Ex Parte Gerold et al

Patent Trial and Appeal Board

Jun 13, 2016

11222595 (P.T.A.B. Jun. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111222,595 0910912005 Bodo Gerold
24978 7590 06/15/2016
GREER, BURNS & CRAIN, LTD
300 S. WACKER DR.
SUITE 2500
CHICAGO, IL 60606
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.
4840.114163 6537
EXAMINER
SZPIRA, TIJLIE ANN
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
06/15/2016 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):
ptomail@ gbclaw. net
docket@gbclaw.net
verify@gbclaw.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BODO GEROLD, CLAUS HARDER, BERND HEUBLEIN,
EV A HEUBLEIN, NORA HEUBLEIN, CHRISTOPH HEUBLEIN, and
HEINZ MUELLER
Appeal2013-003170
Application 11/222,595
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to an endovascular implant.
Appellants appeal from the Examiner's rejections of claims 1-20 under 35
U.S.C. § 112 as indefinite and as obvious under 35 U.S.C. § 103. We have
jurisdiction under 35 U.S.C. § 134(a). The rejections are reversed.
STATEMENT OF CASE
Claims 1-20 are pending. Appeal Br. 6. The claims stand rejected by
the Examiner as follows:
Appeal2013-003170
Application 11/222,595
1. Claims 1-20 under 35 U.S.C. § 112, second paragraph (pre-AIA)
as indefinite for failing to particularly point out and distinctly claim the
subject matter which applicant regards as the invention. Answer 4.
2. Claims 1-4 and 20 under 35 U.S.C. § 103(a) as obvious in view of
Berry (US 6,248,128 Bl, issued June 19, 2001) and Stinson et al. (US
6,245,103 Bl, issued June 12, 2001). Id. at 6. 1
3. Claims 5 and 10-12 under 35 U.S.C. § 103(a) as obvious in view
of Berry, Stinson, and Heublein et al. (Biocorrosion of Magnesium Alloys:
A New Principle in Cardiovascular Implant Technology, 89 Heart 651-656
(2003)). Id. at 7.
4. Claims 6-9 and 13-19 under 35 U.S.C. § 103(a) as obvious in
view of Berry, Stinson, Heublein, and Duffy (Magnesium Alloys- Zirconium
Containing Casting Alloys, 4 Materials World 127-30 (1996)).
There are two independent claims in the appeal, claims 1 and 20. We
select claim 1 as representative. Claim 1 is reproduced below:
1. An endovascular implant comprising a biodegradable
material and having a tubular main body which is open at the
ends and which is dilatable from an unexpanded condition into
an expanded condition, wherein the implant is so designed that,
prior to implantation, when the implant in the expanded
condition is subjected to a radially acting compression pressure
in the range of between 5 and 30 kPa (0.05 - 0.3 bar)
- a cross-sectional area of the implant is reduced to 70%
or less of the original cross-sectional area, or
1 The Examiner stated that the rejection was anticipation under § 102(b );
however, the statement explaining rejection did not assert that the claims
were anticipated, but rather the Examiner applied an obviousness analysis to
the claimed subject matter. Answer 6. Consequently, it is evident that the
Examiner intended the rejection to be under§ 103.
2
Appeal2013-003170
Application 11/222,595
- an internal volume of the implant is reduced to 70% or
less of the original internal volume.
SECTION 112 SECOND PARAGRAPH REJECTION
The Examiner stated that claim 1 is incomplete and indefinite under
35 U.S.C. § 112 because it omits "essential elements" of the claimed
endovascular implant. Final Rej. 3. Specifically, the Examiner found that
the claim is indefinite because no structure of the implant is recited in the
claims. Id.
The claim recites that the endovascular implant has a design which
enables it, when expanded, to respond to "a radially acting compression
pressure in the range of between 5 and 30 kPa" by reducing to "70% or less
of the original cross-sectional area." The endovascular implant is defined
functionally by what it does, rather than by specific structure. However, a
functional limitation does not necessarily mean that a claim is indefinite.
