Ex Parte Dominguez

Patent Trial and Appeal Board

Feb 4, 2019

12902085 (P.T.A.B. Feb. 4, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/902,085 10/11/2010
119800 7590 02/06/2019
Donald K. Jones
Apollo Endosurgery US, Inc.
1120 S. Capital of Texas Hwy
Bldg 1, Suite 300
Austin, TX 78746
FIRST NAMED INVENTOR
Zachary Dominguez
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.
A-8802 1426
EXAMINER
COLELLO, ERIN L
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
02/06/2019 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):
USIPDocketing@apolloendo.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ZACHARY DOMINGUEZ 1
Appeal2017---006775
Application 12/902,085
Technology Center 3700
Before DEMETRA J. MILLS, JOHN G. NEW, and JAMES A. WORTH,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant states that the real party-in-interest is Apollo Endosurgery, Inc.
App. Br. 3.
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Application 12/902,085
SUMMARY
Appellant files this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 21, 22, 25, 29-31, and 43--48.
Specifically, claims 21, 25, 29-31, 44--45, and 47 stand rejected as
unpatentable under 35 U.S.C. § 112, first paragraph, as failing to comply
with the written description requirement.
Claims 22 and 46 stand rejected as unpatentable under 35 U.S.C.
§ 112, second paragraph, as being indefinite.
Claims 22 and 43 stand rejected as unpatentable under 35 U.S.C.
§ 102(b) as being anticipated by Sosnowski et al. (US 2007/0149994 A 1,
June 28, 2007) ("Sosnowski").
Claims 21, 25, and 43 stand rejected as unpatentable under 35 U.S.C.
§ I02(b) as being anticipated by Lointier et al. (US 2007/0118168 Al, May
24, 2007) ("Lointier").
Claim 22 stands rejected as unpatentable under 35 U.S.C. § I02(b) as
being anticipated by Li (US 2009/0082644 Al, March 26, 2009) ("Li").
Claims 21 and 25 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of Sosnowski and Lointier.
Claims 29-31 and 44 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of Sosnowski and Burnett
(US 6,994,095 B2, February 7, 2006) ("Burnett").
Claims 45 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Sosnowski, Lointier, and Kim et al.
(US 2007 /0250020 Al, October 25, 2007) ("Kim").
Claims 46 and 48 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of Sosnowski and Kim.
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Claim 47 stands rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Sosnowski, Burnett, and Kim.
Claims 29, 30, 31, and 44 stand rejected under 35 U.S.C. § 103(a) as
being obvious over the combination of Li and Burnett.
Claims 45 and 48 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Lointier and Kim.
Claim 46 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Li and Kim.
Claim 47 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Li, Burnett, and Kim.
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to intragastric devices for the
treatment of obesity. Abstr.
REPRESENTATIVE CLAIM
Claims 21 and 22 are representative of the claims on appeal. Claim
21 recites:
21. An intragastric device for occupying space in a patient's
stomach and for treating obesity, the intragastric device
compnsmg:
a plurality of round protrusions connected directly to one
another and protruding outward from a center region of the
intragastric device, the protrusions permit rotation of the
intragastric device as stomach muscles contract, wherein the
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protrusions are sized for individually temporarily blocking the
entrance of the pylorus to the stomach, without residing within
the pylorus, thereby temporarily stopping flow of food from the
stomach, the device adapted to remain in the stomach and
function therein for at least one year to treat obesity, wherein the
intragastric device defines a common fluid-filled cavity within
the center region and the protrusions, and the intragastric device
is constructed of a continuous depressable wall defining the
cavity.
App. Br. 29. Claim 22 recites:
22. An intragastric device for occupying space in a patient's
stomach and for treating obesity, the intragastric device
compnsmg:
a plurality of legs coupled to one another and extending
from a center of the intragastric device, wherein each leg has a
proximal end at the center of the intragastric device and has a
distal end opposite the proximal end; and
a plurality of round protrusions attached to corresponding
ones of the plurality of legs at the distal ends thereof, the
protrusions permit[t]ing rotation of the intragastric device as
stomach muscles contract
wherein the protrusions are sized for individually
temporarily blocking the entrance of the pylorus to the stomach,
without residing within the pylorus, thereby temporarily
stopping flow of food from the stomach, the device adapted to
remain in the stomach and function therein for at least one year
to treat obesity,
wherein the protrusions are partial-spheres,
wherein each partial-sphere has a diameter that is larger
than a diameter of its corresponding leg, and
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wherein the intragrastric [sic] device defines a common
fluid-filled cavity within the center, the legs, and the protrusions,
and the intragastric device is constructed of a continuous
depressable wall defining the cavity.
