Ex Parte Rodriguez et al

Patent Trials and Appeals Board

Feb 14, 2019

14579231 - (D) (P.T.A.B. Feb. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/579,231 12/22/2014
23517 7590 02/19/2019
MORGAN, LEWIS & BOCKIUS LLP (BO)
1111 PENNSYLVANIA A VENUE, N.W.
WASHINGTON, DC 20004
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Andres Rodriguez
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.
RPN-035/107506-5035 2324
EXAMINER
HAKOMAKI, JAMES R
ART UNIT PAPER NUMBER
3753
NOTIFICATION DATE DELIVERY MODE
02/19/2019 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):
kcatalano@morganlewis.com
patents@morganlewis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDRES RODRIGUEZ, PEDRUM MINAIE, TUN MIN SOE,
JASON SHIH, ANDREW DUNN, ANDREW URAZAKI, BIN WANG,
and FUKANG JIANG 1
Appeal2018-005684
Application 14/579,231
Technology Center 3700
Before EDWARD A. BROWN, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a) from the
Examiner's final rejection of claims 1-19. Final Act. 1 (Office Action
Summary). We have jurisdiction under 35 U.S.C. § 6(b ). For the reasons
explained below, we find error in the Examiner's rejections of these claims.
Accordingly, we REVERSE the Examiner's rejections.
1 "The real party in interest is the assignee of the present application,
MiniPumps, LLC." App. Br. 2. We thus proceed on the basis that, for
purposes of this appeal, MiniPumps, LLC is the "Appellant."
Appeal2018-005684
Application 14/579,231
CLAIMED SUBJECT MATTER
The disclosed subject matter "relates to refill systems incorporating a
refill needle, reservoirs, a system of passive check valves of known cracking
pressures, a pressure actuation pump used to refill drug pump devices, and
various sensors throughout the system." Spec. ,r 6. Apparatus claim 1 and
method claim 13 are independent. Claim 1 is representative of the claims on
appeal and is reproduced below.
1. Apparatus for refilling a reservoir, the apparatus
compnsmg:
a plurality of reservoirs;
a plurality of reservoir fluid channels each associated with
one of the reservoirs;
an outlet fluid channel fluidically connected to the
reservoir fluid channels;
a plurality of valves, each having a cracking pressure, for
fluidically sealing the reservoir fluid channels and the outlet fluid
channel;
at least one pressure sensor for monitoring pressure in the
reservoir fluid channels and the outlet fluid channel;
at least one actuation mechanism;
a needle having a lumen in fluid communication with the
outlet fluid channel, the needle being configured for insertion
into a drug-delivery port of an implantable medical device; and
a controller for actuating the at least one actuation
mechanism and various ones of the valves in accordance with the
monitored pressure and a protocol comprising a sequence of
steps whereby fluidic pathways are opened between different
ones of the reservoirs and the needle in a washing and filling
sequence, each of the steps being associated with an expected
pressure level.
Frazier et al.
Shih et al.
REFERENCES
US 2004/0176732 Al
WO 2009/137777 A2
2
Sept. 9, 2004
Nov. 12, 2009
Appeal2018-005684
Application 14/579,231
THE REJECTIONS ON APPEAL 2, 3
Claims 1-5 and 7-19 are rejected under 35 U.S.C. § 102(a)(2) as
being anticipated by Shih.
Claim 6 is rejected under 35 U.S.C. § 103 as being unpatentable over
Shih and Frazier.
ANALYSIS
The Rejection of Claims 1-5 and 7-19
as being anticipated by Shih
The Examiner finds that Shih discloses an apparatus and method for
refilling a reservoir having all of the limitations recited. Final Act. 5. More
particularly, the Examiner finds that:
Shih discloses an apparatus ( 400) for refilling a reservoir (108),
the apparatus comprising: a plurality of reservoirs ( 428, 420,
436); a plurality of reservoir fluid channels (408, 404, 412) each
associated with one of the reservoirs; an outlet fluid channel
fluidically connected to the reservoir fluid channels; [and] at
least one sensor (442) for monitoring pressure in the reservoir
fluid channels and the outlet fluid channel.
Final Act. 5; see also Ans. 8 (citing Shih ,r 78).
Appellant disagrees, stating that Shih's element 442 is a "bubble
detector" that "merely serves to detect the presence of gas in a fluid channel"
and "has no ability to monitor pressure in the reservoir fluid channels as
required by appealed claims 1 and 13." App. Br. 9; see also Shih ,r 66.
2 In the Final Office Action, the drawings are objected to for failure to
comply with 37 C.F.R. § 1.121(d). See Final Act. 2-3. However, this
objection is not within the jurisdiction of the Board. See 37 C.F.R. § 1.181.
3 The Examiner has withdrawn the 35 U.S.C. § 112(d) rejection of claims 2,
7-9, and 12. See Ans. 7; see also Final Act. 4.
3
Appeal2018-005684
Application 14/579,231
Appellant's contentions are persuasive. Shih's Figure 10 illustrates a
plurality of bubble detectors 442 residing within tool 400. See Shih Fig. 10.
Shih discloses that "the bubble detector 442 serves to detect gas." Shih ,r 66.
The Examiner states, "Shih' s detector can measure differences in pressure in
that a bubble can exert a different pressure depending upon its size of the
