Ex Parte Shalon et al

Board of Patent Appeals and Interferences

Jun 20, 2012

11231482 (B.P.A.I. Jun. 20, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TADMOR SHALON, DANIEL JACOBS, SEAN S. CAHILL,
and SCOTT WETENKAMP
__________

Appeal 2011-004376
Application 11/231,482
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and JACQUELINE
WRIGHT BONILLA, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a tissue
expansion device, which the Examiner has rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Tissue expansion devices can be used to correct a deficit of normal
tissue “result[ing] from, for example, burns, tumor resection surgery (e.g.
mastectomy) or congenital deformities” (Spec. 1: 11-12). “Most
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commercially available tissue expanders function as an implantable balloon
with an extracorporeal or imbedded valve that allows periodic inflation” (id.
at 1: 24-25). The Specification discloses a “self contained implantable tissue
expansion device including an expandable compartment and fill source” (id.
at 2: 22-23).
Claims 55-58 and 62-67 are on appeal. Claim 55 is representative and
reads as follows:
55. A tissue expansion device, the device comprising:
(a) an expandable compartment adapted for implanting into tissue of a
body of a subject and being configured for expansion of surrounding tissue
to a desired expansion state;
(b) a compressed gas source positioned completely within said
expandable compartment communicating only with the expandable
compartment for controllable inflation thereof by regulatable transfer of a
gas such that inflation of said expandable compartment results in
controllable expansion of surrounding tissue to said desired expansion state.
Issue
The Examiner has rejected claims 55-58 and 62-66 under 35 U.S.C.
§ 103(a) as obvious based on Gedebou1 and Bales2 (Answer 3), and has
rejected claim 67 as obvious based on Gedebou, Bales, and Cantenys3
(Answer 5). The same issue is dispositive for both rejections.
The Examiner finds that Gedebou discloses a tissue expansion device
that includes an expansion means that is completely contained within an
expandable compartment, but does not teach a pressurized gas source as the

