Ex Parte Kassem

Patent Trial and Appeal Board

Aug 31, 2018

13848295 (P.T.A.B. Aug. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/848,295 03/21/2013 Salim Kassem
124541 7590 09/05/2018
Mintz Levin/Cadman & Shurtleff
One Financial Center
Boston, MA 02111
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
054343-042D01US 9269
EXAMINER
ZIMBOUSKI, ARIANA
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
09/05/2018 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):
ipdocketingbos@mintz.com
ipfileroombos@mintz.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SALIM KASSEM 1
Appeal2017-002231
Application 13/848,295
Technology Center 3700
Before ANNETTE R. REIMERS, JILL D. HILL, and
BRENT M. DOUGAL, Administrative Patent Judges.
REIMERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Salim Kassem (Appellant) appeals under 35 U.S.C. § 134(a) from the
Examiner's decision to reject claims 3, 5, and 8-22. Claims 1, 2, 4, 6, and 7
have been canceled. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 In the Appeal Brief, DePuy Synthes Products, LLC is the applicant as
provided under 37 C.F.R. § 1.46 and is identified as the real party in interest.
Appeal Brief 1 (hereinafter "Appeal Br.") (filed Mar. 22, 2016).
Appeal2017-002231
Application 13/848,295
CLAIMED SUBJECT MATTER
The claimed subject matter relates to "methods for non-invasively
storing and accessing data related to medical devices, and more particularly
to non-invasively storing and accessing data related to shunts." Spec. ,r 2,
Figs. 1, 2, 8. Claims 9, 21, and 22 are independent.
Claims 9 and 22 are illustrative of the claimed subject matter and
recite:
9. A method, comprising:
positioning a distal end of a ventricular catheter within a
ventricle;
coupling a proximal end of the ventricular catheter to a
valve inlet formed on an implantable valve, and coupling a valve
outlet formed on the valve to a drainage catheter such that fluid
flows from the ventricle through the valve to the drainage
catheter; and
using an external reading device to obtain first data
telemetrically from a pressure sensor disposed in the valve and
including a first antenna, and to obtain second data telemetrically
from a radio frequency identification tag disposed in the valve as
a physically separate component from the pressure sensor, the
radio frequency identification tag including a second antenna,
and the first data being indicative of a pressure measurement
obtained by the pressure sensor, and the second data including
non-pressure measurement data.
22. A method, comprising:
implanting a valve in a patient such that a proximal end of
a ventricular catheter is coupled to a valve inlet of the valve, a
distal end of the ventricular catheter is positioned within a
ventricle of the patient, and a valve outlet of the implanted valve
is coupled to a drainage catheter such that fluid flows from the
ventricle through the valve to the drainage catheter, the valve
including a first pressure sensor disposed therein; and
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Application 13/848,295
implanting a second pressure sensor at a location external
to the implanted valve;
wherein a radio frequency identification tag is disposed in
the implanted valve, the radio frequency identification tag being
configured to telemetrically communicate first data indicative of
pressure sensed by the first pressure sensor to an external reading
device, and being configured to telemetrically communicate
second data indicative of pressure sensed by the second pressure
sensor telemetrically to the external reading device.
REJECTIONS
I. Claims 5, 8-10, 13, 16, 18, and 20-22 stand rejected under 35
U.S.C. § I03(a) as unpatentable over Mauge (US 2006/0211946
Al, published Sept. 21, 2006) and Berger (US 2005/0247319 Al,
published Nov. 10, 2005).
II. Claims 3 and 11 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Mauge, Berger, and Mirmobin (US
2007/0252691 Al, published Nov. 1, 2007).
III. Claim 12 stands rejected under 35 U.S.C. § I03(a) as unpatentable
over Mauge, Berger, Mirmobin, and Sharma (US 2008/0242944
Al, published Oct. 2, 2008).
IV. Claims 14 and 17 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Mauge, Berger, and Ericson (US 6,533,733 Bl,
issued Mar. 18, 2003).
