Ex Parte MOSS et al

Patent Trial and Appeal Board

Jun 14, 2018

14642590 (P.T.A.B. Jun. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/642,590 03/09/2015
40518 7590 06/14/2018
LEVINE BAGADE HAN LLP
2400 GENG ROAD, SUITE 120
PALO ALTO, CA 94303
FIRST NAMED INVENTOR
Samuel MOSS
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.
ALLRNZ00401 6384
EXAMINER
TON, MARTIN TRUYEN
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
06/14/2018 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 SAMUEL MOSS, MATTHEWS. LAKE,
JONATHAN WECKER, SHANTANU K. GAUR, SAMUEL G. LEVY,
BRUCE A. HORWITZ, and JINYOUNG DANIEL GWAK
Appeal2017-005269
Application 14/642,590
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
medical device for occupying a space within a patient's body. The
Examiner rejected2 the claims as indefinite, anticipated, and obvious. We
have jurisdiction under 35 U.S.C. § 6(b ). We affirm-in-part.
1 Appellants identify the Real Party in Interest as Allurion Technologies, Inc.
(See App. Br. 3).
2 We herein refer to the Specification, filed Mar. 9, 2015 ("Spec."); Final
Office Action, mailed Dec. 10, 2015 ("Final Act."); Appeal Brief, filed Nov.
14, 2016 ("App. Br."); Examiner's Answer, mailed Dec. 14, 2016 ("Ans.");
and the Reply Brief, filed Feb. 14, 2017 ("Reply Br.").
Appeal2017-005269
Application 14/642,590
Statement of the Case
Background
"Gastric bypass surgery is the current gold standard treatment for
patients with a body mass index ('BMI') of greater than 40" (Spec. ,r 4).
"While gastric bypass surgery results in decreased food consumption and
weight loss for a majority of recipients, it requires life-altering, permanent
anatomic modifications to the gastrointestinal tract and can result in severe
complications" (Spec. ,r 4). "One less-invasive intervention that has begun
to gain popularity is an intragastric balloon. Intragastric balloons can be
placed endoscopically or positioned using other methods and generally must
be removed endoscopically or rely on the body's natural digestive processes
for removal" (Spec. ,r 6).
The Claims
Claims 1-16, 18, 21, 22, and 45 are on appeal. Independent claims 1
and 45 are representative and read as follows:
1. A medical device for occupying a space within a
patient's body and for use with a fluid delivery conduit that
allows transport of a fluid into the medical device, the medical
device comprising:
a device body defining a reservoir;
a tunnel member having an elongate flattened shape, the
tunnel member comprising a first open end located within the
reservoir and a second open end located exterior to the device
body, the tunnel member having at least two interior opposing
surfaces that define a tunnel lumen extending between the first
open end and the second open end; and
where the tunnel lumen is sized to slidably receive the
fluid delivery conduit within the second open end such that the
fluid delivery conduit separates the interior opposing surfaces
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Application 14/642,590
deforming the elongate flattened shape to an elongated
expanded shape; wherein removal of the fluid delivery conduit
causes the tunnel member to revert to the elongate flattened
shape such that the interior opposing surfaces move together to
narrow the tunnel lumen and increase a resistance to fluid flow
through the tunnel lumen.
45. A fluid fill valve for use with a medical device for
occupying a space within a patient's body and for use with a
fluid delivery conduit the valve comprising:
a first layer of fluid impermeable membrane and a second
layer of fluid impermeable membrane, wherein a portion of the
layers are sealingly joined to form a valve body, the valve body
having an internal end disposed inside the device and an
external end external to or at the surface of the device;
wherein the first layer and second layer include an
unsealed region that forms a lumen longitudinally extending in
the valve body from the external end to the internal end:
a substance within the lumen between the first layer and
second layer that increases the resistance to fluid flow through
the lumen; and
where the first layer and second layer are configured to
join together in the lumen reducing a diameter of the lumen
region to resist passage of fluids therethrough, where the lumen
is configured to permit advancement of the fluid delivery
conduit therethrough.
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Application 14/642,590
The Issues 3
A. The Examiner rejected claim 45 under 35 U.S.C. § I02(a)(l) as
anticipated by Becker4 (Final Act. 6-7).
