Ex Parte Kracker

Patent Trial and Appeal Board

Jan 24, 2018

12164776 (P.T.A.B. Jan. 24, 2018)

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.
12/164,776 06/30/2008 Stefan G. Kracker P0032522.00/LG10126.L33 1863
27581 7590 01/26/2018
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
EISEMAN, ADAM JARED
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
01/26/2018 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEFAN G. KRACKER
Appeal 2017-000223
Application 12/164,7761
Technology Center 3700
Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
DEBORAH KATZ, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to systems and
methods for controlling the operation of devices that measure the oxygen
saturation levels of patients. The Examiner entered two rejections for
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm the first obviousness rejection, except as to two claims.
We affirm the second obviousness rejection, except as to one claim.
1 Appellant states that the “real party in interest is Medtronic pic of Dublin,
Ireland, which is the ultimate parent entity of the assignee of record,
Medtronic, Inc. of Minneapolis, MN.” Appeal Br. 3.
Appeal 2017-000223
Application 12/164,776
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 15, 17—21, 24—29, and 31, under 35 U.S.C. § 103(a), as
being unpatentable over McCutcheon2 (Ans. 2—6); and
(2) Claims 22, 23, 33, 35, and 36, under 35 U.S.C. § 103(a), as being
unpatentable over McCutcheon and Bhunia3 (id. at 6—8).
Claim 15 is representative and reads as follows (Appeal Br. 18 (some
indentation added)):
Claim 15: A system comprising:
a memory;
an optical perfusion sensing module configured to
generate an electrical signal indicative of a blood oxygen
saturation level of a patient; and
a processor configured to receive the electrical signal
from the optical perfusion sensing module, determine a
perfusion value based on the electrical signal is within a
threshold range of values, store at least one of the electrical
signal or the perfusion value in the memory, and modify an
operation of the optical perfusion sensing module in response to
determining the perfusion value is within the threshold range of
values,
wherein the modification of the operation comprises,
while the optical perfusion sensing module remains powered
on, stopping storage of any electrical signals indicative of the
blood oxygen saturation level of the patient generated by the
optical perfusion sensing module in the memory.
2 US 2009/0247849 A1 (published Oct. 1, 2009).
3 US 2007/0239053 A1 (published Oct. 11, 2007).
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Application 12/164,776
OB VIOUSNES S—MCCUTCHEON
The Examiner’s Prima Facie Case
In rejecting claims 15, 17—21, 24—29, and 31, the Examiner cited
McCutcheon as teaching or suggesting a system having nearly all of the
steps and features recited in the rejected claims, but found that McCutcheon
differed from the rejected claims in that “McCutcheon does not explicitly
disclose that the processor stops storage of all/any electrical signals
indicative of the blood oxygen saturation level when the perfusion value is
within the threshold range of values” as recited in Appellant’s claims 15 and
27. Ans. 3 (citing McCutcheon || 21—79, Figs. 1—9).
As evidence that it would have been obvious to modify McCutcheon’s
system to include that feature, the Examiner cited McCutcheon as disclosing
that its system enters a low power mode upon detecting an oxygen perfusion
level within a threshold range, noting in particular McCutcheon’s teaching
that, in the low power mode, ‘“the type and amount of data generated by the
pulse oximeter, including how it is analyzed, stored and displayed may
vary’.” Id. at 4 (quoting McCutcheon | 50).
Therefore, the Examiner reasoned, “McCutcheon contemplates
modifying the storage of the measured/determined signal indicative of blood
oxygen saturation level to the memory while in the low power mode when
the parameter is within a threshold range of values.” Id.
Based on those teachings, the Examiner concluded that it would have
been obvious
to modify McCutcheon’s system so that it does not store any
electrical signal indicative of blood oxygenation level to
memory while the signal is in the threshold range as obvious to
try, choosing from a finite number of identified predictable
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Application 12/164,776
solutions (either the amount of data stored to memory is the
same, less than, or none; until in the system switches to the high
power mode again when the signal is out of the threshold range
of values).
Id.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Appellant separates the argument traversing the Examiner’s first
rejection into four groups. Appeal Br. 7—13. We select claim 15 as
representative of the claims in the first group. 37 C.F.R. § 41.37(c)(l)(iv).
Appellant does not persuade us that the preponderance of the evidence
does not support the Examiner’s prima facie case of obviousness as to claim
15. In particular, Appellant does not persuade us (see Appeal Br. 7—9; Reply
Br. 2—A) that modifying McCutcheon’s system, so that no signals relating to
oxygen saturation are stored during McCutcheon’s low power mode, as
recited in claim 15, would change the system’s principle of operation.
