Ex parte Jervis

Board of Patent Appeals and Interferences

Feb 26, 2001

08483291 (B.P.A.I. Feb. 26, 2001)

1
The opinion in support of the decision being entered today was
not written for publication and is not binding precedent of
the Board.
Paper No. 27
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte JAMES E. JERVIS
__________
Appeal No. 1999-2649
Application 08/483,291
___________
HEARD: February 7, 2001
___________
Before CALVERT, FRANKFORT, and BAHR, Administrative Patent
Judges.
CALVERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the final rejection of claims 21,
23, 25 to 31, 34 to 38, 40 to 42 and 44 to 46. Claims 32, 33,
39 and 43 were also finally rejected, but the examiner states
on page 2 of the answer that claims 32 and 33 are allowed, and
Appeal No. 1999-2649
Application 08/483,291
At the oral hearing counsel for appellant pointed out1
that the statement in the first paragraph on page 13 of the
brief, to the effect that appellant’s memory alloy element
does not require treatment to obtain SIM properties, is
incorrect.
2
claims 39
and 43 were canceled by an amendment filed with appellant’s
brief.
The involved invention generally concerns medical devices
made of shape memory alloys (SMA) which display the property
of stress-induced martensite (SIM) . The particular subject1
matter in issue is defined by the claims on appeal, which are
reproduced in Appendix A of appellant’s brief.
The references applied in rejecting the claims on appeal
are:
Foster, Jr. 4,485,805 Dec. 4,
1984
Balko et al. (Balko) 4,512,338 Apr. 23,
1985
Middleman et al. (Middleman) 5,231,989 Aug.
3, 1993
(filed Feb. 15,
1991)
Schetky, Shape-Memory Alloys, 20 Kirk-Othmer Encyclopedia of
Appeal No. 1999-2649
Application 08/483,291
The examiner incorrectly refers to this reference as2
“Seader”, which is the name of the author of a preceding
entry. We will refer to it in this decision as “Kirk-Othmer.”
3
Chemical Technology 726-736 (3d Ed. 1982).2
The appealed claims stand finally rejected on the
following grounds:
(1) Claims 21, 23, 25 to 31, 34 to 38, 40 to 42 and 44 to 46,
unpatentable over Balko in view of Kirk-Othmer and Foster,
under 35 U.S.C. § 103(a).
(2) Claims 21 and 23, unpatentable for obviousness-type
double pantenting over claims 1 and 2 of Middleman.
(3) Claims 21 and 23, unpatentable over Middleman under either
35 U.S.C. § 102(e) or 103(a).
Rejection (1)
Balko discloses a medical device in which an element such
as wire element 24 or 34 is carried within a sheath 20 or 36,
and is released from the sheath at a desired position in a
vessel 16, 30 or other body channel. The element is made of
an SMA, such as Nitinol, which has a martensite transformation
Appeal No. 1999-2649
Application 08/483,291
4
temperature somewhat below or about body temperature (37EC).
The temperature of the element is maintained below the
transformation temperature until it is in position, as by
using an insulating sheath. When the element is released from
the sheath it is warmed by the body tissue to a temperature
above its martensite transformation temperature, and reforms
into its coiled form (col. 4, lines 13 to 27). Balko does not
disclose that the SMA used displays SIM, but the examiner,
citing Kirk-Othmer page 731, lines 13 to 20 [sic: 14 to 21],
and page 733, line 6, takes the position that Nitinol can
exhibit SIM (superelastic) properties, and therefore that the
Nitinol disclosed by Balko would inherently have SIM
properties at about body temperature.
The cited portion on page 731 of Kirk-Othmer reads:
The other property peculiar to marmem alloys is
the ability under certain conditions to exhibit
superelastic behavior. Although in one sense, the 3-
8% apparently recoverable strain of the memory
effect is truly an extended or pseudoelastic
behavior, an even further elastic range is possible.
