Ex Parte Wardle

Patent Trial and Appeal Board

May 25, 2016

13167644 (P.T.A.B. May. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/167,644 06/23/2011
66854 7590
SHAY GLENN LLP
2755 CAMPUS DRIVE
SUITE 210
SAN MATEO, CA 94403
05/27/2016
FIRST NAMED INVENTOR
John Wardle
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.
10502-710.200 8499
EXAMINER
KLEIN, BENJAMIN JACOB
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
05/27/2016 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):
info@shayglenn.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN WARDLE
Appeal2014-005244
Application 13/167,644
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL 1
This is an appeal under 35 U.S.C. § 134 involving claims 1, 4--9, 11-
13, 16, and 18 (App. Br. 2). Examiner entered rejections under 35 U.S.C.
§103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellant's invention "relates to systems, devices and methods for
deploying ocular implants in the eye" (Spec. i-f 3). Independent claim 1 is
1 Appellant identifies the Real Party in Interest as Ivantis, Inc. (App. Br. 2).
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Application 13/167,644
representative and reproduced in the Claims Appendix of Appellant's
Appeal Brief.
Claims 1, 4--9, 11-13, 16, and 182 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Silvestrini. 3
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Silvestrini suggests
devices, methods and systems for treatment of eye disease such
as glaucoma. Implants are described herein that enhance
aqueous flow through the normal outflow system of the eye with
minimal to no complications. The implant can be reversibly
deformed to a first shape, such as a generally linear shape
conducive to insertion. Upon insertion, the implant can deform
to a second shape, such as a generally non-linear shape
conducive to retention \'l1ithin the eye. The shape also improves
fluid flow from the anterior chamber and prevents or reduces
clogging.
(Silvestrini Abstract; see also Final Act. 4--5.)
FF 2. Silvestrini suggests that
[t]he change in shape can be an outward expansion or can be any
other change in shape, such as to change from a straightened to
a non-straightened (e.g., curved or wavy) shape. The shape
change can occur in a variety of manners. For example, the
braided structure can be spring-loaded or biased such that the
strands of the braid move relative to one another or deform so
2 We note that Examiner identified claim 10 as being rejected (see Final Act.
4) although claim 10 has been canceled (see App. Br. 3).
3 Silvestrini et al., US 2010/0137981 Al, published June 3, 2010.
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Application 13/167,644
that the braid springs open to cause the openings between the
strands to enlarge in size. The strands of the braid can be formed
of a material, such as a spring metal or superelastic metal, that is
heat or cold treated or pressure set to a desired spring-open
configuration. The strands can also be formed of a polymer or
can be formed of a composite (fiber-reinforced strands).
(Silvestrini i-f 44; see also Final Act. 4--5.)
FF 3. Silvestrini suggests that
[ d]uring delivery of the implant into the eye, the implant is
constrained in an alternate shape and then is released to permit
the implant to revert to the heat-set shape. Alternately, the
spring-open action can be provided by coating the openings, the
fibers, and/or the fiber cross-over locations in the braided
structure with an elastomer. In another embodiment, the braided
structure is at least partially formed of a shape-change material
that changes shape in response to predetermined conditions, such
as a change in temperature.
(Silvestrini i-f 45; see also Final Act. 4--5.)
FF 4. Silvestrini suggests that
[t]he shape change can occur in a variety of manners. For
example, the implant can be manufactured of a thermoplastic
elastomer (TPE) that is capable of being reversibly deformed as
discussed in more detail below. The implant 105 can be heat-set
such that it is has a tendency to return from the first, constrained
shape desired during delivery to the second, relaxed shape
desired for retention and fluid passage. The implant 105
maintains the first shape when the implant is constrained in some
manner such as by a guidewire or other delivery mechanism or
device having a lower flexibility or elasticity than the shape
changing portion of the implant 105. When the implant 105 is at
or near the desired location in the eye, the constraint(s) can be
removed or the implant released, such as by removal of the
guidewire or other structure, so that he implant transitions or
changes toward the second, retention shape[].
(Silvestrini i-f 54; see also Final Act. 4--5.)
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Application 13/167,644
FF 5. Silvestrini suggests that
[ o ]ther materials of manufacture or materials with which the
implant can be coated or manufactured entirely include silicone,
thermoplastic elastomers (HYTREL, KRATON, PEBAX), ... ,
PLLA, parylene, PEEK, polysulfone, polyamideimides (PAI)
and liquid crystal polymers. . . . In order to maintain a low
profile, well-known sputtering techniques can be employed to
coat the implant. Such a low profile coating would accomplish
a possible goal of preventing migration while still allowing easy
removal if desired.
(Silvestrini i-f 72; see also Final Act. 4--5.)
FF 6. Silvestrini suggests that
[t]he implant can also be manufactured of, coated or layered with
a material that expands outward once the implant has been placed
in the eye. The expanded material fills any voids that are
positioned around the implant. Such materials include, for
