Ex Parte Tobias et al

Patent Trials and Appeals Board

Jun 6, 2019

13910730 - (D) (P.T.A.B. Jun. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/910,730 06/05/2013
29052 7590 06/10/2019
Eversheds Sutherland (US) LLP
999 PEACHTREE STREET, N.E.
Suite 2300
ATLANTA, GA 30309
FIRST NAMED INVENTOR
Irene Sophie Tobias
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
17648-0153 1066
EXAMINER
FISHER, MELISSA L
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
06/10/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IRENE SOPHIE TOBIAS, HEEJIN LEE, MICHAEL J. CIMA,
and JORDAN DIMITRAKOV
Appeal2017-009597
Application 13/910,730
Technology Center 1600
Before DEBORAH KATZ, JOHN G. NEW, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2017-009597
Application 13/910,730
Introduction
Appellants 1 seek our review, under 35 U.S.C. § I34(a), of the
Examiner's decision to reject claims 1---6, 9--11, 13-17, 19, 20, 22, and 25. 2
(App. Br. 2.) We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-
IN-PART.
The Examiner rejected claims 1-3, 6, 9--11, 13, 14, 17, and 25 under
35 U.S.C. § I03(a) as being obvious over Ottoboni. 3 (See Final Act. 2-7.)
The Examiner also rejected claims 1---6, 9--11, 13-17, 19, 20, 22, and
25 under 35 U.S.C. § I03(a) as being obvious over Ottoboni in view of
Ruane4 et al. (See Final Act. 7-9.)
Appellants' Specification is directed to drug delivery devices for
controlled, local release of drug to a tissue site. (See Specification ("Spec.")
1:12-14.) Appellants' claims recite implantable devices that are placed in a
patient's bladder through the urethra. The claimed devices have resorbable,
elastic bodies that allow for diffusion of the drug out of the device, for
example as the body of the device degrades. (See App. Br. 19--22.)
Findings of Fact
1. Ottoboni teaches bioerodible devices and preparations that
provide sustained release of drug when placed through the urethra in the
bladder. (Ottoboni abstract.)
1 Appellants report that the real party in interest is Massachusetts Institute of
Technology and Children's Medical Center Corporation. (See App. Br. 2.)
2 Claims 7, 8, 12, 18, 21, 23, and 24 were canceled. (See App. Br. 2.)
3 Ottoboni et al., US Patent 6,039,967, issued March 21, 2000.
4 Ruane et al., US Patent Application 2007/0196423 Al, published August
23, 2007.
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Application 13/910,730
2. Ottoboni provides Figure 1, which is reproduced below
II 10
FIG L
Figure 1 of Ottoboni depicts a device with a drug reservoir (10) and a
backing (12) having a mucoadhesive (11). (See Ottoboni 4:47--49.)
3. Ottoboni provides Figure 3, which is reproduced below.
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FIG. 3~
Figure 3 depicts an embodiment that is a filament network ( 17) containing
drug. (See Ottoboni 4:53-56.)
4. Ottoboni teaches that the devices can be made of flexible or
gel-like material that can be coiled or compressed to fit through a catheter
and can then uncoil or expand, having sufficient shape memory, to be
retained in the bladder for an extended period of time. (See Ottoboni 5: 1-9.)
5. Ottoboni teaches that carrier materials suitable for the device
embodiments taught include polycaprolactone. (See Ottoboni 2:35--43.)
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6. Ruane teaches coatings for medical devices that have a layer of
biodegradable elastomer over a layer of releasable therapeutic agent. (See
Ruane abstract.)
7. Ruane teaches that the material of the coatings on the device are
bioabsorbable by erosion under physiological conditions. (See Ruane ,r 47.)
8. Ruane teaches that the bioabsorbable elastomer can be cross-
linked polymers of glycerol and sebacic acid. (See Ruane ,r 115.)
9. Ruane teaches that the coated devices may be inserted in the
bladder. (See Ruane ,r 140.)
Analysis
The Examiner finds that Ottoboni teaches bioerodible, sustained
release preparations of drugs that provide sustained release in the bladder.
