Ex Parte Harris et al

Patent Trial and Appeal Board

Feb 13, 2019

12113784 (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/113,784 05/01/2008
21884 7590 02/14/2019
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
FIRST NAMED INVENTOR
Jason L. Harris
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.
END-6291USNP 1717
EXAMINER
MARCETICH, ADAM M
ART UNIT PAPER NUMBER
3781
MAIL DATE DELIVERY MODE
02/14/2019 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 JASON L. HARRIS, MARKS. ZEINER,
and MICHAEL J. STOKES
Appeal2017-005446
Application 12/113,784
Technology Center 3700
Before GEORGE R. HOSKINS, MICHAEL L. WOODS, and
SEAN P. O'HANLON, Administrative Patent Judges.
WOODS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jason L. Harris, Mark S. Zeiner, and Michael J. Stokes (collectively,
"Appellants") appeal from the Examiner's rejection of claims 1, 3, 4, and 6-
15. Appeal Br. 3. We have jurisdiction over this appeal under 35 U.S.C. §
6(b).
SUMMARY OF THE DECISION
We REVERSE.
Appeal2017-005446
Application 12/113,784
CLAIMED SUBJECT MATTER
Appellants' invention relates to "a hybrid method for combining
gastric volume reduction surgery with the application of a duodenal sleeve."
Spec. 1 (Field of Invention).
Claims 1 and 15 are the independent claims, and claim 1 is
reproduced below with emphases added to particular limitations at issue in
this appeal.
1. A method for treating a patient, comprising:
creating at least one incision to gain access to a
peritoneal cavity;
performing a gastric volume reduction procedure;
introducing a duodenal sleeve for transporting chyme
exiting the stomach to prevent gastric contents in the form of
chyme from interacting with at least a portion of a duodenum,
the duodenal sleeve including a proximal opening and a distal
opening, the step of introducing further includes anchoring the
proximal opening to, or distal to, muscle in a pyloric portion of
the stomach; and
directing the chyme leaving the stomach inside the
duodenal sleeve and bypassing the duodenum such that there is
no mixing of chyme with bile until the chyme reaches a
Jejunum.
Appeal Br. 19 (Claims App.).
THE REJECTIONS
I. Claims 1, 3, 4, and 15 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Gertner (US 2006/0074473 Al, published Apr. 6, 2006)
and Levine (US 2005/0085923 Al, published Apr. 21, 2005). Final Act. 2.
II. Claims 6-14 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Gertner, Levine, and Harris (US 2008/0249566 Al,
published Oct. 9, 2008). Final Act. 7.
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Appeal2017-005446
Application 12/113,784
ANALYSIS
Re} ection I: Gertner and Levine
The issue before us is whether the Examiner's reasoning for
combining Gertner with Levine is supported by the evidence.
"[R ]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with
approval in KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007).
Examiner's Rejection
In rejecting claims 1, 3, 4, and 15, the Examiner relies on Gertner for
disclosing a method for reducing the volume of a stomach, including the
steps of "creating at least one incision to gain access to a peritoneal cavity"
and "performing a gastric volume reduction procedure." Final Act. 2-3
( citations omitted). The Examiner acknowledges that "Gertner teaches the
invention substantially as claimed ... with the exception of introducing a
duodenal sleeve." Id. at 3 (emphasis added).
To address the claimed "introducing a duodenal sleeve," the Examiner
relies on Levine and asserts that Levine discloses a method for applying a
sleeve. Id. ( citing Levine ,r,r 10, 91 ).
In combining Gertner with Levine, the Examiner reasons, "[ o ]ne
would be motivated to modify Gertner with the duodenal sleeve of Levine
since Gertner explicitly calls for implanting the stent of Levine." Id. at 4
(citing Levine ,r 123 (emphasis added)). The Examiner further reasons, "it
would have been obvious ... to modify Gertner with the duodenal sleeve of
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Appeal2017-005446
Application 12/113,784
Levine in order to limit nutrient absorption with a device recognized by
Gertner." Id.
Appellants 'Argument
Appellants argue, inter alia, that "Gertner does not explicitly call for
implanting the stent of Levine in conjunction with gastric volume
reduction." Appeal Br. 9. Appellants explain, "the disclosure of Gertner
does not lead one to the conclusion presented by the Examiner but rather
leads one skilled in the art to a completely different conclusion." Id.
We agree.
Our Analysis
The Examiner asserts, "Gertner explicitly calls for implanting the
stent of Levine," and reasons that, because of this disclosure, "[ o ]ne would
be motivated to modify Gertner with the duodenal sleeve of Levine." Final
