Ex parte PALERMO

Board of Patent Appeals and Interferences

Mar 24, 2000

08605765 (B.P.A.I. Mar. 24, 2000)

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journal and (2) is not binding precedent of the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. 17
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte THOMAS PALERMO
____________
Appeal No. 2000-0448
Application No. 08/605,765
____________
ON BRIEF
____________
Before CALVERT, COHEN, and BAHR, Administrative Patent Judges.
CALVERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the final rejection of claims
1 to 28, all the claims remaining in the application.
Appeal No. 2000-0448
Application No. 08/605,765
2
The appealed claims are drawn to a method for enhancing
occlusion, or for occluding, a body lumen, and are reproduced
in the appendix of appellant’s brief.
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Application No. 08/605,765
3
The references applied in the final rejection are:
Guglielmi et al. (Guglielmi) 5,354,295 Oct.
11, 1994
Brunelle et al., Endovascular Electrocoagulation with a
Bipolar Electrode and Alternating Current: A Follow-up Study
in Dogs, 148 Radiology 413-415 (Aug. 1983) (Brunelle)
Claims 1 to 28 stand finally rejected as unpatentable
over Guglielmi in view of Brunelle, under 35 U.S.C. § 103(a).
Rejection Pursuant to 37 CFR § 1.196(b)
Pursuant to 37 CFR § 1.196(b), claims 19 and 26 are
rejected for failure to comply with 35 U.S.C. § 112, second
paragraph.
Claim 19 reads:
19. The method of claim 18 wherein at
least a portion of the surrounding wall is
thermally damaged to induce local swelling and
narrowing of the body lumen around the vaso-
occlusive element and to temporarily lock the
vaso-occlusive element in place at the target
site, further comprising:
releasing the vaso-occlusive element.
In view of the recitation that the vaso-occlusive element is
temporarily locked in place by local swelling and narrowing of
the body lumen, the recitation of "releasing" the element
implies that it is released from the temporary lock. However,
such a release of the element is contrary to appellant’s
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Application No. 08/605,765
4
disclosure on page 6, lines 29 to 33, which states that the
occlusion of the lumen (blood vessel) "will slowly and
permanently lock the coil [element] in position at the
occlusion site" (emphasis added),
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Application No. 08/605,765
We speculate that appellant may have intended the step of1
"releasing" to mean releasing the vaso-occlusive element from
some other apparatus (e.g., as disclosed at page 16, lines 32
to 34), but, unlike claim 22, no such apparatus is recited in
claims 19 and 26.
5
while it is "temporarily held in place by the spasm or
narrowing of the vessel." Thus, when claim 19 is read in
light of the disclosure, this inconsistency between the claim
and the disclosure renders the claim indefinite. Cf. In re
Cohn, 438 F.2d 989, 993, 169 USPQ 95, 98 (CCPA 1971).
Claim 26 contains similar recitations and is indefinite
for the same reason as claim 19. 1
Rejection Under 35 U.S.C. § 103(a)
For the reasons stated above, we would have to engage in
considerable speculation as to the meaning and scope of claims
19 and 26 in order to evaluate their rejection under § 103(a).
Therefore, in accordance with In re Steele, 305 F.2d 859, 862,
134 USPQ 292, 295 (CCPA 1962), the rejection of claims 19 and
26 under § 103(a) will not be sustained, pro forma. This
should not be taken as an indication, however, that these
claims would necessarily be patentable over prior art if the §
112, second paragraph, rejection (supra) were overcome.
Appeal No. 2000-0448
Application No. 08/605,765
6
Turning now to the remaining claims, the basis of the
rejection under § 103(a) is set forth on pages 2 and 3 of the
Examiner’s Answer. In essence, the examiner finds that it
would have been obvious, in view of Brunelle, to apply high
frequency electrical energy instead of the DC voltage applied
by Guglielmi.
First considering claim 1, appellant argues that it would
not have been obvious to combine the references as proposed by
the examiner because (1) neither reference discloses enhancing
the occlusion of a partially occluded vessel, (2) neither
reference discloses a vaso-occlusive element deployed at the
target site before applying high frequency energy, and (3)
neither reference discloses applying high frequency energy to
and through a pre-deployed element to thermally damage the
lumenal wall (brief, pages 9 and 10). Also appellant contends
that Guglielmi teaches against applying energy which would
cause injury to the vessel wall (brief, pages 14 and 15).
We do not agree with these arguments. As to argument
(1), while the preamble of claim 1 does recite "A method of
enhancing occlusion," the claim does not specify that the
vessel is partially occluded. The argument is therefore not
Appeal No. 2000-0448
Application No. 08/605,765
We note that in claim 2, "coil" has no antecedent basis,2
and apparently should be --element--.
