Ex Parte Ferry et al

Board of Patent Appeals and Interferences

Aug 10, 2007

10337236 (B.P.A.I. Aug. 10, 2007)

The opinion in support of the decision being entered today is not binding
precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte STEVEN J. FERRY, ROGER N. HASTINGS,
and REED A. HOUGE

Appeal 2007-2812
Application 10/337,236
Technology Center 3700
__________

Decided: August 10, 2007
__________

Before LORA M. GREEN, NANCY J. LINCK, and RICHARD M.
LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the final rejection of claims 1-21
and 23. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF CASE
The claimed invention is drawn to a magnetically navigable medical
guidewire which is used to navigate medical devices through a subject’s
vasculature (Spec. 1: [0001]). Claims 1-21 and 23 are pending. The
following rejections are on appeal (Answer 2-3):
Appeal 2007-2812
Application 10/337,236

1) Claims 1-3, 6-12, 15, 16, 18, and 21 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Anderson (US 4,244,362);
2) Claims 4, 5, and 17 stand rejected under 35 U.S.C. § 103(a) as
obvious over Anderson in view of Engelson (US 6,221,061);
3) Claims 13, 14, 19, and 20 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Anderson, or alternatively, under 35 U.S.C. § 103(a) as
obvious over Anderson; and
4) Claims 1 and 23 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Kuntz (US 4,790,809).
We select claims 1, 4, 14, and 23 from each rejection as representative
of each grouping for the purpose of deciding this appeal. See 37 C.F.R. §
41.37(c)(1)(vii). With respect to the rejection based on Kuntz, claims 1 and
23 are separately argued by Appellants. Therefore, we consider both these
claims in addressing this rejection.
Claims 1, 4, 3 (on which claim 4 depends), 14, 13 (on which claim 14
depends), and 23 read as follows:
1. A magnetically navigable medical guidewire, comprising an
elongate wire having a proximal end, and a distal end; a hollow
cylinder secured on the distal end of the wire forming the tip of
the guidewire; a magnetically responsive element inside said
hollow cylinder; and a dome-shaped cap securing the
magnetically responsive element inside the hollow cylinder.

3. The magnetically navigable medical guidewire according to
claim 1 wherein the hollow cylinder is radiopaque.

4. The magnetically navigable medical guidewire according to
claim 3 wherein the radiopaque hollow cylinder is made of gold
or a gold alloy.

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13. The magnetically navigable medical guidewire according to
claim 1 wherein the size and material of the magnetically
responsive element and the stiffness of the distal end portion of
the wire are such that, when the guidewire is held at a point 0.5
inches proximal to its distal tip, the maximum angle of
deflection of the guidewire tip relative to the body of the
guidewire is at least 30 degrees when the applied magnetic field
has a magnitude of at least 0.1 Tesla.

14. The magnetically navigable medical guidewire according to
claim 13 wherein the size and material of the magnetically
responsive element and the stiffness of the distal end portion of
the wire are such that, when the guidewire is held at a point 0.5
inches proximal to its distal tip, the maximum angle of
deflection of the guidewire tip relative to the body of the
guidewire is at least 30 degrees when the applied magnetic field
has a magnitude of up to about 0.15 Tesla.

23. The magnetically navigable medical guidewire according to
claim 1 wherein the magnetically responsive element is
configured to align the distal end of the guidewire with the
direction of a magnetic field that is applied from an external
source magnet.

CLAIM INTERPRETATION
Claim 1 is directed to a “magnetically navigable medical guidewire”.
It comprises: 1) “an elongate wire”; 2) “a hollow cylinder” secured on one
end of the wire; 3) “a magnetically responsive element” inside the cylinder;
and 4) “a dome-shaped cap securing the magnetically responsive element
inside the hollow cylinder.”
The preamble of claim 1 recites that the medical guidewire is
“magnetically navigable.” The terms appearing in a preamble may be
deemed limitations of a claim when they “give meaning to the claim and
properly define the invention.” Gerber Garment Technology, Inc. v. Lectra
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Sys., Inc., 916 F.2d 683, 688, 16 USPQ2d 1436, 1441 (Fed. Cir. 1990)
(quoting Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 896,
221 USPQ 669, 675 (Fed. Cir. [1984]), cert. denied, 469 U.S. 857 (1984)).
“Although no ‘litmus test’ exists as to what effect should be accorded to
words contained in a preamble, review of a patent in its entirety should be
made to determine whether the inventors intended such language to
represent an additional structural limitation or mere introductory language.”
In re Paulsen, 30 F.3d 1475, 1479, 31 USPQ2d 1671, 1673 (Fed. Cir. 1994).
In this case, the Specification indicates that “magnetically navigable
guidewires have been developed which can be controlled with the
application of an external magnetic field” (Spec. 1: [0002]). The navigation
is enabled by having a “magnetically response element” at the guidewire tip
that is deflected in the desired direction by the externally applied magnetic
field (Spec. 6: [0022]). The guidewire is described by the Specification as
being “sufficiently stiff that it can be advanced in the selected direction by
pushing [its] . . . proximal end” (Spec. 4: [0017]), but it also must be flexible
enough that its direction can be displaced (“deflection angle”) by the
external magnetic field (see Spec 6: [0025]). Thus, the phrase “magnetically
navigable medical guidewire” would be understood by persons of skill in the
art, in the light of the Specification, to mean that the guidewire comprises a
“magnetically responsive element” which enables it to be directed
(“navigable”) to a desired site in a blood vessel (see Answer 4) and that it is
also be flexible enough to be steered through blood vessels. The
“magnetically responsive element” is explicitly recited in the claim. With
respect to the flexibility requirement, we do not interpret the phrase to
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Application 10/337,236

