Ex Parte Stahmann et al

Board of Patent Appeals and Interferences

May 18, 2012

11136195 (B.P.A.I. May. 18, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JEFFREY E. STAHMANN,
QUAN NI, and JESSE W. HARTLEY
__________

Appeal 2011-000147
Application 11/136,195
Technology Center 3700
__________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a system for
predicting thoracic fluid accumulation. The Examiner entered rejections for
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
Heart failure can result in “fluid collecting in the subject‟s thorax,
which may become a barrier to normal oxygen exchange. The fluid build-up
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in the thorax may result in pulmonary edema or pleural effusion. These
conditions, if left untreated, may in turn lead to death” (Spec. 1).
“Unfortunately, the time associated with detection of thoracic fluid
accumulation may be too late to prevent the significant clinical intervention
(e.g., hospitalization) resulting from such fluid accumulation” (id. at 4).
Appellants thus invented “systems, devices, and methods [which]
predict an occurrence of impending thoracic fluid accumulation in subjects
and further, in one example, adjust or initiate one or more therapies to
prevent, decrease, or minimize such impending fluid accumulation using the
prediction” (id.).
Claims 1-13 and 28-45 stand rejected and appealed (App. Br. 4).
Claim 1, the only independent, is representative and reads as follows
(emphasis added):
1. A system comprising:
a prediction criteria module, adapted to store one or more
thoracic fluid accumulation prediction criteria;
a parameter collection device, adapted to sense or receive at
least one thoracic fluid accumulation parameter that is statistically
associated with impending thoracic fluid accumulation; and
a thoracic fluid accumulation prediction module, coupled to the
prediction criteria module to receive the one or more thoracic fluid
accumulation prediction criteria, and coupled to the parameter
collection device to receive the at least one thoracic fluid
accumulation parameter,
wherein the thoracic fluid accumulation prediction module is
adapted to predict an occurrence of impending thoracic fluid
accumulation occurring during a specified prediction time period,
using the one or more thoracic fluid accumulation prediction criteria
and the at least one thoracic fluid accumulation parameter, wherein
the thoracic fluid accumulation prediction module is adapted to
predict the occurrence of impending thoracic fluid accumulation using
an estimated thoracic fluid accumulation probability which is
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computed from a conditional thoracic fluid accumulation probability
associated with the at least one thoracic fluid accumulation parameter.

The following rejections are before us for review:
(1) Claims 1-13, 28, 29, 31, 34, and 40-45, under 35 U.S.C. § 103(a)
as obvious over Lackey
1
and Halperin
2
(Ans. 3-6);
(2) Claim 30, under 35 U.S.C. § 103(a) as obvious over Lackey,
Halperin, and Landesberg
3
(Ans. 6-7);
(3) Claim 32, under 35 U.S.C. § 103(a) as obvious over Lackey,
Halperin, and Fayram
4
(Ans. 7);
(4) Claims 33 and 36, under 35 U.S.C. § 103(a) as obvious over
Lackey, Halperin, and Tehrani
5
(Ans. 7-8);
(5) Claim 35, under 35 U.S.C. § 103(a) as obvious over Lackey,
Halperin, and Stahmann
6
(Ans. 8-9);
(6) Claim 37, under 35 U.S.C. § 103(a) as obvious over Lackey,
Halperin, and Larsen
7
(Ans. 9); and
(7) Claims 38 and 39, under 35 U.S.C. § 103(a) obvious over Lackey,
Halperin, and Turcott
8
(Ans. 9-10).
DISCUSSION

