Ex Parte Gaur et al

Patent Trial and Appeal Board

Sep 6, 2017

13039067 (P.T.A.B. Sep. 6, 2017)

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.
13/039,067 03/02/2011 Shantanu Gaur ALLRNZ00700 1052
40518 7590 09/06/2017
LEVINE BAGADE HAN LLP
2400 GENG ROAD, SUITE 120
PALO ALTO, CA 94303
EXAMINER
TON, MARTIN TRUYEN
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
09/06/2017 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 SHANTANU GAUR,
SAMUEL LEVY, and JONATHAN WECKER
Appeal 2016-007093
Application 13/039,067
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 appeal1 under 35U.S.C. § 134 involving claims to a device
for temporarily occupying a portion of a stomach. The Examiner rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
1 Appellants identify the real party in interest as Allurion
Technologies, Inc. (App. Br. 3).
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Application 13/039,067
Statement of the Case
Background
“Typical weight loss treatment modalities, excluding diet and
exercise, have focused either on promoting malabsorption ... or restricting
gastric volume (for example, gastric bypass surgery, gastric bands, and/or
intragastric balloons)” (Spec. 1:20-23). “[SJurgical interventions remain
highly invasive, expensive, and only applicable to morbidly obese patients”
{id. at 1:24—25).
Expandable polymer systems comprised of hydrogels or
cellulose derivatives have been described previously but
typically suffer from limited efficacy and numerous
disadvantages. Residence time in the stomach is typically less
than six hours, requiring a substantial and rigorous regimen of
treatment compliance to provide round-the-clock satiety.
Insufficient structural integrity in the inhospitable gastric milieu
typically drives this short residence time.
(Spec. 2:3-7).
The Claims
Claims 44^48, 50-58, and 60-65 are on appeal. Claim 63 is
representative and reads as follows:
63. A method of inducing weight loss in a patient
comprising:
positioning a construct within a stomach, such that the
construct includes a fluid-permeable membrane, and a filler
material enclosed within the one or more fluid permeable
membrane, wherein the construct is adapted to enter the
stomach of a patient in a first compressed state, and responsive
to insertion into the stomach, to expand into a second expanded
state, and wherein the fluid-permeable membrane is structurally
unmodified in a gastric environment; and
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delivering a degradation formulation into the stomach,
such that the degradation formulation causes disruption of the
structural integrity of the construct and causes release of the
filler material from the construct such that the filler material
passes from the stomach.
The issues
A. The Examiner rejected claims 44, 47, 48, 50, 51, 53—55, 57, 58, 60,
and 62—65 under 35 U.S.C. § 103(a) as obvious over Kasic2 and Weitzner3
(Final Act. 4—11).
B. The Examiner rejected claims 45 and 46 under 35 U.S.C. § 103(a) as
obvious over Kasic, Weitzner, and Marco4 (Final Act. 11—13).
C. The Examiner rejected claim 52 under 35 U.S.C. § 103(a) as obvious
over Kasic, Weitzner, and Dann5 (Final Act. 13).
D. The Examiner rejected claim 56 under 35 U.S.C. § 103(a) as obvious
over Kasic, Weitzner, Dann, and Lew6 (Final Act. 14—15).
E. The Examiner rejected claim 61 under 35 U.S.C. § 103(a) as obvious
over Kasic, Weitzner, and Sampson7 (Final Act. 15).
A. 35 U.S.C. § 103(a) over Kasic and Weitzner
The Examiner finds Kasic teaches
a device for temporarily occupying a portion of a stomach for
use with a degradation material that permits release of the
2 Kasic, II, US 2009/0192535 Al, published July 30, 2009.
3 Weitzner et al., US 2008/0249635 Al, published Oct. 9, 2008
4 Marco et al., US 2007/0156248 Al, published July 5, 2007.
5 Dann et al., US 2007/0010864 Al, published Jan. 11, 2007.
6 Lew et al., US 5,167,962, issued Dec. 1, 1992.
7 Sampson et al., US 6,981,980 B2, issued Jan. 3, 2006.
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device from the stomach (Figure 2; 20), the device comprising:
a membrane (Figure 4C; 110) having at least one responsive
material mechanically secured thereto to form an expandable
structure having an enclosed volume (Figure 4C; 130), wherein
the reference teaches that the device may have a membrane
made from a first material and a second material, wherein the
first and second materials are operably connected to form the
enclosure volume, with one of the first or second materials
having a differing degradation rate from the other
(Final Act. 4). The Examiner acknowledges that Kasic “does not
specifically teach a degradation material, wherein the . . . mechanical
properties of the responsive material do not change until the degradation
material structurally weakens the responsive material” (Final Act. 5).
