Ex Parte Stahmann et al

Patent Trial and Appeal Board

Jun 21, 2017

13933628 (P.T.A.B. Jun. 21, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/933,628 07/02/2013 Jeffrey E. Stahmann 279.857US3 3252
45458 7590 06/23/2017
smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER
PO BOX 2938 NGUYEN, HUONG Q
MINNEAPOLIS, MN 55402
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
06/23/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY E. STAHMANN,
JOHN D. HATLESTAD, and JESSE W. HARTLEY
(Applicant: Cardiac Pacemakers, Inc.)
Appeal 2016-005496
Application 13/93 3,62 s1
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RICHARD J. SMITH, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a system that
senses thoracic impedance as well as a neurohormone or creatine level. The
Examiner rejected the claims as lacking enablement, as indefinite, and for
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses that, in “pulmonary edema, fluid
accumulates in extracellular spaces, such as the spaces between lung tissue
1 Appellants state that the “real party in interest of the above-captioned
patent application is the assignee, Cardiac Pacemakers, Inc.” App. Br. 2.
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cells. One cause of pulmonary edema is congestive heart failure (CHF). . .
Spec. 1.
The Specification explains that pulmonary edema may be detected by
“monitoring an impedance of a subject’s thoracic cavity. ... In pulmonary
edema, a reduction in thoracic impedance indicates an increase in the
amount of fluid inside the subject’s lungs.” Id. at 6. The Specification
discloses that thoracic impedance can be measured by measuring the current
across electrodes implanted at different locations in a patient’s thorax. Id. at
8.
The Specification discloses a system that uses not only a patient’s
thoracic impedance as a measure of pulmonary edema, but also uses the
patient’s “neurohormone level (particularly the neurohormone level referred
to in the art as brain (also known as ‘B-type’) natriuretic peptide (BNP)). . .
as a pulmonary edema related factor.” Id. at 21 (reference number omitted).
As explained in the Specification, an “increase in BNP may correlate to an
indication of pulmonary edema. Serum levels of BNP can help identify
CHF as the origin of dyspnea, which is commonly referred to ‘shortness of
breath.’ Serum levels of BNP > 500 pg/ml are most consistent with
CHF.” Id.
Claim 1 is representative, and reads as follows (App. Br. 14):
1. A system comprising:
an implantable thoracic impedance measurement
circuit, adapted to sense a thoracic impedance signal from a
subject;
a parameter collection device, adapted to sense or
receive physiologic information about the subject, the
physiologic information selected from a physiologic
information group including at least one of a neurohormone
level or a creatinine level; and
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a processor, coupled with the thoracic impedance
measurement circuit to accept the thoracic impedance signal,
and coupled with the parameter collection device to accept the
physiologic information,
wherein the processor is adapted to determine a
pulmonary edema indication using the thoracic impedance
signal and the physiologic information, wherein the thoracic
impedance signal is adjusted in view of the physiological
information or a thoracic impedance threshold is adjusted in
view of the physiological information.
The Examiner entered and maintained the following rejections:
(1) Claims 5, 6, and 8, under 35 U.S.C. § 112, first paragraph, as
failing to comply with the enablement requirement (Final Action 2—3
(entered April 10, 2015); Ans. 2);
(2) Claims 5, 6, and 8, under 35 U.S.C. § 112, second paragraph, as
indefinite (Final Action 3^4; Ans. 2);
(3) Claims 1, 3, 4, 7—9, 12, 14, 16, and 17, under 35 U.S.C. § 103(a),
for obviousness over Combs2 and Florio3 (Final Action 5—7; Ans. 2);
(4) Claim 2, under 35 U.S.C. § 103(a), for obviousness over Combs,
Florio, Zhu,4 and Er5 (Final Action 7—8; Ans. 2);
(5) Claim 5, under 35 U.S.C. § 103(a), for obviousness over Combs
and Florio, combined with either Kadhiresan6 or Wang7 (Final Action 9;
Ans. 2);
2 US 6,512,949 B1 (issued Jan. 28, 2003).
3 US 2004/0186523 A1 (published Sept. 23, 2004).
4 US 2003/0191503 A1 (published Oct. 9, 2003).
5 US 6,266,565 B1 (issued July 24, 2001).
6 US 5,974,340 (issued Oct. 26, 1999).
7 US 2004/0215097 A1 (published Oct. 28, 2004).
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(6) Claims 6 and 13, under 35 U.S.C. § 103(a), for obviousness over
Combs, Florio, and Belalcazar8 (Final Action 9-10; Ans. 3);
(7) Claims 10 and 11, under 35 U.S.C. § 103(a), for obviousness over
Combs, Florio, and Girouard9 (Final Action 11; Ans. 3); and
(8) Claim 15, under 35 U.S.C. § 103(a), for obviousness over Combs,
Florio, and Er (Final Action 11—12; Ans. 3).