V. Claim 19 stands rejected under 35 U.S.C. § I03(a) as unpatentable
over Mauge, Berger, and Butler (US 2007/0210923 Al, published
Sept. 13, 2007).
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Application 13/848,295
ANALYSIS
Rejection I
Claims 5, 8-10, 13, 16, 18, 20, and 21
Independent claim 9 is directed to a method including the step of
"using an external reading device ... to obtain second data telemetrically
from a radio frequency identification tag[2J disposed in the valve as a
physically separate component from the pressure sensor." Appeal Br. APP.
A: Claims on Appeal, A. The Examiner finds that Mauge discloses the
method of claim 9 substantially as claimed except "using an external reading
device to obtain second data telemetrically from [an RFID] tag disposed in
the valve as a physically separate component from the pressure sensor, the
[RFID] tag including a second antenna and the second data including non-
pressure measurement data." Final Act. 4--5. 3 The Examiner finds that
Berger discloses an "RFID tag, which includes an antenna, under the coating
of an outer surface of a medical implant and an external reading device that
obtains data telemetrically from the RFID tag," and wherein the data
includes "non-pressure measurement data, such as make and model of the
device or for identifying the instruments used to insert and remove the
medical device." Id. at 5 (emphasis added) (citing Berger, Abstract, ,r,r 2, 8-
12, 30, 35). The Examiner concludes that it would have been obvious
to add an RFID tag, including an antenna, under the coating of
an outer surface of the valve and an external reading device that
obtains data telemetrically from the RFID tag, the data including
non-pressure measurement data, such as make and model of the
device or for identifying the instruments used to insert and
remove the medical device, as disclosed by Berger, in order to
2 Hereinafter "RFID tag."
3 Final Office Action (hereinafter "Final Act.") ( dated Oct. 6, 2015).
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Application 13/848,295
help identify the valve without having to physically see the valve.
Consequently, the RFID tag would be disposed in the valve as
a physically separate component.
Final Act. 5 ( emphases added).
As an initial matter, we agree with the Examiner that the data
disclosed in Berger includes "non-pressure" data, "such as make and model
of the device or for identifying the instruments used to insert and remove the
medical device." See Final Act. 5; see also Berger ,r 35. However, claim 9
recites "non-pressure measurement data." Appeal Br. APP. A: Claims on
Appeal, A. The Examiner fails to provide sufficient evidence or technical
reasoning to support the finding that Berger discloses "non-pressure
measurement data" or to adequately explain how incorporating the teachings
of Berger to help "identify the valve" of Mauge has anything to do with
measuring data.
Claim 9 further recites that the RFID tag is "disposed in the valve."
Appeal Br. APP. A: Claims on Appeal, A (emphasis added). Adding an
RFID tag within a coating on the outer swface of a valve would constitute
the RFID tag being disposed on the valve, but we fail to see and the
Examiner fails to adequately explain how adding an RFID tag within a
coating on the outer surface of a valve would further constitute the RFID tag
being "disposed in the valve," as claimed. See Final Act. 5; see also Adv.
Act. 2 ("[T]his additional RFID tag would be disposed on the outer swface
but within a coating, it would still be disposed within the valve" ( emphases
added)); Appeal Br. 9; Appeal Br. APP. A: Claims on Appeal, A (emphasis
added). 4
4 Advisory Action (hereinafter "Adv. Act.") (dated Jan. 4, 2016).
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In the Answer, the Examiner states that "Berger discloses, generally,
the use of an RFID, antenna, and associated reader 'embedded or mounted
into an implantable medical device for the identification of the medical
device as to manufacturer and model."' Ans. 4 ( citing Berger ,r,r 8-12, Final
Act. 5); 5 see also Berger ,r 11 ("The RFID tags can be attached or integrated
in the objects for identification" ( emphasis added)); id. ,r 12 ("The present
invention is directed to a RFID tag embedded or mounted into an
implantable medical device" ( emphasis added)). In this case, we agree with
the Examiner that Berger discloses the RFID tag can be "disposed in the
valve." See Ans. 4; see also Berger ,r,r 8-12; Appeal Br. APP. A: Claims on
Appeal, A ( emphasis added). However, similar to that discussed above, the
Examiner fails to provide sufficient evidence or technical reasoning to
adequately explain how incorporating the teachings of Berger to allow for
"identification of the medical device" of Mauge has anything to do with
measuring data. See Ans. 4 ("[T]he RFID tag [ of the modified Mauge
device] allow[ s] for the identification of the medical device."); see also
Appeal Br. APP. A: Claims on Appeal, A.
