Ex Parte Doyle et al

Patent Trial and Appeal Board

Aug 28, 2017

12714248 (P.T.A.B. Aug. 28, 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.
12/714,248 02/26/2010 Peter Doyle H-RM-01639 6322
94654 7590
Covidien LP
ATTN: IP Legal
6135 Gunbarrel Avenue
BOULDER, CO 80301
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
08/30/2017 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):
ip.legal@covidien.com
medtronic_mitg-pmr_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER DOYLE and JOSEPH DOUGLAS VANDINE1
Appeal 2016-003877
Application 12/714,248
Technology Center 3700
Before ERIC B. GRIMES, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method, device, and system for managing a spontaneous
breathing trial in a medical ventilator. Claims 1, 4, 6—15, 19—21, and 23—26
are on appeal as rejected under 35 U.S.C. § 112, second paragraph, and
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as “Covidien LP.” Br. 2.
Appeal 2016-003877
Application 12/714,248
STATEMENT OF THE CASE
The Specification explains, “[mjedical ventilator systems have been
long used to provide supplemental breathing support to patients. . . .
[Spontaneous breathing trials [“SBT”] help to determine whether the patient
is ready to be weaned from ventilator support.” Spec. 1:4—9.
Claims 1, 14, and 20 are the independent claims, are representative,
and are reproduced below (emphasis added to identify Appellants’ argued
limitations; see Br. 24, 29, 32—33, 35, 36—38, 40, 45^47, 48, 50, 54, 55):
1. A method for managing a spontaneous breathing trial in a
medical ventilator, comprising:
initiating a spontaneous breathing trial for a patient being
ventilated on a medical ventilator;
monitoring a plurality of sensors to obtain a plurality of sensor
measurements during the spontaneous breathing trial, wherein
the plurality of sensor measurements are utilized to determine
carbon dioxide elimination levels, spontaneous exhaled minute
volume, and breathing work estimate;
determining whether at least one of carbon dioxide
elimination levels, spontaneous exhaled minute volume, and
breathing work estimate is outside of a desired range for a
predetermined amount of time;
ending the spontaneous breathing trial based on at least a
determination that at least one of the carbon dioxide
elimination levels, spontaneous exhaled minute volume, and
breathing work estimate is outside of the desired range for the
predetermined amount of time;
displaying at least one of the carbon dioxide elimination
levels, spontaneous exhaled minute volume, and breathing work
estimate as a function of time for the spontaneous breathing
trial, and
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displaying the determination that caused the ending of the
spontaneous breathing trial for the patient.
14. A medical ventilator system, comprising:
a processor;
a gas regulator controlled by the processor, the gas regulator
adapted to regulate a flow of gas from a gas supply to a patient
via a patient circuit;
a breath frequency sensor controlled by the processor, the
breath frequency sensor is adapted to measure breath frequency
of the patient;
a spontaneous tidal volume sensor controlled by the
processor, the spontaneous tidal volume sensor is adapted to
measure spontaneous tidal volume of the patient;
wherein the processor calculates an RSBI based on the
measured spontaneous tidal volume and the measured breath
frequency of the patient;
a spontaneous exhaled minute volume sensor controlled by
the processor, the spontaneous exhaled minute volume sensor is
adapted to measure spontaneous exhaled minute volume of the
patient;
a carbon dioxide elimination sensor controlled by the
processor, the carbon dioxide elimination sensor is adapted to
measure carbon dioxide elimination levels of the patient;
a flow sensor controlled by the processor, the flow rate sensor
is adapted to determine the flow rate of the gas delivered to the
patient circuit;
wherein the processor calculates a breathing work estimate
based at least on the flow rate measured by the flow sensor;
a spontaneous breathing trial manager in communication with
the processor, the breath frequency sensor, the spontaneous tidal
volume sensor, the carbon dioxide elimination sensor, the flow
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sensor, and the spontaneous exhaled minute volume sensor, the
spontaneous breathing trial manager comprising:
a threshold monitor module that determines whether
the RSBI calculation and at least one of the exhaled carbon
dioxide elimination levels, the spontaneous exhaled
minute volume, and the breathing work estimate are
outside of a desired range for a predetermined amount of
time, and
a ventilation module that ends the spontaneous
breathing trial based on the RSBI calculation and a
determination that at least one of the exhaled carbon
dioxide elimination levels, the spontaneous exhaled
minute volume, and the breathing work estimate are
outside of the desired range for the predetermined
amount of time ',
a user interface in communication with the processor and the
spontaneous breathing trial manager; and
a display module controlled by the processor, the display
module displays the RSBI and at least one of the carbon dioxide
elimination levels, the breathing work estimate, and the
spontaneous exhaled minute volume of the patient as a function
of time for a spontaneous breathing trial and displays the
reason for ending the spontaneous breathing trial, wherein the
reason includes a listing of any parameter thresholds there
were breached to cause the ending of the spontaneous breathing
trial.
