Ex Parte Shekalim

Board of Patent Appeals and Interferences

Jul 5, 2012

11885158 (B.P.A.I. Jul. 5, 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.
11/885,158 08/27/2007 Avraham Shekalim 41877 1470
67801 7590 07/06/2012
MARTIN D. MOYNIHAN d/b/a PRTSI, INC.
P.O. BOX 16446
ARLINGTON, VA 22215
EXAMINER
CRONIN, ASHLEY L
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
07/06/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte AVRAHAM SHEKALIM
__________

Appeal 2011-009757
Application 11/885,158
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to an apparatus and method for removing deposits on the
inner surface of a tube, and a catheter for removing atheroma from a blood
vessel. The Patent Examiner rejected the claims for anticipation and
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-
part.
Appeal 2011-009757
Application 11/885,158

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STATEMENT OF THE CASE
Claims 1-3, 7, 11-16, 20, 24-29, 33, and 37-39 are on appeal.1 Claim
1 is representative and reads as follows (emphasis added):
1. Apparatus for removing deposits from a selected location on the inner
surface of a tubular structure, comprising:
an expansible device constructed such that in its non-expanded
condition, it is introducible into the tubular structure, manipulatable therein
to said selected location of the tubular structure, and radially-expansible
therein to engage the inner surface of the tubular structure and the deposits
to be removed;
and at least one elongated scraper cord carried on the outer surface of
said expansible device, said scraper cord being of a flexibility and a
thickness to engage the inner surface of said tubular structure upon the
expansion of said expansible device, and having a circumferentially-
extending intermediate length axially movable with respect to and along the
outer surface of said expansible device in its expanded condition to scrape
away said deposits from the inner surface of the tubular structure.

The Examiner rejected the claims as follows:
 claims 1-3, 7, 12-16, 20, 24, 27-29, 33, 38, and 39 under 35 U.S.C.
§ 102(a) as anticipated by McMurtry (US 2004/0122465 A1); and
 claims 11, 25, 26, and 37 under 35 U.S.C. § 103(a) as unpatentable
over McMurtry and Cragg (US 5,370,653).

ANTICIPATION
The Issue
The Examiner’s position is that McMurtry’s guidewire (labeled 15 in
McMurtry’s Figure 5) is a scraper cord “having a circumferentially-

1 The Examiner’s Answer states that rejections of claims 4-6, 8-10, 17-19,
21-23, 30-32, and 34-36 were withdrawn. (Ans. 3.)
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Application 11/885,158

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extending intermediate portion (since the cord 15 has a thickness three-
dimensional, it extends circumferentially).” (Ans. at 4.)
Appellant contends “one skilled in the art would not construe the
above-quoted recitation from claim 1 as ‘reading on’ the thickness of the
guidewire of McMurtry et al., nor that the guidewire of McMurtry et al. is
capable of performing the function of the scraper cord in Applicant's
construction, namely to scrape away deposits from the inner surface of the
tubular structure.” (App. Br. 8.) According to Appellant, the “interpretation
as given to it by the Examiner would not be a reasonable one, particularly in
the light of the Specification where the ‘circumferentially-extending
intermediate length’ which is axially movable with respect to and along the
outer surface of the expansible device (balloon) in its expanded condition
performs a critical function in Applicant's invention, namely ‘to scrape away
said deposits from the inner surface of the tubular structure’, regardless the
diameter of the cord.” (Id. at 9.)
The issue is whether claim 1’s “scraper cord . . . having a
circumferentially-extending intermediate length axially movable with
respect to and along the outer surface of said expansible device” is
reasonably interpreted to include McMurtry’s guidewire.

Findings of Fact
1. McMurtry’s Figure 5 is reproduced here:
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Application 11/885,158

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2. McMurtry described Figure 5:
FIG. 5 illustrates the balloon catheter of FIG. 1, with the balloon
fully inflated, so that the balloon working length contacts and dilates
the stenotic region. The section of the guidewire 15 extending along
the outer surface of the balloon contacts the stenosed section of the
blood vessel during inflation of the balloon 14. As a result, the section
of the guidewire 15 frictionally engages the blood vessel wall, so that
the balloon 14 has an insubstantial amount of longitudinal slippage
proximally or distally from the desired position in the blood vessel 27.
The balloon 14 is then deflated, and the balloon catheter 10 can be
withdrawn proximally over the guidewire 15 leaving the guidewire in
place, or withdrawn with the guidewire 15.

(Id. at 4, ¶ [0026].)
3. McMurtry taught:
The guidewire thus facilitates dilating the stenosis, by enhancing the
ability of the inflated balloon to remain in position in contact with the
stenosed section of the blood vessel wall, with an insubstantial
amount of longitudinal slippage proximally or distally from the
desired position in the blood vessel.

(Id. at 2, ¶ [0010].)
4. Appellant’s Specification explains the operation of the embodiments
illustrated in Figures 1a-1c as follows:
Each scraper cord 4 is releasably retained on the outer surface of
balloon 3 in the configuration illustrated in Fig. 1a, e.g. by a pressure
sensitive adhesive, but is movable, by a force applied to its proximal
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Application 11/885,158

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end 4b, along the outer surface of the balloon as the cord is pulled in
the proximal direction (leftward in Fig. 1a) through its opening 5 in
catheter tube 2.

(Spec. 5, l. 33 – 6, l. 4.)
5. The ordinary meaning of axially includes “in the direction or line of
the axis.”2

Principles of Law
To anticipate a claim, a prior art reference must disclose
every limitation of the claimed invention, either explicitly or
inherently. Anticipation is an issue of fact, and the question
whether a claim limitation is inherent in a prior art reference is
a factual issue.