Claim 15 recites a system that has an optical sensing module that
generates signals indicative of a patient’s blood oxygen saturation level.
Appeal Br. 18. Claim 15’s system also includes a memory. Id.
Claim 15’s system also includes a processor that determines whether
the patient’s blood oxygen saturation level is within a threshold range. Id.
When the processor determines that the patient’s blood oxygen saturation
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level is within the threshold range, the processor stops the system from
storing, in the memory, any signals indicative of the blood oxygen saturation
level of the patient generated by the optical perfusion sensing module. Id.
McCutcheon, like claim 15, describes a system that has an optical
sensing module that generates signals indicative of a patient’s blood oxygen
saturation level. See McCutcheon, abstract (disclosing “systems and
methods for reducing power consumption of a pulse oximeter”).
Similar to claim 15, McCutcheon’s system includes a processor that
changes the system’s mode of operation when it receives signals indicating
that the patient’s blood oxygen saturation is within a threshold range. See id.
(McCutcheon’s system “operates] a pulse oximeter in a high power mode,
the pulse oximeter using a sensor to generate data indicative of the oxygen
saturation of the patient’s blood at a first resolution and switching the pulse
oximeter to a low power mode upon detection of data indicative of a non-
critical situation”) (emphasis added).
As Appellant contends, McCutcheon discloses certain embodiments in
which the pulse oximetry data is monitored during the low power mode, to
allow the system to determine whether it should switch back to high power
mode. See, e.g., id. 148 (“[T]he determination operation 308 may determine
that the oximeter should operate in a high power mode if the data does not
match any data profiles associated with a low power mode . . . .”).
In certain embodiments, however, the switch from low power mode to
high power mode is not based on pulse oximetry data indicating that a
switch from low power to high power is required. Specifically, McCutcheon
discloses embodiments in which the switch from low power mode to high
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power mode is based on whether a predetermined amount of time elapses
after the system switches to low power mode.
For example, in one embodiment, the processor may “determine[]
from the data that [the] patient is moving. This may be determined from the
pulse oximetry data itself. . . .” McCutcheon | 67; see also id. at Fig. 5
(describing movement-associated embodiment).
The processor then performs “a switching operation” in which “the
pulse oximeter is switched to a low power mode corresponding to the
movement data profile. The low power mode associated with movement may
be a mode in which no measurements are taken or any one or more of the
low power modes described . . . [previously].” Id. (emphasis added).
In the movement-associated embodiment, the system “remains in the
low power mode for a predetermined time interval and[] after the time
interval has elapsed, returns the pulse oximeter to the high power mode in
high power mode operation.” Id. 168.
In the next embodiment described in McCutcheon, “a data profile is
provided that is indicative of the data received from a patient with a stable
pulse and stable oxygen saturation.” Id. 169. Upon receiving data
indicative of a stable patient, “a switching operation ... is performed in
which the pulse oximeter is switched to a low power mode corresponding to
the stable patient data profile. The low power mode associated with a stable
patient may be any one or more of the low power modes described above.'1'’
Id. 170 (emphasis added).
In the patient stability-associated embodiment, as in the movement-
associated embodiment, the system “remains in the low power mode for
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another predetermined time interval and, after the time interval has elapsed,
returns the pulse oximeter to the high power mode . . . Id. 171.
Similar to the two previous embodiments described in the reference,
McCutcheon discloses an embodiment in which the data indicates inaccurate
oxygen saturation measurements are occurring, resulting in a switch to a low
power mode, which “may be a mode in which no measurements are taken,”
and in which the system “may return to a high power mode . . . after the
expiration of a predetermined time period . . . Id. 173.
Given McCutcheon’s description of a low power mode in which no
data measurements are taken, and in which the switch back to high power
mode is based solely on the passage of a predetermined amount of time, we
agree with the Examiner that an ordinary artisan would have considered it
obvious to stop storing signals relating to blood oxygen saturation during
that low power mode, as recited in Appellant’s claim 15. Because no blood
oxygen saturation measurements are taken during that low power mode, and
because the switch back to high power mode is based on the passage of time
rather than data indicating a requirement for a switch, Appellant does not
persuade us that modifying McCutcheon in the manner posited by the
Examiner would change the principle of operation of McCutcheon’s system.
