Ex Parte Smith

Board of Patent Appeals and Interferences

Mar 27, 2012

11553780 (B.P.A.I. Mar. 27, 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.
11/553,780 10/27/2006 David Smith 1951-0001 4320
28078 7590 03/27/2012
MAGINOT, MOORE & BECK, LLP
CHASE TOWER
111 MONUMENT CIRCLE
SUITE 3250
INDIANAPOLIS, IN 46204
EXAMINER
HANRAHAN, BENEDICT L
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
03/27/2012 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 DAVID SMITH
__________

Appeal 2011-000746
Application 11/553,780
Technology Center 3700
__________

Before LORA M. GREEN, STEPHEN WALSH, and
ERICA A. FRANKLIN, 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 indwelling endourethral drainage catheter. The Patent
Examiner rejected the claims for obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We affirm-in-part.
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STATEMENT OF THE CASE
Claims 1-5 and 7-12 are on appeal. Claim 1 is representative and
reads as follows (letters in brackets added by the Board for reference
purposes):
1. An [a] indwelling endourethral drainage catheter comprising:
[b] a tubular distal portion having a distal end adapted to be situated
outside the patient when the drainage catheter is indwelling, said distal
portion defining a distal lumen extending along the length thereof;
[c] a spiral proximal portion attached to said distal portion, said
proximal portion defining a proximal lumen in communication with said
distal lumen and further defining a helical outer channel along the length of
said spiral proximal portion, said outer channel in fluid communication with
said proximal lumen; and
[d] an anchor assembly for anchoring the catheter within the urethra,
said anchor assembly adapted to be disposed externally of the bladder and
urethra.

The Examiner rejected the claims as follows:
 claims 1-3, 5, and 7-12 under 35 U.S.C. § 103(a) as unpatentable over
Von Oepen
1
and Glassman;
2
and
 claim 4 under 35 U.S.C. § 103(a) as unpatentable over Von Oepen,
Glassman, and Tihon.
3

OBVIOUSNESS
The Issues
The Examiner‟s position is that Von Oepen described a catheter
having all the elements comprising Appellant‟s catheter but for the anchor

1
Randolf Von Oepen, US 2005/0267442 A1, published Dec. 1, 2005.
2
Jacob A. Glassman, US 4,810,247, issued March 7, 1989.
3
Claude Tihon, US 5,738,654, issued April 14, 1998.
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assembly defined in claim 1, part [d]. (Ans. 4, citing Van Oepen‟s Figures
and text.) The Examiner found that Glassman described a corresponding
anchor assembly attached to an indwelling endourethral drainage catheter.
(Id., citing Glassman‟s Figures.) The Examiner concluded that it would
have been obvious to modify Van Oepen‟s catheter with Glassman‟s anchor
assembly “in order to restrain the catheter from riding up into the urethral
canal and into the bladder. Doing so would prevent careless handling of the
catheter.” (Id.)
Appellant first disputes the Examiner‟s finding that Von Oepen
described all the elements but for the anchor assembly. (App. Br. 1.)
Appellant contends that (i) the terms distal and proximal distinguish the
claimed catheter from Von Oepen‟s; (ii) the Von Oepen “device is an „over
the wire‟ catheter primarily for introduction into the cardiovascular system;”
(iii) “while it is important that the „tubular distal portion‟ of Applicant‟s
claimed invention reside outside the patient, it is equally important, and
necessary, for the tubular portion 130 of Von Oepen reside inside the
patient;” (iv) the „“distal‟ lumen of the Von Oepen device (hypotube 177) is
directly connected to inflation lumen 174” and “inflation lumen 174 within
the catheter portion disposed within the patient cannot, by necessity, open to
the patient to drain any body fluids;” and (v) “the Von Oepen device does
not include a helical outer channel that is in communication with the
„proximal lumen‟ as that term is defined in Applicant's claim 1.” (Id. at 1-
4.)
Appellant next disputes that the references were properly combined.
According to Appellant, “[t]he rejection of all of the pending claims is
premised upon the Examiner's contention that it would be obvious to
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incorporate the „penile cup‟ disclosed in Glassman with the „over the wire‟
cardiovascular catheter of Von Oepen.” (Id. at 9.) Appellant contends that
(A) Von Oepen‟s disclosure is not relevant to the field of endourethral
drainage catheters (id. at 9-12); (B) there is no rational basis for combining
Glassman with Von Oepen (id. at 12-16); and (C) Glassman did not disclose
an “anchor assembly” (id. at 16-17). Appellant thus concludes that “this
combination of references fails to establish a prima facie case for
obviousness of claim 1 or its dependent claims.” (Id. at 18.)