impose any specific structure1 on the guidewire as long as it capable of
being navigated through a blood vessel.
According to the Specification, the “magnetically responsive
element . . . can include a permanent magnetic material or a permeable
magnetic material” (Spec. 3: [0017]. An example of the permanent
magnetic material is disclosed to be neodymium-iron-boron (Spec. 5:
[0022]). A “magnetic material” has the properties of a magnet or capable of
being attracted by a magnet.2 Thus, we interpret the phrase “magnetically
responsive element” to mean an element which comprises a magnet or a
material capable of being attracted by a magnet.
FINDINGS OF FACT
Anderson
1. Anderson describes an endotracheal tube control device which acts as a
guide for inserting an endotracheal tube into the throat of a patient
(Anderson, Abstract).
2. The device is a stylet 23 which comprises a main body 25 and a magnet
27 at its distal end (Anderson, at col. 5, l. 23 to col. 6, l. 21 and Figs. 1-2).
3. “The main body 25 of the stylet is comprised of a coiled spring”
(Anderson, at col. 6, ll. 5-7 and Fig. 2).
4. A magnet 27 is secured to the distal end of the main body 25 (Anderson,
at col. 6, ll. 10-11 and Fig. 2).

1 The Specification describes the relationship between the deflection angle
of the wire and the wire characteristics, the magnetically response element,
and the external magnetic field (Spec. 6: [0027]), but does not state that they
must possess any specific value.
2 The Random House Dictionary 805 (1982).
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5. The magnet 27 is encased in an inert housing 29 (Anderson, at col. 6, ll.
11-14) which is shown in Fig. 3 to be dome-shaped.
6. The stylet 23 is inserted into the throat of the patient and then guided into
the trachea using an external magnet 41 (Anderson, at col. 6, ll. 27-46 and
Figs. 5-7).
7. The stylet 23 comprising the magnet 27 is “responsive to the external
magnet” and is guided by an external magnet into the trachea (Anderson, at
col. 4, ll. 33-66).
Application of Anderson to the claims
8. The main body 25 of the stylet 23 is an “elongate wire” (Findings of Fact
(“FF”) 3; Anderson, at col. 6, ll. 5-7 and Fig. 2) as recited in claim 1.
9. The inert housing 29 of Anderson’s stylet 23 is a hollow cylinder (FF 5;
Anderson, at col. 6, ll. 11-14 and Fig. 3) attached to the end of the stylet 23,
satisfying the limitation of claim 1 of a “hollow cylinder secured on the
distal end of the wire forming the tip of the guidewire.” (See Final Office
Action 3.)
10. A magnet 27 which is “responsive” to an external magnet (FF 6, 7;
Anderson, at col. 4, ll. 33-66) is “encased in the inert housing” (FF 5;
Anderson, at col. 6, ll. 11-14), meeting the limitation in claim 1 of a
“magnetically responsive element inside said hollow cylinder.” (See Final
Office Action 3.)
11. The inert housing 29 has a dome-shaped end (FF 5; Anderson, at col. 6,
ll. 11-14 and Fig. 3) which holds the magnet as required by the recitation in
claim 1 of a “dome-shaped cap securing the magnetically responsive
element inside the hollow cylinder.” (See Final Office Action 3.)
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12. Anderson describes all elements of the magnetically navigable medical
guidewire of claim 1. (See also Final Office Action 3.)
13. In regard to claim 14, Anderson does not expressly disclose the
stiffness or magnetic strength of the magnetically responsive element, but
Fig. 5 suggests that the guidewire has a tip that is flexible enough to deflect
to at least 30 degrees when subjected to the magnetic field of magnet 41.
(See also Final Office Action 7.)
Kuntz
14. Kuntz describes a retrieving catheter 21 which comprises an elongate
tube (Kuntz, at col. 3, l. 40 and Fig. 1, 28) for introducing into the urethra
(Kuntz, at col. 4, ll. 10-16).
15. The retrieving catheter 21 can have a magnet 27 at its end (Kuntz, col.