Id. at 29--30.
A.
Issue
ISSUES AND ANALYSES
Rejection of claims 21, 25, 29-31, 44--45, and 47 under 35 U.S.C.
§ 112, first paragraph as lacking written descriptive support
Appellant argues that the Examiner erred in finding that the
limitations reciting "connected directly to one another," in claim 21 and its
dependent claims, and "leg having an outer surface that tapers from the
center of the intragrastric device to the leg end," in claim 29 and its
dependent claims, 2 do not find written support in Appellant's Specification.
See App. Br. 6, 8.
Analysis
Appellant argues that that Figure 4 of the Specification, and its
associated description in paragraph [0042], describe an embodiment of an
intragastric device 400 that has protrusions 405 that "may be configured to
contact each other ( and thereby creating space and allowing for more
protrusions 405 to be added to the surface)." App. Br. 6-7. Appellant
argues further that Figure 2 of the Specification shows that the protrusions
2 Dependent claim 44 depends from independent claim 22, but also recites
the disputed limitation of claim 29. App. Br. 32.
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205 are directly connected to one another. Id. at 7. Figure 2 is reproduced
below:
F1G.2
Figure 2 of Appellant's Specification depicts a perspective view
of an embodiment of an intragastric device
Appellant argues that Figure 2 shows areas of overlap between
adjacent protrusions 205 which are indicative of protrusions 205 that are
"connected directly to one another." App. Br. 7. Therefore, Appellant
asserts, a person of ordinary skill in the art would have understood that the
Specification supports the limitation reciting "connected directly to one
another."
The Examiner responds that that the embodiment depicted in Figure 4
of Appellant's Specification is not being claimed in claim 21: claim 21
additionally includes the limitation "wherein the protrusions are sized for
individually temporarily blocking the entrance of the pylorus to the stomach
without residing within the pylorus, thereby temporarily stopping flow of
food from the stomach." Ans. 4. However, the Examiner finds, paragraph
[0042] and Figure 4 do not show that the embodiment of Figure 4 includes
protrusions that are sized for individually temporarily blocking the entrance
of the pylorus nor does paragraph [0042] show that the teachings of
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protrusions 405 that can be configured to contact each other, can be used in
the other embodiments. Id. Rather, the Examiner finds, because the
limitations of claim 21 appear to be drawn to the embodiment shown in
Figure 2, paragraph [0042] does not provide support for the phrase
"connected directly to one another," as recited in claim 21. Id.
The Examiner also finds that it is not clear from Figure 2 that the
protrusions are in fact directly connected to one another, especially
considering that most of the protrusions have different perspectives relative
to the viewer and therefore the specifics of the connection of the protrusions
are difficult to determine. Ans. 4. The Examiner also finds that there is no
disclosure in the Specification clearly explaining what is occurring in Figure
2, and that, looking at Figure 2, it appears that there are spaces between
connected protrusions, the limitation therefore does not appear to have
support in the original disclosure. Id.
We are not persuaded by the Examiner's reasoning. We agree with
the Examiner that Appellant's Specification discloses that the small
protrusions depicted on the device of Figure 3 appear to be designed so as to
"upon contact with the inner stomach wall of the patient ... further
trigger[ing] hormone release or otherwise aid the patient in feeling full,"
rather than: "temporarily blocking the entrance of the pylorus to the stomach
without residing within the pylorus, thereby temporarily stopping flow of
food from the stomach," as recited in claim 21. See Spec. ,r 41.
However, claim 21 requires that the protrusions are "connected
directly to one another." We observe that Figure 2 depicts the outer surface
of the intragastric device as being made of a uniform material, i.e., there are
no visible joints, sutures, or divisions between the protrusions and the rest of
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the surface material of the device. Appellant's Specification discloses, with
reference to Figure 2, that:
The intragastric device 200 may be constructed of rubbers,
fluorosilicones, flouroelastomers, thermoplastic elastomers or
any combination thereof to improve the durability of the
intragastric device 200 inside the patient's stomach. However,
the intragastric device 200 may be constructed of a continuous,
thin, depressable wall and be hollow inside (filled with air) to
keep the intragastric device 200 light. Alternatively, the
intragastric device 200 may be filled with a liquid gel such as
silicon.
