Ex Parte Bailey et al

Patent Trial and Appeal Board

Feb 16, 2016

12143278 (P.T.A.B. Feb. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/143,278 06/20/2008
48004 7590 02/16/2016
EGL/Cook - Indianapolis
BRINKS GILSON & LIONE
CAPITAL CENTER, SUITE 1100
201 NORTH ILLINOIS STREET
INDIANAPOLIS, IN 46204-4220
FIRST NAMED INVENTOR
F. Kristen Bailey
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.
13997/003 (PA-6429-RFB) 9052
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
MAILDATE DELIVERY MODE
02/16/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte F. KRISTEN BAILEY
and
JEFFRY S. MELSHEIMER
Appeal2013-008203
Application 12/143,278
Technology Center 3700
Before NEALE. ABRAMS, CHARLES N. GREENHUT,
and JASON W. MELVIN, Administrative Patent Judges.
ABRAMS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
F. Kristen Bailey et al. (Appellants) seek our review under 35 U.S.C.
§ 134(a) from the Examiner's decision rejecting claims 1-23. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b ).
We AFFIRM.
Appeal2013-008203
Application 12/143,278
THE INVENTION
The claimed invention is directed to an assembly for delivery of
nutritional products to the jejunum.
Claim 1, reproduced below, is illustrative of the subject matter on
appeal.
1. An assembly for delivery of nutritional products to the
jejunum of a patient through a stoma formed in the abdominal
wall and the stomach wall of the patient, comprising:
a first tubular member having a proximal end and a distal
end, said proximal end configured to communicate with an area
exterior of the patient, and said distal end configured to be
disposed within an interior space of the stomach of the patient,
at least a portion of said distal end within said stomach interior
space configured for maintaining said stomach wall in
substantial apposition with said abdominal wall;
a second tubular member having a proximal end and a
distal end, said proximal end configured to communicate with
an area exterior of the patient and said distal end configured to
substantially extend into the jejunum of the patient;
a hub having a plurality of sealable openings, a first one
of said openings communicating with said first tubular member,
and a second one of said openings communicating with said
second tubular member; and
a first closure member sized and arranged for selectively
sealing said first opening, and a second closure member sized
and arranged for selectively sealing said second opening.
THE PRIOR ART
The Examiner relied upon the following as evidence of
unpatentability:
J ascalevich
Vazquez
Chait
Meier
McMichael
us 3,144,868
us 4,356,824
us 5, 727 ,555
US 6,458,106 Bl
US 2003/0225393 Al
2
Aug. 18, 1964
Nov. 2, 1982
Mar. 17, 1998
Oct. 1, 2002
Dec. 4, 2003
Appeal2013-008203
Application 12/143,278
THE REJECTIONS
Claims 1---6, 8, 10 and 16-21 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Chait and Jascalevich.
Claims 7 and 9 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Chait, Jascalevich and McMichael.
Claim 22 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Chait, Jascalevich, McMichael and Vazquez.
Claim 23 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Chait, Jascalevich, McMichael, Vazquez and Meier.
OPINION
Claims 1-6, 8, 10 and 16--21
Obviousness - Chait and Jascalevich
The Examiner found all of the subject matter recited in claim 1 to be
disclosed by Chait, except for "a second tubular member having a length
such that it is capable of being extended into the jejunum of a patient."
Ans. 5. However, the Examiner points out that Chait recognizes that the
disclosed device may be used in the stomach, jejunum, or cecum, and that
the length of the tubular member can be varied so as to be appropriate for a
particular region of the gastrointestinal tract. Id. Jascalevich is cited for its
teaching of a similar device comprising first and second tubular members
extending from a common hub, which comprises portions disposed inside
and outside of the patient's body to span the abdominal wall and the stomach
wall. Ans. 6-7. The Examiner concludes that it would have been obvious to
provide the Chait device with a second tubular member extending from the
hub in order to allow access to two separate portions of the gastrointestinal
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Appeal2013-008203
Application 12/143,278
tract. Ans. 7-8. In response to Appellants' arguments, the Examiner states
that
Jascalevich clearly discloses a dual-lumen gastrostomy tube
(Fig. 1) that provides first and second tubes (12 and 14) for
allowing drainage or feeding functions as necessary.
Jascalevich discloses that such devices are of benefit as the
single device includes the requisite lumens to simultaneously
perform both suction and feeding as is required by certain types
of gastro-intestinal surgery (Fig. 1, Col. 1, Ln. 1-40).