A patent applicant is free to recite features of an apparatus either
structurally or functionally. See In re Swinehart, 439 F.2d 210, 212
... (CCPA 1971) ("[T]here is nothing intrinsically wrong with ...
[defining something by what it does rather than what it is] in drafting
patent claims.").
In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997) (bracketed material in
original). The '595 Specification describes structures which meet the
claimed functional limitation. '595 Spec. ,-r,-r 34-39. Consequently, the
skilled worker upon reading the claimed language would understand that the
claimed functionality encompasses such disclosed structures. The Examiner
did not specifically identify the essential element allegedly omitted from the
claim.
3
Appeal2013-003170
Application 11/222,595
For the foregoing reasons, we conclude that the Examiner erred in
rejecting the claims as indefinite. The § 112, second paragraph, rejection of
claims 1-20 is reversed.
OBVIOUSNESS REJECTIONS
Claim 1 is directed to an endovascular implant comprising a
biodegradable material which has a tubular main body, open at the ends, and
"which is dilatable from an unexpanded condition into an expanded
condition." The main limitation at issue in the claimed endovascular
implant is the requirement that "prior to implantation, when the implant in
the expanded condition is subjected to a radially acting compression
pressure in the range of between 5 and 30 kPa (0.05 - 0.3 bar)," the "cross-
sectional area of the implant is reduced to 70% or less of the original cross-
sectional area." Claim 20 is a directed to a method of treating a patient
comprising inserting an endovascular implant with the same characteristics
of claim 1 into the patient.
The Examiner found Berry discloses a stent ("endovascular implant")
"which is dilatable from an unexpanded condition into an expanded
condition" as recited in claim 1. Non-final Rej. 4. The Examiner found that
Berry's stent also satisfied the claimed requirement that radially acting
compression at the range recited in claim 1 resulted in a reduction in cross-
sectional area of 70%. Id. The Examiner found that Berry does not describe
its stent as comprising a biodegradable material. Id. To meet this limitation
of the claim, the Examiner relied upon the teaching in Stinson of a stent
comprising a biodegradable material. Id. The Examiner determined it
would have been obvious to one of ordinary skill in the art to have made
4
Appeal2013-003170
Application 11/222,595
Berry's stent from a biodegradable material "to allow for the manufacturing
costs of the device to be reduce[ d], as well as increase the bio-compatibility
of the device." Id. at 4-5.
Appellants contend that Berry's teachings are insufficient to satisfy
the elements of claims 1 and 20 which recite a 70 percent or greater
reduction in volume or cross sectional area in response to a radial
compression pressure in the range of between 5 and 30 kPa. Appellants'
arguments are supported by a preponderance of the evidence.
Berry teaches that the stent is expanded to a diameter of 8 mm. Berry,
col. 14, 11. 12-14. Based on the equation for calculating the area of a cross-
section of a circular tube (n x (d/2)2), the cross-sectional area of the
expanded stent is about 50.26 mm2. The elastic behavior of the stent was
evaluated by subjecting the expanded stent to increasing external pressure in
a chamber. Id. at col. 13, 1. 59 to col. 14, 11. 2-65. "Pressure within the
chamber was increased from atmospheric pressure in 500 pascal
increments." Id. at col. 14, 11. 28-29. "The test was stopped when the
luminal area measurement had decreased by 10 mm2." Id. at col. 14, 11. 33-
34. Thus, during the test, the cross-sectional area went from about 50.26
mm2 to about 40.26 mm2, which is reduction in cross-sectional area to about
80% of the original area. Berry therefore did not achieve the recited
reduction of cross-sectional area of the implant to "70% or less of the
original cross-sectional area." Thus, the question is whether Berry's data can
be extrapolated to determine the pressure when the stent area is reduced to
70% of its original area.
