Court Opinion

ID: 800026
Source: CourtListenerOpinion
Date Created: 2012-05-17 17:08:27+00
Date Added: 2024-06-11T12:13:00.790593
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
               __________________________

             (Reexamination No. 90/007,751)
      IN RE BAXTER INTERNATIONAL, INC.
             __________________________

                       2011-1073
               __________________________

    Appeal from the United States Patent and Trademark
Office, Board of Patent Appeals and Interferences in
Reexamination No. 90/007,751.
              ____________________________

                 Decided: May 17, 2012
             ____________________________

   WILLIAM F. LEE, Wilmer Cutler Pickering Hale and
Dorr, LLP, of Boston, Massachusetts, argued for the
appellant. With him on the brief were WILLIAM G.
MCELWAIN, DAVID L. CAVANAUGH, TODD C. ZUBLER,
THOMAS G. SAUNDERS and HEATHER M. PETRUZZI, of
Washington, DC.

    SYDNEY O. JOHNSON, JR., Associate Solicitor, Office of
the Solicitor, United States Patent and Trademark Office,
of Alexandria, Virginia, argued for appellee. With him on
the brief were RAYMOND T. CHEN, Solicitor, and JANET A.
GONGOLA, Associate Solicitor. Of counsel was SCOTT C.
WEIDENFELLER, Associate Solicitor.
IN RE BAXTER INTL                                         2

    MICHAEL E. FLOREY, Fish & Richardson P.C., of Min-
neapolis, Minnesota, for amici curiae, Fresenius USA,
Inc., et al.
              __________________________

  Before NEWMAN, LOURIE, and MOORE, Circuit Judges.
   Opinion for the court filed by Circuit Judge LOURIE.
   Dissenting opinion filed by Circuit Judge NEWMAN.
LOURIE, Circuit Judge.
    Baxter International Inc. (“Baxter”) appeals from the
decision of the Board of Patent Appeals and Interferences
(“the Board”) affirming the examiner’s rejections of claims
26–31 of U.S. Patent 5,247,434 (“the ’434 patent”) for
obviousness under 35 U.S.C. § 103(a). See Ex parte Bax-
ter Int’l, Inc., No. 2009-006493, 2010 WL 1048980
(B.P.A.I. Mar. 18, 2010) (“Board Decision”); Ex parte
Baxter Int’l, Inc., No. 2009-006493, 2010 WL 3032865
(B.P.A.I. July 20, 2010) (“Board Rehearing Decision”).
Because the Board did not err in determining that those
claims would have been obvious to one of ordinary skill in
the art, we affirm.
                      BACKGROUND
                            I.
     This patent appeal relates to hemodialysis machines
that can function in place of a patient’s kidney to cleanse
the blood of toxins using a solution called a dialysate.
During hemodialysis, the patient’s blood is pumped
though the hemodialysis machine and the dialysate acts
to absorb the toxins. To ensure that the process does not
filter essential nutrients from the blood, a hemodialysis
machine must facilitate the monitoring and control of a
number of parameters.
3                                         IN RE BAXTER INTL

    Baxter owns the ’434 patent, entitled “Method and
Apparatus for Kidney Dialysis,” which discloses and
claims a hemodialysis machine integrated with a touch
screen user interface that allows an operator to monitor
and control a number of parameters. Figure 8 of the
patent, reproduced below, depicts an exemplary touch
screen interface:

    As depicted above, the interface allows an operator to
monitor and control a number of treatment parameters,
such as the dialysate temperature, and the patent details
the computer system that interfaces with the touch screen
to control the delivery of the dialysate and other liquids.
Claim 26 of the patent, reproduced below, recites the
elements of the integrated hemodialysis machine:
IN RE BAXTER INTL                                       4

       26. A hemodialysis machine comprising:
       (a) means for controlling a dialysate pa-
             rameter selected from a group con-
             sisting of dialysate temperature and
             dialysate concentration, and means
             for delivering the dialysate to a
             dialysate compartment of a hemodi-
             alyzer; and
       (b) a user/machine interface operably cou-
              pled to said dialysate-delivery
              means, the user/machine interface
              comprising a touch screen adapted
              to display an indicium correspond-
              ing to a parameter pertinent to op-
              eration of the hemodialysis machine
              for performing hemodialysis and to
              permit the user, by touching the in-
              dicium, to cause a change in the pa-
              rameter.
’434 patent, col.40 ll.29–43 (emphases added). Dependent
claim 30 includes an additional means plus function
limitation, reciting that the hemodialysis machine further
comprises a “means for delivering an anticoagulant to a
patient.” Id. col.40 ll.60–64. Finally, dependent claims
27, 30, and 31 recite that the touch screen provide “in-
dicium soliciting” specific information from the machine’s
user: “programmed settings of a time-varying machine-
operating parameter” (claim 27); “input from the user
corresponding to a rate of anticoagulant delivery” (claim
30); or “a programmed setting of an alarm limit about the
machine-operating parameter” (claim 31). Id. col.40 ll.44–
47, 60–68.
5                                          IN RE BAXTER INTL

