Ex Parte Quijano et al

Patent Trial and Appeal Board

Aug 21, 2018

13556032 (P.T.A.B. Aug. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/556,032 07/23/2012
12603 7590 08/23/2018
Perkins Cole LLP - ReShape Medical
1201 Third Ave.
Suite 4800
Seattle, WA 98101
FIRST NAMED INVENTOR
Rodolfo C. Quijano
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.
076140-8018.USOl 2445
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/23/2018 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):
patentprocurement@perkinscoie.com
apoledna@perkinscoie.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RODOLFO C. QUIJANO,
ANDREW H. CRAGG, HOSHENG TU,
STEPHEN SOSNOWSKI, and GEORGE WALLA CE 1
Appeal2017-010497
Application 13/556,032
Technology Center 3700
Before JENNIFERD. BAHR, JAMES P. CALVE, and
ARTHUR M. PESLAK, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Office Action
finally rejecting claims 32-35, 41, and 52-57. See Appeal Br. 21. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 ReShape Medical, Inc. is identified as the real party in interest. Appeal Br.
1.
Appeal2017-010497
Application 13/556,032
CLAIMED SUBJECT MATTER
Claims 55 and 56 are independent. Claim 55 is reproduced below.
55. A system for treating obesity, the system comprising:
a gastric space filler comprising-
a first balloon connected to a second balloon by a
conduit, wherein the first and second balloons each
have a diameter of at least 60 mm,
wherein the first and second balloons are configured to
be positioned within and occupy a substantial
volume of a gastric cavity in a human patient in an
inflated state; and
an instrument throughput channel extending through the
conduit, wherein the instrument throughput channel is
configured to receive instruments,
wherein the conduit comprises an inter-balloon section spaced
between the first and second balloons, the inter-balloon
section having a length of more than 10 mm, and
wherein the gastric space filler is configured to be delivered to
the gastric cavity through an esophagus of the patient.
REJECTI0NS 2
Claims 32-35, 41, 52, 55, and 56 are rejected under 35 U.S.C.
§ I03(a) as unpatentable over Levy (US 2005/0273060 Al, pub. Dec. 8,
2005) and Burnett (US 2009/0259236 A2, pub. Oct. 15, 2009). 3
Claims 32-35, 41, 52, 55, and 56 are rejected under 35 U.S.C.
§ I03(a) as unpatentable over Levy and Bangs (US 5,234,454, iss. Aug. 10,
1993).4
2 The rejection of claims 56 and 57 under 35 U.S.C. § 112, first paragraph,
for lack of written description was withdrawn. See Ans. 2; Final Act. 2-3.
3 The caption of this rejection lists claims 32-35 and 52-56, but findings are
provided for claims 32-35, 41, 52, 55, and 56. See Final Act. 3-6.
4 The caption of this rejection lists claims 32-35, 41, and 52-56, but findings
are provided for claims 32-35, 41, 52, 55, and 56. See Final Act. 6-9.
2
Appeal2017-010497
Application 13/556,032
Claims 53, 54, and 57 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Levy, Burnett/Bangs, and Annunziata (US 2008/0208135
Al, pub. Aug. 28, 2008).
ANALYSIS
Claims 32-35, 41, 52, 55, and 56
Rejected Over Levy and Burnett
Appellants present arguments for claims 55 and 56. Appeal Br. 8-14.
Independent Claim 5 5
The Examiner finds that Levy teaches a system for treating obesity as
recited in claim 55 comprising gastric space filler 10 having first and second
balloons 30, 40 connected by conduit 20 and having a diameter greater than
50 mm, which overlaps or encompasses the claimed diameter of at least 60
mm. Final Act. 3--4. The Examiner finds that Levy teaches an intra-balloon
section with spacing S 1 having a length of about 5-10 mm that approximates
the claimed length range of more than 10 mm to render obvious the claimed
range because the ranges perform the same function. Id. at 4--5.
The Examiner also finds that Burnett teaches a similar device system
comprising first and second balloons 14, 16 connected by a conduit 10 and
an inter-balloon section (bridging member 10) having a length of 20 mm or
longer that renders obvious the claimed length of more than 10 mm. Id. at 5.
