Ex Parte Chmiel et al

Patent Trial and Appeal Board

Jun 23, 2016

12857118 (P.T.A.B. Jun. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/857,118 08/16/2010 Alan Chmiel
26294 7590 06/27/2016
TAROLLI, SUNDHEIM, COVELL & TUMMINO LLP,
1300EASTNINTH STREET, SUITE 1700
CLEVELAND, OH 44114
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.
ZIN-019240 US PRI 3413
EXAMINER
LONG,FONYAM
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
06/27/2016 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):
rkline@tarolli.com
docketing@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALAN CHMIEL, HEATHER GORNIK,
JOHN R. BARTHOLOMEW, CARLOS GRODSINSKY,
and JONATHAN SCHAFFER
Appeal2013-011068
Application 12/857,118 1
Technology Center 3600
Before BIBHU R. MOHANTY, MEREDITH C. PETRA VICK, and
BRADLEY B. BAY AT, Administrative Patent Judges.
PETRA VICK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Alan Chmiel, et al. (Appellants) seeks our review under 35 U.S.C. §
134 of the final rejection of claims 1-5, 7-16, and 18-32.2 We have
jurisdiction under 35 U.S.C. § 6 (b ).
1 The real parties in interest, identified by Appellants, are ZIN
Technologies, Inc. and the Cleveland Clinic Foundation. Appeal Br. 3.
2 The Claims Appendix submitted with the Appeal Brief includes
amendments presented in an After Final Amendment filed on May 24, 2013.
The Examiner, however, denied entry of the amendments. See Advisory
Action entered May 31, 2013. Our decision refers to the currently pending
Appeal2013-011068
Application 12/857,118
SUMMARY OF DECISION
We AFFIRM-IN-PART the rejection of claims 1-5, 7-16, and 18-
32.3
THE INVENTION
Claims 1, 18, 23, and 29 are independent. Claims 1, 18, and 23 are
reproduced below and are illustrative of the subject matter on appeal. Claim
29 is similar to claim 1.
1. A patient monitoring system comprising:
a patient unit configured as a server in a network to read
and write data in a remote database, the patient unit comprising:
a device interface configured to provide for data
communication with a measurement device, the patient
unit being programmed to selectively retrieve results data
indicative of at least one patient condition from the
measurement device;
a communication module configured to provide
two-way communication via the network with the remote
database, the server being configured to employ the
communication module to retrieve encounter instruction
data for the patient unit from the remote database for a
given patient encounter, the encounter instruction data
comprising a plurality of main sequence steps that include
at least one set of predetermined queries, at least one of the
plurality of main sequence steps being programmed to
claims, which can be found in the Replacement Claims Appendix attached to
the Reply Brief.
3 We reference the Appellants' Appeal Brief ("App. Br.," filed May. 28,
2013), Appellants' Reply Brief ("Reply Br.," filed Sept. 6, 2013), the Final
Office Action ("Final," mailed Dec. 27, 2012), and the Examiner's Answer
("Ans.," mailed July 9, 2013).
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trigger a conditional branch of sequence steps in response
to detecting an off-nominal condition at the at least one of
the plurality of sequence steps, the conditional branch of
sequence steps being programmed to obtain additional
information about the off-nominal condition and to return
to complete the plurality of main sequence steps, the
server being configured to employ the communication
module to send response data to the remote database for
the given patient encounter, the response data comprising
stored user responses, including the additional information
about the off-nominal condition, and the results data; and
a user interface programmed to present at least one
of the predetermined queries to a user and to receive user
responses to the each of the predetermined queries for the
given patient encounter, the user responses for each of the
predetermined queries being stored in memory of the
patient unit as the response data for the given encounter;
and
a back office system programmed to access the remote
database and to retrieve the response data from the remote
database for at least one patient unit, the back office system
further being programmed to at least one of add or modify the
encounter instruction data in response to retrieved response data
for the given encounter, the encounter instruction data being
stored in the remote database for a next patient encounter at the
patient unit.
