Marc HUBREGTSE et al.

Patent Trials and Appeals Board

Jan 31, 2020

13488610 - (D) (P.T.A.B. Jan. 31, 2020)

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.
13/488,610 06/05/2012 Marc HUBREGTSE 069818-1810 4010
22428 7590 01/31/2020
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
CHEN, TSE W
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
01/31/2020 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte MARC HUBREGTSE and JOHAN REMMERSWAAL
____________

Appeal 2018-005788
Application 13/488,610
Technology Center 3700
____________

Before: JOHN C. KERINS, WILLIAM A. CAPP, and
BRANDON J. WARNER, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the non-final
rejection of claims 1–15 and 18. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Ureca B.V. as the real party in
interest. Appeal Br. 3.
Appeal 2018-005788
Application 13/488,610
2

THE INVENTION
Appellant’s invention is a catheter assembly for passing an occlusion
in veins or arteries. Spec. 1–2. Claim 18, reproduced below, is illustrative
of the subject matter on appeal.
18. A catheter assembly, comprising:
a hollow catheter having an operative end; and
a loop wire moveably arranged with respect to the hollow
catheter to form a cutting loop located forwardly of the
operative end of the catheter,
wherein the cutting loop includes a distal cutting edge
portion extending from the operative end of the hollow catheter,
the distal cutting edge portion being positioned at the distal tip
of the cutting loop at a forward most point of the catheter
assembly,
wherein the cutting loop includes a first diameter that
extends along a longitudinal axis of the hollow catheter and a
second diameter that extends perpendicular to the longitudinal
axis, the first diameter configured to vary in a direction along
the longitudinal axis of the hollow catheter such that the first
diameter remains larger than the second diameter, and
wherein the loop wire is supported by the hollow catheter
and arranged so that a pushing force from several grams to
several hundred grams can be exerted by the cutting loop at the
distal cutting edge portion in the direction along the
longitudinal axis of the hollow catheter to push aside and cut
tissue within a vein or artery in the direction along the
longitudinal axis of the hollow catheter when the cutting loop is
longitudinally extended.

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THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Okada US 4,643,187 Feb. 17, 1987
Kerin US 5,716,321 Feb. 10, 1998
Dunham US 5,797,948 Aug. 25, 1998
The following rejections are before us for review:2
1. Claims 1–12, 15, and 18 are rejected under 35 U.S.C. § 112, first
paragraph, for failure to comply with the written description requirement.
2. Claim 8 is rejected under 35 U.S.C. § 112, first paragraph, for
failure to comply with the enablement requirement.
3. Claims 1–12, 15, and 18 are rejected under 35 U.S.C. § 112,
second paragraph, as indefinite.
4. Claims 1–5, 7, 15, and 18 are rejected under 35 U.S.C. § 102(b) as
anticipated by Okada.
5. Claims 1–6, 9, 11, 15, and 18 are rejected under 35 U.S.C.
§ 102(b) as anticipated by Kerin.
6. Claim 8 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Okada.
7. Claim 10 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Okada and Dunham.
8. Claim 12 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kerin.

