westiaw.
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`2012 WL 4667630 (C.A.Fed.)
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`Page 1
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`For Opinion See 2012 WL 5275335,678 F.3d 1357
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`Federal Circuit.
`
`United States Court of Appeals,
`
`In Re BAXTER INTERNATIONAL INC.
`No. 2011-1073.
`September 10, 2012.
`
`Appeal from the United States Patent and Trademark Office, Board of Patent Appeals and Interferences.
`(Reexamination No. 90/007,751)
`
`Response of Appellee- Director of the United States Patent and Trademark Office Opposing Rehearing and Rehearing
`En Bane
`
`Raymond T. Chen, Solicitor.Sydney 0. Johnson, Jr., Scott C. Weidenfeller, Associate Solicitors, Mail Stop 8, U.S.
`Patent and Trademark Office, P.O. Box 1450, Alexandria, Virginia 22313-1450, 571-272-9035, Attorneys for the
`Director of the United States Patent and Trademark Office.
`
`*iT ABLE OF CONTENTS
`
`I. Introduction ... 1
`
`II. Background And Summary Of Panel Decision ... 2
`
`III. Argument ... 4
`
`A. Neither Rehearing Nor Rehearing En Bane Is Warranted Because The Panel's Analysis Of The
`Means-Plus-Function Limitation Does Not Conflict With The Patent Statute Or Precedent From This Court ... 4
`
`B. The Panel Decision Does Not Conflict With This Court's Fresenius Decision ... 11
`
`IV. Conclusion ... 15
`
`Cases
`
`*ii TABLE OF AUTHORITES
`
`Aoyama. In re. 656 F.3d 1293 (Fed. Cir. 20 11) ... 4
`
`Berger. In re. 279 F.3d 975 (Fed. Cir. 2002) ... 7, 8, 11
`
`Donaldson Co .. In re. 16 F.3d 1189 (Fed. Cir. 1994) ... . passim
`
`Ethicon v. Quigg. 849 F.2d 1422 (Fed. Cir. 1988) ... 15
`
`VERSATA EXHIBIT 2065
`SAP v. VERSATA
`CASE CBM2012-00001
`
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`2012 WL 4667630 (C.A.Fed.)
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`Fresenius U.S.A., Inc. v. Baxter Int'Linc., 2007 WL 518804 (N.D. Cal. 2007) ... 2, 11
`
`Odetics. Inc. v. Storage Tech. Corp .. 185 F.3d 1259 (Fed. Cir. 1999) ... 5
`
`SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312 (Fed. Cir. 2006 000 9
`
`Swanson. In re. 540 F.3d 1368 (Fed. Cir. 2008) oo. 2, 15
`
`United States v. Dunkel, 927 F.2d 955 (7th Cir. 1991) 000 9
`
`Watts. In re, 354 F.3d 1362 (Fed. Cir. 2004) •oo 7, 8, 11
`
`Statutes
`
`35 U.S.C. § 112 00 0 4
`
`35 u.s.c. § 282 00 ! 12
`
`Regulations
`
`37 C.P.R. § 41.37(c)(vii) 0 00 7
`
`I. INTRODUCTION
`
`Baxter seeks review of the Panel's decision concerning a means-plus-function ("MPF') limitation. Baxter makes a
`fact-bound argument that the pumps and pump lines in the prior art identified by the Examiner do not satisfy the
`"means for delivering dialysate" limitation of claim 26. Both the Board and this Court squarely rejected that argument
`in light of the evidence of record. Baxter now attempts to recast the Panel's review of this fact question as an an(cid:173)
`nouncement of a new legal standard for MPF analysis that conflicts with the Patent Statute and precedent from this
`Court. Baxter asserts that the Panel decision "deviated" from the MPF analysis standards established by this Court,
`when in fact the Panel expressly noted the USPTO's MPF analysis and this Court's pertinent en bane precedent, and
`simply affirmed the agency's factual findings with which Baxter disagrees. In affirming the USPTO's decision, the
`Panel did not overlook any fact or rule of law.
