Ex Parte Weitzner et al

Patent Trial and Appeal Board

Aug 29, 2016

13070365 (P.T.A.B. Aug. 29, 2016)

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.
13/070,365 03/23/2011 Barry Weitzner 10121/14905
(05-00407US2)
1890
30636 7590 08/29/2016
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
EXAMINER
SU, SUSAN SHAN
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
08/29/2016 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 BARRY WEITZNER, KATIE KRUEGER,
CLAUDE CLERC, and WILLIAM BERTOLINO
__________

Appeal 2014-009094
Application 13/070,365
Technology Center 3700
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

PER CURIAM

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involves claims 9–12, 18–20,
22, 23, and 25–27 (App. Br. 1). Examiner entered rejections under 35
U.S.C. §102(e) and 35 U.S.C. §103(a). We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.

1 Appellants identify the Real Party in Interest as Boston Scientific Scimed,
Inc. (App. Br. 2).
Appeal 2014-009094
Application 13/070,365

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STATEMENT OF THE CASE
Appellants’ invention “relates to anti-obesity dual stents which are
secured in the duodenum adjacent to the stomach to reduce digestion and
absorption of food” (Spec. ¶ 1). Independent claim 9 is representative and
reproduced in Appellants’ Appeal Brief.
Claims 9, 10, 12, 18–20, 22, 23, and 25–27 stand rejected under 35
U.S.C. § 102(e) as being anticipated by Bessler.2
Claim 11 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Bessler and Stack.3

Anticipation:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
Examiner’s finding that Bessler teaches Appellants’ claimed invention?

2 Bessler et al., US 7,211,114 B2, issued May 1, 2007.
3 Stack et al., US 2004/0117031 A1, published June 17, 2004.
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FACTUAL FINDINGS (FF)
FF 1. Bessler’s Figure 2 is reproduced below.

Figure 2 shows
a gastric bypass stent 2 comprises a stent member 4 at the
proximal end 6 of a tubular member 8 and, optionally, a stent
member 10 at the distal end 12 of tubular member 8. Proximal
tubular end 6 comprises a one-way valve member 16 to permit
passage of food and liquid, and the wall 18 of tubular member 8
comprises one[-]way openings or valves 20 to permit gastric acid
or fluid to flow into stent 2.
. . . the distal portion 14 of valve member 16A may optionally
extend to or through tubular member distal end 12, whereby food
from a patient’s esophagus (not shown), i.e., ingested food,
would not be contacted by gastric acid or fluid within stent 2 or
by digestive enzymes within the duodenum (not shown).
(Bessler 2:45–62; see also Ans. 2–3, 5–6.)
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FF 2. Bessler teaches
The width, length, and other parameters of the stent of the
invention will vary, especially according to the patient, as one
skilled in the art would appreciate. The overall length of the stent
will be from about 10 to about 40 cm, preferably from about 12
to about 30 cm, and the expanded diameter will be from about
1.5 to about 4 cm, preferably from about 2 to about 3 cm.
(Bessler 3:31–37; see also Ans. 9.)
FF 3. The Specification teaches that “[a]lthough subject to substantial
variation in different individuals, the pylorus 25 has a maximum open
diameter of about 2 cm, and the duodenum 20 has a diameter which
typically is about 18 to 20 mm in a representative patient” (Spec. ¶ 27; see
also Ans. 9).
FF 4. Figure 1 of the Specification is reproduced below:

Figure 1 shows that “[t]he outer structure 40 and the inner structure 57
therein, are sized to fit within the duodenum 20 in substantially coaxial
relation therewith” (Spec. ¶ 39; see also Ans. 9).
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FF 5. The Specification teaches that “[t]he retainer structure 77 is the
transverse dimension of the outer surface 42 of the outer structure 40 being
sufficiently large to press against the inner surface 30 of the duodenum 20
when the proximal port structure 72 has substantially the same longitudinal
position as the papilla of Vater 35” (Spec. ¶ 42; see also Ans. 9), and “[s]uch
outward flaring provides for the papilla-supplied and pylorus-supplied
structures 40b, 57b to fit snugly within the duodenum 20 and possible other
locations of deployment” (Spec. ¶ 54; see also Ans. 9).
ANALYSIS
Appellants’ independent claim 9 requires, inter alia, a stent having (a)
“a proximal end of the stent being selected to closely match an inner
diameter of a portion of a duodenum into which it is to be implanted so that
substantially all chyme flowing through the duodenum enters the proximal
end of the stent,” (b) “the first elongated element being configured and
dimensioned for insertion to a desired location in a duodenum,” (c) “the first
port being located along a length of the first elongated member so that, when
the first proximal end is inserted to the desired location within a duodenum,
the first port opens to a papilla of vater,” (d) “an outer portion of the second
elongated element is coupled to the first elongated element so that all chyme
flowing through the duodenum enters the second channel of the second
elongated element,” and (e) “a retainer configured to retain the first and
second elongated elements at the desired position within the duodenum” (see
Appellants’ claim 9).

