Ex Parte Wood et al

Patent Trial and Appeal Board

Jul 6, 2016

11975347 (P.T.A.B. Jul. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111975,347 10/17/2007
44765 7590 07/08/2016
INTELLECTUAL VENTURES - ISF
ATTN: DOCKETING, ISF
3150 - 139th Ave SE
Bldg.4
Bellevue, WA 98005
FIRST NAMED INVENTOR
Lowell L. Wood JR.
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.
0107-028-001-COOOOl 8076
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
07/08/2016 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):
ISFDocketlnbox@intven.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LOWELL L. WOOD, JR., CLARENCE T. TEGREENE,
WILLIAM H. GATES III, and RODERICK A. HYDE
Appeal2014-001175
Application 11/975,347
Technology Center 3700
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to an
injectable material delivery device. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Searete, LLC (see
App. Br. 4).
Appeal2014-001175
Application 11/975,347
Statement of the Case
Background
The Specification teaches "intelligently-controlled material delivery
systems including devices that are capable of being deployed
transcutaneously, percutaneously, or subdermally into a natural or an
engineered body cavity of an animal. The device is capable of long-term
delivery of material in vivo and may be adapted to receive extemally-
provided delivery material" (Spec. 7:8-13).
The Claims
Claims 1, 2, 9, 11, 12, 18, 24, 28, 31, 38, 40, 67, 68, 75, 77-80, 90,
94, 95, 103, 105, 132, 134, and 383 are on appeal. Claim 1 is representative
and reads as follows:
1. An injectable material delivery device percutaneously
deployable in an animal via needle injection under pressure,
compnsmg:
at least one deformable reservoir having a
biologically inert, deformable outer surface, the at
least one deformable reservoir the deformable
reservoir configured to receive, retain and dispense at
least one material, including at least one outlet
through which the at least one material may exit the at
least one deformable reservoir; and
at least one controllable output mechanism
operably linked to the at least one outlet to control the
dispensing of at least a portion of the at least one
material from the at least one deformable reservoir.
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Application 11/975,347
The issues2
A. The Examiner rejected claims 1, 2, 11, 12, 24, 40, 67, 68, 77-80, 90,
94, 95, 105, 132, 134, and 383 under 35 U.S.C. § 103(a) as obvious over
Reinicke3 and DiDomenico4 (Ans. 5-8; Final Act. 5-8).
B. The Examiner rejected claims 9, 38, 75, and 103 under 35 U.S.C.
§ 103(a) as obvious over Reinicke, DiDomenico, and Thompson5 (Ans. 8;
Final Act 8-9).
C. The Examiner rejected claim 18 under 35 U.S.C. § 103(a) as obvious
over Reinicke, DiDomenico, and Barreras6 (Ans. 9; Final Act. 9).
D. The Examiner rejected claims 28 and 31 under 35 U.S.C. § 103(a) as
obvious over Reinicke, DiDomenico, and Blomquist7 (Ans. 9-10; Final Act.
9-10).
A. 35 U.S.C. § 103(a) over Reinicke and DiDomenico
The Examiner finds that Reinicke teaches
an injectable delivery device 12 percutaneously deployable in
an animal via needle injection under pressure (figures 4-7). The
device is comprised of at least one deformable reservoir
(figures 5-7) having a biologically inert, deformable outer
surface (Col. 5 1126-30) configured to receive, retain and
2 We note that the Examiner has withdrawn the anticipation
rejection over Reinicke (see Ans. 4).
3 Reinicke, US 4,834, 704, issued May 30, 1989.
4 DiDomenico, US 4,714,462, issued Dec. 22, 1987.
5 Thompson et al., US 2002/0107472 Al, published Aug. 8, 2002
("Thompson").
6 Barreras, Sr. et al., US 5,733,313, issued Mar. 31, 1998
("Barreras").
7 Blomquist, US 2003/0163223 Al, published Aug. 28, 2003.
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Application 11/975,347
dispense at least one material (Col.3 ll 1-14), including at least
one outlet (figure 5, through which plug 10 extends) through
which at least one material may exit the deformable reservoir.