18. A patient monitoring system comprising:
a patient unit configured as a server in a network to read
and write data in a remote database, the patient unit comprising:
a device interface configured to provide for data
communication with a measurement device, the patient
unit being programmed to selectively retrieve results data
indicative of at least one patient condition that is measured
by the measurement device;
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a communication module configured to provide
two-way communication with the remote database via the
network, the server configured to employ the
communication module to retrieve encounter instruction
data for the patient unit from the remote database for a
given patient encounter that includes a plurality of
predefined sequence steps that involve at least one set of
predetermined queries to be presented to the user for the
given patient encounter, the server also being configured
to employ the communication module to send response
data to the remote database for the given patient encounter,
the response data comprising at least one of stored user
responses and the results data;
a user interface programmed to present at least one
of the predetermined queries to a user and to receive user
responses to the each of the predetermined queries for the
given patient encounter based on the encounter instruction
data, the user responses for each of the predetermined
queries being stored in memory of the patient unit as the
response data for the given encounter; and
a back office system programmed to access the
remote database and to retrieve the response data from the
remote database for at least one patient unit, the back
office system further being programmed to at least one of
add or modify the encounter instruction data that is stored
in the remote database for a next patient encounter at the
patient unit, wherein the back office system comprises a
rules engine that includes predetermined rules
programmed according to a predetermined patient
procedure protocol, the back office system employing the
rules to generate the encounter instruction data that is
retrieved by the patient unit during the given encounter to
modify at least one of the plurality of predefined sequence
steps;
wherein the sequence of predefined steps comprises
an update dosage sequence step, the patient unit retrieving
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an updated dosage instruction for the given encounter
from the remote database during execution of the update
dosage sequence step of the given encounter, a dosage
query being presented as part of the update dosage
sequence step, based on the instruction data, requesting
that the user enter a dosage confirmation response via the
user interface of the patient unit, the dosage confirmation
response being stored as response data in the remote
database to indicate that the user has received the updated
dosage instruction for a next treatment interval.
23. A method for remote patient management, comprising:
initiating a given encounter at a patient unit in response to
a user input provided at the patient unit;
opening a two-way wireless communication channel
between the patient unit and a remote database, such that the
patient unit operates as a server to retrieve encounter instruction
data for the given encounter from the remote database, the
encounter instruction data defining a sequence of steps to be
executed at the patient unit for the given encounter according to
a predetermined patient procedure protocol;
executing each of the sequence of steps at the patient unit,
at least some of the sequence of steps requesting responses from
the user to confirm compliance with the respective step and at
least one of the sequence of steps corresponding to test
subroutine;
executing the test subroutine at the patient unit to receive
results data indicative of a patient condition;
sending response data for the given encounter from the
patient unit to the remote database via a communication channel;
and
retrieving by the patient unit updated encounter instruction
data from the remote database for a next encounter at the patient
unit, the updated encounter instruction data being generated
based on the response data, which is sent to and stored in the
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remote database for the given encounter, and based on historical
patient data, corresponding to response data from at least one
previous encounter at the patient unit, to provide a sequence of
steps to be executed at the patient unit for the next encounter at
the patient unit.
THE EVIDENCE
The Examiner relies upon the following as evidence of
unpatentability:
Bossi
Brown
Valk
US 2008/0059228 Al
US 2008/0097170 Al
US 2008/0194924 Al
THE REJECTIONS
Mar. 6, 2008
Apr. 24, 2008
Aug. 14, 2008
The following rejections are before us for review:
claims 1, 3-5, 7-16, and 18-32 are rejected under 35 U.S.C. §103(a)
as being unpatentable over Bossi and Brown,
claim 2 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Bossi, Brown, and Valk, and
claims 29-32 are rejected under 35 U.S.C. § 101 as being directed to
non-statutory subject matter.
ISSUES
The first major issue is whether claims 1, 3-5, 7-16, 21-22 and 29-32
are unpatentable over Brown and Bossi. Specifically, whether Brown
discloses a patient unit that has a communication control module that is
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Application 12/857,118
configured to retrieve encounter instruction data for the patient unit from the
remote database for a given patient encounter and that the encounter
instruction data comprises
a plurality of main sequence steps that include at least one set of
predetermined queries, at least one of the plurality of main
sequence steps being programmed to trigger a conditional branch
of sequence steps in response to detecting an off-nominal
condition at the at least one of the plurality of sequence steps ..
