Ex Parte Konieczynski et al

Patent Trial and Appeal Board

Nov 14, 2012

12024402 (P.T.A.B. Nov. 14, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DAVID D. KONIECZYNSKI, ALAN J. DEXTRADEUR, and
WILLIAM L. ROHR
__________

Appeal 2010-010890
Application 12/024,402
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and RICHARD M.
LEBOVITZ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
implantable drug delivery system, which the Examiner has rejected for
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1-4, 7, 8, 10, 14-17, 19-26, and 28 are on appeal. Claims 1
and 16 are representative and read as follows:
1. An implantable drug delivery system, comprising:
an infusion pump including a fluid outlet;
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a fluid delivery pathway effective for extending from the fluid outlet
to a discharge portion remote from the pump and positionable at a target
tissue site,
a controlled release drug assembly, said drug assembly being
configured for controllably releasing drug material, and communicating with
said fluid delivery pathway such that the drug material is released into said
fluid delivery pathway, and
an array of sensors in communication with the controlled release drug
assembly, the sensors being implanted in various locations in the target
tissue site and being configured to communicate information to the
controlled release drug assembly regarding the distribution of the drug
material in the target tissue site;
wherein the pump assembly is effective to deliver a carrier fluid to the
fluid outlet such that the drug material released into the fluid pathway
discharges at the discharge portion to treat the target tissue site.

16. The system of claim 1, wherein the flow rate ranges from about
0.5 to about 20 microliters per minute.

The claims stand rejected as follows:
• Claims 1, 3, 4, 7, 8, 10, 15, 19, 22-26, and 28 under 35 U.S.C.
§ 103(a) based on Uhland1 and Richter2 (Answer 3) and
• Claims 2, 14, 16, 17, 20, and 21 under 35 U.S.C. § 103(a) based on
Uhland, Richter, and Rosenberg3 (Answer 6).
I.
Issue
The Examiner has rejected claims 1, 3, 4, 7, 8, 10, 15, 19, 22-26, and
28 as obvious based on Uhland and Richter (Answer 3). The Examiner finds

1 Uhland, US 2004/0034332 A1, Feb. 19, 2004.
2 Richter, US 6,334,859 B1, Jan. 1, 2002.
3 Rosenberg et al., US 4,596,575, June 24, 1986.
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that Uhland discloses an implantable drug delivery system meeting all the
limitations of claim 1, “including use of biosensors to release a medicament
(Paragraph 7), [but] it does not disclose the sensors implanted directly in the
tissue being treated” (id. at 4).
The Examiner finds that Richter discloses “an implantable device for
delivery of medicaments . . . that releases an appropriate amount of
medicament in response to a sensed stimulus generated by the tissue being
treated from an array of sensors” (id.). The Examiner concludes that it
would have been obvious “to modify the device of Uhland with an array of
sensors implanted within the target tissue as taught by Richter as it would
provide only the expected result of providing a biosensor to the device of
Uhland capable of controlling the release of medicament from the device”
(id.).
Appellants contend that the cited references do not disclose several of
the claim limitations: a fluid delivery pathway (Appeal Br. 5-8), discharge
of a drug material to treat the target tissue site (id. at 9), or discharge remote
from the pump (id. at 10-11). Appellants also contend that Richter does not
disclose the array of sensors required by the claims (id. at 11-15) and it
would not have been obvious to modify Richter’s sensors to perform as
claimed (id. at 15-19).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Uhland and Richter would
have made obvious an implantable drug delivery system meeting the
limitations of claim 1?
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Findings of Fact
1. Uhland discloses an apparatus “for the delivery of molecules to a
site via a carrier fluid. The apparatus include[s] microchip devices which
have reservoirs containing the molecules for release. The apparatus and
methods provide for active or passive controlled release of the molecules.”
(Uhland 1, ¶ 7.)
2. Uhland discloses that “[r]elease from an active device can be
controlled by a preprogrammed microprocessor, remote control, or by
biosensors” (id.).
3. Uhland discloses an embodiment in which “a microchip device is
incorporated into an implantable micropumping system, for example for the
delivery of drugs over extended periods of time, such as is needed [for] the
delivery of insulin to diabetics and treating certain kind of severe chronic
pain” (id. at 9, ¶ 108).
4. Uhland discloses that Rosenberg describes a “[m]icropump
apparatus suitable for use in these devices” (id.).
5. Uhland discloses that the “micropump pumps the carrier fluid
across one or more surfaces of the microchip device” (id.) and that “[a]s the
fluid passes over or around the activated and opened reservoir, the solid drug
dissolves in the carrier fluid, forming a solution that is pumped into the
extra-cellular environment” (id. at 9, ¶ 109).
6. Uhland discloses that its apparatus can be
used to deliver drugs systemically to a patient by releasing the
drugs into a fluid delivered intravenously. As used herein, the
term “drug” includes therapeutic, prophylactic, and diagnostic
agents, unless otherwise indicated. Drug molecules to be
released during intravenous drug delivery applications include,
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but are not limited to, antibiotics, chemotherapeutic agents, in
vivo diagnostic agents (e.g., contrast agents), sugars, vitamins,
toxin antidotes, anti-inflammatory agents, [and] painkillers.
(Id. at 5, ¶ 52.)
7. Rosenberg discloses “liquid delivery systems . . . particularly
useful as an implantable micro-pump for delivering insulin or other drugs”
(Rosenberg, col. 1, ll. 7-9).
8. Rosenberg’s Figure 1 is reproduced below:

Figure 1 shows “one form of [Rosenberg’s] liquid delivery system”
(id. at col. 2, l. 22).
9. Rosenberg states that the system shown in Figure 1 “includes a
controller 2 which controls a pump 3 such as to deliver the insulin from an
insulin-feed unit 4. Pump 3 does not act directly on the insulin within unit 4,
but rather indirectly by means of a drive liquid supplied from a drive liquid
unit 5. The insulin . . . from unit 4 is pumped . . . into the body via a fitting
6 and a feed tube 7.” (Id. at col. 2, ll. 31-38.)
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10. Richter discloses “devices which are implanted within the body of
a living animal or human to impart a therapeutic benefit to a target tissue”
(Richter, col. 1, ll. 7-9).
11. Richter discloses that its devices are “for selectively electrically
stimulating body tissues or organs and also for selectively delivering a
medicament to a target tissue or organ” (id. at col. 1, ll. 10-13).
12. Richter states that its invention “provide[s] improved treatment
by reducing the time between the sensing of a specific activity within the
tissue or organ being treated and the onset of the delivery of the electrical
stimulus or medicament drug to the site of the sensed activity” (id. at col. 1,
ll. 14-18).
13. Richter discloses that “a sensor or an array of sensors
communicat[es] with a tissue or organ being treated . . . [and] with one or
more actuators adapted to selectively deliver a predetermined amount of an
electrical impulse or a medicament to the tissue or organ being treated in
response to the sensed stimulus” (id. at col. 2, ll. 42-48).
14. Richter discloses that the
sensors . . . monitor the tissue being treated for a variety of
preselected physiological activities and parameters which
indicate the need for treatment and the amount of treatment
required. These physiological activities and parameters include,
e.g., but are not limited to, changes in neurological activity,
temperature, pressure, fluid discharge from the target area,
chemical composition of the discharge, and chemical changes
in the tissue being treated.
(Id. at col. 4, ll. 51-60.)
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15. Richter discloses that “[t]he sensor or sensors 11 may be
implanted at several points on or in the tissue or organ being treated” (id. at
col. 4, ll. 61-62).
Analysis
We agree with the Examiner that the disclosures of Uhland and
Richter would have made obvious a system meeting the limitations of claim
1. Uhland discloses an implantable drug delivery system that includes a
controlled release drug assembly that releases a drug into a carrier fluid and
pumps the carrier fluid and drug into the extracellular environment (FF 5).
Uhland discloses that the release of a drug by its system can be controlled by
biosensors (FF 2). Uhland discloses that its system can include a
micropump like that described by Rosenberg (FF 4). Rosenberg describes a
micropump apparatus that includes a pump with a fluid outlet, a fluid
delivery path, and a discharge portion (or feed tube) that is separate, or
remote, from the pump (FF 9).
Richter discloses an implantable device, for delivering a medicament,
that includes an array of sensors (FF 13) implanted in the tissue to be treated
(FF 15) that monitors the tissue for parameters indicating a need for
treatment (FF 14) and actuates the release of a medicament in response to
the sensed stimulus (FF 13). In view of these teachings, it would have been
obvious to a person of ordinary skill in the art to modify Uhland’s drug
delivery system to include Richter’s array of sensors to control release of
drug by Uhland’s system, because Uhland expressly teaches using a
biosensor to control release of a drug from its system and Richter discloses
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an array of sensors for controlling release of a drug from an implantable
drug delivery system.
Appellants argue that Uhland does not disclose the “fluid delivery
pathway” required by claim 1 (Appeal Br. 5-6). Appellants also argue that
Rosenberg does not disclose discharge at a site remote from the pump of its
system (id. at 7, 10) and that Richter does not remedy this deficiency (id. at
7-8, 11).
These arguments are unpersuasive. Uhland discloses that
Rosenberg’s micropump apparatus is suitable for use in Uhland’s
implantable system (FF 4). Rosenberg describes a drug delivery system that
includes a fluid delivery pathway (e.g., elements 4, 6, and 7 shown in
Rosenberg’s Figure 1; FF 8). Contrary to Appellants’ position, Rosenberg’s
system discharges its drug at a site remote from its pump, because the pump
3 in Rosenberg’s system is separate from, and therefore remote from, feed