Moreover, given McCutcheon’s description of a low power mode in
which no data measurements are taken, and in which the switch back to high
power mode is based solely on the passage of a predetermined amount of
time, Appellant does not persuade us (see Appeal Br. 9) that McCutcheon
teaches away from claim 15’s stopping storage of signals relating to blood
oxygen saturation during that low power mode, nor are we persuaded (see
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id. at 10; Reply Br. 3—6) that the Examiner erred in considering it obvious to
try such a modification of McCutcheon’s system.
In sum, Appellant does not persuade us, for the reasons discussed, that
the preponderance of the evidence fails to support the Examiner’s
conclusion of obviousness as to claim 15. We, therefore, affirm the
Examiner’s rejection of claim 15 over McCutcheon. Because they were
argued in the same grouping as claim 15 (Appeal Br. 7), claims 17—21, 24,
25, and 31 fall with claim 15. See 37 C.F.R. § 41.37(c)(l)(iv).
Turning to the next claim grouping argued by Appellant, claim 26
recites “[t]he system of claim 15, further comprising a cardiac signal sensing
module, wherein the processor controls an operation of the cardiac signal
sensing module based on the electrical signal generated by the optical
perfusion sensing module.” Appeal Br. 20.
As to claim 26, Appellant contends that McCutcheon “has not been
shown to have described that an operation of a cardiac sensing module is
controlled based on a signal generated by an optical perfusion sensing
module.” Appeal Br. 11—12.
The Examiner responds that paragraphs 74 and 75 of McCutcheon
disclose “the cardiac sensing module (EKG) wherein operation of the EKG
and optical perfusion detector are controlled and handled by the processor in
response to the electrical signal generated by either the EKG or optical
perfusion detector.” Ans. 11.
In this instance, we conclude that Appellant has the better position.
In the embodiment cited by the Examiner, McCutcheon discloses that,
“[w]hen a pulse oximeter is used in conjunction with an electrocardiograph,
the caregivers have a second method of monitoring the heart function of a
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Application 12/164,776
patient. Such a situation may be considered non-critical for pulse oximetry
measurements because proper heart function can be determined directly
from the electrocardiograph.” McCutcheon 174.
Thus, when McCutcheon’s system “detect[s]. . . data generated by the
electrocardiograph to which the oximetry has access . . . , a switching
operation 804 identifies a low power mode for use by the oximeter in
conjunction with the electrocardiograph.” Id. 175. After switching to a low
power mode, the “system may return to a high power mode upon detection
of a change in data being generated or after the expiration of a
predetermined time period . . . .” Id.
Accordingly, although McCutcheon’s switch to low power mode in
this embodiment occurs when the system detects the presence of an EKG
machine, McCutcheon does not disclose that the EKG machine is controlled
by the system’s processor “based on the electrical signal generated by the
optical perfusion sensing module” as claim 26 requires. See Appeal Br. 20.
Because Appellant persuades us, therefore, that a preponderance of the
evidence does not support the Examiner’s conclusion of obviousness as to
claim 26, we reverse the Examiner’s rejection of that claim over
McCutcheon.
Turning to the next claim grouping argued by Appellant, claim 27
recites a system having essentially the same elements as recited in claim 15,
discussed above, but claim 27 recites those elements using “means for”
language. Appeal Br. 20.
Appellant’s arguments regarding claim 27 are essentially the same as
those addressed above in relation to claim 15. See id. at 12 (arguing no
reason to modify McCutcheon to stop storing signals indicative of blood
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oxygen saturation level; also arguing, “for reasons analogous to those stated
above with respect to independent claim 15 (Group 1), one o[f] ordinary
skill in the art would not have had any reason to modify McCutcheon’s
system in the manner proposed by the Examiner in order to arrive at the
invention of claim 27”).
Because, for the reasons discussed above as to claim 15, we do not
find these arguments persuasive, we affirm the Examiner’s rejection of claim
27. Because it was argued in the same grouping as claim 27 (Appeal Br. 12—
13), we also affirm the Examiner’s rejection of claim 28. See 37 C.F.R.
§ 41.37(c)(l)(iv).
Turning to the next claim grouping argued by Appellant, claim 29
recites “[t]he system of claim 27, further comprising means for controlling
an operation of a cardiac signal sensing module based on the electrical
signal.” Appeal Br. 21.
Claim 29, thus, requires the claimed system to be able to control the
cardiac signal sensing module based on a signal indicative of blood oxygen
saturation, similar to claim 26 discussed above.