Appellant contends that "neither Mauge nor Berger teaches or
suggests a pressure sensor and an RFID tag that is a physically separate
component from the pressure sensor. Instead, the only disclosure in both
Mauge and Berger is for a single chip to include all of an implant's
electronics such that the components are not physically separate." Appeal
Br. 9-10; see also Reply Br. 5. 6 As such, according to Appellant,
"regardless of where Berger's RFID tag is added to Mauge's implantable
5 Examiner's Answer (hereinafter "Ans.") (dated Oct. 3, 2016).
6 Reply Brief (hereinafter "Reply Br.") (filed Nov. 22, 2016).
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valve 200, it would be part of the same chip as the valve's pressure sensor so
as to not be a physically separate component from the pressure sensor as
required by claim 9." Appeal Br. 10.
In this case, assuming arguendo that the Examiner is proposing to
modify Mauge' s valve 200 by embedding or mounting the RFID tag of
Berger into Mauge's valve 200 (i.e., the RFID tag being disposed in the
valve), the Examiner fails to provide sufficient evidence or technical
reasoning to establish that the RFID tag is "a physically separate
component" from the pressure sensor in Mauge's modified device (i.e., the
RFID tag and the pressure sensor of the modified Mauge device are "without
a physical link or connection ( e.g., a mechanical, electrical, or
communication link or connection) between them."). See Spec. ,r 30; see
also Appeal Br. APP. A: Claims on Appeal, A; Ans. 4--5; Appeal Br. 9--10;
Reply Br. 5. Stated differently, the Examiner fails to establish how the
RFID tag and pressure sensor of the modified Mauge device are positioned
such that their "positions .... requir[ e] the two to be physically separate."
See Ans. 4--5.
The Examiner appears to take an alternate approach in the Answer. In
particular, the Examiner appears to propose modifying Mauge's device to
include a second chip with the RFID tag teachings of Berger. See Ans. 5. 7
In this case, the Examiner fails to apprise us why a skilled artisan would
7 To the Extent the Examiner is proposing to modify Mauge's device to
include a second chip with the RFID tag teachings of Berger "within a coating
on the outer surface" of Mauge's valve (see Ans. 5), similar to that discussed
above, adding a second chip having an RFID tag within a coating on the outer
surface of a valve would constitute the second chip RFID tag being disposed
on the valve not "disposed in the valve," as claimed. See Appeal Br. APP. A:
Claims on Appeal, A (emphases added).
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have been motivated to modify Mauge' s device to include a second chip, in
particular, given that "each of Mauge and Berger [disclose] a single chip to
include all needed electronics." See id.; see also Reply Br. 5; Appeal Br. 9-
12. Even assuming arguendo that a skilled artisan would have been
motivated to modify Mauge's device to include a second chip having an
RFID tag, the Examiner still fails to provide sufficient evidence or technical
reasoning to adequately establish that the RFID tag of the second chip would
necessarily be "a physically separate component" from the pressure sensor
of the first chip in Mauge's modified device (i.e., the second chip RFID tag
and the first chip pressure sensor of the modified Mauge device would
necessarily be "without a physical link or connection ( e.g., a mechanical,
electrical, or communication link or connection) between them."). See Spec.
,r 30; see also Appeal Br. APP. A: Claims on Appeal, A; Ans. 5.
Independent claim 21 is directed to a method and includes language to
the RFID tag being "disposed in the implanted valve, the [RFID] tag being a
physically separate component from the pressure sensor." Appeal Br. APP.
