Ex Parte Brown et al

Patent Trial and Appeal Board

Mar 18, 2013

11712869 (P.T.A.B. Mar. 18, 2013)

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.
11/712,869 02/28/2007 INV001Peter S. Brown CZ-005.C3 8513
7590 03/18/2013
Shirley L. Church, Esq.
P.O. Box 81146
San Diego, CA 92138
EXAMINER
SMITH, RUTH S
ART UNIT PAPER NUMBER
3737
MAIL DATE DELIVERY MODE
03/18/2013 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PETER S. BROWN and CLAUDIO ZANELLI
__________

Appeal 2011-007597
Application 11/712,869
Technology Center 3700
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to processes and
devices for inducing vibrations in a patient‟s body, for the purpose of
disrupting and thereby removing unwanted structures, such as thrombi. The
Examiner entered rejections for utility, written description, indefiniteness,
anticipation, and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
“Vibrating medical devices, such as intravascular devices used in
intravascular intervention, have been known in the art for some time and
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have been employed for a variety of uses” including “breaking up thrombi
and other intravascularly disposed masses either through direct mechanical
contact, generation of ultrasound or pressure weaves to impact the mass, or
enhancing the action of lysing agents” (Spec. 1).
Appellants‟ invention is directed to an apparatus that includes a
device, such as an intravascular device, that “incorporates a ferromagnetic or
ferrimagnetic material, that is, a material that is susceptible to the attractive
effects of magnetic fields” (id. at 4). To induce the device to vibrate inside
the patient‟s body, a “pulsed magnetic field source, that is, a source that
changes over time in magnitude and/or direction, of sufficient strength is
disposed outside the patient‟s body in sufficient proximity to the intrabody
device to induce motion in the device through the oscillating magnetic field
that it emits” (id.).
As the Specification explains, “[b]y vibrating a thrombus at its
resonance frequency, which is the frequency at which the thrombus absorbs
the most mechanical energy from the vibrations emanating from the
intrabody object and exhibits the greatest response to it, the structure of the
thrombus is shattered much more quickly than at other frequencies” (id. at 9-
10). Also, the “concept of breaking up thrombi and other tissue by vibrating
the tissue over a range of frequencies is not limited solely to the method of
the present invention, but may be used in conjunction with any other method
of inducing intrabody vibrations, including any . . . prior art methods” (id. at
10).
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Claims 1, 3-6, 8-22, 24-32, 39, and 41-47 stand rejected and appealed
(App. Br. 4).
1
Claims 1 and 39 illustrate the appealed subject matter and
read as follows:
1. A method of oscillating or vibrating tissue or other matter
target site within a living body, comprising the steps of:
providing an object into which a ferromagnetic or
ferrimagnetic material has been rigidly incorporated to render the
object susceptible to the attractive effects of at least one magnetic
field;
disposing the object at a specific location within the
body, so that during application of a magnetic signal from at least one
magnetic field generator, the object is in direct contact with the tissue
or other matter target site to be oscillated or vibrated;
disposing a magnetic field generator configured to be
adjacent and external to the living body, with no physical connection
to the object, where the magnetic field generator generates an
oscillating magnetic field which induces a macroscopic mechanical
oscillating or vibrating motion in the object; and
adjusting at least one amplitude or frequency of an
alternating current applied to the magnetic field generator, whereby
macroscopic mechanical oscillation or vibration in the object is
sufficient to permanently alter a physical structure of the tissue or
other matter target site.

39. An assembly for generating vibrations within a living
body, comprising:
an object into which a ferromagnetic or ferrimagnetic
material has been rigidly incorporated to render the object susceptible
to the attractive effects of at least one magnetic field, where the object
is configured to be positioned in direct contact with or adjacent to a
tissue or other matter target site within a living body, so that during
application of a magnetic field to a magnetic field generator, the
object is in direct contact with the tissue or other matter;
a magnetic field generator configured to be disposed

1
Appeal Brief entered October 1, 2010.
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adjacent and external to the living body, with no physical connection
to the object, where the magnetic field generator is useful for
generating an oscillating magnetic field which induces macroscopic
mechanical oscillating or vibrating motion in the object; and
a device which enables adjustment of at least one of the
amplitude or frequency of an alternating current applied to the
magnetic field generator, whereby a physical structure of the
tissue or other matter target site is permanently altered.

