Ex Parte Schiff et al

Patent Trial and Appeal Board

Oct 23, 2018

13622378 (P.T.A.B. Oct. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/622,378 09/19/2012 David Robert Schiff
32182 7590 10/25/2018
Becton, Dickinson and Company/fhe Webb Law Firm
One Gateway Center
420 Ft. Duquesne Blvd., Suite 1200
Pittsburgh, PA 15222
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.
4606 - 122359 (P-9742) 1049
EXAMINER
ZAM ORY, JUSTIN L
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
10/25/2018 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):
patents@webblaw.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte DAVID ROBERT SCHIFF, MATHIEU DOMINIC TURPAULT,
ANTONIO GATTA, and JOHN DEPLER COLEMAN
Appeal2017-010922
Application 13/622,378
Technology Center 3700
Before BART A. GERSTENBLITH, CYNTHIA L. MURPHY, and
TARA L. HUTCHINGS, Administrative Patent Judges.
MURPHY, Administrative Patent Judge.
DECISION ON APPEAL
The Appellants 1 appeal under 35 U.S.C. § 134 from the Examiner's
rejection of claims 1, 3-5, 7-10, 12, 13, 15-18, 20, and 24. We have
jurisdiction over this appeal under 35 U.S.C. § 6(b).
We AFFIRM.
1 The Appellants identify the real party in interest as "Becton Dickinson
France, S.A.S." (Appeal Br. 3.)
Appeal2017-010922
Application 13/622,378
STATEMENT OF THE CASE
According to the Appellants, the claimed invention "is directed to a
pre-filled syringe assembly having a rotatably advanceable plunger rod
which results in a smaller packaging footprint allowing for reduced storage
space." (Spec. ,r 2.)
Illustrative Claim
1. A syringe assembly, comprising:
a syringe barrel having a first end, a second end, and a
sidewall extending therebetween defining a chamber;
a stopper slideably disposed at least partially within the
chamber; and
a plunger rod having an inner member engaged with a
portion of the stopper and an outer member adapted for
rotational advancement with respect to the inner member to
axially displace the outer member with respect to the inner
member,
wherein the plunger rod is transitionable from a collapsed
position in which a portion of the inner member is nested within
the outer member, to an extended position in which the same
portion of the inner member extends outside the outer member,
wherein the inner member comprises a non-helical radial
extension and the outer member defines a track adapted to
receive the radial extension therein,
wherein the track extends within a sidewall of the outer
member between a proximal end and a distal end, the distal end
comprising a restraint for locking the radial extension therein in
the extended position, and
wherein the restraint includes a flattened recess within
the sidewall of the outer member such that the radial extension
is secured within the recess within the sidewall of the outer
member when the restraint locks the radial extension therein to
prevent axial movement of the outer member with respect to the
inner member.
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Application 13/622,378
Rejection
The Examiner rejects claims 1, 3-5, 7-10, 12, 13, 15-18, 20, and 24
under 35 U.S.C. § I03(a) as unpatentable over Janish2 in view of Page. 3
(Non-Final Action 2.)
ANALYSIS
Claims 1, 9, and 15 are the independent claims on appeal, with the rest
of the claims on appeal depending therefrom. (See Appeal Br., Claims App.)
Independent claims 1 and 15 are drawn to "[a] syringe assembly," and
independent claim 9 is drawn to "[a] plunger rod assembly." (Appeal Br.,
Claims App.) The Examiner determines that the claimed assemblies would
have been obvious over the combined teaching of Janish and Page (see Non-
Final Action 2); and the Appellants argue the Examiner errs in making this
determination (see Appeal Br. 11-19; see also Reply Br. 2-8). For the
following reasons, we are unpersuaded by the Appellants' arguments.
Independent claims 1, 9, and 15 recite a "plunger rod" having an
"inner member" and an "outer member" so that it can transition from a
"collapsed position" to an "extended position." (Appeal Br., Claims App.)
In the collapsed position, "a portion of the inner member is nested within the
outer member." (Id.) In the extended position, "the same portion of the
inner member extends outside of the outer member." (Id.)
The Examiner finds that Janish discloses a syringe assembly having a
plunger rod. (See Non-Final Action 2.) Janish discloses a syringe assembly
2 US 2009/0318880 Al, published December 24, 2009. Our quotations from
this reference omit bolding of drawing-related numerals.