                             II.
    The ’434 patent has been subject to litigation. In
2003, one of Baxter’s competitors, Fresenius, filed a
declaratory judgment action in the United States District
Court for the Northern District of California, seeking,
among other claims, a declaration that the patent’s claims
were invalid. Fresenius Med. Care Holdings, Inc. v.
Baxter Int’l, Inc., No. C 03-1431 SBA, 2007 WL 518804, at
*1 (N.D. Cal. Feb. 13, 2007). The parties tried Fresenius’s
invalidity claims to a jury, which found that Fresenius
had proved by clear and convincing evidence that claims
26–31 of the patent would have been obvious at the time
the invention was made. Id. at *2. After trial, Baxter
moved for judgment as a matter of law, and the district
court granted Baxter’s motion. Id. at *2, *8–9. In par-
ticular, the district court concluded that Fresenius failed
as a matter of law to show by clear and convincing evi-
dence that Fresenius’s proffered prior art, viz., the CMS
08 Manual, the Cobe C3 Manual, or the Seratron System,
contained the “means for controlling” and “means for
delivering” limitations of claim 26. Id. at *8.
    Upon the entry of a final judgment, Fresenius ap-
pealed. We affirmed the district court’s grant of judgment
as a matter of law, but for “somewhat different reasons
than those articulated by the district court.” Fresenius
USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1299 (Fed.
Cir. 2009). We concluded that “Fresenius failed to pre-
sent any evidence—let alone substantial evidence—that
the structure corresponding to the means for delivering
dialysate limitation [in claim 26], or an equivalent
thereof, existed in the prior art.” Id. In particular, Fre-
senius failed to identify “the structure in the specification
that corresponds to the means for delivering dialysate”
and further failed to compare the identified structure to
those structures present in the prior art. Id. at 1300. We
IN RE BAXTER INTL                                         6

thus held that the district court correctly granted Baxter’s
motion for judgment as a matter of law. Id.
                            III.
    In 2006, in parallel with the Fresenius litigation, the
United States Patent & Trademark Office (“PTO”) began
to reexamine the ’434 patent, stimulated by Fresenius. In
the course of those proceedings, the examiner found that a
number of references rendered obvious claims 26–31 of
the patent, including, among other references, the CMS
08 Manual, the Sarns 9000 Manual, U.S. Patent
4,370,983 (“Lichtenstein”), and U.S. Patent 4,710,166
(“Thompson”). Specifically, with regard to claims 26–29
and 31, the examiner concluded that those claims would
have been obvious in light of the combined teachings of
the CMS 08 Manual, Lichtenstein, the Sarns 9000 Man-
ual, and two other references not at issue on appeal.
Board Decision, 2010 WL 1048980, at *4. Regarding
claim 30, the examiner concluded that it would not have
been patentable over a combination of the same refer-
ences in view of Thompson. Id.
    Baxter appealed the examiner’s final rejections to the
Board. After briefing and oral argument before the Board
but prior to issuance of the Board’s decision, we decided
the Fresenius case. Shortly thereafter, Baxter petitioned
the Director of the PTO to remand the reexamination to
the examiner to consider the rejections in light of our
Fresenius decision. The Director denied the petition but
ordered the Board to consider our decision in Fresenius.
    The Board affirmed the examiner’s rejections of
claims 26–31. Regarding our Fresenius decision, the
Board discussed the holding of the case and concluded
that “[a]lthough claims 26–31 were not proven invalid in
court, a lower standard of proof and the broadest reason-
able interpretation standard of claim construction apply
7                                         IN RE BAXTER INTL

at the PTO and therefore the agency is not bound by the
court’s determination.”       Board Decision, 2010 WL
1048980, at *12 (citing Ethicon, Inc. v. Quigg, 849 F.2d
1422, 1429 (Fed. Cir. 1988); In re Swanson, 540 F.3d
1368, 1377 (Fed. Cir. 2008)).
     Turning to the merits of the examiner’s rejections, the
Board found that the CMS 08 Manual describes the
“control of Na, K, and HCO3 flow rates using a control
unit that may be programmed in ten minute intervals
(i.e., a microprocessor) and a pump driven by a stepper
motor,” a disclosure that met the corresponding structure
in the specification identified by Baxter and the examiner
for the “means for controlling” limitation. Board Decision,
2010 WL 1048980, at *14. The Board also found that
Baxter “did not assert that Lichtenstein lacks any struc-
ture corresponding to element (a) of claim 26” and thus
declined to address the rejections based on Lichtenstein.
Id.
    The Board also affirmed the examiner’s findings re-
garding the “soliciting” limitations in claims 27, 30, and
31. With respect to claim 27, the Board found that the
CMS 08 Manual disclosed that a user can adjust or con-
trol time-dependent hemodialysis parameters such as the
ultrafiltrate rate and the concentration of substances in
the dialysate. Board Decision, 2010 WL 1048980, at *14.
Regarding claim 30, the Board found that Thompson in
combination with the CMS 08 Manual or the Sarns 9000
Manual rendered obvious the “indicium soliciting input
from the user corresponding to a rate of anticoagulant
delivery” limitation. Id. at *9–10, *15. Finally, the Board
found that the Sarns 9000 Manual described the “in-
dicium soliciting, from the user, a programmed setting of
an alarm limit about the machine-operating parameter”
limitation in claim 31. Id.
IN RE BAXTER INTL                                         8

