Ex Parte Ahmed

Board of Patent Appeals and Interferences

Apr 13, 2012

11925418 (B.P.A.I. Apr. 13, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/925,418 10/26/2007 A. Mateen Ahmed 9299a 2948
21905 7590 04/16/2012
CONNORS ASSOCIATESpc
13421 Danbury Lane #135i
SEAL BEACH, CA 90740
EXAMINER
TREYGER, ILYA Y
ART UNIT PAPER NUMBER
3761
MAIL DATE DELIVERY MODE
04/16/2012 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 A. MATEEN AHMED
__________

Appeal 2011-000676
Application 11/925,418
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a system
for relieving fluid pressure from a body cavity. The Examiner rejected the
claims as anticipated and as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm-in-part.

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Statement of the Case
Background
“[T]his invention comprises a portable system for relieving fluid
pressure from a body cavity of a patient. It includes a drainage catheter for
insertion into the body cavity” (Spec. 2, l. 29 to 3, l. 2).
The Claims
Claims 58-71 are on appeal. Claims 58 and 61 are representative and
read as follows:
58. A system for relieving fluid pressure from a body
cavity of a patient comprising
a drainage catheter for insertion into the body
cavity, said catheter having an outlet end and an inlet end
including at least one drainage aperture, said inlet end
adapted to be inserted into the cavity at a predetermined
position within the cavity with said outlet end extending
from the body cavity,
a one-way pressure-responsive valve that opens
when the differential between atmospheric pressure and
the pressure within the body cavity exceeds a
predetermined difference and closes when said
differential is less than said predetermined difference,
said valve having an outlet and an inlet in fluid
communication with the outlet end of the drainage
catheter to permit pressure-regulated flow of fluid from
the body cavity through the catheter, said outlet of the
pressure-responsive valve being at substantially
atmospheric pressure and the inlet of the pressure-
responsive valve being at the pressure within the body
cavity,
a reservoir having an inlet in fluid communication
with the outlet of the pressure-responsive valve so as to
receive the fluid that passes therethrough, and
a mounting member adapted to be detachably
coupled to the patient nearby the body cavity,
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said drainage catheter, pressure-responsive valve,
and reservoir being configured to be attached to the
mounting member in predetermined fixed positions
relative to each other where the inlet end of the drainage
catheter, the inlet and outlet of the pressure-responsive
valve, and the inlet of the reservoir all lie in substantially
the same plane so essentially no hydrostatic pressure
affects the flow of fluid from the cavity of the patient
even with changing positions of the patient.

61. The system of Claim 58 where the body cavity is
within the cranium and the mounting member comprises
a headband adapted to be wrapped around the head of the
patient.

The issues
A. The Examiner rejected claims 58 and 71 under 35 U.S.C. § 102(b) as
anticipated by Krueger1 (Ans. 3-6).
B. The Examiner rejected claim 60 under 35 U.S.C. § 103(a) as obvious
over Krueger (Ans. 6-7).
C. The Examiner rejected claim 59 under 35 U.S.C. § 103(a) as obvious
over Krueger and Kirsch2 (Ans. 7-8).
D. The Examiner rejected claims 61-70 under 35 U.S.C. § 103(a) as
obvious over Krueger and Bunegin3 (Ans. 8-12).

1 Krueger et al., US 5,772,625, issued Jun. 30, 1998.
2 Kirsch et al., US 5,385,541, issued Jan. 31, 1995.
3 Bunegin et al., US 4,995,401, issued Feb. 26, 1991.
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A. 35 U.S.C. § 102(b) over Krueger
The Examiner finds that “Krueger discloses an external drainage
assembly 10 (Fig. 1) for a surgical patient that is able to mount to an IV
pole, making it portable” (Ans. 3). The Examiner finds that the “drainage
assembly 10 (Fig. 1) comprises a catheter 11 (Fig. 1) inserted into the head
or cranium 12 (Fig. 1) of the patient. The catheter is connected to a stopcock
valve 15 (Fig. 1), tubing lines 20, 23 (Fig. 1), and a pressure-activated one-
way valve 24” (Ans. 3-4). The Examiner finds that “[d]ownstream of the
valve 24 (Fig. 1), tubing 25 (Fig. 1) leads to burette or reservoir 55 (Fig.1)
for collection of fluid from the patient. The entire assembly is attached to an
IV pole 31 (Fig. 30) via mounting strap or member 98” (Ans. 4).
The Examiner finds that the “drainage apparatus is placed in a
position relative to the patient’s head such that the apparatus is leveled with
the patient’s Foramen of Monro” (Ans. 4). The Examiner finds that the
“recitation with respect to the manner in which a claimed apparatus is
intended to be employed does not differentiate the claimed apparatus from a
prior art apparatus satisfying the claimed structural limitations” (Ans. 4).
Appellant contends that the “structure called for in Claims 58 and 71
is absent in Krueger et al. Krueger has moveable components that required
adjustment relative to each other each time the patient moves. The
components of Krueger are not in fixed positions” (App. Br. 16). Appellant
contends that “Krueger has a drain bag 81 that is not ‘nearby the body
cavity.’ Their bag is not adapted to be coupled to the body of the patient as is
Applicant’s structure” (App. Br. 16).
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Appellant contends that “this specific ‘predetermined fixed position’
of a mounted reservoir bag, allowing for a patient to change positions
regardless of the reservoir bag’s position, was either overlooked or factually
misinterpreted by the Examiner” (App. Br. 17-18). Appellant contends that
“the manner of operating the apparatus differentiates claim 58 from the prior
art” (App. Br. 22).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Krueger anticipates claims 58
and 71?
Findings of Fact
1. Figure 1 of Krueger is reproduced below:

“FIG. 1 is an elevational view of the external ventricle drainage assembly
attached to a patient” (Krueger, col. 2, ll. 36-37).
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2. Krueger teaches “an external drainage assembly 10 for a
surgical patient including tubing 11 which is attached to a suitable catheter
in the form of a ventricle drain, the catheter being attached to the head 12 of
the patient by a suture tab 13 to prevent relative movement between the
catheter and patient” (Krueger, col. 3, ll. 62-67).
3. Krueger teaches that
beyond the exit of the catheter from the patient’s scalp is a
four-way patient line stopcock 15 . . . which provides a
catheter port 16, an ICP support panel and upper portion of
the drainage bag showing monitoring port 17 and a Y-
connector port 19 controlled by a handle 18. This valve is
followed by a length of tubing 20 terminating in a Y-
connector, needle-less valve assembly 21 having a sampling
site 22.

(Krueger, col. 4, ll. 8-14).
4. Krueger teaches that “[t]ubing 23 downstream of the valve
assembly contains a low-pressure, one-way valve 24 to help prevent reflux
of fluid into the ventricles or lumbar subarachnoid space” (Krueger, col. 4,
ll. 14-17).
5. Krueger teaches “a collection burette 55 mounted on a support
panel 27 for collection and measurement of the fluid collected from the
patient” (Krueger, col. 4, ll. 19-21).
6. Krueger teaches “a level/tape measuring device 105 utilized by
a surgical nurse or other technician to determine the positioning of the
support panel 27 relative to the patient during surgery” (Krueger, col. 6, ll.
4-8).

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7. Figure 5 of Krueger is reproduced below:

“FIG. 5 is a cross sectional view . . . showing the panel attached to the IV
pole” (Krueger, col. 2, ll. 45-46).
8. Krueger teaches that:
The support panel 27 is suspended from the IV pole 31 via
the suspension cord 29 and the drainage system height is
positioned via the cord lock 30. If the panel is directly
connected to the IV pole 31, the pole mount clamps 33 on
the back of the support panel 27 are pushed onto the IV pole
and secured in place by the “Velcro” connection of straps 35
. . . The straps should be securely tightened or the support
panel may slip.

