Ex Parte Solem et al

Board of Patent Appeals and Interferences

May 24, 2012

11343382 (B.P.A.I. May. 24, 2012)

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.
11/343,382 01/30/2006 Jan Otto Solem PVI-5703DIV 6622
7590 05/25/2012
Edwards Lifesciences LLC
Legal Department
One Edwards Way
Irvine, CA 92614
EXAMINER
MCEVOY, THOMAS M
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
05/25/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAN OTTO SOLEM and PER OLA KIMBLAD
__________

Appeal 2011-002052
Application 11/343,382
Technology Center 3700
__________

Before DEMETRA J. MILLS, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a method of delivering a shape changing member or
device to a blood vessel or mitral valve annulus. The Patent Examiner
rejected the claims for obviousness. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
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STATEMENT OF THE CASE
The Specification states that a medical device of the invention
comprises a member having a preferred state of shape, towards which
the member by means of inherent forces strives when being in a non-
preferred state of shape, and a delay means having a weakenable
inherent stiffness to hold the member in the non-preferred state of
shape for a period of time after the device is inserted into the body of
the organism. . . . By delaying the change of shape this way, the
device is allowed to heal on to body tissue of the organism before a
change of shape of the device occurs. . . . The normal healing
process that occurs in every living organism is thus allowed to provide
a well-established fixation of the device.

(Spec. 2, [0010].)
Claims 1-12, 14-16, and 18-20 are on appeal. Claims 1 and 11 are
representative and read as follows (emphasis added):
1. A method of delivering a shape-changing member to a blood vessel in
a patient to reshape the blood vessel in the patient, the shape-changing
member comprising proximal and distal end portions and biased to move
from a first stretched configuration to a second configuration and comprising
a resorbable material maintaining the shape-changing member in the first
biased and stretched configuration, the method comprising: inserting the
shape-changing member into the blood vessel; and fixing the proximal and
distal end portions of the shapechanging member to an inner wall of the
blood vessel; wherein the resorbable material is resorbed in the patient's
body, thereby causing the shape-changing member to adjust from the first
configuration to the second configuration for reshaping the blood vessel.

11. A method of delivering a shape-changing device to a mitral valve
annulus in a patient's body to reshape the mitral valve annulus of the body,
the device comprising a shape-changing member and first and second
spaced-apart self-expandable stents located at opposite ends of the shape-
changing member, the shape-changing member having an elongated shape
and being biased towards shortening the shape-changing member along a
longitudinal axis, the device further comprising a resorbable material to
maintain the shape-changing member in the elongated shape the method
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comprising inserting the device at least partially into a coronary sinus and
fixing the first and second self-expandable stents to an inner wall of the
coronary sinus and wherein the shape-changing member shortens over time
to draw the first and second selfexpandable stents toward each other for
reshaping the mitral valve annulus.

The Examiner rejected the claims as follows:
 claims 1-12, 14-16, and 18-20 under 35 U.S.C. § 103(a) as
unpatentable over Solem ‘4321 and Camrud;2 and
 claims 1-12, 14-16, and 18-20 under 35 U.S.C. § 103(a) as
unpatentable over Solem ‘6113 and Santamore.4

DISCUSSION
A. The Rejection over Solem ‘432 and Camrud
The Examiner’s position is that Solem ‘432 taught a method for
delivering a shape changing member to a blood vessel in order to reshape the
mitral valve annulus. (Ans. 3.) The Examiner found that Solem’s method
differed from Appellants’ by “fail[ing] to disclose that the shape changing
member comprises a resorbable material wherein the resorbable material is
resorbed in the patient's body, thereby causing the shape-changing member
to adjust from the first configuration to the second configuration. However,
Solem et al. do disclose that the shape changing member is held in the
stretched configuration by a sheath and then released from the sheath to
assume the second configuration (col. 3, line 37 to col. 4, line 3).” (Id. at 4.)