    Following the Board decision, Baxter requested re-
hearing, which the Board denied. Board Rehearing
Decision, 2010 WL 3032865, at *1. In particular, the
Board rejected Baxter’s argument that the Board had
erroneously equated “soliciting” with “control” or “adjust,”
reiterating that the CMS 08 Manual disclosed that “the
machine interface solicits the user for entry of data to
control various parameters such as sodium concentra-
tion.” Id.
    Baxter timely appealed, and we have jurisdiction un-
der 28 U.S.C. § 1295(a)(4)(A).
                       DISCUSSION
                             I.
     The scope of our review in an appeal from a Board de-
cision is limited. We review the Board’s factual findings
for substantial evidence and review the Board’s legal
conclusions de novo. In re Kotzab, 217 F.3d 1365, 1369
(Fed. Cir. 2000). A finding is supported by substantial
evidence if a reasonable mind might accept the evidence
to support the finding. Consol. Edison Co. v. NLRB, 305
U.S. 197, 229 (1938).
    Although the ultimate determination of obviousness
under 35 U.S.C. § 103 is a question of law, it is based on
several underlying factual findings, including the differ-
ences between the claimed invention and the prior art.
Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
Similarly, the determination of what a reference teaches
is a question of fact. Rapoport v. Dement, 254 F.3d 1053,
1060–61 (Fed. Cir. 2001); see also In re Gartside, 203 F.3d
1305, 1316 (Fed. Cir. 2000). Thus, we review those fac-
tual determinations for substantial evidence. Kotzab, 217
F.3d at 1369.
9                                         IN RE BAXTER INTL

    In contrast, claim construction is a legal issue that we
review de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d
1448, 1454–55 (Fed. Cir. 1998) (en banc). To ascertain
the scope and meaning of the asserted claims, we look to
the words of the claims themselves, the specification, the
prosecution history, and, lastly, any relevant extrinsic
evidence. Phillips v. AWH Corp., 415 F.3d 1303, 1315–17
(Fed. Cir. 2005) (en banc).
                            II.
                            A.
    As an initial matter, the PTO argues that Baxter
waived its arguments regarding the “means plus function”
limitations in claims 26 and 30 because it failed to timely
present those arguments to the Board. Baxter responds
that it presented those issues to the Board in its opening
brief, its reply brief, and at oral argument. Baxter also
argues that the Director allowed Baxter to pursue those
arguments in its order denying Baxter’s petition to re-
mand the case from the Board to the examiner.
     We agree with the PTO that Baxter waived its argu-
ments regarding the “means for delivering an anticoagu-
lant” limitation in claim 30 by failing to timely raise them
before the Board. Absent exceptional circumstances, see
In re DBC, 545 F.3d 1373, 1379–80 (Fed. Cir. 2008), we
generally do not consider arguments that the applicant
failed to present to the Board, In re Watts, 354 F.3d 1362,
1367–68 (Fed. Cir. 2004). Although Baxter recited the
“means for delivering anticoagulant” claim language in
the background of its opening brief before the Board,
Baxter did not raise that limitation in the arguments
section, instead arguing that “Claim 30 Is Patentable
Because the Prior Art, Including the Thompson Patent,
Fails To Teach or Suggest Touch-Screen Control.” J.A.
7883:11a, 7883:59a. In its reply brief before the Board,
IN RE BAXTER INTL                                         10

Baxter did not address the examiner’s rejection of claim
30 in any respect. See J.A. 9358–59. Unsurprisingly, the
Board did not provide an analysis of the “means for deliv-
ering an anticoagulant limitation,” but only addressed
Baxter’s arguments regarding the “indicium soliciting
from the user” limitation of claim 30. Board Decision,
2010 WL 1048980, at *9–10, *15.
    Ultimately, Baxter failed to raise the “means for de-
livering an anticoagulant” limitation before the Board,
and, contrary to Baxter’s arguments, the Director’s order
denying Baxter’s petition did not preserve for appeal
arguments relating to a claim limitation that Baxter
never put at issue before the Board. Finally, Baxter has
not presented an exceptional circumstance that would
allow us to consider arguments that it failed to present to
the Board. We accordingly decline to address them.
    The record does indicate, however, that Baxter timely
raised its arguments regarding the examiner’s analysis of
limitation (a) of claim 26 as well as the substantive merit
of those rejections, at least regarding the rejections based
on the CMS 08 Manual. J.A. 7883:42a–45a. While those
arguments did not specifically name the cases that Baxter
primarily relies upon on appeal, we do not require such
case specificity to preserve a point of error for appeal. See
Nelson v. Adams USA, Inc., 529 U.S. 460, 469–70 (2000)
(explaining that the general rule of error preservation
“does not demand the incantation of particular words” but
simply requires that the lower tribunal “be fairly put on
notice as to the substance of the issue”). Thus, we will
address Baxter’s arguments on those issues.
                             B.
     Regarding claim 26, Baxter raises a number of argu-
ments on appeal. First, Baxter argues that the PTO
failed to perform the structural analysis required by In re
11                                         IN RE BAXTER INTL