3 US 4,923,446, issued May 8, 1990.
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Application 13/622,378
in which a plunger rod 300 comprises a "first plunger rod piece 310" and a
"second plunger rod piece 320." (Janish ,r 37.) These plunger-rod
components are shown in our below annotated version of Janish's Figure 3.
Janish Figure 3
Janish's Figure 3 depicts a disassembled perspective view of a two-piece
plunger rod. (Id. ,r 16.) As shown in the above drawing, "the second plunger
rod piece 320 fits inside the hollow receptacle 314 of the first plunger rod
piece 310." (Id. ,r 38.) Thus, Janish's first plunger rod piece 310 is an "outer
member," and Janish's second plunger rod piece 320 is an "inner member."
As also shown in the above drawing, Janish's outer member 310 has "a distal
locking recess 330 and a proximal locking recess 340," and Janish's inner
member 320 has "proximal locking element 350." (Id. ,r 38.) The frames of
the plunger-rod members 310 and 320 "are shaped to prevent rotational
motion." (Id. ,r 37 .)
Janish's outer member 310 and Janish's inner member 320 are
"slidably mounted to each other, permitting the overall length of the plunger
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Application 13/622,378
rod to be adjusted from a compressed length to an extended length." (Janish
,r 37.) Thus, Janish's plunger rod 300 transitions from a "collapsed
position," whereat a portion of its inner member 320 is nested within its
outer member 310, and an "extended position," whereat the same portion of
the inner member extends outside of the outer member. These collapsed and
extended positions are shown, respectively, in our below annotated versions
of Janish's Figures 4 and 7.
Janish Figure 4
Janish Figure 7
Janish's Figure 4 illustrates the two-piece plunger rod in the compressed
position, and Janish's Figure 7 illustrates the two-piece plunger road in the
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Application 13/622,378
extended position. (Id. ,r,r 17, 20.) As shown in the above drawings, the
locking element 350 is engaged with the locking recess 330 when Janish's
plunger rod is in the collapsed position shown in Figure 4; and the locking
element 350 is engaged with the locking recess 340 when Janish's plunger
rod is in the extended position shown in Figure 7. As indicated above, in
Janish's plunger rod 300, the outer member 310 and the inner member 320
"are shaped to prevent rotational motion" (id. ,r 37), and this ensures that the
locking element 350 remains aligned with the collinearly-arranged locking
recesses 330 and 340 as the outer and inner members 310 and 320 linearly
advance from the collapsed position to the extended position.
Independent claims 1 and 9 also require the outer member to be
adapted, or configured, "for rotational advancement with respect to the inner
member." (Appeal Br., Claims App.) Independent claim 15 similarly
recites the "rotation of the outer member about the inner member." (Id.)
The Examiner finds that Page teaches rotational advancement of an outer
member with respect to an inner member. (See Non-Final Action 3.) Page's
outer and inner members are shown in our below annotated version of
Page's Figure 1.
Page Figure 1
inner n1em her outer men1ber
radial extension
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Application 13/622,378
Page's Figure 1 depicts a perspective drawing of a syringe ( or inner
member) and shield (or outer member). (Id. at col. 1, 11. 44--45.) As shown
in the above drawing, a track on Page's outer member "slidably engages" a
radial extension on Page's inner member. (Id. at col. 2, 11. 5-14.) When this
radial extension is situated at the distal end of the track (i.e., the right-hand
end in the illustrated orientation), Page's inner member will be nested within
Page's outer member; and when this radial extension is at the proximal end
of the track (i.e., the lefthand end in the illustrated orientation), Page's inner
member will extend outside Page's outer member.
The Examiner determines that "[ o ]ne of ordinary skill in the art,
having access to both prior art references," namely, Janish and Page, "would
realize that the plunger rod of Janish could be modified in the manner taught
by Page so as to change the effective length of the plunger via rotation rather
than linear advancement." (Non-Final Action 4.) Thus, in the Examiner's
proposed combination of the prior art, Janish' s outer member 310 is
provided with a curved track that slidably engages a radial extension
provided on Janish's inner member 320. And, to transition Janish's
modified plunger rod 300 from the collapsed position to the extended
position, the outer member 310 is rotated relative to the inner member 320.
The Appellants argue that neither Janish nor Page teach a plunger rod
in which an outer member rotationally advances with respect to an inner
member. (See Appeal Br. 13-15; see also Reply Br. 2-3.) We are not
persuaded by this argument because it is not aligned with the Examiner's
rejection. The Appellants do not dispute that Janish teaches a plunger rod in
which an outer member advances with respect to an inner member; and the
Appellants do not dispute that Page teaches that an outer member can
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Application 13/622,378
rotationally advance with respect to an inner member. In the Examiner's
proposed combination of the prior art, Janish's modified plunger rod 300
comprises an outer member 310 that rotationally advances with respect to an
inner member 320.
