BAXTER HEALTHCARE CORP et alv.MILLENIUM BIOLOGIX, LLC

Patent Trials and Appeals Board

Mar 21, 2014

09971148 - (R) (P.T.A.B. Mar. 21, 2014)

Trials@uspto.gov Paper 10
Tel: 571-272-7822 Entered: April 18, 2014

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

v.

MILLENIUM BIOLOGIX, LLC
Patent Owner
_______________

Case IPR2013-00591
Patent 6,585,992
_______________

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

OSINSKI, Administrative Patent Judge.

DECISION

Petitioners’ Request for Rehearing
37 C.F.R. § 42.71
Case IPR2013-00591
Patent 6,585,992

2

I. INTRODUCTION
Baxter Healthcare Corp. et al. (“Petitioners”) request rehearing of our
Decision not to institute inter partes review as to those challenges based on
Leshkivich (Ex. 1013) and Bigi (Ex. 1019). Rehearing Req. 4, 15. The issue is
whether Petitioners have demonstrated that the patent claims being challenged are
not entitled to the benefit of the filing date of WO 97/09286 (“Pugh”) such that
Bigi is available as prior art. We deny the Request for Rehearing.
II. STANDARD OF REVIEW
Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a
panel will review the decision for an abuse of discretion.” An abuse of discretion
occurs when a “decision was based on an erroneous conclusion of law or clearly
erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v.
Celanese Polymer Specialties Co. Inc., 840 F.2d 1565, 1567 (Fed. Cir. 1988). See
also 37 C.F.R. § 42.71(d). 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
Petitioners argue that the Board erred in failing to determine that Pugh does
not provide adequate written description under 35 U.S.C. § 112 for the recited
claim limitation that a portion of at least one of the calcium, oxygen, and
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phosphorous elements “is substituted” with elemental silicon. Rehearing Req. 1.
1

More particularly, Petitioners argue that the Board improperly relied on the
erroneous legal conclusion that “as a matter of law, an earlier filed published
application could not simultaneously be anticipatory prior art against the claims,
while failing to provide the necessary support under 35 U.S.C. § 112 to entitle
those claims to benefit under 35 U.S.C. § 119 or § 120 to that earlier filed
application.” Id. at 1-2 (citing Dec. (Paper 8) 9); id. at 4-6.
The Board did not make such an erroneous statement of law, but rather
pointed out the inconsistency of Petitioners’ position based on the particular claim
language at issue, factual allegations, and arguments made by Petitioner in the
petition filed against Patent Owner. Dec. (Paper 8) 8-10. Petitioners’ primary
complaint on rehearing, moreover, does not acknowledge the stated basis for the
Board’s decision—evidence relied on by Petitioner was outside the four corners of
the application as of its filing date, contrary to the rule of Ariad v. Eli Lilly,
2
and
otherwise lacked sufficient probative value to persuade the Board that Petitioner
had satisfied its burden of proof. Id. at 10-11. In short, the Board did not
misapprehend the law or facts, nor abuse its discretion, in ruling against
Petitioners’ insufficient written description argument.
Petitioners further argue that “conception cannot be established nunc pro
tunc.” Rehearing Req. 8 (citing Heard v. Burton, 333 F.2d 239, 242 (CCPA 1964);
Langer v. Kaufman, 465 F.2d 915, 920 (CCPA 1972)). Petitioners also reference

1
We note that the only grounds on which a challenge to a claim may be based in
inter partes review is 35 U.S.C. § 102 or § 103. 35 U.S.C. § 311(b); 37 C.F.R.
§ 42.104(b)(2).
2
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)(en
banc).
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Chen v. Bouchard, 347 F.3d 1299, 1307 (Fed. Cir. 2003) and Hyatt v. Boone, 146
F.3d 1348, 1353 (Fed. Cir. 1998) in support of their position that an inherent
feature must be recognized by and appreciated by the inventor to show possession
and compliance with § 112, first paragraph. Rehearing Req. 10-11. As a first
matter, our review of the Petition indicates that Petitioners did not cite any of this
case law on which it now appears to rely. We could not have overlooked or
misapprehended a legal argument that was not presented. Moreover, we are not
persuaded that Pugh’s supposed failure to recognize or appreciate an inherent
property—silicon substitution—prevents the claims of the ’992 patent from being
entitled to the benefit of Pugh’s filing date.
3