Donaldson Co., 16 F.3d 1189 (Fed. Cir. 1994). Baxter also
argues that the Board’s findings that the prior art dis-
closes the “means for controlling” and “means for deliver-
ing the dialysate” limitations are not supported by
substantial evidence and contradict the findings of the
district court and this court in the Fresenius litigation, to
both of which the PTO failed to give serious consideration.
Regarding the “means for controlling” limitation, Baxter
argues that none of the pages of the prior art references
cited by the examiner and the Board actually disclose a
microprocessor. With respect to the “means for deliver-
ing” limitation, Baxter argues that the prior art “pumps
and pump lines” identified by the examiner do not deliver
dialysate to a dialysate compartment of a hemodialyzer
but instead deliver fluids to other destinations.
    The PTO responds that a structural analysis was per-
formed for the “means for controlling” and “means for
delivering” limitations. It also argues that substantial
evidence shows that the CMS 08 Manual and Lichten-
stein disclose the structure corresponding to the chal-
lenged means plus function limitations. Finally, the PTO
argues that the lower court’s decision and this court’s
decision in Fresenius do not control the reexamination
proceeding because the PTO and the court system apply
different approaches to determine invalidity and pat-
entability.
    We agree with the PTO that substantial evidence
supported the Board’s findings on claim 26. Regarding
Baxter’s arguments that the examiner did not specifically
determine the corresponding structure for the “means
plus function” limitations in limitation (a), the record
indicates that both the examiner and Baxter agreed that
the corresponding structure disclosed in the specification
for the “means for controlling” limitation included a
microprocessor and a concentrate pump. Board Decision,
IN RE BAXTER INTL                                       12

2010 WL 1048980, at *14; J.A. 9283–84. Similarly, rather
than engage in a purely functional analysis of the “means
for delivering the dialysate” limitation, the examiner
identified a pump, the same type of structure that Baxter
contends is the corresponding structure for the “means for
delivering the dialysate” limitation. See J.A. 7883:10a,
9284.
     Turning to Baxter’s specific arguments regarding the
teachings disclosed in the references, we conclude that
substantial evidence supports the Board’s finding that the
prior art discloses limitation (a) of claim 26. Regarding
the “means for controlling” limitation, the CMS 08 Man-
ual discloses a “computer modeling system” with a
“[p]rocessor” and describes that “electrolyte concentra-
tions” are delivered via “stepper motor driven line pumps”
that can be “programmed in ten minute intervals.” J.A.
284, 288, 290. Even if Baxter could overcome the Board’s
express finding that Baxter “did not assert that Lichten-
stein lacks any structure corresponding” to limitation (a)
of claim 26, Board Decision, 2010 WL 1048980, at *14,
that reference, in any event, discloses a “microcomputer”
that is programmable to carry out specific procedures,
including hemodialysis. Lichtenstein, col.3 ll.64–65, col.8
ll.23–25; see also id. col.20 ll.9–15 (“Computer systems
such as the . . . Intel ‘Multibus’ for its SBC 80 Microcom-
puter System, can be purchased as assembled units to
provide the microcomputer functions, when appropriately
programmed.”). The descriptions in both references are
similar to the microcontroller and concentrate pumps
identified by Baxter as the corresponding structure for the
“means for controlling” limitation. ’434 patent, col.16
ll.45–48, col.17 ll.29–33 (explaining that the microproces-
sor is “built using an Intel 8040 microcontroller” and that
the concentrate pumps “are stepper motor driven . . .
13                                        IN RE BAXTER INTL

diaphragm pumps which deliver a calibrated volume of
concentrate per stepper motor revolution”).
     Substantial evidence also supports the Board’s finding
that the prior art disclosed structure corresponding to the
“means for delivering the dialysate” limitation. While
Baxter argues that the specific pumps in the CMS 08
Manual do not deliver dialysate to a dialysate compart-
ment of a hemodialyzer but instead perform other func-
tions, the reference discloses a “dialysate mixing system”
that must be connected to a hemodialyzer, which neces-
sarily requires the dialysate to be pumped between the
machines. J.A. 292–99. In addition, on their face, the
pumps identified by the examiner in the CMS 08 Manual
appear similar in structure and functionality to the
“concentrate” pumps and pump lines that Baxter identi-
fied as corresponding structure in the ’434 patent for this
“means plus function” limitation. J.A. 7883:10a (identify-
ing concentrate pump 22 and “the associated structure”).
Further, even if Baxter’s arguments regarding Lichten-
stein are properly before us, that reference also teaches
that a pump delivers dialysate through a flow meter into
the dialysate side of a dialysis container used in connec-
tion with hemodialysis equipment. Lichtenstein, col.12
ll.60–61, col.13 ll.41–47.
    We also reject Baxter’s argument that the Board erred
because it “ignored” our decision in Fresenius and failed to
“give serious consideration” to the district court’s Fresen-
ius decision. Opening Br., Baxter Int’l Inc. at 36, 41, 2011
WL 5997217. First, as recounted above, the Board ex-
pressly considered our decision in Fresenius. More fun-
damentally, the PTO in reexamination proceedings and
the court system in patent infringement actions “take
different approaches in determining validity and on the
same evidence could quite correctly come to different
conclusions.” Swanson, 540 F.3d at 1377 (quoting Ethi-
IN RE BAXTER INTL                                         14