20. A pressure support system comprising:
a processor;
a pressure generating system adapted to generate a flow of
breathing gas controlled by the processor;
a ventilation system including a patient circuit controlled by
the processor;
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a spontaneous exhaled minute volume sensor controlled by
the processor, the spontaneous exhaled minute volume sensor is
adapted to measure spontaneous exhaled minute volume of the
volume of the patient;
a carbon dioxide elimination sensor controlled by the
processor, the carbon dioxide elimination sensor is adapted to
measure carbon dioxide elimination levels of the patient;
a flow sensor controlled by the processor, the flow rate sensor
is adapted to determine the flow rate of the gas delivered to the
patient circuit;
wherein the processor calculates a breathing work estimate
based at least on the flow rate measured by the flow sensor;
a spontaneous breathing trial manager in communication with
the processor, the breath frequency sensor, the spontaneous tidal
volume sensor, the carbon dioxide elimination sensor, the flow
sensor, and the spontaneous exhaled minute volume sensor;
the spontaneous breathing trial manager comprising
a threshold monitor module that determines whether at
least one of the exhaled carbon dioxide elimination levels,
the spontaneous exhaled minute volume, and the breathing
work estimate are outside of a desired range for a
predetermined amount of time, and
a ventilation module that ends the spontaneous
breathing trial based on a determination that at least one
of the exhaled carbon dioxide elimination levels, the
spontaneous exhaled minute, and the breathing work
estimate are outside of the desired range for the
predetermined amount of time ',
a user interface in communication with the processor and the
spontaneous breathing trial manager; and
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a display module controlled by the processor, the display
module displays the determination that caused the ending the
spontaneous breathing trial for the patient.
Br. 57, 60-63 (Claims App’x).
The following rejections are on appeal:
Claims 24—26 stand rejected under 35U.S.C. § 112, second
paragraph, as indefinite. Final Action 3.
Claims 1, 4, 6—10, and 24 stand rejected under 35 U.S.C. § 103(a)
over Viasys,2 Hillsman,3 and Viertio-Oja.4 Id. at 4.
Claims 11—13 stand rejected under 35 U.S.C. § 103(a) over Viasys,
Hillsman, Viertio-Oja, and MacIntyre.5 Id. at 11.
Claims 14, 15, 19—21, 23, 25, and 26 stand rejected under 35 U.S.C.
§ 103(a) over Sanborn,6 Viasys, Viertio-Oja, and Hillsman. Id. at 15.
DISCUSSION
We adopt the Examiner’s findings of fact, reasoning, and
determinations as to the scope and content of the prior art. Only those
arguments made by Appellants in the Brief have been considered in this
2 Roxanne Venard and Angela King, Viasys Healthcare, Clinical Bulletin,
Pulmonetic Systems (March 7, 2007) (“Viasys”).