1
U.S. Patent App. Pub. No. 2005/0070778 A1 (filed August 20, 2004).
2
U.S. Patent App. Pub. No. 2006/0241510 A1 (filed August 3, 2005).
3
U.S. Patent No. 6,406,422 B1 (issued June 18, 2002).
4
U.S. Patent App. Pub. No. 2006/0116590 A1 (filed March 3, 2005).
5
U.S. Patent App. Pub. No. 2005/0085865 A1 (filed October 15, 2003).
6
U.S. Patent App. Pub. No. 2005/0004609 A1 (filed July 2, 2003).
7
U.S. Patent App. Pub. No. 2003/0040472 A1 (filed June 15, 2001).
8
U.S. Patent No. 6,409,675 B1 (issued June 25, 2002).
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In rejecting claim 1, the Examiner found that Lackey described a
system for predicting pulmonary edema that included the claimed prediction
criteria module, parameter collection device, and thoracic fluid accumulation
module, “wherein the prediction module is adapted to predict an occurrence
of impending thoracic accumulation using one or more thoracic fluid
accumulation prediction criteria and at least one thoracic fluid accumulation
parameter” (Ans. 3-4). The Examiner found that Lackey did not teach
the impending fluid accumulation during a specified prediction
time period, and the prediction module adapted to predict the
occurrence of impending fluid accumulation if the probability
exceeds a specified threshold value, wherein the probability is
computed from a conditional thoracic fluid accumulation
probability associated with the at least one thoracic fluid
accumulation parameter.

(Id. at 4.)
To meet that deficiency the Examiner cited Halperin as teaching
techniques for predicting and monitoring clinical episodes that were
applicable to the detection and prediction of pulmonary edema (id.). Based
on the references‟ combined teachings, the Examiner reasoned that an
ordinary artisan would have considered it obvious to “modify the pulmonary
edema prediction system of Lackey with the applicable prediction methods
taught by Halperin in order to create subject-specific data regarding the
probability of an impending pulmonary edema” (id.).
Appellants contend that neither reference describes the limitation
“wherein the thoracic fluid accumulation prediction module is adapted to
predict an occurrence of impending thoracic fluid accumulation occurring
during a specified prediction time period, as recited in claim 1” (App. Br. 9).
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Specifically, Appellants urge, while the Examiner cited paragraph [0543] of
Halperin as teaching that feature,
the Halperin et al. reference has a publication date of October
26, 2006 with a filing date of August 3, 2005, and claims
benefit to US Provisional Application 60/674,382, filed April
25, 2005, and US Provisional Application 60/692,105, filed on
June 21, 2005.
However, the present application was filed May 24,
2005. Based on the above referenced priority dates for the
Halperin reference, only the subject matter of US Provisional
Application 60/674,382, filed April 25, 2005 is applicable
against the present application as a 35 U.S.C. 102(e) reference.

(Id. at 10.)
Appellants contend that they have “studied US Provisional
Application 60/674,382, and cannot find any reference to subject matter
regarding calculating the probability of a clinical episode „occurring during a
specified prediction time period,‟ as recited in claim 1” (id.). Appellants
argue that, at best, Halperin discloses predicting “that an episode may
happen. In other words, Halperin only discusses an open-ended prediction”
(id. at 11).
In contrast, Appellants argue, a “specified time period” as recited in
claim 1 “includes a starting point and an ending point. A prediction of
something happening in the future does not include an ending point. Again,
it is simply an open-ended prediction” (id. at 11). Accordingly, Appellants
urge, “the subject matter of something „occurring during a specified time
period‟ does not necessarily flow from the open-ended prediction of the
Halperin reference” (id.).
The Examiner responds that the „382 provisional application discloses
that its methods predict the onset and progression of clinical episodes, and
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that the “use of the term „onset‟ gives further credence that a specified time
period is inherent to the provisional application. The term prediction, in
cases of clinical episodes, is virtually meaningless without being associated
with some sort of a time period” (Ans. 10 (citing „382 application at 16, 18,
35)).
The Examiner further finds that an open-ended prediction “to a time
ad infinitum would be absolutely useless in any medical context. Moreover,
the specification of the instant application fails to provide a special
definition of the phrase „specified time period‟ such that the metes and
bounds of the limitation would exclude an open-ended time period” (id. at
10-11).
Alternatively, the Examiner reasons
Even if applicant‟s argument that a specified prediction
time period is not inherent in the disclosure of the provisional
application is valid, it would, at the very least, be obvious to
one of ordinary skill in the art to utilize a predetermined time
period for predicting onsets of clinical episodes as predictions
would be useless without an associated time frame.