con, 849 F.2d at 1428). In particular, a challenger that
attacks the validity of patent claims in civil litigation has
a statutory burden to prove invalidity by clear and con-
vincing evidence. Id. (citing 35 U.S.C. § 282); see also
Microsoft Corp. v. i4i Ltd., 131 S. Ct. 2238, 2242 (2011).
Should the challenger fail to meet that burden, the court
will not find the patent “valid,” only that “the patent
challenger did not carry the ‘burden of establishing inva-
lidity in the particular case before the court.’” Swanson,
540 F.3d at 1377 (quoting Ethicon, 849 F.2d at 1429 n.3
(internal citations omitted)). In contrast, in PTO reex-
aminations “the standard of proof—a preponderance of
the evidence—is substantially lower than in a civil case”
and there is no presumption of validity in reexamination
proceedings. Id. at 1378.
    This case thus illustrates the distinction between a
reexamination and a district court proceeding. In Fresen-
ius, we upheld the district court’s grant of judgment as a
matter of law because the patent challenger failed to meet
its burden to prove invalidity by clear and convincing
evidence—it “failed to present any evidence . . . that the
structure corresponding to the means for delivering
dialysate limitation [in claim 26], or an equivalent
thereof, existed in the prior art” and did not identify “the
structure in the specification that corresponds to the
means for delivering dialysate” or compare the identified
structure to those structures present in the prior art.
Fresenius, 582 F.3d at 1299. Ultimately, we concluded
that the clear and convincing burden of proof in the
“means plus function” context “cannot be carried without
clearly identifying the corresponding structure in the
prior art.” Id. at 1300.
    In contrast, during the reexamination, the examiner
sufficiently identified the corresponding structure recited
in the ’434 patent and identified the structures in the
15                                        IN RE BAXTER INTL

prior art such that a reasonable person might accept that
evidence to support a finding that claim 26 is not pat-
entable under a preponderance of the evidence standard
of proof. Moreover, in addition to relying on the CMS 08
Manual, the examiner based those rejections on prior art
references that were not squarely at issue during the trial
on the invalidity issues, such as Lichtenstein and Thomp-
son. See Fresenius, 2007 WL 518804, at *7–8 (discussing
the Cobe C3 Manual, the CMS 08 Manual, the Sarns
9000, and the Seratron System). Thus, because the two
proceedings necessarily applied different burdens of proof
and relied on different records, the PTO did not err in
failing to provide the detailed explanation now sought by
Baxter as to why the PTO came to a different determina-
tion than the court system in the Fresenius litigation.
     Lest it be feared that we are erroneously elevating a
decision by the PTO over a decision by a federal district
court, which decision has been affirmed by this court, the
following additional comments must be made. When a
party who has lost in a court proceeding challenging a
patent, from which no additional appeal is possible,
provokes a reexamination in the PTO, using the same
presentations and arguments, even with a more lenient
standard of proof, the PTO ideally should not arrive at a
different conclusion.
    However, the fact is that Congress has provided for a
reexamination system that permits challenges to patents
by third parties, even those who have lost in prior judicial
proceedings. Usually one would expect that any such
reexamination, such as the one before us, would raise new
issues. In this case, the patent examiner relied on new
prior art that had not been raised in the prior district
court proceeding. Why Fresenius did not present that
prior art before the district court we do not know. But the
Director apparently found that a substantial new ques-
IN RE BAXTER INTL                                        16

tion of patentability had been raised and the examiner
was then entitled to conduct a reexamination on the basis
of the new art presented and her search of the prior art.
Thus, this case is not about the relative primacy of the
courts and the PTO, about which there can be no dispute.
Finally, we could not conclude that the PTO was barred
from conducting the reexamination of the ’434 patent
because of the final judgment in Fresenius without over-
ruling Ethicon and Swanson, which we cannot do. See
Hometown Fin., Inc. v. United States, 409 F.3d 1360, 1365
(Fed. Cir. 2005) (“[W]e are bound to follow our own prece-
dent as set forth by prior panels . . . .”).
                            C.
    Lastly, Baxter argues that the Board erroneously con-
strued the term “soliciting” in claims 27, 30, and 31 and,
under a correct construction of that term, the rejections of
those claims were not supported by substantial evidence.
In particular, Baxter argues that the Board implicitly
construed “soliciting” in an overbroad manner to encom-
pass a touch screen user interface that allows a user to
adjust or control the machine, a construction that is not
supported by the specification. Baxter argues that the
term should have been construed to require the machine
to actively seek an action by a user.
    We disagree. The PTO does not dispute Baxter’s con-
struction of “soliciting” as requiring the touch screen user
interface to actively seek an action by the user, and the
Board applied a construction identical in scope, requiring
the machine interface to prompt the user for entry of
specific data. J.A. 40. That requirement finds support in
the written description. E.g., ’434 patent, col.10 ll.1–6
(describing that the machine “solicits” a sodium value “by
means of a pop-up keypad”).
17                                        IN RE BAXTER INTL

    Under that construction, substantial evidence sup-
ports the rejections of claims 27, 30, and 31. In particu-
lar, the CMS 08 Manual discloses the “soliciting”
limitation in claim 27 because the reference depicts a user
interface that prompts the user to input a variety of time-
varying operating parameters, such as the ultrafiltration
rate and the sodium electrolyte profile. J.A. 307–08.
Similarly, substantial evidence supports the PTO’s find-
ing that the Sarns 9000 Manual teaches the “soliciting”
limitation in claim 31 because that reference discloses a
user interface that prompts the user to input a pressure
alarm limit. J.A. 450.
    Finally, substantial evidence supports the Board’s
finding that the CMS 08 Manual or the Sarns 9000 Man-
ual, when combined with Thompson, renders obvious the
“indicium soliciting input from the user corresponding to
a rate of anticoagulant delivery” limitation in claim 30.
As explained above, the CMS 08 Manual and the Sarns
9000 Manual disclose providing an “indicium soliciting”
input from a user. Baxter does not contest that Thomp-
son teaches delivering anticoagulants to a patient. See
Thompson, col.1 ll.9–25. Nor does Baxter contest on
appeal that, in view of Thompson’s disclosure, it would
have been obvious to one of ordinary skill in the art to
modify the user interface described in the CMS 08 Man-
ual or the Sarns 9000 Manual to provide an indicium
soliciting input from the user that corresponds to a rate of
anticoagulant delivery.
                       CONCLUSION
    We have considered Baxter’s remaining arguments
and conclude that they are without merit. For the forego-
ing reasons, the Board’s determination that claims 26–31
were not patentable is
                       AFFIRMED
  United States Court of Appeals
      for the Federal Circuit
                __________________________

