Ex parte Buscemi

Board of Patent Appeals and Interferences

May 27, 1998

08541658 (B.P.A.I. May. 27, 1998)

Application for patent filed October 2, 1995. According1
to the appellant, the application is a continuation of
Application No. 08/134,978, filed October 12, 1993, now
abandoned.
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered
today (1) was not written for publication in a law
journal and (2) is not binding precedent of the Board.
Paper No. 24
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte PAUL J. BUSCEMI
____________
Appeal No. 97-2552
Application No. 08/541,6581
____________
ON BRIEF
____________
Before CALVERT, ABRAMS, and NASE, Administrative Patent Judges.
NASE, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal from the examiner's final
rejection of claims 3 through 8. Claims 1, 2 and 9 through 18
have been allowed.
We REVERSE and enter a new rejection pursuant to 37 CFR
Appeal No. 97-2552
Application No. 08/541,658
§ 1.196(b).
Appeal No. 97-2552 Page 3
Application No. 08/541,658
This patent has an effective filing date under 35 U.S.C. 2
§ 102(e) of May 3, 1993.
BACKGROUND
The appellant's invention relates to a catheter. An
understanding of the invention can be derived from a reading of
exemplary claim 3, which appears in the appendix to the
appellant's brief.
The prior art references of record relied upon by the
examiner in rejecting the appealed claims are:
Gottschalk et al. 5,035,621 July 30, 1991
(Gottschalk)
Levy 5,092,773 March 3, 1992
Thomas 5,184,044 Feb. 2, 1993
References made of record by this panel of the Board are:
Sinofsky 5,207,670 May 4, 1993
(Sinofsky '670)
Sinofsky 5,540,677 July 30, 19962
(Sinofsky '677)
Claims 3, 4, 5 and 8 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Levy in view of Thomas.
Claims 6 and 7 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Levy in view of Thomas and Gottschalk.
Appeal No. 97-2552 Page 4
Application No. 08/541,658
Rather than reiterate the conflicting viewpoints advanced by
the examiner and the appellant regarding the above-noted
rejections, we make reference to the final rejection (Paper No.
15, mailed August 8, 1996) and the examiner's answer (Paper No.
20, mailed February 20, 1997) for the examiner's complete
reasoning in support of the rejections, and to the appellant's
brief (Paper No. 19, filed January 22, 1997) for the appellant's
arguments thereagainst.
OPINION
In reaching our decision in this appeal, we have given
careful consideration to the appellant's specification and
claims, to the applied prior art references, and to the
respective positions articulated by the appellant and the
examiner. Upon evaluation of all the evidence before us, it is
our conclusion that the evidence adduced by the examiner is
insufficient to establish obviousness with respect to any of the
claims on appeal. Accordingly, we will not sustain the
examiner's rejections under 35 U.S.C. § 103. Our reasoning for
this determination follows.
Appeal No. 97-2552 Page 5
Application No. 08/541,658
Implicit in the above-noted rejections under 35 U.S.C. § 103
is the examiner's determination (final rejection, pp. 3-4) that
Levy teaches or suggests all the claimed limitations of
independent claim 3 except for the claimed fluid light guide
means. The examiner then concluded that the claimed fluid light
guide means was suggested by the teachings of Thomas.
The conclusion that the claimed subject matter is obvious
must be supported by evidence, as shown by some objective
teaching in the prior art or by knowledge generally available to
one of ordinary skill in the art that would have led that
individual to combine the relevant teachings of the references to
arrive at the claimed invention. See In re Fine, 837 F.2d 1071,
1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988).
Our review of Levy reveals that it fails to teach or suggest
all the remaining claimed limitations of independent claim 3
except for the claimed fluid light guide means. Accordingly,
even if the examiner's conclusion that the claimed fluid light
guide means was suggested by the teachings of Thomas is correct,
the combined teachings of the references would not have arrived
Appeal No. 97-2552 Page 6
Application No. 08/541,658
at the claimed invention. In that regard, Levy does not teach or
suggest the following elements from independent claim 3:
(1) a catheter constructed and arranged for insertion into
vessels, ducts, veins, arteries, or blood vessels of a living
body, and (2) a supply of photocurable fluid soft tissue repair
material.
The examiner believes that the above-noted elements are met
by the device shown in Figure 2 of Levy. We do not agree.
The device shown in Figure 2 of Levy is used for treating
mineralized body tissues, including a variety of dental tissues
and bone. The device shown in Figure 2 of Levy includes an
optical fiber 30 for conducting laser radiation to a region to be
filled or coated, and two supply tubes 32 and 34 each connected
to receive components of the coating or filling material from a
respective supply unit 36 or 38. One example of a method carried
out with the aid of the device shown in Figure 2 taught by Levy
is where a mixture of materials, such as hydroxyapatite, ceramic
and a dark colored material, e.g., carbon black, all in powdered
form, is projected from tube 32 by being entrained in an air
stream, while H PO is projected from tube 34 by being entrained3 4
Appeal No. 97-2552 Page 7
Application No. 08/541,658
in a second air stream. The two streams mix together in a region
illuminated by reaction-producing laser radiation emanating from
fiber 30 and react to form calcium phosphate. In addition, Levy
discloses that depending on the ingredients of the mixture, the
reaction product could be monobasic calcium phosphate, dibasic
calcium phosphate, or tribasic calcium phosphate.