tube 7 from which the drug is discharged into the patient’s body (FF 9).
Appellants also argue that Uhland and Richter do not disclose that
“drugs are delivered to a target tissue site to treat the target tissue site as
required by claim 1” (Appeal Br. 9). Appellants argue that the insulin and
pain medication described by Uhland “are not delivered to a target tissue site
to treat the target tissue site, but rather are released into the body, often
subcutaneously, and diffused through the body to effect treatment at a tissue
site that is remote from the delivery site” (id.).
This argument is also unpersuasive. Claim 1 is directed to a product,
not a method of using it, and therefore requires only that the prior art product
be capable of functioning as recited in the claim. See Catalina Mktg. Int’l,
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Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002) (“[T]he
patentability of apparatus . . . claims depends on the claimed structure, not
on the use or purpose of that structure.”). Appellants have provided no
persuasive basis for concluding that Uhland’s system is not capable of
delivering a drug to treat tissue locally rather than systemically.
Appellants also argue that Uhland and Richter do not disclose the
array of sensors required by claim 1 because “[f]or the sensors of Richter to
meet the limitations of claim 1, the sensors would have to sense and
communicate information about the drug material in the tissue in which the
sensors are implanted, and specifically, the distribution of the drug material
therein” (Appeal Br. 12). Appellants argue that “Richter only discloses
sensors that may be implanted in the body for the limited purpose ‘to
monitor the tissue being treated for a variety of preselected physiological
activities and parameters which indicate the need for treatment and the
amount of treatment required,’” and therefore does not disclose the sensors
required by the claim (id.).
This argument is also unpersuasive. As the Examiner pointed out
(Answer 10), Appellants’ Specification states that “[s]ystems of the
invention may employ one or more sensors that provide output signals upon
which the controller operates to determine a pumping or drug release
regimen. The sensors may sense fluid pressure, detect the level or presence
of a substance, a drug or a metabolite, or detect a physiologic condition to
which the treatment is applied.” (Spec. 9-10, emphasis added.) Thus,
Appellants’ Specification supports the Examiner’s interpretation of the
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claims as encompassing a system that includes sensors that detect
“parameters which indicate the need for treatment” (FF 14) by a drug.
Appellants acknowledge the above passage in the Specification
(Reply Br. 5) but argue that the sensors required by claim 1 “are clearly
sensors that may ‘detect the level or presence of a substance, a drug or a
metabolite’ and not sensors that may ‘detect a physiologic condition’” (id. at
6).
We disagree. Claim 1 does not recite an array of sensors that “detects
the level or presence of . . . a drug,” as recited in the Specification, only one
that “communicate[s] information . . . regarding the distribution of the drug
material in the target tissue site” (claim 1). The Specification states:
Advantageously, an array of sensors may themselves be
implanted at positions to determine the spatial distribution in
the target tissue of the drug delivered by the delivery system,
and a processor or controller may operate accordingly to
achieve the deliver [sic] the desired dose or concentration
distribution, or to achieve the desired control of sensed
conditions during changing metabolic and tissue states.
Spec. 10, ll. 2-6. The Specification thus describes an embodiment in which
sensors communicate with a controller to either achieve the desired dose or
concentration distribution or to achieve the desired control of sensed
conditions.
Richter’s sensors that detect a physiological parameter that indicates
the need for treatment with a drug – i.e., a parameter resulting from
insufficient tissue presence of the drug – is reasonably interpreted to meet
the claim limitation of information regarding the distribution of the drug
material in the target tissue site. This interpretation is consistent with the
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Specification’s embodiment of sensors that allow a controller to achieve a
desired control of sensed conditions.
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000). If Appellants wish to limit the claims to
require an array of sensors that directly detects the level or presence of a
