Ex Parte Levy et al

Patent Trial and Appeal Board

Aug 4, 2017

14073665 (P.T.A.B. Aug. 4, 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.
14/073,665 11/06/2013 Samuel G. LEVY ALLRNZ02000 1000
40518 7590 08/04/2017
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
08/04/2017 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 SAMUEL G. LEVY, SHANTANU K. GAUR,
JONATHAN WECKER, and BRUCE A. HORWITZ
Appeal 2017-008400
Application 14/073,665
Technology Center 3700
Before GEORGE R. HOSKINS, BRANDON J. WARNER, and
LEE L. STEPINA, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Samuel G. Levy et al. (“Appellants”)1 appeal under 35 U.S.C. § 134
from the Examiner’s decision rejecting claims 1, 2, and 4—25 in this
application. The Board has jurisdiction over the appeal under 35 U.S.C.
§ 6(b).
We REVERSE.
1 The Appeal Brief identifies Allurion Technologies, Inc. as the real party
interest. Appeal Br. 3.
Appeal 2017-008400
Application 14/073,665
CLAIMED SUBJECT MATTER
Claim 1 is the sole independent claim, and it recites:
1. An ingestible delivery system configured to mimic a
naturally formed bolus of food to facilitate ingestion by a patient,
the delivery system comprising:
a bio-compatible material encasing a gastric device in a
compressed configuration, where the bio-compatible material
extends from the gastric device to prevent the patient from
sensing the gastric device during ingestion and forms a body
configured to reduce a gagging reflex of the patient, where the
bio-compatible material is elastically deformably compliant;
the body having a front, a first side, a second side, and a
rear, the body comprising:
a bottom surface having a smoothly continuous surface
extending from the front of the body to the rear of the body;
a top surface opposite to the bottom surface, the top
surface having a bulge region, where the body has a maximum
thickness as measured between the top and bottom surface at the
bulge region, where the top surface comprises a front tapering
surface that smoothly tapers from the bulge region to the front of
the body and a rear tapering surface that smoothly tapers from
the bulge region to the rear of the body, such that a thickness of
the body decreases from the bulge region along both the front
tapering surface and rear tapering surface and the thickness of
the body decreases from the bulge region towards the first and
second sides of the body, where a length of the front tapering
surface is greater than a length of the rear tapering surface; and
the gastric device being releaseable from the bio­
compatible material subsequent to ingestion such that the gastric
device can assume an expanded profile.
Appeal Br. 20 (Claims App.).
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Application 14/073,665
REJECTIONS ON APPEAL
Claims 1, 2, 4—16, and 18—232 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Brister (US 2010/0137897 Al, pub. June 3, 2010) and
Martin (US 2013/0296751 Al, pub. Nov. 7, 2013).
Claim 17 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Brister, Martin, and Kasic (US 2009/0192535 Al, pub. July 30, 2009).
Claim 24 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Brister, Martin, and Berge (US 2010/0062057 Al, pub. Mar. 11, 2010).
Claim 25 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Brister, Martin, and Toyota (US 2010/0121224 Al, pub. May 13,
2010).
ANALYSIS
A. Obviousness over Brister and Martin
In rejecting claim 1, the Examiner finds Brister discloses an ingestible
delivery system comprising a material encasing a gastric device in a
compressed configuration, with the gastric device being releasable from the
material subsequent to ingestion. Final Act. 4—5. As to the shape of
Brister’s delivery system, the Examiner focuses on Figures 5 A and 5B. Id.
Those Figures are reproduced below:
2 The Examiner’s statement of this rejection additionally includes claim 25
(see Final Act. 4), but the supporting analysis fails to address claim 25 (see
id. at 4—12). Further, elsewhere the Examiner finds the combination of
Brister and Martin “does not teach a length and width that fall within the
exact ranges” of claim 25. See id. at 14. For these reasons, we do not
include claim 25 as being subject to this rejection.
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Application 14/073,665
Figure 5A is a cross-sectional view and Figure 5B is a perspective view of a
capsule device in a “delivery” state that is “compact,” “non-inflated,” and/or
“compressed” to facilitate swallowing. Brister || 55—56, 104, 156. The
Examiner finds Brister’s capsule has a bulge region with front and rear
tapering surfaces as recited in claim 1, but the length of the front tapering
surface is not greater than the length of the rear tapering surface, as claimed.
Final Act. 4—5. The Examiner cites Brister’s paragraph 156 as indicating
that the capsule “may be of any number of shapes that may facilitate
swallowing of the device while producing minimal discomfort of the
patient.” Id. at 5.
The Examiner relies on Martin as “providing a body acting as a bolus
simulator to mimic a naturally formed bolus of food and shaped to facilitate
swallowing” and “having a variety of shapes.” Id. (citing Martin || 177,