(See Final Act. 4, citing Ottoboni abstract; FF 1.) In one embodiment,
Ottoboni provides a device with a "drug reservoir." (See Final Act. 4, citing
Ottoboni 4:47--49 and Fig. 1; FF 2.) In another embodiment, the device of
Ottoboni is an elongated filament. (See Final Act. 4, citing Ottoboni Fig. 3;
FF 3.) The devices of Ottoboni can have shape memory that allows them to
be coiled or compressed to fit through a catheter and then uncoil or expand
to be retained in the bladder for an extended period of time. (See Final Act.
5, citing Ottoboni 5: 1-9; FF 4.)
The Examiner finds further that Ruane teaches implantable medical
devices coated with biodegradable elastomer and a releasable therapeutic
agent. (See Final Act. 8; see Ruane abstract; FF 6.) The Examiner finds that
Ruane teaches glycerol and sebacic acid can be used as the bioabsorbable
elastomer. (See Final Act. 8, citing Ruane ,r 115; FF 8.)
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Application 13/910,730
Claim 19
Appellants' claim 19 recites:
An implantable drug delivery device comprising:
a resorbable, elastic device body having at least one
elongated sidewall and at least one drug reservoir defined
therein, wherein the device body comprises a hydrophobic
elastomeric polyester which degrades in vivo by surface
erosion; and
a drug formulation in the drug reservoir, wherein the
device body provides controlled release of the drug in vivo by
diffusion through the sidewall of the device body,
wherein the drug delivery device is deformable from a
first configuration suited for passing the drug delivery device
through a lumen of a urethral catheter or cystoscope into the
patient's bladder to a second configuration suited for retaining
the drug delivery device in the bladder upon exiting the urethral
catheter or cystoscope.
(App. Br. 22.) The Examiner rejected claim 19 and claims 20, 22, and 25,
which depend on claim 19, as being obvious over the teachings of Ottoboni
and Ruane. (See Final Act. 7-9.)
Appellants argue that it is not clear where Ottoboni discloses a device
with an elongated sidewall and a reservoir defined therein. (See App. Br. 8.)
Appellants argue that the term "reservoir" is used in Ottoboni to refer to a
portion of the device formed from the drug-carrier composition, not defined
by the device body. (See id.) Appellants argue that "[t]here is no disclosure
in Ottoboni of a device body that defines a payload reservoir, let alone such
a device body having an elongated sidewall." (App. Br. 8.)
We are not persuaded by this argument that Ottoboni does not render
obvious the device recited in Appellants' claim 19. Claim 19 requires "a
resorbable, elastic device body having at least one elongated sidewall and at
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least one drug reservoir defined therein, wherein the device body comprises
a hydrophobic elastomeric polyester which degrades in vivo by surface
erosion .... " (App. Br. 22.) There are no express limitations in claim 19
that require how the payload reservoir is defined or that excludes a payload
reservoir defined by the drug-carrier composition. ( Contra Reply Br. 8-9
(arguing that the term "reservoir" refers to an open volume, e.g., a hollow
bore containing a payload).) We are not persuaded that a device wherein the
sidewalls and ends, as well as the drug reservoir, are created by the drug-
carrier composition is excluded in claim 19. That is, Appellants' claim 19
does not require the sidewall and drug reservoir to be made of a different
material, or be structurally defined as other than the drug-carrier
composition. Appellants do not direct us to any definition or other statement
in their Specification that excludes defining the claimed payload reservoir by
the drug-carrier composition. Under the broadest reasonable interpretation
of the claim, Ottoboni suggests a device with an elongated sidewall and a
drug reservoir. See In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379
(Fed. Cir. 2007) ("[T]he PTO must give claims their broadest reasonable
construction consistent with the specification. Therefore, we look to the
specification to see if it provides a definition for claim terms, but otherwise
apply a broad interpretation.") ( citation omitted).
Appellants argue that the Examiner inappropriately "conflates"
different embodiments of Ottoboni in regard to the limitation of the device
of claim 19 being deformable from a first configuration to a second
configuration so that it is retained in the bladder after placement by a
catheter of cystoscope. (See App. Br. 14--15.) According to Appellants, the
teaching in Ottoboni that the device of Figure 1, which relies on a
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mucoadhesive coating to keep a drug reservoir holding a large amount of
drug in place, is contrary to the teaching of the devices of Figures 3 through
5, which is held in place by the shape memory of the material. (See id.)