4, ll. 11-15 and Fig. 5).
16. The magnet 27 has a cylindrical core 32 which is covered by a hollow
stainless steel cap 33 shown in Fig. 5 as being dome-shaped (Kuntz, col. 5,
ll. 15-19).
17. “The cap 33 serves to . . . attach the magnet 27 to the catheter 21”
(Kunz, col. 5, 11. 1-21 and Fig. 5).
18. The magnet “preferably” is comprised of neodymium-iron-boron
material (Kuntz, col. 5, ll. 15-17).
Application of Kuntz to the claims
19. The retrieving catheter 21 comprises an elongate tube (FF 14; Kuntz, at
col. 3, l. 40 and Fig. 1, 28), meeting the limitation of claim 1 of “an elongate
wire having a proximal end.” (See Final Office Action 5-6.)
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20. A stainless steel cap 33 is attached to the end of the catheter 21 (FF 16;
Kuntz, col. 5, ll. 15-19). This element is the same structure as the “hollow
cylinder” structure of claim 1. (See Final Office Action 5-6.)
21. Kuntz’s catheter 21 has a magnet 27 at its end which is secured inside a
dome-shaped cap 33 (FF 15-17; Kuntz, col. 4, ll. 11-15, col. 5, ll. 15-19, and
Fig. 5), satisfying the limitation of claim 1 of a “magnetically responsive
element inside said hollow cylinder” and of “dome-shaped cap securing the
magnetically responsive element inside the hollow cylinder.” (See Final
Office Action 5-6.)
22. Kuntz describes all the elements of claim 1 (FF 19-21; Final Office
Action 5-6).
23. “In regards to claim 23, Kuntz discloses a guidewire [catheter] 21
wherein the magnetically responsive element 27 comprises a permanent
magnetic element that is capable of aligning the distal end of the guidewire
21 with the direction of a magnetic field that is applied from an external
source magnet (see column 5/lines 15-22)” (Final Office Action 6).

DISCUSSION
Anderson
Claims 1-3, 6-12, 15, 16, 18, and 21 stand rejected under 35 U.S.C. §
102(b) as anticipated by Anderson (Answer 2).
Anticipation under 35 U.S.C. § 102 requires that “each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference.” Verdegaal Bros., Inc. v. Union Oil
Co., 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). In this
case, we agree with the Examiner’s findings that Anderson anticipates claim
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Application 10/337,236

1 because it describes every element and limitation of it (Findings of Fact
(“FF”) 8-12).
Appellants contend that, contrary to Anderson, claim 1 recites a
medical device that is magnetically navigable. According to Appellants,
“Anderson does not disclose a ‘magnetically navigable’ device whose tip
may be oriented in different directions by an external magnet, but rather a
device that is moved in only a single direction - towards a magnet” (Br. 73).
We do not find this argument persuasive. We have interpreted the
phrase “magnetically navigable” to require the guidewire to comprise a
“magnetically response element” and possess sufficient flexibility that it can
be navigated by an external magnet through a blood vessel. (See supra at p.
4-5). Anderson’s guidewire comprises a “magnetically response element”
(FF 4, 10) and is described as being guided through the throat and into
patient’s trachea using an external magnet (Anderson, at col. 6, ll. 27-46 and
Figs. 5-7; FF 6), indicating that it possesses the requisite flexibility. Thus,
we agree with the Examiner’s determination (Answer 3; FF 12) that this
structure meets the claimed limitation of “magnetically navigable device” as
we have interpreted it.
Appellants’ argument is deficient because they have not identified a
structural limitation that distinguishes the guidewire of claim 1 from the
device described in Anderson. They contend that “unlike Anderson, the
distal end [of the claimed device] may be oriented in a desired direction
other than towards the magnet by changing the direction of the magnetic
field” (Br. 7), but do not explain why Anderson’s device – which has the