3 U.S. Patent No. US 6,273,088 B1 (Aug. 14, 2001) (“Hillsman”).
4 U.S. Patent App. Pub. No. US 2011/0108034 A1 (May 12, 2011) (“Viertio-
Oja”).
5 Neil R. MacIntyre, Evidence-Based Guidelines for Weaning and
Discontinuing Ventilatory Support, 120 Chest 375S—95S (2001)
(“MacIntyre”).
6 U.S. Patent App. Pub. No. US 2007/0272242 A1 (Nov. 29, 2007)
(“Sanborn”).
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Decision. Arguments not presented in the Brief are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015).
Indefiniteness
“A claim is indefinite when it contains words or phrases whose
meaning is unclear,” i.e., “ambiguous, vague, incoherent, opaque, or
otherwise unclear in describing and defining the claimed invention.” In re
Packard, 751 F.3d 1307, 1310-13 (Fed. Cir. 2014); see also MPEP
§ 2173.02(1) (Rev. 07.2015, Nov. 2015) (advising examiners that a rejection
for indefmiteness is appropriate “after applying the broadest reasonable
interpretation to the claim, if the metes and bounds of the claimed invention
are not clear”). “[I]f a claim is amenable to two or more plausible claim
constructions, the USPTO is justified in requiring the applicant to more
precisely define the metes and bounds of the claimed invention by holding
the claim unpatentable under 35 U.S.C. § 112, second paragraph, as
indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 2008 WL 5105055, at *5
(BPAI 2008) (precedential). We ask whether one of ordinary skill in the art
would understand what is claimed when the claim is read in light of the
Specification. Power-One, Inc. v. Artesyn Techs., Inc., 599 F.3d 1343, 1350
(Fed. Cir. 2010).
In rejecting claims 24—26 as indefinite, the Examiner stated:
Regarding claims 24-26, the limitation “displaying a breath type
utilized after the ending of the spontaneous breathing trial” of
claim 24 and the comparable limitations of claims 25 and 26 are
indefinite, as it is unclear to what “after the ending of the
spontaneous breath trial” refers. It is unclear if “after the ending
of the spontaneous breath trial” refers to when the breath type is
displayed (e.g., displaying, after an SBT is ended, the type of
breath that was used during the SBT) or if “after the ending of
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the spontaneous breath trial” refers to when the displayed breath
type is utilized (e.g., displaying what breath type is used after an
SBT has ended).
Final Action 3.
Appellants argue that “displaying a breath type utilized after the
ending of the spontaneous breathing trial,” as recited by claim 24 and as
substantially recited by claims 25 and 26, refers both to when the breath type
is utilized and when it is displayed. Br. 22. Appellants argue the
Specification’s 37 and 47 support such an interpretation of this claim
language because, there, it describes that the SBT manager returns a
ventilator to its settings prior to an SBT when the SBT is halted for failing
some predetermined threshold and describes that a display lists the breath
type utilized by the ventilator. This is not persuasive.
The claim language at issue is vague and is inclusive of each of the
interpretations suggested by the Examiner and Appellants. As the Examiner
further stated,
As currently presented, the identified limitation does not
clearly convey Appellant’s asserted intention that “after” refers
to both when the breath type is utilized and when the breath type
is displayed, since at least three possible, reasonable
interpretations have been identified (i.e., that “after” refers to
when the displaying occurs: displaying, after the ending of the
spontaneous breathing trial, a breath type that was utilized; that
“after” refers to what the breath type is during what time: a breath
type that is utilized after the ending of the spontaneous breathing
trial, is displayed; or that “after” refers to both when the
displaying occurs and what the breath type is during the after
time).
Ans. 3. The portions of the Specification cited by Appellants (see Spec.
8:18—9:4, 11:21—28) do not clarify that the claims (or any embodiment of the
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invention) are limited to any one of the possible interpretations. As such, in
view of the above-cited precedent, the claims are indefinite. Such confusion
in claim language meaning might cured by amendment in line with
Appellants’ current contentions on claim interpretation; however, we affirm
the rejection.
