Ex Parte Doty

Patent Trial and Appeal Board

Oct 29, 2012

11215590 (P.T.A.B. Oct. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DAVID DOTY
__________

Appeal 2011-005990
Application 11/215,590
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method of
delivering a therapeutic agent. The Examiner entered rejections for
indefiniteness and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse the indefiniteness rejection, but affirm the obviousness
rejection in part.
STATEMENT OF THE CASE
Appellant’s invention involves the use of an intravascular device to
deliver a therapeutic agent directly to a treatment site in a patient’s
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circulatory system (Spec. 5). The device includes an expandable member
that can be inflated “to achieve [blood] vessel occlusion” (id. at 10), but
which “need not provide an absolute occlusion of the vessel” (id. at 11).
The Specification further explains:
As the blood vessel is temporarily occluded by the expandable
member . . ., the therapeutic agent(s) is/are not carried away by
blood flow thereby creating a therapeutic agent reservoir. As
such, the therapeutic agent(s) is/are more likely to act on the
tissue and/or penetrate the relatively fine venous epithelia and
into the tissue of the treatment site.

(Id. at 11.)
Claims 10-16 and 22-27 stand rejected and appealed (App. Br. 5).
Claims 10 and 23, the independent claims, illustrate the appealed subject
matter and read as follows:
Claim 10: A method of delivering at least one therapeutic agent,
the method comprising:
providing an elongate element comprising a polymer and
including at least one tip cut in the polymer positioned adjacent a
distal tip portion of the elongate element, the at least one tip cut
providing flexibility to the elongate element;
varying spacing of the at least one tip cut during positioning of
the elongate element within a vessel;
occluding the vessel with the elongate element to produce an
occluded vessel; and
delivering the at least one therapeutic agent to tissue adjacent
the occluded vessel.

Claim 23: A method of delivering a therapeutic agent in a
vessel, the method comprising:
providing a polymer elongate element having a wall and a distal
tip portion, the polymer elongate element having at least one tip cut
formed in and extending partially through the wall adjacent the distal
tip portion;
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occluding the vessel with the polymer elongate element to
produce an occluded vessel; and
delivering the therapeutic agent to tissue adjacent the occluded
vessel;
wherein spacing of the at least one tip cut varies when
positioning the polymer elongate element within the vessel.

The following rejections are before us for review:
(1) Claim 25, under 35 U.S.C. § 112, second paragraph, indefinite
(Ans. 3); and
(2) Claims 10-16 and 22-27, under 35 U.S.C. § 103(a) as obvious over
Glantz
1
and Larson
2
(Ans. 4-6);
INDEFINITENESS
Claim 25 recites “[t]he method of claim 23 wherein the polymer
elongate element further comprises metallic reinforcement connected in
combination with the polymer elongate element” (App. Br. 18).
In rejecting claim 25 as indefinite, the Examiner states that he is
“unsure whether the metallic reinforcement is part of the polymer elongate
element or is merely connected to the polymer elongate element” (Ans. 3).
The Examiner contends that he “may best construe the claim to read:
wherein the polymer elongate element includes a metallic reinforcement
which is in turn connected and combined with the polymer elongate element
itself. The Examiner asserts that this limitation renders the claim indefinite”
(id. at 6).

1
U.S. Patent App. Pub. No. 2003/0225434 A1 (published December 4,
2003).
2
U.S. Patent App. Pub. No. 2003/0055401 A1 (published March 20, 2003).
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We are not persuaded. While claim 25 may encompass any of a large
number and variety of possible combinations between the polymeric
elongate element and the metallic reinforcement, it is well settled that
“breadth is not to be equated with indefiniteness.” In re Miller, 441 F.2d
689, 693 (CCPA 1971).
Thus, while claim 25 may be broad, we are not persuaded that the
Examiner has adequately explained why an ordinary artisan would have
been unable to determine the metes and bounds of the subject matter it
encompasses. We therefore reverse the Examiner’s indefiniteness rejection.
OBVIOUSNESS
In rejecting claims 10-16 and 22-27 as obvious, the Examiner cited
Glantz as describing a therapeutic agent delivery method substantially as
claimed, including the use of a catheter with a flexibility-imparting tip cut
adjacent to its distal tip (see Ans. 4). The Examiner conceded, however, that
Glantz did not “explicitly teach wherein the elongate element comprises a
polymer” (id. at 5).
To address that deficiency, the Examiner cited Larson as teaching that
“catheter sections may be constructed out of either nitinol or a polymer”
(id.). Based on the references’ teachings, the Examiner concluded that an
ordinary artisan would have considered it obvious “to construct an elongate
element or at least a portion of the elongate element from a polymer” (id.).
The Examiner reasoned that “it has been held to be within the general skill
of a worker in the art to select a known material on the basis of its suitability
for the intended use as a matter of obvious design choice” (id. (citing In re
Leshin, 277 F.2d 197 (CCPA 1960)).
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As stated in 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. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

