Ex Parte Heruth et al

Board of Patent Appeals and Interferences

Feb 28, 2012

10873764 (B.P.A.I. Feb. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KENNETH T. HERUTH, MARK S. LENT,
and JUSTIN A. BLANCO
__________

Appeal 2010-009861
Application 10/873,764
Technology Center 3700
__________

Before TONI R. SCHEINER, DEMETRA J. MILLS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims directed to a drug delivery catheter and a method of locating it within
a subject. The claims have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm-in-part.

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STATEMENT OF THE CASE
Claims 1, 3, 4, 6, 11-13, 15-22, 24, 25, 27, 32-34, 36-49, and 51 are
pending and on appeal. Claims 2, 5, 7, 8-10, 14, 23, 26, 28-31, 35, and 50
have been cancelled. Appellants have argued the claims in several groups
(see App. Br. 11), accordingly, we choose claims 1, 4, 15, 17, 22, 44, and 49
as representative of those groups. 37 C.F.R. § 41.37(c)(1)(vii):
1. A drug delivery catheter comprising:
an elongated body comprising a proximal end and distal end;
a lumen extending along the elongated body to a first infusion section
spaced from the proximal end of the elongated body;
one or more openings in the lumen within the first infusion section;
a permeable membrane covering the one or more openings in the first
infusion section;
a first tracking element attached to the elongated body at a first
selected location proximate the first infusion section to allow a practitioner
to determine the position of the first infusion section; and
a second tracking element, wherein the second tracking element is
attached to the elongated body at a second selected location, and wherein the
second tracking element operates on a different modality than the first
tracking element.
4. The catheter of claim 1, wherein the first tracking element comprises
an active tracking element comprising a transmitter.
15. The catheter of claim 13, wherein the second selected location is
proximate the second infusion section.
17. The catheter of claim 13, wherein the first infusion section is spaced
apart from the second infusion section along the elongated body by an axial
distance of one human vertebral level or more.
22. A drug delivery system comprising:
a drug delivery apparatus comprising a pump and a drug reservoir;
a catheter comprising:
an elongated body comprising a proximal end and distal end;
a lumen extending along the elongated body to a first infusion
section spaced from the proximal end of the elongated body;
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one or more openings in the lumen within the first infusion
section;
a permeable membrane covering the one or more openings in
the first infusion section;
a first tracking element attached to the elongated body at a first
selected location proximate the first infusion section to allow a practitioner
to determine the position of the first infusion section; and
a second tracking element, wherein the second tracking element is
attached to the elongated body at a second selected location, and wherein the
second tracking element operates on a different modality than the first
tracking element; and
a tracking system adapted to determine the location of the first
tracking element.
44. A method of locating a drug delivery catheter within a spinal region,
the method comprising:
providing a catheter comprising:
an elongated body comprising a proximal end and distal end;
a lumen extending along the elongated body to a first infusion
section spaced from the proximal end of the elongated body;
one or more openings in the lumen within the first infusion
section; and
a permeable membrane covering one or more openings in the
first infusion section;
a first tracking element attached to the elongated body at a first
selected location proximate the first infusion section;
a second tracking element, wherein the second tracking element is
attached to the elongated body at a second selected location, and wherein the
second tracking element operates on a different modality than the first
tracking element; and
introducing the catheter into the spinal region of a subject;
tracking the first tracking element on the catheter to determine the
position of the first infusion section within the spinal region; and
advancing the catheter into the spinal region until the first infusion
section is at a selected location within the spinal region.
49. The method of claim 44, further comprising tracking the second
tracking element.
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Claims 1, 3, 4, 6, 11-13, 15-22, 24, 25, 27, 32-34, 36-49, and 51 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over Petersen (US
2003/0045861 A1, March 6, 2003) and Whitehurst (US 2006/0241717 A1,
October 26, 2006), as evidenced by Ebersole (US 6,578,017 B1, June 10,
2003).