`
`Baxter also insists that the Panel's decision conflicts with this Court's Fresenius decision because the reexamination
`proceeding and the district court litigation reached different outcomes while involving the same limitation and the
`same prior art- the CMS08 Manual. However, the Panel noted that the different outcomes were justified because the
`two proceedings applied different burdens of proof and relied on different records. Indeed, different outcomes are
`particularly appropriate here because Fresenius failed to satisfy its burden of proof in the district court, and the Ex(cid:173)
`aminer relied on a prior art reference in the reexamination proceeding that was not discussed by the district court judge
`in overturning the jury's obviousness determination. Given the significant differences between the two proceedings,
`Baxter's conflict theory is untenable, and its petition should be denied.
`
`II. BACKGROUND AND SUMMARY OF PANEL DECISION
`
`Baxter International Inc., ("Baxter") owns U.S. Patent No. 5.247,434 ("the '434 patent"). In 2003, Fresenius, Inc.,
`("Fresenius") filed a suit against Baxter seeking a declaratory judgment of invalidity and non-infringement of the '434
`patent. Fresenius U.S.A., Inc. v. Baxter lnt'Linc., 2007 WL 518804 (N.D. Cal. 2007). The jury found claim 26 invalid
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`as obvious over the prior art. However, the district court granted Baxter's motion for judgment as a matter of law
`because Fresenius had failed to provide the jury with substantial evidence to support its verdict. Fresenius. 2007 WL
`518804 *9, 14. In affirming the district court's decision, the Court held that Fresenius failed to present to the jury "any
`evidence ***that the structure corresponding to the means for delivering dialysate limitation, or an equivalent thereof,
`existed in the prior art." Fresenius, 582 F.3d at 1299.
`
`In 2005, while the district court litigation was pending, Fresenius filed a request for ex parte reexamination of the '434
`patent, which was subsequently granted. With respect to element (a) of claim 26, the Examiner (A9284; A9292) and
`the Board (A34) found that the CMS08 Manual and Lichtenstein describe element (a) of claim 26.
`
`A divided panel of this Court found that substantial evidence supported the Board's findings on claim 26. Op. 11. After
`noting the In re Donaldson Co., 16 F.3d 1189 (Fed. Cir. 1994) (en bane), decision, the Panel found that the Examiner
`properly analyzed the claimed function, and that she "identified a pump, the same type of structure that Baxter con(cid:173)
`tends is the corresponding structure for the 'means for delivering the dialysate' limitation." Op. 12. The Panel noted
`that "on their face, the pumps identified by the Examiner in the CMS08 Manual appear similar in structure and func(cid:173)
`tionality to the 'concentrate' pumps and pump lines" that Baxter identified as the corresponding structure for the
`means for delivering dialysate limitation. Op. 13. And like the Examiner and the Board, the Panel found that Lich(cid:173)
`tenstein discloses a pump that delivers dialysate into the dialysate compartment of a hemodialyzer./d.
`
`The Panel rejected Baxter's argument that the Board erred in failing to provide a detailed explanation of why it reached
`a different outcome than the one issued by the Fresenius Court. The Panel held that there was no error because the
`reexamination proceeding and the district court litigation applied different burdens of proof and relied on different
`records. Op. 13.
`
`Judge Newman dissented, stating that the Panel decision violates the Constitution because "for the issue of validity,
`the evidence, and the parties in interest are the same in the agency reexamination as in the finally resolved litigation."
`Dissent l .
`
`Ill. ARGUMENT
`
`A. Neither Rehearing Nor Rehearing En Bane Is Warranted Because The Panel's Analysis Of The
`Means-Plus-Function Limitation Does Not Conflict With The Patent Statute Or Precedent From This Court
`
`The parties agree that a MPF limitation "shall be construed to cover the corresponding structure, material, or acts
`described in the specification and equivalents thereof." 35 U.S.C. § 112, 1[ §.;Donaldson. 16 F.3d at 1193. When the
`MPF limitation is construed as part of a patentability determination, a three-step analysis is required. The first step is to
`define the particular function of the claim limitation. In re Aoyama. 656 F.3d 1293, 1297 (Fed. Cir. 2011). The next
`step is to identify the corresponding structure for the function disclosed in the specification. Id. The final step is to
`determine whether the disclosed and prior art structures are the same or equivalent. Donaldson. 16 F.3d at 1193;
`Odetics. inc. v. Storage Tech. Corp .. 185 F.3d 1259, 1267 (Fed. Cir. 1999).