1 Jan Otto Solem et al., US 6,210,432 B1, issued April 3, 2001.
2 Allan R. Camrud et al., WO 00/62708, published Oct. 26, 2000.
3 Jan Otto Solem et al., US 2001/0018611 A1, published Aug. 30, 2001.
4 William P. Santamore et al., US 2002/0188170 A1, filed April 25, 2002.
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The Examiner next found that
Camrud et al. disclose that linking members for stent sections can be
held in a less flexible state by a resorbable sheath, thread or other
interconnecting structure in order to facilitate deployment and
adjusted to a more flexible second configuration after the sheath or
thread is resorbed. This also allows stent sections to be held stationary
relative to each other until deployment. (p. 1, lines 33-35; p. 2, lines
10-12, 29-32; p. 3, lines 19-29; p. 14, lines 16-18; p. 15, lines 14- 33;
Figures 1-5, 9 and 10) where the interconnecting structure can be
resorbed immediately after deployment or gradually (p. 2, lines 29-
31).

(Id. at 4.) The Examiner found that a person of ordinary skill in the art
would have appreciated that using stent sections as Camrud used them to
temporarily fix the shape changing member in place would have been less
damaging to the vessel than Solem’s hooks. (Id. at 5.) The Examiner
accordingly concluded that it would have been obvious to a person of
ordinary skill in the art to replace Solem’s hooks with stent sections, and “to
have provided a resorbable sheath, thread or other interconnecting structure
on the shape-changing member of Solem et al. in order to facilitate
deployment of the stent sections and then adjust to the second configuration
after the interconnecting structure is resorbed.” (Id.)
Appellants contend that neither Solem nor Camrud teaches or
suggests a resorbable material maintaining the shape-changing member in
the first biased and stretched configuration. (App. Br. 3.) Appellants also
contend that because Solem’s device is use to change the shape of the vessel,
but Camrud’s device is designed to conform to the shape of the vessel, the
two “teach away” from each other, and one skilled in the art would not have
combined these “opposite” teachings. (Id. at 5-6.)
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Appellants further argue that (i) the rejection “does not specify how
the combination should be made” (Reply Br. 1-2); (ii) “one of ordinary skill
in that art would not consider the Solem '432 and Camrud structures
analogous” (id. at 2); and (iii) the suggested combination “does not meet the
limitation of claim 1 of a shape-changing member biased to move from a
first stretch configuration . . . and the limitation of a resorbable material to
maintain the shape-changing member in the elongated shape” (id. at 3.)
The Examiner maintains that “[o]ne of ordinary skill in the art would
recognize that any of the interconnecting structures of Camrud et al. are
adaptable to the Solem et al. device to either augment or replace the function
of stabilizer 12,” and “it is readily apparent from Camrud et al. that some
form of interconnecting structure could be applied to stabilize the stretched
configuration of member 8 since Camrud et al. teach that a resorbable
material can be used to fix the longitudinal position of two stent sections (p.
14, lines 15-18 and elsewhere).” (Ans. 8.)
We find the Examiner’s explanation problematic because it does not
explain how or why any of Camrud’s structures would have been perceived
as functionally equivalent to Solem’s stabilizing instrument 12. As Solem
describes it, rod-shaped instrument 12 “forces” a stent “into a stretched or
extended state” by grasping the stent from the inside. (Solem, col. 3, ll. 47-
54.) Camrud’s “connecting structure holds the stent sections substantially
stationary relative to one another,” and allows them to move after
deployment. (Camrud 1, ll. 33-34.) The rejection presented no evidence
that any of Camrud’s structures perform equivalently to Solem’s instrument
12 to force a stent into a stretched state. As Appellants contend, Camrud’s
structures were deployed to conform to the vessel’s configuration, not to
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shorten it. (See Reply Br. 3, Camrud teaches that the stent sections are
already substantially fixed before in-growth.) Thus, it is not evident that
“some form” of Camrud’s structures would be applied to restrain a shape
changing member in a biased, stretched configuration. Put another way,
there is a difference in operation between Camrud’s devices and Solem’s,
but the rejection did not adequately resolve how and why a person of
ordinary skill would have adapted Camrud’s devices to operate in Solem’s
method. The rejection over Solem ‘432 and Camrud is reversed.