Spec. ,r 3 7 ( emphasis added). We note that the language of claim 21 does
not require that the protrusions directly adjoin each other, but only that the
protrusions be "connected directly to one another." We find that, because
there is no discernible boundary, or intervening different material, between
protrusions and that the continuous wall of the device runs from protrusion
to protrusion without an intervening break, that the protrusions are directly
connected, as opposed to indirectly connected, or unconnected, to each
other. We consequently disagree with the Examiner's reasoning with
respect to this limitation.
Appellant next argues that Figure 3 of Appellant's supports the
limitation of claim 29 reciting:
[A] plurality of legs attached to one another and projecting
outward from a center of the intragastric device such that the
intragastric device is rotationally variant depending on natural
contractions of the patient's stomach, wherein each leg terminates
in a leg end larger than the rest of the leg, the leg having an outer
surface that tapers from the center of the intragastric device to the
leg end, and wherein the leg ends are sized for individually
temporarily blocking the pylorus of the patient when the leg end
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contacts the pylorus but is too large to fit within the pylorus
opening[.]
Specifically, Appellant disputes the Examiner's finding that the
Specification fails to provide written descriptive support for: "the leg having
an outer surface that tapers from the center of the intragastric device to the
leg end." See Final Act. 4; App. Br. 22.
According to Appellant, a review of Figure 3 of the Specification
would lead a person of ordinary skill in the art to understand that the left
upper leg 305 is shown in side elevation, even though the other legs are
shown in isometric. App. Br. 9. Appellant asserts that, when the side profile
of the upper left leg of Figure 3 is viewed, it is clear that the leg
305 is tapered. Id.
The Examiner responds that Appellant's Figure 3 is drawn in
perspective and therefore does not inherently show that the legs are tapered.
Ans. 5. The Examiner finds that Figure 3, and the other figures are not
drawn to scale and do not show multiple views of the same embodiment and
therefore it is difficult to determine specific details from the drawings alone.
Id. at 5---6. The Examiner finds that if the taper was critical to the invention,
the taper would have been disclosed within the text of the Specification,
which would include additional information about the tapering legs. Id. at 6.
The Examiner finds that, because the tapered leg limitations are not
discussed within the text of the Specification at all, the tapering of the legs is
not critical and that the disputed limitation is not supported. Id.
We agree with the Examiner. Figure 3 of Appellant's Specification is
reproduced below:
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)5
!
FIG.3
Figure 3 of Appellant's Specification depicts a perspective view
of an embodiment of the claimed intragastric device
With respect to this embodiment, Appellant's Specification discloses:
FIG. 3 illustrates another embodiment of the intragastric
device 300. As shown, the intragastric device 300 has four
"legs." The configuration of the four legs may be asymmetrical
as shown. If divided into "the top two legs" and "the bottom two
legs[,]" the "pairs of legs" appear joined at the center and
"twisted 90 degrees" to form the configuration as shown.
However, this is merely one example of any of a plurality of
configurations for any of a plurality of leg numbers. For
example, additional legs may be attached or removed, and/or the
configuration may be altered. In addition, each leg portion 305
may be joined to one end 310. The ends 310, as shown, caps the
end of the leg portion 305 and has a diameter substantially
thicker than the diameter of the leg portion 305. Accordingly,
the ends 310 may be sized such that it blocks the patient's pylorus
temporarily when the ends 310 comes into contact with the
pylorus, and thereby slowing gastric emptying and allowing the
patient to feel full for a longer period of time without the ends
310 getting stuck or wedged into the pylorus. In addition, the
configuration of the intragastric device 300 may produce
variations in how the intragastric device 300 sits or rotates inside
the patient's stomach. Normal stomach contractions may cause
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the intragastric device 300 to move around or rotate about the
stomach, and due to the device's configuration, different points
on the inner stomach walls may be stimulated, thereby limiting
the ability of the stomach to adapt over a long period of time.
Spec. ,r 39. We observe that nothing in this passage discloses the legs:
"having an outer surface that tapers from the center of the intragastric device
to the leg end," as required by claim 29. See Final Act. 4. The "upper leg"
leg in Figure 3 does appear to be tapered in a manner consistent with the
limitation, but Figure 3 is not a scale drawing, rather, it is a perspective
drawing, and a person of ordinary skill could reasonably interpret the
apparent tapering of the legs as a perspective effect of the legs extending out
of the plane of the paper. Furthermore, as noted, there is no textual support
for the claimed tapering of the legs.