Jascalevich discloses that it is a benefit of the disclosed device
to be able to located two separate locations of the GI tract
simultaneous with a single device (Col. 1, Ln. 41-57). An
ordinary artisan would reasonably recognize and appreciate that
multifunction devices are often desirable, particularly in the
medical arts, as it allows one device to function in place of two,
thereby eliminating any redundant materials, decreasing the
amount of time required to place a single catheter as compared
to multiple catheters, and requiring only one stoma instead of
two decreasing the time and invasiveness of the requisite
surgical intervention [e.g. a single stoma is easier to form an
maintain that two separate stoma].
Ans. 27. The Examiner also points out that "the scant teachings of Chait
suggesting a medical professional employ two separate devices (i.e. Col. 5,
Ln. 65 - Col. 6, Ln. 15) CANNOT reasonably be construed to comprise a
'teaching away,"' and that Chait suggests "that in some scenarios it is
obvious to use 'more than one catheters of the present invention' (Col. 6, Ln.
11-12)." Ans. 28-29. Finally, the Examiner asserts that the cited prior art is
capable of performing the functions specified in claim 1, in that Chait
discloses that the catheters may be sized and disposed to operate in any of
the stomach, jejunum, and Jascalevich discloses catheters of a suitable
length to reach the jejunum by way of the stomach. Ans. 35.
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Appeal2013-008203
Application 12/143,278
Among the arguments offered by Appellants is that Chait "extols the
benefits of a single catheter device" and "teaches the medical profession to
merely employ two separate devices," and not the claimed multi-tube
assembly. Br. 8. Appellants also assert that the cited references fail to teach
or suggest a device wherein the distal end of the first tubular member is
configured to be disposed within the stomach and the distal end of the
second tubular member is configured to be extendable into the jejunum, with
both extending from a hub and having closure members, that neither
reference "recognizes the desirability of combining a plethora of features
into a single efficient assembly," and that Chait "proceeds in a direction
contrary to the very teachings of Jascalevich." Br. 10-12.
Chait is directed to a catheter that finds "particular use" in the areas of
gastrostomy and gastrojunstomy, but may be used in any application where
connection from the outside of the patient's body to an internal cavity is
desired. Chait, col. 1, 11. 9-18. The catheter comprises an elongated tube
102 that extends from a hub (base portion) 124. Several helically wound
loops, which can oriented along the axis of the catheter or perpendicular
thereto, are located near the proximal end of tube 102 and cooperate with
hub 124 to maintain stomach wall 146 in substantial apposition with
abdominal wall 140. See id. at col. 5, 11. 10-38; Figures 8 and 9. A cover
126 is provided at the hub 124 to prohibit fluid leaking from the catheter
when in the closed position. Chait also teaches that "those skilled in the art
will recognize the use of the present invention for access to other body
cavities is analogous" and that various catheter lengths must be provided to
accommodate the different uses (id. at col. 4, 11. 39---62), and that patients
"frequently have several long term indwelling catheters in place for different
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Appeal2013-008203
Application 12/143,278
purposes," such as for infusion of drugs and/or feeding (id. at col. 5, 1. 65-
col. 6, 1. 15).
The Jascalevich device comprises a hub (body) 10 through which pass
a first tubular member 16, designated as a suction tube, and a second tubular
member 18, designated as a feeding tube. The device is described in the
context of providing means for aspirating and providing feeding following
gastro-intestinal surgery. Jascalevich, col. 1, 11. 10-12. Jascalevich explains
that in operation the distal end of one of the tubes can be placed in a first
body cavity and the distal end of the other in a second body cavity,
depending upon the function to be performed. Id. at col. 3, 11. 26-46, Figs. 2
and 3. Thus, J ascalevich presents a manifestation of Chait' s teachings
regarding multiple catheters in the form of an arrangement in which multiple
tubular members are carried by a common hub, and can extend therefrom to
be placed in different organs and used for different purposes.
We therefore we agree with the Examiner's reasoning that it would
have been obvious to modify the Chait device by providing a second tubular
member mounted on the hub in the manner specified in claim 1. In view of
the teaching of Chait, we also are of the view that it one of ordinary skill in
the art would have found it obvious to provide the second tubular member
with a sealing member at its proximal end.
In arriving at this conclusions, we have carefully considered all of
Appellants' arguments, but they have not persuaded us that the Examiner's
decision to reject claim 1 is in error. In this regard, we note that
'"[A ]pparatus claims cover what a device is, not vvhat a device does"
(Jleo,v!ett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464~ 1468 (Fed.
