Ex Parte 7,835,927 et al

Patent Trial and Appeal Board

Apr 25, 2013

90009912 (P.T.A.B. Apr. 25, 2013)

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.
90/009,912 06/06/2011 7,835,927 080625-0055 9553
80236 7590 04/25/2013
McDermott Will & Emery LLP
The McDermott Building
500 North Capitol Street, N.W.
Washington, DC 20001
EXAMINER
FOSTER, JIMMY G
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
04/25/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex Parte CAREFUSION 303, INC.

Appeal 2013-002868
Reexamination Control Nos. 90/011,697 and 90/009,912
Patent 7,835,927 B2
Technology Center 3900
____________________

Before JEFFREY B. ROBERTSON, JAMES P. CALVE, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL

Appellant, patent owner CareFusion 303, Inc., appeals under 35
U.S.C. §§ 134(b) and 306 from the final rejection of claims 1-46. We have
jurisdiction under 35 U.S.C. § 6(b)(2).
We affirm.

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STATEMENT OF THE CASE
This proceeding arose from two separate requests for ex parte
reexamination of U.S. Patent 7,835,927 B2 (the “‟927 Patent”),
Reexamination Control Nos. 90/011,697
1
and 90/009,912.
2
Pursuant to 37
C.F.R. § 1.565(c), the separate requests were merged into a single
proceeding on October 14, 2011.
3

The ‟927 Patent is entitled “Medication Management System,” was
issued November 16, 2010 to David L. Schlotterbeck et al., and is assigned
to Appellant. See App. Br. 2.

CLAIMED INVENTION
According to the ‟927 Patent, the invention “is directed to a new and
improved information management system and method capable of
monitoring, controlling and validating the administration of medical care in
a health care facility.” (Col. 3, ll. 63-67.) The system utilizes a data base
comprising at least one hard limit and at least one soft limit. The
Specification of the ‟927 Patent describes these limits as follows:
The [health care] facility may set a soft limit for a drug infusion
parameter that is a value not normally exceeded in the
administration of this drug, but which may be exceeded in
exceptional circumstances. The facility may set a hard limit on
a drug infusion parameter that is a value not to be exceeded in
this facility. (Col. 9, ll. 10-14.)

1
Request for Reexamination filed May 18, 2011.
2
Request for Reexamination filed June 6, 2011.
3
Decision Merging Reexamination Proceedings, mailed October 14, 2011.
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Claim 11 on appeal reads as follows and with emphasis added:
11. A system for use with a patient medical device, the
device having specific operating data associated with it, the
system comprising:
a first processor configured to accept user inputs related
to operating data limits associated with the medical device and
to generate a data base from those user inputs, the data base
comprising at least one hard limit and at least one soft limit;
and
a second processor configured to:
receive the data base generated by the first
processor;
compare the actual operating data of the medical
device with the data base
limits; and
monitor the comparison and if the comparison
shows that at least one of the actual operating data of the
medical device exceeds the at least one soft limit
established in the data base, provide an indication the
operating data of the medical device are outside the at
least one soft limit in the data base, and if at least one of
the programmed pumping parameters exceeds the at
least one hard limit established in the data base, require
that the at least one pumping parameter be changed to a
value within the at least one hard limit before operation
of the infusion pump can begin.

(Clm Appx., App. Br. 53; bracketing and underlining omitted for clarity.)

EVIDENCE
The Examiner relies upon the following prior art references:
Ford et al.
Suresh et al.
Sweeney et al.
US 5,681,285
US 7,263,492 B1
WO 99/10830
Oct. 28, 1997
Aug. 28, 2007
Mar. 4, 1999

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REJECTIONS
The Examiner makes the following rejections (Final Rej. 2-5, 12-42):
1. Claims 11-16, 19 and 20 under 35 U.S.C. § 102(b) as anticipated by
Sweeney;
2. Claims 1-46 under 35 U.S.C. § 103(a) as unpatentable over Sweeney;
3. Claim 18 under 35 U.S.C. § 103(a) as unpatentable over Sweeney and
Suresh; and
4. Claims 1-46 under 35 U.S.C. § 103(a) as unpatentable over Sweeney
and Ford.
PRINCIPLES OF LAW
Claim Construction
“During reexamination, as with original examination, the PTO must
give claims their broadest reasonable construction consistent with the
specification.” In re Suitco Surface, Inc., 603 F.3d 1255, 1259 (Fed. Cir.
2010). “Construing claims broadly during prosecution is not unfair to the
applicant (or, in this case, the patentee), because the applicant has the
opportunity to amend the claims to obtain more precise claim coverage.” In
re American Academy of Science Tech Center, 367 F.3d 1359, 1364 (Fed.
Cir. 2004) (appeal from reexamination proceeding).
Obviousness
“Section 103(a) forbids issuance of a patent when „the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.”‟ KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
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(2007) (quoting 35 U.S.C. § 103(a)). “What matters is the objective reach of
the claim. If the claim extends to what is obvious, it is invalid under § 103.”
KSR, 550 U.S. at 419. To be nonobvious, an improvement must be “more
than the predictable use of prior art elements according to their established
functions.” Id. at 417. Further, “the analysis need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
a court [or the Office] can take account of the inferences and creative steps
that a person of ordinary skill in the art would employ.” Id. at 418.
ANALYSIS
Construction of “processor configured to”
Independent claim 11 recites “a first” and “a second processor
configured to” carry out certain functions that are also recited in the claim.
The Examiner construes the term “processor configured to” as merely
requiring that a processor be capable of being programmed with software to
perform corresponding functions recited in the claim. Final Rej. 5-6; Ans. 9.
In other words, according to the Examiner, the term encompasses only
hardware (i.e., a processor) and does not include software for performing the
corresponding functions recited in the claim. Thus, under the Examiner‟s
construction, apart from the preamble, the claim merely would require non-
programmed processors and nothing more beyond the ability of those
processors to be programmed as described in the claim.
The Examiner asserts that “[t]here is nothing in the description of the
reexamined patent to dictate that the wording „configured to . . .‟ must be
construed essentially to mean being loaded with a program which will run to
. . . .” Ans. 9. The Examiner also points out that “the description of the
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reexamined patent uses a related term, i.e., „configurations,‟ when hardware,
per se, is being described.” Ans. 9 (citing ‟927 Patent col. 6, ll. 21-25).
Appellant argues that the term “processor configured to” should be
construed to require programming having the appropriate instructions to
execute the stated functions. App. Br. 19; Reply Br. 16.
We construe the term “processor configured to” as meaning: a
processor that is programmed to perform the corresponding functions recited
in the claim. Although the Specification does use the term “configurations”
to describe various hardware components that may be included in the control
system and interface, that disclosure does not prohibit another term,
“configured to,” from referring to software or programming when describing
a processor. Indeed, the ‟927 Patent does use the latter term in connection
with software/programming. ‟927 Patent col. 20, ll. 62-67 (“In establishing
the institutional guidelines and preparing the drug library with the hard and
soft limits, a computer program configured to accept user inputs related to
pump operating parameter limits specific to the drugs contained in the
library and to generate a data base from those user inputs is provided.”).
Thus, it would be unreasonable in light of the Specification, to apply a
disclosure regarding hardware “configurations” or arrangements to the
actual requirements of the individual hardware components themselves in
relation to the functions performed by those hardware components and as
recited in the claims. Therefore, our construction above comports with the
broadest reasonable construction consistent with the specification. See, e.g.,
‟927 Patent col. 7, ll. 58-64; col. 20, ll. 62-67 (discussing “software” and
“computer program” in context of invention).
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Rejection of Claims 11-16, 19, and 20 as Anticipated by Sweeney
Independent claim 11 recites, in relevant part, “a first processor
configured to accept user inputs related to operating data limits associated
with the medical device and to generate a data base from those user inputs,
the data base comprising at least one hard limit and at least one soft limit[.]”
The Examiner asserts that Sweeney discloses both soft and hard limits
but concedes that it does not do so in a single database. Final Rej. 12. The
Examiner maintains that the claim nevertheless is anticipated by Sweeney
because, as construed by the Examiner, the claim does not require the recited
database having soft and hard limits. Final Rej. 5-6; Ans. 9.
As set forth above, however, we have rejected the Examiner‟s
proposed construction. Sweeney cannot anticipate claim 11 because it does
not disclose “a first processor configured . . . to generate a data base . . .
comprising at least one hard limit and at least one soft limit[.]” Accordingly,
we reverse the rejection of claim 11 as anticipated by Sweeney. For the
same reason, we reverse the rejection of dependent claims 12-16, 19, and 20,
all of which are ultimately dependent on claim 11.

Rejection of Claims 1-46 as Obvious over Sweeney
Independent claim 1 requires, in relevant part, a first program
configured to “generate a data base . . . comprising at least one hard limit
and at least one soft limit” and a second program configured to, in part,
monitor the comparison of pumping parameters programmed into the
infusion pump such that:
if at least one of the programmed pumping parameters exceeds
the at least one soft limit established in the data base, provide
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an indication to a pump operator that at least one of the
programmed pumping parameters is outside the at least one soft
limit in the data base, and if the at least one of the programmed
pumping parameters exceeds the at least one hard limit
established in the data base, require that the at least one
programmed pumping parameter be changed to a value within
the at least one hard limit before operation of the infusion pump
can begin.

Appellant argues that Sweeney does not disclose a hard limit and,
therefore, does not disclose or make obvious a data base having both hard
and soft limits. App. Br. 30.
The Examiner and Appellant assert contrasting interpretations of
certain excerpts from Sweeney, including the following excerpt:
The clinician is notified of inaccuracies and asked to correct
them if he or she still wishes to proceed. However, in certain
circumstances, such as for example where the requested dosage
exceeds the maximum allowed level, the system does not allow
or approve delivery. In one embodiment, the system can be
overridden with the appropriate authorization. (Sweeney p. 27,
ll. 24-30.)

The above Sweeney excerpt discloses a soft limit (wherein “the
system can be overridden with the appropriate authorization”) as well as a
hard limit (“where the requested dosage exceeds the maximum allowed
level, the system does not allow or approve delivery”). Appellant argues
that this is not actually a hard limit because “[i]f a limit of Sweeney‟s data
base can be overridden in one embodiment and the same limit in the same
data base cannot be overridden in a second embodiment, this reflects only
the configuration of the system, e.g. whether override is enabled in the
system[.]” App. Br. 24 (citing Sweeney Fig. 24B).
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Appellant‟s argument is not commensurate with the scope of claim 1,
which claims a system comprising a program that is “configured to . . . if the
at least one of the programmed pumping parameters exceeds the at least one
hard limit established in the data base, require that the at least one
programmed pumping parameter be changed to a value within the at least
one hard limit before operation of the infusion pump can begin.” Sweeney
discloses such a configuration in the form of a system that does not allow
delivery of a requested dosage that exceeds a maximum allowed level. That
is, a system in which the override is not enabled still functions as a hard
limit in that the maximum allowed level cannot be exceeded.
Appellant points out that in Sweeney “[t]he clinician is notified of
inaccuracies and asked to correct them if he or she still wishes to proceed”
(p. 27, ll. 24-25 (emphasis added)), suggesting that correction of the inputs is
voluntary and not required to proceed. Reply Br. 6. The next sentence,
however, states that at least “in certain circumstances, such as for example
where the requested dosage exceeds the maximum allowed level, the system
does not allow or approve delivery” of the drug dose. (P. 27, ll. 26-27.)
While the following sentence in Sweeney discloses that the system can be
overridden with the appropriate authorization (p. 27, ll. 28-30), that
configuration is only disclosed as being an option in “one embodiment.” (P.
27, l. 28.) Thus, the overriding mechanism is not necessarily present, but is
an optional embodiment in Sweeney‟s system.
Another Sweeney excerpt relied upon by the Examiner states:
In one embodiment, delivery of the medication is not allowed to
proceed if the error-checking process determines that it may be
inappropriate to administer the medication as prescribed. In
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one embodiment, the halted system can be overridden by a
health care professional with the appropriate authorization
clearance level. (Sweeney p. 21, l. 34 – p. 22, l. 2.)

This excerpt also discloses a soft limit (wherein “the halted system
can be overridden”) as well as a hard limit (“delivery of the medication is
not allowed to proceed if the error-checking process determines that it may
be inappropriate to administer the medication as prescribed”).
Appellant argues that Sweeney does not actually disclose a hard limit
because Sweeney only discloses situations where it may be inappropriate to
administer the medication as prescribed. Reply Br. 5. Thus, Appellant
asserts that Sweeney leaves open the possibility of “allowing a physician to
make a definitive determination that it is appropriate to administer the
medication as prescribed, which is necessarily followed by an ability for the
physician to override the error-checking process and allow the medication to
be administered without a change to the prescription.” Reply Br. 5.
We are not persuaded by Appellant‟s argument. Regardless of the
correctness of the error-checking process, Sweeney states that “delivery of
the medication is not allowed to proceed” (p. 21, ll. 34-35), which is a
definitive statement of a hard limit.
Similar to the excerpt discussed above, Sweeney does state that in
“[i]n one embodiment, the halted system can be overridden by a health care
professional with the appropriate authorization clearance level[,]” but
Sweeney does not state that overriding is required in all embodiments let
alone the embodiment of the prior sentence. (P. 21, l. 37 – p. 22, l. 2.)
We therefore agree with the Examiner‟s findings that Sweeney
discloses both hard and soft limits.
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The Examiner further points out that Sweeney discloses that multiple
levels of authorization may be accommodated in the same embodiment (i.e.,
in the same system) so as to require different levels of security depending on
the operations to be performed. Final Rej. 15 (citing Sweeney p. 22, l. 22 –
p. 23, l. 2). Based on such disclosure, the Examiner asserts:
it would have been obvious to one of ordinary skill in the art to
combine in the same data base the limits permitting override
with the limits [that] do not permit override. Regarding such a
combination, one of ordinary skill in the art would have found
it obvious to provide a data base in a medication delivery
system that includes both hard and soft limits with respect to
certain delivery aspects, for example as indicated in the IV
Template (see p 64). This is because it would have been
obvious to employ multiple levels of authorization in the same
medication delivery system, by including (1) a first level of
authorization in which no delivery override is permitted for one
type of system-identified error, but also by including (2) a
second level of authorization in which delivery override, such
as by an appropriately authorized person, is permitted for a
different type of system-identified error. Accordingly, for these
reasons it would have been obvious to have provided the same
data base of Sweeney with both hard and soft limits. (Final
Rej. 15.)

The Examiner‟s stated rationale adequately supports a prima facie
conclusion of obviousness of claim 1 over Sweeney.
Appellant presents similar arguments for each of independent claims
11, 24, and 34.
In addition, Appellant expressly states that dependent claims 2-10, 12-
20, 21-23, 25-33, and 35-41 stand or fall with the independent claim from
which they depend. App. Br. 20, see 37 C.F.R. § 41.37(c)(1)(vii)(2008).
Further, Appellant does not present any arguments with respect to claims 42-
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46. Accordingly, our comments regarding claim 1 apply equally to those
claims as well.

Rejection of Claim 18 as Obvious over Sweeney and Suresh
Appellant does not present any arguments with respect to the rejection
of claim 18 as unpatentable over Sweeney and Suresh beyond those
presented with respect to claim 18 as unpatentable over Sweeney alone --
arguments we have found not persuasive. Thus, our comments regarding
claim 1 apply equally to claim 18.

Secondary Considerations
Appellant presented purported evidence of secondary considerations
(long-felt but unresolved need, copying by others, and praise by others) in an
attempt to establish that the claimed inventions are not obvious. In the Final
Rejection, however, the Examiner pointed out the lack of nexus between the
Appellant‟s evidence and the claimed inventions. Specifically, the Examiner
noted:
The submitted evidence is largely focused on
achievements in the art to employ dosing limits in operator
programmable infusion pumps in order to avoid dosing errors.
However, using dosing limits already exists in the disclosure of
Sweeney and thus in the prior art. Moreover, to the extent that
employing hard limits constitutes the key element in the
evidence, the Examiner points out that Sweeney discloses using
hard limits. Additionally, to the extent that soft limits might
additionally contribute to the evidence in any way, Sweeney is
considered by the Examiner to disclose soft limits as well.

The thing that is actually missing in Sweeney, therefore,
is not the inclusion of hard limits in a data base or the inclusion
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of soft limits in a data base. What is missing in Sweeney but
claimed by Patent Owner is an inclusion of both hard limits and
soft limits in the same data base . . . . Thus, the determination
to be made is whether including both limits, as opposed to (in
the prior art) including only one of either of the limits (even in
the same prior art disclosure) would have been obvious to one
of ordinary skill in the art. (Final Rej. 43.)

Appellant responds that a nexus between Appellant‟s evidence and the
claimed inventions does exist because Sweeney does not disclose a hard
limit or a database that includes both hard and soft limits. (App. Br. 27.) As
determined above, Sweeney does disclose a hard limit. Thus, to satisfy the
nexus requirement, Appellant should have proffered evidence tailored only
to the advent of a database that includes both hard and soft limits. See, e.g.,
J.T. Eaton & Co., Inc. v. Atlantic Paste & Glue Co., 106 F.3d 1563, 1571
(Fed. Cir. 1997) (holding “the asserted commercial success of the product
must be due to the merits of the claimed invention beyond what was readily
available in the prior art”). Appellant, by admission, did not.
For example, and as stated by the Examiner, “the evidence which has
been submitted by Patent Owner to show long-felt need concerns actually
the more basic need of reducing catastrophic errors in programming an
infusion pump. However, although Patent Owner‟s claimed invention would
satisfy such a need, Sweeney‟s disclosed invention, which is the prior art,
would also satisfy that need.” Final Rej. 44.
With respect to praise by others, Appellant argues that “the
differentiation of „Preferred‟ over „Acceptable‟ [by the ECRI Institute]
indicates that ECRI recognized the combination of hard and soft limits as a
significant advance over a single set of soft limits. The 2002 ECRI report
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noted that the Baxter units had several disadvantages including „The system
lacks „hard limits‟ capability.‟” App. Br. 28. The prior art included hard
limits. Thus, Appellant has not shown praise by others of the claimed
invention beyond what was already available in the prior art.
With respect to copying, “Appellant submits that the continuous
growth and widespread adoption of „Dose Error Reduction Software‟
(DERS) in the infusion pump industry is evidence of widespread
copying . . .” App. Br. 29. Even if such growth and widespread adoption of
DERS occurred, and even if it did so because of the inclusion of a database
having soft and hard limits as opposed to including soft or hard limits (which
Appellant has not shown), this would still not constitute evidence of
copying. Appellant has not, in any way, pointed out that a competitor has
copied Patent Owner‟s infusion pump in order to include the hard- and soft-
limit features. Further, the mere fact of copying (even when proved) is
insufficient to make the action significant in an obviousness analysis. Cable
Elec. Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1028 (Fed. Cir. 1985),
overruled on other grounds by, Midwest Indus., Inc. v. Karavan Trailers,
Inc., 175 F.3d 1356, 1359 (Fed. Cir. 1999) (en banc).
In sum, Appellant‟s secondary considerations evidence is insufficient
to outweigh the evidence in favor of obviousness.
Accordingly, we sustain the rejections of independent claims 1, 11,
24, and 34 as obvious over Sweeney. We also sustain the rejection of
dependent claims 2-10, 12-20, 21-23, 25-33, and 35-41 as unpatentable over
Sweeney, which claims fall with the independent claim from which they
depend. See App. Br. 20; 37 C.F.R. § 41.37(c)(1)(vii)(2008). We also
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sustain the rejection of claims 42-46 as unpatentable over Sweeney, which
claims were not argued by Appellant.
Finally, we also sustain the rejection of claim 18 as unpatentable over
Sweeney and Suresh.

Rejection of Claims 1-46 as Obvious over Sweeney and Ford
Because we are sustaining the rejection of claims 1-46 over Sweeney
alone, we find it unnecessary to reach the rejection of the same claims over
Sweeney and Ford. Cf. In re Gleave, 560 F.3d 1331, 1338 (Fed. Cir. 2009).

DECISION
The rejection of claims 11-16, 19 and 20 as anticipated by Sweeney is
reversed.
The rejection of claims 1-46 as unpatentable over Sweeney is
affirmed.
The rejection of claim 18 as unpatentable over Sweeney and Suresh is
affirmed.

No time period for taking action in connection with this appeal may
be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2010).

AFFIRMED

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Patent Owner:
McDermott, Will & Emery LLP
The McDermott Building
500 North Capitol St., N.W.
Washington, DC 2001

Third Party Requester:
Turner Boyd LLP
2570 W. El Camino Real, #380
Mountain View, CA 94040

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