The following rejections are before us for review:
(1) Claims 1, 3-6, 8-22, 24-32, 39, and 41-47, under 35 U.S.C. § 101
as lacking patentable utility (Ans. 3);
(2) Claims 1, 3-6, 8-22, 24-32, 39, and 41-47, under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description requirement
(Ans. 3);
(3) Claims 39 and 41-47, under 35 U.S.C. § 112, second paragraph, as
indefinite (Ans. 4);
(4) Claims 39 and 42-45, under 35 U.S.C. § 102(e) as anticipated by
Brisken
2
(Ans. 4);
(5) Claims 39, 42, and 43, under 35 U.S.C. § 102(e) as anticipated by
Ueda
3
(Ans. 4);
(6) Claim 41, under 35 U.S.C. § 103(a) as obvious over Brisken (Ans.
4-5);
(7) Claims 39 and 41-45, under 35 U.S.C. § 103(a) as obvious over
Ueda (Ans. 5); and
(8) Claims 39 and 41-47, under 35 U.S.C. § 103(a) as obvious over
Brisken and Ueda (Ans. 5-6).

2
U.S. Patent No. 5,728,062 (filed November 30, 1995).
3
U.S. Patent No. 5,681,260 (filed December 9, 1994).
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UTILITY/WRITTEN DESCRIPTION
As the Examiner‟s utility and written description rejections share
essentially the same rationale, we consider them together. Specifically, the
Examiner contended that, “[w]hile it is understood that the claimed
invention can be used to alter the target site, it does not appear that it can
permanently alter a living tissue site” (Ans. 3).
The Examiner found that a “well known definition for the term
„permanent‟ is „not capable of being reversed or returned to original
condition‟. The specification fails to disclose that the use of the device will
prevent the conditions from occurring again” (id.; see also id. at 4).
In responding to Appellants‟ arguments, the Examiner explains that
Appellants are
narrowly interpreting the term “permanent” and one skilled in
the art would recognize that such a term would define a
condition that once removed would not reoccur, which is not
the case when using Appellant‟s invention. An equivalent
analogy would be referring to a treatment of cancer as a cure for
cancer. A cure would be the permanent elimination of cancer
cells from the body while a treatment merely means a removal
of the cancer cells but those cells could easily reappear in the
future. It is well recognized in the art that “cures” for cancer do
not exist while treatments do.