The Examiner finds Weitzner teaches “a device for temporarily
occupying a volume of the stomach, wherein one or both elements of the
device may be biodegradable or dissolvable by a solvent, which manually
breaks down the material” (id.). The Examiner finds it would have been
obvious
to weaken the responsive material of the Kasic reference by
introducing a degradation material to the stomach after a
sufficient period, the degradation material being a solvent, as in
the Weitzner reference, to allow for a patient to control the time
of expulsion of the expandable structure from the patient’s
stomach
(id.).
The issue with respect to obviousness is: Does the evidence of record
support the Examiner’s conclusion that Kasic and Weitzner render obvious
the method and constructs of claims 44, 62, and 63?
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Findings of Fact
1. Kasic teaches “devices and methods related to treatment of
obesity in animals or humans” (Kasic 12).
2. Kasic teaches
the device is configured so that the maximum size of the self-
expanding component is sufficiently small that each component
can be passed from the stomach through the pyloric sphincter.
Accordingly, the user or medical practitioner need not be
worried about whether the component has appropriate
biodegradation rates or that the device will obstruct the pyloric
sphincter or the GI tract.
(Kasic 113).
3. Kasic teaches a “swallowable self-expanding gastric space
occupying device. In an aspect, the device has a membrane through which
gastric liquid or fluid can pass, wherein the membrane provides an enclosure
volume separated from the gastric environment by the membrane” (Kasic
114).
4. Kasic teaches “the membrane is a composite, in that it may be
made from two or more distinct materials that may be different chemically
to provide a different rate of degradation” (Kasic 114).
5. Kasic teaches: “Within the enclosure volume is a self-
expanding component, such as a plurality of self-expanding components.
The components are capable of expanding in volume upon contact with a
gastric fluid, such as water for example, thereby expanding the device from
an unexpanded volume to an expanded volume” (Kasic 114).
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6. Kasic teaches:
The first and second materials are operably connected to form
the enclosure volume and the first material has a higher rate of
decomposition in the gastric environment than the second
material. The operable connection between the two materials
provides a well-defined enclosure volume, but upon substantial
degradation or dissolution of at least a portion of the first
material, the enclosure opens, thereby releasing the self­
expanding components from the enclosure.
(Kasic 119).
7. Kasic teaches:
Materials 610 and 620 can dissolve (e.g., degrade) at
different times so that after a user-selected time, an opening in
the membrane becomes large enough to release the self­
expanding components. For example, material 620 may be a
material that does not degrade or dissolve in the stomach, such
as, for example a highly cross-linked polymer, a silicone-based
material, or other inert material as known in the art including,
but not limited to, fats, waxes, carbohydrate polymers (poly and
oligosaccharides). In that situation, the dissolution of 610
results in release of material 620 from the membrane, loss of
membrane integrity, release of self-expanding components 300
and movement out of the stomach and through the lower GI
tract.
(Kasic 181).
8. Kasic teaches that a “material that is ‘not substantially
biodegradable’ refers to a material that does not significantly dissolve, erode
or otherwise decompose or degrade, and maintains overall physical integrity,
such as a decrease in bulk material volume or mass that is less than 10%, for
a user-specified time period” (Kasic 151).
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9. Weitzner teaches “a gastric balloon 200 . . . [that] includes a net
or bag 204 which, after insertion into a desired portion of the GI tract (e.g.,
the stomach), is filled with a filler material until the balloon 200 takes up a
desired volume” (Weitzner 116).