As discussed above regarding claim 26, in the embodiment cited by
the Examiner, McCutcheon’s switch to low power mode occurs when the
system detects the presence of an EKG machine, but McCutcheon does not
disclose that the EKG machine is controlled by the system’s processor based
on the electrical signal generated by the optical perfusion sensing module as
claim 29 requires. See McCutcheon || 74—75. Because Appellant
persuades us, therefore, that a preponderance of the evidence does not
support the Examiner’s conclusion of obviousness as to claim 29, we reverse
the Examiner’s rejection of that claim over McCutcheon.
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OBVIOUSNESS—
MCCUTCHEON AND BHUNIA
The Examiner’s Prima Facie Case
In rejecting claims 22, 23, 33, 35, and 36, the Examiner relied on the
teachings in McCutcheon, discussed above, and cited Bhunia as evidence
that
it would have been obvious to one of ordinary skill in the art at
the time of the invention to modify McCutcheon’s system to
switch the system from a low power mode to a high power
mode to modify operation of the optical perfusion sensing
module in response to detecting a cardiac arrhythmia in the
sensed cardiac signal as taught by Bhunia in order to confirm a
cardiac arrhythmia and all parameters associated therewith.
Ans. 7—8.
Analysis
In the first group of claims argued by Appellant in relation to this
ground of rejection (claims 22, 23, and 35), and in the final group argued
(claim 36), Appellant relies on the arguments addressed above as to claims
15 and 27, and in addition contends only that Bhunia does not remedy the
previously argued deficiencies as to McCutcheon. Appeal Br. 14, 17.
Because, for the reasons discussed above, we do not find those
arguments persuasive, we affirm the Examiner’s rejection of claims 22, 23,
35, and 36.
Claim 33, the remaining claim argued separately, reads as follows:
The system of claim 15, further comprising a cardiac
signal sensing module configured to monitor a cardiac signal
indicative of electrical activity of a heart of the patient, wherein
the processor is configured to modify a monitoring frequency of
the cardiac signal by the cardiac signal sensing module
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responsive to the perfusion value being within the threshold
range of values.
Appeal. Br 21.
Appellant contends that “the Examiner failed to show a disclosure or
suggestion in Bhunia of at least ‘modif/Eng] a monitoring frequency of the
cardiac signal by the cardiac signal sensing module responsive to the
perfusion value being within the threshold range of values, ’ as recited in
claim 33.” Appeal Br. 15 (citation omitted, emphasis by Appellant).
The Examiner responds that Bhunia “provides motivation for the
modification as described (namely from paragraph [0047] and figure 4 of
Bhunia) to confirm the detection algorithm and record data with regards to
the cardiac episode.” Ans. 12.
We conclude that Appellant has the better position, in this instance.
We acknowledge Bhunia’s disclosure that, once cardiac signal data
indicative of a “malignant cardiac event” is detected (Bhunia 147), Bhunia’s
system then uses optical data from multiple wavelengths to measure
variation in tissue oxygenation, to, thereby, confirm whether the cardiac
signal data is truly indicative of an unstable cardiac rhythm {id. 148).
Claim 33, however, requires the monitoring frequency of the cardiac
signal to be modified in response to the oxygen perfusion value being within
the threshold range of values. Appeal Br. 21. We are not persuaded that the
Examiner has explained adequately how Bhunia’s teaching, in which the
oxygen saturation data is used in response to the detection of a potential
cardiac event, teaches or suggests the essentially opposite configuration
recited in claim 33, in which the cardiac monitoring frequency is modified in
response to oxygen saturation data.
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Accordingly, because we are not persuaded, for the reasons discussed,
that the Examiner has explained adequately why the combination of
McCutcheon and Bhunia teaches or suggests a system having all of the
features of the system recited in claim 33, we reverse the Examiner’s
rejection of that claim over those references.
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 15, 17—21, 24, 25, 27, 28, and 31, under 35 U.S.C. § 103(a), for
obviousness over McCutcheon.
However, for the reasons discussed, we reverse the Examiner’s
rejection of claims 26 and 29, under 35 U.S.C. § 103(a), for obviousness
over McCutcheon.
For the reason discussed, we affirm the Examiner’s rejection of claims
22, 23, 35, and 36, under 35 U.S.C. § 103(a), for obviousness over
McCutcheon and Bhunia.
However, for the reason discussed, we reverse the Examiner’s
rejection of claim 33, under 35 U.S.C. § 103(a), for obviousness over
McCutcheon and Bhunia.
TIME PERIOD
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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