INDEFINITENESS
In rejecting claims 5, 6, and 8 as indefinite, the Examiner concluded
that “the term ‘module’ has not been clearly defined by the specification to
be hardware or software and thus renders the claims indefinite. It is noted
that paragraph 0056 appears to state that said modules may be software or
firmware.” Final Action 4.
As the Examiner noted (Ans. 3), the Appeal Brief did not address this
rejection. See App. Br. generally. The Reply Brief also does not include
argument directed to this rejection. See Reply Br. generally.
Given the absence of substantive argument directed to this rejection,
we summarily affirm it. See MPEP § 1205.02 (Arguments and evidence not
presented in an appeal brief “are waived for purposes of the appeal and the
Board may summarily sustain any grounds of rejections not argued.”).
ENABLEMENT
In rejecting claims 5, 6, and 8 as lacking enablement, the Examiner
concluded that Appellants’ Specification “does not make clear what the
‘module’ recited in said claims refers to, therefore preventing one of
8 US 2004/0102712 A1 (published May 27, 2004).
9 US 2003/0055461 A1 (published Mar. 20, 2003).
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ordinary skill in the art from being able to make the device. Thus the claims
are not enabled.” Final Action 2—3.
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.
Appellants do not argue the claims subject to this ground of rejection
separately. We select claim 5 as representative of the rejected claims.
37C.F.R. §41(c)(l)(iv).
Claim 5 reads as follows:
5. The system as recited in claim 1, further comprising:
a blood impedance measurement circuit, adapted to sense
a blood impedance signal from the subject; and
a blood impedance correction module coupled with the
blood impedance measurement circuit,
wherein the blood impedance correction module is
adapted to extract from the thoracic impedance signal a blood
resistivity-influenced component using the blood impedance
signal, and
wherein the processor is adapted to determine the
pulmonary edema indication using, at least in part, a blood
resistivity-compensated thoracic impedance signal.
App. Br. 15 (emphasis added).
As evidence that a skilled artisan would be able to make the module
recited in claim 5 based on the disclosures in the Specification, Appellants
cite the following passage:
FIG. 3 illustrates one conceptualization of various
circuits, sensors, devices, or modules which are implemented
either in hardware or as one or more sequences of steps carried
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out on a microprocessor or other controller. Such circuits,
sensors, devices, or modules are illustrated separately for
conceptual clarity; however, it is to be understood that the
various circuits, sensors, devices, or modules of FIG. 3 need not
be separately embodied, but may be combined or otherwise
implemented, such as in software or firmware.
Spec. 18-19.
Based on this disclosure, Appellants contend that “a ‘module’ as
recited in the claims can be ‘implemented either in hardware or as one or
more sequences of steps carried out on a microprocessor or other controller.’
Accordingly, one of skill in the art would be enabled to make such a
device.” App. Br. 9. In particular, Appellants contend, “[n]o undue
experimentation would be needed to practice the invention. It would be
straightforward for a designer to choose the appropriate hardware or
software to perform the functions described.” Id.
We find that the preponderance of the evidence supports the
Examiner’s position.
As our reviewing court has explained, while the Specification need
not disclose what is well known in the art, “that general, oft-repeated
statement is merely a rule of supplementation, not a substitute for a basic
enabling disclosure. It means that the omission of minor details does not
cause a specification to fail to meet the enablement requirement.”
Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366, (Fed. Cir. 1997)
(citation omitted).
Similar to the situation here,
when there is no disclosure of any specific starting material or
of any of the conditions under which a process can be carried
out, undue experimentation is required; there is a failure to meet
the enablement requirement that cannot be rectified by asserting
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that all the disclosure related to the process is within the skill of
the art. It is the specification, not the knowledge of one skilled
in the art, that must supply the novel aspects of an invention in
order to constitute adequate enablement. This specification
provides only a starting point, a direction for further research.
Id.
Despite their assertion that making a module with the functionality
recited in claim 5 would be straightforward, Appellants do not explain with
adequate particularity, or advance persuasive evidence demonstrating, how
the cited disclosures in the Specification demonstrate that the blood
impedance module can be implemented in hardware or software. In
particular, neither the passage cited by Appellants, nor Figure 3, provides the
specific steps and components that are to be employed to make a blood
impedance module having the functionality required by claim 5.
We, therefore, affirm the Examiner’s rejection of claim 5 for lack of
enablement. Claims 6 and 8 fall with claim 5. 37 C.F.R. § 41(c)(l)(iv).
OBVIOUSNESS—COMBS AND FLORIO
The Examiner’s Prima Facie Case
We select claim 1 as representative of the claims subject to this
rejection. 37 C.F.R. § 41(c)(l)(iv).
