Ex Parte St. Pierre

Patent Trial and Appeal Board

Mar 27, 2018

13091792 (P.T.A.B. Mar. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/091,792 04/21/2011
121974 7590 03/29/2018
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Ernest J. St. Pierre
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.
0073-034004 5275
EXAMINER
SNOW, BRUCE EDWARD
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
03/29/2018 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ndeane@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERNEST J. ST. PIERRE
Appeal2017-003988
Application 13/091,792 1
Technology Center 3700
Before FRANCISCO C. PRATS, TIMOTHY G. MAJORS, and
DAVID COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method of placing a medical stent within a body of a patient. The Examiner
rejected the claims on appeal under 35 U.S.C. § 112, second paragraph, as
indefinite for failing to point out and distinctly claim the subject matter
which the applicant regards as the invention, and under 35 U.S.C. § 103(a)
as obvious.
We affirm.
1 According to Appellant, the real party in interest is Boston Scientific
Scimed, Inc. App. Br. 2.
Appeal2017-003988
Application 13/091,792
STATEMENT OF THE CASE
The Specification discloses:
The present invention provides medical stents for
facilitating drainage of fluid and methods for placing such
stents. For example, such stents can be placed in a ureter to
facilitate drainage of fluid from a patient's kidney to a patient's
bladder. Generally, stents according to the invention have a
"softer" end and a "harder" end. The harder end generally
resides in the patient's kidney while the softer end generally
resides in the patient's bladder. The harder end transitions to the
softer end in a transition section produced by a co-extrusion
process where deposition of a first material is gradually ceased
and deposition of a second is gradually increased.
Spec. ,-r 4.
Claims 14--21, 24--32, and 34--36 are on appeal. Claim 14 is
illustrative and reads as follows (emphasis added to highlight limitation at
issue):
14. A method of placing a medical stent within a body of a
patient, comprising:
inserting a medical stent into a body of a patient, the
medical stent including a single-piece stent body, the single-
piece stent body including a proximal retention structure, a
distal retention structure, and a central portion;
disposing the proximal retention structure of the medical
stent within a kidney of the patient, the proximal retention
structure being constructed from at least a first material having
a first durometer value, the medical stent defining a
longitudinal axis, the first material being an ethylene vinyl
acetate (EV A) of a first type;
disposing the distal retention structure of the medical
stent within a bladder of a patient, the distal retention structure
being constructed from at least a second material having a
second durometer value, the second durometer value being
greater than the first durometer value, the second material being
an EV A of a second type, the EV A of the first type and the
EV A of the second type including a radiopaque material;
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Application 13/091,792
disposing at least a portion of the central portion of the
medical stent within a ureter of the patient, the central portion
of the medical stent being located between the proximal
retention structure and the distal retention structure, the central
portion being constructed from the first material and the second
material, the first material and the second material being
continuously co-extruded within the central portion such that
the first material and the second material are distinct from each
other and arranged substantially asymmetrically within a plane
normal to the longitudinal axis, the relative amount of the first
material and the second material within the central portion
varying non-linearly across multiple planes perpendicular to the
longitudinal axis along a length of the central portion; and
disposing at least a portion of suture of the medical stent
within the body of the patient, the suture being coupled to the
distal retention structure, a portion of the suture extending
through at least a portion of a lumen defined by the distal
retention structure.
App Br. 18.
The claims stand rejected as follows:
Claims 14--21, 24--32, and 34--36 were rejected under 35 U.S.C.
§ 112, second paragraph, as indefinite for failing to point out and distinctly
claim the subject matter which the applicant regards as the invention.
Claims 14--21, 24--32, and 34--36 were rejected under 35 U.S.C.
§ 103 (a) as obvious over the combination of Goldberg, 2 Wang, 3 and
Clayman, 4 as evidenced by Elton. 5
2 Goldberg et al., US Patent No. 4,874,360, issued Oct. 17, 1989
("Goldberg").
3 Wang, US Patent No. 6, 135,992, issued Oct. 24, 2000 ("Wang").
4 Clayman et al., US Patent No. 6,656,146 Bl, issued Dec. 2, 2003
("Clayman").
5 Elton, US Patent No. 5,290,585, issued Mar. 1, 1994 ("Elton").
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Appeal2017-003988
Application 13/091,792
OBVIOUSNESS
Appellant argues claims 14--21, 24--32, and 34--36 together. We
designate claim 14 as representative.