Obviousness
“[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (citing U.S. v. Adams,
383 U.S. 39, 50-51 (1966)). “The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” Id. “[Fjamiliar items may have obvious uses
beyond their primary purposes, and in many cases a person of ordinary skill
will be able to fit the teachings of multiple patents together like pieces of a
puzzle.” Id. at 420. As to motivation to combine separately disclosed
subject matter, “the question is whether there is something in the prior art as
a whole to suggest the desirability, and thus the obviousness, of making the
combination.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation
omitted).
1. Obviousness and Claim 1
Upon reviewing the evidence of record in view of the above-cited
precedent, we find the Examiner has established a prima facie case that
claim 1 would have been obvious over Viasys, Hillsman, and Viertio-Oja.
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See Final Action 4—11, 28; Ans. 3—9. Claims 4, 6—10, and 24 were not
argued separately and fall with claim 1.
For example, and most relevant in view of the Appellants’ argued
claim limitations, Viasys discloses “[d]uring the SBT, the clinician should
monitor and assess the patient’s tolerance. The clinician can use one or
more of the criteria listed ... to evaluate for a successful SBT.” Viasys 2
(monitoring during the SBT). The criteria listed by Viasys include: gas
exchange, including PaCO2; hemodynamic stability; stable ventilator
pattern; mental status; appearance, including signs of work of breathing',
rapid shallow breathing index (RSBI) or f/Vt (respiratory rate / tidal
volume).1 Id. at 2—3 (criteria to define tolerance of an SBT). Further,
Hillsman discloses that it is an “object of the invention ... to sense and
signal deficient ventilation on a breath by breath basis in order to monitor
patient safety during the weaning [SBT] process, and therefor[e] to permit
logical termination of the weaning [SBT] trial.” Hillsman 3:60-67.
Hillsman also discloses measuring “Minute Ventilation,” calculating the
“minimum safe Tidal Volume,” and measuring “C02 ... by parallel arterial
blood gas measurements.” Id. at 12:47—13:11, see also id. at 8:29-43.
Moreover, Viertio-Oja discloses, in addition to a central nervous system
sensor, “a gas-analysis monitor” to “measure a gas exchange parameter such
as . . . VC02” is provided to monitor a critical threshold thereof to ascertain
whether an SBT should be terminated. Viertio-Oja 125 (Viertio-Oja also
7 We understand tidal volume (Vt) refers to “[t]he volume of air inhaled or
exhaled in a single breath.” See The American Heritage Medical Dictionary,
tidal-volume, http://www.yourdictionary.com/tidal-
volume#americanheritage, visited Aug. 9, 2017.
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discloses several other types of monitoring sensors, e.g., an
electrocardiograph, a movement sensor, a pulse oximeter, or a spirometer).
Therefore, each of the cited references teaches using sensors to measure
breathing parameters, including those of claim 1, to determine whether an
SBT patient is performing within designated tolerances so as to continue or
terminate the SBT.
Viasys discloses that its ventilator includes a display window and,
e.g., “the patient’s RSBI during the SBT will appear in the display window,”
and “[t]he patient parameters (including PIP, MAP, f, f/Vt, Vte, VE) are
monitored and displayed.” Viasys 2, 5—6. Hillsman discloses “displaying
the ‘primary breathing pattern’ (respiratory tidal volume and rate)” and “a
computer based controlling system that displays the desired breathing
patterns.” Hillsman 4:9—13, 4:39-40. Hillsman discloses the display “could
be in a standard volume/time display[,] wherein the volume and time
parameters are proportionately displayed” and displaying “tidal volume”
versus “respiratory rate cycle time.” Id. at 7:5—10, 7:20-49. Viertio-Oja
discloses measuring and “showing how the responsiveness (R) of a patient
varies over a number of hours” and graphing such responsiveness versus
time. Viertio-Oja 13, 21, Fig. 3. Further, Viertio-Oja discloses that the
SBT duration may be determined based on the patient’s ability to maintain
the proper V02 to VC02 ratio, e.g., shorter than 1 minute or longer than 10
minutes. Id. 126. Thus, these references teach measuring and displaying
relevant patient data, such as RSBI, exhaled tidal volume, effort, minute
ventilation, breathing rate, and CO2 content as a function of time for SBT.