B. The Examiner rejected claims 1, 2, 9, 10, 14, 16, 21, and 22 under 3 5
U.S.C. § I03(a) as obvious over Quijano 5 and Becker (Final Act. 8-13).
C. The Examiner rejected claims 3-8 under 35 U.S.C. § I03(a) as
obvious over Quijano, Becker, and Wiesner6 (Final Act. 13-14).
D. The Examiner rejected claims 11-13 under 35 U.S.C. § I03(a) as
obvious over Quijano, Becker, and Berman7 (Final Act. 14--15).
E. The Examiner rejected claim 15 under 35 U.S.C. § I03(a) as obvious
over Quijano, Becker, and Melinyshyn8 (Final Act. 15-16).
F. The Examiner rejected claim 18 under 35 U.S.C. § I03(a) as obvious
over Quijano, Becker, and Brister9 (Final Act. 16-17).
A. 35 USC§ 102(a)(l) over Becker
The Examiner finds Becker anticipates the valve of claim 45, which
requires first and second layers with a lumen and "a substance within the
3 Because the Examiner, in the Advisory Action mailed Mar. 11, 2016,
entered Appellants' After-Final amendment filed Feb. 9, 2016 that amended
the claims to address the 35 U.S.C. § 112(b) rejection, and the Examiner
does not restate this rejection in the Answer, we treat this rejection as
withdrawn by the Examiner.
4 Becker, US 5,595,521, issued Jan. 21, 1997.
5 Quijano et al., US 2008/0243071 Al, published Oct. 2, 2008.
6 Wiesner et al., US 5,348,537, issued Sept. 20, 1994.
7 Berman et al., US 4,133,315, issued Jan. 9, 1979.
8 Melinyshyn et al., US 4,949,756, issued Aug. 21, 1990.
9 Brister et al., US 2010/0137897 Al, published June 3, 2010.
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Application 14/642,590
lumen between the first layer and second layer that increases the resistance
to fluid flow through the lumen" (see Final Act. 7; claim 45). The Examiner
asserts that the heat-resistant ink of element 63 is a substance
applied to an inner wall of the tunnel via the inner surface of
layer 62, wherein said heat-resistant ink is applied to the film
layer 62 to allow the film layers 62 and 64 to form a fluid tight
seal, which increases the resistance to fluid flow through the
tunnel when the seal is formed. Therefore, given that the
substance of the heat-resistant ink allows for said fluid tight
seal, it is therein a substance within the tunnel member that
increases the resistance to fluid flow through the formation of
the fluid tight seal. Furthermore, it may also be argued that any
substance within the tunnel will inherently serve to increase the
resistance to fluid flow through the tunnel by nature of simply
decreasing the diameter of the tunnel at a specific portion of the
tunnel lumen. Therefore, the heat-resistant ink on the inner
wall of the film layer 62 may be interpreted as a substance that
increases the resistance to fluid flow simply by decreasing the
diameter of the lumen at the portion where it is applied.
(Ans. 2-3).
Appellants contend:
The Examiner provides no support for the thickness of the
applied ink. Furthermore, the Examiner ignores the
texture/surface properties that the ink imparts on the valve
layer. The Examiner fails to address the equally likely
possibility that the application of the ink reduces a drag or a
frictional resistance of fluids/liquids moving against the ink as
compared to the valve film alone.
(Reply Br. 3--4).
The issue with respect to anticipation is: Does the evidence of record
support the Examiner's conclusion that Becker teaches "a substance within
the lumen between the first layer and second layer that increases the
resistance to fluid flow through the lumen" as required by claim 45?
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Application 14/642,590
Findings of Fact
1. Figure 7 of Becker is reproduced below:
22
40
' )
.44 .~ ... _, ~
I
r·
24
\
63
/
28 76 32
"The ink coating 63 is applied to the bottom surface of upper valve layer 62,
as shown, for example, in FIG[]. 7 ... It is important that the heat-resistant
ink 63 be applied in the region of bonding portion 56 to prevent
unintentional valve closure during balloon manufacture" (Becker 5:5-9).
Principles of Law
"Inherency ... may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient." MEHL/Biophile Int 'l. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999).
Analysis
We find that Appellants have the better position because there is no
evidence in Becker that the ink coating layer 63 "increases resistance to fluid
flow through the lumen" as required by claim 45. In the Specification, the
substances that increase resistance
can be a hygroscopic material, a material swells upon contact
with the patients bodily fluids or a liquid within the reservoir, a
low-solubility material, a bio-compatible lubricant, and/or a
viscous material where after removal of the fluid delivery
member a cohesion of the viscous material increases a force
required to separate the interior opposing surfaces.
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Application 14/642,590
(Spec. ,r 12). Notably absent from this description of materials that increase
resistance is "ink."
We also are not persuaded by the Examiner's reasoning that an "ink
coating layer" would inherently constrict the passageway and thereby
inherently increase resistance (see Ans. 2-3). Becker does not apply the ink
for such a purpose, applying the ink instead to prevent bonding during
balloon manufacture thereby "prevent[ing] unintentional valve closure
during balloon manufacture" (See, e.g., Becker 4:65-5: 10). Moreover, as
Appellants point out, inks which reduce the coefficient of drag may reduce,
not increase, flow resistance (see Reply Br. 3--4 ). The Examiner has not
provided evidence whether the ink coating layer in Becker has a frictional
coefficient that would be expected to increase or decrease resistance relative
to the layers on which it is coated. Therefore the Examiner does not provide
the factual predicate necessary for establishing that Becker's "ink coating
layer" necessarily serves to increase resistance.
In addition, the Examiner has not established a prima facie case under
the burden shifting rationale of In re Best, 562 F.2d 1252, 1254--55 (CCPA
1977), because the Examiner does not identify any specific inks used as
coating layers in Becker that Appellants could test in order to rebut the
inherency position.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Becker teaches "a substance within the lumen between the first layer
and second layer that increases the resistance to fluid flow through the
lumen" as required by claim 45.
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Application 14/642,590
B. 35 US.C. § 103(a) over Quijano and Becker
The Examiner finds Quijano teaches a "medical device for occupying
a space within a patient's body and for use with a fluid delivery conduit that
allows transport of a fluid into the medical device [], the medical device
comprising: a device body defining a reservoir [] and a valve for introducing
fluid into the reservoir" (Final Act. 8). The Examiner acknowledges
Quijano "does not specifically teach the specific structure of said valve"
(Id.).
The Examiner finds Becker teaches "a self-sealing valve system for
inflatable structures, wherein the valve comprises a tunnel member having
an elongate flattened shape" where
the fluid delivery conduit separates the interior opposing
surfaces deforming the elongate flattened shape to an elongated
expanded shape [], wherein removal of the fluid delivery
conduit causes the tunnel member to revert to the elongate
flattened shape such that the interior opposing surfaces move
together to narrow the tunnel lumen
(Final Act. 8-9). The Examiner finds it obvious "to have the valve of the
Quijano reference have the same structure as that of the Becker reference to
provide an improved valve which may be inexpensively produced" (Id. at 9).
The issue with respect to obviousness is: Does the evidence of record
support the Examiner's conclusion that Quijano and Becker suggest a
medical device with a valve as required by claim 1?
Findings of Fact
2. Quijano teaches "intragastric balloons for treatment of morbid
obesity" (Quijano 2).
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Application 14/642,590
3. Figure 5 of Quijano is reproduced below:
Fl(}. 5
"FIG. 5 shows an overall view of a 2-balloon gastric space filler system 10
of the present invention. The system may comprise an entrance section 11, a
first balloon section 12, a second balloon section 14, an inter-balloon section
13, and a drug dispensing section 15" (Quijano ,r 53).
4. Quijano teaches that a "first drug reservoir pouch 27 A in the
first balloon, the second drug reservoir pouch 27B in the second balloon and
the drug reservoir 27C in the inter-balloon section may be in controlled fluid
communication" (Quijano ,r 59).
5. Becker teaches "an improved valve for use with balloons"
(Becker 1: 50-51) where the "present invention helps to insure the formation
of a continuous tubular passageway which extends from the neck of the
balloon to the balloon interior" (Becker 6: 1-3).