The plug 10 and its stem 1 Oa, grooves 1 b and opening 1 Oc are a
controllable output mechanism linked to the outlet to control
the dispensing of the material form the reservoir.
(Final Act. 5). The Examiner finds that Reinicke "does not disclose the
device as being controllable once implanted via a remote controller" (id.).
The Examiner finds that "DiDomenico discloses an implantable device
which has an electrical restrictor placed in the outlet to control the pump
output" (Final Act. 6). The Examiner finds it obvious to "make the device
of Reinicke electrical by adapting the electrical components (including,
among others, sensors, a remote controller and processor to control a
solenoid) of DiDomenico to fit within Reinicke to allow for control and
interrogation of the device after it has been implanted" (id.).
The issue \'l1ith respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Reinicke and DiDomenico
render the claims obvious?
Findings of Fact
1. The Specification teaches that the "term 'deformable' means
that the reservoir has the ability to change its shape in at least one
dimension" (Spec. 40: 15-16).
2. The Specification teaches that "the use of a remote controller
positioned either inside or outside of the animal that is capable of
transmitting a control signal to activate the controllable output mechanism to
cause exit of material from the reservoir" (Spec. 9:2--4).
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Application 11/975,347
3. The Specification teaches that
the controllable output mechanism includes one or more
electrically or magnetically active components, the electrically
or magnetically active component may respond to an
electromagnetic control signal in a first manner (e.g., by
heating) and the response of the controllable output mechanism
may be produced in response to the electrically or magnetically
active component ...
(Spec. 24:31to25:4).
4. Reinicke teaches a "drug infusion pump module that is
implantable by injection, filled with a medication as an integral step in the
injection process, and automatically provides continuous infusion of the
medication for a period of several months" (Reinicke 1 :61---66).
5. Reinicke teaches that the "implanted module is made entirely of
biocompatable [sic] materials such as medical grade polysulfone or the like,
medical grade Latex or silicon elastomer or the like and medical grade
stainless steel" (Reinicke 5:25-30).
6. Reinicke teaches that the "8 psig pressure exerted on the drug
by the elastic stretch of the balloon forces drug to flow out the stainless steel
flow restrictor tube 14 and into the peritoneal cavity" (Reinicke 5:9-12).
7. Reinicke teaches that a "flow restrictor is incorporated in an
outlet of the device to regulate the drug dosage which is delivered to the
infusion site by a catheter connected to the outlet" (Reinicke 1 :45--48).
8. DiDomenico teaches
to address the shortcomings of constant flow devices and obtain
significant flexibility in dosage rates, research has been
conducted into so called "implantable programmable" pumps.
In the definition of system requirements dealing with such
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Application 11/975,347
implantable programmable pumps, a device which will provide
programmable bolus and basal flow rates over a wide dynamic
range is a standing system requirement.
(DiDomenico 1 :29-37).
9. DiDomenico teaches a device comprising:
A storage chamber 10 comprises the positive pressure drug
reservoir in accordance with this invention. The second
component is the check valve 100 which is interposed between
the storage chamber 10 and a pumping chamber 200 having
associated with it a drive mechanism 210 and electronics
module 220. A flow restrictor 230 forms an outlet establishing
fluid communication between the system as implanted and
infusion site 240 in a living body under treatment.
(DiDomenico 4:22-31 ).
10. DiDomenico teaches that an "output signal is provided from the
electronics module 220 to the solenoid 214 to vary the flow rate, i.e. the
pulse repetition rate is changed achieve proper flo\'l/ rate" (DiDomenico 7:5-
8).
11. DiDomenico teaches that
the system in a closed loop mode can use signals from both
differential pressure transducer 232 and the actual displacement
of the pumping element 212. Such would compare the stroke
per unit time relatively to the differential pressure change per
unit time and matching those system operating characteristics to
a signature of the two values stored in a ROM in the electronics
module 220. By comparing actual values to a map of predicted
values, the accuracy of the delivered quantity can be corrected
by adjusting the flow rate instructed from the ROM.