We select claim 10 as representative of the claims Appellant did not
argue separately. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellant’s arguments do not persuade us that a preponderance of the
evidence fails to support the Examiner’s conclusion of prima facie obvious
as to claim 10. Specifically, we are not persuaded, as Appellant argues (see
App. Br. 12-14; also Reply Br. 6), that the Examiner erred in finding that an
ordinary artisan would have been prompted to use a polymeric material to
construct the elongate element of Glantz’s device.
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), the
Supreme Court reaffirmed that “when a patent claims a structure already
known in the prior art that is altered by mere substitution of one element for
another known in the field, the combination must do more than yield a
predictable result.”
The Court also reaffirmed the obviousness of solving a problem by
selecting a known option:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
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instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 421.
Here, contrary to Appellant’s argument that Glantz’s disclosure is
limited to the use of metal for its device, Glantz explicitly states:
The material used to construct the elongate body 26 and the
distal tip 22 of the catheter is, for example, a metal such as
nitinol. . . . It should be noted, however, that there are many
materials that can be used in the present invention and this
discussion relates only to the preferred embodiment by example
only and in no way limits the teachings of the invention.

(Glantz [0022] (emphasis added).)
Moreover, Larson discloses that catheters which include a flexibility-
imparting spiral cut in the elongate element, similar to that used by Glantz
(see Glantz [0021]), can be formed using polymeric materials (see Larson
[0006]). In particular, Larson discloses that polymeric material and metals
may be used alternatively to form the spirally cut, flexibility-imparting,
“transition member” (see id. at [0011] (“The transition member may be
made from a stainless steel hypotube or other metallic tube, such as nitinol,
an unreinforced polymeric tube, a reinforced polymeric tube, or any other
suitable material or element.”)).
Thus, given Glantz’s teaching that many materials can be used to form
the elongate body and spirally cut distal tip of its catheter, and given
Larson’s disclosure that polymeric materials were suitable alternatives to
metals in such applications, we are not persuaded that the Examiner erred in
finding that an ordinary artisan would have been prompted to use a polymer
to construct Glantz’s device, as claim 10 requires.
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We are also unconvinced that the references fail to suggest claim 10’s
requirement of delivering the therapeutic agent to tissue “adjacent the
occluded vessel” (App. Br. 17).
We agree with Appellant that Glantz discloses administering its
therapeutic agent only before and after the device’s balloon is inflated to
compress the plaque in a blood vessel (see Glantz [0034]-[0036]).
Nonetheless, when claim 10 is given its broadest reasonable construction as
it would be interpreted by an ordinary artisan in light of the Specification,
we are not persuaded that claim 10 fails to encompass administering a
therapeutic agent in the manner described by Glantz.
Specifically, Appellant urges that, based on the dictionary meaning of
the term “occlude” (see App. Br. 19 (Evidence Appendix)), an ordinary
artisan would understand claim 10’s requirement of delivering a therapeutic
agent to tissue adjacent the “occluded vessel” as requiring total occlusion of
the vessel, as would occur only when Glantz’s balloon was inflated (see
App. Br. 14-15; Reply Br. 6-7). However, contrary to Appellant’s argument
that an ordinary artisan would understand that there are no degrees of
occlusion, but rather only complete blockage, Appellant’s own Specification
discloses that the described methods can be accomplished without “an
absolute occlusion of the vessel” (Spec. 11).
Moreover, when Glantz uses the term “occluded vessel 50” (see,
e.g., Glantz [0033], [0034]), the corresponding Figures show that the vessel
is not completely blocked, but only partially obstructed by plaque formations
indicated by reference numeral 50 (see id., e.g., at Fig. 6). Thus, while the
dictionary definitions advanced by Appellant may be pertinent, in this
instance prior art in this specific field indicates that the precise term used in
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claim 10, “occluded vessel,” encompasses blood vessels which are only
partially blocked.
Accordingly, given the manner in which the prior art uses the claim
term “occluded vessel,” and given that Appellant’s Specification recognizes