Cir. 1990)), and that although the features of an apparatus may be recited
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Appeal2013-008203
Application 12/143,278
either structurally or functionally (Jn re Schreiber, 128 F.3d 1473, 1478
(Fed. Cir. 1997)), if the Examiner concludes that a functional limitation is an
inherent characteristic of the prior art and has explained that the prior art
structure inherently possesses the functionaHy defined limitations of the
claimed apparatus) the burden then shifts to applicant to establish that the
prior art does not possess the characteristic relied upon (id). It is our view
that the Examiner adequately explained on pages 3 and 4 of the Final Action
\vhy the tubular members disclosed in Chait and Jazcalevich inherently are
capab1e of functioning in the manner recited in Appellants' claim L
Although Appellants assert that this is not the case (Br. 10), their response
does not include evidence or convincing argument in support of that
conclusion.
It therefore is our view that the Examiner has established the
obviousness of the subject matter recited in independent claim 1, and the
rejection of this claim is sustained.
\Vith regard to claim 4, Appellants argue that neither of the references
teaches or suggests that the hub comprises a "housing member" configured
to be extendable into the stoma. Br. LL In the absence of anv limiting ..; ,_
description in the claini of the housing nieniberi the proximal section 118 of
Chaif s device and the portion of Jascalevich~ s tubing distal to openings 16
and 18 meet the terms of this claim, and the rejection is sustained.
AppeHants' argument regarding dependent claim 6 (Br. 1 OJ is not
persuasive because Chait clearly discloses a stylet capable of straightening
the curled portion of the tubular member in the interior space of the organ
. ! . ! < < • d < ~ < t < 1 • .-, (-' l 4 l 6'" ·1 ~ J q mto wn1cn 1t 1s mserte i as rec1teci mt ns CEam1. ,"Jee A) . · , . j---{'.O . ), . _.:
Fig. 5. ·rhe rejection of claim 6 is sustained.
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Appeal2013-008203
Application 12/143,278
The argument regarding dependent claim 8 (Br. 13----14) is not
persuasive because modification of the Chait device in the manner proposed
bv the Examiner wou1d result in a second tubular member extending through ,.. ..._. ...._
a second opening in the hub, as is required by this claim. The rejection of
claim 8 is sustained.
Likewise, Appellants; argument regarding claim 21 is not persuasive
because Chait comprises an opening having a closure sized and configured
for selectively sealing the opening. See Col. 4, 11. 27----38. As explained by
the Examiner on page 26 of the Final Action, it wou1d have been obvious to
provide the same structure vvhen adding a second tubular member to the
Chait device. The rejection of claim 21 is sustained.
Appe11ants have chosen not to argue the separate patentability of
claims 2, 3~ 5 and 10, which depend from claim l (Br. 13), independent
claim 16~ and dependent claims 17---20 (Br. 15), and therefore the rejection
of these claims also is sustained.
Claims 7 and 9
Obviousness - Chait, Jascalevich and McMichael
Appellants also have chosen not to argue the separate patentability of
claims 7-9, which depend from claim l (Br. 13), independent claim 16, and
dependent cfaims 17-20 (Br. 15-16). Therefore, this t\.:jection is sustained.
Claim 22
Obviousness - Chait, Jascalevich, McMichael and Vazquez
Claim 22 is an independent claim that recites, in somewhat different
terms, the subject matter set forth in claim 1, and adds a stylet and details of
the structure of the hub and the closure members. Appellants refer to the
arguments they advanced against the rejection of claim 1, and additionally
assert that "[n]either McMichael nor Vazquez lends any support to the
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Appeal2013-008203
Application 12/143,278
Examiner's combination of Chait and Jazcalevich." Br. 16, 17. In the
absence of any new arguments regarding the two basic references, the
rejection of claim 22 is sustained on the basis of the reasoning set forth
above with regard to the rejection of claim 1.
Claim 23
Obviousness - Chait, Jascalevich, McMichael, Vazquez and Meier
Claim 23 depends from claim 22. The sole argument advanced here is
that Meier does not teach the features in claim 22 that Appellants believe
have not been taught by the references cited against that claim. The
rejection of claim 22 having been sustained, the rejection of claim 23 also is
sustained.
DECISION
All of the rejections are sustained.
The decision of the Examiner 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).
AFFIRMED
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