3 Appeal Brief filed Nov. 15, 2006.
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same structure of the claimed guidewire – could not perform this function
when contacted with an appropriate external magnetic field. It appears that
Appellants are arguing that the claimed device is used differently than
Anderson’s. However, a method of use is not claimed here; only a device is
claimed and that device is described by Anderson.
For the foregoing reasons, we affirm the rejection of claim 1. Claims
2, 3, 6-12, 15, 16, 18, and 21 fall with claim 1 because they were not
separately argued.
Claims 13, 14, 19, and 20 under 35 U.S.C. § 102(b) as anticipated by
Anderson, or alternatively, under 35 U.S.C. § 103(a) as obvious over
Anderson (Answer 3).
Claim 14, the only claim argued by Appellants in this grouping recites
the size and material of the magnetically responsive element
and the stiffness of the distal end portion of the wire are such
that, when the guidewire is held at a point 0.5 inches proximal
to its distal tip, the maximum angle of deflection of the
guidewire tip relative to the body of the guidewire is at least 30
degrees when the applied magnetic field has a magnitude of up
to about 0.15 Tesla.
The Examiner contends that “Anderson does not expressly disclose
the stiffness or magnetic strength of the magnetically responsive element.
Instead, figure 5 appears to suggest that its guidewire has a tip that is flexible
enough to deflect to at least 30 degrees when subjected to the magnetic field
of magnet 41” (Final Office Action 7; FF 13).
When the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing patentability is possessed by
the prior art, “it possesses the authority to require the applicant to prove that
the subject matter shown to be in the prior art does not possess the
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characteristic relied on.” In re Swinehart, 439 F.2d 210, 213, 169 USPQ
226, 229 (CCPA 1971); In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,
433 (CCPA 1977). See also In re Spada, 911 F.2d 705, 709, 15 USPQ2d
1655, 1658 (Fed. Cir. 1990). Having shown that Anderson’s device has the
same structure as the claimed guidewire (FF 8-12), we find that the
Examiner properly shifted the burden to Appellants to prove that it would
not deflect at least 30 degrees when contacted with the magnitude of
magnetic field recited in claim 14.
Appellants contend that the claimed
magnetic field strength of not more than .15 Tesla is well below
that which could attract the present magnetically responsive
element towards the direction of a magnet (the only direction
which Anderson discloses). As Anderson discloses the
attraction of a highly magnetic tip towards an external magnet,
the structure recited in Anderson is likely to be attracted
towards the external magnet as intended, rather than aligning
with the field of the magnet.
(Br. 8).
We are not persuaded by this argument. Anderson describes a
guidewire which satisfies the structural requirements of claim 14.
Appellants argue that Anderson describes “a highly magnetic tip” (Br. 8),
but this does not distinguish it from the magnetic element of claim 14 which
is not limited to a particular magnetic material or amount of magnetic
attractiveness. There is no evidence in the record rebutting the Examiner’s
reasonable presumption that Anderson’s guidewire would perform the same
function in response to a 0.15 Tesla field as recited in claim 14.
Accordingly, we affirm the rejection of claim 14. Claims 13, 19, and 20 fall
with claim 14 because they were not separately argued.
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Anderson in view of Engelson
Claims 4-5 and 17 stand rejected under 35 U.S.C. § 103(a) over
Anderson in view of Engelson (Answer 3).
The Examiner contends:
Anderson discloses a magnetically navigable guidewire 23, as
described in claims 3 or 16 above, that teaches all the
limitations of the claims except the radiopaque hollow cylinder
tip is neither made of gold, gold alloys, platinum, or platinum
alloys. Engelson et al. teach a radiopaque medical device
wherein the tip is made of a radiopaque element from a list
consisting of gold and platinum. It would have obvious at the
time Applicant’s invention was made to provide a magnetically
navigable guidewire similar to that of Anderson with a
radiopaque tip similar to that of Engelson et al. in order to
permit monitoring of its tip location (see Engelson et al.,
column 8/lines 25-30).
(Final Office Action 6.)
It is the Examiner’s burden to establish prima facie obviousness. See,
e.g., In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993). Obviousness requires a teaching that all elements of the claimed
invention are found in the prior art and “a reason that would have prompted
a person of ordinary skill in the relevant field to combine the elements in the
way the claimed new invention does” KSR Int’l Co. v. Teleflex Inc., 127 S.
Ct. 1727, 1741, 82 USPQ2d 1385, 1396 (2007). Here, the Examiner has
provided evidence of all elements of the claimed invention and a reason that
would have prompted a person of skill in the art to combine them to achieve
the claimed invention. Appellants do not identify any defect in the
Examiner’s reasoning and we find none. Consequently, we affirm the
rejection of claim 4. Claims 5 and 17 fall with claim 4 because they were
not separately argued.
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Kuntz