7
commensurate with the scope of the claim. Argument (2) is
likewise not well taken, because in the Guglielmi process, the
electrical energy is not applied until after the coil has been
deployed in place at the target site to be occluded (see col.
8, lines 14 to 18). Contrary to what appellant seems to
believe, neither claim 1 nor claim 2 requires that the
electrical energy be applied through a vaso-occlusive element
(coil) which was deployed at the target site at some time2
prior to deployment of the apparatus which applies the
electrical energy.
Concerning appellant’s remaining arguments, Brunelle, in
the "Discussion" section on pages 414 and 415, states that
there are several drawbacks to DC electrothrombosis, which is
the method employed by Guglielmi to occlude, inter alia, an
artery or vein (col. 6, line 59). Brunelle discloses that, as
opposed to DC electrothrombosis:
The main phenomenon in AC current
electrocoagulation is local rise [in?]
temperature leading to thermic coagulation
of surrounding tissues . . . .
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8
This method has been [word obscured] surgical
practice for many years and has greatly
facilitated hemostasis. Thrombosis occurs
secondary to direct trauma of the vessel wall;
because of [the?] lesion of the vessel wall, the
occlusion is permanent . . . . Because of the
nature of the lesion, there is no risk of distal
embolization. [pages 414 to 415]
Brunelle states in the "Conclusion" (page 415):
Our results show that AC current
electrocoagulation with a bipolar electrode is
an effective way of occluding small vessels. It
is a safe, reliable, and innocuous technique.
In our experience, we have not seen distal
embolization or vessel wall perforation. AC
current electrocoagulation is faster than DC
electrocoagulation, . . . .
We consider that this disclosure by Brunelle would suggest to
one of ordinary skill in the art the use of high frequency
(Brunelle
discloses 100 KHz) AC current instead of DC in the
electrothrombosis method of Guglielmi. The skilled worker
would have been motivated to so modify the Guglielmi process
by Brunelle’s disclosure of the advantages of using AC, i.e.,
it is faster than DC, as well as being "a safe, reliable and
innocous Technique." Appellant’s argument that Guglielmi does
not teach thermally damaging the lumenal wall is not
Appeal No. 2000-0448
Application No. 08/605,765
9
persuasive, because according to Brunelle, such damage is a
characteristic of the use of AC current, as opposed to DC.
Both AC and DC methods result in occlusion, and the fact that
AC causes injury (trauma) of the vessel wall would not have
dissuaded one of ordinary skill from using high frequency AC
in place of Guglielmi’s DC because Brunelle teaches not only
that the use of AC "is a safe, reliable, and innocuous
technique," but also "we have not seen distal embolization or
vessel wall perforation" (supra).
We therefore conclude that claims 1 and 2 are
unpatentable over Guglielmi in view of Brunelle, and will
sustain the rejection of those claims as well as of claims 6
and 7, which appellant has not grouped or argued separately.
37 CFR
§ 1.192(c)(7).
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Application No. 08/605,765
10
Claim 3 reads:
3. The method of claim 1 wherein the
applying step comprises:
advancing an RF device through the lumen to
the target site; and
engaging at least one electrode on the RF
device against the vaso-occlusive element which
has already been deployed.
Appellant argues that this claim is patentable in that neither
Guglielmi nor Brunelle discloses engaging an electrode against
an already deployed vaso-occlusive element (coil). We agree
with this argument, which has not been responded to by the
examiner. Guglielmi positions the electrode and coil (e.g.,
52 and 56) into position together as a single unit, and there
is no teaching or suggestion in either reference that the
electrode be advanced and engaged against an already-deployed
coil, as claimed. Accordingly, the rejection of claim 3, and
of claims 4 and 5 dependent thereon, will not be sustained.
Likewise, since independent claim 10 contains similar
limitations, we will not sustain its rejection, nor the
rejection of claims 11 to 18 dependent thereon.
Claims 8 and 9 recite that the electrical resistance of
the vaso-occlusive element is "substantially less than" (claim
8), or "substantially equal to or slightly less than" (claim
Appeal No. 2000-0448
Application No. 08/605,765
The expression "substantially equal to" does not appear3
to have antecedent basis in the specification. 37 CFR §
1.75(d)(1).