The dispute with respect to obviousness centers on whether the person
of ordinary skill in the art would have found it obvious to form the central
portion of Goldberg's medical stent from continuously co-extruded
materials.
The Examiner found that Goldberg disclosed a method of inserting a
medical stent within the body, but acknowledged that Goldberg did not
disclose that the central portion of the claimed medical stent was formed
from first and second materials that had been continuously co-extruded.
Ans. 2, 3. The Examiner found, however, that Wang disclosed "a similar
method and stent for use in various body lumens comprising a ...
continuously co-extruded central portion [formed] from ... first and second
materials." Id. Wang also disclosed that forming a differential stiffness
catheter by co-extrusion was advantageous, stating:
[T]he flexible material[ s] that form[] the distal section are
sequentially co-extruded, e.g., "wedged into" one another to
produce an extremely secure, practically non-breakable joint
between the two materials. The merging of the two materials is
very smooth and gradual to eliminate the buckling and kinking
that usually occurs at abrupt joints between two materials of
different stiffness. The gradual transition also facilitates
tracking of the guidewire and is short enough to be useful in
catheter applications, including so-called microcatheters.
Wang, col. 3, 11. 12-20 (cited at Ans. 4). The Examiner then concluded that
it "would have been obvious to one having ordinary skill in the art to have
utilized the teaching of Wang to make the medial stent of Goldberg by
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Application 13/091,792
forming a continuously co-extruded central portion of the first and second
materials for the reasons stated by Wang." Ans. 4--5.
Appellant argues that "the medical catheter of Wang is formed by a
sequential co-extrusion [process] in which proximal and distal catheter
portions formed from discrete/different materials are 'wedged-into' one
another." App. Br. 13. According to Appellant, "the sequentially co-
extruded central portion of Wang is unlike the continuously co-extruded
central portion recited by independent claims 14, 24 and 30." Id. at 14.
Appellant explains: "the 'wedged-in' structure produced via sequential co-
extrusion requires a distinct junction/boundary between the two polymers
(i.e., flow of one polymer abruptly stops at the same time flow of the second
polymer starts)." Id. In contrast, "[a] 'wedged-in' structure does not (and
cannot) form if the separate/distinct polymers are allowed to form a mixture
(i.e., polymer gradient) required by a continuous co-extrusion." Id. We are
not persuaded.
Appellant's argument requires that we construe the term "continuous
co-extrusion" to require that the polymers involved in the extrusion form a
mixture. Appellant cites Wang as recognizing a distinction between
continuous and sequential extrusion (App. Br. 14--15), but the portion of
Wang cited by Appellant merely discloses that one can minimize the
problem that resin will continue to flow after an extrusion head is shut off by
"keeping residual flow volume small" or "through the use of modulators."
Wang col. 9, 1. 66- col. 10, 1. 10. It does not suggest a distinction between
continuous and sequential extrusion, much less that the skilled artisan would
have understood the term "continuous co-extrusion" to require a mixing of
polymers.
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Application 13/091,792
The Specification does not use the term "continuously co-extruded,"
and Appellant does not identify any portions of the Specification as
supporting their construction. However, the Specification does use the term
"continuous" to describe extrusion processes. It states:
In a continuous process, the first section 24 is formed from one
type of EVA; a transition section (i.e., the third section, 22),
then, is formed by gradually ceasing the deposition of the first
type of EVA and gradually increasing the deposition of a
second type of EVA; and the other end of the stent, the second
section 20, is formed from the second type of EV A after the
first type of EV A has ceased being extruded. Each type of EV A
has a different durometer value, with the first type of EV A
having a durometer value that is less than the durometer value
of the second type of EV A. The two materials in the third
section 22 are separate, are distinct, and are associated with
each other in an irregular configuration. Additionally, other
materials may be mixed with the first and/or second types of the
EVA prior to extrusion. For example, radiopaque materials,
such as bismuth subcarbonate, and/or colorants can be added.
The addition can occur at the site of manufacture or a supplier
can supply the EV A already compounded with the radiopaque
material alone or 5 with the colorant alone or with both the
radiopaque material and the colorant. Even if these materials
are mixed, the fact that one EV A type has a durometer value
less than the second EV A type can mean that the section of the
stent formed from the first type of EV A is "softer" than the
section of the stent formed from the second type of EV A.
Spec. i-f 27 (emphasis added). This passage suggests that "continuous"
extrusion encompasses processes in which deposition of one material
gradually increases while deposition of another material gradually decreases.