2 Rejections of claims 13 and 14 have been withdrawn in view of
Appellant’s election to cancel these claims. Appeal Br. 12.
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OPINION
Indefiniteness of Claims 1–12, 15, and 18
The Examiner considers that the term “several” grams renders
independent claims 1 and 18 indefinite. Non-Final Action 4. The Examiner
states that it is unclear whether “several” includes 2, 3, 4 or even 10. Id.
Appellant argues that a person of ordinary skill in the art would
understand that “several” means more than one. Appeal Br. 14.
In response, the Examiner notes that “several” may be defined as “an
indefinite number more than two and fewer than many.” Ans. 7.
The PTO can properly reject a claim as indefinite if the claim is
ambiguous, vague, incoherent, opaque, or otherwise unclear. In re
Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014). The test for definiteness
under 35 U.S.C. § 112, is whether “those skilled in the art would understand
what is claimed when the claim is read in light of the specification.”
Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed.
Cir. 1986) (citations omitted).
Appellant’s Specification teaches:
By using a combination of a rigid catheter and a rigid loop wire
material, a separation action can be performed in a forward
direction, i.e. in the longitudinal plane of the 20 catheter-loop.
Depending on the condition of the patient, the operating force
will apply for bypassing an occlusion. Due to calcification, it is
possible that a substantial force needs to be exerted by the front
side of the loop. In that case, the loop thus chosen must be
small in order to make the rigidity of the assembly of loop and
catheter as high as possible. The force exerted when passing/
bypassing the occlusion may vary from several grammes and
preferably tens of grammes, to several hundred grammes of
force. This rigidity is significantly higher than the rigidity
required only for introducing a catheter in a vein/artery.
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Spec. 3–4. Taken in context, a person of ordinary skill in the art would
understand that the recital of “several” is intended to be a term of
approximation rather than a strict lower limit to the amount of force to be
exerted. Such words of approximation are considered to be descriptive
terms that are commonly used in patent claims to avoid a strict numerical
boundary to the specified parameter. See, e.g., Anchor Wall Sys. v.
Rockwood Retaining Walls, Inc., 340 F.3d 1298, 1311 (Fed. Cir. 2003).
We do not sustain the Examiner’s Section 112 indefiniteness rejection
of claims 1–12, 15, and 18.
Written Description – Claims 1–12, 15, and 18
The Examiner finds that Appellant’s drawings show a side view of the
apparatus, in which a first diameter can be seen, but fails to limit a second
diameter along an axis that extends into and out of the figure. Non-Final
Action 2–3. Also, the Examiner finds that there is no written description
support for the limitation in claim 1 directed to a distal cutting edge portion
with a uniform circular cutting edge cross-section. Id. at 3.
Appellant asserts that the two recited diameters are used to define an
elliptical shape of the loop wire as it projects from the distal end of the
catheter. Appeal Br. 9–11.
In response, the Examiner states that the Specification fails to show
support for a second diameter with the claimed dimension that extends in the
“z” axis, perpendicular to the longitudinal axis. Ans. 6. More particularly,
the Examiner states that the Specification is silent as to how much the loop
moves away from the longitudinal axis or along the z-axis. Id. The
Examiner reminds us that the claim language at issue was added by
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amendment in an effort to distinguish over prior art that taught a loop that
was offset from a central longitudinal axis. Id.
In reply, Appellant focuses exclusively on the Examiner’s remarks
regarding an axis extending into and out of the page. Reply Br. 4.
Appellant fails to address the Examiner’s findings regarding lack of support
in the Specification for diameters that reside within the plane of the ellipse
formed by the loop along the “z” axis. Id. More importantly, Appellant fails
to direct our attention to any portion of the Specification and/or drawings
that provides written description support for the claim language at issue. See
generally Reply Br.
An ellipse may have a major axis and a minor axis that are comprised
of diameters that pass through the center of the ellipse. In the instant case,
we understand that, in claim 1, the major axis of the ellipse formed by
Appellant’s loop extends along a longitudinal axis of the hollow catheter,
and that the minor axis is perpendicular to the major axis within the plane
defined by the ellipse. Claim 1 requires that the first diameter (along the
longitudinal axis) of the cutting loop is configured such that it remains larger
than the second diameter (along the perpendicular axis) of the loop. Claims
App.
Appellant provides Figures 1, 2 and 3a–c with accompanying
disclosure in the Specification. According to the Specification, Appellant’s
catheter assembly consists of a hollow catheter 2 that can be advanced
through a vein or artery. Spec. 11, Figs. 1–3c. Attachment 4 is provided at
the effective end 5 where loop wire end 9 of loop 8 is attached. Id. Loop
wire end 3 extends along the length of the catheter past control wheel 7. Id.
Loop wire end 3 can be moved back and forth and loop 8 can thereby be
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made smaller or larger. Id. As we understand the Specification and
accompanying drawings, moving loop wire end 3 back and forth can be
accomplished in a manner that would cause the first (longitudinal) diameter
to be smaller than the second (perpendicular) diameter. The mere fact that
Figures 3a and 3b depict a particular condition of the loop where the
longitudinal axis is greater than the perpendicular axis is insufficient to
establish that the invention is “configured” so that such lengths remain so
relative to each other. Indeed, Figures 1 and 3c suggest that the longitudinal
axis may be the shorter of the two. See Figs. 1, 3c. We are unable to discern
any support in Appellant’s disclosure about “configuring” the assembly so
that the first diameter always remains larger than the second diameter.
When a written description cannot be found in the Specification, as filed, the