A: Claims on Appeal, C. The Examiner relies on the same unsupported
findings in Mauge and Berger discussed above. See Final Act. 4--5; see also
Ans. 4--5. As such, the Examiner's findings with respect to Mauge and
Berger are deficient for claim 21 as well.
For these reasons, we do not sustain the Examiner's rejection of
independent claims 9 and 21, as well as dependent claims 5, 8, 10, 13, 16,
18, and 20 as unpatentable over Mauge and Berger.
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Claim 22
Independent claim 22 is directed to a method including an RFID tag
"disposed in the implanted valve," and wherein the RFID tag is "configured
to telemetrically communicate first data indicative of pressure sensed by the
first pressure sensor to an external reading device, and [is] configured to
telemetrically communicate second data indicative of pressure sensed by the
second pressure sensor telemetrically to the external reading device."
Appeal Br. APP. A: Claims on Appeal, C, D.
The Examiner finds that Mauge discloses the method of claim 22
substantially as claimed except an RFID tag "disposed in the implanted
valve," wherein the RFID tag is "configured to telemetrically communicate
first data indicative of pressure sensed by the first pressure sensor to an
external reading device, and [is] configured to telemetrically communicate
second data indicative of pressure sensed by the second pressure sensor
telemetrically to the external reading device." Final Act. 7-8. The
Examiner finds that Berger discloses an "RFID tag, which includes an
antenna, under the coating of an outer surface of a medical implant and an
external reading device that obtains data telemetrically from the RFID tag,"
and wherein the RFID tag "is associated with a sensor and stores data related
to the sensor." Final Act. 8 (emphasis added) (citing Berger, ,r,r 2, 8-12, 30,
34, 35, Abstract). The Examiner concludes that it would have been obvious
"to add an RFID tag, including an antenna, under the coating of an outer
surface of the valve." Id. (emphasis added). The Examiner also concludes
that it would have been obvious to have the method of Mauge and Berger
include the RFID tag being associated with the sensors and storing data
related to the sensors, "as Berger discloses the [RFID] tag storing sensor
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data, in order to get and store additional helpful information from the
patient." Id.
The Examiner further finds that "storing data from multiple sources in
one location as opposed to multiple locations is well known in the art and
would allow for the user to go to one location to get the data." Id. In the
Advisory Action, the Examiner cites to the Zhang and Field references as
evidence that it is well known "to store data from multiple sources in one
location." See Adv. Act. 2 (citing Zhang, ,r 73; Field, ,r 22). 8 Based on the
foregoing, the Examiner concludes that it would have been obvious "to use
an external reading device that obtains data telemetrically from the RFID
tag, as disclosed by Berger, in order to get information from the valve
without having to physically see the valve. Consequently, as the RFID
transmits data, both first data and second data would be communicated."
Final Act. 8.
Appellant contends that even if Mauge and Berger were combined,
"the combination would lack a valve having disposed therein an RFID tag
that can communicate data indicative of pressure sensed by a pressure sensor
that is implanted at a location external to the valve." Appeal Br. 18. In
particular, Appellant contends that each of the valves of the modified Mauge
device "would have its own RFID tag with its own pressure sensor and its
own antenna for communicating data externally" as "[t]his is the only
construction and use disclosed by Mauge, in which the pressure sensor 212
in the pressure sensor assembly 206 includes its own antenna, and disclosed
8 Zhang (US 2008/0065646 Al, published Mar. 13, 2008); Field (US
2006/0212439 Al, published Sept. 21, 2006).
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by Berger, in which the RFID tag 14 includes its own pressure sensor 26 and
its own antenna." Appeal Br. 18; see also Reply Br. 11-12.
Appellant further contends that at best, the Zhang and Field references
support the notion that a device like its computer system/computing device
"that stores and communicates data, such as Berger's RFID tag and Mauge's
sensor and antenna as purported by the Examiner, stores and communicates
its own data to an external device as an aggregator, not that a single RFID
tag would be the aggregator as seemingly alleged by the Examiner." See
Reply Br. 12-13; see also Appeal Br. 20-21.