From our review of Levy, we find no teaching or suggestion
that the device shown in Figure 2 of Levy is constructed and
arranged for insertion into vessels, ducts, veins, arteries, or
blood vessels of a living body. It is our view that the inherent
size of Levy's device would be larger than that recited in claim
3. In addition, we find no teaching or suggestion that the
device shown in Figure 2 of Levy has a supply of photocurable
fluid soft tissue repair material. In that regard, it is our
opinion that the none of the materials stored in Levy's supply
units 36 and 38 are photocurable fluid soft tissue repair
material.
We have also reviewed Thomas and Gottschalk applied in the
rejections of the claims under appeal but find nothing therein
which makes up for the deficiencies of Levy discussed above.
Appeal No. 97-2552 Page 8
Application No. 08/541,658
Accordingly, we cannot sustain the examiner's rejection of
appealed claims 3 through 8 under 35 U.S.C. § 103.
New ground of rejection
Under the provisions of 37 CFR § 1.196(b), we enter the
following new ground of rejection.
Claims 3 and 4 are rejected under 35 U.S.C. § 103 as being
unpatentable over Sinofsky '670 or Sinofsky '677 in view of
Thomas.
Sinofsky '670 discloses photoreactive suturing of biological
materials for joining living tissues and promoting the healing of
small biological structures. Figure 13 shows an apparatus 81 for
remote application of sutures which can be incorporated into a
catheter, endoscope or arthroscope and disposed adjacent to a
remote anastomotic site. The apparatus 81 includes a suture port
means 85 and a laser means 83. The suture port means 85 delivers
a photoreactive suture material to the anastomotic site, the
suture material comprising a structure with at least a portion of
Appeal No. 97-2552 Page 9
Application No. 08/541,658
the structure formed by a crosslinking agent such that upon
irradiation of the suture material the crosslinking agent adheres
to the biological material and thereby provides closure at the
anastomotic site. The laser means 83 provides the necessary
light energy in the form of laser radiation to effect
crosslinking of the suture material at the anastomotic site.
Sinofsky '670 teaches (column 2, lines 38-46) that various
"biological glue" materials can be employed as crosslinking
agents in either solid, liquid, gel or powder form to form
a bond to tissue segments and thereby hold them together while
natural healing processes occur. Examples of such crosslinking
agents include collagen, elastin, fibrin, albumin and various
other photoreactive polymeric materials. In addition, Sinofsky
'670 (column 2, lines 60-65) uses the terms "anastomosis" and
"anastomotic site" to broadly encompass the joinder of biological
structures, including, for example, incision and wound healing,
repair of blood vessels and other tubular structures, sealing of
fissures, nerve repairs, reconstructive procedures, and the like.

Appeal No. 97-2552 Page 10
Application No. 08/541,658
Sinofsky '677 uses the terms "endoscope" and "endoscopic"3
to broadly encompass instruments such as laproscopes, cytoscopes,
colonoscopes, sigmoidoscopes, arthroscopes, esophagoscopes,
bronchoscopes, gastroscopes, thoracoscopes, peritoneoscopes,
culdoscopes, catheters and the like (column 2, lines 62-66).