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Application 14/642,590
6. Figures 1 and 2 of Becker are reproduced below:
Fig. 1
Fig. 2
In the preferred embodiment, the valve 50 is inserted between
balloon film layers 12, 14 and is bonded to the balloon films by
the same operation which seals the marginal edges of the
balloon films. As shown in FIGS. 1 and 2, for example, in a
single step the various layers of assembly 10 are bonded
together with heated dies conforming to the outer periphery of
the balloon films (including heat-sealing portions 54, 58), as
well as the cross sealing or valve seal 56 at the center of the
"H" pattern.
(Becker 4:7-15).
7. Figure 8 of Becker is reproduced below:
(
64
12
)
p· 8 .... tg.
' 1 63 14
10
i " 56 76
36
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Application 14/642,590
"FIG. 8 is a view similar to that of FIG. 7 showing the probe at a later stage
of insertion" (Becker 2:19--20).
8. Figure 12 of Becker is reproduced below:
50
Fig. 12
...
14
"FIG. 12 is a cross-sectional view taken along the line 12-12 of FIG. 2, but
shown after inflation" (Becker 2:28-29).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 8-13; FF 1-8) and agree that
the claims are obvious over the cited prior art. We select claim 1 as
representative. 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv) ("[T]he failure of appellant to
separately argue claims which appellant has grouped together shall
constitute a waiver of any argument that the Board must consider the
patentability of any grouped claim separately.") We address Appellants'
arguments below.
Appellants contend "the valve of Becker does not extend beyond the
device body but remains within a neck of the balloon" (App. Br. 13).
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Application 14/642,590
Appellants further contend "Becker teaches against insertion of any member
through the valve otherwise the valve would stretch and fail to function as a
valve" (Id.).
We find these arguments unpersuasive because we agree with the
Examiner that claim 1 "simply states that the valve must be sized to slidably
receive the fluid delivery conduit within the second open end. This
limitation does not suggest that the entirety of the conduit must be inserted
to run through the valve" (Ans. 4). Even if we treated this functional
recitation as having some structural consequence, Schreiber teaches that
writing a claim that mixes structural and functional limitations comes at a
price. In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). ("[C]hoosing
to define an element functionally, i.e., by what it does, carries with it a
risk."). The price is that when the structural limitations are met by a single
prior art reference, and when the examiner "has reason to believe" that the
prior art reference inherently teaches the functional limitation, the burden
shifts to the patent applicant to show that the functional limitation cannot be
met by the single prior art reference. Id.; see also Best, 562 F.2d at 1254--55
(CCPA 1977).
Here the Examiner reasonably finds that
the tip of the conduit, or the needle, shown in the Becker
reference may slidably be received into the valve to fill the
balloon without stretching the valve, as shown in Figures 7 and
8 of the Becker reference, [therefore] the reference does in fact
teach the limitation and operation of the device as recited in the
claims [and] would not render the device inoperable.
(Ans. 4). That is, Figure 8 of Becker shows inflation probe 40 with tip 42
slidably received by valve 50 in the lumen defined by valve film layers 62
and 64 (FF 7) consistent with the requirement of claim 1.
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Application 14/642,590
Appellants contend "Becker does not teach or suggest positioning of
any conduit through the valve but instead teaches the use of slits at the
opening of the valve to allow nesting of a probe within the slit area" (App.
Br. 14). Appellants contend "the Examiner's assertion of stretching the
valve cannot be satisfied by Becker under an anticipation analysis" (Id.).
We find this argument unpersuasive because the rejection is for
obviousness, not anticipation. It is the combination of Becker and Quijano,
and what these references suggest together, not what either reference
independently teaches, that renders claim 1 obvious. "Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references." In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). As already noted,
Figure 8 of Becker reasonably shows tip 42 slidably received by valve 50
(FF 7).
Appellants contend "the Examiner does not provide any rationale as to
why one would proceed contrary to the teaching of Becker and position any
conduit through the valve seal or even how one would position a conduit
having sufficient column strength through the delicate valve without
damaging the valve" (Id. at 14). Appellants contend "Becker teaches against
delivery of an inflation mechanism through the valve to deform from an
elongated flattened shape to an elongated expanded shape. As noted above,
Quijano does not teach this requirement either" (App. Br. 15).