Findings of Fact
1. We adopt the Examiner‟s findings of fact as set out in the Grounds of
Rejection and Response to Argument sections of the Answer.
2. Von Oepen‟s Abstract reads (emphasis added):
The invention includes a catheter having an elongate main body
portion and a distal body portion. The elongate main body portion has
a proximal end and a distal end. The main body portion further
includes a coil having at least one complete turn about a central axis,
the coil defining a passage along the central axis. The elongate distal
body portion extends from the distal end of the main body portion. In
accordance with a further aspect of the invention, the distal body
portion has a proximal end and a distal end and can include a
guidewire lumen defined along at least a portion of a length between
the distal end and the proximal end of the distal body portion. The
guidewire lumen has a distal guidewire port and a proximal guidewire
port defined in communication therewith. The passage can be in fluid
communication with an exterior of the catheter.

3. Von Oepen disclosed that its “invention relates to a catheter for
treating a luminal system of a patient.” (Von Oepen, ¶ 3.)
4. Van Oepen described its catheter in structural and fluid
communication terms. (Id. at ¶¶ 9-15.)
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5. In an option, Van Oepen stated that “the catheter can further include
an elongate guide member.” (Id. at ¶ 16.)
6. Von Oepen stated that “[t]he devices and methods presented herein
may be used for treating the luminal systems of a patient. The present
invention is particularly suited for treatment of the cardiovascular
system of a patient.” (Id. at ¶ 38.)
7. Von Oepen stated that “[i]n accordance with another aspect of the
invention, the distal portion can include a device for performing an
interventional procedure.” (Id. at ¶ 45.)
8. Von Oepen‟s Figure 1 is reproduced here:

{FIG. 1 is a partial side view of a first representative embodiment of
[Von Oepen‟s] catheter having a main body portion with a coil-
defined guidewire passage in accordance with the present invention.
(Id. at ¶ 24.)}
9. Appellant‟s Specification states:
The present invention contemplates an indwelling urinary
drainage catheter 10 shown in FIG. 2 that includes a proximal tip 12
sized and configured to pass through the bladder sphincter into the
bladder. The proximal tip 12 is preferably bullet-nosed or rounded to
facilitate passage through the urethra and to minimize the potential
for damage to the delicate tissues within the urethra. As shown in
FIG. 2, the proximal tip does not incorporate any retention element,
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such as the balloon tip of the typical Foley catheter. Although some
form of retention element may be included in the proximal tip 12, the
present invention contemplates anchoring of the catheter 10 outside
the patient's body, as explained in more detail herein. In addition, the
tip may be provided with openings for fluid flow, although the present
invention does not require openings of this sort. This proximal tip may
be radio-opaque for visibility by x-ray or other imaging source to
verify the position of the tip. In a specific embodiment, the proximal
tip 12 may have a length of about 6mm.

(Spec. 12, ¶ 26, emphasis added.)
10. Glassman described its element 27 as follows:
Such cup, irrespective of its exact material structure, will be freely
slidable over the catheter 11 before insertion of the catheter into the
urethra 12. To this end the cup will have a constrictable end orifice 24
at its primary end 27, adapted to receive any size catheter snugly
therethrough. The cup can then be shifted upwardly along the catheter
to enclose the penile head 25, the corona 16 and the penile shaft 26.
Preferably, the orifice 24 will be formed within the tubular resilient
ferrule 27 to insure a stretch fit liquid-tight joining of the penile-cup
and catheter 11.

(Glassman, col. 3, ll. 3-13.)
11. Ordinary meanings for the word “tip” include:
1. The end of a pointed or projecting object.
2. A piece or an attachment, such as a cap or ferrule, meant to be fitted
to the end of something else: the barbed tip of a harpoon.
(The Free Dictionary by Farlex, www.thefreedictionary.com/tip, last
visited March 22, 2012.)

Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
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KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[I]f a technique
has been used to improve one device, and a person of ordinary skill in the art
would recognize that it would improve similar devices in the same way,
using the technique is obvious unless its actual application is beyond his or
her skill.” KSR, 550 U.S. at 417. “One of the ways in which a patent‟s
subject matter can be proved obvious is by noting that there existed at the
time of invention a known problem for which there was an obvious solution
encompassed by the patent‟s claims.” Id. at 419-420.
Two criteria have evolved for determining whether prior art is
analogous: (1) whether the art is from the same field of endeavor, regardless
of the problem addressed, and (2) if the reference is not within the field of
the inventor‟s endeavor, whether the reference still is reasonably pertinent to
the particular problem with which the inventor is involved.
In re Clay, 966 F.2d 656, 658-9 (Fed. Cir. 1992).