`
`Baxter contends that the Panel deviated from these well-established principles when it stated that the disclosed and the
`prior art structures "appear similar in structure and functionality." Pet. 7-8. However, the Panel clearly demonstrated
`that it was affirming the USPTO's conclusions, which were based on *5 the Examiner's proper three-step MPF anal(cid:173)
`ysis of the means for delivering dialysate limitation. First, the Examiner found that the function is supplying dialysate
`to the hemodiaylzer. A9284. Second, the Examiner found that structure for the function disclosed in the specification
`includes pumps and pump lines (A9284) - the same structure Baxter identified as corresponding to this limitation.
`A7883:10a (explaining that the corresponding structure is pump 22 and associated structure). Finally, the Examiner
`found that the CMS08 Manual's pumps and pump lines deliver dialysate to the hemodiaylzer. The Board agreed with
`the Examiner's factual findings that the CMS08 Manual describes claim 26. A34. The Panel properly applied this
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`Court's precedent, noted the Examiner's MPF analysis of the means for delivering dialysate limitation (Op. 12), and
`affirmed the Board's finding that the prior art discloses the structure corresponding to the means for delivering dia(cid:173)
`lysate in claim 26. Op. 13. The Panel's statement that the structures "appear similar in structure and functionality" does
`not alter its application of the correct standard.
`
`Nor did the Panel break new legal ground when it used the word "similar" in its MPF analysis. Pet. 7. According to
`Baxter, the Panel's emphasis on "similarity" is inappropriate because it "fundamentally alters the standard for ana(cid:173)
`lyzing means-plus-function limitations." /d. Baxter is wrong on that score. Neither the statute nor decisions from this
`Court require "magic words" when *6 analyzing MPF limitations. All that is required is a finding that the claimed and
`prior art structures are the same or equivalent, and that is exactly what happened here - the Panel found that the
`structures are equivalent, although it used the word "similar" rather than "equivalent" in its analysis. After noting that
`the structure of the means for controlling is a microprocessor and concentration pumps, the Panel found that the
`CMS08 Manual discloses a processor and stepper motor driven line pumps that can be programed, and that Lichten(cid:173)
`stein discloses a microcomputer that is programmable to permit hemodialysis. Op. 12. As the Panel correctly found,
`the "description in both references are similar to the microcontroller and concentrate pumps identified for the 'means
`for controlling' limitation" in the specification. /d. Therefore, while the Panel used the word "similar," its analysis
`demonstrates that it found the disclosed and prior art structures equivalent. Accordingly, the Panel's use of the word
`"similar" instead of "equivalence" in its analysis was a distinction without a difference, and it did not conflict with the
`statute or this Court's prior decisions.
`
`Baxter argues that the Panel's decision cannot be sustained because the pumps the Examiner cited do not perform the
`identical function required by the claim. Pet. 8. But Baxter never asserted that the pumps relied on by the Examiner fail
`to perform the required function. Rather, in its appeal brief to the Board, as it relates to the means for delivering di(cid:173)
`alysate found in element (a), Baxter only *7 argued that "Element (a) is only met if the reference cited provides the
`specific structure disclosed in the specification of the '434 Patent that supports the means-plus-function claim under 35
`U.S.C. § 112, paragraph 6." A 7883:42a-45a (emphasis added). The Board rules explicitly warn that arguments not
`raised in the briefs are untimely. 37 C.F.R § 41.37(c)(vii) ("Any arguments or authorities not included in the brief or
`a reply brief*** will be refused consideration"). Therefore, Baxter's arguments concerning the function of the pumps
`in the CMS08 Manual are waived. See e.g., In re Watts, 354 F.3d 1362. 1367-68 (Fed. Cir. 2004) (arguments not
`raised to the Board are waived).
`
`In any event, contrary to Baxter's contention, the pumps that the Panel and the Examiner identified perform the
`identical claimed function, namely, delivering dialysate to the dialysate compartment of a hemodialyzer. As the Panel
`observed, the CMS08 Manual discloses a "dialysate mixing system' that must be connected to a hemodialyzer, which
`necessarily requires the dialysate to be pumped between the machines." Op. 13. Indeed, the CMS08 Manual describes
`using pumps and pump lines in its system. A305-306. As the Examiner found, the pumps and pump lines supply
`dialysate to a hemodialyzer. A9284.
`
`Baxter contends that the Examiner, the Board, and the Panel failed to find that the CMS08 Manual discloses structure
`corresponding to supply pump 42 and flow equalizer 54 in the '434 patent, which Baxter asserts are also part of the
`MPF *8 limitation. Pet. 9. However, Baxter is presenting this specific issue for the first time in its petition. After the
`Examiner identified the pumps and pump lines in the CMS08 Manual as the corresponding structure for the means for
`delivering limitation, Baxter never alleged that the Examiner's finding was erroneous because she did not find supply
`pump 42 and flow equalizer 54 in the CMS08 Manual as well. Thus, Baxter waived its newly-minted argument about
`the supply pump and flow equalizer. See 37 C.P.R. § 41.37(c)(vii); Watts. 354 F.3d at 1367-68.
`
`Moreover, Baxter's generic arguments about the "associated structure" in its briefs were entirely insufficient to inform
`the Examiner, the Board, and the Panel of the features in the corresponding structure that Baxter believed were
`missing from the Examiner's findings. In its brief to the Board, Baxter generally argued that the "corresponding
`structure is a pump 22" and ''the associated structure described in Col. 1, line 58-Col. 2, line 12" (A7883:10a), not
`5:30-32, which it now cites, Pet. 9. As Baxter correctly notes, the specification lists "at least 30 components" for the
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`associated structure. /d. Baxter's opening brief to this Court was even less specific. In that brief, Baxter simply argued
`that the corresponding structure includes "ultiple structures" (Baxter Br. at 32); it did not assert that the CMS08
`Manual fails to disclose the supply pump and flow equalizer. The Examiner, the Board, and the Panel were not ex(cid:173)
`pected to respond to such skeletal arguments by hunting through the list of at least 30 components, comparing each *9
`with the CMS08 Manual, and determining whether the component is disclosed by the CMS08 Manual. Indeed, this
`Court has treated this sort of argument as waived. See SmithKline Beecham Corp. v. Apotex Core .. 439 F.3d 1312,
`1320 (Fed. Cir. 2006) (citing United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) ("A skeletal 'argument,' does
`not preserve a clam. ***Judges are not like pigs, hunting for truffles buried in briefs.")).
`
`There is no merit to Baxter's assertion that the Panel's alternative holding that Lichtenstein teaches the means for
`delivering dialysate limitation is a new ground. Pet. 10. Both the Examiner and the Board expressly found that
`Lichtenstein teaches this limitation. Lichtenstein teaches that pump P2 delivers dialysate through lines to the dialysate
`compartment 44 of hemodialyzer 42. See A202, Fig. 3; A220, col. 13,11. 40-47. The Examiner found that the
`"CMS08/A2008 and Lichtenstein hemodialysis devices note particular means for delivering, via pumps and pump
`lines, treated fluids to a patient." A9292. Thus, the Board observed that "the Examiner found that the teachings of
`CMS08 [Manual] and/or Lichtenstein describe, or suggest, to one of ordinary skill in the art, element (a) of claims 26
`("means for delivering the dialysate to a dialysate compartment of a hemodialyzer")." AlO (emphasis added). The
`Board found that Baxter "did not assert that Lichtenstein lacks any structure corresponding to element (a) of claim 26,"
`and properly concluded that the CMS08 Manual or *10 Lichtenstein describe element (a) of claim 26. A34.
`
`Baxter's related argument - that the Panel ignored structural elements that Lichtenstein does not disclose, such as the
`flow equalizer - also fails. Pet. 10. Although the Examiner and the Board found that Lichtenstein teaches each of the
`means limitations of element (a), Baxter did not contest these findings. Significantly, in its opening brief to this Court,
`Baxter failed to assert that Lichtenstein does not disclose a flow equalizer, even after the Board pointed out that Baxter
`"did not assert that Lichtenstein lacks any structure corresponding to element (a) of claim 26." A34. Because Baxter
`chose not to alert the Court to the structure that it perceived to be missing from Lichtenstein, the argument was waived,
`and the Panel was not required to address it. Watts, 354 F.3d at 1367-68.