We find these arguments unpersuasive, both for the reasons given
above regarding the functional nature of the limitation and because
Appellants do not identify a teaching in Becker that discourages, discredits,
or otherwise teaches away from any particular placement of the conduit in
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the valve. A teaching away requires a reference to actually criticize,
discredit, or otherwise discourage the claimed solution. See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004) ("The prior art's mere disclosure of
more than one alternative does not constitute a teaching away from any of
these alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed"). The specific teaching
identified by Appellants in column 1, lines 34--37 of Becker are drawn to
prior art valves, not to the valves of Becker.
Appellants contend: "An elongate expanded shape is not the same as
an expanded shape. Clearly, claims 1 and 21 require that the tunnel lumen
can receive the fluid delivery conduit to form an elongated expanded shape"
(Reply Br. 5).
We find this argument unpersuasive because we agree with the
Examiner that the "fluid delivery conduit separates the interior opposing
surfaces deforming the elongate flattened shape to an elongated expanded
shape (Figure 8; 36)" (Final Act. 8). Neither Claim 1 nor the Specification
define the extent of elongation required for either an "elongate flattened
shape" or "an elongated expanded shape." Figures 7 and 8 of Becker show
transition of a conduit from the flattened shape in Figure 7 to an expanded
shape in Figure 8 that is elongate to some degree. Moreover, Becker teaches
"the formation of a continuous tubular passageway" (FF 5) that is reasonably
interpreted as an "elongate expanded shape." Thus, both a reasonable
reading of Becker and a reasonable interpretation of the phrase "elongated
expanded shape" support the Examiner's obviousness position.
Conclusion of Law
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Application 14/642,590
The evidence of record supports the Examiner's conclusion that
Quijano and Becker suggest a medical device with a valve as required by
claim 1.
C. 35 US.C. § 103(a) over Quijano, Becker, and Wiesner
Appellants contend "Becker does not teach or suggest any substance
within its valve that increases a resistance to fluid flow through the lumen
upon removal of a fluid delivery member" (App. Br. 16). Appellants
contend:
(Id.)
One of skill in the art, using the teachings of Becker, would
avoid putting extraneous materials in the valve given that such
materials will increase the tension upon the valve film leading
to deformation. The addition of Wiesner does nothing to
address the contrary teachings of Becker, which cautions
against stretching of the valve and teaches away from putting a
substance into the valve[.]
The Examiner responds "Becker does not contain contrary teachings
with respect to the claimed invention" (Ans. 6).
We find the Examiner has the better position. Becker does not teach
away from valve stretching, as noted above, and Becker clearly suggests
placing an ink coating in the valve (FF 1 ), even if that coating may or may
not inherently result in increased resistance to fluid flow. Wiesner teaches
the inclusion of a "lubricious material" where "[ u Jpon contact with an
aqueous based liquid, the lubricous material causes the polymer material
defining the bearing surface to swell, thereby sealing the interface between
the bearing surface and the movable member so as to prevent the passage of
a significant amount of liquid therethrough" (Wiesner 3 :22-2 7). The
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Examiner reasonably finds it obvious to combine Becker, Quijano and
Wiesner to "additionally include the swellable substance of the Wiesner
reference to further prevent the passage of significant amounts of liquid
through the valve after removal of the fluid conduit" (Final Act. 14 ).
D.-F. 35 US.C. § 103(a)
Appellants do not separately argue these obviousness rejections,
instead relying upon their arguments to overcome the combination of
Quijano and Becker. The Examiner provides sound fact-based reasoning for
combining each of Berman, Melinyshyn, and Brister (see Final Act. 14--17).
Having affirmed the obviousness rejection of claim 1 over Quijano and
Becker for the reasons given above, we also find that the further
combinations render the rejected claims obvious for the reasons given by the
Examiner.
SUMMARY
In summary, we reverse the rejection of claim 45 under 35 U.S.C.
§ 102( a )(1) as anticipated by Becker.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Quijano and Becker. Claims 2, 9, 10, 14, 16, 21, and 22 fall
with claim 1.
We affirm the rejection of claims 3-8 under 35 U.S.C. § 103(a) as
obvious over Quijano, Becker, and Wiesner.
We affirm the rejection of claims 11-13 under 35 U.S.C. § 103(a) as
obvious over Quijano, Becker, and Berman.
We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as
obvious over Quijano, Becker, and Melinyshyn.
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We affirm the rejection of claim 18 under 35 U.S.C. § 103(a) as
obvious over Quijano, Becker, and Brister.
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-IN-PART
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