Ex Parte Ginggen

Patent Trial and Appeal Board

Jul 24, 2017

12619900 (P.T.A.B. Jul. 24, 2017)

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.
12/619,900 11/17/2009 Alec Ginggen 22719-107
(COD5011USCNT1)
9520
21125 7590 07/26/2017
NUTTER MCCLENNEN & FISH LLP
SEAPORT WEST
155 SEAPORT BOULEVARD
BOSTON, MA 02210-2604
EXAMINER
GILBERT, ANDREW M
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
07/26/2017 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):
docket @ nutter.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALEC GINGGEN
Appeal 2015-005261
Application 12/619,900
Technology Center 3700
Before EDWARD A. BROWN, LYNNE H. BROWNE, and
BRANDON J. WARNER, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Alec Ginggen (Appellant) appeals under 35 U.S.C. § 134 from the
rejection under 35 U.S.C. § 103(a) of claims 1—11, 16—27, and 31—35 as
unpatentable over Adams (US 2004/0073196 Al, pub. Apr. 15, 2004) and
Flaherty (US 6,669,669 B2, iss. Dec. 30, 2003). We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
Appeal 2015-005261
Application 12/619,900
CLAIMED SUBJECT MATTER
The claims are directed to an implantable pump with integrated refill
detection. Spec. 1. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. An implantable device with an integral refill port with refill
instrument placement detection, comprising:
a refill port integral with the implantable device having:
a pierceable septum disposed on the refill port for
admitting a refill instrument, the pierceable septum having
a first outer surface at least a portion of which is exposed
outside the refill port and a second inner surface at least a
portion of which is exposed inside the refill port; and
a detector disposed inside the refill port with respect
to the second inner surface of the pierceable septum for
determining the placement of a refill instrument within the
refill port; and
control electronics located within the implantable device
in electronic communication with the detector, the detector
sending an electronic communication to the control electronics
based upon the placement of a refill instrument within the refill
port;
wherein the electronic communication triggers activation
of a diagnostic program to be run by the control electronics.
DISCUSSION
Appellant argues independent claims 18, 28, and 31 with claim 1. See
Appeal Br. 8. Appellant does not provide separate argument for any of the
dependent claims, except for claim 34. Id. at 12. Thus, Appellant argues
claims 1—11, 16—27, 31—33, and 35 together. We select claim 1 as the
illustrative claim, and claims 2—11, 16—27, 31—33, and 35 stand or fall with
claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
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Appeal 2015-005261
Application 12/619,900
Claims 1—11, 16—27, 31—33, and 35
The Examiner finds that Adams discloses all of the limitations of
claim 1 except “for expressly disclosing wherein the electronic
communication triggers activation of a diagnostic program to be run by the
control electronics, the diagnostic program being a fluid pressure or level.”
Final Act. 4. In particular, the Examiner finds that Adams discloses “an
integral refill port with refill instrument placement detection (Fig 3;
Summary; |11).” Id. The Examiner further finds that “Flaherty teaches that
it is known to have a refill port (Fig 30a-b) and infusion device (100),
wherein the electronic communication triggers activation of a diagnostic
program to be run by the control electronics.” Id. at 5 (citations omitted).
Based on these findings, the Examiner determines that it would have been
obvious
to modify the device and method as taught by Adams et al with
the diagnostic program and sensors checking the fluid level or
pressure of the port reservoir as taught by Flaherty for the
purpose of monitoring the fluid level of the port reservoir to
properly activate after refilling or disable the infusion device if
too much or too little liquid is in the reservoir.
Id. (citing Flaherty 7:14—23).
Appellant contends that “[njeither of the references, alone or
combined, discloses[,] teaches[,] or suggests the feature of triggering a
diagnostic procedure based upon a communication by the detector that the
refill instrument has been appropriately placed.” Appeal Br. 10 (emphasis
omitted). In support of this contention, Appellant argues that “Adams has
no diagnostic capability at all,” and that “Flaherty merely provides sensors
for the purpose of monitoring the flow of drugs into the patient, and to test
whether there are any blockages in that flow path.” Id.
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Application 12/619,900
Responding to this argument, the Examiner explains that the
combined teachings of Adams and Flaherty suggest the limitation at issue.
