Ex Parte Olson et al

Patent Trial and Appeal Board

Nov 21, 2012

12119885 (P.T.A.B. Nov. 21, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/119,885 05/13/2008 Greg Olson 1001.2375101 3896
11050 7590 11/21/2012
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
SCHALL, MATTHEW WAYNE
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
11/21/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte GREG OLSON, MICHAEL S. ARNEY,
and SCOTT R. SCHEWE
__________

Appeal 2011-008425
Application 12/119,885
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC GRIMES, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method of making a medical device, such as a balloon catheter system,
comprising a member having a polymer and an alignable material, such as
magnetically alignable fibers. The Examiner has rejected claims as
anticipated or obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse, but enter a new rejection of claims 14-17 under 37 C.F.R.
§ 41.50(b).
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STATEMENT OF THE CASE
The Specification describes a medical device, such as a balloon
catheter system, including a catheter comprising a shaft member having a
polymer and an alignable material, such as magnetically alignable fibers
(Spec. 8).
Claims 1, 3-17, and 21 are on appeal.
1
Independent claims 1 and 14
are representative, and read as follows:
1. A method of manufacturing a medical device comprising:
contacting a non-fluid first tubular member and a second tubular
member, the first tubular member comprising a first polymer and an
alignable material different from the first polymer;
aligning the alignable material; and
bonding the first and second members together concurrent with the
step of aligning the alignable material.
14. A method of manufacturing a tubular medical device or a medical
device component having a longitudinal axis, the method comprising:
introducing a first composition comprising a first polymer and an
alignable material into a cavity;
aligning the alignable material to have an orientation parallel to the
longitudinal axis; and
solidifying the first composition in the cavity.
The claims stand rejected as follows:

1
Claims 18-20 have also been rejected but Appellants state that they are not
appealing the rejection of these claims and have in effect withdrawn these
claims from Appeal (Appeal Br. 3). A withdrawal of claims from Appeal
“operates as an authorization to cancel those claims from the application.”
See Manual of Patent Examining Procedure § 1215.03. Accordingly, we
have not included canceled claims 18-20 in our deliberations.
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(I) claims 1, 3-6, 8, 10-17, and 21 under 35 U.S.C. § 102(e) as
anticipated by Stinson (U.S. Pat. No. 7,029,495 B2, issued Apr.
18, 2006); and
(II) claims 7 and 9 under 35 U.S.C. § 103(a) as obvious over
Stinson in view of Goodin et al. (U.S. Pat. Appl. Pub. No.
2005/0119616 A1, published Jun. 2, 2005).
I.
Issue
In relation to claim 1, Appellants argue that “Stinson fails to teach
contacting a first and second tubular member,” stating that Stinson instead
teaches “forming a multilayer sheet into a single tubular member” (App. Br.
6). Appellants also assert that Stinson “fails to teach concurrent bonding of
the first and second tubular members and aligning the alignable material of
the first tubular member,” but instead “teaches sequential alignment and
bonding” (id.).
The Examiner finds that Stinson discloses a method “comprising:
contacting a non-fluid first tubular member and a second tubular member
(column 2, lines 45-59; column 4, lines 28-31),” and “aligning the alignable
material and bonding the first and second members together concurrent with
the step of aligning the alignable material (column 4, lines 28-31)” (Ans. 3-
4, 7). The Examiner also states that “[a]ll material is „alignable,‟ and
placing two materials next to each other is „aligning‟ them” (id. at 7). The
Examiner further states that the members of claim 1 “can be formed into
tubes after the aligning and bonding steps have taken place” (id.). The
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Examiner also states that Stinson “discloses another method that rejects [sic,
anticipates?] this claim in column 5, lines 23-30” (id. at 8).
Regarding claim 14, Appellants argue that “Stinson does indeed teach
articles of manufacture where the fibers are oriented longitudinally, but
nowhere connects these articles to the one method of manufacture that uses
magnetism to orient the fibers” (Appeal Br. 9). Appellants further assert that
“Stinson does not teach a method of manufacturing a tubular device where a
first composition comprising an alignable material is introduced into a
cavity, where the alignable material is aligned longitudinally and then the
compos[i]tion is solidified in the cavity” (id.).
The Examiner states that “Stinson discloses the material is aligned
magnetically (column 5, lines 12-20)” (Answer 4). In addition, the
Examiner notes that claim 14 does not require a tubular device or magnetism
to orient the fiber, and the steps of introducing and aligning in claim 14 can
happen in any order (id. at 9).
The issue with respect to this rejection is: Does the Examiner
establish by a preponderance of the evidence that Stinson anticipates claims
1, 3-6, 8, 10-17, and 21?
Findings of Fact
1. Stinson teaches that “[t]o support a passageway open, endoprostheses
can be made of relatively stiff and strong materials” (Stinson, col. 1, ll. 45-
47).
2. Stinson discloses “an endoprosthesis having a tubular member
including a polymer matrix and a plurality of fibers in the matrix,” where the
fibers are stiffer than the polymer, and “can be oriented substantially
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circumferentially, longitudinally, and/or radially relative to a longitudinal
axis of the tubular member” (Stinson, col. 2, ll. 3-10; see also ll. 23-26).
3. Stinson further describes an “endoprosthesis having a tubular member
having a first layer including a first polymer, and a second layer including a
second polymer and a plurality of fibers in the second polymer” (id. at ll. 45-
50; ll. 23-28).
4. Stinson states that in certain embodiments “a plurality of sheets 28
can be laminated together, e.g., using an adhesive or by heat bonding, and
wrapped around a mandrel to form tubular member 23 and endoprosthesis
22” (id. at col. 4, ll. 28-31).
5. Stinson also discloses that a “multilayer endoprosthesis in which the
layers are different can be made by winding a sheet of polymer (with or
without fibers) around a preformed tubular member” such as shown in
Figure 3 (id. at col. 5, ll. 21-28). Stinson further discloses “close fitting
tubular members (with or without fibers) having an adhesive material
between the tubular members” (id. at ll. 28-31).
6. In addition, Stinson describes embodiments where “fibers 26 are
oriented in one or more directions to strengthen matrix [of polymer] 24,” and
where fibers are “oriented longitudinally, i.e., parallel to the length of the
endoprosthesis, which can enhance axial stiffness” (id. at col. 3, ll. 40-50).
7. When describing an embodiment, Stinson teaches “forming a
polymeric sheet 28 having the fibers oriented parallel to longitudinal axis C
of the sheet” (id. at col. 4, ll. 5-9). In relation to such a sheet, Stinson states
that “sheet 28 can be formed by positioning, e.g., laying flat, fibers 26 in a
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desired orientation in a mold. The matrix polymer can then be introduced
into the mold in a solid or liquid state. Heat and/or pressure are then applied
to allow the polymer to encapsulate the fibers” (id. at ll. 14-19).
8. Stinson also teaches that “[n]umerous methods can be used to orient
fibers 26 perpendicular to longitudinal axis E of sheet 46. For example,
fibers 26 can be manually pressed into an unsolidified sheet of polymer,
and/or the fibers can be sprayed into an unsolidified sheet of polymer using a
spray nozzle” (id. at col. 4, ll. 61-66; see also col. 4, l. 66 - col. 5, l. 20).
9. Stinson similarly teaches that in certain embodiments, magnetic fibers
