Ex Parte Radojicic

Patent Trial and Appeal Board

Mar 17, 2017

12228697 (P.T.A.B. Mar. 17, 2017)

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.
MR-1003 6931
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
12/228,697 08/16/2008
759036088
KANG LIM
3494 Camino Tassajara #444
Danville, CA 94506
Milan Radojicic
03/17/2017 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 PATENT TRIAL AND APPEAL BOARD
Ex parte MILAN RADOJICIC
Appeal 2015-006074
Application 12/228,697
Technology Center 3700
Before MICHAEL L. HOELTER, LYNNE H. BROWNE, and
BRENT M. DOUGAL, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Milan Radojicic (Appellant) appeals under 35 U.S.C. § 134 from the
rejection of claims 1—3, 5—9, 11—14, 16—22, 32, and 34. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
Appeal 2015-006074
Application 12/228,697
CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A spinal catheter comprising:
an elongate shaft having a distal end and a proximal end,
wherein the distal end is adapted for placement in a spinal fluid
pathway, epidural space, ventricle or cistern;
monitoring lumen connected to a monitoring port at a
distal end, wherein the monitoring port is a first port housing a
transducer, wherein the transducer determines pressure data in
the spinal fluid pathway, epidural space, ventricle or cistern;
an inlet lumen formed on the elongate shaft and connected
to an inlet port, wherein the inlet port is a second port;
an outlet lumen connected to an outlet port, wherein the
outlet port is a third port, wherein at least one of the inlet port
and the outlet port supplies infuses or exchanges fluid to establish
changes in volume; and
an I/O system configured to receive the pressure data and
generate impedance measurements based upon the relationship
between the changes in volume and the pressure data.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Cioanta US 2002/0082556 A1 June 27, 2002
Purdy US 2003/0097082 A1 May 22, 2003
Kucharczyk US 6,626,902 B1 Sept. 30, 2003
Scarborough US 2004/0193045 A1 Sept. 30, 2004
Reich US 2005/0020962 A1 Jan. 27, 2005
Neff US 2005/0171452 A1 Aug. 4, 2005
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REJECTIONS1
I. Claims 1—3, 5—9, 11—14, 16—22, 32, and 34 stand rejected under
35 U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement.
II. Claims 1—3, 5—9, 11—14, 16—22, 32, and 34 stand rejected under
35 U.S.C. § 112, second paragraph, as being indefinite.
III. Claims 1, 3, 5—9, 11—14, 16, 17, 19-22, and 32 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over Purdy,
Kucharczyk, and Scarborough.
IV. Claim 2 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Purdy, Kucharczyk, Scarborough, and
Cioanta.
V. Claim 18 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Purdy, Kucharczyk, Scarborough, Neff, and
Reich.
VI. Claim 34 stands rejected 35 U.S.C. § 103(a) as unpatentable
over Purdy, Kucharczyk, Scarborough, and Reich.
DISCUSSION
Rejection I
The Examiner determines that there is no support in the Specification,
as filed, for “the limitation ‘an I/O system configured to receive the pressure
data and generate impedance measurements based upon the relationship
1 We do not consider the Examiner’s Specification objection as these issues
pertain to petitionable, not appealable matters and are not within the
jurisdiction of the Board. See MPEP §§ 1002 and 1201.
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between the changes in volume and the pressure data’” as required by claim
1. Final Act. 3^4 (emphasis omitted). The Examiner explains that:
inclusion of the priority document provides the following
recitation directed towards “compliance/impedance
measurements”: “Ports would allow for sampling, removal and
exchange of spinal fluid thereby allowing infusion studies to
establish a pressure/volume relationship of the spinal
compartment and compliance/impedance measurements of the
spinal cord in injury and disease . . . “ [formatting altered for
emphasis]. Looking at this recitation the specification appears to
suggest that “pressure/volume relationships” and
“compliance/impedance measurements” are two separate and
distinct functions (note the use of the “and” conjunction
separating the two clauses. In any case, there is no support for
generating “impedance measurements based upon the
relationship between the changes in volume and the pressure
data”. The specification makes no correlation between the two
functions and therefore cannot be relied upon for the claim
limitations.
Id. at 4 (emphasis omitted).
Appellant contends that “compliance and impedance measurements, if
actually measured rather than merely modeled, require the usage of the
relationship between volume and pressure.” Appeal Br. 16. In support of
this contention, Appellant proffers Marmarou (A Nonlinear Analysis of the
Cerebrospinal Fluid System and Intracranial Pressure Dynamics, Anthony
Marmarou et al., J. Neurosurg., Vol. 48, March 1978, pp. 332—344) and
Aygok (Cerebrospinal Fluid Infusion studies: Current View and Concepts in
Assessment of Post-Traumatic Hydrocephalus, Gunes A. Aygok et al, Inf 1
Neurotrauma Letter, Issue 22, International Brain Injury Assoc., 2010 pp. 1—
3) noting that:
the Marmarou reference explicitly states, at page 333, that “The
amount of pressure rise will depend upon the intracranial
compliance. By definition, the ratio of change in volume to
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Application 12/228,697
change in pressure dV/dP equals the compliance (C) which can
be obtained by measuring the slope of a volume-pressure curve
of the system under study.”
