Ex Parte Stinson

Board of Patent Appeals and Interferences

Dec 17, 2009

10721702 (B.P.A.I. Dec. 17, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JONATHAN S. STINSON
____________

Appeal 2009-005585
Application 10/721,7021
Technology Center 3700
____________

Decided: December 17, 2009
____________

Before SCOTT R. BOALICK, JOHN C. KERINS, and
STEVEN D.A. MCCARTHY, Administrative Patent Judges.

BOALICK, Administrative Patent Judge.

DECISION ON APPEAL

1 Application filed November 25, 2003. Application 10/721,702 is a
divisional of U.S. Patent No. 6,652,582, filed October 8, 1999, which is a
divisional of U.S. Patent No. 5,980,564, filed August 1, 1997.
The real party in interest is Schneider (USA), Inc.
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This is an appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 30, 44, 46, 50-59 and 76-84. Claims 45 and 47-49 have been
withdrawn and claims 1-29, 31-43 and 60-75 have been cancelled. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

STATEMENT OF THE CASE
Appellant’s invention relates to a bioabsorbable implantable medical
device formed from a bioabsorbable material. (Spec. Abstract.) The
medical device has elongated filaments which include hollow portions to
accumulate by-product from the degradation of the bioabsorbable material.
(Spec. Abstract.) The medical device can be a stent in which the filaments
are helically wound and interwoven into a braided configuration.
(Spec. 3:10-12.)
Claims 30 and 82 are exemplary:
30. A bioabsorbable endoprosthesis consisting essentially of:

a plurality of elongate elements having an outer surface, the
elements including a bioabsorbable polymer adapted to undergo
degradation in vivo, the elements including an elongate, axially
extending reservoir portion adapted to collect a by-product of the
degradation of the bioabsorbable polymer;

wherein the elements occupy a total element volume
including a reservoir volume occupied by the at least one
reservoir portion, and the reservoir volume is at least about ten
percent of the total element volume.

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82. A bioabsorbable endoprosthesis comprising:

a plurality of elongate elements interbraided into a tubular,
radially expandable structure, each of the elongate elements having an
outer surface, the elements including a bioabsorbable polymer adapted
to undergo degradation in vivo, the elements including an elongate,
axially extending reservoir portion adapted to collect a by-product of
the degradation of the bioabsorbable polymer;

wherein the [sic] each of the elements occupies a total element
volume including a reservoir volume occupied by the at least one
reservoir portion, and the reservoir volume is at least about ten percent
of the total element volume;

the number of elements, N, is equal to about (D/(0.022D +
0.17)) ± 4 filaments, where D, in mm, is the free state diameter of the
tubular structure; and

the elongate elements have a thickness, t in mm, of about
(D/(1.8D + 15)) ± 0.03 mm, where D, in mm, is the free state diameter
of the tubular structure.

The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Buscemi 5,500,013 Mar. 19, 1996

Claims 30, 44, 46, 50-59 and 76-84 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by, or in the alternative, under 35 U.S.C.
§ 103(a) as being obvious over, Buscemi.
Except as noted in this decision, Appellant has not presented any
substantive arguments directed separately to the patentability of the
dependent claims. In the absence of a separate argument with respect to
those claims, they stand or fall with the representative independent claim.
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See 37 C.F.R. § 41.37(c)(1)(vii). Only those arguments actually made by
Appellant have been considered in this decision. Arguments that Appellant
did not make in the Briefs have not been considered and are deemed to be
waived. See id.