FINDINGS OF FACT
1. Figure 13 of the Specification, reproduced below, depicts an
embodiment of the invention consistent with the claimed invention, wherein
catheter 1020 is attached to a fluid delivery/reservoir 1000:

Figure 13 of the Specification depicts an embodiment of the invention
wherein catheter 1020 is attached to a fluid delivery/reservoir 1000.
2. In discussing Figure 13, the Specification teaches that “tracking
elements 1090 attached to the elongated body of the catheter 1020 . . . are
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preferably in a construction suitable for the tracking system 1100 to use in
determining the position of the tracking elements 1090 when the catheter
1020 is located within the body of a subject” (Spec. ¶ 148).
3. The Specification teaches that “the tracking elements 1090 may
take the form of coils if the tracking system 1100 uses electromagnetic
energy/fields to perform the tracking function. Other constructions may . . .
include light reflectors/emitters if tracking is performed optically, radio-
opacity if the tracking is accomplished using fluoroscopy, etc.” (Spec. ¶
148.) “[W]here two or more tracking elements are provided, the tracking
elements may operate with the same modality (e.g., they may both be coils
used in an electromagenetic tracking system, both be reflectors in an optical
tracking system, etc.)” (Id. at ¶ 150.) Alternatively, “the tracking elements
may operate using different modalities (e.g., one may be a coil used in an
electromagnetic tracking system and another a reflector used in an optical
system, etc.)” (Id.) Thus, “modalities” refers to methods of detecting the
tracking elements, rather than the tracking elements themselves.
4. Additionally, the Specification teaches that:
A passive tracking element . . . is one that does not actively
transmit or emit energy, e.g., a reflector, an electromagnetic
coil, etc. An active tracking element . . . is one that transmits a
signal or emits energy that can then be detected to determine
the position of the tracking element (e.g., light emitting diodes,
RF transmitters, etc.)
(Spec. ¶ 149.)
5. All of the claims on appeal require, in relevant part, a catheter
with an elongated body, an infusion section spaced from the proximal end of
the elongated body, a first tracking element attached to the elongated body at
a first location proximate the first infusion section, and a second tracking
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element attached to the elongated body at a second location, where the first
and second tracking elements operate according to different modalities.
6. Petersen discloses a catheter attached to a drug reservoir and
pump 14, wherein the catheter comprises an elongated tubular section with
“a microporous membrane that allows distribution of a therapeutic agent
from multiple longitudinal positions on a single catheter, known as diffusion
sections” (Petersen ¶¶ 6, 18). As shown in the cross section of Petersen‟s
Figure 4, reproduced below, “catheter 22 consists of an elongated tubular
section 49” with “solid sections 41 and microporous membrane sections 42”
(id. at ¶ 28). “[A] radio-opaque material may be added to the solid sections
41 to allow for easier viewing of the catheter with imaging” (id.):

Figure 4 is a cross sectional view of the distal end of Petersen‟s
catheter showing multiple solid sections 41 (which may be radio-opaque for
easier imaging) and microporous membrane (i.e., diffusion) sections 42.
7. The radio-opaque material in Petersen‟s catheter is a tracking
element (see FF3). Thus, Petersen discloses a catheter with a single type of
tracking element (i.e., a first tracking element) proximate the microporous
section of its elongated body. In addition, Petersen‟s reference to “imaging”
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in this context implicitly suggests a “modality” e.g., fluoroscopy, by which
the tracking element operates (Spec. ¶ 148; FF3).
8. Petersen also teaches that
[T]he physician predetermines a selected site or sites within the
brain and has a catheter made with the diffusion section or
sections . . . located at these identified sites. One technique . . .
for predetermining the selected sites would be to have an MRI
taken of the effected [sic] area. This imaging technique would
assist the physician in determining the proper treatment sites.
Those skilled in the art will understand that a CT scan, a
fluoroscope, or a brain biopsy could also be used to determine
the selected sites.
(Petersen ¶ 19.)
According to Petersen, in addition to treating sites in the brain,
“[t]hose in the art will understand that the system . . . could be used to treat
other areas of the human body including the heart, liver, or kidney” (id. at ¶
20).
9. Whitehurst discloses “systems and methods for introducing one
or more stimulating drugs and/or applying electrical stimulation to the
extradural motor cortex” (Whitehurst ¶ 9). A system control unit (SCU)
and “one or more electrodes are surgically implanted to provide electrical
stimulation from an implantable signal/pulse generator (IPG) and/or one or
more infusion outlets and/or catheters are surgically implanted to infuse
drug(s) from an implantable pump” (id. at ¶¶ 9, 10). “When a catheter is
used, it includes at least one infusion outlet . . . usually positioned at least at
a distal end, while a proximal end of the catheter is connected to [the] SCU”
(id. at ¶ 50).
10. Whitehurst‟s SCU contains electronic circuitry, including “an
inductive coil for receiving and transmitting RF [radio frequency] data . . .
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and additional discrete electronic components . . . e.g. capacitors(s),
resistor(s), coil(s), and the like” (Whitehurst ¶ 54).
11. Figure 3 of Whitehurst, reproduced below, illustrates internal
and external components of Whitehurst‟s system, including SCU 130,
catheter 160 with outlet 162, drug pump 165, and inductive coil 170:

Figure 3 of Whitehurst illustrates internal and external components of
Whitehurst‟s system, including SCU 130, catheter 160 with outlet 162, drug
pump 165, and inductive coil 170.
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12. The RF transmitter and/or coils in Whitehurst‟s SCU are
tracking elements (see FFs 3, 4). Thus, Whitehurst‟s system includes a
catheter with a tracking element attached to its elongate body (FF9).
Principles of Law
During examination, the PTO must interpret terms in a claim using
“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 the written description contained in the applicant‟s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Nevertheless, “courts must not „import[ ] limitations from the specification
into the claim.‟ . . . [I]t is improper to „confin[e] the claims to th[e]
embodiments‟ found in the specification . . . .”‟ In re Trans Texas Holdings
Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (citations omitted, bracketed
text in internal quotes in original).
This can be a difficult balancing act. However, as our reviewing court
has instructed, “the line between construing terms and importing limitations
can be discerned with reasonable certainty and predictability if the court's
focus remains on understanding how a person of ordinary skill in the art
would understand the claim terms.” Phillips v. AWH Corp., 415 F.3d 1303,
1323 (Fed. Cir. 2005) (en banc).
Finally, “the patentability of apparatus or composition claims depends
on the claimed structure, not on the use or purpose of that structure.”
Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed.
Cir. 2002).
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DISCUSSION
The Examiner finds that Petersen discloses a catheter with “a first
[passive] tracking element (radiopaque 41) . . . attached to the elongated
body at a first selected location proximate the first infusion section” (Ans.
3), and “a second [active] tracking element . . . such as: CT scan, a
fluoroscope or a brain biopsy” (id.), “but Petersen [is] silent that the second
tracking element is attached to the elongated body at a second selected
location” (id.). The Examiner finds that Whitehurst discloses a “similar
catheter device” comprising a system control unit (SCU), which includes
both active and passive tracking elements, “attached to the catheter
elongated body” (id.).
The Examiner concludes that it would have been obvious “to modify
the device of Petersen with an active tracking element attached to the
elongated body of catheter . . . in order to receive or transmit data to deliver
electrical stimulation and also to determine the selected sites inside the
body” (id. at 4).
Claim 1
As discussed above, claim 1 requires a catheter with an elongated
body, an infusion section spaced from the proximal end of the elongated
body, a first tracking element attached to the elongated body at a first
location proximate the first infusion section, and a second tracking element
attached to the elongated body at a second location, where the first and
second tracking elements operate according to different modalities (FF5).
With respect to claim 1, Appellants contend that:
[N]othing has been identified within the disclosures of Petersen
and Whitehurst et al. (taken alone or together) that teaches or
suggests a drug delivery catheter that includes a first tracking
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element attached to an elongated body at a first location and a
second tracking element that is attached to the elongated body
at a second selected location, and wherein the second tracking
element operates on a different modality than the first tracking
element[.]
(App. Br. 13.)
In addition, Appellants contend that “nothing within Whitehurst et al.
describes the electronic circuitry 170, the power source and/or power storage
device 180, or the electrodes 152 being used, or even capable of being used,
as tracking elements” (id. at 18), and moreover, the “microstimulator SCU
130 is a separate body . . . to which electrode leads 150 and catheters 160 are
attached” (id. at 16).
Interpreting claim 1 in light of the Specification, we agree with
Appellants on several points. Specifically, we agree that the first and second
tracking elements must be different (FFs 3, 4), that the first and second
tracking elements must be detectable by different means (i.e., modalities)
(FF3), and that the first and second tracking elements must be physically
attached to the elongated body of the catheter. In addition, we agree with