It also suggests that "continuous" extrusion encompasses processes where
two materials are separate and distinct. See also, e.g., id. i-f 31 (also
disclosing "continuous" extrusion as involving increasing deposition of one
material while decreasing deposition of a second material to produce a
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Application 13/091,792
transition section formed from two separate and distinct materials); id. i-f 34
(same). The Specification also discusses "co-extrusion" as involving
sequential deposition of two materials. It states: "The harder end transitions
to the softer end in a transition section produced by a co-extrusion process
where deposition of a first material is gradually ceased and deposition of a
second is gradually increased." Id. i-f 4.
Absent persuasive evidence in support of Appellant's narrowing
construction, we find that under the broadest reasonable interpretation, the
term "continuously co-extruded" encompasses processes in which deposition
of one material increases while deposition of a second material decreases,
resulting in a structure having two separate and distinct materials.
We tum now to Appellant's argument that Wang does not disclose a
continuously co-extruded catheter. Wang describes a process for producing
a differential stiffness catheter as follows:
In the first phase, the flow of resin "B" is stopped while the
flow of resins "A" and "C" are on. This forms the soft distal
section 16 from resin "A" with a thin inside layer 13 formed of
the material of resin "C". The flow of resin "B" is then
commenced while the rate of flow of resin "A" is reduced and
the flow of resin "C" continues. In this phase, the transition
section 19 is formed. In the third phase, the flow of all three
resins is on to form the stiff, multi-layered proximal section 18.
In the last phase, the flow of resin "B" is stopped and the rate of
flow of resin "A" is increased to purge out resin "B". The cycle
is then repeated starting with the first phase. Note that in all
phases the flow of resin "C" is continuous and at a constant
rate. This illustration of a complete cycle of a process
performed according to the principles of the invention shows
that the process extrudes different resins sequentially as well as
simultaneously. Prior art processes teach only simple co-
extrusion in which different resins are extruded simultaneously
only.
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Application 13/091,792
Wang, col. 12, 11. 3-21. We agree with the Examiner that the process
described in Wang is similar to that disclosed in the Specification in that
"the central portion is co-extruded from a first and second material gradually
increasing one of the first and second materials while decreasing the other of
said first and second materials (and vice versa) in a continuous process."
Ans. 10-11. We further agree with the Examiner that "[ t ]he central portion
(transition section) is [formed in] a continuous process of simultaneously
extruding (co-extruding) a first and second material." Id. at 11-12. Having
rejected Appellant's narrowing construction, we find no basis for
distinguishing Wang's transition section from the continuously co-extruded
central portion recited in claim 14.
Appellant does not identify any other alleged errors in the Examiner's
obviousness finding. Accordingly, we affirm the Examiner's conclusion that
claim 14 would have been obvious over the combination of Goldberg,
Wang, and Clayman, as evidenced by Elton. Because they were not argued
separately, claims 15-21, 24--32, and 34--36 fall with claim 14.
INDEFINITENESS
In rejecting claims 14--21, 24--32, and 34--36 as indefinite, the
Examiner found that the term "continuously co-extruded" was "ambiguous
in view of applicant's disagreement with the examiner." Ans. 2. The
Examiner explained "[i]t is the examiner's position that Wang teaches
continuously co-extruding the first material and second material within the
central portion." Id.
While we recognize that the Examiner and the Appellant disagree on
the scope of the term "continuously co-extruded," that alone does not
provide a basis for finding the term indefinite. As the Examiner has not
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Application 13/091,792
identified any evidence that the skilled artisan would be unable to discern
the metes and bounds of the claim, the Examiner has not satisfied the burden
of demonstrating unpatentability based on indefiniteness. See In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992) ("[T]he examiner bears the initial
burden ... of presenting a prima facie case of unpatentability").
Accordingly, we reverse the Examiner's rejection of claims 14--21, 24--32,
and 34--36 as indefinite.
SUMMARY
In summary, we affirm the Examiner's rejection of claims 14--21,
24--32, and 34--36 under 35 U.S.C. § 103(a) as obvious over the combination
of Goldberg, Wang, and Clayman, as evidenced by Elton.
We reverse the Examiner's rejection of claims 14--21, 24--3 2, and
34--36 under 35 U.S.C. § 112, second paragraph, as indefinite for failing to
point out and distinctly claim the subject matter which the applicant regards
as the invention.
AFFIRMED
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