B. The Rejection over Solem ‘611 and Santamore
Claim 1
The Examiner’s position is that Solem ‘611 described a method for
delivering a shape changing member to a vessel in order to reshape the
mitral valve annulus, including shortening the shape changing member, but
Solem ‘611 did not disclose that the shape changing member is held in a first
configuration by a resorbable tube, thread, or other interconnecting structure.
(Ans. 6.)
The Examiner found that Santamore described a device for reshaping
myocardial vessels, the device “deployed and held in a first configuration
using an absorbable structure which forms a guidewire-like structure with
the spring. When the absorbable structure deteriorates, the central spring
assumes a second configuration and pulls the tissue together (Figures 12B
and 12D; paragraph 0128).” (Id. at 7.) The Examiner concluded “[i]t would
be obvious to one of ordinary skill in the art in view of Santamore et al. to
have used a spring device with an absorbable restraining tube or thread as
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the shape changing member with the Solem et al. device in order to allow
one to control the time between deployment and actuation.” (Id.)
Appellants draw attention first to their own declared dates of
conception and reduction to practice, December 28, 2001, and January 11,
2002, respectively. (App. Br. 7.) Appellants point out that the Santamore
reference is a published application filed after those dates on April 25, 2002,
although Santamore claims priority to a provisional application filed April
27, 2001, before Appellants’ dates of conception and reduction to practice.
Appellants state: “For purposes of this appeal only, Applicant admits that
the drawings of Figs. 12b and 12d of Santamore are supported by the
provisional application (See Figs. 6d and 6e of the provisional application).”
(Id.)
Rather than finding only Figures 12b and 12D supported by the
provisional application, we find that all the relevant teachings in the
Santamore published application (US 2002/0188170 A1) cited in the
rejection are supported by Santamore’s provisional application 60/286,521.
In other words, the effective date for the Santamore disclosures cited in the
rejection is April 27, 2001. See 35 U.S.C. § 102(e); 35 U.S.C. § 119(e). To
be clear, Santamore’s provisional application Figures 6d and 6e are
reproduced here:
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The legend reads: “Prestretched spring or fibers or guidewires or
Dissolvable spacers in spring, etc.” The provisional application explains
Figures 6d and 6e as follows:
In another embodiment shown in Fig. 6d, the spring is kept in this pre-
stretched condition by bio-absorbable material placed between the
coils. Over time, the material dissolves and is absorbed and the spring
is allowed to shorten under its bias as shown in Fig. 6e. Once allowed
to shorten, the device not only resists extension, but also resiliently
pulls the tissue together throughout the cardiac cycle. The spring with
the bio-absorbable material in one embodiment resembles a standard
clinical guide wire in appearance. The bio-absorbable material can
have different absorption rates. Several of these spring devices are
placed into the infarct tissue to reduce the infarct size. These springs
may be made of fibers that have mechanical characteristics that pull
the ends closer together, thereby shrinking the infarct tissue. This
pulling together can occur rapidly (seconds to hours) and/or gradually
over days to months. This pulling together shrinks the infarct size and
decreases wall stress in the peri-infarct tissue. Metals exhibiting shape
memory and/or martensitic-austenitic transitions at body temperature
can also be employed.