(Id. at 11.)
Appellants reply that it is not inherent in the „382 application‟s
disclosure of predicting clinical episodes that the prediction relates to a
specified time period since “[a]n open-ended prediction of the onset of a
disease or other condition is certainly better than no prediction at all” (Reply
Br. 3). Thus, Appellants urge, “[i]f some parameter of a patient‟s condition
is changing in some known way, then it would appear to be worthwhile to
know that such a change could be a sign of the onset of the condition at
some time in the future” (id.).
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Moreover, Appellants urge, an ordinary artisan viewing Appellants‟
Specification would have understood the term “specified time period” to
mean a period that “includes a starting point and an ending point. A
prediction of something merely happening in the future does not include an
ending point” (Reply Br. 4 (citing Specification 3-4, 14-15)).
Further, Appellants urge, the Examiner erred in concluding that it
would have been obvious in view of the cited references to predict the onset
of clinical episodes within a specified time period because “there may be a
value to an open-ended prediction as opposed to no prediction at all. None
of the cited references discuss any need or means for providing a probability
assertion of an impending disease state for a specified period of time, as in
the present subject matter” (Reply Br. 5).
Accordingly, Appellants conclude, “the combination of the Lackey et
al reference and the subject matter of US Provisional Application
60/674,382 does not make obvious the present claimed invention since each
limitation is not included or suggested by the combination” (id.).
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‟ arguments do not persuade us that a preponderance of the
evidence fails to support the Examiner‟s conclusion that claim 1 would have
been prima facie obvious to an ordinary artisan in view of the cited
references.
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It is well settled that, during examination, the PTO must interpret
terms in a claim using “the broadest reasonable meaning of the words in
their ordinary usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant‟s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
However, “while „the specification [should be used] to interpret the
meaning of a claim,‟ courts must not „import[ ] limitations from the
specification into the claim.‟ . . . [I]t is improper to „confin[e] the claims to
th[e] embodiments‟ found in the specification . . . .” In re Trans Texas
Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (quoting Phillips v.
AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (citations omitted,
bracketed text in internal quotes in original).
Here, claim 1 recites a system for predicting occurrences of thoracic
fluid accumulation. The system includes a thoracic fluid accumulation
prediction module “adapted to predict an occurrence of impending thoracic
fluid accumulation occurring during a specified prediction time period.”
While Appellants urge that an ordinary artisan would have understood
a specified prediction time period to have discrete beginning and end points,
and to exclude open-ended time periods, claim 1 simply does not specify any
particular beginning and end points for the prediction time period. It may be
true, as Appellants argue, that the Specification describes predicting thoracic
fluid accumulations “during a specific prediction time period” (Spec. 3-4),
and that a specific prediction time period can be associated with a
probability of thoracic fluid accumulation (id. at 13-14).
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As noted above, however, it is improper to import limitations from the
Specification into the claims. See In re Trans Texas Holdings Corp., 498
F.3d at 1299.
Thus, in our view, when given its broadest reasonable interpretation
consistent with the Specification, claim 1‟s “specified prediction time
period” encompasses any specified time period during which an occurrence
of impending thoracic fluid accumulation can be predicted, regardless of
whether that period has a discrete end point. That is, given the breadth of
the language in the claim, Appellants‟ arguments do not persuade us that,
even when viewed in light of the Specification, claim 1 excludes a fluid
accumulation module adapted merely to predict an occurrence of impending
thoracic fluid accumulation occurring in the near future.
Appellants‟ arguments also do not persuade us that the „382
provisional application fails to teach a module adapted to predict a clinical
episode within such a specified time period. For example, the claims of the
„382 provisional application recite “an apparatus for prediction and
monitoring of clinical episodes” that includes a “means for comparing of
said [physiological] signs with reference signs to determine whether a
clinical episode is eminent [sic, imminent] or in progress, and to quantify its
degree or severity” where the clinical episode is “an episode of . . .
Congestive Heart Failure” („382 application, at pp. 34-35). As the „382
application explains, one condition correlated with congestive heart failure is
fluid retention in the lung tissue (id. at p. 7).
Given this disclosure of a system that includes a means that predicts
whether a clinical episode of congestive heart failure is imminent, that is,
likely to occur at any moment in the near future, we are not persuaded that
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the „382 application fails to teach a clinical episode prediction module that is
adapted to predict a clinical episode that occurs during a specified prediction
time period.
Also, we agree with the Examiner that, even if such a teaching were
not present in the „382‟s disclosure, an ordinary artisan would have
considered it obvious “to utilize a predetermined time period for predicting
onsets of clinical episodes as predictions would be useless without an
associated time frame” (Ans. 11).Specifically, Lackey describes its
pulmonary edema detecting system as informing the practitioner that
pulmonary edema events will occur in the future (see Lackey [0156]
(“Future hydration monitoring results can be predicted based on the current
state of the monitored individual and on past hydration monitoring results
obtained with the same or with other individuals or a population or
demographic group.”)). Indeed, Lackey suggests that its system predicts
such events when they are imminent, that is, when likely to occur in the near
future:
With trend analysis and prediction of future hydration
state, it is possible to prevent serious hydration problems from
occurring by providing treatment or intervention
recommendations to the subject and/or a care provider prior to
serious hydration problems occurring. . . . For some
conditions, such as a prediction that fluid is building in lung
tissue during the onset of pulmonary edema, a recommended
intake of a pharmaceutical agent can be automatically provided.