1 Gedebou et al., Patent Application Publication US 2004/0147953 A1,
July 29, 2004.
2 Bales et al., US 6,579,301 B1, June 17, 2003
3 Cantenys, US 5,129,915, July 14, 1992
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expansion means (Answer 4). The Examiner finds that Bales discloses an
expandable compartment that is controllably expanded by a pressurized gas
source (id.), and concludes that the claimed device would have been obvious
because “the substitution of one known expansion means for another would
have yielded predictable results to one of ordinary skill in the art” (id.).
Appellants contend that the Examiner has not shown prima facie
obviousness because a skilled worker would not have considered it obvious
to combine the teachings of Gedebou and Bales (Appeal Br. 4-5) and the
references would not suggest a compressed gas source that is completely
within the expandable compartment because Bales’ gas source is partially
outside of its expandable compartment (Reply Br. 2).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that a device meeting all the limitations of claim 55
would have been obvious based on the disclosures of Gedebou and Bales?
Findings of Fact
1. Gedebou discloses that prior art tissue expanders comprise an
inflatable body having an inflation valve attached to it (Gedebou, ¶ 5) to
allow the gradual introduction of fluid into the inflatable body by injection
(id. at ¶ 6).
2. Gedebou discloses that such systems suffer from several
drawbacks: “Because virtually all fluids introduced into inflatable-type
tissue expanders must necessarily be administered by injection, the
procedure by which such fluids are introduced can be painful and increase
the risk of an inadvertent needle stick experience” (id. at ¶ 8); “the use of
hypodermic needles to delivery fluid frequently results in the inadvertent
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puncture of the inflatable body” (id. at ¶ 9); the need for skilled health
workers to administer the injections increases the expense and
inconveniences the patients (id. at ¶ 10); and efforts to minimize the number
of injections can cause the tissue expander to be expanded too rapidly,
causing pain and tissue damage to the patient (id.).
3. Gedebou discloses “non-fluidized tissue expanders and systems
that are operative to selectively and controllably expand in a completely self-
contained environment without requiring any type of inflation means” (id. at
¶ 3).
4. Gedebou discloses that its tissue expanders “omit any type of fluid-
filled, inflatable body requiring the repetitious input of fluids via injection to
effectuate the desired expansion of the device” (id. at ¶ 12).
5. Gedebou discloses that its device includes an expandable
encapsulated body mass (id. at ¶ 13) and “an adjustable distraction
mechanism” that is “entirely self contained within the encapsulated body
mass” and operative to expand the encapsulated body mass at a desired rate
of expansion (id. at ¶ 14).
6. Gedebou discloses that the distraction mechanism “may take any
of a variety of means known in the art, including both mechanical and
electro-mechanical mechanisms” (id. at ¶ 15).
7. Gedebou discloses that “the distraction mechanism element of the
present invention should be deemed to encompass any type of mechanical
mechanism capable of selectively and controllably applying an outwardly-
expansive force operative to increase the surface area of a tissue expander
while remaining self-contained therein” (id. at ¶ 49).
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8. Gedebou discloses that “the encapsulated body mass will be caused
to selectively expand to a desired shape and/or size over a desired length of
time without requiring the inflation of an inflatable body using an externally
delivered fluid or any other system whereby an expansive material needs to
be injected into the expander” (id. at ¶ 17).
9. Gedebou discloses that its “tissue expanders . . . completely
eliminate all risks and drawbacks associated with prior art tissue expanders
requiring the use of hypodermic needles and the like to inflate an inflatable
body or the like” (id. at ¶ 36).
10. Bales discloses a gastric balloon for insertion into a patient’s
stomach to reduce the available capacity of the stomach for food (Bales, col.
1, ll. 9-15).
11. Bales discloses that its device “includes a flexible bladder, a
relatively rigid reservoir coupled to the bladder and adapted to hold a
bladder inflation fluid, and an inflation/deflation system adapted to move or
permit movement of the fluid from the reservoir and into the bladder” (id. at
col. 2, ll. 27-31).
12. Bales discloses that the inflation system can include a pump to
transfer fluid (gas or liquid; id. at col. 3, l. 39) from the reservoir to the
bladder (id. at col. 3, ll. 48-52).
13. “Alternatively, the pump can compress a gas into the reservoir.
Then, the gas can be expanded through the pump or a valve to inflate the
bladder. This design permits a greater than two to one ratio of [beginning to
final] volume.” (Id. at col. 4, ll. 19-23.)
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14. Bales states that “while the balloon device is shown configurable
between two sizes, with the bladder substantially empty of fluid and
substantially full of fluid, it will be appreciated that the pump may be
operated to cause the device to assume additional intermediate sizes” (id. at
col. 6, ll. 17-21).
Analysis
We agree with the Examiner that the device of claim 55 would have
been obvious to a person of ordinary skill in the art based on Gedebou and
Bales. Gedebou discloses a tissue expansion device that includes an
expandable compartment and an adjustable distraction mechanism that can
expand the expandable compartment at a desired rate (FF 5). Gedebou states
that the distraction mechanism can be any one of a variety of mechanical or
electromechanical mechanisms known in the art (FF 6) and “should be
deemed to encompass any type of mechanical mechanism capable of
selectively and controllably applying an outwardly-expansive force