The Examiner determines it would have been obvious to modify the device
of Levy to include an inter-balloon section longer than 10 mm as taught by
Burnett to allow placement of Levy's device through the pyloric valve or
another gastric opening with sufficient tolerance for the balloon members to
move proximally and distally relative to the pyloric valve and also to prevent
the two balloons from rubbing against each other. Id.
3
Appeal2017-010497
Application 13/556,032
Appellants argue that it would not have been obvious to modify Levy
so second balloon 40 has a diameter "of at least 60 mm" because Levy sizes
balloon chambers 30, 40 to prevent migration through the pylorus and avoid
undue pressure on opposing tissue. Appeal Br. 9. 5 Appellants argue that the
average and maximum diameters of the duodenum are 24.8 mm and 35 mm
so a skilled artisan would size second chamber 40 to avoid undue pressure
on fragile duodenal tissue and "would not modify Levy's second chamber 40
to have 'a diameter of at least 60 mm,' as recited in claim 55." Id. at 10.
Whether or not the average diameter of the duodenum is 24.8 mm, as
Appellants argue (Appeal Br. 9--10; Reply Br. 2-3), Levy expressly teaches
to make the diameter of chambers 30, 40 "more preferably greater than 5
cm." Levy ,r 122; Final Act. 3--4. Therefore, Levy teaches to size second
chamber 40 to a diameter (i.e., greater than 50 mm) that is greater than the
maximum diameter cited by Appellants for the duodenum (i.e., 35 mm).
It is well-settled that the prior art's teaching of dimensional values
that overlap claimed ranges creates a prima facie case of obviousness. See
In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012). "Such
overlap itself provides sufficient motivation to optimize the ranges." Id.
As the Examiner also points out, Levy places distal balloon 40 in the
duodenal bulb (DB) area, which is larger than the main duodenum, and the
duodenum diameters cited by Appellants may not pertain to morbidly obese
patients, and do not pertain to the larger duodenal bulb area as illustrated by
Levy. Ans. 10-11; see also Levine 6 ,r 40; Levy ,r,r 90, 101, Figs. 8, 9.
5 Citations to "Appeal Br." refer to the Appeal Brief that was filed on March
28, 2017, rather than the Supplemental Appeal Brief that was filed on April
25, 2017, with an updated Claims Appendix.
6 US 2007/0005147 Al (pub. Jan. 4, 2007).
4
Appeal2017-010497
Application 13/556,032
Appellants do not provide any evidence or arguments that the claimed
range of more than 60 mm is critical, or that it achieves unexpected results
or functions differently than Levy's disclosed range of greater than 5 cm
(50 mm). See In re Peterson, 315 F.3d 1325, 1330-31 (Fed. Cir. 2003).
The Examiner reasons that skilled artisans would have been motivated
to increase the diameter of Levy's second chamber 40 to more than 60 mm,
as claimed, to fit in the duodenal bulb of patients with larger duodenum and
duodenum bulbs, to retain the device as Levy desires. Ans. 10; Levy ,r 122.
Appellants' arguments do not apprise us of error in this reasoning. Reply
Br. 3. If a maximum duodenum diameter is 3 5 mm, as Appellants assert
(Reply Br. 2-3; Appeal Br. 18), Levy's teaching to make diameter D1 of
second chamber 40 "more preferably greater than 5 cm" (i.e., 50 mm) is
evidence that the duodenum diameter does not limit the diameter of second
chamber 40, at least for morbidly obese patients using Levy's device. See
Levy ,r,r 3, 6. Levy also teaches that the diameter of expandable chamber 40
helps to maximize the displacement of central outlet 24 from the walls of the
duodenum to reduce the risk of bile reflux into the stomach. See id. ,r 118.
