Ex Parte Wentling

Board of Patent Appeals and Interferences

Aug 28, 2008

10857427 (B.P.A.I. Aug. 28, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte Medical Components, Inc.
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Appeal 2008-1974
Application 10/857,427
Technology Center 3700
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Decided: August 28, 2008
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Before JAMESON LEE, RICHARD TORCZON, and SALLY C.
MEDLEY, Administrative Patent Judges.

LEE, Administrative Patent Judge.

DECISION ON APPEAL

A. Statement of the Case
This is a decision on appeal by the real party in interest, Medical
Components, Inc. (MC), under 35 U.S.C. § 134(a) from a final rejection of
claims 17-21 and 25-28. We have jurisdiction under 35 U.S.C. § 6(b).

Appeal 2008-1974
Application 10/857,427

References Relied on by the Examiner
Humbert US 4,846,223 Jul. 11, 1989
Manska US 5,156,186 Oct. 20, 1992

The Rejections on Appeal
The Examiner rejected claims 17-21 and 25-28 under 35 U.S.C.
§ 112, second paragraph.
The Examiner rejected claims 17-21, 25, 27, and 28 under 35 U.S.C.
§ 102(b) as anticipated by Manska.
The Examiner rejected claim 26 under 35 U.S.C. § 103(a) as
unpatentable over Manska and Humbert.

B. Principles of Law
A claim is indefinite if, when read in light of the specification, it does
not reasonably apprise those skilled in the art of the scope of the invention.
Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir.
2003).
The analysis of a claim rejection based on prior art should not be
performed where it is necessary to engage in speculation as to the meaning
of claim terms and assumptions as to the scope of a claim. See In re Steele,
305 F.2d 859, 862 (CCPA 1962).

C. Analysis
The invention relates to a connector for a medical device wherein the
connector forms a fluid passage and incorporates a sealing device therein for
selectively restricting fluid flow through the passage. (Spec. 3:¶ 6.)
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Application 10/857,427

Claim 17 is the independent claim and is reproduced below (Claims
App’x):
17. A connector for being secured to a catheter that extends
into a venous opening of a patient, comprising:

a body having a proximal end, a distal end adapted to be
secured to a proximal end of a catheter lumen, and an axially
extending passage extending therethrough between the proximal end
and the distal end, fluidly connecting the proximal end and the distal
end, wherein the proximal end includes a fitting for releasably
connecting the connector to an external device, the body further
having a valve body extending laterally with respect to the axially
extending passage to lateral ends, with the valve body containing a
cylinder-receiving passage; and

a cylinder rotatably disposed within the cylinder-receiving
passage of the valve body and being rotatable between a first position
and a second position,

wherein the cylinder includes an opening extending generally
diametrically therethrough, and further includes first and second ends
at least one of which includes an actuating section, and the first and
second ends, including the at least one actuating section, extend only
minimally beyond the lateral ends of the valve body,

wherein when the cylinder is in the first position, the proximal
end of the body is in fluid communication with the distal end of the
body and wherein, when the cylinder is in the second position, the
proximal end of the body is not in fluid communication with the distal
end of the body.

MC must show error in the Examiner’s decision rejecting claims 17-
21 and 25-28.
Rejections under 35 U.S.C. § 112, second paragraph
The Examiner rejected claims 17-21 and 25-28 as indefinite under
35 U.S.C. § 112, second paragraph based on a limitation appearing in
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Application 10/857,427

independent claim 17. Claims 19 and 27 were further rejected as indefinite
based on limitations added by each of those claims. We address the
indefiniteness rejections of claims 17, 19, and 27 separately.
The rejection of claim 17 as indefinite
The Examiner rejected independent claim 17 as being indefinite
because of a lack of clarity of the limitation in claim 17 of “first and second
ends, including the at least one actuating section, extend only minimally
beyond the lateral ends of the valve body.” (Claims App’x 11:14-16.) The
Examiner explained (Ans. 3:8-12):
The examiner is unsure as to the degree of the relative term
“minimally” and as to the nature of “the lateral ends of the valve
body”. It is unclear as to the relative degree and criticality of the term
“minimally” in view of the handles (236) in Figure 6, which extend
away from the valve body. It is unclear as to the claimed structure.

MC argues that (App. Br. 4:9-15):
The artisan of routine skill would understand that "only
minimally" with respect to the first and second ends clearly means
only to the extent necessary to include a flange that overlaps the end
surface of the valve body and thus secure the cylinder within the valve
body since the cylinder is to be held rotatably therewithin, and with
respect to the actuating section, only to the extent necessary to enable
actuation thereof, that is, to enable rotation thereof to be performed
(i.e., by tool engagement therewith or manual engagement therewith).