11
9) the electrical resistance of tissue at the target site. 3
Guglielmi does not expressly disclose this limitation, but, as
pointed out by the examiner, does disclose that coil 28 or 56
is made of platinum (col. 7, line 57; col. 9, line 17), which
is one of the materials of which appellant’s coil may be made
(page 13, line 28). It therefore appears that the coil of
Guglielmi would inherently meet the limitations of these
claims, appellant not having defined the scope of
"substantially less" or "slightly less", and their rejection
will be sustained.
Claim 20 reads:
20. A method for occluding a body lumen
comprising:
positioning at least one electrically
conductive, vaso-occlusive element at a target
site within the body lumen; and
applying sufficient high frequency
electrical energy to the vaso-occlusive element
to generate a thermal reaction at the target
site, while said electrically conductive, vaso-
occlusive element remains in place at the target
site and wherein the thermal reaction induces
thrombosis to hold the element in place.
Appeal No. 2000-0448
Application No. 08/605,765
12
We consider this claim to be unpatentable over Guglielmi in
view of Brunelle, essentially for the reasons discussed above
with respect to claim 1. Brunelle discloses, in the part of
pages 414 and 415 quoted supra, that applying high frequency
AC current will cause a local rise in temperature leading to
thermic coagulation of surrounding tissues, and that there is
trauma of the vessel wall. This would constitute a "thermal
reaction at the target site," as claimed, and in practicing
the method of Guglielmi as modified by Brunelle would
inherently induce thrombosis to hold the element (coil) in
place, for as appellant discloses at page 4, lines 18 to 33,
such heating of the luminal wall induces fibrogenic occlusion
of the vessel around the vaso-occlusive element, and at page
6, lines 29 to 31, the fibrogenic occlusion of the vessel
"will slowly and permanently lock the coil in position at the
occlusion site." Appellant’s argument that generating a
thermal reaction would be contrary to Guglielmi’s disclosure
of non-thermally detaching the coil is not persuasive, because
the thermal reaction is in the vessel wall, not in the coil,
which, being made of platinum, a low resistance material,
would itself undergo little if any heating.
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Application No. 08/605,765
13
We will accordingly sustain the rejection of claim 20, as
well as of dependent claims 21 to 25, which have not been
argued separately.
The rejection of claim 27 will not be sustained, since
the examiner has not identified, and we do not find, any
suggestion or teaching in either reference of the particular
step called for by this claim.
The rejection of claim 28 will be sustained. As noted
above concerning claims 1 and 2, Guglielmi discloses initially
deploying the coil at the target site, as claimed, before
applying any electrical energy.
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Application No. 08/605,765
14
Conclusion
The examiner’s decision to reject claims 1 to 28 under
35 U.S.C. § 103(a) is affirmed as to claims 1, 2, 6 to 9, 20
to 25 and 28, and reversed as to claims 3 to 5, 10 to 19, 26
and 27. Claim 19 and 26 are rejected pursuant to 37 CFR §
1.196(b).
In addition to affirming the examiner's rejection of one
or more claims, 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. 53,131,
53,197 (Oct. 10, 1997), 1203 Off. Gaz. Pat. & Trademark Office
63, 122 (Oct. 21, 1997)). 37 CFR § 1.196(b) provides, "[a]
new ground of rejection shall not be considered final for
purposes of judicial review."
Regarding any affirmed rejection, 37 CFR § 1.197(b)
provides:
(b) Appellant may file a single request for
rehearing within two months from the date of the
original decision . . . .
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
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Application No. 08/605,765
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ground of rejection to avoid termination of proceedings (37
CFR § 1.197(c) as to the rejected claims:
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(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 . . . .
Should the appellant elect to prosecute further before
the Primary Examiner pursuant to 37 CFR § 1.196(b)(1), in
order to preserve the right to seek review under 35 U.S.C. §§
141 or 145 with respect to the affirmed rejection, the
effective date of the affirmance is deferred until conclusion
of the prosecution before the examiner unless, as a mere
incident to the limited prosecution, the affirmed rejection is
overcome.
If the appellant elects prosecution before the examiner
and this does not result in allowance of the application,
abandonment or a second appeal, this case should be returned
to the Board of Patent Appeals and Interferences for final
action on the affirmed rejection, including any timely request
for reconsideration thereof.
Appeal No. 2000-0448
Application No. 08/605,765
17
No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
AFFIRMED-IN-PART; 37 CFR § 1.196(b)
IAN A. CALVERT )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
IRWIN CHARLES COHEN ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
JENNIFER D. BAHR )
Administrative Patent Judge )
IAC/sld
Appeal No. 2000-0448
Application No. 08/605,765
18
John T. Raffle
Townsend, Townsend & Crew LLP
Two Embarcadero Center, 8th Floor
San Francisco, CA 94111-3834