With respect to written descriptive support, our reviewing court has
held that: "the test for sufficiency is whether the disclosure of the application
relied upon reasonably conveys to those skilled in the art that the inventor
had possession of the claimed subject matter as of the filing date." Ariad
Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. March
2010). We agree with the Examiner that there is no disclosure in
Appellant's Specification that would reasonable convey to an artisan of
ordinary skill that Appellant's were in possession, or even contemplated, a
requirement that the legs possess: "an outer surface that tapers from the
center of the intragastric device to the leg end," as recited by claim 29. App.
Br. 5.
We consequently reverse the Examiner's rejection of claims 21, 25,
45. We affirm the Examiner's rejection of claims 29-31, 44, and 47.
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B. Rejection of claims 22 and 46 under 35 U.S.C. § 112, second
paragraph as indefinite
Issue
Appellant argues the Examiner erred in concluding that the limitation
of claim 22 reciting: "a plurality of round protrusions attached to
corresponding ones of the plurality of legs" is indefinite as failing to
particularly point out and distinctly claim the subject matter which the
inventor regards as the invention. App. Br. 9.
Analysis
Appellant argues that a person of ordinary skill in the art would
appreciate that the recited correspondence between the round protrusions
and legs is one to one, as shown in Figure 3 of Appellant's Specification.
App. Br. 10.
The Examiner responds that the language of the disputed limitation is
such that it is unclear if each protrusion of the plurality of protrusions is
attached to a corresponding leg of the plurality of legs, or if a plurality of
protrusions are attached to a plurality of legs. Ans. 6. The Examiner finds
that, because the limitation includes a "plurality of protrusions" and the term
"corresponding ones," the meaning of the limitation is unclear. Id. The
Examiner finds that if the limitation means that the plurality of protrusions
and plurality of legs have a one-to-one correspondence, it would be more
clear if the limitation specified that each protrusion of the plurality of
protrusions is attached to a corresponding leg of the plurality of legs. Id.
However, the Examiner finds, as written, it is not clear whether the current
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claim language recites a one-to-one correspondence or if a plurality of
protrusions can be on a plurality of legs. Id. at 6-7. Consequently, the
Examiner concludes the limitation is vague and indefinite. Id. at 7.
We agree with the Examiner. The test for definiteness under the
second paragraph of 35 U.S.C. § 112 is "whether those skilled in the art
would understand what is claimed when the claim is read in light of the
specification." Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d
1565, 1576 (Fed. Cir. 1986).
Claim 22 recites: "a plurality of round protrusions attached to
corresponding ones of the plurality of legs." From the language of this
limitation the meaning of the term "corresponding ones" is ambiguous and
defies a simple interpretation. Does "corresponding ones" refer to round
protrusions attached to other round protrusions on the plurality of legs? Or
does it imply, as Appellant argues and as depicted in Figure 3 supra, a one-
to-one correspondence between a single round protrusion and a single leg?
Or does it refer to multiple round protrusions attached to multiple
corresponding legs? Figure 3 of Appellant's Specification is directed to an
embodiment of the claims, but not to all possible embodiments, given the
ambiguity of the claim language.
Because the language of the disputed limitation is incapable of
expressing an unambiguous meaning, we agree with the Examiner's
conclusion that the claims are indefinite and we affirm the Examiner's
rejection of the claims.
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C. Rejection of claims 22 and 43 as being anticipated by Sosnowski
Issue
Appellant contends that the Examiner erred in finding that Sosnowski
discloses the limitation of claim 22 reciting: "[wherein] the protrusions are
sized for individually temporarily blocking the entrance of the pylorus to the
stomach, without residing within the pylorus, thereby temporarily stopping
flow of food from the stomach." See App. Br. 11.
Analysis
The Examiner finds that Sosnowski discloses an intragastric device
for occupying space in a patient's stomach and for treating obesity, the
intragastric device comprising: (1) a plurality of legs coupled to one another
and extending from a center of the intragastric device, and that each leg has
proximal end at the center of the intragastric device and a has a distal end
opposite the proximal end; and (2) a plurality of round protrusions attached
to corresponding ones of the plurality of legs at the distal ends, the
protrusions permitting rotation of the intragastric device as stomach muscles
contract. Final Act. 6-7 (citing Sosnowski Figs, 15a-b). The Examiner
finds that Sosnowski discloses that the protrusions are sized for individually
temporarily blocking the entrance of the pylorus to the stomach, without
residing within the pylorus, thereby temporarily stopping flow of food from
the stomach. Id. at 7.
Appellant argues that the only paragraph of Sosnowski that mentions
the relevant features if Figures 15A-B is paragraph [0097], and that that
paragraph fails to expressly describe the size or any such functionality of
those balloons. App. Br. 12.
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Appellant argues further that Sosnowski fails to inherently disclose
the alleged teaching. App. Br. 12. Appellant contends that the fact that
Sosnowski' s device is used to fill an intragastric space does not necessarily
provide the functionality of the balloons of Figures 15A-B (elements 81A-
D) of temporarily blocking the pylorus, much less that the balloons are sized
for individually temporarily blocking the entrance of the pylorus. Id. at 12-
13.
The Examiner responds that the disputed limitation is drawn to a
functional limitation and does not actually specify a specific size or specific
structure limitations. Ans. 7. The Examiner notes that, where it has been
held that a recitation with respect to the manner in which a claimed
apparatus is intended to be employed does not differentiate the claimed
apparatus from a prior art apparatus satisfying the claimed structural
limitations. Id. ( citing Ex parte Mas ham, 2 USPQ2d 164 7, 164 7 (BP AI
1987)).
The Examiner finds that, since the structure of Sosnowski includes a
plurality of protrusions and is used to fill the intragastric space, each
protrusion is therefore capable of taking up/blocking space to the entrance of
the pylorus and is therefore capable of blocking the pylorus to temporarily
stop flow of food.
We find Appellant's argument persuasive. As an initial matter, we
disagree with the Examiner's finding that the disputed limitation is strictly
functional and does not specify a precise size or specific structure limitation.
See Ans. 7. Rather, the limitation recites that the protrusions are: "sized for
individually temporarily blocking the entrance of the pylorus to the stomach,
without residing within the pylorus." See App. Br. 11. Although not
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specifying a size measured in quantitative units, we find that a person of
ordinary skill in the art of intragastric devices would know the size range of
pyloric valves and would understand the size of protrusion required to block
the entrance to the pylorus without residing in the pylorus. The limitation is
thus directed to a structural limitation of the claim.
In discussing the embodiments depicted in Figures 15A-B, Sosnowski
discloses that:
FIG. 15A shows one embodiment of a multiballoon space
filler device 80A, whereas FIG. 15B shows an alternate
embodiment of a multi-balloon space filler device 80B. In an
illustrated embodiment, the multi-balloon space filler 80A may
comprise individual balloons 81A, 81B, 81C, 81D (or individual
space fillers) that have different sizes or are arranged at different
planes. For example, the balloon 81D may not lie at the same
plane bounded by balloons 81A, 81B and 81C. The balloons are
connected by one or more connecting members 82. In one
embodiment, the multiballoon space filler device has one fluid
infusing connector 83 or a valve. The infusing connector 83 is
preferably reverted or configured into a recess of the device, so
it can never contact walls of a stomach. In one alternate
embodiment, the multi-balloon space filler device has multi-
valves (not shown) for inflation through the middle channel 82
that goes through at least two balloons to be filled independently.
Sosnowski ,r 97. Sosnowski thus expressly discloses that the embodiments
depicted in Figures 15A and 15B act as intragastric space filler devices, but
does not disclose that the balloons 81A-D are: "sized for individually
temporarily blocking the entrance of the pylorus to the stomach, without
residing within the pylorus, thereby temporarily stopping flow of food from
the stomach." See Reply Br. 11. Furthermore, there is nothing in this
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passage of Sosnowski to indicate that the balloons 81 A-D are necessarily
sized so as to block the entrance to the pylorus without residing within.
Furthermore, Sosnowski repeatedly discloses that the various
embodiments of its claimed invention are expressly designed so as to not
block the entrance to the pylorus. By way of example, paragraph [0065] of
Sosnowski discloses:
The distal projections 408 serve to engage the stomach
near the pylorus 16 such that the projections 408 prevent the
device 400 from entering the intestinal tract 20, while preventing
the body of the device from engaging the sphincter to block off
the sphincter or otherwise prevent food from passing from the
stomach into the intestinal tract.
(Emphasis added); see also ,r,r 98, 109. We consequently are not persuaded
by the Examiner's reasoning that Sosnowski anticipates the claims, and we
reverse the Examiner's rejection of the claims.
D. Rejection of claims 21, 25 3, and 43 as being anticipated by Lointier
Issue
Appellant argues the Examiner erred in finding that Lointier discloses
the limitation of claim 21 reciting: "wherein the protrusions are sized for
individually temporarily blocking the entrance of the pylorus to the stomach,
without residing within the pylorus, thereby temporarily stopping flow of
food from the stomach." App. Br. 19.
3 We include the rejection of claim 25 in our analysis of claims 21 and 43
on this ground based on the common claim language and requirements.
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Analysis
The Examiner finds that Lointier discloses an intragastric device in
which the protrusions are sized for individually temporarily blocking the
entrance of the pylorus to the stomach, without residing within the pylorus,
thereby temporarily stopping flow of food from the stomach, as recited in
the claims. Final Act. 9 ( citing Lointier ,r,r 18, 36, 99).
Appellant points to paragraph [0018] of Lointier, upon which the
Examiner relies, as disclosing, respectively: "[ a ]nother object of the
invention is to propose a novel intragastric balloon making it possible
significantly to increase the extent to which food is blocked in the stomach."
App. Br. 19. Appellant argues that this passage discloses, at most,
increasing the extent to which food is blocked within the stomach. Id. at 20.
According to Appellant, Lointier discloses ensuring that the outside
wall of the balloon is shaped to co-operate with the wall of the stomach to
define channels for passing food from an upstream zone towards the
downstream zone. App. Br. 20 (citing, e.g., Lointier ,r 105). Appellant
asserts that this is done to guarantee that food can pass through the channels
and to avoid the plug effect where food would be blocked from reaching the
pylorus. Id. ( citing, e.g., Lointier ,r 109). Therefore, Appellant contends,
Lointier fails to disclose that its disclosed protrusions are sized for
individually temporarily blocking the entrance of the pylorus to the stomach,
without residing within the pylorus, thereby temporarily stopping flow of
food from the stomach. Id. at 20-21.
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We are persuaded by Appellant's arguments. The Examiner repeats
the finding that the disputed limitation is a functional limitation that can be
met by the structure disclosed in Lointier. As we have explained supra, we
disagree. Furthermore, we agree with Appellant that Lointier expressly
discloses that:
In completely independent manner, the invention also
provides an intra-gastric balloon for treating obesity, for
implanting in the stomach of a patient in order to reduce the
volume of the stomach, said balloon comprising an outside wall
for coming into contact with the wall of the stomach, the balloon
subdividing the stomach into an upstream zone and a
downstream zone in order to constitute a barrier for the passage
of food between these two zones, the outside wall being shaped
so to co-operate with the wall of the stomach to define channels
for passing food from the upstream zone to the downstream zone.
Lointier ,r 3 (emphasis added); see also ,r,r 81, 83, 87, 91, 102-109, 111, 113.
Lointier defines the upstream zones and downstream zones: "[t]he balloon
thus forms a barrier between an upstream zone of the stomach which is in
communication with the esophagus, and a downstream zone of the stomach
which is in communication with the remainder of the digestive tract," i.e.,
the pylorus. Id. at ,r 83.
Consequently, rather than disclosing protrusions that are sized for
individually temporarily blocking the entrance of the pylorus to the stomach,
without residing within the pylorus, as required by the claims, Lointier
discloses an intragastric device that forms a barrier in the stomach between
the esophagus and the pylorus. Most importantly Lointier does not disclose,
either expressly or inherently, that any protrusion of the device is sized to
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temporarily block the entrance of the pylorus without residing in it.
Consequently, we reverse the Examiner's rejection of the claims.
E. Rejection of claim 22 as being anticipated by Li
Issue
Appellant argues that the Examiner erred in finding that Li discloses,
inter alia, the limitation of claim 22 reciting: "wherein the protrusions are
sized for individually temporarily blocking the entrance of the pylorus to the
stomach, without residing within the pylorus, thereby temporarily stopping
flow of food from the stomach." App. Br. 14.
Analysis
The Examiner finds that Li discloses an intragastric device, the
protrusions of which are sized for individually temporarily blocking the
entrance of the pylorus to the stomach, without residing within the pylorus,
thereby temporarily stopping flow of food from the stomach. Final Act. 12
(citing Li ,r,r 21, 51, Figs. 2, 3a, and 4a). The Examiner finds that Figures 2,
3a, and 4a show that the protrusions of the device have a size for
individually temporarily blocking the entrance of the pylorus without
residing the in pylorus. Id.