example, hydrogels, foams, lyophilized collagen, or any material
that gels, swells, or otherwise expands upon contact with body
fluids.
(Silvestrini i-f 74; see also Final Act. 4--5.)
ANALYSIS
Appellant's independent claim 1 requires, inter alia, a "sacrificial
material constraining at least a portion of the implant body in a radially
collapsed state" and "wherein the ocular implant is configured to assume the
radially expanded state when the sacrificial material erodes or dissolves"
(Appellant's claim 1 ).
Based on Silvestrini, Examiner concludes that, at the time of
Appellant's invention was made, it would have been prima facie obvious to
"try coating the device in the finite number of combinations; either the
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Application 13/167,644
radially contracted state or radially expanded state and coating of the
proximal and/or distal portion" and to "coat the device in the radially
collapsed state, since Silvestrini clearly discloses the desire to maintain the
device in a radially collapsed state prior to implantation, in order to ensure
that the implant remained in the radially contracted state until deployment"
(Final Act. 5-6). We are not persuaded.
Notwithstanding Examiner's assertion to the contrary, Silvestrini, at
best, suggests that "the braided structure can be spring-loaded or biased such
that the strands of the braid move relative to one another or deform so that
the braid springs open to cause the openings between the strands to enlarge
in size" (FF 2), "the braided structure is at least partially formed of a shape-
change material that changes shape in response to predetermined conditions,
such as a change in temperature" (FF 3), and "the implant is constrained in
some manner such as by a guidewire or other delivery mechanism or device
having a lower flexibility or elasticity than the shape changing portion of the
implant" (FF 4). Although Silvestrini suggests that"[ o ]ther materials of
manufacture or materials with which the implant can be coated," "a low
profile coating would accomplish a possible goal of preventing migration
while still allowing easy removal if desired" (FF 5; emphasis added).
Silvestrini also suggests that "[t]he expanded material fills any voids that are
positioned around the implant. Such materials include, for example,
hydrogels, foams, lyophilized collagen, or any material that gels, swells, or
otherwise expands upon contact with body fluids" (FF 6; emphasis added).
The admonition that "obvious to try" is not the standard under
§ 103 has been directed mainly at two kinds of error. In some
cases, what would have been 'obvious to try' would have been
to vary all parameters or try each of numerous possible choices
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Application 13/167,644
until one possibly arrived at a successful result, where the prior
art gave either no indication of which parameters were critical or
no direction as to which of many possible choices is likely to be
successful. In others, what was "obvious to try" was to explore
a new technology or general approach that seemed to be a
promising field of experimentation, where the prior art gave only
general guidance as to the particular form of the claimed
invention or how to achieve it.
In re 0 'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988) (citations omitted).
Accordingly, while Silvestrini suggests using materials or coatings that
change shape due to temperature, that prevent migration, or that expand
upon contact with body fluids, Silvestrini does not suggest a "sacrificial
material constraining at least a portion of the implant body in a radially
collapsed state" or a "sacrificial material [that] erodes or dissolves."
Examiner's assertion that that it is obvious to "try coating the device in the
finite number of combinations" and to "coat the device in the radially
collapsed state" does not account for Silvestrini giving "no indication of
which parameters were critical or no direction as to which of many possible
choices is likely to be successful" in light of Silvestrini' s failure to suggest
using materials that erode or dissolve for shaping the implant.
We agree with Appellant that "Silvestrini does not address at all how,
whether or why the PLLA might bioerode or what the implications for the
implant might be" (Reply Br. 3), and that "[m]ost significantly, nothing in
either Silvestrini's disclosure or in Schneider's disclosure suggests that the
coatings of their respective devices would necessarily have the same
thickness or perform that same constraining function" (id. at 4). "The Patent
Office has the initial duty of supplying the factual basis for its rejection. It
may not ... resort to speculation, unfounded assumptions or hindsight
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Application 13/167,644
reconstruction to supply deficiencies" in the cited references. Jn re Warner,
379 F.2d 1011, 1017 (CCPA 1967).
In sum, Examiner failed to establish an evidentiary basis on this
record to support a conclusion that it would have been obvious to modify
Silvestrini to have a "sacrificial material constraining at least a portion of the
implant body in a radially collapsed state" and "wherein the ocular implant
is configured to assume the radially expanded state when the sacrificial
material erodes or dissolves."
Accordingly, we reverse the rejection of claim 1. Because they
depend on claim 1, the rejection of claims 4--9, 11-13, 16, and 18 is reversed
as well.
CONCLUSION OF LAW
The preponderance of the evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1, 4--9, 11-13, 16, and 18 under 35 U.S.C.
§ 103(a) as unpatentable over Silvestrini is reversed.
REVERSED