Appellants that Petersen does not disclose “a second tracking element that
operates on a different modality as a first tracking element” (App. Br. 13), as
Petersen merely teaches that an implant site can be chosen using various
techniques (i.e., modalities) including a CT scan or fluoroscopy, but says
nothing about corresponding tracking elements attached to the catheter (see
FFs 3, 4, 8).
Nevertheless, we agree with the Examiner‟s conclusion that the
invention of claim 1 would have been obvious over the combined teachings
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of Petersen and Whitehurst, “in order to receive or transmit data . . . and also
to determine the selected sites inside the body” (Ans. 4).
Petersen discloses a catheter with solid radio-opaque sections
proximate the microporous sections of its elongate body “to allow for easier
viewing of the catheter with imaging” (Petersen ¶ 28; FF6). According to
the Specification, radio-opacity serves as a passive tracking element (Spec.
148; FF3). Whitehurst discloses a catheter attached to an SCU comprising
“an inductive coil for . . . transmitting RF data . . . and additional discrete
electronic components . . . e.g. capacitors(s), resistor(s), coil(s), and the like”
(Whitehurst ¶ 54; FF10). According to the Specification, RF transmitters
and coils are tracking elements (FFs 3, 4). This is so whether Whitehurst
intends to use the transmitter and/or coils for tracking purposes or not. See
Catalina Mktg., 289 F.3d at 809. Moreover, while the second tracking
element required by claim 1 must be attached to the elongate body of the
catheter, unlike the first tracking element, it need not be proximate a
diffusion section. Whitehurst‟s SCU with its RF transmitter and/or coil is
attached to the proximal end of the elongate body of a catheter (FF9).
Thus, as Petersen and Whitehurst support the Examiner‟s finding that
an ordinary artisan would have considered it obvious to include both types
of tracking elements claimed, configured as claimed, the rejection of claim 1
as unpatentable over Petersen and Whitehurst is affirmed. Claims 3, 6, 11-
13, 16, 18, 19, and 21 were not separately argued, and therefore fall with
claim 1.
Claim 22
Claim 22 is directed to a drug delivery system which includes all the
components of claim 1, and additionally includes a pump and a drug
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reservoir, and a tracking system adapted to determine the location of the first
tracking element.
The Examiner finds that Petersen discloses a pump 10, with a drug
reservoir, attached to catheter, and also discloses “first . . . tracking elements
. . . [and] therefore the tracking system adapted to determine the location of
the tracking elements” (Ans. 4).
In addition to reiterating their arguments with respect to claim 1
(which we found to be unpersuasive), Appellants contend that “the cited
references, taken alone or together, [fail to] teach or suggest a tracking
system in combination with the other elements recited in the [claimed] drug
delivery systems” (App. Br. 20). Appellants contend that “the components
of Whitehurst et al. relied on by the Examiner . . . do not, in fact, constitute a
tracking system. Rather, the identified components are part of a control
system used to operate and/or program the SCU 130” (id. at 21).
Appellants‟ argument is not persuasive. Petersen discloses radio-
opaque solid sections proximate the diffusion sections “to allow for easier
viewing of the catheter with imaging” (FFs 6, 7). The fact that the radio-
opaque sections are used for imaging implicitly suggests a corresponding
tracking system, and claim 22 merely requires “a tracking system adapted to
determine the location of the first tracking element.”
The rejection of claim 22 as unpatentable over Petersen and
Whitehurst is affirmed. Claims 24, 27, 32-34, 37, and 39-43 were not
separately argued, and therefore fall with claim 22.
Claim 44
Claim 44 is directed to a method of locating a drug delivery catheter
within a spinal region.
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The Examiner finds that claims 44-49 and 51 “encompass the same
scope of invention as to that of claims 1-43 above except they are draft[ed]
in a method format instead of an apparatus format . . . [and] are therefore
rejected for the same reason” (Ans. 5).
Appellants contend that claim 44 “is not . . . merely an apparatus
claim drafted in a „method format‟” but “explicitly recites „introducing the