Analysis
I. Claim 1
Von Oepen described its invention as a catheter for use in body
lumens generally. (FF 3, 4, 6.) Von Oepen did not limit the use of its
catheter to the cardiovascular system, but only said the catheter was
“particularly suited” to use in the cardiovascular system. (FF 6.) Von
Oepen did not describe its catheter as necessarily including a guidewire.
Instead, use with a guidewire was explicitly described as an additional
embodiment. (FF 5.) Von Oepen did not describe its catheter as necessarily
including an inflation feature. Instead, that option was explicitly described
as an additional embodiment. (FF 7.) Based on the evidence, we find
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Appellant‟s arguments unpersuasive because they contradict Von Oepen‟s
explicit teachings.
Von Oepen described its catheter as generally useful in body lumens,
not limited to blood vessel lumens. Appellant focuses many of its arguments
on which end would be proximal or distal if Von Oepen‟s catheter were
inserted into a blood vessel, and which end would be proximal or distal if
Von Oepen‟s catheter were inserted into a urethra. We agree with the
Examiner‟s response to those arguments. Essentially, a catheter is a
catheter, and labeling the proximal and distal ends relative to their positions
when in use for a particular application does not create a structural
difference from one catheter to another. When the catheter is on the shelf
before insertion into either a urethra or a blood vessel, proximal and distal
would also fail to define structural differences because they relate to
alternate future placements, not structure. For the reasons explained by the
Examiner, we find that Von Oepen‟s catheter meets claim 1‟s limitations for
the tubular distal portion and the spiral proximal portion.
We agree with Appellant‟s contention that Von Oepen did not say its
catheter was an “indwelling endourethral drainage catheter.” However,
because Von Oepen‟s catheter has the same tubular and spiral portions
defined in claim 1, it is an indwelling endourethral drainage catheter whether
Von Oepen called it that or not.
Appellant also argues that because Von Oepen‟s catheter had a
guidewire and had an inflation feature, it could not have been used as an
indwelling endourethral drainage catheter. This argument is unpersuasive
because it treats Von Oepen‟s general use disclosure as limited to Von
Oepen‟s optional embodiments. (FF 5, 7.)
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Appellant argues that it was improper to combine these references.
We disagree. The three references are all in the field of catheters and were
therefore properly combinable. See Clay, 966 F.2d at 658-9. Von Oepen
provided a catheter for general use in body lumens, and there is no dispute
that the urethra is a body lumen. A person of ordinary skill in the catheter
art would therefore have considered Von Oepen‟s catheter to be available for
use in any body lumen, including the urethra. Finally, we find Appellant‟s
contention that Glassman did not disclose an “anchor assembly”
unpersuasive because it is contrary to the evidence. There is no requirement
that a prior art reference such as Glassman must use the exact terms recited
in a claim to conclude that the claim would have been obvious.
Claims 2, 5, 7-9, and 12 have not been argued separately and therefore
stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

II. Claim 3
The Issue
Appellant contends:
Claim 3 recites the proximal portion - i.e., the portion within the
patient – as including a tip. In keeping with Applicant's specification,
the term tip means more than merely the “end” of the proximal
portion. The tip is shown in FIG. 2 as being solid and rounded to
facilitate introduction into the urethra. See, Specification, p. 12, ll. 11-
16.