Levy further teaches that the diameter of second chamber 40 is sized
to prevent migration back through the pylorus into the stomach. Id. ,r,r 121-
122. Levy teaches a "non-limiting example" of an adult pylorus that opens
sufficiently large to pass an object of 2.5-3 cm, so Levy teaches to make the
diameter of outer chamber 40 greater than 5 cm to prevent outer chamber 40
from passing through the pylorus. Id. ,r 122. The Examiner thus reasons
that a skilled artisan would have been motivated to make the diameter of
outer chamber 40 at least 60 mm for patients with larger intestinal tracts
(Ans. 11) to prevent migration of second chamber 40 back into the stomach.
5
Appeal2017-010497
Application 13/556,032
The Examiner proposes to modify Levy's second balloon 40 to be "at
least 60 mm" to fit closely within the larger-diameter duodenal bulb, rather
than the narrower duodenum of a patient based on Levy's teachings of a
diameter of more preferably greater than 5 cm and the general knowledge in
the art that the duodenal bulb area is larger than the duodenum, such that a
larger diameter of second balloon 40 of at least 60 mm would have been
obvious to provide for patients whose anatomy requires such dimensions to
ensure a close fit of second balloon 40. Ans. 10, 11-12. Levy also teaches
to inflate chamber 40 so it is "snug against opposing tissue." Levy ,r 121.
Moreover, the Examiner points out that configuring Levy's device for
use within the stomach of a patient, as claimed, provides further motivation
for a skilled artisan to modify the diameter of second chamber 40 to at least
60 mm as claimed. Ans. 10. Levy recognizes the use of such intra-gastric
balloons in the prior art. Id. ,r 21; see Reply Br. 5. Levy also teaches that
larger diameters can be used for balloons placed inside the stomach and
combination therapies can be used. See Levy ,r,r 136,218, Fig. 17.
The Examiner also reasons that Levy and Burnett render obvious an
inter-balloon length of "more than 10 mm" because Levy teaches an inter-
balloon length of "about 5 to 10 mm," and Burnett teaches greater than 2 cm
(20 mm). Final Act. 4--5. We agree with the Examiner that Levy's range is
close enough to the claimed range of more than 10 mm to perform the same
functions to the extent "about 10 mm" could be construed as not overlapping
the claimed range. Id. at 5; Ans. 12. See In re Peterson, 315 F.3d at 1329
("a prima facie case of obviousness exists when the claimed range and the
prior art range do not overlap but are close enough such that one skilled in
the art would have expected them to have the same properties").
6
Appeal2017-010497
Application 13/556,032
Appellants do not ascribe any criticality or different function to the
claimed open-ended inter-balloon length of "more than 10 mm." Nor do
Appellants apprise us of error in the Examiner's reason for modifying Levy
to increase the inter-balloon length of Levy to more than 10 mm as taught by
Burnett "for the benefits of allowing a placement through the pyloric valve
or through another gastric opening such that there is sufficient tolerance for
the balloon members to move proximally and distally relative to the pyloric
valve; and preventing the two balloons rubbing against each other." Final
Act. 5; Ans. 12; see Appeal Br. 12-13.
The Examiner's reasoning is supported by a rational underpinning
based on Levy's teaching to insert device 10 through a patient's esophagus
and position inter-balloon section (passage 20) of device 10 in the pylorus so
distal chamber 40 is located within the duodenal bulb past pyloric sphincter
PV and proximal chamber 30 is located within gastric antrum GA as shown
in Figures 3---6. Levy ,r,r 93-101. Then, chambers 30, 40 are expanded. Id.
,r 102, Fig. 7-9. The expansion reduces the inter-balloon section 20 to the
length of the pylorus so chambers 30, 40 are snug against opposing tissue
and squeeze against the pylorus. Id. ,r 121. The articulation of a reason with
a rational underpinning also addresses Appellants' hindsight argument. See
In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (hindsight argument
is of no moment where the Examiner provides a sufficient, non-hindsight
reason to combine the references). A longer inter-balloon section provides
easier positioning within the pylorus after which inflation of chambers 30,
40 can center device 10 and reduce inter-balloon section 20 to a desired
length. Thus, we sustain the rejection of claim 55 and its dependent claims
32, 34, 35, 52, and 53, which Appellants do not argue separately.