ISSUE
With respect to independent claim 30, Appellant argues that this claim
is not anticipated by or obvious over Buscemi because of the transitional
phrase “consisting essentially of.” (App. Br. 5-11, 14-21.) In particular,
Appellant argues that “Buscemi fails to disclose that its stent 10 may consist
essentially of fibers 18” because “[t]he main body 11 of the stent 10 of
Buscemi is an essential feature of Buscemi’s stent 10, and the main body
may not be removed from the stent 10 without destroying the intent, function
and purpose of Buscemi’s stent 10.” (App. Br. 6; see also App. Br. 15,
Reply Br. 4-5.) Appellant also argues that the Examiner used impermissible
hindsight reconstruction by “pick[ing] and choos[ing] from a reference only
so much that supports the alleged rejection” and that “the fibers 18 [are]
inoperable as a[n] endoprosthesis when the main body 11 is removed.”
(App. Br. 16.)
With respect to independent claim 82, Appellant argues that Buscemi
does not teach or suggest all the features of this claim. (App. Br. 11-14,
22-25.) In particular, Appellant argues that Buscemi does not teach or
suggest that “the number of elements, N, is equal to about (D/(0.022D +
0.17)) ± 4 filaments, where D, in mm, is the free state diameter of the tubular
structure” and that “the elongate elements have a thickness, t in mm, of
about (D/(1.8D + 15)) ± 0.03 mm, where D, in mm, is the free state diameter
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of the tubular structure” because Buscemi is silent as to the relationship of
number of filaments and their thickness. (App. Br. 12, 23.) Dependent
claim 81, which depends from independent claim 30, recites similar
limitations. Appellant also argues that the Examiner used impermissible
hindsight reconstruction. (App. Br. 25.)
Appellant’s arguments present the following issue:
Has Appellant shown that the Examiner erred in rejecting claims 30,
44, 46, 50-59 and 76-84 under 35 U.S.C. § 102(b), or in the alternative,
under 35 U.S.C. § 103(a)?
The resolution of this issue turns on the following subsidiary issues:
1. Has Appellant shown that the Examiner erred in finding that
Buscemi teaches or suggests “[a] bioabsorbable endoprosthesis consisting
essentially of . . . a plurality of elongate elements,” as recited in claim 30?
2. Has Appellant shown that the Examiner erred in finding that
Buscemi teaches or suggests that “the number of elements, N, is equal to
about (D/(0.022D + 0.17)) ± 4 filaments, where D, in mm, is the free state
diameter of the tubular structure” and that “the elongate elements have a
thickness, t in mm, of about (D/(1.8D + 15)) ± 0.03 mm, where D, in mm, is
the free state diameter of the tubular structure,” as recited in claim 82?

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FINDINGS OF FACT
The record supports the following findings of fact (FF) by a
preponderance of the evidence.

Specification
1. Appellant’s Specification describes that “[t]he tubular and self-
expandable body or structure formed by the interwoven filaments 20,
30, 40 is a primary prosthetically-functional structure of stent 10, and
for this reason the device can be considered to substantially consist of
this structure to the exclusion of other structures.” (Spec. 18:13-16.)
Furthermore, “it is known that other structures and features can be
included in stents, and in particular features which enhance or
cooperate with the tubular and self-expandable structure.” (Spec.
18:16-17.) An example is “the inclusion of a covering . . . to reduce
the porosity or open spaces in the structure so that the stent can be
used to prevent tissue ingrowth or be used as a graft.” (Spec. 18:20-
22.)

Buscemi
2. Buscemi relates to “a device for providing mechanical support and a
uniform release of drugs to a vessel lumen of a living being.” (Col. 1,
ll. 12-14.) Buscemi describes a biodegradable stent 10 (col. 4, ll. 7-8)
that “provides mechanical support to a tubular vessel 12 in a living
being” (col. 4, ll. 12-14; fig. 1).

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3. “The stent 10 includes a generally tubular main body 11 and a
plurality of fibers 18 disposed around the main body 11.” (Col. 4,
ll. 16-18; figs. 1, 2.) As an example, the fibers 18 are formed of poly-
L-lactide, a biodegradable material. (Col. 4, ll. 54-56.) The fibers 18
are either solid, hollow or a combination of both (col. 4, ll. 46-47),
and, in one embodiment, can be braided or woven around the main
body 11 (col. 4, ll. 41-42). The stent 10 also includes a plurality of
apertures 14. (Col. 4, l. 18; fig. 1.) The apertures can be “both
asymmetrical and symmetrical shapes such as ovals, circles, or
rectangles . . . in a variety of sizes.” (Col. 5, ll. 41-44.) Such
apertures 14 function to “permit[] epithelial cells to grow on the
stent 10” (col. 6, ll. 6-7) to encapsulate particles of the stent 10 during
biodegradation (col. 6, ll. 7-10).

4. Figures 1 and 3 illustrate an embodiment where “the fibers [18] are
arranged concentrically around the main body [11].” (Col. 4,
ll. 34-35.) These figures show that there are approximately twenty
fibers 18 around the main body 11 in this embodiment. Buscemi is
silent as to the number of fibers 18 surrounding the main body 11 in
the embodiment where the fibers 18 are braided or woven around the
main body 11.

5. The stent 10 has a length from 1 mm to 50 mm and a diameter from
1 mm to 50 mm. (Col. 4, ll. 25-28.) The fibers 18 have an outer
diameter not exceeding 0.2 mm (i.e., 200 μm). (Col. 4, ll. 61-62.)
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When the fibers 18 are hollow, they have a wall thickness that ranges
from 25 to 100 μm. (Col. 4, ll. 62-64.)