       IN RE BAXTER INTERNATIONAL, INC.
              __________________________

                        2011-1073
              (Reexamination No. 90/007,751)
                __________________________

    Appeal from the United States Patent and Trademark
Office, Board of Patent Appeals and Interferences.
               __________________________

NEWMAN, Circuit Judge, dissenting.

     The Patent and Trademark Office’s Board of Patent Ap-
peals and Interferences, on reexamination of a patent that
had previously been litigated to final judgment in the dis-
trict court and on appeal to the Federal Circuit, states that
“the agency is not bound by the court’s determination.”
BPAI Op. at 26. My colleagues appear unperturbed by the
agency’s nullification of this court’s final decision. Instead,
the court itself ignores our own prior final decision, al-
though it is the law of this case. Thus the court violates not
only the constitutional plan, but also violates the rules of
litigation repose as well as the rules of estoppel and preclu-
sion—for the issue of validity, the evidence, and the parties
in interest are the same in this agency reexamination as in
the finally resolved litigation.

   No authority, no theory, no law or history, permits ad-
ministrative nullification of a final judicial decision. No
IN RE BAXTER INTL                                           2

concept of government authorizes an administrative agency
to override or disregard the final judgment of a court.
Judicial rulings are not advisory; they are obligatory. In
San Remo Hotel, L.P. v. City & County of San Francisco,
545 U.S. 323 (2005) the Court explained:

   The general rule implemented by the full faith and
   credit statute—that parties should not be permitted
   to relitigate issues that have been resolved by courts
   of competent jurisdiction—predates the Republic. It
   “has found its way into every system of jurispru-
   dence, not only from its obvious fitness and propri-
   ety, but because without it, an end could never be
   put to litigation.”

Id. at 336-37 (quoting Hopkins v. Lee, 19 U.S. 109, 114 (6
Wheat.) (1821)).

     Finality is fundamental to the Rule of Law. In Southern
Pacific Railroad v. United States, 168 U.S. 1 (1897) the
Court stressed the importance of repose and conclusiveness
following upon judicial decision:

   This general rule is demanded by the very object for
   which civil courts have been established, which is to
   secure the peace and repose of society by the settle-
   ment of matters capable of judicial determination.
   Its enforcement is essential to the maintenance of
   social order; for the aid of judicial tribunals would
   not be invoked for the vindication of rights of person
   and property if, as between parties and their priv-
   ies, conclusiveness did not attend the judgments of
   such tribunals in respect of all matters properly put
   in issue, and actually determined by them.
3                                              IN RE BAXTER INTL

Id. at 49. All departments of government are bound by the
finality of the judicial ruling. “Judgments, within the
powers vested in courts by the Judiciary Article of the
Constitution, may not lawfully be revised, overturned or
refused faith and credit by another Department of Govern-
ment.” Chi. & S. Airlines, Inc. v. Waterman S.S. Corp., 333
U.S. 103, 114 (1948).

    In Plaut v. Spendthrift Farm, Inc., 514 U.S. 211 (1995)
the Court traced the finality of judicial rulings in relation to
the executive branch to Hayburn’s Case, 2 U.S. (2 Dall.) 409
(1792), which “stands for the principle that Congress cannot
vest review of the decisions of Article III courts in officials of
the Executive Branch.” Plaut, 514 U.S. at 218. The Court
explained:

    The record of history shows that the Framers
    crafted this charter of the judicial department with
    an expressed understanding that it gives the Fed-
    eral Judiciary the power, not merely to rule on
    cases, but to decide them, subject to review only by
    superior courts in the Article III hierarchy—with an
    understanding, in short, that “a judgment conclu-
    sively resolves the case” because “a ‘Judicial Power’
    is one to render dispositive judgments.”

Id. at 218–19 (quoting Frank H. Easterbrook, Presidential
Review, 40 Case W. Res. L. Rev. 905, 926 (1990)) (emphasis
in original). In Town of Deerfield v. Federal Communica-
tions Commission, 992 F.2d 420, 428 (2d Cir. 1993), the
court elaborated that revision by the FCC of the court’s
order would render the court’s previous judgment merely
advisory, and thus in violation of the Constitution.