179). According to the Examiner, “a number” of the shapes disclosed in
Martin “hav[e] a length of a front tapering surface being greater than a
length of a rear tapering surface.” Id. at 6 (citing Martin, Figs. 43, 125, and
140). The Examiner determines it would have been obvious to alter the
shape of Brister’s capsule “to match the various shapes and contour features
of the Martin device, including a front taper surface that is greater than the
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Application 14/073,665
rear taper surface ... to better facilitate the swallowing of the device to
produce minimal discomfort for the patient.” Id. (citing Martin H 176—
180); see also id. at 3 (expounding on obviousness rationale).
Appellants argue, in part, that the Examiner’s combination of Brister
and Martin is improper because it fails to consider Brister and Martin in their
entireties. Appeal Br. 12. In particular, Appellants contend “Martin teaches
devices that are never swallowed.” Id. at 12, 14—15; see also id. at 8—11
(citing Martin 11 17, 149, 153, 161, 167, 170, 177, 199, 203,212-214, 227,
229). Thus, Appellants’ view is that the Examiner’s rejection lacks the
requisite rational underpinning required for obviousness by KSR Int 7 Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007). Appeal Br. 15.
In answer, the Examiner finds that, while Martin’s device “is not
intended to be swallowed” because it is tethered in place within the user’s
mouth, Martin’s device “configuration is still meant to simulate and induce
swallowing.” Ans. 3 (citing Martin 1177). The Examiner’s position is that
the shape of Martin’s device is “not disqualified]. . . from being a relevant
teaching to modify a device that is supposed to be swallowed,” such as
Brister’s capsule. Id. at 3^4 (analogizing to the structure of a practice
baseball being tethered in place yet still relevant to an untethered baseball
used in a live game). Thus, the Examiner maintains that a person of
ordinary skill in the art would have been motivated to combine Brister with
Martin “to achieve a shape that better facilitates swallowing with minimal
discomfort as desired” by Brister. Id. at 4 (emphasis added).
We are persuaded that the Examiner has failed to provide a sufficient
articulated reason with a rational underpinning, supported by a
preponderance of the evidence, to support the legal conclusion of
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Application 14/073,665
obviousness. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) {cited with
approval in KSR v. Teleflex, 550 U.S. at 418); In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992) (“After evidence or argument is submitted by the
applicant. . . , patentability is determined on the totality of the record, by a
preponderance of evidence with due consideration to persuasiveness of
argument.”). In particular, the reason the Examiner proffers for modifying
the shape of Brister’s swallowed capsule to be as recited in claim 1 is that
Martin teaches “a body acting as a bolus simulator to mimic a naturally
formed bolus of food and shaped to facilitate swallowing.” Final Act. 5
(citing Martin 1177); Ans. 3^4.
The Examiner’s suggestion that Martin’s bodies are “shaped to
facilitate swallowing” of a device, such as disclosed in Brister, is not
supported by a preponderance of the evidence. Instead, Martin’s bodies are
inserted into a patient’s mouth to induce the patient to perform a swallowing
action, without the bodies themselves being swallowed. Martin || 4, 6, 17,
149, 153. At best, Martin discloses that its body comprises an absorbent
material, such as foam, to release a bolus to be swallowed, such as water,
without the body itself being swallowed. Id. at || 176—180. Thus, the
Examiner fails to provide a rational underpinning to support the proffered
modification of Brister’s swallowed capsule with teachings from Martin.
There is no rational relationship between the shape of Martin’s unswallowed
body and the use of such a shape to modify Brister’s capsule to facilitate
swallowing of Brister’s capsule. The Examiner’s tethered baseball analogy
is inapt, because the tethered baseball is actually hit by a bat, whereas
Martin’s body is never swallowed.
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For the foregoing reasons, we conclude the Examiner errs in rejecting
claim 1 as unpatentable over Brister and Martin. The Examiner’s additional
consideration of claims 2, 4—16, and 18—23, each of which depends directly
or indirectly from claim 1, does not cure the noted deficiency in the rejection
of claim 1. See Final Act. 6—12. Therefore, we also do not sustain the
rejection of those claims as unpatentable over Brister and Martin.
B. Other Rejections
The Examiner’s additional consideration of claims 17, 24, and 25,
each of which depends directly or indirectly from claim 1, in light of Kasic,
Berge, or Toyota, does not cure the noted deficiency in the rejection of
claim 1. See Final Act. 12—15. Therefore, we do not sustain the rejections
of claimsl7, 24, and 25.
DECISION
The Examiner’s decision to reject claims 1, 2, and 4—25 is reversed.
REVERSED
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