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Appellants’ independent claim 26 similarly requires, inter alia, (a)
“the first elongated element being configured and dimensioned for insertion
to a desired location in a duodenum,” (b) “so that, when first proximal end is
inserted into the desired location within the duodenum, the port opens to a
papilla of vater,” and (c) “a retainer configured to retain the first and second
elongated elements in a desired position within the duodenum” (see
Appellants’ claim 26).
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans. 2–11; FF 1–5), and agree that the claims are anticipated
by Bessler. We address Appellants’ arguments below.
We recognize, but are not persuaded by, Appellants’ contention that
the Examiner’s rejection based on a “capable of performing the
intended use” analysis is improper. Furthermore, it is
respectfully submitted that the logic behind this decision is
particularly apt in the field of medical devices for which a precise
match to the intended function is imperative as subtle differences
can make a device suitable for use in one application positively
harmful if applied in a way for which it was not designed.
(App. Br. 8; see also Reply Br. 4–9). Bessler teaches
a gastric bypass stent 2 comprises a stent member 4 at the
proximal end 6 of a tubular member 8 and, optionally, a stent
member 10 at the distal end 12 of tubular member 8. Proximal
tubular end 6 comprises a one-way valve member 16 to permit
passage of food and liquid, and the wall 18 of tubular member 8
comprises one[-]way openings or valves 20 to permit gastric acid
or fluid to flow into stent 2.
(Bessler, col. 2, lns. 45-52)
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(FF 2.) Bessler teaches all of the claims’ structural limitations. Bessler
teaches using the stent in the stomach as opposed to the duodenum. We
observe that Appellants’ claims are directed to an apparatus instead of a
method of use. Appellants’ specification teaches that “[a]lthough subject to
substantial variation in different individuals, the pylorus 25 has a maximum
open diameter of about 2 cm, and the duodenum 20 has a diameter which
typically is about 18 to 20 mm in a representative patient” (FF 3 (emphasis
added)), “[t]he outer structure 40 and the inner structure 57 therein, are sized
to fit within the duodenum 20 in substantially coaxial relation therewith” (FF
4 (emphasis added)), “[t]he retainer structure 77 is the transverse dimension
of the outer surface 42 of the outer structure 40 being sufficiently large to
press against the inner surface 30 of the duodenum 20 when the proximal
port structure 72 has substantially the same longitudinal position as the
papilla of Vater 35” (FF 5), and “[s]uch outward flaring provides for the
papilla-supplied and pylorus-supplied structures 40b, 57b to fit snugly within
the duodenum 20 and possible other locations of deployment” (FF 5).
Bessler teaches
The width, length, and other parameters of the stent of the
invention will vary, especially according to the patient, as one
skilled in the art would appreciate. The overall length of the stent
will be from about 10 to about 40 cm, preferably from about 12
to about 30 cm, and the expanded diameter will be from about
1.5 to about 4 cm, preferably from about 2 to about 3 cm.
(FF 2 (emphasis added).) Therefore, we agree with Examiner that “[a]s
such, Bessler’s device is materially capable of, and configured to, being
placed inside the duodenum” (Ans. 10). “A patent applicant is free to recite
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features of an apparatus either structurally or functionally. . . . Yet, choosing
to define an element functionally, i.e., by what it does, carries with it a risk.”
In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). “‘Functional’
terminology may render a claim quite broad. By its own literal terms a
claim employing such language covers any and all embodiments which
perform the recited function.” In re Swinehart, 439 F.2d 210, 213
(CCPA 1971).
We recognize, but are not persuaded by, Appellants’ contention that
The Court of Appeals for the Federal Circuit recently
issued its decision In re Giannelli, Docket No. 2013-1167 (Fed.
Cir., Jan. 13, 2014) in which it reiterated that the claim language
“adapted to,” “made to,” [“]designed to,” and “configured to”
should be interpreted to mean that the device is designed or
constructed to be used as recited in the claim, not merely
“capable of”[]the recited use. See id., 7, 9. The court reversed the
Patent Trial and Appeal Board and held that it was an error to
apply a “mere capability” standard to claims elements “adapted
to” the recited use. See id., 9.
(App. Br. 6; see also Reply Br. 12–14.) As Examiner explains,
the evidence on which the Federal Circuit based that decision is
different from the situation of the current Application. The
Federal Circuit looked into the Specification of Giannelli for
structural support of the “adapted to” language (which the
Federal Circuit equates to “configured to”, “designed to”, or
“made to”) in the claim. It was found in Giannelli that the
handles and other components of the exercise machine are
connected/positioned in a particular way to perform the recited
function, but the reference used to reject Giannelli clearly does
not have those structural connections. In other words, the
Giannelli case presents a correlation between the actual