Appellant argues that Li discloses that distal projections 108, 108',
and 108" serve to engage the stomach near the pylorus 16 such that the
projections 108 prevent the device 100 from entering the small intestine 20,
and simultaneously preventing the body of the device from engaging the
pyloric channel to block off the pylorus or otherwise prevent food from
passing from the stomach to the intestinal tract. App. Br. 14 (citing Li ,r 53,
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see also Fig. 2). Therefore, argues Appellant, in contradistinction to the
protrusions of claim 22, the distal projections 108, 108', and 108" are not
"sized for individually temporarily blocking the entrance of the pylorus to
the stomach, without residing within the pylorus, thereby temporarily
stopping flow of food from the stomach." Id. at 1-15. Rather, Appellant
argues, the distal projections 108, 108', and 108" function instead to prevent
the blockage of the pylorus altogether. Id. at 15. Appellant argues that
Figures 3A, 4A, and 5-7 similarly show distal projections positioned to
prevent blockage of the pylorus. Id. (citing Li ,r,r 56, 60, 65, 68, 71).
We agree with Appellant. By way of example, Figure 2 of Li is
reproduced below.
Figure 2 of Li depicts an embodiment of an intragastric balloon
device having a single interior chamber and a shape that is at
least partially conforming to the interior shape of the stomach
comprising dimples and a pyloric prong
With reference to Figure 2, Li discloses:
Additionally, as shown in the embodiment of FIG. 2 a
series of distal projections 108, 108', 108" are provided that
extend away from the exterior surface 106 of the device. The
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Application 12/902,085
distal projections 108 serve to engage the stomach near the
pylorus 16 such that the projections 108 prevent the device 100
from entering the small intestine 20, and simultaneously
preventing the body of the device from engaging the pyloric
channel to block off the pylorus or otherwise prevent food from
passing from the stomach into the intestinal tract.
Li ,r 53 (emphasis added). The other embodiments disclosed by Li in
Figures 3A, 4A, and 5-7 are similarly configured.
We agree with Appellant that Li thus discloses that its protrusions
108, 108', and 108" (i.e., Li's "pyloric prong," see, e.g., ,r 21 (claim 38)) are
designed so as to prevent temporarily blocking the entrance of the pylorus,
thereby permitting flow of food from the stomach, the opposite of the
corresponding limitation recited in claim 22. We therefore reverse the
Examiner's rejection upon this ground.
F.
Issue
Rejection of claims 21 and 25 4 as being obvious over Sosnowski and
Lointier
Appellant argues that the combined cited prior art neither teaches nor
suggests the limitation of claim 21 reciting: "the protrusions are sized for
individually temporarily blocking the entrance of the pylorus to the stomach,
without residing within the pylorus, thereby temporarily stopping flow of
food from the stomach." App. Br. 15.
4 Appellant does not argue the rejection of claim 25 on this ground, either
separately or grouped together with other claims. We include the rejection
of claim 25 in our analysis of claim 21 on this ground.
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Analysis
We have explained supra our reasoning as to why neither Sosnowski
nor Lointier disclose the disputed limitation of claim 21. We employ the
same reasoning in finding that neither Sosnowski nor Lointier teaches or
suggests: "protrusions ... sized for individually temporarily blocking the
entrance of the pylorus to the stomach, without residing within the pylorus."
Indeed, as we have explained, both Sosnowski and Lointier teach the
importance of not blocking the entrance to the pylorus. See, e.g., Sosnowski
,r,r 65, 78, 98, 109; Lointier ,r,r 3, 83, 105. We consequently reverse the
Examiner's rejection of the claims.
G.
Issue
Rejection of claims 29-31, and 445 as being obvious over Sosnowski
and Burnett
Claim 29 recites, in relevant part: "wherein the leg ends are sized for
individually temporarily blocking the pylorus of the patient when the leg end
contacts the pylorus but is too large to fit within the pylorus opening,
thereby temporarily stopping flow of food from the stomach." Appellant
5 Appellant does not argue the rejection of claims 30, 31, or 44 on this
ground, either separately or grouped together with other claims. We
include the rejection of these claims in our analysis of claim 29 on this
ground.
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argues, inter alia, that, as argued for claim 22 supra, the combined cited
prior art neither teaches nor suggests this limitation. App. Br. 21.
Analysis
The Examiner relies on Burnett as teaching a pyloric valve corking
device with tapered leg connecting between two enlarged protrusions. Final
Act. 17 ( citing Burnett Fig. 4A). The Examiner finds that this is an
equivalent structure to a constant diameter leg connecting two enlarged
protrusions, in which the leg has an outer surface that tapers from the
proximal end to the distal end. Id. (citing Figs. 2A-B, 4B).
We have explained why we find that Sosnowki does not disclose the
disputed limitation recited supra. For the same reasons, we find that
Sosnowski neither teaches nor suggests that limitation. Burnett teaches a
device that resides within the pylorus, contrary to the requirements of the
disputed limitation. See Burnett Figs. 7 A---C. We consequently reverse the
Examiner's rejection of the claims upon this ground. Furthermore, because
we find this issue to be dispositive, we do not reach Appellant's additional
arguments.