bubble(s) and the location of the sensor."4 Final Act. 10; see also App. Br.
9--11. However, the Examiner does not explain, or provide any supporting
evidence to show, how Shih discloses "monitoring pressure" in the recited
channels based on the mere detection of bubbles therein.
Nevertheless, the Examiner states, "Shih does teach the use of
pressure sensors." Ans. 8 (replicating a portion of Shih ,r 78). Appellant
again disagrees arguing, "Shih does not describe, teach or suggest
implementing a pressure sensor in the refilling tool for monitoring pressure
in the reservoir fluid channels" as recited. App. Br. 12 ( emphasis added).
Appellant's contention is again persuasive. However, as an initial
matter, we note that apparatus claim 1 recites a refilling tool having "at least
one pressure sensor for monitoring pressure in the [tool's] reservoir fluid
channels and the [tool's] outlet fluid channel." App. Br. 16 (Claims App.).
Method claim 13, on the other hand, recites "providing a refill apparatus"
and "monitoring a pressure level." App. Br. 18 (Claims App.). Thus, in
contrast to claim 1, claim 13 does not expressly recite what pressure level is
being monitored (i.e., that found in the refill apparatus or that of the
4 The Examiner's statement "a bubble can exert a different pressure
depending upon its size" is indicative of the well-known Boyle's Law (P 1V1
= P2V2) which compares "the same [bubble] under two different sets of
conditions." See https://en.wikipedia.org/wiki/Boyle's_law.
4
Appeal2018-005684
Application 14/579,231
implanted device being refilled). However, claim 13 also recites "providing
a refill apparatus comprising at least one pump, a plurality of reservoirs, a
plurality of reservoir fluid channels each associated with one of the
reservoirs, a plurality of valves, each having a cracking pressure . ... " App.
Br. 18 (Claims App.) (emphasis added).
Appellant's Specification discloses that "[t]he controller [of the refill
apparatus] may be configured to control the pump so as to maintain a
pressure through the outlet lumen below a pressure causing damage to an
implantable device," "[t]he controller may be configured to control the pump
so as to maintain, during a filling or aspiration step, a pressure through the
outlet lumen above a cracking pressure of check valves in the fluid lines
operatively used during the filling or aspiration step," and "[t]he controller
may be configured to monitor the at least one pressure sensor and, upon
detection of an expected pressure level following an expected interval, to
initiate or terminate a protocol step." Spec. ,r 11 ( emphasis added); see also
Spec. ,r 12. We thus understand, consistent with Appellant's Specification,
that the claimed step "monitoring a pressure level" in claim 13 is directed to
the "pressure level" within the refill apparatus itself, rather than a pressure
found within the implanted device being refilled.
Referring once again to paragraph 78 of Shih relied on by the
Examiner (see supra), it is not disputed that Shih discloses an "implantable
drug-delivery device 100" comprising a "chamber 108" as part of this
implantable device. See Shih ,r 39; see also Figs. lA-lB. Paragraph 78 of
Shih specifically discloses circuitry, and that "the governing circuitry 444
may monitor or track the pressure in the drug chamber 108, as described
above, to prevent it from surpassing a critical value." Shih ,r 78; emphasis
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Appeal2018-005684
Application 14/579,231
added. 5 This passage evidences that Shih monitors or tracks a pressure
within the implantable drug delivery device, i.e., within chamber 108, not
within any tool (i.e., 400) used to refill that chamber. See Shih ,r 64. The
Examiner does not direct us to any disclosure where a reservoir in Shih' s
refill tool 400 (as contrasted with Shih's implanted device 100) is tracked or
monitored. Thus, Appellant's contention that "Shih does not describe, teach
or suggest implementing a pressure sensor in the refilling tool for monitoring
pressure in the reservoir fluid channels," is also persuasive. App. Br. 12
( emphasis added).
In summation, and based on the record presented, we do not sustain
the stated rejection of claims 1-5 and 7-19 because the Examiner has not
established by a preponderance of the evidence that Shih anticipates any of
independent claims 1 and 13.
The Rejection of Claim 6
as being obvious over Shih and Frazier
Claim 6 depends from claim 1. App. Br. 16 (Claims App.). The
Examiner's rejection of claim 6 as unpatentable over Shih and Frazier is
based on the same unsupported findings in Shih as those discussed above.
See Final Act. 8-9. The Examiner relies on Frazier as disclosing a biosensor
and does not rely on Frazier to remedy the deficiencies of Shih. Final Act.
8-9. Accordingly, for reasons similar to those discussed above, we do not
sustain the rejection of claim 6 over Shih and Frazier.
5 The Examiner reproduced this passage in the Answer but "108" was
omitted. See Ans. 8
6
Appeal2018-005684
Application 14/579,231
DECISION
The Examiner's rejections of claims 1-19 are reversed.
REVERSED
7