“can be oriented by placing an unsolidified sheet having the fibers in a
magnetic field such that the magnetic flux lines are perpendicular to
longitudinal axis E of the sheet” (id. at col. 5, ll. 12-16).
10. Immediately thereafter, Stinson also states that “[t]o compensate for
changes in the orientation of fibers 26 during expansion of endoprosthesis
42, the magnetic flux lines may be non-perpendicular to longitudinal axis E
to orient fibers 26 in a desired initial orientation” (id. at ll. 16-20).
11. Stinson teaches that alignable material, i.e., fibers, “can be formed of
any material that is stiffer and/or stronger, e.g., in the long axis, than the
polymer(s) in the matrix of an endoprosthesis,” and that “the fiber material
can include carbon ….” (id. at col. 9, ll. 57-64).
12. Stinson describes forming an endoprosthesis (id. at col. 11, l. 64 – col.
12, l. 23), such as the one shown in Figure 10, using a “tube mold 70 having
a tubular cavity 72” (id. at col. 11, ll. 65-67). Stinson also states:
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During fabrication, a mixture of polymer(s) and fibers,
e.g., ferromagnetic or paramagnetic fibers, is introduced to
cavity 72. To orient the fibers circumferentially within cavity
72, a current is passed through coil 74 to induce flux lines
extending circumferentially about mold 70. … In
embodiments, no magnetic field is created, but mold 70 is
rotated to radially orient the fibers, e.g., asymmetrical fibers, as
in spin casting described above.
(Id. at col. 12, ll. 13-23.)
Analysis
Anticipation of Claims 1, 3-13, and 21
Appellants argue that Stinson “fails to teach concurrent bonding of the
first and second tubular members and aligning the alignable material of the
first tubular member” as recited in claim 1 (App. Br. 6). In response, the
Examiner cites Stinson, column 4, lines 28-31, in support (Ans. 4, 7). In
most relevant part, this passage in Stinson teaches that sheets may be
laminated together, e.g., by heat bonding (FF 4). The cited passage does not
discuss aligning alignable material (fibers) described elsewhere in the
reference (FF 2, 6-12), much less teach that aligning of fibers occurs
concurrently, i.e., at the same time, as bonding of multiple sheets. The
Examiner does not point to any teaching in Stinson that describes concurrent
aligning of fibers (alignable material) and bonding of two tubular members.
Because the Examiner does not establish how Stinson discloses a
method comprising the step of “bonding the first and second [tubular]
members together concurrent with the step of aligning the alignable
material,” the Examiner fails to establish a prima facie case that claim 1 is
anticipated by this reference. Because claims 3-13 and 21 depend, either
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directly or indirectly, on claim 1, the Examiner fails to establish anticipation
of these dependent claims as well.
Anticipation of Claims 14-17
The Examiner rejects claim 14 as anticipated by Stinson, citing
column 4, lines 5-19, and column 11, line 64 – column 12, line 23, of the
reference (Ans. 4-5, 9). The Examiner also states that “Stinson further
discloses the material is aligned magnetically (column 5, lines 12-20)” (id. at
4).
We agree with Appellants that Stinson does not expressly teach a
method “where a first composition comprising an alignable material is
introduced into a cavity, where the alignable material is aligned
longitudinally and then the compos[i]tion is solidified in the cavity” (App.
Br. 9). In the method described in column 4, lines 5-19, for example,
alignable fibers are oriented parallel to longitudinal axis C of the sheet, but
the method introduces the polymer into the mold only after orienting the
fibers (FF 7). Thus, the method does not “introduc[e] a first composition
comprising a first polymer and an alignable material into a cavity,” as
recited in claim 14.
The method described at columns 11-12 of Stinson only refers to
orienting the fibers “circumferentially within cavity 72” (FF 12) and
therefore does not “align[] the alignable material to have an orientation
parallel to the longitudinal axis” as recited in claim 14. Likewise, although
Stinson teaches that “magnetic flux lines may be non-perpendicular to
longitudinal axis E to orient fibers 26 in a desired initial orientation” (FF 10)
in the method described in column 5, lines 12-20, this part of Stinson does
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not expressly teach aligning the fibers parallel to the longitudinal axis.
Thus, the Examiner does not establish by a preponderance of the evidence
that Stinson anticipates claim 14. We therefore reverse the anticipation
rejection in relation to claim 14, and likewise the anticipation rejections of
claims 15-17, which depend on claim 14.
Obviousness of Claims 14-17 - New Ground of Rejection
As noted by the Examiner, Stinson teaches an embodiment where,
“[d]uring fabrication, a mixture of polymer(s) and fibers, e.g., ferromagnetic
or paramagnetic fibers, is introduced to cavity 72” (FF 12; Ans. 5), therefore
describing the “introducing” step of claim 14. In addition, although Stinson
discloses embodiments having fibers that are oriented perpendicular to a
relevant longitudinal axis (FF 8, 9, 12), the reference also repeatedly teaches
that fibers may be “oriented longitudinally, i.e., parallel to the length of the
endoprosthesis, which can enhance axial stiffness” (FF 6, 2). Such teachings
suggest the option of aligning the fibers as recited in claim 14, even in
relation to other method embodiments that otherwise oriented the fibers in a
different direction.
Stinson also teaches solidifying a relevant composition when it refers
to using a mold to make sheets by introducing fibers and a liquid matrix
polymer into the mold, where “[h]eat and/or pressure are then applied to
allow the polymer to encapsulate the fibers” (FF 7; see also FF 8-9 (referring
to an “unsolidified sheet”). Similarly, Stinson describes a “tube mold 70