Sinofsky '677 discloses endoscopic systems for3
photoreactive suturing of biological materials for joining living
tissues and promoting the healing of small biological structures.
Figure 3 shows an endoscopic apparatus 81 for remote application
of sutures. The apparatus 81 can be a catheter, arthroscope or
other form of endoscope and disposed adjacent to a remote
anastomotic site. The apparatus 81 includes a suture material
delivery port 85 and a laser port 83. In Figure 4, an
alternative embodiment is shown, simply consisting of a suture
material delivery port 85 and a laser port 83 housed within a
tubular casement 81. This instrument can be constructed small
enough (e.g., less than about 2.0 micrometers) so that it can
pass through a conventional endoscope instrument delivery
channel. The suture port 85 delivers a photoreactive suture
material 36 to the anastomotic site 30 where it can be draped
across a fissure 32 or similar region requiring closure. The
suture port can be equipped with a valve or wiper 69 to terminate
or periodically stop the flow of suture material. The suture
Appeal No. 97-2552 Page 11
Application No. 08/541,658
material comprises a structure with at least a portion of the
structure formed by a crosslinking agent such that upon irradi-
ation of the suture material the crosslinking agent adheres to
the biological material and thereby provides closure at the
anastomotic site. The laser means 83 provides the necessary
light energy in the form of laser radiation to effect
crosslinking of the suture material at the anastomotic site.
Sinofsky '677 teaches (column 2, lines 52-61) that various
"biological glue" materials can be employed as crosslinking
agents in either solid, liquid, gel or powder form to form a bond
to tissue segments and thereby hold them together while natural
healing processes occur. Examples of such crosslinking agents
include collagen, elastin, fibrin, albumin and various other
photoreactive polymeric materials. In addition, Sinofsky '677
(column 3, lines 16-21) uses the terms "anastomosis" and
"anastomotic site" to broadly encompass the joinder of biological
structures, including, for example, incision and wound healing,
repair of blood vessels and other tubular structures, sealing of
fissures, nerve repairs, reconstructive procedures, and the like.
Thomas discloses at column 5, lines 21-23, that light rod 16
of his dental curing light gun could employ a liquid light guide.
Appeal No. 97-2552 Page 12
Application No. 08/541,658
After the scope and content of the prior art are determined,
the differences between the prior art and the claims at issue are
to be ascertained. Graham v. John Deere Co., 383 U.S. 1, 17-18,
148 USPQ 459, 467 (1966).
Based on our analysis and review of Sinofsky '670 and
Sinofsky '677 and claims 3 and 4, it is our opinion that the only
difference is the limitation that a fluid light guide means is
positioned within the catheter relative to the optical fiber so
as to direct the radiation emitted by the fiber toward the target
site. In this regard, it is our opinion that the claimed supply
of photocurable fluid soft tissue repair material reads on the
crosslinking agents disclosed by both Sinofsky '670 and Sinofsky
'677. In addition, it is our view that the apparatus 81 of
Sinofsky '670 and the apparatus 81 of Sinofsky '677 are
inherently constructed and arranged for insertion into vessels,
ducts, veins, arteries, or blood vessels of a living body.
Appeal No. 97-2552 Page 13
Application No. 08/541,658
The test for obviousness is what the combined teachings of4
the references would have suggested to one of ordinary skill in
the art. See In re Young, 927 F.2d 588, 591, 18 USPQ2d 1089,
1091 (Fed. Cir. 1991) and In re Keller, 642 F.2d 413, 425, 208
USPQ 871, 881 (CCPA 1981).
In applying the test for obviousness, we reach the4
conclusion that it would have been obvious to one of ordinary
skill in the art at the time the invention was made to modify the
surgical instruments of either Sinofsky '670 or Sinofsky '677 to
employ a liquid light guide as suggested and taught by Thomas for
the self evident advantage of having the liquid act to guide the
light to the anastomotic site.
CONCLUSION
To summarize, the decision of the examiner to reject claims
3 through 8 under 35 U.S.C. § 103 is reversed and a new rejection
of claims 3 and 4 under 35 U.S.C. § 103 has been added pursuant
to provisions of 37 CFR § 1.196(b).
This decision contains a new ground of rejection pursuant to
37 CFR § 1.196(b)(amended effective Dec. 1, 1997, by final rule
notice, 62 Fed. Reg. 53131, 53197 (Oct. 10, 1997), 1203 Off. Gaz.
Pat. Office 63, 122 (Oct. 21, 1997)). 37 CFR § 1.196(b) provides
Appeal No. 97-2552 Page 14
Application No. 08/541,658
that, "A new ground of rejection shall not be considered final
for purposes of judicial review."

37 CFR § 1.196(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 proceedings (§ 1.197(c)) as to
the rejected claims:
(1) Submit an appropriate amendment of the claims
so rejected or a showing of facts relating to the
claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the
application will be remanded to the examiner. . . .
(2) Request that the application be reheard under
§ 1.197(b) by the Board of Patent Appeals and
Interferences upon the same record. . . .
Appeal No. 97-2552 Page 15
Application No. 08/541,658
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
REVERSED; 37 CFR § 1.196(b)
IAN A. CALVERT )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
NEAL E. ABRAMS ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
JEFFREY V. NASE )
Administrative Patent Judge )
Appeal No. 97-2552 Page 16
Application No. 08/541,658
LEONIEDE M. BRENNAN
VIDAS, ARRETT STEINKRUAS, P.A.
SUITE 2000
6109 BLUE CIRCLE DRIVE
MINNETONKA, MN 55343-9131
APPEAL NO. 97-2552 - JUDGE NASE
APPLICATION NO. 08/541,658
APJ NASE
APJ CALVERT
APJ ABRAMS
DECISION: REVERSED;
37 CFR § 1.196(b)
Prepared By: Delores A. Lowe
DRAFT TYPED: 14 May 98
FINAL TYPED: