Ex Parte Langley et al

Patent Trial and Appeal Board

Nov 8, 2013

10433642 (P.T.A.B. Nov. 8, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte CHRISTOPHER NIGEL LANGLEY,
SHANE ALISTAIR DAY, ROBERT FREDERICK VEASEY,
and ROBERT WOOLSTON
____________________

Appeal 2010-009672
Application 10/433,642
Technology Center 3700
____________________

Before: PHILLIP J. KAUFFMAN, LYNNE H. BROWNE, and
BART A. GERSTENBLITH, Administrative Patent Judges.

KAUFFMAN, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the Examiner’s
decision to reject claims 1-3, 5-7, 10, 11, 13, 14, and 16. Appellants’
representative presented oral argument on October 17, 2013. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

The Invention
Appellants’ claimed invention relates to “improvements in a portable
injection device for dispensing controlled quantities of a medicament.”
Spec. 1:3-5. Independent claim 1, reproduced below, is the sole independent
claim on appeal:
1. An injection device, comprising:
a drive mechanism to expel selectively a dose of
medicament from a medicament cartridge through a needle unit;
an electronic control unit to control the drive
mechanism, and
a dispense button to generate a dispense button
signal to the electronic control unit indicative of the dose to be
expelled in which an arm button causes a first arm button signal
to be sent to the electronic control unit to permit the dose to be
expelled,
wherein the arm button must generate the first arm
button signal for a predetermined period of time greater than the
transmission time of the first arm button signal to the electronic
control unit before the electronic control unit will respond to
the dispense button signal.

Evidence Relied Upon
Niehoff
Jensen
Klitmose
US 5,681,286
US 6,248,090 B1
US 6,277,098 B1
Oct. 28, 1997
Jun. 19, 2001
Aug. 21, 2001
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The Rejections
The following rejections are before us on appeal:
I. Claim 1 under 35 U.S.C. § 112, first paragraph, as failing to comply
with the written description requirement.
II. Claims 1, 3, 6, and 14 under 35 U.S.C. § 102(b) as anticipated by
Niehoff.
III. Claims 2, 5, 7, 10, 11, 13, and 16 under 35 U.S.C. § 103(a) as
unpatentable over Niehoff and either Klitmose or Jensen.

OPINION
I. Written description requirement
Appellants amended claim 1 so that the last clause recites “wherein
the arm button must generate the first arm button signal for a predetermined
period of time greater than the transmission time of the first arm button
signal to the electronic control unit before the electronic control unit will
respond to the dispense button signal.” App. Br. 32, Claims App’x, Claim 1
(added language underlined); see also Ans. 3. The Examiner determined
that Appellants’ original disclosure does not contain an adequate written
description of the added language. Ans. 3.
Appellants concede that the added language does not have verbatim
support in the original disclosure, but assert that the disclosure reasonably
conveys Appellants possessed the claimed subject matter for two reasons.
App. Br. 15-16; see also Reply Br. 2. These reasons relate to a timing
sequence and a display panel.
Timing Sequence
According to Appellants, a person of ordinary skill in the art
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would understand that, based on the application's objective of
avoiding inadvertent pressing of the arm button based on
timing, rather than for example, physical placement of actuating
buttons, the recited predetermined period of time would
necessarily be greater than the recited transmission time.
App. Br. 16. Appellants elaborate that the Specification describes that the
device is configured so that it is not possible to inadvertently depress the
primer button and “describes a timing sequence to address a concern the
inventors had over inadvertent button pressing.” App. Br. 16-17 (citing Fact
4, at App. Br. 10). For the reasons that follow, this contention is
unpersuasive.
Appellants’ disclosure states that when end cap 6 is in place over the
second end of main housing 4 it is not possible to inadvertently depress
primer button 26. Spec. 2:25; 3:5-8; figs. 1, 2. In light of this, Appellants’
characterization that the device is configured to prevent inadvertent pressing
of the arm button through a timing sequence is a mischaracterization in that
inadvertent button pressing is prevented by end cap 6, not a timing sequence.
Further, the Specification’s disclosure that end cap 6 protects the
primer button from being inadvertently depressed, may fairly imply that
Appellants sought to prevent inadvertently priming the device. However,
such disclosure falls short of demonstrating that Appellants possessed an
injection device wherein the first arm button signal is generated for a
predetermined period of time greater than the transmission time of that
signal to the electronic control unit.
Display Panel
Appellants assert that “one skilled in the art would understand that,
based on the application's disclosure of the display panel displaying the
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armed status, the recited predetermined period of time would necessarily be
greater than the recited transmission time.” App. Br. 16.
Appellants’ argument that the first arm button signal must necessarily
be generated for a predetermined period of time greater than the
transmission time of that signal to the receiving device so that the signal may
be displayed is premised on the interpretation that claim 1 calls for the signal
to be displayed. However, claim 1 does not recite a display panel, and does
not otherwise call for the signal to be displayed.1 Therefore, Appellants’
contention is unpersuasive.
Further, to the extent that Appellants’ argument suggests that a signal
necessarily must be generated for a period of time greater than the
transmission time of that signal to the receiving device (i.e., the electronic
control unit), we cannot agree. First, the Specification describes that the
“arm button is preferably held down for a predetermined period of time
before injector 2 becomes armed” (Spec. 5:23-25), but does not state that the
predetermined period of time must exceed the transmission time of the
signal to the receiving device. Second, once generated, a signal may be
successfully transmitted to another device, such as an electronic control unit,
even if the transmission time exceeds the period of time the signal was
generated.
The “hallmark of written description is disclosure.” Ariad Pharms.,
Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Here