As an initial matter, similar to the discussion above for claim 9, claim
22 recites that the RFID tag is "disposed in the valve." Appeal Br. APP. A:
Claims on Appeal, D ( emphasis added). Adding an RFID tag within a
coating on the outer swface of a valve would constitute the RFID tag being
disposed on the valve, but we fail to see, and the Examiner fails to
adequately explain, how adding an RFID tag within a coating on the outer
surface of a valve would further constitute the RFID tag being "disposed in
the valve," as claimed. See Final Act. 8; see also Adv. Act. 2 ("[T]his
additional RFID tag would be disposed on the outer surface but within a
coating, it would still be disposed within the valve" ( emphases added));
Appeal Br. 16.
In this case, we agree with Appellant that "Zhang and Field are each
directed to aggregating data from a plurality of sources that each
independently gathers and stores its own data and communicates that data to
the aggregator" and that the communications of Zhang and Field "fail to
teach or suggest that one source communicates data gathered by another
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source. Instead, the communications of Zhang and Field are akin to each of
a plurality of implants independently communicating data gathered by its
on-board sensor( s) - not any external sensors - to some outside
'aggregator."' Appeal Br. 21; see also Zhang, Abstract, ,r,r 3 8, 73; Field, ,r
22; Reply Br. 12-13.
Regardless of whether "storing data from multiple sources in one
location as opposed to multiple locations is well known in the art," claim 22
requires that the RFID tag be configured to store data indicative of pressure
sensed by a second pressure sensor (i.e., another pressure sensor) that is
implanted at a location external to the implanted valve. See Ans. 7; Final
Act. 7-8; Appeal Br. 18-19; id. at APP. A: Claims on Appeal, D; Reply Br.
10-12. Here, we agree with the Examiner that Mauge discloses the step of
"implanting a second pressure sensor at a location external to the implanted
valve." See Final Act. 7; see also Ans. 8; Mauge, ,r,r 10, 58; Appeal Br.
APP. A: Claims on Appeal, D. We further agree with the Examiner that
Berger discloses an RFID tag "disposed in the valve" that is "configured to
telemetrically communicate first data indicative of pressure sensed by the
first pressure sensor to an external reading device." See Final Act. 8; see
also Ans. 4, 7; Berger, ,r,r 11, 12, 32, 35, Fig. 3; Appeal Br. APP. A: Claims
on Appeal, D. However, given that Berger merely discloses an RFID tag
within the valve that communicates/stores data from its own integrated
sensors, not from any other sensors that are implanted elsewhere and that
each of Zhang and Field merely "stores and communicates its own data to an
external device" and does not communicate/store "data gathered by another
source," we fail to see and the Examiner fails to adequately explain how an
RFID tag disposed in valve 200 of Mauge's modified device would be
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configured to communicate data gathered by another pressure sensor
external to the implanted valve in Mauge to the external reading device. See
Final Act. 7-8; see also Ans. 7; Appeal Br. 18-21, id. at APP. A: Claims on
Appeal, D Reply Br. 11-13 (emphasis added).
For these reasons, we do not sustain the Examiner's rejection of
independent claim 22 as unpatentable over Mauge and Berger.
Rejections 11-V
Claims 3, 11, 12, 14, 17, and 19
TheExaminer'sobviousnessrejectionsofclaims3, 11, 12, 14, 17,
and 19 are each based on the same unsupported findings discussed above
with respect to independent claim 9. See Final Act. 8-11. The Examiner
does not rely on Mirmobin, Sharma, Ericson, or Butler to remedy the
deficiencies of Mauge and Berger. Accordingly, for reasons similar to those
discussed above for claim 9, we do not sustain the Examiner's obviousness
rejections of claims 3, 11, 12, 14, 17, and 19.
DECISION
We REVERSE the decision of the Examiner to reject claims 3, 5, and
8-22.
REVERSED
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