(60/286,521 at 19, ¶ [062].)
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The Examiner found that Santamore disclosed a “device for reshaping
myocardial tissue.” (Ans. 6-7.) Appellants’ Reply Brief appears to indicate
that the only disclosure in Santamore’s published application entitled to the
April 27, 2001 date is Figures 12d and 12e, because they are supported by
Figures 6d and 6e in the provisional application. (Reply Br. 3.) If
Appellants mean that only the descriptive material in Figures 6d and 6e can
be relied upon to support the rejection, and no evidence of reshaping
myocardial tissue may be relied upon, we disagree. Santamore’s provisional
application taught how to use its device to reshape myocardial tissue,
including to reduce mitral valve regurgitation. (See 60/286,521 at Figure 19
(illustrating placement to reduce regurgitation); at 13, ¶ [046] (brief
description of Figure 19); at 28-29, ¶¶ [090]-[091] (explaining application to
mitral valve regurgitation).) We find that the Santamore’s disclosure of a
device for reshaping myocardial tissue has an effective disclosure date of
April 27, 2001, and therefore agree with the Examiner that Santamore taught
reshaping myocardial tissue. The Examiner properly found Santamore
pertinent to the mitral valve problem Solem addressed, and properly
combined the teachings of both references.
Appellants concede that Santamore taught a delay between
deployment and actuation, but contend the Examiner failed to explain why
one of ordinary skill in the art would have applied Santamore’s teaching to
Solem’s device. (App. Br. 7.) The fact that both references addressed the
same problem is sufficient motivation to combine their teachings. See
Princeton Biochemicals, Inc. v. Beckman Coulter, Inc., 411 F.3d 1332,
1338-1339 (Fed. Cir. 2005) (affirming obviousness where motivation was
found in the knowledge of those skilled in the art at the time, and where the
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nature of the problem also supplied a motivation). “In other words, the
nature of the problem called for exactly the solutions in the prior art.” Id. at
1339. Accord, DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H.
Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir. 2006) (“the ‘evidence’ of
motive will likely consist of an explanation of the well-known principle or
problem-solving strategy to be applied”). Santamore explained how the
delay worked in 60/286,521 at 19, ¶ [062], quoted above. We disagree that
the Examiner had a burden to justify Santamore’s teaching of delay. “[I]f a
technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417
(2007).
Appellants further contend that “the present invention provides a more
secure fixation of a medical device for providing a change of shape in a part
of the body of an organism” but neither Solem nor Santamore taught that
feature, and the Examiner did not identify any other reason for controlling
the time between deployment and actuation. (Id. at 8.) First, claim 1 does
not require that the method produce a more secure fixation. Claim 1
requires only a shape change caused by resorbable material being resorbed,
which is what Santamore taught. Second, Santamore expressly taught using
resorbable material to be resorbed over months, thus controlling the time
between deployment and actuation, see 60/286,521 at 19, ¶ [062], quoted
above. Appellants have not produced evidence that Sanatmore’s delay of
months would fail to produce the same fixation, or shown that it would have
failed to produce the same fixation. On this record, it appears that
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Appellants are describing the results that Santamore’s delay period would
have produced, when applied to Solem’s method, because the process steps
claimed are the same as suggested by Solem and Santamore. The inherent
properties of prior art elements need not be disclosed in the prior art. See In
re Woodruff, 919 F.2d 1575, 1577-78 (Fed. Cir. 1990) (obviousness
rejection affirmed where using claimed elements in the manner suggested by
the prior art necessarily resulted in effect); In re Baxter Travenol Labs., 952
F.2d 388, 392 (Fed. Cir. 1991) (“Mere recognition of latent properties in the
prior art does not render nonobvious an otherwise known invention.”).
Santamore taught using resorbable material to be resorbed over a
range of days to months. Appellants do not dispute that Santamore’s range
of days to months would have allowed tissue to grow into the device, thus
producing the secure fixation result that Appellants argue their method
achieves in whatever time range is required for resorbable material to be
resorbed. “[W]here there is a range disclosed in the prior art, and the
claimed invention falls within that range, there is a presumption of
obviousness. But the presumption will be rebutted if it can be shown:
(1) that the prior art taught away from the claimed invention, In re Geisler,
116 F.3d 1465, 1471 (Fed. Cir. 1997); or (2) that there are new and
unexpected results relative to the prior art, In re Woodruff, 919 F.2d 1575,
1578 (Fed. Cir. 1990).” Iron Grip Barbell Co., Inc. v. USA Sports, Inc.,
392 F.3d 1317, 1322 (Fed. Cir. 2004).

Claims 2, 10-12, and 14-20
Appellants point to limitations recited in claims 2, 10, 11, 14, 15, and
19, and argue that these claims are patentable “for the reasons given above
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in connection with claim 1” and because they contain an additional (or
more) limitation(s) “further distinguishing the claim from the cited [prior]
art when considered as a whole.” (App. Br. 9-10.)
“A statement which merely points out what a claim recites will not be
considered an argument for separate patentability of the claim.” 37 C.F.R.
§ 41.37(c)(1)(vii) (2008). The Appeal Brief’s statements regarding claims 2,
10, 11, 14, 15, and 19 only point out what these claims recite, and do not
constitute arguments for separate patentability. Accordingly, like claims 3-
9, claims 2, 10-12, and 14-20 have not been argued separately and therefore
stand or fall with claim 1.

SUMMARY
We reverse the rejection of claims 1-12, 14-16, and 18-20 under
35 U.S.C. § 103(a) as unpatentable over Solem ‘432 and Camrud.
We affirm the rejection of claims 1-12, 14-16, and 18-20 under
35 U.S.C. § 103(a) as unpatentable over Solem ‘611 and Santamore.
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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