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Hillsman discloses using the above-identified sensed patient data to
ascertain “an objective measure of exhaustion” such that “the weaning trial
[SBT] could then be safely terminated,” that “an alarm could be sounded for
failure to stay within the defined minimum safe Tidal Volume safety
parameters,” and that “[i]f continued failure to achieve minimum respiratory
goals is not achieved then a definable and logical end point of the weaning
trial can be made before the patient is in danger due to acute ventilatory
failure.” Hillsman 4:57—5:3, 13:2—11. Hillsman further discloses the
monitor system “coordinate[s] patient and ventilator action and thus
permit[s] optimal ventilator action,” where “if the patient failed in the
weaning [SBT] trial then the normal functions of ventilator backup support
would activate independently.” Id. at 4:35—36, 8:5—7. Viertio-Oja discloses
determining “[i]f the patient’s VC02 . . . falls below a critical threshold” and
discloses monitoring “for a period of time, such as a number of hours ... to
identify an alert period.” Viertio-Oja 23, 25. Further, Viasys discloses an
SBT is terminated when “[t]he user turns the SBT OFF” or “[a]n SBT alarm
(SBT f, SBT f/VT) has been active for 5
minutes” and “[i]f any SBT alarm remains active for 5 minutes, the
ventilator will resume ventilation with the previous vent settings.” Viasys 2,
5—6. Thus, these references teach that an SBT is to be ended if the measured
patient breathing data veers outside prescribed ranges for too long.
Viasys, as identified above, discloses that if “[a]n SBT alarm (SBT
f, SBT f/VT) has been active for 5 minutes” the
SBT will terminate, and these determinations are displayed. Id. Hillsman,
as identified above, displays the measured patient data leading to ending the
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SBT trial, including via monitoring alarms. Further, Hillsman discloses “the
last minute of actual Tidal Volumes could be displayed and the [Minute
Ventilation] trend displayed on a minute by minute basis.” Hillsman 13:9—
11. Viertio-Oja discloses “[a]fter finishing one or more spontaneous
breathing trials, the controller 18 may compile a summary regarding the
patient’s performance during the spontaneous breathing trial or trials. The
summary may include trend information of parameters such as V02, VC02,
respiration rate, and minute volumes.” Viertio-Oja 131. Thus, each of the
references teaches that the measured patient data used to decide to terminate
the SBT is displayed. In sum, as determined by the Examiner, the combined
references cited thereby render the argued claim limitations obvious.
Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. We address
Appellants’ arguments below.
Appellants argue that neither Viasys (as allegedly acknowledged by
the Examiner) nor the other cited art teaches or suggests the following:
(1) “displaying a basis for the step of ending the SBT”; (2) “displaying at
least one of carbon dioxide elimination levels, spontaneous exhaled minute
volume, and breathing work estimate as a function of time”; (3) “displaying
a determination that at least one of the carbon dioxide elimination levels,
spontaneous exhaled minute volume, and breathing work estimate is outside
of the desired range for the predetermined amount of time.” Br. 23—24.
Appellants argue Hillsman does not teach or disclose the first (1) of
the above-identified, alleged omissions of Viasys because Hillsman
discloses that the display of patient (breathing) performance continues even
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after the performance drops below some negative limit and does not disclose
displaying the end of SBT during performance parameter breaches,
therefore, Hillsman fails to disclose displaying the basis for ending the SBT.
