BioDelivery Sciences International, Inc.v.MonoSol Rx, Llc.

Patent Trial and Appeal Board

Nov 12, 2015

11517982 (P.T.A.B. Nov. 12, 2015)

Trials@uspto.gov Paper 9
Tel: 571-272-7822 November 12, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

BIODELIVERY SCIENCES INTERNATIONAL, INC.,
Petitioner,

v.

MONOSOL RX, LLC,
Patent Owner.
____________

Case IPR2015-00167
Patent 8,765,167 B2
____________

Before FRANCISCO C. PRATS, JACQUELINE WRIGHT BONILLA, and
ZHENYU YANG, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION
Petitioner’s Request for Rehearing
37 C.F.R. § 42.71
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I. INTRODUCTION
BioDelivery Sciences International, Inc. (“Petitioner”) filed a Request
for Rehearing of the Board’s decision dated May 20, 2015 (Paper 6,
“Decision”), which denied inter partes review of claims 13, 33, 39, 45, 52,
59, 66, 73, 83, 89, 95–108, 117, and 118 of U.S. Patent No. 8,765,167 B2
(Ex. 1001, “the ’167 patent”). Paper 7 (“Req. Reh’g.”).
In our Decision, we denied institution based on grounds in the Petition
(Paper 2, “Pet.”) asserting, inter alia, that the Chen reference (Ex. 1002),
1
either alone or in view of other cited references, anticipated or rendered
obvious the challenged claims. Dec. 1, 3–4, 31. In its Request, Petitioner
contends that we erroneously relied upon only Example 1 in Chen in our
analysis, instead of viewing the disclosure as a whole. Req. Reh’g. 1, 4–12.
Petitioner also asserts we overlooked that “according to the ’167 patent and
Monosol itself, controlled drying, rather than the specific combination of
ingredients, imparts the uniform distribution,” and therefore substituting any
ingredients in the film of Example 1 in Chen would not make a difference to
our analysis. Id. at 1–3, 7–8.
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) (citations omitted). A request for rehearing “must
specifically identify all matters the party believes the Board misapprehended

1
WO 00/42992 A2 (published July 27, 2000) (Ex. 1002) (“Chen”).
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or overlooked, and the place where each matter was previously addressed.”
37 C.F.R. § 42.71(d).
II. ANALYSIS
Petitioner argues that we improperly focused only on Chen’s Example
1 in our analysis. Req. Reh’g. 6 (citing Dec. 15–16). As discussed in our
Decision, however, Petitioner relied upon Example 1 in Chen, in particular,
to establish that Chen’s film compositions inherently disclosed the
“substantial uniform distribution” element of the challenged claims. Dec.
14–15; Pet. 32–33. As also discussed in our Decision, Petitioner did not
explain sufficiently how Chen’s Example 1 disclosed other elements recited
in the challenged claims, such as vitamin E, vitamin E TPGS, or sodium
benzoate, as recited in claim 13, or the specific polymers (other than HPMC)
and sodium benzoate, as recited in claim 95. Dec. 15.
In its Request, Petitioner does not argue that we erred in those
findings. Rather, Petitioner contends that we determined that Petitioner “had
not explained how substituting these ingredients from elsewhere in the
disclosure for ones listed in Example 1 would still result in a film with the
claimed uniform distribution” of an active ingredient. Req. Reh’g. 1–2.
Petitioner then asserts: “But that was not [Petitioner’s] burden to prove
because, according to the ’167 patent and [Patent Owner] Monosol itself,
controlled drying, rather than the specific combination of ingredients,
imparts the uniform distribution,” and “substituting, say, the HEC polymer
for HPMC (as disclosed in Example 1) should not make a difference.” Id. at
1–3, 7–8 (citing Pet. 6–7, 21, and 19–30 generally). Thus, according to
Petitioner, “Chen teaches that any of the ingredients may be combined to
produce the film” exhibiting the recited “substantially uniform distribution”
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feature. Id. at 8; see also id. at 3 (stating that “the ingredients are
interchangeable” in Chen relation to this feature).
We are not persuaded that Petitioner argued in its Petition that “Chen
teaches that any of the ingredients may be combined to produce the film”
exhibiting “substantially uniform distribution” feature. Req. Reh’g. 2–3
(citing Pet. 6–7), 7–8 (citing Pet. 21, and 19–30 generally). For instance,
Petitioner does not point us adequately to where pages 6–7 of the Petition,
which provides a summary of the prosecution history of the ’167 patent, or
pages 32–33 of the Petition relating to the “substantial uniform distribution”
element of the challenged claims, make the argument. In addition, Petitioner
does not explain adequately how statements in the claim charts, for example
on page 21 of the Petition, or pages 19-30 of the Petition generally, make the
argument. Pet. 21; Req. Reh’g. 7–8. We cannot have misapprehended or
overlooked a matter that Petitioner failed to raise previously.
Even assuming Petitioner had presented such an argument, however,
Petitioner does not persuade us that the portions of Chen cited in the Petition
adequately disclose that combining any of the components in Chen would
have resulted necessarily in a “substantially uniform distribution” film, as
recited in the challenged claims.
When determining whether to institute a trial, we considered whether
Petitioner had shown a reasonable likelihood of establishing that Chen
described, expressly or inherently, a film having: (1) all components recited
in the challenged claims, i.e., the recited polymer, active component, and
anti-tacking agent; and (2) the recited feature of maintaining “substantially
uniform distribution” that “is measured by substantially equal sized
individual unit doses which do not vary by more than 10% of said desired
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amount of said active component.” Dec. 6–7 (reproducing challenged
claims 13 and 95). Petitioner persuaded us that Chen disclosed (1), i.e.,
recited components, albeit in lists among other choices for each component.
Dec. 10–11, 13–14. We also assumed, for the purposed of the Decision, that
Chen disclosed, in Example 1, a film having (2), the “substantially uniform
distribution” limitation. Id. at 12, 14–15. Information before us, however,
did not establish sufficiently that Chen disclosed, expressly or inherently, a
film having both (1) and (2). Id. at 12, 15–16.
Petitioner’s arguments and information cited in the Petition, for
example on pages 32–34 of the Petition regarding Example 1, were
insufficient in this regard. Likewise, Petitioner’s claim charts did not
overcome this deficiency. Pet. 21–22, 24–25. In relation to the
“substantially uniform distribution” limitation, the Petition cited to certain
portions of Chen, i.e., portions of Ex. 1002, 15–23, Fig. 2, Examples 1–8.
For example, Petitioner pointed to where Chen stated that “[i]n addition to
the active agent and the hydrocolloid, any of the ingredients listed above
may be added and dispersed or dissolved uniformly in the hydrocolloid
solution.” Ex. 1002, 15:20–23; Req. Reh’g. 7–8, 14 (citing Pet. 21); Pet. 21
(in relation to a “substantially uniform distribution of said desired amount of
said active” in claim 13); Dec. 11. Such statements, and Examples 1–8 in
Chen, however, do not persuade us that Chen necessarily discloses a film
having the specific components recited in the challenged claims and
“substantially equal sized individual unit doses which do not vary by more
than 10% of said desired amount of said active component,” as also
specifically required in the challenged claims.
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Petitioner also relies on the ’167 patent itself to make an argument
that the “controlled drying, rather than the specific combination of
ingredients, imparts the uniform distribution.” Req. Reh’g. 2, 8, 13–14
(citing Pet. 6–7, 30; Ex. 1001, 6:61–64, 7:4–10, 20:25–27). We are not
persuaded that the cited passages in the ’167 patent disclose what Petitioner
asserts they disclose. Id.; Ex. 1001, 6:61–64, 7:4–10, 20:25–27. While
some disclosures indicate that certain mixing and drying processes can
provide “uniform” films (Ex. 1001, 6:61–64, 7:4–10), those disclosures do
not state that any combination of disclosed components, regardless of which
ones or how much, will have the uniform distribution as recited in the
claims. Petitioner’s brief point alleging that the “300 examples of the ’167
patent” include combinations interchangeably, also raised for the first time
in the Request (Req. Reh’g. 3, 14–15 (citing Ex.1001, 26:60–40:49
generally)), does not persuade us otherwise for the same reason.
Petitioner also argues, without explaining where the Petition makes
the argument, that Chen uses the same controlled drying process described
in the ‘167 patent, and therefore, Chen necessarily makes the recited film
using that process. Req. Reh’g. 3, 8. Notably, however, Petitioner does not
establish sufficiently that Chen and the ’167 patent describe the same exact
drying process, or that any differences in the processes have no relevant
impact on the uniformity aspect of the film. See id. (citing Ex. 1002, 17
(Chen’s “Examples 1-8 are dried at 50° C for 9 minutes”); Ex. 1001, 27:22–
28 (’167 patent “Examples dried at 80° C for 10 minutes”), 25:4–5 (“The
temperature at which the films are dried is . . . most desirably 80° C or
less”).
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Additionally, Petitioner argues, for the first time in its Request,
without citing the Petition or evidence of record, that the film of Chen’s
Example 1 contains “benzoate, which is merely added in its acid form in
Chen as opposed to its salt form recited in the claims,” which Petitioner
asserts is “a distinction without difference.” Req. Reh’g. 2, 9–10.
Conclusory attorney argument, raised for the first time in a Request for
Rehearing, does not provide a rationale to modify our Decision.
For the reasons discussed above, Petitioner has not demonstrated
adequately that we misapprehended or overlooked any matter or evidence,
such as the Chen reference in its entirety or disclosures in the ’167 patent, in
our Decision denying institution.
III. CONCLUSION
We deny Petitioner’s Request for Rehearing.

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PETITIONER:

Danielle Herritt
Kia Freeman
MCCARTER & ENGLISH, LLP
dherritt@mccarter.com
kfreeman@mccarter.com

PATENT OWNER:

Daniel Scola
Michael Chakansky
HOFFMANN & BARON, LLP
dscola@hbiplaw.com
mchakansky@hbiplaw.com