In rejecting claim 1 over Combs and Florio, the Examiner cited
Combs as describing a pulmonary edema monitoring system including a
thoracic impedance unit, as required by claim 1. Final Action 5. The
Examiner found that, similar to claim 1, Combs’ device included a device
capable of sensing physiologic information, such as respiration rate, as well
as the capability of determining a pulmonary edema indication based on
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measuring the thoracic impedance in combination with the secondary
physiologic information. Final Action 5.
The Examiner found that Combs’ system differed from the system of
Appellants’ claim 1 in that Combs did not “disclose said physiological
information being at least one neurohormone level or a creatinine level.” Id.
at 6.
As evidence that it would have been obvious to monitor at least one
neurohormone level or a creatinine level, as required by claim 1, the
Examiner cited Florio as disclosing that “BNP - a neurohormone - increases
with pulmonary edema.” Id. (citing Florio | 82). The Examiner found,
moreover, that it was “well known in the art that indicators of pulmonary
edema include at least heart sounds, creatinine level, B-type natriuretic
peptide (BNP) level - a neurohormone, excessive perspiration, pallor, and
anxiety.” Id.
Based on the references’ combined teachings, the Examiner
concluded that it would have been obvious to modify Combs’ device to
sense or receive a neurohormone level as taught by Florio “to effectively
improve the pulmonary edema indicator function of Combs et al by
advantageously providing more and different parameters to more accurately
determine the onset of pulmonary edema, wherein in combination the
thoracic impedance signal is adjusted in view of the physiological
information.” Id.
Analysis
Appellants do not persuade us that preponderance of the evidence fails
to support the Examiner’s prima facie case that the system of claim 1 would
have been obvious to an ordinary artisan.
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Combs discloses a system composed of “implantable devices
including but not limited to tissue stimulators having measurement
capability for determining impedance measurements and is particularly well
suited to measure long term edema variations within a living body.” Combs
1:7—11. Combs explains that it “is commonly understood that Transthoracic
Impedance measurements give a good indication of the level of edema in
patients.” Id. at 1:15—17.
In one embodiment, Combs discloses that the impedance monitoring
circuit can be part of a pacemaker system. Id. at 5:36-40. As the Examiner
found, Combs explains that, in that system, as in Appellants’ claim 1,
physiologic information in addition to the thoracic impedance information
can be used to adjust the threshold at which the device is activated:
For additional beneficial data generation purposes other sensors
may be included in the implanted device and data therefrom
temporally matched with edema data to provide additionally
beneficial diagnostic data. Each sensor can be thought of as a
system for providing an indication of patient condition, either
when it’s [sic] output is taken alone or combined in manners
known to those in the art to determine patient condition. Such
included sensor systems or subsystems could include, for
example, diurnal cycle indicators, position or posture
indicators, resting indicators, heart beat cycle indicators,
breathing indicators, movement indicators, and so forth, each
providing a signal value that could be stored or used to trigger
an activity of the implanted device.
Id. at 5:43—55 (emphasis added).
Combs also focuses on respiratory rate as the type of physiologic
information to be used alongside thoracic impedance in its pulmonary
edema-monitoring system (Combs 2:39-53), and discloses that the
respiration rate and thoracic impedance data can be combined in evaluating
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the patient’s status, as well as adjusting an alarm threshold, as the Examiner
also found, and as required by Appellants’ claim 1:
A device can be constructed using the respiration rate as
described alone or in combination with the DC impedance
measurement of edema described above. If both are used a
mixed value should ultimately be relied upon to indicate the
level of edema the patient is subjected to. Many ways can be
devised to combine these signals, including simply adding them
throughout the potential range and using the total value for the
indicator; relying on one measure only, in situations where it is
superior, or simply recording both separately and reporting
them out through telemetry for analysis together by a doctor or
other attendant (human or automatic). Alarms can be initiated
thorough whatever patient or doctor communication system is
used with the device at whatever level is programmed in for the
variable or variables used to evaluate these measures of edema.
Id. at 15:16—30 (emphasis added).
Combs does not appear to describe using a neurohormone level or a
creatinine level to adjust the threshold of a pulmonary edema indication, as
required by claim 1. The Examiner found, nonetheless, and Appellants do
not dispute, that increased BNP and creatinine levels were known in the art
to be associated with pulmonary edema. Final Action 6.
Thus, given that increased BNP and creatinine levels undisputedly
were known in the art to be associated with pulmonary edema, and given
Combs’ teaching of the desirability of using a variety of physiologic
information, such as respiratory rate, to adjust thoracic impedance-based
pulmonary edema indication thresholds, we agree with the Examiner that an
ordinary artisan had good reason for, and a reasonable expectation of
success in, using a neurohormone level or a creatinine level to adjust the
threshold of a pulmonary edema indication, as required by claim 1. We,
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therefore, also agree with the Examiner that the system recited in
Appellants’ claim 1 would have been obvious to an ordinary artisan.