Br. 26—27. Regarding the same argued claim limitation, Appellants further
contend that Viertio-Oja cannot provide such a displaying step because,
although the reference teaches monitoring CO2 levels, aborting the SBT if
the CO2 (relative to O2) elimination falls below a dangerous level, and
compiling a summary page (display) of the CO2, respiratory rate, and minute
volumes data from the SBT leading to its termination, the reference does not
disclose displaying the basis for ending the SBT and the summary is only
compiled after the SBT is finished, leaving one to guess at the reason the
ventilator ended the SBT. Id. at 29—32. These arguments are not persuasive.
As determined by the Examiner, the first (1) alleged-requirement of
claim 1 as argued by Appellants, i.e., displaying (identifying) the basis for
SBT termination, is not a claim limitation. Ans. 6—7. The claim merely
requires that the determination that caused the ending of the SBT is
displayed, not that the system necessarily identifies that the displayed
determination caused this ending. Id. The Examiner determined that
Hillsman’s display of breathing parameters in breach of breathing goals,
which would lead to SBT termination, teaches the limitation at issue. We
agree and, as discussed above, under the broadest reasonable interpretation
of the claim, the cited prior art combination teaches the claim limitation (in
several instances). Our decision is not based on the following, but even if
expressly identifying the patient data that caused the determination to end
the SBT was a limitation, as urged by Appellants, specific alarms and
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displays for individual patient data are disclosed by the references, as
identified above, which would make such an element obvious.
Appellants argue Hillsman does not teach or disclose the second (2) of
the above-identified, alleged omissions of Viasys because Hillsman is
limited to displaying only a universal standard display of single breaths
(inhalation and exhalation), which is not graphed versus time. Br. 24—26.
Appellants’ argument is not persuasive.
Citing Hillsman at 4:52—5:3, 7:5—10, 7:20-49, and 8:15—43, the
Examiner responds to this argument, stating:
Though the time scale may differ for each type of display, both
the standard volume/time display and the primary breathing
pattern display illustrate volume as function of time. As the
claims fail to limit the displaying as a function of time to any
particular time scale, either of the standard volume/time display
or the primary breathing pattern display disclosed by Hillsman
would meet the limitations of Appellant’s “displaying at least
one of spontaneous exhaled minute volume [...] as a function of
time for the spontaneous breathing trial” step.
Ans. 4. We agree and, as discussed above, the cited prior art teaches and
renders obvious the claim limitation.
Appellants argue Hillsman does not teach or disclose the third (3) of
the above-identified, alleged omissions of Viasys because Hillsman does not
teach that minimum respiratory goals are based on CO2 elimination levels
(alleging Hillsman does not teach monitoring CO2 elimination levels), work
estimates (alleging Hillsman does not teach monitoring breathing work
estimate), or exhaled minute volume. Br. 28—29. This argument is not
persuasive.
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The Examiner responded that “Hillsman teaches when continued
failure to achieve minimum respiratory goals is not achieved then a
definable and logical end point of the weaning trial can be made” and
“Hillsman discusses trends in tidal volume and/or minute volume (‘Minute
Ventilation’) as the monitored and displayed parameter(s) upon which it is
determined that respiratory goals are met.” Ans. 7—8 (citing Hillsman 4:52—
5:3). Also, the
[EJxaminer further note[d] that the “displaying at least one of the
carbon dioxide elimination levels [. . .] as a function of time for
the spontaneous breathing trial” limitation does not indicate such
information is displayed during the trial, nor does the claim limit
in what manner the information is displayed (other than “as a
function of time”). The summary disclosed by Viertio-Oja
includes trend information (i.e., information over time) of
monitored parameters obtained during the trial (Viertio-Oja,
1 [0031]), thereby “displaying at least one of the carbon dioxide
elimination levels [. . .] as a function of time for the spontaneous
breathing trial” as claimed.
Id. at 8—9. We note that, as discussed above, each of the cited prior art
references teaches measuring at least one of the claimed patient data
parameters, e.g., CO2 elimination levels and exhaled minute volume, in
particular, and using such measurements to determine the successfulness of
an SBT and whether the trial should be terminated. See, e.g., Viasys 2—3, 5—
6; Hillsman 8:29-43, 12:47—13:11; Viertio-Oja 125. Therefore, we agree
with the Examiner that the claim limitation is taught by the cited art.