(Id. at 7.)
We are not persuaded.
It is well settled that the PTO must apply “the broadest reasonable
meaning of the words in their ordinary usage as they would be understood
by one of ordinary skill in the art, taking into account whatever
enlightenment by way of definitions or otherwise that may be afforded by
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the written description contained in the applicant‟s specification.” In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997) (emphasis added).
Here, we acknowledge that Appellants‟ process claims all require the
practitioner to permanently alter a physical structure of tissue or other matter
at a target site, and also acknowledge that Appellants‟ apparatus claims
require the claimed assembly to be capable of permanently altering the
physical structure of the target tissue or other matter at a target site.
As the Specification explains, a thrombus may be “shattered” by
vibrating it at its resonant frequency (Spec. 10). The Specification also
discusses the “concept of breaking up thrombi and other tissue by vibrating
the tissue over a range of frequencies” (id.). Indeed, the Examiner concedes
“that the claimed invention can be used to alter the target site” (Ans. 3).
Given the Specification‟s explanation of how Appellants‟ invention
works, which the Examiner appears to concede would be readily understood
by a skilled artisan, we are not persuaded that the artisan would have
reasonably interpreted the claims‟ recitation of permanently altering tissue or
other matter at a target site as encompassing permanent alteration of that site
such that a clot or thrombus could never reoccur. Rather, we agree with
Appellants that when a clot or thrombus is disrupted according to
Appellants‟ disclosure, an ordinary artisan would understand that that
particular clot or thrombus would be permanently destroyed or altered, and
that if a new clot or thrombus were to form, the new clot or thrombus would
be viewed as a different structure than the one which was destroyed.
As we are therefore not persuaded that the Examiner‟s utility and
written description rejections are based on a reasonable claim interpretation,
we reverse those rejections.
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INDEFINITNESS
In rejecting claim 39 and its dependents as indefinite, the Examiner
stated that “[i]n claim 39, lines 5-6, it is unclear as to how the field is applied
to the generator. It appears that as disclosed the field is applied by the
generator” (Ans. 4). The Examiner further contended that “that one skilled
in the art would not understand how a field is applied to the generator when
it is the generator itself that applies the field” (id. at 7).
Under § 112, second paragraph, “[a] claim is indefinite if, when read
in light of the specification, it does not reasonably apprise those skilled in
the art of the scope of the invention.” Amgen Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir. 2003).
We are not persuaded that a skilled artisan reading claim 39 would
have failed to understand its scope.
Claim 39 recites an assembly for generating vibrations within a living
body. The assembly includes an object into which a ferromagnetic or
ferromagnetic material has been rigidly incorporated, so as to render the
object susceptible to the attractive effects of a magnetic field. The assembly
also includes a magnetic field generator capable of generating a magnetic
field that induces macroscopic mechanical oscillating or vibrating motion in
the object.
As to the language at issue, claim 39 requires the object to be
configured to be positioned in direct contact with, or adjacent to, tissue or
other matter at a target site within a living body, “so that during application
of a magnetic field to a magnetic field generator, the object is in direct
contact with the tissue or other matter” (App. Br. CL-9 (emphasis added)).
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The language at issue may be less artfully drafted than the Examiner
desires. We are not persuaded, however, that an ordinary artisan would have
failed to understand that claim 39 requires the object to be configured such
that, when a magnetic field is generated by the magnetic field generator, the
object is capable of direct contact with tissue or other matter inside a living
body.
Thus, as we are not persuaded that claim 39 fails to apprise an
ordinary artisan of the scope of the claimed subject matter, we reverse the
Examiner‟s indefiniteness rejection of that claim and its dependents.
ANTICIPATION – BRISKEN
The Examiner found that claims 39 and 42-45 “are directly readable
on Brisken before it is completely assembled. The device of Brisken
includes a catheter having a ferromagnetic material incorporated therein and
a magnetic field generator” (Ans. 4). The Examiner further found that
“[a]ny means for turning the device on or off would inherently provide a
device which enables adjustment of frequency or amplitude of an alternating
current applied to the generator” (id.).
The Examiner also noted that “the claims are directed to „An
assembly‟ and an assembly can be defined as a group of components
gathered together for a common purpose and does not require a physical
connection” (id.). Thus, the Examiner argues, “the „assembly‟ of parts
disclosed by Brisken would be capable of functioning as set forth in the
claims when fully constructed, however, the claim language does not require
such a structural connection before being used for its intended purpose” (id.
at 7-8).
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It is well settled that, for a reference to anticipate a claim “[e]very
element of the claimed invention must be literally present, arranged as in
the claim.” Richardson v. Suzuki Motor Co., Ltd., 868 F.2d 1226, 1236
(Fed. Cir. 1989) (emphasis added).
Here, Brisken describes a vibrating catheter (Brisken, abstract) that
can be “engaged directly against a vascular obstruction and used to ablate
the structure by mechanical vibration and shearing or optionally to dissolve
the structure with the simultaneous delivery of a thrombolytic or fibrinolytic
agent” (id. at col. 4, ll. 39-41).
As Brisken explains, the distal end of the catheter includes “a
magnetostrictive material, such as a polycrystalline alloy of terbium,
dysprosium, and iron, and a coil disposed coaxially about the linear element.
The coil is disposed to provide a magnetic field parallel to the longitudinal
direction of the linear element” causing the tip of the catheter to vibrate (id.
at col. 3, ll. 21-26). Thus, because the ferromagnetic material and the
magnetic field generator are both in the catheter‟s tip, both elements are in
the patient‟s body when the vascular obstruction is ablated, unlike the
configuration required by Appellants‟ claim 39.
The Examiner urges that claim 39 encompasses a pre-assembled or
disassembled version of Brisken‟s device. The Examiner does not, however,
point us to any disclosure in Brisken where the reference describes a
collection of the constituent parts of its device, before or after assembly of
the final device.
The Examiner also urges that Brisken‟s device would be capable of
functioning as required by claim 39 when fully constructed. Claim 39,
however, requires the claimed assembly to be capable of permanently
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altering tissue or other matter at a target site when the magnetic field
generator is disposed adjacent and external to a living body, and the
vibrating object is positioned within the body.
As the Examiner points to no evidence showing that a pre-assembled
or disassembled version of Brisken‟s device would be capable of
permanently altering tissue or other matter at a target site within a living
body, we are not persuaded that the Examiner has adequately explained how
or why Brisken describes a device having all of the elements recited in claim
39, arranged as in the claim. We therefore reverse the Examiner‟s
anticipation rejection of claim 39, and its dependent claims 42-45, over
Brisken.
ANTICIPATION – UEDA
In rejecting claims 39, 42, and 43 as anticipated by Ueda, the
Examiner stated:
The claims are directly readable on Ueda et al which disclose a
catheter which includes a ferromagnetic material at the distal
end of the catheter, and a magnetic field generator. Any means
for turning the assembly on or off would provide the device
which is capable of adjusting either the amplitude or frequency
of an alternating current applied to the generator.