PRINCIPLES OF LAW
Anticipation is established when a single prior art reference discloses,
expressly or under the principles of inherency, each and every limitation of
the claimed invention. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342,
1347 (Fed. Cir. 1999); In re Paulsen, 30 F.3d 1475, 1478-79
(Fed. Cir. 1994).
“Section 103 forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.’” KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 406
(2007). In cases involving overlapping ranges, even a slight overlap in
range establishes a prima facie case of obviousness. In re Peterson, 315
F.3d 1325, 1329 (Fed. Cir. 2003). “[T]he existence of overlapping or
encompassing ranges shifts the burden to the applicant to show that [the]
invention would not have been obvious.” Id. at 1330.
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). “To
facilitate review, this analysis should be made explicit.” KSR, 550 U.S.
at 418.
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“By using the term ‘consisting essentially of,’ the drafter signals that
the invention necessarily includes the listed ingredients and is open to
unlisted ingredients that do not materially affect the basic and novel
properties of the invention.” PPG Indus. v. Guardian Indus. Corp., 156
F.3d 1351, 1354 (Fed. Cir. 1998). To construe the phrase “consisting
essentially of,” it is “necessary and proper to determine” the interpretation
that the Specification reasonably supports. In re Herz, 537 F.2d 549, 551
(CCPA 1976). Furthermore, Appellant has the burden of showing that
unclaimed limitations in a prior art reference would materially affect the
basic and novel characteristics of the claimed invention. In re De Lajarte,
337 F.2d 870, 874 (CCPA 1964).

ANALYSIS
We are not persuaded by Appellant’s arguments that the Examiner
erred in rejecting claims 30, 44, 46, 50-59 and 76-81. However, we agree
with Appellant that the Examiner erred in rejecting claims 82-84.

Claims 30, 44, 46, 50-59 and 76-80
Appellant’s arguments (App. Br. 7-11, 14-21) that Buscemi does not
teach or suggest “[a] bioabsorbable endoprosthesis consisting essentially of
. . . a plurality of elongate elements,” as recited in independent claim 30, are
not persuasive.
The Examiner found that Buscemi teaches all the limitations of
independent claim 30. (Ans. 4.) The Examiner further found that the
transitional phrase “consisting essentially of” did not exclude the main
body 11 of Buscemi because Appellant did not meet the burden of showing
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that this unclaimed feature would materially affect the basic and novel
properties of the invention. (Ans. 6-7.) We agree with the Examiner.
First, Appellant argues that the basic and novel features of the
“inventive stent” are “accelerated degradation achieved by filaments having
a reservoir.” (App. Br. 9, 19; see also Reply Br. 5-6.) However, the stent 10
of Buscemi is presumed to possesses similar “accelerated degradation”
properties because it also includes braided or woven hollow fibers 18 formed
of a biodegradable material (e.g., poly-L-lactide) (FF 3) with the fibers 18
having an outer diameter of 200 μm and a wall thickness from 25 to 100 μm
(i.e., “a reservoir volume” of up to about 56% of the total fiber volume)
(FF 5). Appellant has not presented any credible evidence to the contrary.
Next, the Specification describes that “[t]he tubular and self-
expandable body . . . formed by the interwoven filaments 20, 30, 40 is a
primary prosthetically-functional structure of stent 10, and . . . [this] device
can be considered to substantially consist of this structure to the exclusion of
other structures.” (FF 1.) The Specification also describes that “other
structures . . . can be included in stents,” and one example is “the inclusion
of a covering . . . to reduce the porosity or open spaces in the structure so
that the stent can be used to prevent tissue ingrowth or be used as a graft.”
(Id.) Similar to Appellant’s “covering” for stent 10 (see id.), Buscemi’s
main body 11 includes apertures 14 in a variety of shapes and sizes to
control cell growth in the stent 10 (FF 3). Because Appellant’s Specification
indicates that a “covering” for the stent 10 can be included, we conclude that
this “covering” does not materially affect the basic and novel characteristics
of the claimed bioabsorbable endoprosthesis. Therefore, we do not interpret
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the transitional phrase “consisting essentially of” to exclude Buscemi’s main
body 11.
Furthermore, Appellant’s argument that “[t]he main body 11 of the
stent 10 of Buscemi is an essential feature of Buscemi’s stent 10, and the
main body may not be removed from the stent 10 without destroying the
intent, function and purpose of Buscemi’s stent 10” (App. Br. 6; see also
App. Br. 15, Reply Br. 4-5) is not germane. Appellant has not shown that
Buscemi’s main body 11 would materially affect the basic and novel
characteristics of the claimed bioabsorbable endoprosthesis.
Last, Appellant’s arguments that the Examiner used impermissible
hindsight reconstruction by “pick[ing] and choos[ing] from a reference only
so much that supports the alleged rejection” and that “the fibers 18 [are]
inoperable as a[n] endoprosthesis when the main body 11 is removed” (App.
Br. 16) are not persuasive. As discussed previously, the transitional phrase
“consisting essentially of” does not exclude Buscemi’s main body 11. Thus,
the rejection is not based upon “pick[ing] and choos[ing]” among the
features of Buscemi to exclude the main body 11 or removal of the main
body 11 such that the fibers 18 are inoperable as an endoprosthesis.
Therefore, Appellant has not shown that the Examiner erred in finding
that Buscemi teaches or suggests “[a] bioabsorbable endoprosthesis
consisting essentially of . . . a plurality of elongate elements,” as recited in
independent claim 30.
We conclude that Appellant has not shown that the Examiner erred in
rejecting claim 30 under 35 U.S.C. § 102(b) or in the alternative, under 35
U.S.C. § 103(a). Because Appellant has not presented arguments regarding
claims 44, 46, 50-59 and 76-80, we affirm the rejection of these claims
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under 35 U.S.C. § 102(b) or in the alternative, under 35 U.S.C. § 103(a) for
the same reasons as independent claim 30, from which they depend.