(Id. at [0158]; see also [0159] (“Analysis of the results of such hydration
monitoring can be used to gather information about the reonset and/or
progression of pulmonary edema, both in the monitored patient and in
population groups that include the monitored patient.”)).
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It might be true that these disclosures do not explicitly state that the
prediction is for a specific time period, or that the time period has a discrete
beginning and end point. However, as the Supreme Court has noted, the
obviousness analysis “need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007);
see also id. at 421 (“A person of ordinary skill is . . . a person of ordinary
creativity, not an automaton.”).
Here, given Lackey‟s teaching that its system can predict pulmonary
fluid accumulation events to an extent that such events can be prevented, and
to the extent that a pharmaceutical treatment can be provided automatically,
we conclude that an ordinary artisan would have reasonably inferred that it
would be obvious to configure Lackey‟s thoracic fluid accumulation
prediction module such that it would predict an occurrence of impending
thoracic fluid accumulation occurring during a specified prediction time
period occurring in the near future. Accordingly, as Appellants‟ arguments
do not persuade us that the Examiner erred in finding that Lackey and
Halperin would have taught or suggested a system having all of the features
of claim 1 to an ordinary artisan, we affirm the Examiner‟s obviousness
rejection of that claim over those references.
Claims 2-13, 28, 29, 31, 34, and 40-45 fall with claim 1 as they were
not argued separately. See 37 C.F.R. § 41.37(c)(1)(vii).
As to the remaining rejections, Appellants rely entirely on the rejected
claims‟ dependencies from claim 1, and the alleged failure, discussed above,
of Lackey and Halperin to teach or suggest all of the limitations of claim 1,
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even when combined with the additional references cited by the Examiner
(see App. Br. 12-13). As we do not find Appellants‟ arguments persuasive
for the reasons discussed above, we affirm the remaining rejections as well.

SUMMARY
We affirm the Examiner‟s rejection of claims 1-13, 28, 29, 31, 34, and
40-45 as obvious over Lackey and Halperin.
We also affirm the Examiner‟s rejection of claim 30 as obvious over
Lackey, Halperin, and Landesberg.
We also affirm the Examiner‟s rejection of claim 32 as obvious over
Lackey, Halperin, and Fayram.
We also affirm the Examiner‟s rejection of claims 33 and 36 as
obvious over Lackey, Halperin, and Tehrani.
We also affirm the Examiner‟s rejection of claim 35 as obvious over
Lackey, Halperin, and Stahmann.
We also affirm the Examiner‟s rejection of claim 37 as obvious over
Lackey, Halperin, and Larsen.
We also affirm the Examiner‟s rejection of claims 38 and 39 as
obvious over Lackey, Halperin, and Turcott.

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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

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