When many of the martensitic alloys are deformed
well beyond the point of the initial single-
coalesced martensite stage, a stress-induced
martensite-martensite transformation can occur. In
this mode of deformation strain is reversible
through stress release and not by a temperature-
Appeal No. 1999-2649
Application 08/483,291
Declaration of Dr. Lee Middleman under 37 CFR § 1.132,3
dated Feb. 2, 1998, filed Mar. 18, 1998.
5
induced phase change, and recoverable strains as
high as 17% have been observed.
Page 733, line 6, states that an early medical device (an
orthodontic brace) “exploits the superelastic behavior of
Nitinol.” We do not read these portions of Kirk-Othmer as
disclosing that all Nitinol exhibits superelastic (SIM)
properties, but only that “many” of the martensitic alloys do
“when deformed well beyond the point of the initial single-
coalesced martensite stage.” This is consistent with the
declaration of Dr. Middleman , a coinventor of the above-3
listed ‘989 patent, that (para. 11, pages 3 to 4):
Although nitinol can exhibit the properties of an
SIM material it can do so only if it undergoes a
treatment process to make it exhibit the properties
of an SIM material. This process requires an
extensive, time consuming and expensive procedure.
In basing a rejection on the ground that the prior art
would inherently possess a claimed property, the examiner
bears the initial burden of establishing a prima facie case,
as by showing that the claimed and prior art products are
identical or substantially identical or are produced by
Appeal No. 1999-2649
Application 08/483,291
6
identical or substantially identical processes. See, e.g., In
re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA
1977). In the present case, we consider the examiner’s
statement on page 8 of the answer that “both of Balko and
[the] instant application use the nitinol alloy” to be overly
broad. Balko specifically discloses the use of SMAs,
particularly nickel-titanium alloys (nitinol), which
“completely recover to their original shape on being raised to
a higher temperature” (col. 3, lines 37 to 39), whereas
appellant discloses the use of SMAs which display SIM
properties, i.e., in which the shape change is “mechanically,
rather than thermally, actuated and controlled”
(specification, page 8, lines 13 to 16). The alloy preferred
by appellant is nickel-titanium-vanadium, as disclosed in Quin
Patent No. 4,505,767 (id., page 8, lines 22 to 24). As shown
by Kirk-Othmer and the Middleman declaration, nitinol does not
exhibit SIM properties unless it receives additional
treatment, of which there is no suggestion in Balko. We
therefore conclude that the examiner has not made out a prima
facie case that the SMAs disclosed by Balko would inherently
Appeal No. 1999-2649
Application 08/483,291
7
display SIM properties.
The Foster patent contains no disclosure concerning SMAs,
and was cited by the examiner only as evidence of the
obviousness of using a guide wire (recited in claims 21, 37
and 38). In the view we take of this case, further
consideration of Foster is unnecessary.
Each of independent claims 21, 26, 31 and 34 requires, in
varying language, a memory alloy element (claim 21) or a stent
(claims 26, 31 and 34) formed at least partly from an alloy
which displays SIM behavior.
In view of the foregoing discussion, the combination of
Balko and Kirk-Othmer would not have suggested or rendered
obvious these limitations.
Moreover, claim 21, for example, additionally recites
“wherein the alloy is selected so that the transformation can
occur without any change in temperature of the placement
device or the memory alloy element,” and similar limitations
are contained in the last three lines of claim 26, the last
six lines of claim 31, and the last two lines of claim 34.
Even if it were to be assumed that the nitinol disclosed by
Appeal No. 1999-2649
Application 08/483,291
Our understanding is that the Middleman patent and the4
present application are both currently assigned to Medtronic,
Inc.
8
Balko would exhibit some SIM properties, these limitations
would not be met because Balko does not teach transformation
without a change in temperature, but rather, Balko’s entire
disclosure is directed toward using an alloy which will
transform when the temperature rises from below body
temperature to body temperature (or when otherwise heated, see
col. 5, lines 57 to 67).
Accordingly, rejection (1) will not be sustained.