only thing the PTO can reasonably be expected to do is to point out its non-
existence. Hyatt v. Dudas, 492 F.3d 1365, 1377 (Fed. Cir. 2007).
With respect to the uniform, circular cutting edge cross-section issue,
Appellant directs our attention to Figures 1–3c as showing distal cutting
edge portions of a loop wire. Appeal Br. 11. Appellant alleges that a “wire
is generally understood to be an elongated metal circular in cross-section.”
Id. Therefore, Appellant concludes that “the loop wire which forms the
distal cutting edge would have a uniform circular cross-section.” Id.
Appellant also directs our attention to the Declaration of Dr. Katharine Krol,
and represents that Dr. Krol’s testimony establishes that a person of ordinary
skill in the art would understand the Specification as disclosing a cutting
edge portion of the cutting loop with “a uniform circular cross-section.” Id.
at 12.
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In response, the Examiner observes that it is common for wires to
have non-circular cross-sections. Ans. 6 (citing examples).
In reply, Appellant states that its position is not that a wire always has
a “uniform circular cross-section,” but that one of ordinary skill in the art
would understand that Appellant’s loop wire has a “uniform circular cross-
section.” Reply Br. 5. Appellant argues that the Examiner fails to rebut Dr.
Krol’s testimony to that effect. Id. Appellant, once again, represents that
Dr. Krol’s testimony establishes that person of ordinary skill in the art would
understand that the Specification teaches a uniform circular cross-section
and does so “precisely.” Id.
Appellant’s arguments are not persuasive. We agree with the
Examiner that not all wires have a circular cross-section and we further
agree with the Examiner that the Specification provides no written
description for the recited circular cross-section limitation. Ans. 6–7. Dr.
Krol testifies that that Appellant’s device uses a cutting loop with a cutting
edge portion that has a uniform circular cross-section that cuts tissue when
advanced forwardly. See Krol Decl. ¶ 11. Dr. Krol’s testimony appears to
be based on testing a physical embodiment of a device provided by
Appellant and is otherwise devoid of any analysis whereby a person of
ordinary skill in the art would “understand” that Appellant’s Specification
demonstrates possession of a cutting wire with a uniform circular cross-
section. Dr. Krol’s testimony falls short of demonstrating written
description support for the circular cross-section limitation in claim 1.
We sustain the Examiner’s Section 112 written description rejection
of claims 1–12, 15, and 18.
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Enablement of Claim 8
The Examiner rejects claim 8 as non-enabled because it recites the
lower end of a range only. Non-Final Action 3.
Appellant argues that there is no per se prohibition on claiming open-
ended ranges. Appeal Br. 12. Appellant argues that an upper limit is
implicitly directed by the effective operation distance of the catheter
assembly itself. Id. at 13.
In response, the Examiner notes that the upper limit of the claimed
range is open-ended and that the Specification never explains how its scale
gradation would work if the control wheel were turned more than once to
accommodate a large range. Ans. 7. The Examiner never addresses
Appellant’s argument that an upper limit to the range is implied by the size
of the catheter assembly itself. See generally Ans.
It is well settled that open-ended claims are not inherently improper.
Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1376 (Fed.
Cir. 2007). They may be supported if there is an inherent, albeit not
precisely known, upper limit and the Specification enables one of skill in the
art to approach that limit. Scripps Clinic & Research Found. v. Genentech,
Inc., 927 F.2d 1565, 1572 (Fed. Cir. 1991). Here, the Examiner does not
adequately address Appellant’s contention that there is an inherent upper
limit imposed by the size of the catheter assembly.
We do not sustain the Examiner’s non-enablement rejection of
claim 8.
Prior Art Rejections
The Examiner’s prior art rejections are predicated on findings of fact
that each of Okada and Kerin disclose a “cutting loop” as claimed in
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independent claims 1 and 18, the only independent claims presented on
appeal. Final Action 4–8. Appellant disputes such findings and is correct to
do so.
Okada is directed to a high-frequency incising and excising
instrument. Okada, Abstract. In operation, Okada’s loop 16 is hooked
around a polyp (or the like) to be excised, after which the loop is constricted
until it tight binds the neck of the polyp and then high-frequency current is
applied to the wire and polyp is burned away. Okada, col. 5, l. 37 – col. 6,
l. 7. There is no evidentiary support for the Examiner’s finding that Okada
has a cutting loop that is arranged to cut tissue at a distal edge portion of a
cutting loop.
Similarly, Kerin discloses an apparatus for imaging a narrow body
lumen. Kerin, Abstract. To facilitate imaging, Kerin provides a structure
disposed distal to an optical viewing scope. Id. Such structure, which could
take the form of a cage or a wire loop guide, creates controllable separation
between body lumen tissue and the lens of the optical viewing scope to
prevent while-conditions. Id. col. 2, l. 60 – col. 4, l. 8. As with the
grounds of rejection involving Okada, there is no evidentiary support for the
Examiner’s finding that Kerin has a cutting loop that is arranged to cut tissue
at a distal edge portion of a cutting loop.
The erroneous findings of fact detailed in the preceding two
paragraphs taint all of the various grounds of rejection over both of the
independent claims and all of the dependent claims that depend therefrom,
including the Section 103 rejection of claim 10 as Dunham does not cure
such deficiency. Accordingly, we do not sustain any of the Examiner’s
grounds of rejection over the prior art.
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CONCLUSION
In summary:
Claims
Rejected
§ Reference(s)/Basis Aff’d Rev’d
1-12, 15, 18 112 Written Description 1–12, 15, 18
8 112 Enablement 8
1-12, 15, 18 112 Indefiniteness 1-12, 15,
18
1-5, 7, 15,
18
102 Okada 1-5, 7, 15,
18
1-6, 9, 11,
15, 18
Kerin 1-6, 9, 11,
15, 18
8 103 Okada 8
10 103 Okada, Dunham 10
12 103 Kerin 12
Overall
Outcome
1–12, 15, 18

AFFIRMED