Court Opinion

ID: 4691129
Source: CourtListenerOpinion
Date Created: 2021-05-28 15:02:26.766537+00
Date Added: 2024-06-11T08:05:05.947717
License: Public Domain

Case: 20-1937         Document: 30          Page: 1   Filed: 05/28/2021

   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
                       ______________________

     THOMAS SAUNDERS, Wilmer Cutler Pickering Hale and
 Dorr LLP, Washington, DC, argued for appellant. Also rep-
 resented by OMAR KHAN, New York, NY; KATHERINE P.
 KIECKHAFER, Boston, MA.

     BENJAMIN EDWARD WEED, K&L Gates LLP, Chicago,
 IL, argued for appellee. Also represented by KATHERINE
 ALLOR, GEORGE C. SUMMERFIELD, JR.; MICHAEL IRA COHEN,
 Baxter International Inc., Deerfield, IL.
                  ______________________

   Before PROST*, CLEVENGER, and DYK, Circuit Judges.

    ________________________________

    *  Sharon Prost vacated the position of Chief Judge on
 May 21, 2021.
Case: 20-1937     Document: 30     Page: 2    Filed: 05/28/2021

 2                         BECTON, DICKINSON AND COMPANY v.
                             BAXTER CORPORATION ENGLEWOOD

 DYK, 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.                                3
 BAXTER CORPORATION ENGLEWOOD

       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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 4                        BECTON, DICKINSON AND COMPANY v.
                            BAXTER CORPORATION ENGLEWOOD

 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).
                         DISCUSSION
     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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 BAXTER CORPORATION ENGLEWOOD

 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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 6                         BECTON, DICKINSON AND COMPANY v.
                             BAXTER CORPORATION ENGLEWOOD

     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.                               7
 BAXTER CORPORATION ENGLEWOOD

 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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 8                          BECTON, DICKINSON AND COMPANY v.
                              BAXTER CORPORATION ENGLEWOOD

 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.                               9
 BAXTER CORPORATION ENGLEWOOD

     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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 10                           BECTON, DICKINSON AND COMPANY v.
                                BAXTER CORPORATION ENGLEWOOD

 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.                            11
 BAXTER CORPORATION ENGLEWOOD

 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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 12                        BECTON, DICKINSON AND COMPANY v.
                             BAXTER CORPORATION ENGLEWOOD

 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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 BECTON, DICKINSON AND COMPANY v.                             13
 BAXTER CORPORATION ENGLEWOOD

     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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 14                        BECTON, DICKINSON AND COMPANY v.
                             BAXTER CORPORATION ENGLEWOOD

 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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 BECTON, DICKINSON AND COMPANY v.                            15
 BAXTER CORPORATION ENGLEWOOD

 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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 16                       BECTON, DICKINSON AND COMPANY v.
                            BAXTER CORPORATION ENGLEWOOD

 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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 BAXTER CORPORATION ENGLEWOOD

                        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;
Case: 20-1937     Document: 30      Page: 18   Filed: 05/28/2021

 18                         BECTON, DICKINSON AND COMPANY v.
                              BAXTER CORPORATION ENGLEWOOD

 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
Case: 20-1937      Document: 30     Page: 19   Filed: 05/28/2021

 BECTON, DICKINSON AND COMPANY v.                          19
 BAXTER CORPORATION ENGLEWOOD

    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.