Act. 4 ( citing Gertner ,r 123).
The Examiner's reliance on Gertner, however, is misplaced.
The cited paragraph within Gertner that the Examiner relies on
discloses,
In other embodiments, the devices and methods of this
invention can assist in the implantation of devices such as
stents, meshes, stitches, or tubes in the gastrointestinal tract.
The major technical difficulty encountered in placing stents,
tubes, and meshes inside the lumen of the gastrointestinal tract
is that they tent to migrate because the walls of such devices do
not adhere to slippery mucosa. A transgastric or
trans intestinal fastener, implanted with the current
instrumentation would solve this problem. Such a method
would be particularly useful in the attachment of the stent part
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Appeal2017-005446
Application 12/113,784
of the stent-sleeve system outlined in patent application WO
04049982. 1
Gertner ,r 123 (emphases added).
Contrary to the rejection, the above disclosure does not teach,
disclose, or suggest combining a duodenal sleeve with stomach reduction, as
the rejection implies. See Final Act. 4. Rather, this disclosure merely
describes a problem involving stents placed within a gastrointestinal tract, in
that the stents may migrate due to the slippery mucosa within the tract's
inner walls, and using a transgastric or transintestinal fastener, such as
Gertner's anchor, would solve the migration problem. Gertner ,r 123.
Stated differently, Gertner generally discloses "anchors ... used to
pull the walls of [an] organ together." Gertner, (57). Paragraph 123 of
Gertner suggests that these anchors may be used as fasteners to prevent stent
migration. Id. ,r 123. Gertner does not suggest using Gertner's anchors for
stomach reduction while also using a duodenal sleeve.
In the Answer, the Examiner explains in the alternative that Gertner's
goal is to treat obesity, generally, and "Gertner can be read more broadly as
seeking a way to encourage malabsorption" of food. See Ans. 10.
Specifically, the Examiner states, "Gertner generally seeks to inhibit
absorption of nutrients, and recognizes two effective approaches for
achieving this effect." Id. ( citing Gertner ,r 6 ( emphasis added)). The
Examiner further explains that "[i]mplanting the stent-graft system of Levine
would advance the goals of Gertner by interfering with absorption and
mechanically restricting the effective volume of a patient's digestive tract."
Id. (citing in-part Gertner ,r 6 (emphasis added)).
1 Levine and WO 04049982 appear to be related applications.
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Appeal2017-005446
Application 12/113,784
We disagree with the Examiner's assertion that one of Gertner' s goals
is to inhibit the absorption of nutrients. Id. The cited paragraph of Gertner
discloses in full:
Over the past four decades, there have been numerous
surgical procedures and devices developed to treat the morbidly
obese. In general, there are two physiologic aspects of all past
and current procedures: malabsorption and mechanical
restriction/volume reduction.
Gertner ,r 6.
This disclosure merely explains that the numerous surgical procedures
used to treat obesity rely on malabsorption and mechanical
restriction/volume reduction. Id. This disclosure does not identify the
"goals of Gertner [as] interfering with absorption and mechanically
restricting the effective volume of a patient's digestive tract." Ans. 10.
More importantly, however, this disclosure does not support the Examiner's
reasoning that it would have been obvious to add a duodenal sleeve, as
described in Levine, with Gertner' s stomach reduction procedure.
We find nothing in the Final Office Action or Answer that persuades
us that it would have been obvious to combine Gertner' s stomach reduction
procedure with Levine's duodenal sleeve procedure. Accordingly, we do
not sustain the rejection of claims 1, 3, 4, and 15 as unpatentable over
Gertner and Levine.
Rejection II: Gertner, Levine, and Harris
In rejecting dependent claims 6-14 as unpatentable over Gertner,
Levine, and Harris, the Examiner relies on the same unsupported reasoning
discussed above under Rejection I. See Final Act. 7.
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Appeal2017-005446
Application 12/113,784
For the same reasons that we do not sustain Rejection I, we do not
sustain the rejection of claims 6-14 as unpatentable over Gertner, Levine,
and Harris.
SUMMARY
We reverse the rejection of claims 1, 3, 4, and 15 as unpatentable over
Gertner and Levine.
We reverse the rejection of claims 6-14 as unpatentable over Gertner,
Levine, and Harris.
REVERSED
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