See Ans. 3—6. Specifically, the Examiner explains that in Adams
indicator signal (106) [] is indicative of a needle refilling
instrument (20) being properly placed within the refill port (see
Final Rejection dated 11/8/2013, 1 12). The electric indicator
signal (106) can also provide feedback to an[] alarm and to an
infusion pump to, for example, start or stop drug administration
(Adams et al, Tflf 22—23). Thus, Adams et al discloses generation
of an electronic signal that triggers the activation and
performance of several functions (i.e. alarm and control of a
pump) upon the placement of the needle within the refill port.
Id. at 3. The Examiner further explains that:
Flaherty discloses a refill port (Fig 30a-b) and reservoir (30) of a
drug delivery pump (100) having a processor (50) with
programming and circuitry to activate the device as necessary
(see Br. 7—8). The reservoir volume transducer or reservoir
pressure transducer transmits electronic communications to the
processor (50) that controls the activation of the dispenser (40)
and indicates conditions of the reservoir volume (i.e. too
little/much fluid) or pressure (i.e. too low/high). Thus, the
processor (i.e. control electronics) runs a diagnostic program that
tests the fluid pressure or fluid level within the reservoir based
on the feedback from the reservoir volume transducer or
reservoir pressure transducer.
Id. at 4. Based on these observations, the Examiner concludes that
in a modified device and method of Adams et al in view of
Flaherty the modification would result in the device of Adams et
al having a diagnostic program that tests the fluid pressure or
fluid level within the refill port based on the feedback from a
reservoir volume transducer or reservoir pressure transducer.
The electronic communication signal (106) in Adams et al
detecting that the needle has been correctly placed would trigger
activation ... of the diagnostic program and reservoir volume/
pressure transducers as taught by Flaherty to transmit the fluid
level/pressure of the refill port (i.e. empty or leaking or too
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Appeal 2015-005261
Application 12/619,900
much/too little liquid is in and/or being dispensed) after correct
placement of the needle and during the use of the device.
Id. at 5.
Responding to the Examiner’s explanation with regard to Adams,
Appellant argues that “Adams does not provide a refill port” because “[i]n
Adams there is nothing to refill.” Reply Br. 3. Although Appellant admits
that “Adams provides a detector that creates an alarm to let the health care
professional know when the need is properly placed in the vascular access
port,” Appellant contends that Adams’s teaching is limited to that “a person
of ordinary skill should be careful to run the external refill pump only when
the needle is in the refill port.” Id. at 3^4 (citing Adams | 6).
However, claim 1 does not recite a reservoir or any other specific
structure that is to be refilled. See Appeal Br. i (Claims App.). Moreover,
Appellant does not explain why Adams’s teachings are not applicable to a
port on a reservoir or other refillable component. Rather, as discussed
supra, Appellant admits that Adams teaches a detector for detecting proper
placement of a needle in a port. Thus, Appellant’s argument is
unconvincing.
In addition, Appellant argues that “Flaherty appears to provide in its
figure 2 ... an infusion pump that cannot be refilled (the refillable
embodiments, which come much later, have refill ports).” Appeal Br. 10;
see also Reply Br. 5. Responding to this argument, the Examiner identifies
Flaherty’s Figures 30a and 30b as illustrating a refillable reservoir 30 with a
refill port. See Ans. 4.
Responding to the Examiner’s explanation with regard to Flaherty,
Appellant contends that “Flaherty provides a single use fill port as part of its
low cost device. It is not at all clear that Flaherty can provide for refilling at
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Application 12/619,900
all.” Reply Br. 5. Although Flaherty does describe a single use embodiment
(see, e.g., Flaherty 19:17—19), this is not the embodiment relied upon in the
rejection. Rather, as discussed supra, the rejection relies upon an
embodiment with a refillable reservoir. See id. at 7:41—46. Thus,
Appellant’s contention does not apprise us of error.
Appellant further argues that “the notion that the pump can be
disabled if the fluid level is low betrays the notion that in order for
Flaherty’s sensor to work for its intended purpose, it works all the time — it
is not, and would not be, triggered by a (non-existent) re-fill.” Reply Br. 5.
However, as discussed above, the rejection does not propose any
modification of Flaherty’s sensor. Rather, the rejection proposes modifying
Adams’s detector to test fluid pressure or fluid level. See Ans. 5. Moreover,
as discussed supra, Flaherty contemplates re-fill and use of its sensor(s) to
trigger activation. See, e.g., Flaherty 7:31—39. Thus, Appellant does not
apprise us of error.
Next, Appellant argues that in Flaherty “there is no suggestion that
these sensors would be triggered by placement of a needle in a refill port.”