`
`B. The Panel Decision Does Not Conflict With This Court's Fresenius Decision
`
`Besides not conflicting with the Patent Statute and cases involving MPF analysis, such as Donaldson, the Panel's
`decision also does not conflict with this Court's decision in Fresenius. Baxter argues that the Panel decision is in
`"tension" with the Fresenius decision because "[b ]oth decisions reviewed the same limitation of the same claim of the
`same patent in light of the CMS08 Manual" and yet reached different holdings as to whether the CMS08 Manual
`disclosed the limitation. Pet. 12. However, the supposed "tension" is illusory. As the Panel correctly explained, the
`outcomes diverged because the two proceedings applied *11 different burdens of proof and relied on different records.
`Op. 15. Those differences account for the different findings and conclusions.
`
`First, as the Panel explained at the outset, it is well settled that the burden of proof in a civil litigation is different than
`in a USPTO reexamination proceeding. Significantly, a party challenging the validity of patent claims in an in(cid:173)
`fringement action has a statutory burden to prove invalidity by clear and convincing evidence, 35 U.S.C. § 282,
`whereas in a reexamination proceeding, "the standard of proof - a preponderance of the evidence - is substantially
`lower than in a civil case." In re Swanson. 540 F.3d 1368, 1378 (Fed. Cir. 2008).
`
`Regarding claim 26, Fresenius' primary downfall was its failure to meet its burden of proof because it failed to present
`essential evidence to the jury. In fact, the Fresenius Court found that "Fresenius failed to present any evidence- let
`alone substantial evidence -that the structure corresponding to the means for delivering dialysate limitation, or an
`equivalent thereof, existed in the prior art." Fresenius, 582 F.3d at 1299. In the reexamination proceeding, the Ex(cid:173)
`aminer did not make the same mistake as Fresenius. The Examiner expressly stated that the prior art provides "pumps
`and pump lines" that deliver dialysate to the hemodialyzer (A9284)," which is precisely the same structure that Baxter
`argued to the Board performs the function for the means for delivering dialysate limitation. A 7883: lOa. As the Panel
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`found, the Examiner performed the requisite structural *12 analysis for the means for delivering dialysate "to support
`a finding that claim 26 is not patentable under the preponderance of the evidence standard of proof." Op. 15. Thus, the
`record contradicts' Baxter's assertion that the Examiner's discussion of the structure disclosed in the CMS08 Manual is
`just as deficient as what Fresenius argued at trial. Pet. 14-15. The different outcomes are based in part on the fact that
`the Examiner carried her burden of proof while Fresenius did not.
`
`Contrary to Baxter's suggestion, Fresenius did not affirm a finding that the prior art fails to disclose the means for
`delivering dialysate limitation. Pet. 13. In particular, Fresenius did not state that the CMS08 Manual is missing the
`means for delivering dialysate limitation. Rather, Fresenius failed to identify to the jury the structure corresponding to
`the means for delivering dialysate, and to compare it to the structures present in the prior art. See Fresenius, 582 F. 3d
`at 1299. Thus, this Court concluded that the clear and convincing burden of proof in the MPF context "cannot be
`carried without clearly identifying the corresponding structure in the prior art." Fresenius, 582 F.3d at 1300.
`
`Second, as the Panel emphasized, the divergent outcomes were also justified because the records in the two pro(cid:173)
`ceedings were different. Contrary to Baxter's suggestion, the two proceedings did not review the means for delivering
`dialysate limitation in light of only the CMS08 Manual. Pet. 12. Instead, as the Panel correctly found, one of the
`Examiner's rejections relied on a reference that was not *13 addressed by the judge in the district court's analysis of
`claim 26. Op. 15.