that occlusion need not be absolute, we agree with the Examiner that it was
reasonable to interpret “occluded vessel” in claim 10 as encompassing
partial blockage of the vessel, such as would necessarily occur when
Glantz’s catheter was positioned in the vessel (see Glantz [0034]; also, id. at
Figs. 7, 8). We therefore also agree with the Examiner that, when Glantz
describes administering drugs to the treatment area while the vessel is
occluded by the catheter (see id. at [0034], [0036]), Glantz meets claim 10’s
requirement of delivering at least one therapeutic agent to tissue adjacent the
occluded vessel.
In sum, as Appellant’s arguments do not persuade us that Glantz and
Larson fail to teach or suggest using an elongate element comprising a
polymer to occlude a vessel and deliver a therapeutic agent to tissue adjacent
the occluded vessel as recited in claim 10, we affirm the Examiner’s
obviousness rejection of that claim over those references.
As they were not argued separately, claims 11, 13, 16, and 22-27 fall
with claim 10. See 37 C.F.R. § 41.37(c)(1)(vii).
Claim 14 recites “[t]he method of claim 10 further comprising
providing a flexing member adjacent a distal tip portion of the elongate
element” (App. Br. 17). As the Examiner points out, Glantz’s device
includes flexible distal tip 22, composed of flexible coil section 34, which is
adjacent to the distal-most end piece 32 of the device (see Glantz Fig. 2; see
also id. at [0019], [0020]).
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While Appellant urges that the Specification describes a number of
features of the disclosed flexing member (Reply Br. 7-8), none of those
features appears in claim 14. Thus, as we agree with the Examiner that
Glantz discloses providing a device with a flexing member adjacent a distal
tip portion of the device’s elongate element, we also affirm the Examiner’s
obviousness rejection as to claim 14.
Claim 15 recites “[t]he method of claim 10 further comprising
repeating delivery of at least one therapeutic agent to the tissue adjacent the
occluded vessel” (App. Br. 17). As to claim 15, Appellant argues that
Glantz and Larson fail to disclose “repeating delivery of at least one
therapeutic agent to the tissue adjacent the occluded vessel. At most, the
Glantz publication discloses providing therapeutic drugs before and after the
balloon is inflated in the vessel, but not when the balloon occludes the vessel
i.e., adjacent the occluded vessel as claimed” (id. at 15 (citing Glantz
[0034]-[0036])).
As discussed above, however, we are not persuaded that the Examiner
erred in finding that Glantz teaches administering a therapeutic agent to an
occluded vessel as required by claim 10. Moreover, given that it would have
been reasonable to repeat the treatment described in Glantz, as needed, we
are not persuaded that the Examiner was unreasonable in concluding that the
process recited in claim 15 would have been obvious to an ordinary artisan.
We therefore also affirm the Examiner’s obviousness rejection as to claim
15.
We agree with Appellant, however, that the Examiner has not
adequately explained why claim 12 would have been obvious to an ordinary
artisan.
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Claim 12 recites “[t]he method of claim 10 wherein the at least one
therapeutic agent is delivered to a therapeutic agent reservoir” (App. Br. 17).
As the Specification explains, a therapeutic agent reservoir is created when
the expandable member of the device occludes the blood vessel to the extent
that “the therapeutic agent(s) is/are not carried away by blood flow” (Spec.
11).
As Appellant points out, rather than disclosing administration of the
drug while its device’s balloon is inflated, Glantz only discloses
administering its therapeutic agent before and after balloon inflation (see
Glantz [0034]-[0036]). The Examiner urges, nonetheless, that paragraphs
[0034] and [0036] of Glantz “imply the use of a reservoir” (Ans. 4).
The Examiner does not, however, provide any other discussion of this
feature, nor does the Examiner clearly or specifically explain how or why, in
the absence of inflating the device’s balloon, simply inserting Glantz’s
device into a blood vessel would block the blood flow enough to prevent the
administered therapeutic agents from being carried away. As we are not
persuaded that the Examiner has carried the burden of adequately explaining
why claim 12 would have been obvious to an ordinary artisan, we reverse
the Examiner’s rejection of that claim.

SUMMARY
We reverse the Examiner’s rejection of claim 25 as indefinite.
We affirm the Examiner’s obviousness rejection over Glantz and
Larson as to claims 10, 11, 13-16, and 22-27.
However, we reverse the Examiner’s obviousness rejection over
Glantz and Larson as to claim 12.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

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