Becton, Dickinson and Company v. Baxter Corporation Englewood

________________________________
* Sharon Prost vacated the position of Chief Judge on
May 21, 2021.
United States Court of Appeals
for the Federal Circuit
______________________
BECTON, DICKINSON AND COMPANY,
Appellant
v.
BAXTER CORPORATION ENGLEWOOD,
Appellee
______________________
2020-1937
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. IPR2019-
00119.
______________________
Decided: May 28, 2021
______________________
T HOMAS SAUNDERS , Wilmer Cutler Pickering Hale and
Dorr LLP, Washington, DC, argued for appellant. Also rep-
resented by O MAR K HAN, New York, NY; K ATHERINE P.
K IECKHAFER , Boston, MA.
BENJAMIN E DWARD WEED, K&L Gates LLP, Chicago,
IL, argued for appellee. Also represented by K ATHERINE
ALLOR, G EORGE C. SUMMERFIELD, J R.; MICHAEL I RA C OHEN,
Baxter International Inc., Deerfield, IL.
______________________
Before P ROST *, CLEVENGER , and D YK, Circuit Judges.
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BECTON, DICKINSON AND COMPANY v.
BAXTER CORPORATION ENGLEWOOD
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D YK, Circuit Judge.
Becton, Dickinson and Company (“Becton”) appeals a
decision from the Patent Trial and Appeal Board (“Board”),
determining that certain claims of U.S. Patent No.
8,554,579 (“the ’579 patent”) were not invalid as obvious.
We reverse.
BACKGROUND
Baxter Corporation Englewood (“Baxter”) is the owner
of the ’579 patent, which is directed to “[s]ystems for pre-
paring patient-specific doses and a method for telephar-
macy in which data captured while following [a protocol
associated with each received drug order and specifying a
set of steps to fill the drug order] are provided to a remote
site for review and approval by a pharmacist.” ’579 patent,
Abstract.
Becton petitioned for inter partes review of claims 1–
13 and 22 of the ’579 patent. Claims 2–7 and 22 depend,
directly or indirectly, from independent claim 1. Claims 9–
13 depend, directly or indirectly, from independent claim
8. The parties agree that claims 1 and 8 of the ’579 patent
are illustrative.
There are two contested limitations on appeal. The
first is the “verification” limitation, which appears in claim
8 but not claim 1. The second is the “highlighting” limita-
tion, which appears in both claims 1 and 8. The relevant
portion of claim 8, containing both limitations, states:
8. A system for preparing and managing patient-
specific dose orders that have been entered into
a first system, comprising:
. . .
a dose preparation station for preparing a plurality
of doses based on received dose orders, the dose
preparation station being in bi-directional com-
munication with the order processing server and
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BECTON, DICKINSON AND COMPANY v.
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having an interface for providing an operator
with a protocol associated with each received
drug order and specifying a set of drug prepara-
tion steps to fill the drug order, the dose prepa-
ration station including an interactive screen
that includes prompts that can be highlighted by
an operator to receive additional information
relative to one particular step and includes areas
for entering an input;
. . . and wherein each of the steps must be verified
as being properly completed before the operator
can continue with the other steps of drug prepa-
ration process, the captured image displaying a
result of a discrete isolated event performed in
accordance with one drug preparation step,
wherein verifying the steps includes reviewing
all of the discrete images in the data record . . . .
Id. col. 32 l. 52–col. 33 l. 30 (highlighting and verification
limitations emphasized). Claims 1 and 8 are set forth in
full in an Attachment to this opinion.
In asserting that the challenged claims were invalid,
Becton relied primarily on three prior art references: U.S.
Patent No. 8,374,887 (“Alexander”), U.S. Patent No.
6,581,798 (“Liff”), and U.S. Patent Publication No.
2005/0080651 (“Morrison”).