(App. Br. 5.) Appellant contends that as both ends of Von Oepen‟s catheter
terminate in an open tube, Van Oepen‟s device does not have a “tip” as
Appellant uses the term. (Id.)
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The Examiner responds that claim 3 is broad, and there is no need “to
import further structural features, which have not been claimed and only
shown in the Specification, into the claim.” (Ans. 10.)
Appellant replies that “the Examiner has provided no evidence that
„end‟ is otherwise known as a tip” (Reply Br. 3), and the Examiner applied
“an improperly broad definition of the word „tip‟ that is contrary to the
understanding in the art” (id. at 4).
Analysis
According to Appellant‟s Specification, the catheter “includes a
proximal tip 12 sized and configured to pass through the bladder sphincter
into the bladder,” “preferably bullet-nosed or rounded to facilitate passage.”
(FF 9.) This language does not disclaim the kind of tip shown by Von
Oepen, which is intended for insertion into body lumens. Indicating a
preference for a rounded tip is not an express disclaimer of other tips.
“Absent claim language carrying a narrow meaning, the PTO should only
limit the claim based on the specification or prosecution history when those
sources expressly disclaim the broader definition.” In re Bigio, 381 F.3d
1320, 1325 (Fed. Cir. 2004).
The Specification also states that “the present invention contemplates
an indwelling urinary drainage catheter 10 shown in FIG. 2.” (FF 9.)
Contemplation of an example does not limit claim 3‟s tip to the one shown
in Figure 2. The ordinary meaning of tip includes merely the end of a
slender object. (FF 7.) Claim 3 does not limit “tip” in such a way as to
distinguish the end or tip of Von Oepen‟s catheter, and neither does the
Specification disclaim the ordinary meaning of claim. Accordingly, we
agree with the Examiner‟s conclusion that a broad meaning applies.
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III. Claim 4
The Issue
The Examiner found that Van Oepen‟s catheter did not have a blunt
tip as claimed, but that Tihon disclosed a blunt tip adapted for insertion
through a patient‟s urethra. (Ans. 8, citing Tihon‟s Figure 2.) The Examiner
concluded it would have been obvious to modify the tip on Van Oepen‟s
catheter by making it blunt “in order to preclude the flow of body fluids
when the catheter was only in the urethra and had not yet reached the
bladder. Doing so would prevent drainage of urine until insertion of the
device was complete.” (Id.)
Appellant contends that adding a tip or a closed blunt tip would
“destroy the functionality of the Von Oepen cardiovascular catheter. The
end 134 must be open to permit passage of a guidewire, hence the provision
of the guidewire lumen 136. See, Von Oepen, para. 0050, ll. 6-11. Likewise,
the end 152 must be open to provide access to the inflation lumen 174, 174'
through the hypotube 177. See, Von Oepen, para. 0053.” (App. Br. 6.)
Appellant argues that the rejection is not rational because the Van Oepen
device is not an indwelling urinary catheter, and because “it is well known
that bladder internal and external sphincters, not the urethra, control urine
passage from the bladder.” (Id. at 7.)
The Examiner responds that the fluid communication functionality of
Von Oepen‟s catheter would not be destroyed if Tihon‟s tip were added.
(Ans. 10.)
Appellant replies by reiterating its contention that Von Oepen did not
disclose an endourethral catheter but disclosed instead only a coronary rapid
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exchange catheter. (Reply Br. 4.) According to Appellant, “[i]t is only with
the use of hindsight that the Von Oepen coronary catheter can be envisioned
as an indwelling endourethral drainage catheter.” (Id. at 4.)
Analysis
We again reject Appellant‟s contention that Van Oepen disclosed only
a coronary because that contention is contrary to the evidence that Von
Oepen explicitly taught its catheter was broadly useful in body lumens in
general. The explicit evidence is that Von Oepen described its
cardiovascular rapid exchange catheter as one application, albeit a
particularly suitable one. Thus, combining Von Oepen‟s disclosure of a
catheter for use generally in body lumens with other references in the
catheter art, including Glassman and Tihon disclosures of indwelling
endourethral catheters, was appropriate. Each reference “must be read, not
in isolation, but for what it fairly teaches in combination with the prior art as
a whole.” In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986)
(citation omitted). Appellant‟s allegation of hindsight is unpersuasive
because it is based on reading on Von Oepen alone without considering what
it fairly teaches in combination with Glassman and Tihon.

IV. Claims 10 and 11
The Issue
The Examiner found that Glassman‟s ferrule 27 was a clamping
element that is an O-ring, and concluded “it would have been obvious to one
skilled in the art at the time the invention was made to have modified Von
Oepen, in view of Glassman, to include the clamping element mounted on
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the outer surface of the distal portion in order to insure a liquid tight joining
of the shroud and the catheter. Doing so would prevent leakage.” (Ans. 6-7.)
Appellant argues:
As is very apparent from Figs. 1-5, 8 and 9 of Glassman, the ferrule
27 is an integral part of the penile-cup 19 (or shroud in the language
of claim 1). It is the ferrule 27 that forms the “constrictable end
orifice” 24. See, Glassman, col. 3, ll. 5-13. The penile-cup cannot
encircle itself at its integral ferrule. There is simply no “clamping
element encircling” the Glassman ferrule 27, which is necessary to
meet the actual limitations of claim 10.

(App. Br. 8.) Appellant contends “[t]he same error was propagated to claim
11.” (Id.)
The Examiner responds, pointing to element 27 in Glassman‟s Figure
8 [sic, 9], and to columns 3 and 4. (Ans. 11.)
Appellant replies that Glassman‟s Figure 4 shows element 27 as an
integral part of shroud 19c, not as an O-ring. (Reply Br. 5.)
Analysis
The ordinary meaning of “ferrule” includes a ring placed around
something else, and would include O-rings. Although Glassman used the
word ferrule, what it labeled with that word is the “primary end” of the cup,
i.e., an integral, tubular portion of the cup. (FF 10.) What Glassman
described as a ferrule was something that could not “encircle” the shroud in
which it formed an integral portion; it was not a ring placed around
something else, and it was not an O-ring. The rejection of claims 10 and 11
must therefore be reversed.

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SUMMARY
We affirm the rejection of claims 1-3, 5, 7-9, and 12 under 35 U.S.C.
§ 103(a) as unpatentable over Von Oepen and Glassman.
We affirm the rejection of claim 4 under 35 U.S.C. § 103(a) as
unpatentable over Von Oepen, Glassman, and Tihon.
We reverse the rejection of claims 10 and 11 under 35 U.S.C. § 103(a)
as unpatentable over Von Oepen and Glassman.

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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