Claims 82-84
Appellant’s arguments (App. Br. 11-14, 22-25) that Buscemi does not
teach or suggest “the number of elements, N, is equal to about (D/(0.022D +
0.17)) ± 4 filaments, where D, in mm, is the free state diameter of the tubular
structure” and “the elongate elements have a thickness, t in mm, of about
(D/(1.8D + 15)) ± 0.03 mm, where D, in mm, is the free state diameter of the
tubular structure,” as recited in independent claim 82, are persuasive.
The Examiner found that Figure 3 of Buscemi illustrates about twenty
fibers 18 and that Buscemi teaches that the fibers 18 have an outer diameter
of 0.2 mm. (Ans. 7; FF 4.) To satisfy the claim limitation regarding the
number of elements, N, the Examiner further found that substituting a
diameter of 6 mm for Buscemi’s stent 10 (i.e., D = 6) into the claimed
formula of “D/(0.022D + 0.17)) ± 4 filaments” produces a result of twenty
fibers 18 (or “filaments”). (Ans. 7.) Likewise, to satisfy the claim limitation
regarding the element thickness, t, the Examiner found that substituting a
diameter of 6 mm for the stent 10 into the claimed formula of “(D/(1.8D +
15)) ± 0.03 mm” produces a result of 0.2 mm. (Ans. 7.)
In the alternative, the Examiner concluded that claim 82 was obvious
over Buscemi. (Ans. 6, 7.) The Examiner reasoned that because Buscemi
teaches a diameter of the stent 10 ranging from 1 to 50 mm and Figure 3 of
Buscemi illustrates about twenty fibers 18, such “overlapping ranges with
the formula of the claims . . . is [sic] considered prima facie obvious.”
(Ans. 6.) Furthermore, the Examiner concluded that such ranges were
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obvious for the braided fibers 18 of Buscemi because “engineering choices
are made based on optimizing various features including strength.” (Ans. 7.)
We do not agree.
Figures 1 and 3 of Buscemi illustrate an embodiment where the
fibers 18 are arranged concentrically around the main body 11. (FF 4.)
However, Buscemi does not teach the number of fibers 18 surrounding the
main body 11 in an embodiment where the fibers 18 are braided or woven
around the main body (i.e., corresponding to the limitation “a plurality of
elongate elements interbraided into a tubular, radially expandable
structure”). (Id.) Accordingly, the Examiner has not shown that claim 82 is
anticipated by Buscemi.
Furthermore, the Examiner has not articulated reasoning with some
rational underpinning as to how or why one of ordinary skill in the art would
have selected the claimed formulas to optimize particular features when
Buscemi is silent as to the number of fibers 18 braided or woven around the
main body 11 (FF 4). Accordingly, the Examiner has not shown that
claim 82 would have been obvious over Buscemi.
Therefore, Appellant has shown that the Examiner erred in finding
that Buscemi teaches or suggests “the number of elements, N, is equal to
about (D/(0.022D + 0.17)) ± 4 filaments, where D, in mm, is the free state
diameter of the tubular structure” and “the elongate elements have a
thickness, t in mm, of about (D/(1.8D + 15)) ± 0.03 mm, where D, in mm, is
the free state diameter of the tubular structure,” as recited in claim 82.
We conclude that Appellant has shown that the Examiner erred in
rejecting claim 82 under 35 U.S.C. § 102(b) or, in the alternative, under 35
U.S.C. § 103(a). Claims 83 and 84 depend from independent claim 82 and
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Appellant has shown error in the rejection of claims 83 and 84 for the
reasons discussed above regarding claim 82.