Reply Br. 9.
The second major issue is whether claims 18-20 and 26 are
unpatentable over Brown and Bossi. Specifically, whether Brown and Bossi
teaches an update dosage sequence step that includes a dosage query
requesting that the user enter a dosage confirmation response via the user
interface.
The third major issue is whether claims 23-25, 27, and 28 are
unpatentable over Brown and Bossi. Specifically, whether the combination
of Brown and Bossi teaches
retrieving by the patient unit updated encounter instruction data
from the remote database for a next encounter at the patient unit,
the updated encounter instruction data being generated based on
the response data, which is sent to and stored in the remote
database for the given encounter, and based on historical patient
data, corresponding to response data from at least one previous
encounter at the patient unit, to provide a sequence of steps to be
executed at the patient unit for the next encounter at the patient
unit.
Reply Br. 15.
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ANALYSIS
A. Ground Under 35 U.S.C. § 101
Claims 29-32 are rejected under 35 U.S.C. § 101 as being directed to
subject matter which is not patent eligible. See Final 2. In the Appeal Brief,
Appellants argue, that an After-Final Amendment submitted at the same
time as the Appeal Brief overcomes the rejection. App. Br. 18. The
Examiner, however, did not enter the After-Final Amendment. See Ans. 3,
5---6. Appellants do not make any substantive arguments contesting the
rejection and indicate that Appellants intend to amend claims 29-32 to
overcome the rejection after appeal. See Reply Br. 3. As Appellants do not
contest this rejection, we summarily affirm the rejection of claims 29-32
under 35 U.S.C. § 101.
B. Grounds Under 35 U.S.C. § 103
Section 103 forbids issuance of a claim when the differences between
the subject matter sought to be patented and the prior art are such that the
subject matter as a whole would have been obvious at the time the invention
was made to a person having ordinary skill in the art." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 399 (2007), 35 U.S.C. § 103. The ultimate
determination of obviousness under § 103 is a question of law based on
underlying factual findings. Jn re Baxter Jnt'l, Inc., 678 F.3d 1357, 1361
(Fed. Cir. 2012) (citing Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966)). These underlying factual considerations consist of: (1) the "level of
ordinary skill in the pertinent art[,]" (2) the "scope and content of the prior
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art[,]" (3) the "differences between the prior art and the claims at issue[,]"
and (4) "secondary considerations" of non-obviousness such as "commercial
success, long-felt but unsolved needs, failure of others, etc." KSR, 550 U.S.
at 399 (quoting Graham, 338 U.S. at 17-18).
i. Obviousness over Brown and Bossi
a. Claims 1, 3-5, 7-10, 12-16, 21-22 and 29-32
Independent claim 1 requires a patient unit that has a communication
control module that is configured to retrieve encounter instruction data for
the patient unit from the remote database for a given patient encounter and
requires that the encounter instruction data comprises
a plurality of main sequence steps that include at least one set of
predetermined queries, at least one of the plurality of main
sequence steps being programmed to trigger a conditional branch
of sequence steps in response to detecting an off-nominal
condition at the at least one of the plurality of sequence steps[.]
Reply Br. 9. Independent claim 29 requires a similar limitation. Id. at
16-17.
The Examiner and Appellants dispute whether Brown teaches this
limitation. See Final 4--5, Ans. 3--4, App. Br. 19-21, App. Br. 31-35, Reply
Br. 3--4.
Brown discloses a blood glucose monitoring system. Brown,
Abstract. Figure 12 of Brown is reproduced below.
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2016"' .
2018
SERVER
2026
zau
REMOTE
APPARATUS f
h._,,2030
j
MONITORING
DE~'ICE
2028
1_ ____ _
COMMUNICATION
NETWORK
R.b'MOTE
APPARATUS 2
2032
MONITORJNC
DEVICE
2020
Brown's Figure 12 depicts one embodiment of the blood glucose monitoring
system. Id. i-fi-1 46, 111. The system include a server 2018 and a remote
apparatus 2026 connected to a monitoring device 2028. Id. i1i1 112, 113.