For the reasons above we affirm the Examiner’s rejection.
2. Obviousness and Claims 1113
Upon reviewing the evidence of record in view of the above-cited
precedent, we find the Examiner has established a prima facie case that
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claims 11—13 would have been obvious over Viasys, Hillsman, Viertio-Oja,
and MacIntyre. See Final Action 11—15; Ans. 9. Appellants have not
produced evidence showing, or persuasively argued, that the Examiner’s
determinations are incorrect. We address Appellants’ arguments below.
Regarding the rejection of claims 11—13, Appellants argue:
While Macintyre discloses criteria or integrated indexes
utilized for determining a SBT tolerance, Macintyre does not
teach or disclose the display of these criteria or integrated
indexes as a function of time during a SBT. As such, Macintyre
does not teach or disclose displaying at least one of the carbon
dioxide elimination levels, spontaneous exhaled minute volume,
and breathing work estimate as function of time during a
spontaneous breathing trial as required by claim 1.
Br. 34. Further, Appellants argue “[b]y nature of its dependency [from
claim 1], Viasys, Hillsman, Vie[r]tio-Oja and Macintyre also fail to teach or
suggest all the elements of dependent claims 11-13.” Id. at 35.
As discussed above, Appellants’ arguments for the patentability of
claim 1 are not persuasive. Therefore, this argument is also not persuasive
and we affirm the rejection.
3. Obviousness and Claims 14 and 20
Upon reviewing the evidence of record in view of the above-cited
precedent, we find the Examiner has established a prima facie case that
claims 14 and 20 would have been obvious over Sanborn, Viasys, Hillsman,
and Viertio-Oja. See Final Action 15—21, 23—27; Ans. 9—14. Claims 15, 19,
21, 23, 25, and 26 were not argued separately and fall with claims 14 and 20.
We find that claims 14 and 20 recite similar elements to those of
claim 1 argued by Appellants. We will not restate the relevant teachings of
Viasys, Hillsman, and Viertio-Oja, but note that the limitations regarding
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determining whether exhaled CO2, exhaled minute volume, and/or breathing
work estimate are outside predefined thresholds for some time, and
displaying the same data where it breaches predetermined thresholds causing
SBT ending, are taught or suggested by these references, as discussed above.
The Examiner found that Sanborn teaches a medical ventilator system
having a processor and a ventilation control system (i.e., a module) to
control ventilation support based on data received from related patient
sensors, and that it would have been obvious to combine Sanborn with the
other cited references discussed above. Final Action 15—20. We note, the
other cited art also disclose ventilator controls based on measured patient
breathing data under SBT.
Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. We address
Appellants’ arguments below.
Appellants’ arguments essentially restate their contentions regarding
the patentability of claim 1 over the similarly cited prior art (other than
Sanborn, which is not cited by the Examiner for teaching the argued
limitations). For example, similar to the argument made for claim 1,
Appellants argue that Viertio-Oja cannot supply a teaching that the basis for
ending an SBT is displayed, although the references does disclose measuring
CO2, respiration rate, and minute volumes and related trend information,
using such data to abort an SBT, and generating a summary (display) of such
information. Br. 38—39, 49—51. Appellants also argue, again similar to their
arguments for claim 1, that Hillsman does not teach displaying patient data,
e.g., exhaled minute volume, versus time and does not teach displaying the
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Appeal 2016-003877
Application 12/714,248
basis for ending the SBT. Id. at 41—44, 51—54. These arguments are not
persuasive for the reasons set forth above regarding the rejection of claim 1.
For the reasons discussed above, we affirm this rejection.
SUMMARY
The obviousness rejections are each affirmed.
TIME PERIOD FOR RESPONSE
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
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