Id. (emphasis omitted). Appellant further notes that:
Marmarou continues by stating that “The rate of outflow (I~) is
given by the gradient of pressure between CSF space and the
venous system of the dural sinus (Pd) divided by the resistance
to absorption (R).” Thus, the rate of outflow (volume change) is
dependent upon pressure gradient and resistance to absorption.
The term ‘impedance’ in this field, is simply another word for
‘resistance to absorption’. This is confirmed in Marmarou at
page 342 which states “removal of CSF at a rate equal to
formation negates the contribution of the CSF impedance (R) to
the level of ICP.”
Id. (citations and emphasis omitted).
“[T]he test for [written description] sufficiency is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date.” AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en banc). Here, the fact that the Appellant had possession
of an I/O system configured to receive the pressure data and generate
impedance measurements is not contested. Rather, the question is whether
or not Appellant had possession of a system that generates impedance
measurements based on the relationship between the changes in volume and
the pressure data. See Non-Final Act. 4. Appellant proffers evidence that
one skilled in the art would understand that the impedance measurements are
based upon the relationship between the changes in volume and the pressure
data. Appeal Br. 16 (citing Marmarou). The Examiner does not contest this
evidence, rather the Examiner submits that the impedance measurements
could be obtained in a different manner. See Ans. 5. However, the fact that
impedance measurements could be obtained in a different manner does not
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mean that those skilled in the art would understand the measurements to be
obtained in that manner. Rather, as evidenced by Marmarou, one skilled in
the art would understand the impedance measurements to be obtained based
upon the relationship between the changes in volume and the pressure data.
For this reason, we do not sustain the Examiner’s decision rejecting
claim 1, and claims 2, 3, 5—9, 11—14, 16—22, 32, and 34, which depend
therefrom, as failing to comply with the written description requirement.
Rejection II
The Examiner states that:
Regarding Claims 1, 18, and 34, Applicant makes
reference towards “impedance measurements” and “compliance
measurements”, appearing to indicate that they are two different
functions. However, Applicant’s only recitation only introduces
impedance in brief disclosure as "compliance/impedance
measurements". It is therefore not clear how Applicant is
attempting to use the term “impedance”, whether this is a
measurement separate and distinct from physiological
“compliance”, a synonym for “compliance”, or an analog of
“compliance”.
Final Act. 6. However, claim 1 does not recite “compliance” and the
recitation of “cerebrospinal compliance” in claim 18 and “compliance
measurements” in claim 34 are clearly recitations of separate limitations
than the recitation of “impedance measurements” in claim 1. See Appeal Br.
30,32,35.
It appears that the Examiner is reading Appellant’s arguments
pertaining to “compliance/impedance measurements” into the claims in
order to create confusion where none exists. See e.g. Response to Non-Final
Action filed January 9, 2014, p. 15; Appeal Br. 15. Appellant contends that
the terms “compliance” and “impedance” are being used in accordance with
their ordinary and customary meaning. See Appeal Br. 20. We agree.
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We do not sustain the Examiner’s decision rejecting claims 1,18, and
34 as being indefinite.
Rejections III, IV, and V
Claims 1-3. 5. 7-9. 11-14. 16. 17. 19-22. and 32
Appellant argues claims 1—3, 5, 7—9, 11—14, 16, 17, 19-22, and 32
together.2 Appeal Br. 27. We select independent claim 1 as the
representative claim, and claims 2, 3, 5, 7—9, 11—14, 16, 17, 19—22, and 32
stand or fall with claim 1.
The Examiner finds that Purdy discloses all of the limitations of claim
1 except for “a single catheter having the at least three ports” and a system
including “an I/O system configured to receive the pressure data and
generate impedance measurements based upon the relationship between the
changes in volume and pressure data.” Final Act. 8, 9. The Examiner
further finds that Kucharczyk discloses a catheter including
a plurality of ports (6, 8, 10, 12, 14, and 16) . . . that . . . may
include monitoring ports (16, 68, 82) which carrying monitoring
transducers (34, 84, 70) which may be configured to monitor
pressure data (Col. 13, Ln. 3-42). Kucharczyk discloses that
these ports may also include inlet and outlet ports for removing
or delivering fluids (64 and 74; Col. 12, Ln. 56 - Col. 13, Ln. 2).
and that “Scarborough discloses a spinal fluid introduction system (Abstract)
. . . that. . . may be configured to include an I/O system (24) that is
configured to receive pressure and volume data and generate impedance
measurements based thereupon (Par. 22, Par. 75, Par. 76, and Clm. 17).” Id.