Appeal Br. 11; see also Reply Br. 4. Although Appellant is correct about
Flaherty alone, this is not indicative of error, as the rejection relies upon the
combined teachings of Adams and Flaherty to meet the claim limitation at
issue, as discussed supra. Specifically, the rejection relies on Adams to
teach instrument placement detection. See Final Act. 4. Moreover,
Appellant’s argument attacks the reference separately. Such attacks cannot
established nonobviousness when the rejection is predicated upon a
combination of prior art disclosures. See In re Merck & Co., 800 F.2d 1091,
1097 (Fed. Cir. 1986).
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Application 12/619,900
Finally, noting that “[t]he Answer posits that Applicant’s reliance on
the term ‘triggers’ is inappropriate because there is no claim limitation
requiring the diagnostic program to stop,” Appellant contends that “[t]his
position misunderstands the definition of the term ‘triggers.’” Reply Br. 5.
However, it is unclear what statement in section ii of the Answer, Appellant
is contesting. The Examiner correctly points out that claim 1 does not
require that “the diagnostic program must run and end during a time period,
i.e. during a refill of the refill port.” Ans. 6. Appellant does not explain how
the claim differentiates between programs that are triggered and then
continue to run and those that are triggered and then stopped. Thus,
Appellant does not apprise us of error.
In the Reply Brief, Appellant for the first time argues that Adams fails
to disclose an implantable device. See Reply Br. 2. In accordance with
37 C.F.R. § 41.41(b)(2), lacking a showing of good cause, we do not
consider this untimely argument raised for the first time in the Reply Brief,
which is not responsive to an argument raised in the Answer.
For these reasons, we sustain the Examiner’s decision rejecting claim
1, and claims 2—11, 16—27, 31—33, and 35, which fall therewith.
Claim 34
The Examiner finds that “Flaherty discloses triggering a notification
signal via the fluid pressure/level transducer sensors” and that Adams
“discloses triggering an alarm in the event of removal of the needle from the
refill port.” Final Act. 6 (citations omitted). Based on these findings, the
Examiner reasons that it would have been obvious “to modify the
notification signal of Flaherty with the alarm as taught by [Adams] for the
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Application 12/619,900
purpose of indicating to the user that there is an improper fluid level in the
port reservoir.” Id.
Appellant argues that “Adams has no testing. Flaherty only checks to
see if the reservoir is empty. There is no diagnostic feature that tests for a
high drug amount and triggers an alarm.” Appeal Br. 12. Responding to
this argument, the Examiner directs our attention to the section of Flaherty
which states that
the device can include sensors or transducers ... to indicate other
parameters determining flow, pump flowpath prime condition,
blockage in flowpath, contact sensors, rotary motion or other
motion indicators, as well as conditions such as the reservoir 30
being empty or leaking, or the dispensing of too much or too little
fluid from the reservoir, etc.
Flaherty 7:31—39. The Examiner notes that
the reservoir volume transducer can also measure other non­
limiting conditions which a person having ordinary skill in the
art at the time the invention was made would recognize includes
transmitting information to the processor for both a low level
amount and a high level amount within the reservoir (i.e. empty
or too little fluid or too much fluid).
Ans. 9. Based on these noted facts, the Examiner explains that “[i]t is clear
from this disclosure that a reservoir volume transducer in Flaherty is fully
capable of measuring both a high volume level and a low volume level
within the reservoir.” Ans. 9.1 The Examiner further explains that one
skilled in the art “would recognize that such a reservoir volume transducer
and processor as contemplated by Flaherty includes transmitting a signal to
the processor when the fluid level within the reservoir reaches a high level
amount and triggering a response from the processor, i.e. stopping or
1 We understand a high volume level in the reservoir to correspond to the
claimed high drug amount.
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Application 12/619,900
activating the dispenser.” Id. Given these explanations, the Examiner
reasons that it would have been obvious “to modify the notification signal of
Flaherty with the alarm as taught by Adams et al for the purpose of
indicating to the user that there is an improper fluid level in the port
reservoir.” Id.
Appellant does not respond to the Examiner’s logical explanations
and reasoning. See generally Reply Br. The Examiner’s explanations are
supported by reasoning with rationale underpinning. Thus, Appellant does
not apprise us of error.
Accordingly, we sustain the Examiner’s decision rejecting claim 34.
DECISION
The Examiner’s rejection of claims 1—11, 16—27, and 31—35 is
AFFIRMED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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