catheter into the spinal region of a subject[]‟” and “„tracking the first
tracking element on the catheter to determine the position of the first
infusion section within the spinal region.‟” (App. Br. 24.)
However, as the Examiner points out, Petersen teaches that “[t]hose in
the art will understand that the system . . . could be used to treat other areas
of the human body including the heart, liver, or kidney” (Ans. 10 (emphasis
omitted); Petersen ¶ 20; FF8). The Examiner finds that “one skilled in the
art would recognize that the words „other areas of the human body‟ can
include the spinal region” (Ans. 10). We agree with the Examiner that one
of skill in the art would have recognized that the catheter with its tracking
elements could be introduced into the spinal region.
The rejection of claim 44 as unpatentable over Petersen and
Whitehurst is affirmed. Claims 45-48 were not separately argued, and
therefore fall with claim 44.
Claims 4 and 25
Claims 4 and 25 require that “the first tracking element comprises an
active tracking element comprising a transmitter.”
The Examiner‟s position is that “the name of [the] tracking element
can be changed as first tracking element as an active element and second
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tracking element as passive element ; wherein the active tracking element
compris[es] a transmitter, for example: RF link” (Ans. 4).
However, as discussed above, all of the claims require the first
tracking element to be proximate an infusion section. Petersen‟s catheter
has passive tracking elements proximate the infusion sections (FF7). Thus,
meeting the requirements of claims 4 and 25 requires more than just
switching the designations of the first and second tracking elements - it
requires moving Whitehurst‟s RF transmitter to a location proximate an
infusion section.
We agree with Appellants that the Examiner has not adequately
explained why one of ordinary skill in the art would have located
Whitehurst‟s RF transmitter proximate an infusion section, especially as
Whitehurst does not use the transmitter as a tracking element.
The rejection of claims 4 and 25 as unpatentable over Petersen and
Whitehurst is reversed.
Claims 15 and 36
Claims 15 and 36 require that “the second selected location is
proximate the second infusion section.” Thus, the claims require both the
first and second tracking elements, which are different, to be located
proximate infusion sections.
We agree with Appellants that the Examiner has not explained why
one of ordinary skill in the art would have located two different types of
tracking elements infusion sections on the elongated body of the catheter.
The rejection of claims 15 and 36 as unpatentable over Petersen and
Whitehurst is reversed.
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Claims 17 and 38
Claims 17 and 38 require that “the first infusion section is spaced
apart from the second infusion section along the elongated body by an axial
distance of one human vertebral level or more.”
Petersen discloses a catheter with multiple infusion sections spaced
along the length of the catheter, and also teaches, in general, that multiple
infusion sections should be spaced along the catheter to correspond to
treatment sites identified prior to implantation (FF8). Claims 17 and 38
require a distance that is a “vertebral level or more” (emphasis added).
Appellants have not explained why the spacing required by the claims would
not have been obvious over Petersen.
The rejection of claims 17 and 38 as unpatentable over Petersen and
Whitehurst is affirmed.
Claims 49 and 51
Claims 49 and 51 are method claims that require tracking the second
tracking element as well as the first. As discussed above, the first and
second tracking elements are different, and are detectable by different
techniques (i.e., modalities).
We agree with Appellants that the Examiner has not explained why
one of ordinary skill in the art would have had a reason to do so, as the
tracking elements relied on in Whitehurst are not actually used as tracking
elements, even though they meet the physical requirements of tracking
elements.
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SUMMARY
The rejection of the claims as unpatentable over Petersen and
Whitehurst is affirmed with respect to claims 1, 3, 6, 11-13, 16-22, 24, 27,
32-34, 37-48, and reversed with respect to claims 4, 15, 25, 36, 49, and 51.
TIME PERIOD FOR RESPONSE
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-IN-PART

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