having a tubular cavity 72,” as shown in Figure 10 (FF 12). When making
an endoprosthesis, either by heat and/or pressure or other mechanism one
would have had reason to solidify a liquid polymer with fibers in order to
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form an endoprosthesis as described in Stinson, i.e., one that that could
“support a passageway open” or otherwise function as an endoprosthesis (FF
1).
While Stinson does not expressly disclose doing all of the above-
mentioned steps in a single method, we conclude that it would have been
obvious to an ordinary artisan to do so. For example, it would have been
obvious to modify the method described at column 4, lines 5-19, so that one
positioned (oriented) the fibers in the polymer after placing both the polymer
and fibers in the mold, just before solidifying. One reading Stinson would
have had reason to modify the method in this fashion in light of disclosures
elsewhere in the reference, such as a teaching that “[d]uring fabrication, a
mixture of polymer(s) and fibers, e.g., ferromagnetic or paramagnetic fibers,
is introduced to cavity 72” (FF 12).
Nothing in Stinson suggests it would be inappropriate or unworkable
to orient fibers longitudinally after the mixture of polymer and fibers is
introduced to a cavity. Moreover, Stinson refers to “[n]umerous methods”
for orienting fibers (FF 8), implying that it is not critical how or when one
orients fibers before solidifying a mixture. Thus, a preponderance of the
evidence establishes that that Stinson renders obvious claim 14.
Claim 15 depends on claim 14, but further recites that “the alignable
material is aligned magnetically” (claim 15). Appellants suggest that
although Stinson teaches orienting fibers longitudinally, the reference does
not describe doing so in a method that “uses magnetism to orient the fibers”
(App. Br. 9). We are not persuaded by Appellants‟ position in an
obviousness context. As the Examiner notes, “Stinson further discloses the
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material is aligned magnetically (column 5, lines 12-20)” (Ans. 4). This
cited passage in Stinson teaches orienting magnetic fibers using a “magnetic
field such that the magnetic flux lines are perpendicular to longitudinal axis
E of the sheet” (FF 9), i.e., “circumferentially” as noted by Appellants (App.
Br. 10). That said, the same passage states immediately thereafter that “[t]o
compensate for changes in the orientation of fibers 26 during expansion of
endoprosthesis 42, the magnetic flux lines may be non-perpendicular to
longitudinal axis E to orient fibers 26 in a desired initial orientation” (FF 10
(emphasis added)).
As noted previously, Stinson discloses elsewhere that fibers may be
“oriented longitudinally, i.e., parallel to the length of the endoprosthesis,
which can enhance axial stiffness” (FF 6, 2). In other words, Stinson
teaches that “parallel to the longitudinal axis” (as recited in claim 14) is a
“desired initial orientation” for fibers, including magnetic fibers, in some
embodiments. Such teaching would have suggested to an ordinary artisan to
magnetically align fibers “to have an orientation parallel to the longitudinal
axis” (claim 14), as required in claim 15. Thus, a preponderance of the
evidence establishes that Stinson renders claim 15 obvious.
Claims 16 and 17, which depend on independent claim 14, recite that
the alignable material comprises carbon (claim 16), such as a carbon fiber
(claim 17). Stinson expressly teaches that alignable material may comprise
carbon fibers (FF 11). For this reason, and other reasons mentioned above
regarding claim 14, we conclude that claims 16 and 17 are obvious over
Stinson.
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Conclusion of Law
We conclude that the Examiner does not establish that Stinson
anticipates claims 1, 3-6, 8, 10-17, and 21. For the reasons discussed above,
however, we conclude that a preponderance of the evidence establishes that
claims 14-17 are obvious over Stinson.
II.
Issue
Does the Examiner establish by a preponderance of the evidence that
claims 7 and 9 are obvious over Stinson in view of Goodin?
Analysis
As noted above, in relation to the anticipation rejection of claim 1, the
Examiner fails to show that Stinson describes concurrent aligning of fibers
(alignable material) and bonding of two tubular members. In the
obviousness rejection of claims 7 and 9 (which depend on claim 1), the
Examiner does not suggest that Goodin cures this deficiency. Rather, the
Examiner states only that “Goodin teaches first and second members held in
contact by a heat shrink material (paragraph [0028]) and first and second
members bonded by using a laser (paragraph [0030]), in the same field of
endeavor….” (Ans. 6.) This statement does not establish that it would have
been prima facie obvious to an ordinary artisan reading Stinson and Goodin
to align fibers and bond two tubular members concurrently, i.e., at the same
time, in a method of manufacturing a medical device.
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Conclusion of Law
We conclude that the Examiner does not establish by a preponderance
of the evidence that claims 7 and 9 are obvious over Stinson in view of
Goodin.
SUMMARY
We reverse the rejections of claims 1, 3-6, 8, 10-17, and 21 as
anticipated by Stinson, as well as the rejection of claims 7 and 9 as obvious
over Stinson in view of Goodin. We conclude, however, that claims 14-17
are obvious over Stinson, and enter a new ground of rejection under 37
C.F.R. § 41.50(b) on that basis.
TIME PERIOD FOR RESPONSE
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of rejection
. . . shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the examiner, in
which event the proceeding will be remanded to the examiner. . . .

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(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record. . . .
REVERSED; 37 C.F.R. § 41.50(b)

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