(DiDomenico 7:20-30).
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Application 11/975,347
12. DiDomenico teaches that a "solenoid is activated driving an
armature and a bellows pumping element. This displacement of the
armature opens a check valve which draws drug from the storage chamber
into a downstream pumping chamber" (DiDomenico 2: 10-15).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR!nt'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
Analysis
We adopt the Examiner's findings regarding the scope and content of
the prior art (Final Act. 5-8; FF 1-12) and agree that the claimed device
would have been obvious over the teachings of Reinicke and DiDomenico.
We address Appellants' arguments below.
Appellants contend that "none of claims 1, 2, 11, 12, 24 or 40 recite a
'remote controller.' Therefore, it is unclear why the Examiner rejected these
claims as allegedly reciting a 'remote controller.' Reversal of the rejections
with respect to claims 1, 2, 11, 12[,] 24[,] and 40 is warranted for this reason
alone" (App. Br. 17).
We are not persuaded. The Examiner relied upon Reinicke to teach a
device that is deployable via needle injection (FF 4), with a deformable
reservoir composed of an elastomer (FF 5) such as a balloon that contains a
drug for delivery (FF 6) with a flow restrictor outlet to regulate drug dosage
(FF 7).
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Application 11/975,347
The Examiner interpreted "controllable output mechanism" as a
"remote controller," consistent with the Specification (FF 2-3), and relied
upon DiDomenico to teach these elements of claim 1. DiDomenico teaches
a drug delivery device with a reservoir under pressure (FF 9) and uses a
solenoid that is an electronically activated (FF 10) and changes in shape in
response to the signal to displace an armature that opens a check valve to
release drug (FF 12), consistent with the definition of controllable output
mechanism in the Specification (FF 3).
Thus, the Examiner reasonably relies upon DiDomenico to teach the
"controllable output mechanism" elements of claim 1 in using the "remote
controller" language.
Appellants contend that:
Nothing in the record established any motivation to combine
the disclosures of the cited references. Even if a motivation
could be concocted, modification of the primary reference,
Reinicke, would be so extensive as to make the device unfit for
its intended purpose. That is to provide a device that
continuously delivered material the components of
DiDomenico are not suited for injection as already conceded by
the Examiner. Yet, the Examiner wishes to place such
components into Reinicke's injectable device.
(App. Br. 18).
We are not persuaded. The Examiner finds the combination obvious
because the addition of DiDomenico' s electrical components would "allow
for control and interrogation of [Reinicke's delivery] device after it has been
implanted" (Final Act. 6). DiDomenico provides specific reasons to
incorporate controllable mechanisms, teaching that "to address the
shortcomings of constant flow devices and obtain significant flexibility in
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dosage rates, research has been conducted into so called 'implantable
programmable' pumps" (FF 8). Thus, an ordinary artisan, interested in
improving constant flow devices such as those of Reinicke, would have
looked to the implantable programmable mechanisms taught by
DiDomenico to allow for improved control of drug release as noted by the
Examiner (Final Act. 6).
Appellants contend that the "Examiner hasn't made clear how it
would have been obvious to modify Reinicke' s structure. Simply making the
Reinicke device 'electrical' 'to allow for control and interrogation of the
device after it is implanted' still falls short of the claimed system" (App. Br.
18).
We are not persuaded. As the Examiner explains,
DiDomenico shows in figure 1 the electrical module 220 and
solenoid 214 in fluid communication with and on the outlet
tube 38 of the device. If one were to adapt the flow control
system of DiDomenico for Reinicke (as the rejection states) it
naturally flows that it would be added to the analogous
structure of Reinicke, plug 10 (more specifically, stem 1 Oa) as
that is the outlet of the system of Reinicke.
(Ans. 11-12). Thus, the Examiner clearly explains how modifying the
Reinicke device with the flow control system of DiDomenico would
function, and explains that "DiDomenico gives the user the added ability to
use other delivery rates, as one of ordinary skill in the art would appreciate is
desirable as it only increases the abilities of the device" (Ans. 11 ).