The server 2018 includes a database 203 8 that stores script programs
2040. Id. i-f 114. The rejection cites database 2038 as equivalent to the
claimed remote database. Final 4. Script programs 2040 are executed by the
remote apparatus 2026 to communicate queries and messages to the patient
and to receive responses. Brown i-fi-f 114, 133.
The rejection makes no mention of the limitation in dispute and does
not state which element of Brown corresponds to the claimed encounter
instruction data. See Final 4. The rejection, however, does equate the
claimed patient unit to Brown's blood glucose monitor 16 or monitoring
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devices 20 and 22.4 The rejection also equates the claimed remote database
to Brown's database 2038. Id. Given this, it is implicit that the claimed
encounter instruction data, which includes the conditional branch of the
sequence of steps that are triggered by an off-nominal condition, is
equivalent to Brown's script program 2040. Script programs 2040 are stored
and retrieved from database 2038 and script programs 2040 are executed by
remote apparatus 2026 to query the patient, as required by the claim. Brown
iTiT 114, 133.
In the Answer, the Examiner points to Figures 22A, 22B, 23A and
23B of Brown to teach the limitation at issue and, specifically, points to
Figure 22A as teaching the claimed conditional branch. Ans. 4. Figures
22A and 22B depict a flow-chart showing steps, which the Answer alleges to
include a conditional branch of steps. See Ans. 3--4. Figures 22A and 22B,
however, do not depict the steps of Brown's script program 2040, which is
executed by remote apparatus 2026. Figures 22A and 22B depict steps that
are executed by server 2018. Brown iTiT 57, 132. The alleged conditional
branch steps, thus, are not included in program script 2040, as required by
the claim.
Figures 23A and 23B depict a flow chart showing steps of the script
program 2040, which is executed by remote apparatus 2026. Id. iT 140.
4 In the embodiment depicted in Figure 12, monitoring device 2028
corresponds to blood glucose monitor 16 or monitoring devices 20 and 22.
Compare Brown iT 71 to iT 113.
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Application 12/857,118
Figures 23A and 23B, however, do not depict any conditional branch of
steps that are triggered by an off-nominal condition, as required by the
claim.
Although Brown separately teaches elements of the limitation at issue,
Brown does not teach the elements arranged as required by the claim. The
rejection does not rely upon Bossi to cure this deficiency of Brown. See
Final 4--5. We, thus, reverse the rejection of claims 1 and 29, and claims 3-
5, 7-10, 12-16, 21-22, and 30-32, dependent therefrom, under 35 U.S.C. §
103 over Brown and Bossi.
b. Claim 11
Claim 11 depends from claim 6. Claim 6, however, is canceled. As
claim 11 depends from a canceled claim, the scope of claim 6 is indefinite
under 35 U.S.C. § 112. Since the claims fail to satisfy the requirements
under 35 U.S.C. § 112, we are constrained to reverse, proforma, the
Examiner's rejection under 35 U.S.C. § 103 over Brown and Bossi. See In re
Steele, 305 F.2d 859, 862-63 (CCPA 1962) (A prior art rejection cannot be
sustained if the hypothetical person of ordinary skill in the art would have to
make speculative assumptions concerning the meaning of claim language.);
see also In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) ("If no reasonably
definite meaning can be ascribed to certain terms in the claim, the subject
matter does not become obvious- the claim becomes indefinite.")
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c. Claims 18-20
Independent claim 18 requires that the sequence of predefined steps of
the encounter instruction data includes an update dosage sequence step that
is retrieved from the remote database during execution of the update dosage
sequence step of the given encounter and requires that the update dosage
sequence steps includes a dosage query requesting that the user enter a
dosage confirmation response via the user interface. See Reply Br. 13.
The Examiner and the Appellants dispute whether the combination of
Brown and Bossi teaches this limitation. See Final 10, Ans. 5, App. Br. 28-
29, App. Br. 31-35, Reply Br. 4---6. The rejection cites to i-fi-f 143 and 175 of
Bossi as teaching this limitation. Final 10. However, neither of the cited
paragraphs teach the limitation at issue.