Appellants argue that there is no suggestion in Ottoboni that the reservoir of
Figure 1 be deformable to a second configuration as in Figure 3. (See id. at
15.)
We are not persuaded by this argument because the Examiner's
rejection is that Appellants' claims are obvious, not anticipated by the prior
art. (See Ans. 8-9.) The Examiner determines that combining the coiled
filament of Ottoboni with a drug reservoir, as taught in a different
embodiment for the same invention of drug delivery devices, would have
been obvious. (See Ans. 3.) The Supreme Court has explained that an
obviousness analysis "need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007).
Appellants do not direct us to evidence showing that a person of ordinary
skill in the art would not have been able to make a device with a reservoir
that could also change into a second configuration suited for retaining the
device in the bladder once the device had exited a catheter or cystoscope.
See id. at 417 ("[I]f a technique has been used to improve one device, and a
person of ordinary skill in the art would recognize that it would improve
similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill."). Accordingly, we are not
persuaded that the Examiner erred in relying on features of the different
embodiments taught in Ottoboni.
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Appellants also argue that Ottoboni does not teach or suggest
controlled release of drug by diffusion through the sidewall of the device
body, as required in claim 19. (See App. Br. 9.) According to Appellants,
because the filament embodiment of Ottoboni is described as releasing drug
by bioerosion from the exposed ends, modifying the device to provide for
diffusion through the sidewall would alter its principle of operation. (See
id.)
This argument is not persuasive because as the Examiner finds,
Ottoboni teaches a device body of the same material encompassed by
Appellants' claimed devices and that a person of ordinary skill would expect
the same material to have the same properties ( diffusion of the payload) in
other devices. (See Ans. 3--4.) Specifically, Appellants' claim 6 recites that
the device of claim 1 can be made of the elastomeric polymer
poly( caprolactone ), the same material taught in Ottoboni. (See App. Br. 19;
see Ottoboni 2:35--43.) Because the poly(caprolactone) device body claimed
by Appellants provides for controlled release of the payload in vivo by
diffusion through the sidewall, the same diffusion would occur in the
devices of Ottoboni. Thus, the inherent property of poly( caprolactone)
allowing for diffusion of drug renders this element obvious in light of
Ottoboni.
Appellants argue further that Ottoboni teaches a drug core that is
surrounded by a layer of slowly bioerodible material so that the exposed
ends of the core preferentially erode. (See App. Br. 10-11, citing Ottoboni
3: 1-11.) According to Appellants, because Ottoboni fails to provide
guidance on which material is suitable for the outer layer, there is no
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guidance on which material one would use for the sidewall of the claimed
devices. (See App. Br. 11.)
This argument is also unpersuasive because all of the parts of the
devices of Ottoboni are bioerodible to some extent and therefore can release
drug by diffusion. Therefore, we agree with the Examiner that one of
ordinary skill in the art would have considered a device that allows for
diffusion through the sidewalls to at least some extent to have been obvious.
(See Ans. 4.) Appellants do not specify that the amount of diffusion through
the sidewall must be of any particular rate or other limitation in their claims.
Appellants argue that Ruane does not cure the deficiencies of
Ottoboni. (See App. Br. 16-17.) As explained above, we are not persuaded
that the Examiner erred in relying on Ottoboni. The Examiner cited Ruane
for its teaching of using cross-linked polymers of glycerol and sebacic acid
as a modification of the polymers of Ottoboni. (See Ans. 9.) Appellants
argue only that Ruane teaches using these polymers as coatings, but not that
a device body can be formed from them. (See App. Br. 16.)
Appellants do not persuade us that the Examiner erred in rejecting
claim 19 and claims 20, 22, and 25, which depend on claim 19.