In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
“It is well settled that the recitation of a new intended use for an old product
does not make a claim to that old product patentable.” Id.
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the claimed
subject matter may, in fact, be an inherent characteristic of the prior
art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the
characteristic relied on.

Id. at 1478, quoting In re Swinehart, 439 F.2d 210, 212 (CCPA 1971).

2 Webster’s New World College Dictionary, Wiley Publishing, Inc. (2010),
accessed at www.yourdictionary.com/axially, on July 5, 2012.
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Analysis
Claim 1
In the ordinary operation of McMurtry’s apparatus, guidewire 15
would press against deposits lining a blood vessel lumen, helping to secure
the balloon catheter in place by friction. (FF 2.) The Examiner noted,
however, that McMurtry’s guidewire was movable along the outer surface of
the balloon. The Examiner found that if the guidewire were moved along
the outer surface of the balloon while the balloon was inflated and in
position at a stenosis, the moving guidewire would scrape deposits from the
inner surface of the lumen. We agree that the evidence supports those
findings, and it shifts the burden to Appellant to explain that McMurtry’s
guidewire would not so function.
Appellant disputes that McMurtry’s guidewire meets other
requirements: first that it have “a circumferentially-extending intermediate
length,” and second that it be “axially movable with respect to and along the
outer surface of said expansible device.” (App. Br. 9.)
The intermediate length is that part of the guidewire that extends
along the balloon’s surface. As to the requirement that the guidewire extend
circumferentially over the balloon, the Examiner found that because the
guidewire has a thickness, its width or diameter necessarily extended
circumferentially with respect to the balloon’s outer surface. That is, some
portion of the balloon’s circumference is necessarily covered by the width of
the guidewire, even if less than a degree of the circumference. McMurtry’s
guidewire satisfies the first of the disputed requirements.
The term “axially movable” does not appear to distinguish
McMurtry’s guidewire. The claim itself does not specify a reference axis by
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which the direction of movement must be identified. The Specification does
not use the term, and the original claims only required the scraper cord “to
be movable along the outer surface of said expansible device.” None of the
drawings are annotated to indicate what “axially movable” means.
Appellant does not explain the term. If the term encompasses Appellant’s
embodiments illustrated in Specification Figures 1a-1c, in which the cord is
pulled in a proximal direction and drawn longitudinally along the balloon
(see FF 4), McMurtry’s guidewire appears to be capable of the same
longitudinal movement when pulled in a proximal direction. In Appellants’
apparatus and in McMurtry’s apparatus, the cord or guidewire moves
parallel to the longitudinal axis of the balloon, i.e., in line with the
longitudinal axis of the balloon, which meets the ordinary meaning of
axially. (See FF 5.) After considering the evidence and arguments
presented, we agree with the Examiner’s finding that McMurtry’s guidewire
had the capabilities of the scraper cord recited in claim 1

Claim 3
Claim 3 further limits the apparatus by reciting “wherein the scraper
cord has a distal end which is fixed to said expansible device.”
Appellant contends McMurtry’s guidewire does not meet this
requirement. (App. Br. 9-10.) We have considered the Examiner’s response
(see Ans. 9), but agree with Appellant. The rejection of claim 3 is reversed.
Claims 16 and 29 recite the same fixed end limitation that claim 3 recites,
and the rejection of these claims is also reversed.

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Claim 7
Claim 7 further limits the apparatus by reciting “wherein said scraper
cord has a distal end which is also releasably retained on the outer surface of
said expansible device.”
Appellant contends McMurtry’s guidewire does not meet this
requirement. (App. Br. 9-10.) We have considered the Examiner’s response
(Ans. 9), but agree with Appellant that the distal end of McMurtry’s
guidewire is shown beyond the balloon and thus not releasably retained on
the balloon’s outer surface. Claim 20 recites the same limitation that claim 7
recites, and the rejection of claim 20 is also reversed.
Claims 2, 12-15, 24, 27, 28, 33, 38, and 39 have not been argued
separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
Appellant contends that “McMurtry et al. does not disclose a scraping
operation, or any operation for removing deposits, but rather a guiding
operation. Accordingly, one skilled in the art would hardly have been
motivated by Cragg to include a flushing operation since there is nothing in
the McMurtry device as disclosed which removes deposits to be flushed
away.” (App. Br. 15.)
The Examiner responds:
the addition of the flushing mechanism, as suggested and taught by
Cragg, to the device of McMurtry et al. would not be out of the
ordinary for one skilled in the art to combine, since the addition of a
dissolving agent to any catheter device would aid in removing
calcifications that may prohibit proper and smooth movement of the
catheter through a vessel and thus would reduce the efficiency of the
guiding wire held on the expansible device.
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Application 11/885,158

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(Ans. 10.)
Appellant’s contention is persuasive. First, the rejection did not
provide evidence that McMurtry disclosed removing deposits. In our review
of the reference we find that McMurtry taught “dilating the stenosis” rather
than removing deposits. (FF 3.) Second, the Answer’s belated calcifications
theory is unpersuasive because it lacks an evidentiary foundation. The
obviousness rejection is reversed.

SUMMARY
We affirm the rejection of claims 1, 2, 12-15, 24, 27, 28, 33, 38, and
39 under 35 U.S.C. § 102(a) as anticipated by McMurtry.
We reverse the rejection of claims 3, 7, 16, 20, and 29 under
35 U.S.C. § 102(a) as anticipated by McMurtry.
We reverse the rejection of claims 11, 25, 26, and 37 under 35 U.S.C.
§ 103(a) as unpatentable over McMurtry and Cragg.
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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