Ex Parte Keimel et al

Patent Trial and Appeal Board

Dec 5, 2012

11951755 (P.T.A.B. Dec. 5, 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.
11/951,755 12/06/2007 John G. Keimel P0025086.03 8970
64619 7590 12/06/2012
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
12/06/2012 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 PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOHN G. KEIMEL and WILLIAM F. KAEMMERER
____________

Appeal 2010-010228
Application 11/951,755
Technology Center 3700
____________

Before LINDA E. HORNER, MICHELLE R. OSINSKI, and
RICHARD E. RICE, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
John G. Keimel and William F. Kaemmerer (Appellants) seek our
review under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 1,
5, 10, and 11. Claims 2-4 and 12-25 are withdrawn from consideration, and
claims 6-9 are canceled. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
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THE INVENTION
Appellants’ claimed invention relates to “methods for providing
therapy that combines the therapeutic potential of chronic delivery of a
therapeutic agent from a reservoir of an implantable infusion device with the
more acute delivery potential of an access port of the device.” Spec.,
para. [007]. Claim 1, reproduced below, is the sole independent claim on
appeal and is representative of the subject matter on appeal.
1. A method for infusing first and second fluid compositions to a
target location of a subject using an implantable infusion system
including an infusion device and a catheter, the infusion device
having a reservoir and a catheter access port, the catheter having a
delivery region and being operably couplable to the infusion device
such that fluid stored in the reservoir or infused into the access port
is deliverable via the delivery region to a target location of the
subject, the method comprising:
introducing the delivery region of the catheter into the
intrathecal space of the subject at a lumbar level of the spinal canal
and advancing the delivery region rostrally in the intrathecal space
of the spinal canal to a level of C3 or higher;
introducing into the reservoir the first fluid composition
comprising a first polypeptide configured to function as an
endogenous protein;
delivering the first fluid composition to the target location via
the delivery region of the catheter at a substantially constant low
infusion rate sufficient to maintain catheter patency, with
intermittent boluses at a higher rate; and
delivering to the target location the second fluid composition,
wherein the second fluid composition comprises a polynucleic acid
encoding a second polypeptide configured to function as the
endogenous protein and wherein the second fluid composition is
infused into the catheter access port,
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wherein the first and second polypeptides are the same or
different.
THE EVIDENCE
The Examiner relies upon the following evidence:
Makower US 2003/0078562 A1 Apr. 24, 2003
Eisenach US 2003/0181426 A1 Sep. 25, 2003
Zankel US 2005/0042227 A1 Feb. 24, 2005
Hildebrand US 2005/0048641 A1 Mar. 3, 2005
Keimel US 2005/0208090 A1 Sep. 22, 2005
Pyles US 2006/0282043 A1 Dec. 14, 2006
THE REJECTIONS
Appellants seek review of the following rejections:
1. Claims 1, 5, and 10 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Keimel, Makower, Pyles, and Zankel.
2. Claims 1, 5, and 10 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Keimel, Makower, Eisenach, and Zankel.
3. Claim 11 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Keimel, Makower, either Pyles or Eisenach, Zankel, and
Hildebrand.
ANALYSIS
The method of independent claim 1 includes the step of introducing
the delivery region of a catheter into the intrathecal space1 of a subject at a
lumbar level of the spinal canal and advancing the delivery region rostrally

1 The Specification describes that “[a]s used herein, ‘intrathecal’ means the
delivery of a substance to the subarachnoid space” which “is a compartment
within the central nervous system that contains [cerebrospinal fluid].” Spec.,
para. [0062].
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in the intrathecal space of the spinal canal to a level of C3 or higher.2 The
Specification describes that “it has been found that delivery of therapeutic
agent to the intrathecal space at or above the level of C3 of the spinal canal
serves to enhance broad delivery of the therapeutic agent to brain tissue.”
Spec. [0061].
The Examiner determined that “Keimel discloses that the delivery
region of the catheter is inserted into the lumbar level of the spinal canal and
advanced rostrally within the intrathecal space of the spinal canal (Fig. 8;
Par. 7; Par. 58; Par. 100).” Ans. 4. The Examiner found that Keimel “fails
to explicitly disclose that the delivery region of the catheter is advanced
rostrally within the intrathecal space to a level of C3 or higher, specifically
to the cisterna magna.” Id. at 6. The Examiner determined that “Pyles
discloses an intrathecal catheter (10) to be inserted into a patient’s
intrathecal space at the lumbar level of the spinal canal and tunneled
rostrally within the intrathecal space through the thoracic level of the spinal
canal (Figs. 3 and 4; Par. 25)” which the Examiner acknowledges is not
sufficient to reach a level of C3 or higher. Id. The Examiner found that
“Zankel discloses that in order to treat lysosomal storage disorders
pharmaceuticals may be administered intrathecally to either the lumbar area
or the cisterna magna (Par. 40).” Id. The Examiner concluded:

2 The Specification describes that “a level of C3 or above includes a level of
C2 or above, C1 or above, or in the cisterna magna.” Spec., para. [0061].
The cisterna magna is the cerebrospinal fluid-filled space below the
cerebellum. Spec., para. [0062].
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As Keimel illustrates advancing a catheter rostrally from the
lumbar region to a level above the cisterna magna (Fig. 1),3 it
would have been obvious for one having ordinary skill in the art
at the time the invention was made to utilize an intrathecal
catheter inserted into the intrathecal space at the lumbar level
and advanced rostrally therein, as disclosed by Pyles, to the
cisterna magna, as disclosed by Zankel, in order to deliver a
suitable therapeutic to the cisterna magna and treat a lysosomal
storage disorder utilizing suitable known techniques.
Id. at 6-7.4
The Examiner relied on the same findings as to the disclosures in
Keimel and Zankel in the second ground of rejection. Id. at 8, 10. The
Examiner relied on Eisenach to show that “it is known to advance a catheter
with[in] the intrathecal space between the cisterna magna and the lumbar
region for the purpose of intrathecal delivery of a therapeutic (Par. 162).”
Id. at 10. The Examiner acknowledged that Eisenach shows advancing the
catheter in the reverse direction, i.e., caudally, rather than rostrally. Id. at
11. The Examiner determined that the claimed rostral advancement would
have been obvious because “[i]t has been held that the mere reversal of the

3 We note that this statement is inconsistent with the Examiner’s finding on
page 6 of the Answer, discussed supra, that Keimel “fails to explicitly
disclose that the delivery region of the catheter is advanced rostrally within
the intrathecal space to a level of C3 or higher, specifically to the cisterna
magna.”
4 The Examiner did not rely on Makower to show the step of advancing a
catheter rostrally. Ans. 6 (finding that Makower discloses it was known in
the art to use a constant low-volume infusion of fluids to maintain catheter
patency).
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essential working parts of an invention involves only routine and customary
skill in the art.” Id. (citations omitted).
Appellants argue that the Examiner incorrectly found that “Keimel
illustrates advancing a catheter rostrally from the lumbar region to a level
above the cisterna magna.” Reply Br. 8. We agree. Figure 1 of Keimel
fails to show the catheter running through any portion of the patient’s spinal
canal. In fact, Keimel describes with reference to Figure 1 that “the distal
end 22 can be surgically implanted in the brain 12 using well known
stereotactic placement techniques and the catheter 16 can be subsequently
tunneled subcutaneously through the body 14 to the location in the body 14
where the [implanted infusion pump] 20 will be implanted.” Keimel, para.
[0069]. Figure 8 of Keimel shows catheter 87 tunneled subcutaneously and
the distal end and tip positioned between vertebrae 86 to infuse the
therapeutic protein formulation into the intrathecal space. Keimel, para.
[0100]. As such, while Figure 8 of Keimel shows introducing the delivery
region of the catheter into the intrathecal space of the subject at a lumbar
level of the spinal canal, it does not show advancing the delivery region of
the catheter rostrally in the intrathecal space of the spinal canal, nor does it
show advancing this delivery region to a level of C3 or higher. As such,
neither embodiment of Keimel teaches rostral advancement from a lumbar
level.
Pyles and Zankel do not cure the deficiency in Keimel. While Pyles
discloses introduction of a catheter into the intrathecal space at a lumbar
level of the spinal canal and advancement of a catheter rostrally through the
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intrathecal space, as the Examiner acknowledges, it does not disclose
advancing the catheter to a level of C3 or higher. Pyles, para. [0025]; figs.
3, 4; Ans. 6. The Examiner erroneously relied on Figure 1 of Keimel for the
teaching to advance a catheter rostrally from the lumbar region to a level
above the cisterna magna. The Examiner relied on Zankel to suggest
administering a composition for treating lysosomal storage disorders
intrathecally to the cisterna magna (Ans. 6); however, Zankel does not teach
or suggest administering the composition by advancing a catheter rostrally
from a lumbar level of the spinal canal through the intrathecal space to the
cisterna magna. Zankel, para. [0040] (disclosing intrathecal administration
“into the lumbar area or the cisterna magna”) (emphasis added). As such,
the Examiner’s conclusion of obviousness is based on an erroneous finding
as to the scope and content of Keimel. Accordingly, we reverse the rejection
of claims 1, 5, and 10 under 35 U.S.C. § 103(a) as being unpatentable over
Keimel, Makower, Pyles, and Zankel.
The Examiner’s rejection based on Keimel, Makower, Eisenach, and
Zankel suffers from the same shortcoming. Eisenach does not cure the
deficiency in Keimel in that Eisenach teaches advancing the catheter
caudally, as opposed to rostrally, and the Examiner’s reasoning that
advancing a catheter rostrally would be a mere reversal of parts is not based
on a rational underpinning. The Examiner has failed to adequately show that
within the context of this surgical method, reversal of the direction of
advancement of the catheter within the subject would involve routine and
customary skill in the art. Unlike a claim directed to a mechanical apparatus
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in which a reversal of parts may, in some instances, be an obvious matter of
routine skill in the art, in the case of the claimed surgical method, where
none of the cited art shows a prior art method that describes advancing a
catheter rostrally to the level of C3 or higher as claimed, the Examiner must
provide some objective evidence to support the determination that such a
step would involve only routine skill in the art. Because the Examiner’s
conclusion of obviousness is based on an erroneous finding as to the scope
and content of Keimel, we likewise reverse the rejection of claims 1, 5, and
10 under 35 U.S.C. § 103(a) as being unpatentable over Keimel, Makower,
Eisenach, and Zankel.
The rejection of claim 11 under 35 U.S.C. § 103(a) as being
unpatentable over Keimel, Makower, either Pyles or Eisenach, Zankel, and
Hildebrand suffers from the same deficiencies as set forth supra.
DECISION
We REVERSE the decision of the Examiner to reject claims 1, 5, 10,
and 11.

REVERSED

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