H. Rejection of claim 45 as being obvious over Sosnowski, Lointier, and
Kim
Appellant make no argument with respect to the Examiner's rejection
of claim 45 upon this ground. We consequently summarily affirm the
Examiner's rejection. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or
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authorities not included in the appeal brief will be refused consideration by
the Board for purposes of the present appeal").
I. Rejection of claims 46 and 48 as being obvious over Sosnowski and
Kim
Appellant make no argument with respect to the Examiner's rejection
of claim 46 and 48 upon this ground. We consequently summarily affirm
the Examiner's rejection. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or
authorities not included in the appeal brief will be refused consideration by
the Board for purposes of the present appeal").
J. Rejection of claim 47 as being obvious over Sosnowski, Burnett, and
Kim
Appellant make no argument with respect to the Examiner's rejection
of claim 4 7 upon this ground. We consequently summarily affirm the
Examiner's rejection. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or
authorities not included in the appeal brief will be refused consideration by
the Board for purposes of the present appeal").
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K. Rejection of claims 29, 30, 31, and 446 as being obvious over Li and
Burnett
Issue
Claim 29 recites, in relevant part: "wherein the leg ends are sized for
individually temporarily blocking the pylorus of the patient when the leg end
contacts the pylorus but is too large to fit within the pylorus opening,
thereby temporarily stopping flow of food from the stomach." Appellant
argues, inter alia, that, as argued for claim 22 supra, the combined cited
prior art neither teaches nor suggests this limitation. App. Br. 23.
Analysis
The Examiner relies on Burnett as teaching a pyloric valve corking
device with tapered leg connecting between two enlarged protrusions. Final
Act. 17 ( citing Burnett Fig. 4A). The Examiner finds that this an equivalent
structure to a constant diameter leg connecting two enlarged protrusions, in
which the leg has an outer surface that tapers from the proximal end to the
distal end. Id. (citing Figs. 2A-B, 4B).
We have explained why we find that Li does not disclose the disputed
limitation recited supra. For the same reasons, we fins that Li neither
teaches nor suggests that limitation. Burnett teaches a device that resides
within the pylorus, contrary to the requirements of the disputed limitation.
6 Appellant does not argue the rejection of claims 30, 31, or 44 on this
ground, either separately or grouped together with other claims. We
include the rejection of these claims in our analysis of claim 29 on this
ground.
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See Burnett Figs. 7 A---C. We consequently reverse the Examiner's rejection
of the claims upon this ground. Furthermore, because we find this issue to
be dispositive, we do not reach Appellant's additional arguments.
L. Rejection of claims 45 and 48 as being obvious over Lointier and Kim
Appellant make no argument with respect to the Examiner's rejection
of claims 45 and 48 upon this ground. We consequently summarily affirm
the Examiner's rejection. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or
authorities not included in the appeal brief will be refused consideration by
the Board for purposes of the present appeal").
M. Rejection of claim 46 as being obvious over Li and Kim
Appellant make no argument with respect to the Examiner's rejection
of claims 45 and 48 upon this ground. We consequently summarily affirm
the Examiner's rejection. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or
authorities not included in the appeal brief will be refused consideration by
the Board for purposes of the present appeal").
N. Rejection of claim 4 7 as being obvious over Li, Burnett, and Kim
Appellant make no argument with respect to the Examiner's rejection
of claim 4 7 upon this ground. We consequently summarily affirm the
Examiner's rejection. See 37 C.F.R. § 4I.37(c)(iv) ("[A]ny arguments or
authorities not included in the appeal brief will be refused consideration by
the Board for purposes of the present appeal").
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DECISION
The Examiner's rejection of claims 29-31, 44 and 47 under 35 U.S.C.
§ 112, first paragraph is affirmed.
The Examiner's rejection of claims 21, 25, and 45 under 35 U.S.C.
§ 112, first paragraph is reversed.
The Examiner's rejection of claims 22 and 46 under 35 U.S.C. § 112,
second paragraph is affirmed.
The Examiner's rejection of claims 21, 22, 25, and 43 under 35 U.S.C.
§ 102(b) is reversed.
The Examiner's rejection of claims 45--48 under 35 U.S.C. § 103(a) is
affirmed.
The Examiner's rejection of claims 21, 25, 29-31, and 44 under 35
U.S.C. § 103(a) is reversed.
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-IN-PART
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