The claim itself does not provide any context for determining what
constitutes a minimal extension or an upper bound beyond which the
extension cannot be regarded as minimal. MC has not directed us to any
portion of the specification as originally filed that describes the term “only
minimally” or reveals an objective standard for determining its scope.
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In the above-quoted arguments, it is urged that the meaning of “only
minimally” would be clear to a person of ordinary skill in the art. The
meaning is said to be linked to the functions of the first and second ends
securing the cylinder and the rotating actuating section. However, MC’s
claim does not relate the term “only minimally” to any function of the
claimed structure. MC has also not pointed to any part of the specification
in which that term is disclosed to be interrelated with functional
characteristics. Furthermore, MC submitted no declaration from a technical
witness to the effect that a person of ordinary skill in the art would
understand the term “only minimally” to be associated with any particular
function. It is only the argument made in the Appeal Brief that urges such a
meaning for that term. Argument of counsel cannot take the place of
evidence lacking in the record. Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d
588, 595 (Fed. Cir. 1997). MC has not directed us to evidence that the “only
minimally” limitation would have the alleged meaning as argued by MC to a
person of ordinary skill in the art.
A claim is indefinite if, when read in light of the specification, it does
not reasonably apprise those skilled in the art of the scope of the invention.
Amgen Inc., 314 F.3d at 1342. For the reasons discussed above, a person of
ordinary skill would not be reasonably apprised of the scope of the “only
minimally” limitation of claim 17.
We sustain the Examiner’s rejection of independent claim 17 and the
dependent claims 18-21 and 25-28 under 35 U.S.C. § 112, second paragraph,
as indefinite.

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Application 10/857,427

The rejection of claim 19 as indefinite
Claim 19 depends from claim 17 and is indefinite for the same reasons
claim 17 is indefinite. Furthermore, the Examiner pointed to additional
reasons why claim 19 is indefinite. Claim 19 introduces the additional
limitations (Claims App’x 12:4-9):
wherein the cylinder has a tab extending therefrom a small distance in
a direction orthogonal to the catheter, and wherein body comprises a
first stop portion disposed along an outer diameter of the cylinder and
a second stop portion disposed a predetermined arcuate distance
around the outer diameter of the cylinder from the first stop, and
wherein the tab is movably disposed between the first stop portion and
the second stop portion.

The Examiner based the rejection on two limitations relating to the tab
extending : (1) “a small distance,” and (2) “in a direction orthogonal to the
catheter.”
We consider first the “small distance” limitation. The Examiner
found that term unclear and stated “[t]he term ‘small’ is a relative term and
needs to be fully defined with respect to the distance as used in claim 19.”
(Ans. 8:5-6.)
MC argues that “[t]he artisan of routine skill would understand that
the tab of the cylinder is joined to the cylinder and extends from the cylinder
for a small distance (i.e. having a small length)…”(App. Br. 4:21-22.) MC
further argues “[t]he ‘small distance’ is only enough for the tab to physically
abut the stop, and the claim provides the context for understanding ‘small
distance’.” (App. Br. 5:1-3.)
We take MC’s argument to be that the scope of “small distance” is
determined by the operation of the tab in moving between and engaging the
stops. According to MC, a small distance means that which is only enough
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Application 10/857,427

for the tab to act as claimed. However, a tab that extends a distance greater
than one that is “only enough” to abut the stop is still capable of abutting and
moving in the manner specified in the claim, and still extends only a “small
distance” as compared to an even larger extension. Small does not equate to
only enough. The claim reveals no such indication; the specification does
not define the term as such; and MC submitted no declaration evidence
tending to establish that it is conventional for one with ordinary skill in the
art to equate “small distance” to a length that is “only enough” and no more.
As noted before, a claim is indefinite if, when read in light of the
specification, it does not reasonably apprise those skilled in the art of the
scope of the invention. Amgen Inc., 314 F.3d at 1342. MC has not pointed
us to sufficient evidence to establish the standard that a person of ordinary
skill in the art would use to establish the measure for determining what
constitutes a “small distance.” Without an objective standard for the
meaning of “small,” the scope of the claim is indefinite.
We turn now to the “in a direction orthogonal to the catheter”
limitation. In rejecting claim 19 based on that limitation, the Examiner
stated (Ans. 3:15-18):
It is also unclear as to what is “in a direction orthogonal to the
catheter”. It is unclear if the tab is located a small distance in a
direction orthogonal to the catheter or if the tab is extending from the
cylinder in a direction orthogonal to the catheter.

The Examiner also stated (Ans. 9:2-10):
The limitation "the cylinder has a tab extending therefrom a small
distance in a direction orthogonal to the catheter" in claim 19 is
readable in different ways and needs to be clarified. In a first
interpretation, the tab is extending from the cylinder with the tab
being located a small distance in a direction orthogonal from the
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Application 10/857,427

catheter. In a second interpretation, the cylinder has a tab with the tab
extending a small distance in a direction orthogonal to the catheter
from the surface of the cylinder. If the second interpretation is used,
another issue arises with respect to the limitation "in a direction
orthogonal to the catheter" because that as the tab rotates during
actuation, the angle the tab makes with respect to the catheter changes
and is therefore deviating from a direction orthogonal to the catheter.