(Ans. 4.)
Among other things, Appellants argue that Ueda‟s apparatus does not
contain a device which enables adjustment of at least one of the amplitude or
frequency of the alternating current applied to the magnetic field generator,
as claim 39 requires (see App. Br. 51).
We agree.
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Ueda describes an apparatus for guiding a device, such as an
endoscope or catheter, through the body of a patient (see Ueda, col. 14, ll.
46-51). As explained in Ueda, the tip of the device which is inserted into the
patient‟s body has a permanent magnetic (see id. at col. 8, ll. 25-30), and the
device is guided by an externally applied magnetic field generator (see id. at
col. 9, ll. 9-48). Ueda also discloses embodiments in which an alternating
current applied to an external magnetic field generator is used to vibrate the
device when positioned within the patient‟s body (see id. at col. 32, l. 18,
through col. 33, l. 10; see also id. at col. 34, ll. 18-39).
However, the Examiner does not point to any description in Ueda of a
device which enables adjustment of at least one of the amplitude or
frequency of the alternating current applied to the magnetic field generator,
as claim 39 requires. Rather, the Examiner urges that “any means for
turning the device of Ueda et al on or off would inherently enable
adjustment of frequency or amplitude of an alternating current applied to the
generator” (Ans. 8).
We are not persuaded. It might be true that an on/off switch would
enable frequency or amplitude adjustment of an alternating current in an
apparatus that included such an adjusting mechanism. As noted above,
however, the Examiner does not point to, nor do we see, any such
mechanism in Ueda‟s apparatus.
Thus, as the Examiner has not adequately explained why Ueda‟s
apparatus includes all of the features required by claim 39, we reverse the
Examiner‟s anticipation rejection of that claim, and its dependent claims 42
and 43, over Ueda.

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OBVIOUSNESS – BRISKEN
In rejecting claim 41, which depends from claim 39, as obvious over
Brisken, the Examiner stated:
The assembly of Brisken includes a catheter having a
ferromagnetic material incorporated therein and a magnetic
field generator. Brisken discloses the use of a guidewire placed
within the catheter. In the absence of any showing of
criticality, whether one placed the ferromagnetic material at the
distal end of the guidewire or the distal end of the catheter
would have been an obvious design choice of known functional
equivalents in the art. Both arrangements would yield the same
predictable results.

(Ans. 5.)
Even assuming for argument‟s sake, however, that an ordinary artisan
would have considered it obvious to place the ferromagnetic material of
Brisken‟s device at the distal end of a guidewire instead of a catheter as the
Examiner posits, that conclusion does not remedy the shortcomings
discussed above of Brisken as to claim 39, from which claim 41 depends.
We therefore reverse the Examiner‟s rejection of claim 41 as obvious over
Brisken.
OBVIOUSNESS – UEDA
In rejecting claim 41 as obvious over Ueda, the Examiner applied a
similar rationale as when rejecting claim 41 over Brisken:
The use of a guidewire is a well known expedient in the art for
positioning a device in the body. It would have been obvious to
one skilled in the art to have used the teaching of Ueda et al to
provide movement of any known device placed within the body
for medical purposes.