Claims 1 and 23 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Kuntz (Answer 3).
Anticipation under 35 U.S.C. § 102 requires that “each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference.” Verdegaal Bros., Inc. v. Union Oil
Co., 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). In this
case, we agree with the Examiner’s findings (FF 19-21) that Kuntz
anticipates claim 1 and 23 because it describes every element of the claims.
With respect to claim 1, Appellants contend that “[t]he whole intent of
Kuntz is to provide a magnet tip that is attracted by a magnet. . . . which
precludes aligning the tip in directions other than towards the magnet” (Br.
11-12).
The problem with this argument is that Appellants do not identify any
element of the guidewire recited in claim 1 which distinguishes it from the
structure of the device described by Kuntz. We agree with the Examiner’s
finding that Kuntz’s magnet meets the limitation of claim 1 of a
“magnetically responsive element” (FF 21). We do not understand how a
magnetic element having the same structure as claimed would perform any
differently from it as urged by Appellants. In fact, we note that the magnetic
material described as suitable in the claimed medical guidewire (Spec. 5:
[0022]) is the same material (neodymium-iron-boron) described by Kuntz as
preferred (Kuntz, col. 5, ll. 15-17; FF 18). It appears to us that Appellants’
argument is really that the claimed device is used differently that the device
described in Kuntz. Thus, we affirm the rejection of claim 1.
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Claim 23 depends on claim 1, but further recites that “the
magnetically responsive element is configured to align the distal end of the
guidewire with the direction of a magnetic field that is applied from an
external source magnet.”
The Examiner contends that “Kuntz discloses a guidewire [catheter]
21 wherein the magnetically responsive element 27 comprises a permanent
magnetic element that is capable of aligning the distal end of the guidewire
21 with the direction of a magnetic field that is applied from an external
source magnet (see column 5/lines 15-22)” (Final Office Action 6; FF 22).
Appellants contend that “Kuntz teaches a magnetic tip being attracted
towards a magnet. There is every indication that the Kuntz device would not
be capable of being aligned in directions other than towards the magnet
source, because the Kuntz device is intended to be attracted towards a
magnet” (Br. 13) (emphasis added). We do not find the argument
persuasive. The statement that Kuntz’s device “would not be capable of
being aligned in directions other than towards the magnet source” is not
relevant to the patentability of claim 23 because such limitation is not recited
in the claim. Claim 23 recites that the magnetic element aligns with the
guidewire with the direction of the magnetic field, not “aligned in directions
other than towards the magnetic source” as Appellants assert (Br. 13).
Appellants also contend that “there is no indication that the Kuntz
magnet would inherently be capable of aligning with a magnetic field
applied by an external source as required by the claims. The mere fact that a
certain thing might result from a given set of circumstances is not sufficient
to establish inherency” (Br. 14).
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The Examiner finds that the device described by Kuntz has the same
structure recited in claim 23 (FF 19-21). Because the structures are the
same, the Examiner had reasonable basis for believing that they would also
perform the same function, putting the burden on Appellants to provide
arguments or evidence to the contrary. See In re Swinehart, 439 F.2d at 212-
13, 169 USPQ at 228-29; In re Best, 562 F.2d at 1254-55, 195 USPQ at 433-
34. Appellants have provided no objective evidence to rebut this reasonable
presumption.
Appellants also contend that the retrieval catheter 21 of Kuntz has
larger diameter and is made of stiffer material than the “wire in the present
application” (Reply Br. 44). We will not read limitations from the
Specification into the claims. See Sjolund v. Musland, 847 F.2d 1573, 1581,
6 USPQ2d 2020, 2027 (Fed. Cir. 1988) (“[W]hile it is true that claims are to
be interpreted in light of the specification and with a view to ascertaining the
invention, it does not follow that limitations from the specification may be
read into the claims.”); see also In re Van Geuns, 988 F.2d 1181, 1184, 26
USPQ2d 1057, 1059 (Fed. Cir. 1993) (“[L]imitations are not to be read into
the claims from the specification.”). Claim 23 does not require the wire to
have a particular diameter or stiffness. It is Appellants’ burden to show that
Kuntz’s device, which has the same structure as recited in claim 23, can not
align with the direction of an external magnetic field as required by the
claim. Because this burden has not been satisfied, we conclude that
Appellants’ have not shown that the Examiner erred in rejection claim 23
over Kuntz. We affirm the rejection of claim 23.

4 Reply Brief filed March 30, 2007.
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CONCLUSION
The Examiner did not err in rejecting claims 1-21 and 23 over the
prior art. Accordingly, we affirm all rejections on appeal before us.

TIME PERIOD
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

Ssc

HARNESS, DICKEY, & PIERCE, P.L.C.
7700 BONHOMME, SUITE 400
ST. LOUIS, MO 63105
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