Rejection (2)
The examiner asserts that claims 21 and 23 are obvious
over claims 1 and 2 of the commonly-assigned Middleman
patent. According to the examiner, the “elongated tube” of4
patent claim 1 corresponds to the “hollow placement device” of
claim 21, “elastic member” of patent claim 1 to the “memory
alloy element” of claim 21, and the “straightening means” of
patent claim 1 to the “guide wire” of claim 21.
Appellant argues that this rejection should be reversed
Appeal No. 1999-2649
Application 08/483,291
9
regardless of whether we apply the “one-way test” for
obviousness-type double patenting (In re Goodman, 11 F.3d
1046, 1052, 29 USPQ2d 2010, 2015 (Fed. Cir. 1993)), or the
more stringent “two-way test” (In re Braat, 937 F.2d 589, 593,
19 USPQ2d 1289, 1292 (Fed. Cir. 1991)). Since we conclude
that the rejection does not pass the “one-way test,” the
question of which test to apply is moot.
Considering the language of claims 1 and 2 of Middleman
in relation to claim 21, we agree with the examiner that the
“hollow placement device” recited in claim 21 is met by the
“elongated tube” recited in claim 1, and the “memory alloy
element” of claim 21 finds response in the “elastic member”
recited in claim 1 (as modified by claim 2). However, claim
21 further recites “the hollow placement device stressing the
memory alloy element . . . so that the memory alloy element is
in its deformed shape,” the “deformed shape” being “when the
alloy is in its stress-induced martensitic state.” There are
no such limitations in claims 1 and 2 of the patent; rather,
claim 1 recites the opposite, namely, “the elastic member
[memory alloy element] being sufficiently stiff to cause the
Appeal No. 1999-2649
Application 08/483,291
10
distal segment [of the elongated tube (claim 21's “hollow
placement device”)] to bend when the elastic member is in its
bent shape,” the “bent shape” being defined in claim 2 as
being “when the alloy is in its stress-induced martensitic
state” (col. 17, lines 34 and 35). Since claim 21 requires
that the hollow placement device stresses the memory element
so that it is in its SIM state, while claims 1 and 2 of the
patent require that the elastic member (memory alloy element)
cause the tube (hollow placement device) to bend when the
member is in its SIM state, i.e., that the tube does not
stress the elastic member, we find no basis for concluding
that the quoted limitations of claim 21 would be obvious over
the structure recited in patent claims 1 and 2, or vice versa.
Rejection (2) therefore will not be sustained.
Rejection (3)
We will not sustain this rejection.
A reference does not qualify as prior art under 35 U.S.C.
§ 102(e)/103 unless it is a U.S. patent with an effective
filing date prior to the effective filing date of the
application. MPEP § 706.02(a), p. 700-11, col. 1, para. (A)
Appeal No. 1999-2649
Application 08/483,291
The filing date of application 06/541,852, the first in5
the chain of applications resulting in the present case.
11
(Feb. 2000); see, e.g., In re Scheiber, 587 F.2d 59, 199 USPQ
782, (CCPA 1978). Here, appellant asserts at page 31 of the
brief, and the examiner does not disagree, that the effective
filing date of the claims on appeal is October 14, 1983, a5
date well prior to the February 15, 1991, (effective) filing
date of the Middleman patent. Since Middleman does not meet
the § 102(e)/ § 103 prerequisite of having an earlier
effective filing date it does not qualify as prior art under
those sections of the statute, regardless of the fact that
Middleman and the present application have a common assignee
and different inventive entities, as noted by the examiner on
page 11 of the answer.
Appeal No. 1999-2649
Application 08/483,291
12
Conclusion
The examiner’s decision to reject claims 21, 23, 25 to
31, 34 to 38, 40 to 42 and 44 to 46 is reversed.
REVERSED
IAN A. CALVERT )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
CHARLES E. FRANKFORT )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
JENNIFER D. BAHR )
Administrative Patent Judge )
Appeal No. 1999-2649
Application 08/483,291
13
IAC:pgg
Jeffrey G. Sheldon
Sheldon & Mak
225 South Lake Avenue Suite 900
Pasadena, CA 91101