(Id.)
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In rejecting claims 39 and 41-45 over Ueda, the Examiner also
concluded that it would have been obvious to substitute magnets for coils
positioned in the endoscope tip of one of Ueda‟s vibrating embodiments,
reasoning that “[s]uch a modification merely involves the substitution of one
known type of magnetizable element for another” (id.).
Again, however, the Examiner‟s rationale does not remedy the
deficiencies discussed above of Ueda as to claim 39, from which claims 41-
45 all depend. We therefore also reverse the Examiner‟s obviousness
rejection of claims 39 and 41-45 over Ueda.
OBVIOUSNESS – BRISKEN AND UEDA
In rejecting claims 39 and 41-47 as obvious over the combination of
Brisken and Ueda, the Examiner concluded that an ordinary artisan would
have considered it obvious to modify Brisken‟s device “such that the source
used to generate the magnetic field to cause motion in the object has no
physical connection to the object. Such a modification merely involves the
substitution of one known means for applying a magnetic field to cause
object motion for another” (Ans. 6).
Appellants argue that because the functions of the apparatuses
described in Brisken and Ueda are so different, an ordinary artisan would not
have combined their teachings to make the substitution posited by the
Examiner (see App. Br. 59-60).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), the
Supreme Court stated that “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.”
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While the Supreme Court emphasized the importance of a flexible and
commonsense approach when evaluating obviousness, see id. at 418, the
Court also advised that fact finders should nonetheless “be aware, of course,
of the distortion caused by hindsight bias and must be cautious of arguments
reliant upon ex post reasoning.” Id. at 421.
We are not persuaded that the preponderance of the evidence supports
the Examiner‟s finding that an external magnetic field, such as that applied
by Ueda, would have been viewed as a functional equivalent for the coils
used in Brisken‟s device, as the Examiner posits.
In particular, as noted above, the distal end of Brisken‟s catheter
includes a magnetostrictive material that has a coil wrapped around it in
relative proximity (see Brisken, col. 3, ll. 21-26; see also id. at Figures 2, 4).
In contrast, Appellants‟ claim 39 requires the assembly to induce vibration
in the object inside the body, with the magnetic field generator being outside
the body.
The Examiner points to no clear or specific evidence suggesting that
an ordinary artisan would have expected that an externally applied magnetic
field would cause Brisken‟s device to vibrate in a manner that would allow it
to achieve its purpose of ablating vascular obstructions. While we note, as
discussed above, Ueda‟s disclosure of embodiments in which the internal
device is vibrated by an externally applied magnetic field, the Examiner
again points to no clear or specific evidence suggesting that the vibration
achieved by Ueda is sufficient to permanently alter tissue or other matter at a
target site, as required by claim 39.
Thus, as we are not persuaded that a preponderance of the evidence
supports the Examiner‟s conclusion of obviousness as to claim 39, we
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reverse the Examiner‟s rejection of that claim, and its dependents, over
Brisken and Ueda.
SUMMARY
We reverse the Examiner‟s rejection of claims 1, 3-6, 8-22, 24-32, 39,
and 41-47, under 35 U.S.C. § 101 as lacking patentable utility.
We also reverse the Examiner‟s rejection of claims 1, 3-6, 8-22, 24-
32, 39, and 41-47, under 35 U.S.C. § 112, first paragraph, for failure to
comply with the written description requirement.
We also reverse the Examiner‟s rejection of claims 39 and 41-47,
under 35 U.S.C. § 112, second paragraph, as indefinite.
We also reverse the Examiner‟s rejection of claims 39 and 42-45,
under 35 U.S.C. § 102(e) as anticipated by Brisken.
We also reverse the Examiner‟s rejection of claims 39, 42, and 43,
under 35 U.S.C. § 102(e) as anticipated by Ueda.
We also reverse the Examiner‟s rejection of claim 41, under 35 U.S.C.
§ 103(a) as obvious over Brisken.
We also reverse the Examiner‟s rejection of claims 39 and 41-45,
under 35 U.S.C. § 103(a) as obvious over Ueda.
We also reverse the Examiner‟s rejection of claims 39 and 41-47,
under 35 U.S.C. § 103(a) as obvious over Brisken and Ueda.

REVERSED

cdc