5-6) the annuloplasty ring prior to, or during, a surgical implantation
procedure would not be sufficient to control expansion. We determine that
the Examiner’s conclusion of obviousness is supported by adequate
articulated reasoning with rational underpinning.
We sustain the rejection of claims 1-10, 15, 28, 42, 44, 45, and 47.
Claims 37-39, 48, 50, and 52 as unpatentable over Quijano, Navia and
Garrison

Claims 37-39
Appellant argues claims 37-39 as a group. App. Br. 8. We select
claim 37 as representative. Claims 38 and 39 stand or fall with claim 37.
Independent claim 37 calls for “a shape memory member … enabling
the annuloplasty ring to exhibit a compressed form … defining an outer
diameter sized for minimally-invasive delivery of the annuloplasty ring
through an access cannula” and “a holder comprising a handle, a head
defining a groove, and a stem extending between the handle and the head,
such that the annuloplasty ring, in its compressed form, is retained in the
groove.”
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The Examiner found that Quijano discloses an annuloplasty ring that
is adapted to be retracted in a compressed state for minimally invasive
delivery procedures, but that neither Quijano nor Navia discloses a holder
with a groove for delivery of the annuloplasty ring. Ans. 4. The Examiner
further found, however, that “Garrison teaches various annuloplasty ring
holders having a head with a groove (for receiving an annuloplasty ring), a
handle, and a stem for delivering annuloplasty rings in a minimally invasive
procedure via small incision or access ports (see paragraph 0119).” Id. at 4-
5. The Examiner concluded that
it would have been obvious to one of ordinary skill in the art at
the time of the invention to combine the teaching of a holder
having a head with a groove, handle, and stem as taught by
Garrison with the annuloplasty ring, as per Quijano in view of
Navia, the motivation to combine being that a holder secures
the annuloplasty ring during the minimally invasive
implantation process.
Id. at 5.
Appellant argues that Garrison does not disclose or teach “a holder
configured to retain an expandable annuloplasty ring in a ‘compressed form’
that defines an ‘outer diameter sized for minimally-invasive delivery of the
annuloplasty ring through an access cannula,’ as required by claim 37.”
App. Br. 8. Appellant further argues that “Garrison's annuloplasty ring
holder assemblies appear to have only a single form or shape corresponding
to the shape of the cardiac valve annulus for which the ring is being used to
repair” and that “[n]othing in Garrison teaches or suggests how any of its
disclosed holders could be utilized in combination with an annuloplasty ring
such as that disclosed in Quijano, or any expandable annuloplasty ring for
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that matter.” Id. (citing Garrison, figs. 6A-6C, 7A-7C, 8A-8C, 10A-
10G)(italics omitted).
Appellant's arguments attack Garrison individually and do not address
the rejection as articulated by the Examiner, which is based on the
combination of Quijano, Navia and Garrison. See In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986) (one cannot show nonobviousness by
attacking references individually where the rejections are based on
combinations of references) (citing In re Keller, 642 F.2d 413, 425 (CCPA
1981)).
In response to Appellant’s argument that Garrison’s holder is not
configured for retaining a ring in a compressed form for minimally invasive
implantation, the Examiner contends, and we agree, that “the Quijano ring is
inherently in a compressed form when placed on a holder (since the
expanded states occur after implantation)” and that “Appellant has not
shown the Garrison holder to be incapable of use with the Quijano ring.”
Ans. 6-7. Appellant also has not explained why the compressed form of
Quijano’s expandable annuloplasty ring does not define an outer diameter
sized for minimally-invasive delivery of the annuloplasty ring through an
access cannula.
We sustain the rejection of claims 37-39.
Claim 48
Dependent claim 48 depends from claim 42. Appellant argues that
claim 48 is patentable for the same reasons as claim 42. App. Br. 9. For the
reasons discussed supra in respect to the rejection of claim 42, we sustain
the rejection of claim 48.

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Claims 50 and 52
Appellant argues claims 50 and 52 as a group. App. Br. 9-10. We
select claim 50 as representative. Claim 52 stands or falls with claim 50.
Independent claim 50 recites a method of using an annuloplasty ring
including a shape memory member comprising, inter alia, “positioning the
annuloplasty ring in a compressed form on a holder, the compressed form
defining an outer diameter sized for minimally-invasive delivery of the
annuloplasty ring through an access cannula.” Appellant argues that claim
50 is patentable for the same reasons as claims 1 and 37. App. Br. 9. For
the reasons discussed supra in respect to the rejection of claims 1 and 37, we
sustain the rejection of claims 50 and 52.

DECISION
We affirm the rejection of claims 1-10, 15, 28, 37-39, 42, 44, 45, 47,
48, 50, and 52.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED

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