2 Claims 2 and 18 are subject to a different ground of rejection than claim 1;
however, Appellant groups claims 2 and 18 with claim 1 and do not present
arguments pertaining to the separate grounds of rejection (i.e. arguments
pertaining to Rejections III and IV). Accordingly, we understand Appellant
to rely on the same arguments for Rejections III and IV as discussed infra
with respect to Rejection I, and also group claims 2 and 18 with claim 1.
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Based on these findings, the Examiner determines that it would have been
obvious “to configure the catheter of Purdy to include at least three lumens
terminating in at least three ports, as disclosed by Kucharczyk, in order to
supply a unitary, combined catheter that can perform all the specified
infusion, aspiration, sampling, and monitoring functions” and “to configure
the system of Purdy to include an I/O system configured to measure pressure
and volume data to determine the impedance measurement, as disclosed by
Scarborough, in order to control the amount of fluid transferred while
controlling the physiological parameters of the fluid space.” Id. at 9.
Although he acknowledges that “Purdy is capable of measuring
pressure data,” Appellant contends that Purdy “also teaches away from the
monitoring of compliance and/or impedance measures.” Appeal Br. 21. In
support of this contention, Appellant argues that “Purdy contemplates a
catheter system which operates in what is considered a ‘static’ cerebral
spinal fluid environment.” Id. at 21—22. However, even assuming that
Appellant is correct that Purdy is concerned with a “static” cerebral spinal
fluid environment, such teachings do not constitute a teaching away from the
proposed combination. As noted by the Examiner (Ans. 8—9), “teaching
away” requires that the reference “criticize, discredit, or otherwise
discourage” the use of other alternatives. See In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004). We will not read into a reference a teaching away
from a proposed combination when no such language exists. See Dystar
Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d
1356, 1364 (Fed. Cir. 2006).
Appellant further argues that Purdy and Scarborough are
uncombinable because “[t]he entire purpose of Scarborough is to generate a
distended organ, which would be fatal in the setting of the cerebrospinal
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system.” Appeal Br. 22. However, this argument is not responsive to the
rejection as articulated by the Examiner. As discussed supra, the rejection
does not rely on Scarborough’s teachings pertaining to pressure and volume.
Rather, Scarborough is merely relied upon to show that the use of I/O
systems for generating impedance measurements was known in the art. See
Final Act. 9. Appellant does not contest the Examiner’s findings or explain
why Scarborough’s teaching of an I/O system is not applicable to Purdy’s
device. Thus, Appellant fails to apprise us of error.
Then, Appellant argues that “Purdy doesn’t contemplate the
determination of compliance or impedance measurements.” Appeal Br. 23.
Appellant is correct; however, this is not indicative of error, because Purdy
is not relied upon to teach the limitations pertaining to impedance
measurements. Rather, as discussed supra, Scarborough is relied upon to
meet these limitations. Further, we note that compliance measurements are
not claimed. See id. at 30. Moreover, nonobviousness cannot be established
by attacking the references individually when the rejection is predicated
upon a combination of prior art disclosures. See In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986).
In addition, Appellant contends that Scarborough is non-analogous
art. See Appeal Br. 24. In support of this contention, Appellant argues that
“[wjhile the general location of these medical devices [, i.e. Purdy and
Scarborough] are close, they are extremely different in application, result
and intended purpose” and that “the problems being addressed by these two
disclosures are entirely different: one being diagnosis of spine disc
degeneration and the other being issues with the cerebral-spinal fluid
pathway.” Id.
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Appellant compares Scarborough to Purdy (id.); however, this is not
the correct inquiry. “Two separate tests define the scope of analogous prior
art: (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 Bigio, 381
F.3d 1320, 1325 (Fed. Cir. 2004) (citing In re Deminski, 796 F.2d 436, 442
(Fed.Cir.1986); In re Wood, 599 F.2d 1032, 1036 (CCPA 1979)). The
instant Specification describes the field of Appellant’s endeavor as relating
“generally to surgical methods and medical devices. More particularly, it
concerns methods and devices for monitoring and delivering therapeutics to
the spinal cord and brain along a spinal fluid pathway or cistern, particularly
the lumbar cistern.” Spec. 1. Scarborough “relates to a system and method
for introducing fluid into a spine.” Scarborough 12. Thus, Scarborough is
in the same field of endeavor as the instant invention. Furthermore, one of
the problems with which Appellant is involved is monitoring of a pressure-
volume relationship. See Spec. 2. As discussed supra, Scarborough
discloses an I/O system for performing such monitoring. Thus, Scarborough
is reasonably pertinent to a problem with which Appellant is involved.