Bossi discloses a system that manages and delivers individual dosages
of medications to a patient. Bossi, Abstract. Paragraph 143 of Bossi
describes a physician, pharmacist, or other licensed healthcare practitioner
reviewing relevant stored data and modifying a dosing schedule or
medication regimen by entering new instructions into the system, but does
not teach entering instructions that require a patient enter a dosage
confirmation response via the user interface, as required by the claim.
Likewise, paragraph 17 5 describes the dangers of a patient receiving an
older dosage of medication before an update dosage is in place, but does not
teach entering instructions that require a patient to enter a dosage
confirmation response via the user interface. Although the cited paragraphs
teach updating a patient's dosage in the system, neither paragraph teaches
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instructing a patient to enter a confirmation of the updated dosage into the
system. The Examiner provides no other evidence or rationale to teach the
limitation at issue.
Accordingly, we reverse the rejection of claim 18, and claims 19 and
20, dependent therefrom, under 35 U.S.C. § 103 over Brown and Bossi.
d. Claims 23-25, 27, and 28
Independent claim 23 recites a method that includes a step of
retrieving by the patient unit updated encounter
instruction data from the remote database for a next encounter
at the patient unit, the updated encounter instruction data being
generated based on the response data, which is sent to and
stored in the remote database for the given encounter, and based
on historical patient data, corresponding to response data from
at least one previous encounter at the patient unit, to provide a
sequence of steps to be executed at the patient unit for the next
encounter at the patient unit.
Reply Br. 15.
Appellants argue that neither Brown nor Bossi disclose this
limitation. App. Br. 32-33. We disagree.
Brown teaches that its system allows a healthcare provide to review
previously collected data in reports and to send changes and instructions to
the patient. See Brown i-fi-185-87, 131. Brown's system includes a script
generator 2050 that generates new script programs 2040 based upon
information entered by a healthcare provider. Id. i-fi-f 132-134, Fig. 22A,
steps 2202, 2204. Similarly, Boss teaches that a healthcare provider can
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retrieve and evaluate a patient's treatment regimen and makes changes to a
patient's medication regime. See Bossi i-fi-f 125, 143.
Given these teachings of Brown and Bossi, we agree with the
Examiner that it would have been obvious to one of ordinary skill in
the art to modify the system of Brown to update the next script
program for a patient based upon the response and measurement data
from a previous script program, in order to efficiently determine
whether a patient's medication regimen should be modified. See Final
13.
Accordingly, we affirm the rejection of claim 23 under 35
U.S.C. § 103(a) over Brown and Bossi. We also affirm the rejection
of claims 24, 25, 27, and 28, which depend from claim 23, under 35
U.S.C. § 103(a) over Brown and Bossi as Appellants do not separately
argue these claims. See App. Br. 34, 37 C.F.R. § 41.37(c)(l)(iv).
e. Claim 26
Claim 26 depends from claim 23 and additionally requires that the
encounter instruction data includes an update dosage sequence step that
includes "requesting that a user enter a confirmation response at the patient
unit to indicate that the user has received the updated dosage for a next
treatment interval." Reply Br. 16. For the same reasons discussed above
with regards to claim 18, we reverse the rejection of claim 26 under 35
U.S.C. § 103 over Brown and Bossi.
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ii. Obviousness of Claim 2 over Brown, Bossi, and Valk
Claim 2 depends from claim 1. Above, we have reversed the rejection
of claim 1 under 35 U.S.C. § 103 over Brown and Bossi. The Examiner
does not rely upon Valk to cure the deficiency of Brown and Bossi discussed
above. See Final 16. Thus, for the same reasons discussed above, the
rejection of claim 2 under 35 U.S.C. § 103 over Brown, Bossi, and Valk is
reversed.
DECISION
The decision of the Examiner to reject claims 1-5, 7-16, 18-22, and
26 is reversed, and the decision to reject claims 23-25 and 27-32 is
affirmed.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a).
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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