   Yet this court continues to authorize the Patent and
Trademark Office to “revise, overturn, and refuse full faith
IN RE BAXTER INTL                                              4

and credit” to final judgments of the courts, in the words of
Chicago & Southern Airlines, 333 U.S. at 114. Such agency
action has not been authorized by any other court. To the
contrary, when the judicial decision is final as to the issue
before the agency, the decision is binding on the agency.
Finality is reflected in the law of the case doctrine, which
“promotes the finality and efficiency of the judicial process
by protecting against the agitation of settled issues.”
Christianson v. Colt Industries, Inc., 486 U.S. 800, 815–16
(1988). This universal doctrine in not new to the Federal
Circuit, see, e.g., Suel v. Secretary of Health & Human
Services, 192 F.3d 981, 984–85 (Fed. Cir.1999) (The law of
the case doctrine “ensures judicial efficiency and prevents
endless litigation. Its elementary logic is matched by ele-
mentary fairness—a litigant given one good bite at the apple
should not have a second.”); Perkin-Elmer Corp. v. Com-
putervision Corp., 732 F.2d 888, 900 (Fed. Cir. 1984) (the
law of the case doctrine is designed to put an end to issues
that have been fully litigated and resolved).

     The theories of preclusion implement the fundamentals
of judicial finality, for a final judicial determination controls
the issue in all forums. See Federated Dep’t Stores, Inc. v.
Moitie, 452 U.S. 394, 401 (1981) (“This Court has long
recognized that ‘[p]ublic policy dictates that there be an end
of litigation; that those who have contested an issue shall be
bound by the result of the contest, and that matters once
tried shall be considered forever settled as between the
parties.’”) (quoting Baldwin v. Traveling Men's Ass’n, 283
U.S. 522, 525 (1931)). In Allen v. McCurry, 449 U.S. 90, 94
(1980) the Court explained that “res judicata and collateral
estoppel relieve parties of the cost and vexation of multiple
lawsuits, conserve judicial resources, and, by preventing
inconsistent decisions, encourage reliance on adjudication.”
Applying these principles to patent reexamination of the
same issues of fact and law as were decided in judicial
5                                           IN RE BAXTER INTL

proceedings, the principles of preclusion apply. A patent
that has been adjudicated to be valid cannot be invalidated
by administrative action, any more than a patent adjudi-
cated to be invalid can be restored to life by administrative
action.

    In enacting the various reexamination statutes, Con-
gress did not purport to violate the constitutional strictures
governing finality of judicial process. The possibilities for
vexation and abuse were perceived from the initiation of
reexamination; when the first reexamination statute was
proposed, Patent Commissioner Diamond testified that the
statute contained various safeguards and “carefully protects
patent owners from reexamination proceedings brought for
harassment or spite. The possibility of harassing patent
owners is a classic criticism of some foreign reexamination
systems and we made sure it would not happen here.”
Hearings on H.R. 6933, 6934, 3806 & 215, Industrial Inno-
vation & Patent & Copyright Law Amendments, House
Comm. on the Judiciary, 96th Cong., 2d Sess. 594 (1980).
Nonetheless, commentators were skeptical; for example,
Anthony H. Handal, Re-examination: Some Tactical Consid-
erations — A Private Practitioner’s Viewpoint, 9 AIPLA Q.J.
249 (1981), explained that

    a party threatened with litigation has the opportu-
    nity to file reexamination requests on the patents
    concerned, or without doing anything, has the
    threat of such action to use in any negotiation which
    may be in progress. Likewise, a threatened party
    also has the opportunity of putting a number of pat-
    ents into reexamination which are not even related
    to the subject matter of the threat. Thus, even
    where the party threatened with litigation is in a
    relatively weak position with respect to the asserted
    patents, he can very viably threaten to retaliate
IN RE BAXTER INTL                                            6

    against the patent owner by counter-attacking
    where the patent owner is in a relatively weak posi-
    tion.

Id. at 251. When reexamination was later enlarged, an
article by William J. Speranza and Michael L. Goldman,
Reexamination – The Patent Challenger’s View, 69 J. Pat. &
Trademark Off. Soc’y 295 (1987) remarked that reexamina-
tion “has potential for misuse by the patent challenger to
achieve less-than-noble aims, such as delay or harassment,
in an effort to escape liability where no legitimate defense
exists.” Id. at 296. 1

     Today, reexamination is part of the tactical armory of
litigators. However, throughout this history, including the
current legislative proposals to make reexamination more
useful as a less costly alternative to litigation, we have
uncovered no suggestion that reexamination is intended to
deprive a final judgment of the full faith and credit atten-
dant upon final judgments. We have found no hint that
reexamination of the question of patentability is intended to
override judicial resolution of the question of patentability.
Nor would such legislation be contemplated, for “Article III,
§1 safeguards the role of the Judicial Branch in our tripar-
tite system by barring congressional attempts ‘to transfer

    1    A significant number of patents in litigation are also
subject to reexamination. USPTO Reexamination Filing
Data           –         September          30,          2011,
http://www.uspto.gov/patents/stats/index.jsp (70% of patents
undergoing inter partes reexamination and 33% of patents
undergoing ex partes reexaminations are known to be in
litigation). It is reported that 11% of patents accepted for
reexamination by the USPTO are reexamined more than
once, one as many as six times. Robert G. Sterne et al.,
Reexamination Practice with Concurrent District Court
Litigation or Section 337 USITC Investigations, 11 Sedona
Conf. J. 14 (Sept. 2010).
7                                           IN RE BAXTER INTL

jurisdiction [to non-Article III tribunals] for the purpose of
emasculating’ constitutional courts, and thereby preventing
‘the encroachment or aggrandizement of one branch at the
expense of the other.’” Commodity Futures Trading Comm’n
v. Schor, 478 U.S. 833, 850 (1986) (brackets in original,
citations omitted). The Court stressed that “Article III, § 1,
not only preserves to litigants their interest in an impartial
and independent federal adjudication of claims within the
judicial power of the United States, but also serves as ‘an
inseparable element of the constitutional system of checks
and balances.’” Id. (quoting N. Pipeline Constr. Co. v. Mara-
thon Pipe Line Co., 458 U.S. 50, 58 (1982)).