Accordingly, Scarborough qualifies as analogous art under both prongs of
the test outlined in Bigio.
Next, Appellant contends that “impedance and compliance are not
analogous measurements, and Scarborough fails to even contemplate a
compliance measurement.” Appeal Br. 25. In support of this contention,
Appellant argues that:
the impedance measurements of Scarborough are vastly different
from those of the presently claimed invention in regards to
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purpose, means of generating the value (pressure volume
relationship taken internally versus knowing fluid viscosity,
needle size etc. and computing impedance before the device is
even inserted into the patient) and even what the impedance is
measured for (device assembly versus body cavity).
Id. However, none of these alleged differences between Scarborough’s
impedance measurements and the impedance measurements discussed in the
Specification are claimed. See id. at 30. Although the claims are interpreted
in light of the specification, limitations from the specification are not read
into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
Moreover, as discussed supra, compliance measurement is not claimed. See
id. Thus, Appellant does not apprise us of error.
Finally, Appellant argues that “the combination of Purdy and
Kucharczyk would be inoperable for the intended purpose [because]
Kucharczyk fails to address larger volume infusion and only mentions
micro-dialysis as it relates to a microscopic tissue sampling process.”
Appeal Br. 26. Again, Appellant’s argument is not responsive to the
rejection as articulated by the Examiner. As discussed supra, Kucharczyk is
only relied upon to show that catheters with multiple lumens and multiple
ports are known. Appellant does not contest the Examiner’s finding or
explain why Kucharczyk’s teaching of multiple lumens and multiple ports
could not be applied to Purdy’s device. Thus, Appellant doesn’t apprise of
error.
For these reasons, we sustain the Examiner’s decision rejecting claim
1, and claims 2, 3, 5, 7—9, 11—14, 16, 17, 19-22, and 32, which fall
therewith.
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Claim 6
Regarding claim 6, the Examiner determines that although
Purdy fails to explicitly disclose that the pressure transducer
monitors the “central canal size” and presence of “parenchymal
edema”, Examiner submits that these measurements flow
directly from the measurement of pressure, a function provided
by the catheter of Purdy. Examiner submits that by measuring
pressure continually, Purdy would detect changes in the central
canal size, diameter of the vessel impacting pressure of the fluids
therein, as well as parenchymal edema, characterized by an
increase in pressure within the parenchymal space.
Final Act. 10.
Appellant contends that because “the cerebral spinal pathway is being
modeled by Purdy as ‘static’, then even with continuous pressure
measurements, the identification of ‘central canal size’ and presence of
‘parenchymal edema’ is entirely foreign to the disclosure of Purdy.” Appeal
Br. 27—28. In support of this contention, Appellant argues that “[pressure
data alone is not sufficient to ascertain the structure. For example, two
people can have identical blood pressures, but one might be suffering from a
thoracic aortic aneurysm. Only visualization with appropriate imaging . . .
would yield the diagnosis.” Id. at 28 (emphasis omitted).
Responding to this argument the “Examiner submits that changes in
central canal size and parenchymal edema will inherently cause fluctuations
in pressure and volume of the CSF.” Ans. 13. Based on this submission, the
Examiner reasons that “Purdy is purposed to measure fluctuations in general,
ergo Purdy is purposed to detect changes in pressure/volume resultant from
changes in the canal size and instances of edema.” Id. However, the
Examiner makes no findings in support of this submission, and the
Examiner’s reasoning is speculative at best.
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Accordingly, we do not sustain the Examiner’s decision rejecting
claim 6.
Rejection V
Claim 18 is subject to a different ground of rejection than claim 6;
however, Appellant groups claim 18 with claim 6. Appeal Br. 27—28.
Accordingly, we understand Appellant to rely on the same persuasive
arguments discussed supra, in contesting the rejection of claim 18.
Accordingly, we do not sustain the Examiner’s decision rejecting claim 18
for the same reason we do not sustain the Examiner’s decision rejecting
claim 6.
Rejection VI
Appellant does not present arguments pertaining to the rejection of
claim 34, the only claim rejected in Rejection VI. See generally, Appeal Br.
Accordingly, we summarily sustain the Examiner’s decision rejecting claim
34.
DECISION
The Examiner’s rejections of claims 1—3, 5—9, 11—14, 16—22, 32, and
34 under 35 U.S.C. § 112 are REVERSED.
The Examiner’s rejections of claims 1—3, 5, 7—9, 11—14, 16, 17, 19-
22, 32, and 34 under 35 U.S.C. § 103(a) are AFFIRMED.
The Examiner’s rejections of claims 6 and 18 under 35 U.S.C. §
103(a) are REVERSED.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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