Claim 1
Appellants' claim 1 recites:
An implantable medical device comprising:
a resorbable, elastic device body having a first closed
end, an opposed second closed end, at least one elongated
sidewall extending between the first and second closed ends,
and at least one payload reservoir defined thereby; and
a payload stored in the payload reservoir,
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wherein the device body provides controlled release of
the payload in vivo by diffusion through the sidewall of the
device body, and
wherein the implantable medical device is dimensioned
and has an elasticity suitable for deployment of the medical
device into a patient's bladder via the patient's urethra.
(App. Br. 19.) Claim 1 is similar to claim 19, but requires that the device
body have "closed ends."
The Examiner finds that Ottoboni teaches that the filament
embodiment has closed ends. (See Final Act. 4, citing Ottoboni 4:53-56; see
also Ans. 3.) Appellants argue that this finding is an error by the Examiner.
(See App. Br. 8-9.) We agree with Appellants.
The portion of Ottoboni the Examiner cites provides a description of
the filament depicted in Figure 3, without mentioning its ends. (See
Ottoboni 4:53-56 ("FIG. 3 shows a randomly oriented filament network 17
containing the drug. This filament may be saturated with the drug, and may
have a coating to control diffusion rate. The filament may also be
segmented.").) Thus, the portion of Ottoboni the Examiner cites does not
support the finding that Ottoboni teaches a device with closed ends.
Instead, Ottoboni teaches erosion from the ends of the filament. (See
Ottoboni 3:6-11 ("Thus the exposed ends of the core will preferentially
bioerode. At various points along the filament, weakened portions may be
provided by which an outer layer may be detached once the core has been
bioeroded, thereby causing the filament to be eroded in segments starting
from the exposed ends.").) We agree with Appellants that such erosion does
not teach closed ends.
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We note that Appellants' Specification provides that in embodiments,
the device body can have:
plugs or stops 310 may prevent any drug 306 within the core
304 from escaping through end portions. The plugs 310 or
stops may have a range of configurations. For example, the
plugs 310 or stops may be small objects, such as spheres, discs,
or balls, that substantially span the cross-section of the core
304. Example materials that may be used to form the plugs 310
include bioresorbable polymers of the type described below, or
other materials such as stainless steel.
(Spec. 14:24--29.) The Examiner does not find that the ends of the filament
of Ottoboni have plugs, stops, or any other means of closing the end of a
device body.
Accordingly, we agree with Appellants that the Examiner erred in
rejecting claim 1 and dependent claims 2---6, 9-11, and 13 as being obvious
over Ottoboni.
Claim 14
Appellants' claim 14 recites:
An implantable drug delivery device comprising:
a device body formed from a resorbable elastomeric
polymer, the device body having an elongated annular sidewall
defining a hollow bore; and
a payload consisting essentially of solid or semisolid
drug loaded into the hollow bore,
wherein the device is deformable from a first
configuration suited for passing the drug delivery device
through a lumen of a urethral catheter or cystoscope into a
patient's bladder to a second configuration suited for retaining
the device in the bladder upon exiting the urethral catheter or
cystoscope.
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(App. Br. 21.) Claim 14 requires that the payload be loaded into "a hollow
bore."
Appellants argue that Ottoboni does not teach "a payload consisting
essentially of solid or semisolid drug loaded into the hollow bore" as
required in claim 14 because the drug of Ottoboni is disposed in the carrier
material. (See App. Br. 11-14.) Appellants argue that because Ottoboni
relies on the erodible carrier material to control drug release, a person of
ordinary skill in the art would not have modified the filament of Ottoboni to
consist essentially of drug in a hollow bore. (See id.; see Reply Br. 3.)
We agree with Appellants that the Examiner did not find that Ottoboni
does not teach or suggest the design choice of a hollow bore. Accordingly,
we agree that the Examiner erred in rejecting claim 14 and claims 15-17,
which depend on claim 14.
Conclusion
Upon consideration of the record and for the reasons given,
the rejections of claims 1-6, 9-11, and 13-17 under 35 U.S.C.
§ 103(a) over Ottoboni alone or Ottoboni and Ruane are not sustained;
the rejections of claims 19, 20, 22, and 25 under 35 U.S.C. § 103(a)
over Ottoboni alone or Ottoboni and Ruane are sustained.
Therefore, we affirm-in-part the decision of the Examiner.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED-IN-PART
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