7
Appeal2017-010497
Application 13/556,032
Independent Claim 5 6
Independent claim 5 6 recites a gastric space filler with the features of
claim 55 except the second balloon has a diameter of at least 40 mm. The
Examiner relies on Levy and Burnett as for the rejection of claim 55 and
relies on Levy's diameter of greater than 50 mm. See Final Act. 6.
Appellants argue the patentability of claim 56 for the same reasons as
claim 55 and for its additional features. Appeal Br. 14. This argument does
not constitute a separate argument for patentability of claim 56 pursuant to
37 C.F.R. § 4I.37(c)(l)(iv); see In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir.
2011. Levy's chamber diameter D 1 of greater than 50 mm overlaps the
claimed range of at least 40 mm. 7 Thus, we sustain the rejection of claim 56
and its dependent claims 33 and 54, which are not argued separately.
Claims 32-35, 41, 52, 55, and 56
Rejected Over Levy and Bangs
Appellants argue independent claims 55 and 56 separately with their
respective dependent claims. Appeal Br. 14--16. We select claims 55 and
56 as representative, with claims 32-35, 41, and 52 standing or falling with
their respective independent claims. The Examiner relies on Levy to teach
all features of claims 55 and 56 as for the previous rejection except an inter-
balloon length of more than 10 mm, which Bangs teaches (20 mm). Final
Act. 6-7. The Examiner determines it would have been obvious to modify
Levy, as taught by Bangs, to allow the placement of Levy's device with a
sufficient tolerance for the balloons to move proximally and distally relative
to the pyloric valve without rubbing against each other. Id. at 8.
7 Levy also discloses a diameter D 1 of chambers 30, 40 "preferably greater
than 4 cm." Levy ,r 122.
8
Appeal2017-010497
Application 13/556,032
For claim 55, Appellants argue that Levy fails to disclose the claimed
sizing as discussed for the rejection of claim 55 over Levy and Burnett, and
Bangs, like Burnett, fails to cure the deficient teachings of Levy's sizing of
5-10 mm for the inter-balloon section of his device 10. Appeal Br. 15. For
claim 56, Appellants argue patentability for the same reasons as claim 55
and its additional features. Id. at 16. These arguments are not persuasive for
the same reasons as for the rejections of claims 55 and 56 as unpatentable
over Levy and Burnett. See also 37 C.F.R. § 4I.37(c)(l)(iv); In re Lovin,
652 F.3d at 1357 Thus, we sustain the rejection of claims 55 and 56 and of
their respective dependent claims 32-35, 41, and 52.
Claims 53, 54, and 57
Rejected Over Levy, Burnett/Bangs, and Annunziata
Claims 53 and 54 depend respectively from independent claims 55
and 56 and recite "wherein the first and second balloons each have a length
of at least 60 mm." Supp. Appeal Br. 4 (Claims App'x). Claim 57 depends
from claim 56 and recites "wherein the first and second balloons each have a
volume of at least 100 cc." Id. at 5.
Claims 5 3 and 54
The Examiner finds that Annunziata teaches balloons 18, 20 with
diameters of 50---80 mm and 20---50 mm that also represent the length of each
balloon due to their circular or spherical shape. Final Act. 9. The Examiner
determines it would have been obvious to adjust the size and length of the
smaller balloon 20 to at least 60 mm as claimed suitable for each patient and
because discovering an optimum value of a result effective variable (to
occupy the inside of the stomach) involves only routine skill in the art for
controlling the food intake into the stomach. Id. at 9-10; Ans. 15.
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Appeal2017-010497
Application 13/556,032
Appellants argue that the Examiner provides no basis to assert that a
balloon length of 60 mm for the second balloon would have been a suitable
or "optimum value" for a patient in any of the references. Appeal Br. 17-18.
Appellants also argue that the second balloon is placed within the pyloric
canal rather than the stomach; therefore, an optimum value for the second
balloon would not correspond to an objective of occupying space inside a
patient's stomach as the Examiner determines. Id. at 18-19.