1 Dependent claims 5, 10, and 11 add a display panel, further supporting the
interpretation that claim 1 does not call for a display panel. See Liebel-
Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910 (Fed. Cir. 2004) (the
presence of a dependent claim that adds a particular limitation gives rise to a
presumption that the limitation in question is not present in the independent
claim).
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Appellants’ Specification broadly discloses an injection device having an
arm button that is held for a predetermined period of time before the
electronic control unit will respond to the dispense button signal. We fail to
see and Appellants fail to cogently articulate how such disclosure
demonstrates Appellants possessed an injection device having an arm button
that is held for a predetermined period of time great than the transmission
time of the first arm button signal to the electronic control unit before the
electronic control unit will respond to the dispense button. Appellants’
arguments do not apprise us of error in the rejection of claim 1.
Accordingly, we sustain the rejection of claim 1.

II. & III. Anticipation by Niehoff & Obviousness over Niehoff and either
Klitmose or Jensen
Given that we sustained the written description rejection of claim 1,
we consider the amended language that lacks an adequate written description
not to be part of the subject matter of claim 1. Therefore, for purposes of
these prior art rejections, we consider the last clause of claim 1 to read as
follows:
wherein the arm button must generate the first arm button
signal for a predetermined period of time greater than the
transmission time of the first arm button signal to the electronic
control unit before the electronic control unit will respond to
the dispense button signal.
Rejections II and III each rely upon the Examiner’s findings that
Niehoff’s dispense button (forward manual motion button 46 or reverse
manual motion button 47) generates a signal, and Niehoff’s arm button
(enable/accelerate button 48) inherently generates a signal for a
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predetermined period of time. Ans. 4 (Rejection II), 4-5 (relying upon
Rejection II findings for Rejection III). The Examiner’s inherency finding
with regard to the arm button signal is based upon the Examiner’s
interpretation that any signal exists for some timeframe, and because
Appellants have not defined “a predetermined amount of time” as recited in
claim 1, existence of a signal for some timeframe is a predetermined period
of time as claimed.2 Ans. 4.
To the extent that the Examiner reasons that if a signal exists, it exists
for some period of time, we agree. However, that reasoning is not
commensurate in scope with claim 1 because claim 1 does not simply call
for a signal to exist for some period of time.
Claim 1 calls the first arm button signal to be generated for a
predetermined period of time before the electronic control unit will respond
to the dispense button signal. App. Br. 32, Claims App’x, Claim 1.
Consistent with this claim language, the Specification states that the function
of the arm button 16 is to make the dispense button 18 active. Spec. 5:23.
Therefore, if the first arm button signal is generated for a period of time less
than or equal to the predetermined period of time, the electronic control unit
will not respond to the dispense button signal (the dispense button will not
be active), and if the first arm button signal is generated for a period of time
greater than the predetermined period of time, the electronic control unit will
respond to the dispense button signal (the dispense button is active).
As the Examiner acknowledges, Niehoff’s dispense button (forward
manual motion button 46 or reverse manual motion button 47) and arm

2 The Examiner misquotes claim 1 which recites “a predetermined period of
time” rather than “a predetermined amount of time.” See Ans. 4 (emphasis
added); App. Br. 32, Claims App’x, Claim 1.
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button (enable/accelerate button 48) are depressed simultaneously to move
the plunger drive (permitting a dose to be expelled). See Niehoff, col. 4,
l. 65 - col. 5, l. 5. Because Niehoff’s first arm button signal (produced by
enable/accelerate button 48) and dispense button signal (produced by
forward manual motion button 46 or reverse manual motion button 47) are
generated simultaneously, Niehoff’s dispense button (forward manual
motion button 46 or reverse manual motion button 47) is active at the time
the arm button signal (from enable/accelerate button 48) is generated
without a delay of a predetermined period of time with respect to the first
arm button signal.
Therefore, a preponderance of the evidence does not support a finding
that Niehoff’s arm button necessarily generates a signal for a predetermined
period of time before the electronic control unit will respond to the dispense
button signal as called for in independent claim 1. See App. Br. 20; Reply
Br. 4.
Consequently, we do not sustain Rejections II and III.

DECISION
We affirm the Examiner’s decision to reject claim 1 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement.
We reverse the Examiner’s decision to reject claims 1, 3, 6, and 14
under 35 U.S.C. § 102(b) as anticipated by Niehoff, and we reverse the
Examiner’s decision to reject claims 2, 5, 7, 10, 11, 13, and 16 under 35
U.S.C. § 103(a) as unpatentable over Niehoff and either Klitmose or Jensen.
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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)(1)(iv).

AFFIRMED-IN-PART

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