Baxter Healthcare Corp.v.Millenium Biologix, LLC

Patent Trial and Appeal Board

Oct 30, 2014

09971148 (P.T.A.B. Oct. 30, 2014)

Trials@uspto.gov Paper 40
Tel: 571-272-7822 Entered: October 30, 2014

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
BAXTER HEALTHCARE CORP., APATECH, INC., and
APATECH LIMITED,
Petitioner,

v.

MILLENIUM BIOLOGIX, LLC,
Patent Owner.
_______________

Case IPR2013-00582 (Patent No. RE41,251)
Case IPR2013-00590 (Patent No. 6,585,992)
_______________

Before MICHELLE R. OSINSKI, SCOTT E. KAMHOLZ, and
BRIAN P. MURPHY, Administrative Patent Judges.

OSINSKI, Administrative Patent Judge.

DECISION
Petitioner’s Request for Rehearing
37 C.F.R. § 42.71

IPR2013-00582 (Patent No. RE41,251)
IPR2013-00590 (Patent No. 6,585,992)

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I. INTRODUCTION
Baxter Healthcare Corp. et al. (“Petitioner”) filed a Request for
Rehearing (Paper 36,1 “Req.”) of our Order (Paper 33,2 7, “Order”) that
Petitioner’s Reply evidence, Exhibit 1134 ¶¶ 49-61, Exhibit 1135, and
Exhibits 1143-1171, will not be considered by the Board in rendering final
written decisions in the above-captioned cases. We have considered the
Request for Rehearing, but decline to modify the Order.
II. STANDARD OF REVIEW
Under 37 C.F.R. § 42.71(d), the party requesting rehearing bears the
burden of showing a decision should be modified. In its request for
rehearing, the dissatisfied party must identify the matters believed to be
misapprehended or overlooked by the Board and the place in the record
where it previously addressed each matter it submits for review. 37 C.F.R.
§ 42.71(d).
III. DISCUSSION
Petitioner argues that “the Board ‘misapprehended or overlooked’
that: (1) the Ruys Evidence is directly responsive to arguments first raised
by . . . Patent Owner in its Response, and was neither necessary nor
presented to support Petitioners’ prima facie case; and (2) Patent Owner
would not be unfairly prejudiced if the Board allowed this evidence into the
record of this proceeding.” Req. 1.

1 Our citations are to the papers filed in IPR2013-00590. The Request for
Rehearing appears as Paper 35 in IPR2013-00582.
2 See Paper 32, 7 in IPR2013-00582.
IPR2013-00582 (Patent No. RE41,251)
IPR2013-00590 (Patent No. 6,585,992)

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With respect to the first argument, as we explained in the Decision,
“[w]e are cognizant that, although Petitioner’s newly submitted evidence
might have been stimulated by Patent Owner’s Response to the Petition (Pet.
Reply 7), it was Petitioner who decided to rely on the declaration of its
expert without experimental evidence in support of its inherent anticipation
argument.” Order 6. We explained that Petitioner’s Reply belatedly
presents evidence. Order 5 (citing Office Patent Trial Practice Guide, 77
Fed. Reg. 48,756, 48,767 (Aug. 14, 2012)) (“While replies can help
crystalize issues for decision, a reply that raises a new issue or belatedly
presents evidence will not be considered . . . . Examples of indications that a
new issue has been raised in a reply include . . . new evidence that could
have been presented in a prior filing.”) (emphasis added).
As we explained in our Order, Petitioner could have presented the
experimental evidence with its original Petition or requested authorization to
file supplemental information in support of its Petition after Patent Owner’s
Response was served and filed. Order 5. Petitioner has not contended
otherwise, nor offered any evidence to show otherwise. We explained that
the experimental evidence in “Petitioner’s Reply does more than merely
respond to (i.e., rebut), points made in Patent Owner’s Response.” Order 6.
The experimental evidence does not merely rebut points made in Patent
Owner’s Response (such as by explaining why differences in temperature
and/or particle size would not affect microporosity or explaining why Patent
Owner’s argument was unpersuasive speculation), and is instead new
evidence that could have been presented earlier to support its inherency
argument. See 37 C.F.R. § 42.23(b); Rules of Practice for Trials Before the
Patent Trial and Appeal Board and Judicial Review of Patent Trial and
IPR2013-00582 (Patent No. RE41,251)
IPR2013-00590 (Patent No. 6,585,992)