operative to increase the surface area of a tissue expander while remaining
self-contained therein” (FF 7).
Bales discloses an expandable medical device that includes a reservoir
of compressed gas and expands when the gas is allowed to expand into an
expandable bladder (FF 13). It would have been obvious to a person of
ordinary skill in the art to substitute the expansion mechanism disclosed by
Bales for the mechanical or electromechanical mechanisms suggested by
Gedebou, because Gedebou states that any suitable self-contained
mechanical mechanism can be used in its device and the expansion
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mechanism disclosed by Bales is a self-contained mechanism that carries out
a function similar to that of Gedebou’s mechanical mechanisms.
Appellants argue that “the Examiner did not explain which element of
Gedebou’s device she intended to substitute with which element of the Bales
device” and because “the Examiner has not explicitly articulated what
elements from the Gedebou device she intends to substitute with the
pressurized gas of Bales” she has not stated a prima facie case of
obviousness (Appeal Br. 4-5).
This argument is not persuasive. The Examiner found that Gedebou
differed from the claimed invention in that it did not teach an expansion
means comprising a pressurized gas (Answer 4), that Bales taught such an
expansion means (id.), and that it would have been obvious to substitute one
known expansion means for another (id.). The Examiner’s statement of the
rejection makes sufficiently clear what elements from each reference are
being combined.
Appellants argue that “[s]ubstituting Gedebou’s distraction
mechanism with the fluid reservoir, pump, and bladder of Bales requires a
modification of the Bales reservoir and pump in order for them to be
contained, and operable, within the Gedebou body mass. Combining the
teachings of Bales and Gedebou therefore does not ‘yield predictable
results.’” (Appeal Br. 5.)
This argument is also unpersuasive. Naturally, substituting one
expansion mechanism for another will require some modification of the
prior art device, but Appellants have provided no evidence or sound
technical reasoning to support the assertion that the combination would not
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yield predictable results. Appellants’ assertion is contradicted by Gedebou’s
disclosure that any of a wide variety of expansion mechanisms can,
predictably, be used to effect the expansion of its device. See Gedebou,
¶¶ 15, 16, 40, 49).
Appellants argue that “Gedebou teaches away from a device that
expands by fluid inflation, such as the devices taught in Bales” (Appeal Br.
5).
We disagree. Gedebou teaches that prior art tissue expansion devices
are inflated by injection of fluid into them and suffer from various
drawbacks as a result of the need for repeated injections of the patient to
increase the amount of fluid in the expansion device (FF 2). Gedebou does
not disclose that a device that expands as a result of an expanding volume of
fluid, but does not require injections, would suffer the same drawbacks as
the prior art devices, or that such a device would have any drawbacks at all.
Gedebou therefore does not teach away from combining Bales’ expansion
mechanism with Gedebou’s device.
Appellants argue that the Examiner’s combination does not result in a
compressed gas source that is completely within the expandable
compartment because the “Bales gas source is partially outside of the Bales
expandable compartment” (Reply Br. 2).
This argument is unpersuasive as well. Gedebou discloses that its
device is completely self-contained (FFs 3, 8), and Bales discloses that its
expansion mechanism can take the form of a reservoir of compressed gas
that can expand the device by releasing gas (FF 13). Substituting Bales’
compressed-gas reservoir for Gedebou’s mechanical expansion means would
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result in the compressed-gas reservoir taking the place of, for example, the
mechanical jack shown in Gedebou’s Figures 2 and 3. In the device made
obvious by the references, the compressed gas source would therefore be
completely within the expandable compartment.
With regard to claims 62-64, Appellants argue that “claim 62 requires
a regulator configured to enable multiple incremental transfers of gas from
the gas source to controllably inflate the expandable compartment” but the
“Bales device . . . does not provide multiple incremental transfers of gas
from the reservoir to the bladder. Bales only has two states: fully inflated,
and fully deflated” (Appeal Br. 6). However, Bales expressly states that its
device is capable of achieving intermediate sizes between fully inflated and
fully deflated (see FF 14).
With regard to claims 65 and 66, Appellants argue that the Examiner’s
rejection does not address the additional limitations of these claims (Appeal
Br. 7). Appellants also argue that “[o]uter covering 26 in Gedebou is in fact
elastic and therefore is not contoured to any shape, let alone a human breast
shape,” as recited in claim 66 (Reply Br. 3). These arguments are not
persuasive, for the reasons stated by the Examiner (Answer 9-10).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that a
device meeting all the limitations of claim 55, 62, 65, and 66 would have
been obvious based on the disclosures of Gedebou and Bales. Claims 56-58
fall with claim 55 (Appeal Br. 6) and claims 63 and 64 fall with claim 62 (id.
at 7). 37 C.F.R. § 41.37(c)(1)(vii). Appellants have waived the opportunity
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to present additional arguments with regard to the rejection of claim 67
(Appeal Br. 7).
SUMMARY
We affirm the rejection of claims 55-58 and 62-66 under 35 U.S.C.
§ 103(a) based on Gedebou and Bales, and the rejection of claim 67 under
35 U.S.C. § 103(a) based on Gedebou, Bales, and Cantenys.
TIME PERIOD FOR RESPONSE
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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