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structures of the machine and the “adapted to” function of the
machine.
(Ans. 8–9.) Therefore, we are not persuaded by Appellants’ intimation to the
contrary.
We recognize, but are not persuaded by, Appellants’ contention that
“Bessler provides a stomach bypass device that is functionally and
structurally different from a device suitable for insertion and retention within
the duodenum and which operates in an environment that is physically and
chemically different from that of the duodenum” (App. Br. 9; see also Reply
Br. 7–8).
As Examiner explains, “Examiner notes that the current claims do not
recite specific materials or even material properties” and “Examiner notes
that the same materials are present in Bessler’s device: acid-resistant
polymers (which are also classified as ‘biocompatible material’) and nitinol
(see Col. 3 lines 44–46)” (Ans. 10). “[L]imitations are not to be read into
the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184
(Fed. Cir. 1993). See also In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
(“[A]ppellant’s arguments fail from the outset because ... they are not based
on limitations appearing in the claims.”). “Attorney’s argument in a brief
cannot take the place of evidence.” In re Pearson, 494 F.2d 1399, 1405
(CCPA 1974). Therefore, we are not persuaded by Appellants’ intimation to
the contrary.
We recognize, but are not persuaded by, Appellants’ contention that
“Bessler cannot necessarily be inserted into and retained within the
duodenum” (App. Br. 13; see also Reply Br. 9–11).
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We are not persuaded for the reasons discussed above. Further, as
Examiner explains,
(i) Bessler discloses a range of expanded diameters, not only the
4cm diameter (which is twice the size of the average duodenum
diameter); and
(ii) there is no disclosure in the current Specification to clarify
what dimension would necessarily retain the device inside the
duodenum, only that the diameter should be larger than that of
the duodenum[.]
(Ans. 11; FF 2–5.) Therefore, we are not persuaded by Appellants’
intimation to the contrary.
We further recognize, but are not persuaded by Appellants’ contention
that “[m]odifying a prior art reference based on Appellants’ invention and
then applying the proposed modification in a rejection of the
present claims is erroneous and no more than application of impermissible
hindsight” (Reply Br. 11). In the context of an anticipation rejection,
Examiner does not modify Bessler, but finds that Bessler teaches all of the
claimed limitations.

Obviousness:
As set forth above, we found no deficiency in Examiner’s rejection as
it relates to claim 9. Appellants do not dispute the merits of Examiner’s
modification of Bessler as it relates to the rejection of claim 11, other than
“Stack does not cure the deficiency of Bessler, as discussed above in regard
to claim 9” (App. Br. 14). Thus, Appellants fail to establish error in
Examiner’s prima facie case as it relates to the rejection of claim 11.
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CONCLUSION OF LAW
The rejection of claims 9 and 26 under 35 U.S.C. § 102(e) as being
anticipated by Bessler is affirmed. Claims 10, 12, 18–20, 22, 23, and 25 fall
with claim 1, and claim 27 falls with claim 26.
The rejection of claim 11 under 35 U.S.C. § 103(a) as unpatentable
over Bessler and Stack is affirmed.

TIME PERIOD FOR RESPONSE
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