Appellants’ arguments do not persuade us to the contrary.
Appellants contend that the Examiner has not explained “how a BNP
level would be substituted for the respiratory rate of Combs. BNP level and
respiratory rate are different types of indicators for pulmonary edema. There
is no reasoning in the Office Action that would make such a substitution
work without undue experimentation.” App. Br. 10.
As the Examiner contends, however (see Ans. 4), the rejection did not
posit substituting BNP and creatinine levels for Combs’ respiratory rate
information, but instead posited including evaluations of BNP and/or
creatinine levels as part of Combs’ system, including as a measure for
indicating a pulmonary edema threshold. See Final Action 6
(“advantageously providing more and different parameters to more
accurately determine the onset of pulmonary edema, wherein in combination
the thoracic impedance signal is adjusted in view of the physiological
information”).
Appellants contend:
“[Ajlthough Combs et al discusses comparing edema
levels to long term values and adjusting therapy depending on
the levels, there is no discussion in Combs et al or in Florio of
the subject matter of: “the thoracic impedance signal is adjusted
in view of the physiological information or a thoracic
impedance threshold is adjusted in view of the physiological
information,” as recited in claim 1. The combination simply
makes no discussion of such adjustments. Accordingly, claim 1
is not obvious in view of the cited references.
App. Br. 11; see also Reply Br. 2.
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We are not persuaded. Claim 1 recites that “the thoracic impedance
signal is adjusted in view of the physiological information or a thoracic
impedance threshold is adjusted in view of the physiological information.”
App. Br. 14.
As noted above, Combs discloses that “[mjany ways can be devised to
combine” thoracic impedance and respiratory rate information, including
“simply adding them throughout the potential range and using the total value
for the indicator; relying on one measure only, in situations where it is
superior, or simply recording both separately and reporting them out through
telemetry for analysis together by a doctor or other attendant (human or
automatic).” Combs 15:20—26. Immediately thereafter, Combs discloses
“[ajlarms can be initiated thorough whatever patient or doctor
communication system is used with the device at whatever level is
programmed in for the variable or variables used to evaluate these measures
of edema.” Id. at 26—30.
Thus, contrary to Appellants’ argument, as to adjusting the thoracic
impedance threshold based on additional physiologic information, Combs
discloses a number of ways that a thoracic impedance signal and additional
physiologic information can be combined to adjust an alarm threshold.
Appellants do not explain with particularity, or advance specific persuasive
evidence explaining, why an ordinary artisan prompted to use a known
indicator of pulmonary edema, such as BNP levels, in Combs’ system,
would have been unable to include the BNP information into a pulmonary
edema threshold indicator, as recited in Appellants’ claim 1, based on
Combs’ specific teachings about how other physiologic information is
combined with thoracic impedance. Indeed, as noted above, Combs teaches
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that thoracic impedance may be combined with other physiologic data “in
manners known to those in the art to determine patient condition.” Combs
5:48-49.
Thus, given the absence of specific supporting evidence or a
particularized fact-based explanation why the disclosures in Combs would
have been insufficient to allow an ordinary artisan to adjust the thoracic
impedance threshold based on BNP or creatinine level, Appellants do not
persuade us that the Examiner erred in maintaining the obviousness rejection
as to claim 1. We, therefore, affirm the Examiner’s rejection of claim 1 over
Combs and Florio. Because they were not argued separately, claims 3, 4, 7—
9, 12, 14, 16, and 17 fall with claim 1. 37 C.F.R. § 41(c)(l)(iv).
OBVIOUSNESS-
COMBS AND FLORIO
COMBINED WITH ADDITIONAL REFERENCES
In the remaining obviousness rejections, the Examiner relies on
Combs and Florio for the teachings discussed above, and cites additional
references to show that the features recited in dependent claims 2, 5, 6, 10,
11, 13, and 15 would have been obvious elements in a pulmonary edema
monitoring system such as that taught in Combs. Final Action 7—12.
As to these rejections, Appellants argue only that the supplemental
references cited by the Examiner fail to remedy the deficiencies of the
combination of Combs and Florio, discussed above, as to claim 1. App. Br.
12.
As discussed above, however, Appellants do not persuade us that the
combination of Combs and Florio fails to demonstrate that the system
recited in claim 1 would have been obvious. Accordingly, because
Appellants do not demonstrate, nor do we discern, error in the Examiner’s
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rejections of claims 2, 5, 6, 10, 11, 13, and 15, we affirm those rejections as
well.
SUMMARY
We affirm each of the Examiner’s rejections.
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)(l)(iv).
AFFIRMED
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