(Krueger, col. 6, ll. 22-29).
9. Krueger teaches to “ensure that the system has been properly
mounted and leveled with the zero point of the reference scale 42 aligned to
the patient’s Foramen of Monro” (Krueger, col. 6, ll. 32-35).
Principles of Law
It is well settled that during examination, the PTO must interpret
terms in a claim using “the broadest reasonable meaning of the words in
their ordinary usage as they would be understood by one of ordinary skill in
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the art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
Analysis
Claim interpretation
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope cannot be compared to the
prior art. In this case, the limitation in claim 58 at issue is the requirement
that the system components are “configured to be attached to the mounting
member in predetermined fixed positions relative to each other” (Claim 58).
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. Therefore, we first turn to the
Specification to determine whether the phrase “predetermined fixed
position” has any specified definition.
The Specification teaches, regarding the Krueger device, that “the
height of the fluid column 30 regulates the pressure differential through the
drainage catheter 22” (Spec. 11, ll. 15-17). The Specification further teaches
that for the Krueger device, “a nurse or attendant must move the column
each time the patient wishes to move for example for a seated to a lying
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posture or vice versa” (Spec. 11, ll. 24-26). The Specification provides no
specific definition of “predetermined fixed position”.
In light of the Specification, the “predetermined fixed position”
requirement of claim 58 is reasonably interpreted as simply requiring the
components to be in fixed position relative to one another for some period of
time. No particular structures or forms of fixation and no particular amounts
of time are required by the phrase. See In re Zletz, 893 F.2d 319, 322 (Fed.
Cir. 1989) (“[D]uring patent prosecution when claims can be amended,
ambiguities should be recognized, scope and breadth of language explored,
and clarification imposed.”)
Anticipation
Krueger teaches a drainage catheter with outlet and inlet ends (FF 1-3)
connected to a one-way pressure-responsive valve which permits pressure-
regulated flow of fluid from the body cavity through the catheter (FF 4).
Krueger teaches a reservoir in fluid communication with the valve (FF 5)
connected to a mounting member that is coupled to the patient (FF 1, 7, 8).
Krueger teaches that the drainage catheter, pressure-responsive valve
and reservoir are attached to the mounting member in a particular position
relative to the patient (FF 1, 8) where “the system has been properly
mounted and leveled with the zero point of the reference scale 42 aligned to
the patient’s Foramen of Monro” (Krueger, col. 6, ll. 32-35; FF 11).
Appellant contends that the “structure called for in Claims 58 and 71
is absent in Krueger et al . Krueger has moveable components that required
adjustment relative to each other each time the patient moves. The
components of Krueger are not in fixed positions” (App. Br. 16). Appellant
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contends that “Krueger has a drain bag 81 that is not ‘nearby the body
cavity.’ Their bag is not adapted to be coupled to the body of the patient as is
Applicant’s structure” (App. Br. 16).
We are not persuaded. There is no requirement in claim 58 that the
components are not moveable. Appellant does not identify a teaching in
Krueger that the components necessarily require adjustment for every
movement of the patient. Further, the components of Krueger are in fixed
positions when attached to the mounting member. As Krueger teaches “[i]f
the panel is directly connected to the IV pole 31, the pole mount clamps 33
on the back of the support panel 27 are pushed onto the IV pole and secured
in place by the ‘Velcro’connection of straps 35” (Krueger, col. 6, ll. 22-29;
FF 8). The use of the phrase “secured in place” and “securely tightened”
clarifies that these components are reasonably interpreted as being in a fixed
position.
Appellant contends that “this specific ‘predetermined fixed position’
of a mounted reservoir bag, allowing for a patient to change positions
regardless of the reservoir bag’s position, was either overlooked or factually
misinterpreted by the Examiner” (App. Br. 17-18). Appellant contends that
“the manner of operating the apparatus differentiates claim 58 from the prior
art” (App. Br. 22).
We are not persuaded. Appellant’s argument that the “manner of
operating the apparatus differentiates claim 58 from the prior art” highlights
the flaw in the argument. It must be the structure and not simply the mode
of operation or intended use which differentiates a product claim. See In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (“It is well settled that the
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recitation of a new intended use for an old product does not make a claim to
that old product patentable.”) In addition, if the patient is not allowed to
change positions, as Appellant implicitly asserts, then the apparatus
necessarily remains in a predetermined fixed position relative to the
unmoving patient, as well.
Appellant also relies on the Ahmed Declaration4 to overcome the
anticipation rejection. The Ahmed Declaration contends that “a nurse need
not constantly monitor the patient and does not need to make any
adjustments if the patient moves” (Ahmed Dec. 4 ¶ 5). The Ahmed
Declaration contends that “it is the bag position AND the preset open/close
pressure setting of the valve 24 and not solely the valve that controls the
opening and closing of the valve 24” (Ahmed Dec 5 ¶ 6).
We are not persuaded. These represent functional limitations on how
the system is used and not structural limitations in the claims. There is no
requirement in either claim 58 or 71 that either a nurse not monitor a patient
and adjust the device or that the pressure setting of the valve solely controls
the opening and closing of the valve. “[L]imitations are not to be read into
the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184
(Fed. Cir. 1993).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Krueger anticipates claims 58 and 71.