Claim 81
Anticipation Rejection
Appellant has not presented any separate arguments regarding the
anticipation rejection of dependent claim 81, which depends from
independent claim 30. (App. Br. 11.) Therefore, we affirm the rejection of
this claim under 35 U.S.C. § 102(b) for the same reasons as independent
claim 30, from which claim 81 depends.
Obviousness Rejection
Appellant’s argument (App. Br. 21-22) that Buscemi does not teach or
suggest that “the number of elements, N, is equal to about (D/(0.022D +
0.17)) ± 4 filaments, where D, in mm, is the free state diameter of the tubular
structure” and “the elongate elements have a thickness, t in mm, of about
(D/(1.8D + 15)) ± 0.03 mm, where D, in mm, is the free state diameter of the
tubular structure,” as recited in dependent claim 81, is not persuasive.
The Examiner found that using a diameter of 6 mm for Buscemi’s
stent 10 (i.e., D = 6) results in: (1) twenty fibers 18 (or “filaments”) for the
claimed formula “(D/(0.022D + 0.17)) ± 4 filaments”; and (2) a thickness of
0.2 mm of the fibers 18 for the claimed formula “(D/(1.8D + 15)) ± 0.03
mm.” (Ans. 7.) The Examiner concluded that because Buscemi teaches a
diameter of the stent 10 ranging from 1 to 50 mm and Figure 3 of Buscemi
illustrates about twenty fibers 18, such “overlapping ranges with the formula
of the claims . . . is [sic] considered prima facie obvious.” (Ans. 6.) We
agree with the Examiner because, unlike claim 82, claim 81 does not recite
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that the elements are “interbraided into a tubular, radially expandable
structure.”
Buscemi teaches that the diameter of the stent 10 ranges from 1 mm to
50 mm and that the outer diameter of the fibers 18 does not exceed 0.2 mm.
(FF 5.) Buscemi’s Figures 1 and 3 also illustrate about twenty fibers 18
surrounding the main body 11. (FF 4.) Because substituting a diameter of 6
mm for Buscemi’s stent 10 into the claimed formulas results in overlapping
ranges for the number of filaments and the thickness of such filaments, the
Examiner has established a prima facie case of obviousness.2 See Peterson,
315 F.3d at 1329. Appellant has not presented any convincing evidence or
argument to overcome the prima facie showing.
Moreover, although Appellant argues that the Specification “teaches
that a stent of bioabsorbable elements should have similar strength to that of
a metallic stent” (App. Br. 21-22) and that the filaments of the stent “should
have sufficient strength to hold open a body lumen” (App. Br. 22), these
limitations are not claimed.
Therefore, Appellant has not shown that the Examiner erred in finding
that Buscemi teaches or suggests that “the number of elements, N, is equal to
about (D/(0.022D + 0.17)) ± 4 filaments, where D, in mm, is the free state
diameter of the tubular structure” and “the elongate elements have a
thickness, t in mm, of about (D/(1.8D + 15)) ± 0.03 mm, where D, in mm, is
the free state diameter of the tubular structure,” as recited in dependent
claim 81.

2 Again, unlike independent claim 82, which recites “a plurality of elongate
elements interbraided into a tubular, radially expandable structure,”
dependent claim 81 does not recite any specific configuration for the
“plurality of elongate elements.”
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We conclude that Appellant has not shown that the Examiner erred in
rejecting dependent claim 81 under 35 U.S.C. § 102(b) or, in the alternative,
under 35 U.S.C. § 103(a).

CONCLUSION
Based on the findings of fact and analysis above, we conclude that:
(1) Appellant has not shown that the Examiner erred in rejecting
claims 30, 44, 46, 50-59 and 76-81 under 35 U.S.C. § 102(b) or, in the
alternative, under 35 U.S.C. § 103(a).
(2) Appellant has shown that the Examiner erred in rejecting claims
82-84 under 35 U.S.C. § 102(b) or, in the alternative, under 35 U.S.C.
§ 103(a).

DECISION
The rejection of claims 30, 44, 46, 50-59 and 76-81 under 35 U.S.C.
§ 102(b) or, in the alternative, under 35 U.S.C. § 103(a), is affirmed.
The rejection of claims 82-84 under 35 U.S.C. § 102(b) or, in the
alternative, under 35 U.S.C. § 103(a), is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART

bim

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