10. Weitzner teaches
portions of the net 204 and/or the filler material may be
biodegradable or dissolvable. For instance, the net 204 may be
dissolvable by application of a solvent, a dissolving solution or
heat, or may be designed to dissolve after a predetermined
period of time after exposure to stomach fluids (e.g., three
months). Once the net 204 is dissolved or manually broken, the
filler material may be exposed to the same or another dissolving
agent, and may be absorbed or passed through the digestive
system.
(Weitzner^ 16).
Principles of Law
“If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability.” KSRInt’l Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 4—11; FF 1—10) and agree that
the claims are rendered obvious by the prior art. We address Appellants’
arguments below.
Appellants contend
it is apparent from Kasic’s disclosure that the principle of
operation or the intended purpose of Kasic is a gastric space
occupying device that is tailored to degrade on its own after
a well-defined time in the gastric environment of the
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patient. Appellant has previously argued that these teachings
of Kasic contradict Appellant’s claims which require a non-
degradable membrane and a responsive material where the non-
degradable membrane and responsive material both remain
structurally unmodified in the stomach until the responsive
material contacts a degradation material that is added or
delivered to the stomach.
(App. Br. 10). Appellants contend “while Kasic teaches a composite
membrane that might include a material with a lower (or no) degradation
rate, the entirety of the composite membrane is still susceptible to
degradation to release the device’s components and therefore cannot be
considered a non-degradable membrane” (id.).
We find this argument unpersuasive because the rejection is not one
that is premised on Kasic alone. Weitzner teaches several known equivalent
modes of dissolution of obesity gastric devices including dissolution after a
“predetermined period of time,” “dissolvable by application of a solvent,” or
use of “a dissolving solution” (FF 10). Thus, although Kasic suggests an
obesity gastric device that uses materials which dissolve “after a user-
selected time” (FF 7) to release the components of the stomach space filling
device, Weitzner’s teaching that known alternative equivalent modes of
dissolution of obesity gastric devices to dissolution after a “predetermined
period of time” include dissolution “by application of a solvent,” or use of
“a dissolving solution” (FF 10), reasonably renders selection of these
alternative modes of dissolution obvious in the absence of a secondary
consideration.
Our position finds substantial support in the underlying facts of the
KSR decision itself, where the Supreme Court was not persuaded by the
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Federal Circuit’s reliance upon a statement from an “expert that claim 4 was
nonobvious because, unlike in Rixon, the sensor was mounted on the support
bracket rather than the pedal itself.” KSR, 550 U.S. at 415. That is, like the
current case, some reconstruction of the prior art elements in KSR amounting
to a change in the principle of operation of the pedal sensor from mechanical
to electrical would have been required to arrive at the claimed invention.
The Court, however, found that “if a technique has been used to improve one
device, and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill.” Id. at 417.
Here, the obvious substitution of Weitzner’s mode of controlling
dissolution of gastric devices with “a dissolving solution” (FF 10) for
Kasic’s mode of controlling dissolution by use of materials that dissolve
“after a user-selected time” (FF 7) is such an obvious substitution.
Appellants contend
section [0081] of Kasic explicitly teaches a composite
membrane where the mesh fabric material 610 degrades but the
second material 620 does not. But this composite membrane is
still designed to degrade as dissolution of the mesh fabric 610
results in release of materials 620 from the membrane - i.e., a
degradable membrane.
(App. Br. 12). Appellants contend “any attempts to modify Kasic to meet
Appellant’s claim requirements ignore the clearly stated intended purpose of
Kasic to provide a gastric space occupying device where the membrane (or
composite membrane) described by Kasic degrades as a result of being
placed in the patient’s gastric environment” {Id. at 12—13).
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We find this argument unpersuasive for the reasons already discussed
above and because “[n]on-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). A reference “must be read, not in isolation, but for what it fairly
teaches in combination with the prior art as a whole.” Id.
Appellants’ argument fails to address the incorporation of the
teachings of Weitzner that demonstrate the ordinary artisan was aware of
multiple equivalent techniques for removing unwanted gastric devices
including that dissolution of membrane material “by application of a
solvent,” or use of “a dissolving solution” are both alternatives to a
membrane that dissolves after a “predetermined period of time” (FF 10).
Appellants provide no evidence that selection of these alternative modes of
dissolution, suggested by Weitzner, would have been unobvious solutions to
Kasic’s desire for dissolution “after a user-selected time” (FF 7).