4 Declaration of A. Mateen Ahmed, filed Mar. 8, 2010.
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B. and C. 35 U.S.C. § 103(a) over Krueger or over Krueger and Kirsch
The Examiner finds that “Krueger discloses the invention discussed
above, but does not expressly disclose the particular parameter of the
distance range between the outlet of the valve and the inlet of the reservoir”
(Ans. 6). The Examiner finds it obvious “to make the distance range
between the outlet of the valve and the inlet of the reservoir depending of the
portability grade required, since discovering the optimum or workable
ranges involves only routine skill in the art” (Ans. 7). The Examiner also
finds it obvious to “use the slit valve disclosed by Kirsch as the pressure
valve disclosed by Krueger for providing pressure-controlled treatment of
hydrocephalus” (Ans. 8).
Appellant contends that “combining Krueger and Kirsch et al is
irrelevant. It is not the type of control valve that is important. It is the fixed
positions of the components as called for in system of Claims 58 through 71
that is important to eliminate the effects of gravity” (App. Br. 22).
We find that the Examiner has the better position. Having already
found that Krueger anticipates claim 58, we agree with the Examiner that
selecting the optimum distance between the outlet of the valve and inlet of
the reservoir represents routine optimization. See In re Aller, 220 F.2d 454,
456 (CCPA 1955) (“[W]here the general conditions of a claim are disclosed
in the prior art, it is not inventive to discover the optimum or workable
ranges by routine experimentation.”) We also agree that it would have been
obvious to substitute the equivalent valve of Kirsch for the valve of Krueger.
See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (“If a person of
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ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.”)
D. 35 U.S.C. § 103(a) over Krueger and Bunegin
The Examiner finds that “Krueger discloses the claimed invention
discussed above, but does not expressly disclose the mounting member
comprising a headband” (Ans. 8). The Examiner finds that “Bunegin
discloses a device for measuring intracranial pressure, which, like a
cerebrospinal shunt system, must be mounted on a patient’s head. Bunegin's
pressure monitor system is affixed to a harness” (Ans. 8).
The Examiner finds it obvious to “use a headband and head-mounting
system as disclosed by Bunegin to replace or augment the adjustable
mounting strap disclosed by Krueger in order to maintain the position of a
cranium-based medical device level with (as disclosed by Krueger) and on
the patient’s head, as taught by Bunegin” (Ans. 9).
Appellant contends that “[n]either Krueger nor Bunegin recognize, or
in any way suggest, that a fixed structural relationship between the various
inlets and outlets within the system is of any consequence” (App. Br. 33).
Appellant contends that “neither Krueger nor Bunegin discuss that changes
in the internal hydrostatic pressure of the system might endanger a patient”
(App. Br. 33).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Krueger and Bunegin render claims
61 to 70 obvious?

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Findings of Fact
10. Bunegin teaches “a device suitable for use in an anterior
fontanelle pressure sensing system. This device allows one to make rapid
and accurate measurements of the anterior fontanelle pressure of an infant
using a noninvasive technique” (Bunegin, col. 1, ll. 7-11).
11. Bunegin teaches that in a “preferred embodiment, the device is
affixed to the cranium with harness 41. Preferably, the harness has a central
device retaining ring 42 made of a flexible plastic material and adjustable
elastic straps 43 attachable to an adjustable VELCRO ® headband 44 which
can be tightened or loosened to accommodate the size of the cranium of any
particular infant” (Bunegin, col. 7, ll. 30-36).
12. Figure 5 of Bunegin is reproduced below:

“FIG. 5-illustrates an assembled anterior fontanelle monitor (AFM)
monitoring system and also illustrates a preferred manner of attaching the
device to the cranium” (Bunegin, col. 5, ll. 20-23).

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Principles of Law
“Rejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
While we conclude that the Examiner correctly finds that Krueger
anticipates claim 58, and we agree that Bunegin teaches mounting a device
for measuring intracranial pressure on a patient’s head (FF 10-12), we are
not persuaded that it would have been obvious to modify Krueger’s device
to use the head mounting system of Bunegin.
The head mounting system of Bunegin is entirely focused on
measuring pressure in the fontanelle (FF 8). There is no connection between
Bunegin and the drainage system of Krueger. There is also no teaching or
suggestion in Krueger that the drainage support panel could be directly
attached to a patient’s head, but rather Krueger teaches that the support panel
is suspended from an IV pole using straps which may be securely tightened
(FF 8).
We find that the Examiner’s reason to combine, to “maintain the
position of a cranium-based medical device level with (as disclosed by
Krueger) and on the patient’s head, as taught by Bunegin” (Ans. 9)
represents impermissible hindsight. We are not persuaded that an ordinary
artisan, considering Krueger and Bunegin while inventing, would have
reasonably considered incorporating the headband of Bunegin to hold the
drainage catheter assembly of Krueger in place, since the prior art did not
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recognize the idea of placing the complete drainage assembly onto the
patient’s head.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Krueger and Bunegin render claims 61 to 70 obvious.
SUMMARY
In summary, we affirm the rejection of claims 58 and 71 under 35
U.S.C. § 102(b) as anticipated by Krueger.
We affirm the rejection of claim 60 under 35 U.S.C. § 103(a) as
obvious over Krueger.
We affirm the rejection of claim 59 under 35 U.S.C. § 103(a) as
obvious over Krueger and Kirsch.
We reverse the rejection of claims 61-70 under 35 U.S.C. § 103(a) as
obvious over Krueger and Bunegin.

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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