The Appellants also argue that "Janish expressly teaches a device
configured to avoid rotational movement, at least for the plunger rod
assembly." (Appeal Br. 16.) Thus, according to the Appellants, "Janish
very clearly teaches against the use of rotational movement in its plunger
rod." (Id. at 17.) Along this same line, the Appellants argue that a
modification involving rotational movement would "change the principle of
operation" of Janish's plunger rod and/or render it "inoperable for its
intended purpose." (Id.)
We are not persuaded by these arguments because they do not address
the Examiner's explanation about Janish's teachings in this regard. (See
Answer 6-7.) As discussed above, Janish's collinear arrangement of its
locking recesses 330 and 340 requires the outer member 310 and the inner
member 320 to maintain the same linear alignment as they move from the
collapsed position to the extended position. But when Janish's plunger
rod 300 is modified as proposed by the Examiner, this linear alignment
"would cease to be an issue," as the track defined by the outer member 310
would guide the inner member 320 from the collapsed position to the
extended position. (Id. at 7 .)
Moreover, in the modified version of Janish's plunger rod 300, the
outer member 310 and the inner member 320 would still be "slidably
adjustable between a compressed length and an extended length" and
"operable to expel the fluid when placed in the extended state." (Janish
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,r 12.) Additionally, this modification would not prevent Janish's medical
device from "having a syringe with a barrel prefilled with fluid for delivery
to a patient." (Id.) More succinctly, the Examiner's proposed modification
would not change the principle of operation of Janish's plunger rod and/or
render anything inoperable for its intended purpose.
Independent claims 1, 9, and 15 additionally require the outer member
to define "a track," which "extends within a sidewall of the outer member
between a proximal and a distal end." (Appeal Br., Claims App.) The
Appellants argue that, in Janish's plunger rod 300, "there is no 'track'
extending within the sidewall of the outer member (first rod piece 310)
between a proximal and distal end as claimed." (Id. at 14.)
We are not persuaded by this argument because in the Examiner's
combination of the prior art, Janish' s outer member 310 is modified to
include the curved track taught by Page. And, as shown above, Page teaches
a track that extends within a sidewall of an outer member between proximal
and distal ends. (See Page, Fig. 1.) In other words, "the helical track and
pin configuration of Page would be considered to disclose the claimed
structure as the slot in which the pin rides in is a helical track." (Answer 8.)4
The Appellants also advance arguments (see, e.g., Appeal Br. 14,
Reply Br. 6) premised upon their disclosed structure only requiring the
medical practitioner to "grasp any portion of the outer member" and "rotate
the outer member relative to the inner member" in order to "effectuate
transition of the plunger rod to the extended position." (Spec. ,r 36.)
4 As for the Appellants' mention of dependent claims 3, 12, and 16 (see
Appeal Br. 14 ), Page's track is at least partially helical about an outer
surface of the outer member. (See Page, Fig. 1.)
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Application 13/622,378
According to the Appellants, "Janish and Page are silent concerning the
importance of a plunger rod adapted to be expanded with one hand." (Reply
Br. 6.) Be this as it may, the Appellants do not direct our attention to claim
language limiting the claimed structure to a plunger rod accommodating a
one-handed expansion.
The Appellants do point out that dependent claim 4 requires "the
radial extension remains substantially stationary during transition of the
plunger rod from the collapsed position to the extended position." (Appeal
Br., Claims App.) But in the modified version of Janish's plunger rod
assembly 300, this could be accomplished by holding the inner member 320
stationary (with one hand) and turning the outer member 310 (with the other
hand). Again, the Appellants do not direct our attention to claim language
limiting the claimed structure to a plunger rod accommodating a one-handed
expans10n.
For at least these reasons, we are unpersuaded by the Appellants'
arguments that the Examiner errs in determining that the claimed assemblies
would have been obvious over the prior art. Thus, we sustain the
Examiner's rejection of claims 1, 3-5, 7-10, 12, 13, 15-18, 20, and 24 under
35 U.S.C. § 103(a) as unpatentable over Janish in view of Page.
DECISION
We AFFIRM the Examiner's rejection of claims 1, 3-5, 7-10, 12, 13,
15-18, 20, and 24.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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