With respect to the pressure as the stent was deformed, Berry teaches:
5
Appeal2013-003170
Application 11/222,595
The stent of the present invention showed an initially linear
elastic behavior up to approximately 10.0 KPa. Between 10.0
KPa and 20.0 KPa, the stent began to deform more for the same
incremental increase in pressure. This pressure-deformation
behavior indicated that the yield point of the material had been
reached and that the stent was deforming plastically rather than
elastically.
Id. at col. 14, 11. 44-51.
Berry does not include a graph to show the relationship between
cross-sectional area and pressure. Even if it is assumed that the starting
pressure was 0 kPa at 50.26 mm2 (see Appeal Br. 20) and the end pressure
was 20 kPa at 40.26 mm2, the data cannot reasonably be extrapolated to
determine whether the recited reduction in cross-sectional area would have
taken place in the range of "between 5 and 30 kPa" because Berry teaches
that the response to pressure is not linear from 10 to 20 kPa ("Between 10.0
KPa and 20.0 KPa, the stent began to deform more for the same incremental
increase in pressure."). For this reason, there is insufficient information to
determine at what pressure the 70% value is achieved.
The Examiner stated that the stent can be collapsed from the expanded
cross-sectional area of about 50 mm2 to the starting area of about 8 mm2
which the Examiner stated is an about 84% decrease in cross-sectional area
or about 16% of the expanded cross-sectional area. Answer 11. However,
as argued by Appellants, this information does not convey what happens to
the cross-sectional area when the compression pressure is in the range of
between 5 and 30 kPa as recited in claims 1 and 20. The Examiner did not
provide sufficient evidence that "when the implant in the expanded
condition is subjected to a radially acting compression pressure in the range
of between 5 and 30 kPa (0.05 - 0.3 bar) - cross-sectional area of the implant
6
Appeal2013-003170
Application 11/222,595
is reduced to 70% or less of the original cross-sectional area."
Consequently, we agree with Appellants that the Examiner erred in finding
this limitation met by Berry.
Claims 1 and 20 also have the alternative limitation that the "internal
volume of the implant is reduced to 70% or less of the original internal
volume" over the recited pressure range. The Examiner appeared to apply
the same analysis as for the cross-sectional limitation. Answer 10-11.
Thus, we conclude, for the same reasons, that the Examiner did not meet the
burden of establishing that the limitation is described in Berry.
The Examiner did not provide evidence that Stinson's material would
meet the functional limitations of the claim.
Because the Examiner erred, we reverse the obviousness rejection of
claims 1 and 20, and claims 2-4 which depend from claim 1.
Dependent claims 5 and 10-12 are further rejected based on Berry,
Stinson, and Heublein. The Examiner cited Heublein for its teaching of the
specific biodegradable materials recited in the dependent claims. Non-final
Rej. 6. The Examiner did not provide evidence that Heublein describes the
reduction in the cross-sectional area over the claimed range. As explained in
the '595 Specification, the claimed characteristic of 70% reduction of the
original size over the recited pressure range is a function of not only the
material, but also the stent design, such as wire number and diameter used to
make it. '595 Specification i-fi-135-38. Thus, even if the same material is
used in Heublein as recited in the claims, the identity of materials is
insufficient to establish the characteristics of the stent are the same.
Consequently, the rejection of these claims is reversed, as well.
7
Appeal2013-003170
Application 11/222,595
Dependent claims 6-9 and 13-12 are further rejected based on Berry,
Stinson, Heublein, and Duffy. The Examiner cited Duffy for its teaching of
the specific biodegradable materials recited in the dependent claims. Id. at
7. The Examiner did not provide evidence that Duffy describes the
reduction in the cross-sectional area over the claimed range. As explained in
the '595 Specification, the claimed characteristic of 70% reduction of the
original size over the recited pressure range is a function of not only the
material, but also the stent design, such as wire number and diameter used to
make it. '595 Specification ,-r,-r 35-38. Thus, even if the same material is
used in Duffy as recited in the claims, the identity of materials is insufficient
to establish the characteristics of the stent are the same. Consequently, the
rejection of these claims is reversed, as well.
In sum, we reverse Rejections 1--4.
REVERSED
8