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Appeal Board Decisions; Final Rule, 77 Fed. Reg. 48,612, 48,620 (Aug. 14,
2012) (“Section 42.23 provides that oppositions and replies must comply
with the content requirements for a motion and that a reply may only
respond to arguments raised in the corresponding opposition. Oppositions
and replies may rely upon appropriate evidence to support the positions
asserted. Reply evidence, however, must be responsive and not merely new
evidence that could have been presented earlier to support the movant’s
motion.”) (emphasis added).
Petitioner argues that the proper test to exclude evidence is not merely
whether the evidence could have been presented earlier. Req. 7. Petitioner
cites to Berk-Tek LLC v. Belden Tech. Inc., IPR2013-00057, Paper 29, 2
(PTAB Sept. 10, 2013), in which the Board stated “[i]t is not the test for
determining appropriateness of a Reply merely to see whether information
was previously available to [Petitioner] and could have been submitted with
its Petition” and “[i]t . . . would be unreasonable to expect a Petitioner to
submit supporting testimony for every matter that possibly may be involved
in a dispute.” Req. 7. We point out that the Board also noted in its Order in
Berk-Tek that “[o]n the other hand, factual disputes which reasonably should
have been anticipated may require supporting testimony.” Id. Petitioner
reasonably should have anticipated that Patent Owner would undertake to
rebut Petitioner’s technical reasoning in support of its assertion that a
silicon-substituted calcium phosphate material having a microporous
structure necessarily flows from the teachings of Ruys ’93a.
Petitioner also cites to Vibrant Media, Inc. v. General Electric Co.,
IPR2013-00170, Paper 56, 31-32 (PTAB June 26, 2014) in which the Board
stated, “The need for relying on evidence not previously discussed in the
IPR2013-00582 (Patent No. RE41,251)
IPR2013-00590 (Patent No. 6,585,992)

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petition may not exist until a certain point has been raised in the patent
owner response. Much depends on the specific arguments made in the
patent owner response.” Req. 7-8. As an initial matter, we point out that
Petitioner maintains it has no need to rely on the new experimental evidence
to establish that the Ruys ’93a material is microporous. See Req. 6 (“Based
on the opinions of Petitioners’ expert . . . and the admissions by Dr. Ong at
his deposition, the Ruys Evidence plainly is not necessary to establish that
the Ruys 1993a material is microporous”). Moreover, the reason for
Petitioner to bring in the experimental evidence existed both before and after
the Patent Owner response—namely, to support the inherent microporosity
of the material disclosed in Ruys ’93a. The reason to bring in the
experimental evidence did not only begin to exist sometime after Patent
Owner’s response. As to Petitioner’s arguments regarding the Board’s
purported questioning of the relevance of the experimental evidence to
support Petitioner’s inherency argument (see Req. 9-13), we do not take
issue with Petitioner’s characterization of the law on inherency or that the
experimental evidence may be relevant to whether microporosity inevitably
and necessarily flows from the teachings of Ruys ’93a. In fact, the relevance
of the experimental evidence in supporting an inherency argument, even
before Patent Owner’s Response was served and filed, is exactly why such
experimental evidence could, and should, have been presented earlier. For
the foregoing reasons, we are not persuaded that our decision not to consider
the experimental evidence in rendering final written decisions in the above-
captioned cases was based on an incorrect standard such that an abuse of
discretion occurred.
IPR2013-00582 (Patent No. RE41,251)
IPR2013-00590 (Patent No. 6,585,992)

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Because we are not persuaded of error in our decision not to consider
the experimental evidence as belatedly presented evidence, we need not
reach Petitioner’s second argument that the Patent Owner would not be
unfairly prejudiced if the Board allowed the experimental evidence into the
record of the proceeding. Req. 1, 13-15.
IV. ORDER
Accordingly, it is
ORDERED that the Request for Rehearing is denied.

IPR2013-00582 (Patent No. RE41,251)
IPR2013-00590 (Patent No. 6,585,992)

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FOR PETITONER:
Jeffrey P. Kushan, Lead Counsel
Peter S. Choi, Back-up Counsel
SIDLEY AUSTIN LLP

FOR PATENT OWNER:

Marilyn Huston, Lead Counsel
Keith A. Rutherford, Back-Up counsel
James Hall, Back-up Counsel
WONG CABELLO LUTSCH RUTHERFORD & BRUCCULERI, L.L.P.

Andre̍ J. Bahou
MILLENIUM BIOLOGIX, LLC