Much of the cited case law relates to a determination of priority of invention
in the context of interference proceedings, not the right to claim priority to an
earlier filed application. See Hyatt, 146 F.3d at 1353 (considering whether an
earlier filed application serves as a constructive reduction to practice of the subject
matter of an interference count); Heard, 333 F.2d at 243 (considering whether a
junior party’s failure to recognize that he had produced a new form of alumina at
all was indicative that he had not conceived of the invention before the senior
party’s filing date); Langer, 465 F.2d at 920 (also considering whether an earlier
filed application serves as a constructive reduction to practice of the subject matter

3
As Patent Owner argued in its Preliminary Response, adding a theory or
explanation describing the characteristics of a disclosed composition is not new
matter for purposes of preventing an earlier priority date. In re Reynolds, 443 F.2d
384, 389 (CCPA 1971)(by disclosing “a device that inherently performs a function,
operates according to a theory, or has an advantage, a patent application
necessarily discloses that function, theory or advantage even though it says nothing
concerning it. The application may later be amended to recite the function, theory
or advantage without introducing new matter.”); In re Smythe, 480 F.2d 1376,
1384-85 (CCPA 1973)(quoting Reynolds); MPEP 2163.07(a). Prelim. Resp. 26.
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of an interference count). We can distinguish Chen from the present case because
Pugh did describe the characteristics of the product produced by the disclosed
process that distinguished it from other calcium phosphate compounds. For
example, Pugh states that “the optimum composition is formed by conversion of
hydroxyapatite as prepared by the sol-gel process to α-tricalcium phosphate”
(Ex. 1017, 13:15-16); “[t]he proposed mechanism by which silica plays a direct
role in encouraging the formation of the alpha tricalcium phosphate . . . is that the
silicon entities enter the hydroxyapatite crystal structure and stabilizes the alpha
phase with respect to beta.” (Id. at 16:23-27). See also id. at 7:21-25
(“[D]isappearance of calcium phosphate entities from a film, coating or bulk
ceramic piece of this composition, is substantially due to the activity of the
osteoclasts and not due to a dissolution process. The stabilized artificial bioactive
composition is the first such composition which supports both osteoclast and
osteoblast activity . . . .”). The disclosures of Pugh evidence possession of the
invention, whereas Chen “failed to disclose any characteristics of those products
that would evidence possession of the invention.” Chen, 347 F.3d at 1307.
As to Petitioners’ renewed argument regarding Patent Owner’s alleged
admission during prosecution of the ’749 application, that Pugh does not teach or
suggest the substitution of a portion of at least one of calcium, oxygen and
phosphorous by another element, but rather teaches stabilization (Ex. 1009, 202)
(Rehearing Req. 11-14), we remain persuaded by Patent Owner’s argument. The
claims at issue at the time of the prosecution argument in question were of
materially broader scope than the claims now challenged (e.g., with respect to the
ionic radius range of the substituting element), were rejected on a basis different
than the grounds of unpatentability proffered by Petitioners, and were amended
during subsequent prosecution of the ’749 application and during reissue
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proceedings. We gave Petitioners’ petition arguments full consideration, and we
are not persuaded of an abuse of discretion.
We remain unpersuaded that the claims of the ’992 patent are not entitled to
the benefit of Pugh’s filing date. Consequently, Petitioners have not demonstrated
that Bigi is available as prior art under any section of pre-AIA 35 U.S.C. § 102,
and we continue to decline to institute inter partes review as to those challenges
based on Leshkivich and Bigi.

IV. ORDER
Accordingly, it is
ORDERED that Petitioners’ Request for Rehearing of the Decision to
institute inter partes review is denied.

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FOR PETITIONERS:

Jeffrey P. Kushan
Peter S. Choi
1501 K Street, N.W.
Washington, DC 20005
jkushan@sidley.com
peter.choi@sidley.com

FOR PATENT OWNER:

Marilyn Huston
Keith A. Rutherford
James H. Hall
WONG CABELLO LUTSCH RUTHERFORD & BRUCCULERI, LLP
MBIPR@counselip.com

André J. Bahou
MILLENIUM BIOLOGIX LLC
aj.bahou@milleniumbiologix.com