Appellants contend “that the Examiner is attempting to modify the
Kasic device to comprise a fully non-degradable composite membrane but
provides no discussion on why one skilled in the art would proceed contrary
to the numerous explicit teaching of Kasic that discuss a degradable
composite membrane” (App. Br. 13).
We find this argument unpersuasive for the equivalence reasons given
above and because Kasic specifically defines a “not substantially
biodegradable” material (FF 8) and suggests the use of such a material in
combination with another material that is “degradable” or, to use the
language of claim 44, “responsive” (FF 7). Specifically, Kasic teaches
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“material 620 may be a material that does not degrade or dissolve in the
stomach” (FF 7). Kasic then teaches the embodiment where “the dissolution
of 610 results in release of material 620 from the membrane, loss of
membrane integrity, [and] release of self-expanding components 300” (FF
7).
Thus, Kasic teaches a composite membrane composed of a non-
degradable material and a second material that is degradable, reasonably
rendering the device of claim 44 obvious when combined with Weitzner’s
suggestion to use materials that are “dissolvable by application of a solvent”
or through use of “a dissolving solution” (FF 10).
Appellants contend
that the Examiner used impermissible hindsight reconstruction
to combine the “solvent” of Weitzner (see Weitzner, paragraph
[0016]) and the modified gastric space occupying device of
Kasic in order to deprecate the Appellant’s claimed invention.
One of ordinary skill in the art would not have been motivated
by the teachings of Kasic at the time of the invention to
combine the “solvent” of Weitzner with the self-degradable
device of Kasic because Kasic’s device would have no need for
a solvent to aid in the breakdown of the device.
(App. Br. 13).
We are not persuaded. While we are fully aware that hindsight bias
may plague determinations of obviousness, Graham v. John Deere Co., 383
U.S. 1,36 (1966), we are also mindful that the Supreme Court has clearly
stated that the “combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR, 550 U.S. at 416.
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As already discussed, Weitzner teaches three alternative approaches to
dissolving the outer membrane of an obesity gastric device (FF 10), one of
which is the approach chosen by Kasic (FF 7). Therefore, Weitzner clearly
renders the other two approaches that fall within the scope of the claims
obvious as known predictable alternatives in the absence of evidence of
secondary considerations. We note that no such evidence has been argued
by Appellants. We therefore agree with the Examiner that the ordinary
artisan would have recognized
an alternative to [Kasic’s] predetermined degradation time
would be the degradation of the second material, or response
material, through the introduction or a solvent or degradation
material, wherein a person having ordinary skill in the art
would be motivated make this modification to allow a patient to
control the time of expulsion of the expandable structure from
the patient’s stomach.
(Ans. 4—5, citing Weitzner 116; FF 10).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that Kasic
and Weitzner render obvious the method and constructs of claims 44, 62,
and 63.
B.-E. 35 U.S.C. § 103(a) rejections
Appellants do not separately argue these rejections. The Examiner
provides sound fact-based reasoning explaining why the further
combinations of Kasic and Weitzner with Marco, Dann, Lew, and Sampson
render the rejected claims obvious (see Final Act. 11—15). Having affirmed
the rejection of claims 44, 62, and 63 over Kasic and Weitzner for the
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reasons given above, we also find the further rejections render the rejected
claims obvious for the reasons given by the Examiner.
SUMMARY
In summary, we affirm the rejection of claims 44, 62, and 63 under
35 U.S.C. § 103(a) as obvious over Kasic and Weitzner. Claims 47, 48, 50,
51, 53—55, 57, 58, 60, 64, and 65 fall with claims 44, 62, and 63.
We affirm the rejection of claims 45 and 46 under 35 U.S.C. § 103(a)
as obvious over Kasic, Weitzner, and Marco.
We affirm the rejection of claim 52 under 35 U.S.C. § 103(a) as
obvious over Kasic, Weitzner, and Dann.
We affirm the rejection of claim 56 under 35 U.S.C. § 103(a) as
obvious over Kasic, Weitzner, Dann, and Lew.
We affirm the rejection of claim 61 under 35 U.S.C. § 103(a) as
obvious over Kasic, Weitzner, and Sampson.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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