MC disputes that the “in a direction orthogonal to the catheter”
limitation renders the claim indefinite within the meaning of 35 U.S.C.
§ 112, second paragraph. We agree with MC.
The limitation of claim 19 that the tab is extending “in a direction
orthogonal to the catheter” defines the direction of the extension in relation
to the catheter, i.e. orthogonal to the catheter. As noted above, the Examiner
found that the limitation has two defined interpretations. Rather than
suggesting that the limitation is indefinite, that finding provides that the
limitation simply has a scope that is broad enough to encompass two
embodiments. Breadth in scope does not equal indefiniteness. In re Miller,
441 F.2d 689, 693 (CCPA 1971).
In the above-quoted statements, the Examiner justifies the
indefiniteness rejection based on the “in a direction orthogonal to the
catheter” limitation by describing a situation where the tab extension
deviates from the orthogonal direction. That is not a matter of
indefiniteness. The claim calls for the tab to extend “in a direction
orthogonal to the catheter.” That limitation clearly encompasses tabs that
extend in a direction orthogonal to the catheter and excludes those where the
extension of the tab deviates or is not in a direction orthogonal to the
catheter. The limitation does not render the claim indefinite.

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Application 10/857,427

The rejection of claim 27 as indefinite
Claim 27 depends from claim 17 and is indefinite for the same reasons
claim 17 is indefinite. Furthermore, claim 27 was also separately rejected
under 35 U.S.C. § 112, second paragraph as indefinite. Claim 27 introduces
the additional limitations (Claims App’x 12:23 to 13:2):
wherein the cylinder further comprises a manually-engageable [sic]
protrusion disposed on the first end of the cylinder and extending a
small distance in a direction orthogonal to the catheter, and wherein
the protrusion is sized to allow a user to grasp it to operate the
cylinder between the open position and the closed position.

For reasons similar to those for claim 19, the Examiner based the
indefiniteness rejection of claim 27 on the limitations relating to “a small
distance” and “in a direction orthogonal to the catheter.”
We again consider first the “small distance” requirement. As with
claim 19, the Examiner also found the term “a small distance” in claim 27 to
be unclear and stated “[t]he term ‘small’ is a relative term and needs to be
fully defined with respect to the distance as used in claim 27.” (Ans. 9:20-
21.)
MC argues (App. Br. 5:11-14):
…the remainder of the claim gives the clear meaning to “a small
distance”: “wherein the protrusion is sized to allow a user to grasp it
to operate the cylinder between the open position and the closed
position”, i.e., a distance only large enough to enable manual
engagement of the protrusion for actuation/rotation thereof.

MC urges that the “small distance” of the protrusion’s extension is
limited to one that is “only large enough” to be grasped and operated by a
user. However, the claim does describe a protrusion extension that is “only
large enough” as alleged. The claim calls for a protrusion that extends a
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Application 10/857,427

small distance and is sized to allow a user to grasp and operate it. There is
nothing either explicit or intrinsic to the “sized” limitation that provides an
objective standard for measuring the claimed “small distance.” MC does not
explain why the sizing of the protrusion to be grasped and operated in the
manner recited sets an upper bound for the small distance of the protrusion’s
extension, i.e. one that is “only large enough.” A protrusion that is some
size larger than “large enough” is also sized to allow a user to grasp it in the
manner claimed. Would the extension of that larger sized protrusion still be
considered a “small distance?” MC does not point to either a portion of the
specification or any declaration evidence that establishes an objective
standard for determining the meaning of “small.” Without an objective
standard for the meaning of “small,” the scope of the claim 27 is indefinite.
With regard to the limitation in claim 27 of “in a direction orthogonal
to the catheter,” for similar reasons as those discussed above for claim 19,
we do not agree with the Examiner that it renders the claim indefinite. In
claim 27, the direction of the extension of the protrusion is clearly indicated
as orthogonal to the catheter.
We sustain the indefiniteness rejection of claims 17-21 and 25-28
under 35 U.S.C. § 112, second paragraph.
Rejections over prior art
The Examiner rejected independent claim 17 and dependent claims
18-21 and 25-28 as unpatentable over prior art. As discussed above, we
sustain the indefiniteness rejection of claims 17-21 and 25-28. The analysis
of a claim rejection based on prior art should not be performed where it is
necessary to engage in speculation as to the meaning of claim terms and
assumptions as to the scope of a claim. See In re Steele, 305 F.2d at 862.
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Application 10/857,427

Accordingly, we do not reach the merits of the rejection of claims 17-21 and
25-28 over prior art.

D. Conclusion
The rejection of claims 17-21 and 25-28 under 35 U.S.C. § 112,
second paragraph is affirmed.
We do not reach the merits of the rejection of claims 17-21, 25, 27,
and 28 under 35 U.S.C. § 102(b) as anticipated by Manska, and we do not
reach the merits of the rejection of claims 26 under 35 U.S.C. § 103(a) as
unpatentable over Manska and Humbert.
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

SD

Anton P. Ness
FOX ROTHSCHILD LLP
Blue Bell
2000 Market Street
Tenth Floor
Philadelphia, PA 19103

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