Appellants have the better position on this issue. Even if the general
conditions of claims 53 and 54 are known in the art, the Examiner has not
established that duodenal balloon length is recognized as a result-effective
variable. See In re Urbanski, 809 F.3d 1237, 1242 (Fed. Cir. 2016) (holding
that the Board properly found that the prior art recognized reaction time and
degree of hydrolysis as result-effective variables that can be varied in order
to adjust the properties of the hydrolyzed fiber in a predictable manner); In
re Applied Materials, Inc., 692 F.3d at 1297 ("A recognition in the prior art
that a property is affected by the variable is sufficient to find the variable
result-effective"). Even if the length of a balloon placed inside the stomach
is recognized as a result effective variable for occupying the inside of the
stomach (Ans. 15), the Examiner proposes to find an optimal value of the
length of a balloon placed in the duodenum through routine experimentation.
The Examiner has not explained sufficiently how the prior art recognizes the
length of a balloon placed in the duodenum as a result effective variable that
affects any property, such as a patient's appetite, as does gastric balloon size.
Nor are we persuaded that skilled artisans would have been motivated
to increase the length of the second balloon to find a suitable length for a
patient based on Annunziata's teachings.
10
Appeal2017-010497
Application 13/556,032
In this regard, Levy teaches an embodiment with an enlarged chamber
230 in the antral gastric cavity having a maximum diameter and a length of
about 20 cm that fills a substantial volume of the antrum A to increase the
satiety effect, but chamber 240 in the duodenum D is not so enlarged. Levy
,r,r 13 6, 13 7, Fig. 17. Annunziata teaches a similar configuration in Figures
1-3. See Annunziata ,r,r 31, 23. It is not apparent from the teachings of the
prior art of record that the length of the balloon placed in the duodenum is
recognized as a result-effective variable or that the length is comparable to
the length of the balloon placed in the gastric antrum. We agree with the
Examiner that a skilled artisan would recognize from Levy's teachings that
increasing the length of the first balloon 30 that is located within the gastric
antrum A would reduce the volumetric capacity of the stomach causing the
patient to feel full after consuming a reduced amount of food. Ans. 16. We
are not persuaded, however, that this prior art recognition would apply to the
length of the second balloon 40 placed in the duodenum. The finding that a
longer length of second balloon 40 would stabilize the implant at the pyloric
area contradicts Levy, which teaches a toroid shape for second balloon so its
diameter stabilizes the device. Thus, Levy increases the diameter, not the
length, of second balloon 40 to fit in the duodenum bulb. See Appeal Br. 19.
Thus, we do not sustain the rejections of claims 53 and 54.
Claim 57
Based on the Examiner's findings that the device of Levy as modified
by teachings of Burnett/Bangs and Annunziata has the claimed sizes for the
first and second balloons (length and diameter are in the claimed ranges), the
Examiner determines that the first and second balloon each have a volume of
at least 100 cc as recited in claim 57. Final Act. 10.
11
Appeal2017-010497
Application 13/556,032
Because we are not persuaded that the Examiner has established that a
second balloon with the claimed length would have been obvious, we also
are not persuaded that Levy's second balloon as modified by the teachings
of Annunziata would have a volume of at least 100 cc as recited in claim 57.
See Appeal Br. 19--20. We also note that claim 57 depends directly from
claim 56 and therefore is not required to have the length recited in claim 54.
However, the Examiner's findings regarding the volumes of the first and
second balloons, nonetheless, are speculative. See In re Robertson, 169 F.3d
743, 745 (Fed. Cir. 1999) ("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"). Levy does not disclose
spherical chambers 30, 40. Chambers 30, 40 are toroidal and surround an
inner lumen 21 that consumes some of their volume. See Levy ,r,r 117, 118,
Fig. 10.
Thus, we do not sustain the rejections of claim 57.
DECISION
We affirm the rejection of claims 32-35 and 52, 55, and 56 as
unpatentable over Levy and Burnett.
We affirm the rejection of claims 32-35, 41, and 52, 55, and 56 as
unpatentable over Levy and Bangs.
We reverse the rejections of claims 53, 54, and 57 as unpatentable
over Levy, Burnett/Bangs, and Annunziata.
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
12