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Reinicke and DiDomenico render the claims obvious.
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Application 11/975,347
B. 35 U.S.C. § 103(a) over Reinicke, DiDomenico, and Thompson
We recognize, but find unpersuasive, Appellants' contention that
because "the rejection of claims 1 and 67 are reversible, so too are the
rejections of the dependent claims 9 and 75" (App. Br. 20) and Appellants'
similar contention that "so too are the rejections of the dependent claims 38
and 103" (App. Br. 21). As already noted, we agreed with the Examiner that
claims 1 and 67 were unpatentable over Reinicke and DiDomenico.
Appellants contend, regarding claims 9 and 103, that "[n]owhere did
the Examiner state which component of either DiDomenico or Reinicke
would be replaced by a controllable output mechanism that includes a
MEMS device or a NEMS device" (App. Br. 21 ).
We are not persuaded. The Examiner finds that:
Thompson discloses using a MEMS device to control the output
of its device (paragraph 28). It would have been obvious to one
of ordinary skill in the art at the time the invention was made to
use a MEMS controller with the device of DiDomenico and
Reinicke as taught by Thompson in order to help minimize the
size of the device.
(Ans. 8).
Indeed, Reinicke and DiDomenico teach delivery from a reservoir
using a flow restrictor (FF 7, 9), and DiDomenico teaches electronic control
to permit variation of the flow rate (FF 10). Thompson teaches "a Micro
Electro Mechanical System (MEMS) flow restriction with a variable
infusion rate" (Thompson i-f 7) and specifically teaches a "MEMS flow
restrictor 34 is fluidly coupled to the reservoir outlet 36 to receive
therapeutic substance 26 dispensed from the reservoir 32 at the reservoir
rate" (Thompson i-f 28).
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Application 11/975,347
We therefore agree with the Examiner that the ordinary artisan would
have found it obvious to replace the flow restrictors taught by DiDomenico
and Reinicke with the MEMS flow restrictor of Thompson because these are
equivalent components that perform the same function of flow restriction
and control and represent known equivalents. See KSR, 550 U.S. at 417
("[W]hen 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.").
C. 35 U.S.C. § 103(a) over Reinicke, DiDomenico, and Barreras
Appellants do not separately argue claim 18 in this obviousness
rejection, instead relying upon their earlier arguments to overcome
DiDomenico and Reinicke. The Examiner provides sound fact-based
reasoning for combining Barreras with DiDomenico and Reinicke (see Final
Act. 9). Having affirmed the obviousness rejection of claims 1 and 12 over
DiDomenico and Reinicke for the reasons given above, we also find that the
further combination with Barreras renders claim 18 obvious for the reasons
given by the Examiner.
D. 35 U.S.C. § 103(a) over Reinicke, DiDomenico, and Blomquist
Appellants do not separately argue claims 28 and 31 in this
obviousness rejection, instead relying upon their earlier arguments to
overcome DiDomenico and Reinicke. The Examiner provides sound fact-
based reasoning for combining Blomquist with DiDomenico and Reinicke
(see Final Act. 9-10). Having affirmed the obviousness rejection of claim 1
over DiDomenico and Reinicke for the reasons given above, we also find
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that the further combination with Blomquist renders claims 28 and 31
obvious for the reasons given by the Examiner.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Reinicke and DiDomenico. Claims 2, 11, 12, 24,
40, 67, 68, 77-80, 90, 94, 95, 105, 132, 134, and 383 fall with claim 1.
37 C.F.R. § 41.37(c)(l)(iv).
We affirm the rejection of claims 9, 38, 75, and 103 under 35 U.S.C.
§ 103(a) as obvious over Reinicke, DiDomenico, and Thompson.
We affirm the rejection of claim 18 under 35 U.S.C. § 103(a) as
obvious over Reinicke, DiDomenico, and Barreras.
We affirm the rejection of claims 28 and 31under35 U.S.C. § 103(a)
as obvious over Reinicke, DiDomenico, and Blomquist.
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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