drug, they are free to amend the claims to recite that specific limitation. See
In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989) (“[D]uring patent prosecution
when claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed.”). However, the
broadest reasonable interpretation of the claim language, as it stands now,
encompasses the array of sensors disclosed by Richter.
With regard to claim 28, Appellants argue that, in addition to the array
of sensors required by claim 1, claim 28 also requires an array of biosensors
disposed in tissue, where at least one of the infusion pump and controlled
release drug assembly responds to the biosensor signals (Appeal Br. 20).
Appellants argue that “[a]t best, Uhland and Richter only disclose the array
of sensors of claim 1 or the array of biosensors of claim 28, but not both”
(id. at 21).
This argument is unpersuasive. Appellants have pointed to no
definition of “biosensor” that distinguishes it from the sensors disclosed by
Richter, which monitor physiological parameters and therefore can
reasonably be referred to as either “biosensors” or “sensors.” As the
Examiner pointed out (Answer 12), Richter suggests implanting sensors (or
biosensors) at several points in tissue (FF 15). The Examiner interprets an
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“array” of sensors to require simply a plurality of sensors (Answer 11), and
Appellants have pointed to no basis for construing the term more narrowly.
Thus, based on Richter’s suggestion that “sensors 11 may be implanted at
several points on or in the tissue or organ being treated” (FF 15), it would
have obvious to implant at least four sensors – which can reasonably be
considered an array of two sensors plus an array of two biosensors – in the
tissue to be treated.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Uhland and Richter would have made obvious an implantable drug delivery
system meeting the limitations of claim 1, as well as the system of claim 28.
II.
The Examiner has rejected claims 2, 14, 16, 17, 20, and 21 as obvious
based on Uhland, Richter, and Rosenberg (Answer 6). With regard to claims
2, 14, 17, 20, and 21, Appellants rely on the same arguments they presented
with respect to claim 1 (Appeal Br. 24). Those arguments are unpersuasive
for the reasons discussed above, and we affirm the Examiner’s rejection of
claims 2, 14, 17, 20, and 21 based on the findings and reasoning presented in
the Answer (pages 6-8).
With regard to claim 16, Appellants argue that none of the cited
references disclose or suggest a flow rate of about 0.5 to about 20 microliters
per minute, as required by that claim (Appeal Br. 24-26).
This argument is unpersuasive. Claim 16 is directed to a product, not
a method of administering a drug. The recited flow rate therefore is no more
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than a statement of the intended use of the claimed system, and requires only
that the prior art suggest a system that is capable of being used as recited in
claim 16. See Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d
801, 809 (Fed. Cir. 2002) (“[T]he patentability of apparatus . . . claims
depends on the claimed structure, not on the use or purpose of that
structure.”).
Appellants have pointed to no persuasive evidence to show that the
micropump described by Rosenberg, for example, is not capable of
providing a flow rate in the range of 0.5 to 20 microliters per minute.
Appellants’ Specification itself states that the disclosed system, providing a
flow rate in the range recited in claim 16 (Spec. 8-9, ¶ 30) “may be formed
using a conventional infusion pump for the pump assembly” (id. at 9, ¶ 33).
The preponderance of the evidence of record therefore supports the
Examiner’s conclusion that claim 16 would have been obvious based on the
cited references.
SUMMARY
We affirm the rejection of claims 1 and 28 under 35 U.S.C. § 103(a)
based on Uhland and Richter. Claims 3, 4, 7, 8, 10, 15,4 19, and 22-26 fall
with claim 1 because they were not argued separately. 37 C.F.R.
§ 41.37(c)(1)(vii). We also affirm the rejection of claims 2, 14, 16, 17, 20,
and 21 under 35 U.S.C. § 103(a) based on Uhland, Richter, and Rosenberg.

4 Although Appellants list claim 15 under a separate heading (Appeal Br. 19-
20), they present no arguments with respect to claim 15 that are different
from the arguments presented with respect to claim 1. Because claim 15
was not substantively argued separately, it falls with claim 1.
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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

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