`
`In the reexamination proceeding, the Examiner issued two separate rejections of claim 26. The Examiner relied on
`Lichtenstein in one rejection, and the CMS08 Manual in the other rejection. A9284; A9292; Op. 15. The Examiner
`found that Lichtenstein discloses the "means for delivering dialysate" (A9292), and the Board found "no error in the
`Examiner's factual findings and conclusions" that "Lichtenstein describes element (a) of claim 26." AlO; A34.
`
`In contrast, the district court only discussed the Cobe C3 Manual, the CMS08 Manual, the Sarns 9000, and the Sera(cid:173)
`tron System in overturning the jury's obviousness determination. See Fresenius. 2007 WL 518804, at 7-8; Op. 15. The
`district court never addressed Lichtenstein in its analysis of claim 26, and neither it nor this Court concluded that
`Lichtenstein failed to disclose the means for delivering dialysate limitation. /d. Thus, even if Lichtenstein could have
`provided a basis to support the jury's verdict, the district court never addressed it in its decision granting JMOL be(cid:173)
`cause- contrary to Baxter's argument (Pet. 14 n.7) - it was not "squarely before the district court." In other words,
`Fresenius may have waived an argument that Lichtenstein disclosed the disputed limitation, but the USPTO did not.
`Therefore, given that the record in the two proceedings was not the same, a different result was justified, and the
`Panel's decision presents no issue warranting en bane review.
`
`*14 Finally, Baxter argues that the ability of this Court to promote uniformity and stability in patent law is undermined
`by the Panel decision, which it alleges conflicts with the Fresenius decision. Pet. 15. Baxter also notes the dissent's
`concern that the Panel's decision offends Article III. Dissent 1-10.
`
`The dissent is correct that judgments of Article Ill courts may not be over-ridden by agencies of the Executive Branch.
`But a reexamination decision like the one here does nothing of the sort. If a federal court awards relief to a patent
`holder against an infringer, a subsequent reexamination decision that the patent is invalid does not disturb the judg(cid:173)
`ment of the court or alter its binding effect on the parties. In particular, any injunction against infringement will remain
`in force and continue to bind the defendant, the later reexamination decision notwithstanding. Thus, this case does not
`involve a "revision by the [agency] of the court's order [that] would render the court's previous judgment merely
`advisory, and thus in violation of the Constitution." Dissent 3. The prior judgment in the patent holder's favor is not
`rendered "merely advisory" by the later reexamination decision.
`
`Nor is it the case that the reexamination decision somehow "'refuse[s] full faith and credit' to final judgments of the
`courts." /d. The dissent reasons that the subsequent determination of invalidity in a reexamination represents a failure
`by the agency to honor the court's earlier determination. But as the Panel pointed out, a court hearing an infringement
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`suit "only [determines] that 'the patent challenger *15 did not carry the "burden of establishing invalidity in the par(cid:173)
`ticular case before the court.""' Op. 14. There is no inconsistency between that limited determination and a subse(cid:173)
`quent administrative ruling of invalidity that is predicated on a different burden of proof. As this Court recognized in
`Swanson and Ethicon v. Quigg, 849 F.2d 1422, 1429 (Fed. Cir. 1988), the different burdens in the two proceedings
`could reasonably lead to different outcomes. Here, Fresenius's failure to meet its burden of proving that claim 26 was
`invalid did not mean that the Examiner would likewise fail to meet her burden. Indeed, in Fresenius itself, Judge Dyk
`observed that "[ w]hile Fresenius did not establish the invalidity of claims 26-31 [,] ***[i]t is entirely possible that the
`U.S. Patent and Trademark Office will finally conclude that claims 26-31 of the '434 patent are also invalid." 582 F.3d
`at 1306 (Dyk, J., concurring). A different outcome in the two proceedings is particularly unobjec-tionable in light of
`the different records. And of course, the reexamination decision itself is subject to review by this Court, further en(cid:173)
`suring that the judiciary has the final word regarding the validity of the challenged claims. Thus, the Panel's decision
`does not undermine the conclusiveness of judicial decisions under Article III.
`
`Baxter's petition should be denied because it fails to establish that rehearing or rehearing en bane is warranted.
`
`IV. CONCLUSION
`
`In Re BAXTER INTERNATIONAL INC.
`2012 WL 4667630 (C.A.Fed. ) (Appellate Brief)
`
`END OF DOCUMENT
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