     Administrative agency override of judicial final deci-
sions has no counterpart in any other field of subject matter.
From the inception of judicial process in the nation, it was
established that decisions of Article III courts are not sub-
ject to negation by proceedings in the other branches. The
validity of the Baxter patent was resolved upon litigation in
the district court and on appeal to the Federal Circuit. This
judgment cannot be “revised, overturned or refused full
faith and credit by another Department of Government.”
Chi. & S. Airlines, 333 U.S. at 114. Nonetheless, the court
again departs from this principle, trivializes our prior final
judgment, and simply defers to the conflicting agency rul-
ing. This is improper.

    I support the concept of reexamination as an efficient
and economical alternative to litigation in appropriate
cases. My concern is with the distortion of this purpose,
which was designed to provide a path to relief not available
through the existing examination process. It was not in-
tended to undermine the finality of judicial process; it was
not intended to negate the repose provided by adjudication.
IN RE BAXTER INTL                                            8

     The only patents that are reexamined, like the only pat-
ents that are litigated, are patents on inventions that are of
value. Most reexamination requests are granted by the
PTO. 2 Reexamination of the Baxter patent was requested
by Fresenius in 2005, two years into the litigation of Fresen-
ius’ declaratory judgment action against Baxter. The reex-
amination request presented to the PTO the same
references that Fresenius had presented in the litigation.
Judgment in the district court was adverse to Fresenius,
and the Federal Circuit’s final judgment was issued in 2009,
a year before the reexamination decision of the PTO Board.
The Board stated that “the agency is not bound by the
court’s determination.” BPAI Op. at 26. However, when
there has been full litigation and final adjudication under
Article III, the judicial resolution controls. Instead, my
colleagues ignore this court’s prior decision, which is the law
of this case, and simply defers to the PTO, stating that its
reexamination ruling is “supported by substantial evidence.”
Op. at 11–13 & 16. The nature of the burden of proof does
not overcome the strictures of judicial finality.

     The reexamination of Baxter’s patent claims 26–29 and
31 was based solely on the same references on which Fre-
senius relied in the litigation. In response to the panel’s
request during oral argument, Baxter’s counsel wrote that
“all of the art relied upon by the Examiner to reject claims
26–29 and 31 of the ’434 patent (i.e., Lichtenstein ’983, the
Fresenius CMS08 Handbook, the Sarns 9000 Perfusion

    2   The PTO reports that in 2007 through 2011 the per-
centage of reexamination requests granted was 97.1% in
FY2007; 94.0% in FY2008; 93.5% in FY2009; 91.7% in
FY2010; and 89.3% in FY2011. USPTO Performance and
Accountability Report for Fiscal Year 2011, Table 14A at
171, http://www.uspto.gov/about/stratplan/ar/index.jsp. The
report does not distinguish whether the requests were filed
by the patentee or by a third party.
9                                           IN RE BAXTER INTL

System Operators Manual, Rubalcaba ’578, and Kerns ’706,
see A9283) had been presented by Fresenius to the district
court,” Letter from William F. Lee (February 22, 2012). The
PTO Deputy Solicitor wrote that “The Examiner only found
Thompson,” Letter from Sydney O. Johnson, Jr. (February
17, 2012); the Thompson reference was cited only against
claim 30, for showing the inclusion of an anticoagulant in
the dialysis. This aspect does not appear to be significant to
the reexamination, but if it were, the failure of Fresenius to
present such issue does not negate the finality of the deci-
sion upon full adjudication. See Charles Alan Wright,
Arthur R. Miller & Edward H. Cooper, Federal Practice and
Procedure: Jurisdiction, §4426 at 141 (1981) (“Preclusion
cannot be avoided simply by offering evidence in the second
proceeding that could have been admitted, but was not, in
the first.”). Reexamination of the Baxter patent lasted from
2005 to 2010, continuing for a year after final decision in the
Federal Circuit.

     My colleagues justify the PTO’s authority to overrule ju-
dicial decisions on the argument that the standard of proof
is different in the PTO than in the courts. That theory is
flawed, for obviousness is a question of law, and the PTO,
like the court, is required to reach the correct conclusion on
correct law. Any distinction between judicial and agency
procedures cannot authorize the agency to overrule a final
judicial decision. Even if the Federal Circuit were believed
to have erred in its prior decision, the mechanism for cor-
recting an unjust decision is by judicial reopening, not by
administrative disregard. See Christianson, 486 U.S. at 817
(“A court has the power to revisit prior decisions of its own
or of a coordinate court in any circumstance, although as a
rule courts should be loath to do so in the absence of ex-
traordinary circumstances such as where the initial decision
was clearly erroneous and would work a manifest injus-
tice.”). This procedure did not occur in this case.
IN RE BAXTER INTL                                     10

   The court’s final judgment cannot be overridden by ad-
ministrative proceeding. I respectfully dissent.