The Board found that Becton had established that one
of ordinary skill in the art would have been motivated to
combine Alexander and Liff, as well as Alexander, Liff, and
Morrison. The Board also determined that Baxter’s “evi-
dence of secondary considerations [was] weak.” J.A. 34.
However, the Board determined that Alexander did not
teach or render obvious the verification limitation and that
combinations of Alexander, Liff, and Morrison did not
teach or render obvious the highlighting limitation. The
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BECTON, DICKINSON AND COMPANY v.
BAXTER CORPORATION ENGLEWOOD
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Board concluded that, as a result, none of the challenged
claims (1–13, 22) was shown to be unpatentable.1
Becton appeals. We have jurisdiction under 28 U.S.C.
§ 1295(a)(4)(A) and 35 U.S.C. § 141(c).
D ISCUSSION
A patent may not be obtained . . . if 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 per-
tains.
35 U.S.C. § 103(a).2 In reviewing the Board’s determina-
tion on the question of obviousness, “[w]e review the
Board’s legal conclusions de novo and its factual findings
for substantial evidence.” MCM Portfolio LLC v. Hewlett-
Packard Co., 812 F.3d 1284, 1293 (Fed. Cir. 2015).
I
We first address the verification limitation, “wherein
each of the steps must be verified as being properly com-
pleted before the operator can continue with the other steps
of drug preparation process.” ’579 patent, col. 33 ll. 18–21.
The Board construed the limitation under the broadest
1 The Board also found that the challenged claims
were not shown to be unpatentable on a separate third
ground asserted by Becton, which Becton does not appeal.
2 Congress amended § 103 when it enacted the
Leahy-Smith America Invents Act (“AIA”). Pub. L. No.
112-29, § 3(c), 125 Stat. 284, 287 (2011). However, because
the challenged claims of the ’579 patent have an effective
filing date before March 16, 2013, the pre-AIA version of
§ 103 applies. See id. § 3(n)(1), 125 Stat. at 293.
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BECTON, DICKINSON AND COMPANY v.
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reasonable interpretation standard.3 Under the Board’s
construction, which neither party appeals, the verification
limitation requires that “the system will not allow the op-
erator to proceed to the next step until the prior step has
been verified.” J.A. 17. The Board further determined that
the plain language of the verification limitation does not
require “automatic system function” to “trigger verifica-
tion.” Id.4
The Board determined that Alexander does not teach
or render obvious the verification limitation. Specifically,
the Board found persuasive Baxter’s argument that Alex-
ander “only discusses that ‘a remote pharmacist may verify
each step’; not that the remote pharmacist must verify each
and every step before the operator is allowed to proceed.”
See id. at 36–37 (quoting id. at 5284) (citation and empha-
sis omitted). We conclude that the Board’s determination
is not supported by substantial evidence.
3 Because the filing date of the petition for inter
partes review, October 29, 2018, was before November 13,
2018, the broadest reasonable interpretation standard ap-
plies. See Changes to the Claim Construction Standard for
Interpreting Claims in Trial Proceedings Before the Patent
Trial and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018)
(codified at 37 C.F.R. § 42.100); see also Personalized Media
Commc’ns, LLC v. Apple Inc., 952 F.3d 1336, 1340 n.2 (Fed.
Cir. 2020).
4 Baxter refers to the verification limitation as a
“hard stop,” Appellee’s Br. 25, as opposed to a “soft stop,”
which, according to Baxter, “provides information to the cli-
nician about a potential drug safety or efficacy problem and
may offer alternative suggestions for the clinician to con-
sider.” J.A. 5283 (citation omitted). Under the Board’s con-
struction, “‘hard stop’ is merely a short hand for [the
verification limitation] and does not impute any additional
meaning to the claim term.” Id. at 15 n.8.
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BECTON, DICKINSON AND COMPANY v.
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The passage from Alexander on which the Board relied
states:
[I]n some embodiments, a remote pharmacist may
supervise pharmacy work as it is being performed.
For example, in one embodiment, a remote phar-
macist may verify each step as it is performed and
may provide an indication to a non-pharmacist per-
forming the pharmacy that the step was performed
correctly. In such an example, the remote pharma-
cist may provide verification feedback via the same
collaboration software, or via another method, such
as by telephone.
Alexander, col. 9 ll. 47–54 (emphasis added).
In the context of Alexander, “may” does not mean “oc-
casionally,” but rather that one “may” choose to systemati-
cally check each step. This is quite clear from the context
of Alexander.
Alexander is directed to “[a] system and method for re-
motely supervising and verifying pharmacy functions per-
formed by a non-pharmacist at an institutional pharmacy.”
Id. Abstract. Alexander discloses that “software may be
installed at both an institutional pharmacy site and at a
remote pharmacist site allowing a pharmacist to view in
real-time, or near real-time, images of the pharmacy work
being performed.” Id. col. 9 ll. 31–34. “Captured images
and corresponding documentation may be transmitted
from institutional pharmacy to the remotely located phar-
macist, either directly or via a web site accessible to both.”
Id. Abstract. The purpose is to allow the pharmacist to
“authorize” the work. See id.
In this process, the Alexander specification provides
that the non-pharmacist is not authorized to proceed ab-
sent verification by the pharmacist. The abstract states
that “[r]eceiving the pharmacist’s verification may author-
ize the non-pharmacist to further process the work.” Id.
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BECTON, DICKINSON AND COMPANY v.
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Likewise, column two of the specification provides that “a
pharmacist supervises and verifies the work, and subse-
quently authorizes non-pharmacist personnel to further
process the work.” Id. col. 2 ll. 51–53. Plainly, Alexander
discloses systematic step-by-step review and authorization
by the pharmacist.
It is also clear that, without the pharmacist’s verifica-
tion of “each step as it is performed,” id. col. 9 ll. 49–50, the
non-pharmacist is not “authorize[d]” to “further process the
work,” id. col. 2 ll. 52–53; see also id. Abstract. There is no
significant difference between that teaching of Alexander
and the ’579 patent’s verification requirement, which the
Board construed as requiring that “the system will not al-
low the operator to proceed to the next step until the prior
step has been verified.” J.A. 17.
Baxter attempts to sustain the Board on two grounds
not adopted by the Board. Baxter first contends that “Al-
exander does not disclose a system that would stop the op-
erator from proceeding if a prior step was unverified, and
that such an improperly prepared dose ‘could go out to the
patient and cause harm,’” quoting from the deposition tes-
timony of Becton’s expert witness, Dr. Marc Young. Appel-
lee’s Br. 29 (quoting J.A. 3376). Requiring authorization
before proceeding necessarily stops the work if the author-
ization is not forthcoming. The remote operator cannot fur-
ther process the work without authorization. Counsel for
Baxter conceded at oral argument that, in Alexander’s sys-
tem, a non-pharmacist who, without authorization to pro-
ceed, did not stop processing work would likely be
disciplined. Oral Arg. 25:55–26:40, http://oralargu-
ments.cafc.uscourts.gov/default.aspx?fl=20-
1937_04082021.mp3.
Baxter also contends that Alexander’s disclosure is in-
sufficient because the verification limitation requires a
“mechanical . . . prohibition” on continuing the work absent
verification. Id. at 23:37–24:01. The Board’s construction
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BECTON, DICKINSON AND COMPANY v.
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requires that “the system will not allow the operator to pro-
ceed to the next step until the prior step has been verified,”
J.A. 17 (emphasis added), and Baxter contends that the use
of the word “system” implies a mechanical stop.
Nothing in the construction requires a mechanical stop
as opposed to requiring authorization from a pharmacist to
continue. Nor does the specification of the ’579 patent in-
dicate that the “stop” cannot be in the form of an instruc-
tion from a pharmacist. See, e.g., ’579 patent, col. 15 ll. 39–
45 (“If during any step, a verification error arises and there
is a question as to whether the step was properly per-
formed, the dose order processing is prevented from contin-
uing to the next step until the step is verified as being
properly performed or until the dose order is flagged as be-
ing not completed due to an error.” (emphasis added)); id.
col. 18 ll. 25–27, 56–58 (similar).
Finally, Baxter presents the ’579 patent as an improve-
ment to the “‘pull-back’ method” of pharmacist verification
in sterile compounding. See Appellee’s Br. 4. “Often a
pharmacy technician (a non-pharmacist) performs the ster-
ile compounding under a pharmacist’s supervision, with
the pharmacist responsible for final verification of the pre-
pared dose.” Id.
According to the “pull-back” method, after combin-
ing ingredients using one or more syringes, the
technician pulls each syringe back to the position it
was in when it was full of the added component, but
since the ingredients have already been combined,
the syringe would be filled with air. The pulled-
back syringe(s) along with other dose preparation
materials would be in a basket, which the pharma-
cist would then use to reconstruct the process and
verify that the technician had properly prepared
the dose.
Id. (citations omitted).
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BECTON, DICKINSON AND COMPANY v.
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According to Baxter, the pull-back method “left a lot of
room for error in dose preparation of sterile compounds.”
Id. Baxter contends that the ’579 patent improved the
prior art by disclosing a “a system for dose preparation flow
and verification of preparation steps, whereby the system
prevents the dose preparer from proceeding to the next
preparation step if the previous step has not been verified.”
Id. at 5.
The embodiment of Alexander, in which “a remote
pharmacist may verify each step as it is performed and may
provide an indication to a non-pharmacist performing the
pharmacy that the step was performed correctly,” Alexan-
der, col. 9 ll. 49–52, is not the pull-back method (or an elec-
tronic version thereof). The Board’s suggestion to the
contrary, see J.A. 36–37, is not supported by substantial ev-
idence.
We conclude that the Board’s determination that Alex-
ander does not teach the verification limitation is not sup-
ported by substantial evidence.
II
We next address the highlighting limitation, which re-
quires “an interactive screen that includes prompts that
can be highlighted by an operator to receive additional in-
formation relative to one particular step.” ’579 patent,
col. 31 ll. 55–57, col. 33 ll. 4–6. Figure 10 of the ’579 patent,
“an exemplary display of a product preparation screen and
procedure,” id. col. 5 ll. 47–48, shows
an interactive screen in that the user can simply
highlight different areas either to receive more in-
formation or to enter information. For example,
there is a Detail button 622 near the drug identifi-
cation and if additional information is needed con-
cerning this particular drug order, the user can
simply highlight this particular button (as by
“clicking” the box).
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BECTON, DICKINSON AND COMPANY v.
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Id. col. 15 l. 58–col. 16 l. 3.
Id. fig. 10.
The Board determined “that in implementing an elec-
tronic system for preparing medications, one of ordinary
skill in the art would have considered it obvious to provide
a set of drug preparation steps on a computer.” J.A. 41.
Given that determination, the only missing element of this
limitation is the ability to highlight prompts to receive
more information concerning drug preparation steps.
The Liff reference teaches highlighting in the phar-
macy context. See id. at 1496–97 (declaration of Dr. Marc
Young in support of petition for inter partes review). Liff
is directed to “[a]n automated drug dispensing system
[that] includes a cabinet adapted to store a variety of
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BECTON, DICKINSON AND COMPANY v.
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prepackaged pharmaceuticals in a plurality of bins for fill-
ing patient prescriptions.” Liff, Abstract. Liff teaches a
user interface for a workstation, see id. col. 4 ll. 5–9, figs.
14A–14V, which provides the operator with options, such
as “entering a new prescription” and “refilling a prescrip-
tion.” Id. col. 17 ll. 28–31 (referring to fig. 14A).
As Dr. Young testified in his declaration, Liff “teaches
that the user can highlight various inputs and information
displayed on the screen, as illustrated in Figure 14F.” J.A.
1496–97. More specifically, the Board found that Liff
taught “highlight[ing] patient characteristics when dis-
pensing a prepackaged medication,” id. at 43, and Baxter
does not contend that this aspect of the Board’s decision
was in error.
Figure 14F of Liff is below:
Liff, fig. 14F.
Becton does not argue that Liff “directly discloses high-
lighting to receive additional language about a drug
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BECTON, DICKINSON AND COMPANY v.
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preparation step.” Appellant’s Br. 4. Becton instead ar-
gues that “Liff discloses basic computer functionality—i.e.,
using prompts that can be highlighted by the operator to
receive additional information—that would render the
highlighting limitation obvious when applied in combina-
tion with other references,” primarily Alexander. Id. at 4
(emphasis omitted); see also id. at 24–25.
Becton relies on the following testimony of Dr. Young:
A person of ordinary skill in the art would have un-
derstood that additional information could be dis-
played on the tabs taught by Liff and that
additional tabs, with additional information, could
also be displayed in the user interface, depending
on the design needs and expected use of the soft-
ware. For example, a person of ordinary skill in the
art would have found it obvious to include in the
user interface taught by Liff a tab for the prescrip-
tion order and information regarding the prescrip-
tion order that the operator was fulfilling. Such
information could have included the text of the or-
der itself, information relating to who or how the
order should be prepared, or where the order
should be dispensed.
J.A. 1497. The testimony of Baxter’s expert, Dr. Jef-
frey Brittain, was not to the contrary.
The Board found that “this present[ed] a close case.” Id.
at 43. As noted above, the Board agreed that, in light of
Alexander and Liff, “one of ordinary skill in the art would
have considered it obvious to provide a set of drug prepara-
tion steps on a computer.” Id. at 41. Nevertheless, the
Board determined that
Dr. Young fail[ed] to explain why Liff’s teaching to
highlight patient characteristics when dispensing
a prepackaged medication would lead one of ordi-
nary skill to highlight prompts in a drug
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formulation context to receive additional infor-
mation relative to one particular step in that pro-
cess, or even what additional information might be
relevant.
Id. at 43. The Board found that Becton’s arguments with
respect to Morrison did not address the deficiency in its po-
sition based on Alexander and Liff.
The Board’s determination is not supported by sub-
stantial evidence. That Liff’s teaching was “to highlight
patient characteristics when dispensing a prepackaged
medication,” id., does not suggest that a person of ordinary
skill would not have used highlighting (accomplished in the
’579 patent by “‘clicking’ [a] box” labeled “[d]etail,” ’579 pa-
tent, col. 15 l. 64–col. 16 l. 3) with respect to other infor-
mation in the pharmacy field. Dr. Young, without
contradiction, testified to the opposite, stating that “a per-
son of ordinary skill in the art would have found it obvious
to include in the user interface taught by Liff a tab for the
prescription order and information regarding the prescrip-
tion order that the operator was fulfilling.” J.A. 1497. As
the Supreme Court has made clear, “[t]he combination of
familiar elements according to known methods is likely to
be obvious when it does no more than yield predictable re-
sults.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007).
The Board erred in looking to Liff as the only source a
person of ordinary skill would consider for what “additional
information might be relevant.” J.A. 43. “A person of ordi-
nary skill is also a person of ordinary creativity, not an au-
tomaton.” KSR, 550 U.S. at 421. Dr. Young testified that
“[a] person of ordinary skill in the art would have under-
stood that additional information could be displayed on the
tabs taught by Liff” and that “such information could have
included the text of the order itself, information relating to
who or how the order should be prepared, or where the or-
der should be dispensed.” J.A. 1497. Dr. Young further
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testified that “[a] medication dose order for compounding a
pharmaceutical would have been accompanied by direc-
tions for how the dose should be prepared, including step-
by-step directions for preparing the dose.” Id. Baxter
points to no contrary testimony.
We conclude that the highlighting limitation would
have been obvious to one of ordinary skill in the art in view
of Alexander and Liff. The Board’s determination that the
highlighting limitation is not obvious over Alexander and
Liff is not supported by substantial evidence. We need not
reach Becton’s arguments regarding Morrison.
III
As an alternative ground to affirm the Board’s deter-
mination of non-obviousness, Baxter argues that the Board
erred in determining that Alexander is prior art under 35
U.S.C. § 102(e)(2) (pre-AIA).5 This section provides that
“[a] person shall be entitled to a patent unless . . . the in-
vention was described in . . . a patent granted on an appli-
cation for patent by another filed in the United States
before the invention by the applicant for patent.” 35 U.S.C.
§ 102(e)(2).6 It is undisputed that the filing date of the
5 Congress amended § 102 when it enacted the AIA.
Pub. L. No. 112-29, § 3(b)(1), 125 Stat. at 285–87. How-
ever, because the application that led to the ’579 patent
was filed before March 16, 2013, the pre-AIA version of
§ 102 applies. See id. § 3(n)(1), 125 Stat. at 293.
6 The Board noted that “Alexander is not prior art
under 35 U.S.C § 102(e)(1).” J.A. 23. That section provides
that “an application for patent, published under [35 U.S.C.
§ 122(b)], by another filed in the United States before the
invention by the applicant for patent,” is prior art. 35
U.S.C § 102(e)(1) (pre-AIA). The Board found that “the ap-
plicant [for Alexander] expressly requested that the appli-
cation that matured into Alexander ‘not be published under
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application for Alexander is February 11, 2005, which is
before the earliest filing date of the application for the ’579
patent, October 13, 2008; that the Alexander claims were
granted; and that the application for Alexander was filed
by another.
Baxter contends that Alexander nonetheless is not
prior art because all claims in Alexander (granted on Feb-
ruary 12, 2013) were cancelled on February 15, 2018, fol-
lowing inter partes review. Baxter argues that “because
the Alexander ‘grant’ had been revoked, it can no longer
qualify as a patent ‘granted’ as required for prior art status
under Section 102(e)(2).” Appellee’s Br. 35.7
The text of the statute requires only that the patent be
“granted,” meaning the “grant[]” has occurred. 35 U.S.C.
§ 102(e)(2) (pre-AIA). The statute does not require that the
patent be currently valid.
IV
Finally, we address “secondary considerations” of non-
obviousness. See Graham v. John Deere Co. of Kansas City,
383 U.S. 1, 17 (1966). The Board found that Baxter’s evi-
dence of secondary considerations was “weak.” J.A. 33–
35 U.S.C 122(b)’ and was, therefore, never published under
that section.” J.A. 23 (citation omitted). On appeal, Becton
does not argue that Alexander is prior art under grounds
other than 35 U.S.C. § 102(e)(2).
7 Baxter also argues that “even assuming that Alex-
ander’s prior art status is evaluated at the time of patent
filing, a person of skill in the art would not have considered
Alexander to be prior art as of October 2008 [the ’579 pa-
tent’s priority date], or even known of Alexander, because
Alexander was not made public until issuance on February
12, 2013.” Appellee’s Br. 36. The Supreme Court’s decision
in Hazeltine Research, Inc. v. Brenner, 382 U.S. 252, 254–
56 (1965), forecloses this argument.
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34.8 Baxter does not argue that the Board’s determination
in this respect was in error. “[W]eak evidence of secondary
considerations . . . simply cannot overcome the strong
showing of obviousness.” ZUP, LLC v. Nash Mfg., Inc., 896
F.3d 1365, 1375 (Fed. Cir. 2018). Baxter does not mean-
ingfully argue that the weak showing of secondary consid-
erations here could overcome the showing of obviousness
based on the prior art.
CONCLUSION
The Board’s determination that the verification and
highlighting limitations are not obvious is not supported by
substantial evidence. We reverse.
REVERSED
8 Baxter presented evidence of secondary considera-
tions focusing primarily on the verification limitation.
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ATTACHMENT
1. A method for performing telepharmacy comprising the
steps of:
receiving and processing a dose order;
preparing a dose at a medication preparation station based
on the dose order including following a recipe, wherein
the dose is a reconstituted drug and the recipe having
one or more drug preparation steps including using a
diluent for reconstitution;
displaying the recipe on an interactive screen that includes
prompts that can be highlighted by an operator to re-
ceive additional information relative to one particular
step and includes areas for entering an input;
capturing one or more images of a plurality of the drug
preparation steps, each of the images being captured at,
corresponding to, and confirming a performance of one
discrete drug preparation step of the recipe, one cap-
tured image displaying a result of a discrete isolated
event performed in accordance with one drug prepara-
tion step, the drug preparation steps including at least
one step that is an intermediate step involving the dil-
uent that shows the dose prior to completing the dose
preparation and obtaining a completed dose that is in a
state that is suitable for delivery to a patient, wherein
one input comprises an input that is prompted by the
performance of the drug preparation steps;
storing each image associated with the drug preparation
steps of the recipe that has been collected together in a
data record of a database, thereby allowing the cap-
tured image to be later retrieved for inspection;
accessing the data record including the images from a re-
mote site using a portal in communication with the da-
tabase;
inspecting the data record through the portal;
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BECTON, DICKINSON AND COMPANY v.
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reviewing the images in the data record in order to verify
that each of the captured drug preparation steps was
properly completed; and
approving release of the dose to the patient if the reviewing
step confirms that each of the captured drug prepara-
tion steps was properly completed.
’579 patent, col. 31 l. 47–col. 32 l. 18.
8. A system for preparing and managing patient-specific
dose orders that have been entered into a first system,
comprising:
an order processing server executing software on a proces-
sor thereof and connected by a network to the first sys-
tem and configured to receive the patient-specific dose
orders from the first system, the order processing server
including a database configured to store the dose orders
and images that relate to the dose orders, the order pro-
cessing server being configured to generate a dose order
queue listing all dose orders received by the order pro-
cessing server;
a dose preparation station for preparing a plurality of doses
based on received dose orders, the dose preparation sta-
tion being in bi-directional communication with the or-
der processing server and having an interface for
providing an operator with a protocol associated with
each received drug order and specifying a set of drug
preparation steps to fill the drug order, the dose prepa-
ration station including an interactive screen that in-
cludes prompts that can be highlighted by an operator
to receive additional information relative to one partic-
ular step and includes areas for entering an input;
the dose preparation station being configured to present
the protocol and having one or more data input devices
to capture images of a plurality of the set of drug prep-
aration steps that are part of the protocol and are fol-
lowed to fill the drug order, wherein each image
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BECTON, DICKINSON AND COMPANY v.
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associated with the drug preparation steps of the proto-
col is stored together in a data record of the database,
wherein at least one captured image is captured at, cor-
responds to, and confirms a performance of one discrete
drug preparation step in which the dose is not com-
pletely prepared and ready for delivery to the patient
and wherein each of the steps must be verified as being
properly completed before the operator can continue
with the other steps of drug preparation process, the
captured image displaying a result of a discrete isolated
event performed in accordance with one drug prepara-
tion step, wherein verifying the steps includes review-
ing all of the discrete images in the data record; and
a display communicatively coupled to the order processing
server and positionable independently of the dose prep-
aration station, the display outputting the dose order
queue and metrics concerning activity at the dose prep-
aration station.
Id. col. 32 l. 52–col. 33 l. 30.
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