Ex Parte 7666337 et al

Patent Trial and Appeal Board

Mar 27, 2015

95002171 (P.T.A.B. Mar. 27, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/002,171 09/10/2012 7666337 117744-00030 1084
23869 7590 01/27/2016
Hoffmann & Baron LLP
6900 Jericho Turnpike
Syosset, NY 11791
EXAMINER
DIAMOND, ALAN D
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
01/27/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE PATENT TRIAL AND APPEAL BOARD
____________

BIODELIVERY SCIENCES INTERNATIONAL, INC.
Requester and Cross Appellant

v.

MONOSOL RX, LLC
Patent Owner and Appellant
____________

Appeal 2014-008893
Reexamination Control 95/002,171
Patent 7,666,337 B2
Technology Center 3900
____________

Before CHUNG K. PAK, JEFFREY B. ROBERTSON, and
RAE LYNN P. GUEST, Administrative Patent Judges.

GUEST, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING

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Patent Owner of U.S. Patent 7,666,337 B2 (hereinafter, “the ‘337
patent”), MonoSol Rx, LLC (hereinafter “Patent Owner”), requested
rehearing under 37 C.F.R. § 41.79 of the Board’s Decision of March 27,
2015, (hereinafter “Decision”) affirming the Examiner’s rejections of claims
25-27, 29-54, 62-75, and 77 in an inter partes reexamination. See Patent
Owner’s Request for Rehearing 1, filed April 27, 2015, (hereinafter
“Request”). Respondent and Third Party Requester, BioDelivery Sciences
International, Inc. (hereinafter “Requester”), also filed Comments in
response to Patent Owner’s Request in accordance with 37 C.F.R.
§ 41.79(c). See Requester’s Comments in Opposition to Patent Owner’s
Request 1, filed May 26, 2015 (hereinafter “Comments “).
In particular, the Decision affirmed the following Examiner’s
rejections:
1. Claims 25-27, 29-39, 45-54 and 62-75 under 35 U.S.C. § 103(a) as
being unpatentable over Chen and
2. Claims 39-44 and 77 under 35 U.S.C. § 103(a) as being
unpatentable over Chen and Staab.
Patent Owner contends that the Board misunderstood or overlooked
the following principles:
1. The high burden in establishing an inherency-based obviousness
rejection, as discussed in a recent Federal Circuit case, Par
Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1194-1197 (Fed.
Cir. 2014) (Request 1);
2. An obligation to fully set forth its finding and the grounds for its
decision to maintain the rejection of claims 39-44 and 77 under 35
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U.S.C. § 103(a) as being unpatentable over Chen and Staab
(Request 4); and
3. Patent Owner’s evidence of secondary considerations of non-
obviousness (Request 5).

INHERENCY-BASED OBVIOUSNESS
Patent Owner contends that the Board overlooked the “high standard
for relying on inherency in an obviousness analysis” in accordance with the
Federal Circuit’s ruling in Par. Request 6-8. In particular, Patent Owner
argues that
similar to the missing evidence in Par, there is absolutely no
evidence that the drying method disclosed in Chen naturally
results in the required “substantially uniform distribution of the
pharmaceutical active, in that the amount of the pharmaceutical
active varies by no more than l 0%” and “rapidly form a
viscoelastic film ... within about the first 4 minutes to maintain
said uniform distribution of said pharmaceutical active by
locking in or substantially preventing migration of said
pharmaceutical active.”
Request 8-9. Patent Owner argues that the Board erred in finding that
Chen inherently teaches (1) the recited uniformity of active material and (2)
inherently has the step of “locking-in” the active within the first 4 minutes of
drying. Request 2-3; 8-9.
Unlike the Par case, the finding of inherency in the Decision is based
on sound evidence. A finding that the uniform distribution of active is
inherent is reasonably based on the additive weight test described in Chen on
the basis that it is identical to the additive weight test described in the ’337
Patent. Decision 30. Likewise, the “locking-in” step is found to be inherent
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based on Patent Owner’s own assertion that the uniformity shown by the
additive weight test of Chen would have been impossible to achieve but for
the locking-in step occurring. See Decision 30-31. Accordingly, Patent
Owner points to no “missing” or “insufficient” evidence similar to that
described in Par.
Patent Owner also argues for the first time in the Request for
Rehearing that Figure 5, in showing that Chen’s dosage units do not have
identical release profiles “with little or no statistical deviation,” as
represented by the “substantially large” error bars therein, demonstrates a
lack of uniformity because “uniform distributions of the same components[]
must have identical dissolution, erodibility, and other physical traits.”
Request 3-4.
We agree with Requester that these are new and unsupported
arguments. See Comments 9. During the appeal, Patent Owner argued only
that Figure 5 of Chen demonstrates that “[i]n six instances the amount of
pharmaceutical active released from Chen’s unit dose films is greater than
110% of the expected/desired amount” (PO App. Br. at 44) (emphasis
added), which we found was not persuasive for the reasons discussed in our
Decision. See Decision 31. A request for rehearing is an inappropriate time
for new arguments or evidence. See 37 C.F.R. § 41.79(b)(1) (“Arguments
not raised in the briefs before the Board and evidence not previously relied
upon in the briefs are not permitted in the request for rehearing except as
permitted by paragraphs (b)(2) [i.e., for good cause] and (b)(3) [i.e., when a
new ground of rejection has been entered] of this section.”). Likewise,
Requester, has not had adequate opportunity to respond to the new
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arguments and is not entitled to submit evidence to do so. See 37 C.F.R. §
41.79(c).
Moreover, Patent Owner’s arguments that uniform dosage units would
inherently “dissolve, erode, disintegrate, disperse, etc. in exactly the same
manner” and that “the only logical explanation for the difference in release
profiles is that the active in the Chen films lack a substantially uniform
distribution” (Request 13-14) were submitted without any evidentiary
support. In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Accordingly,
we do not find this new argument persuasive. Other “logical” explanations
for the difference in release profiles may exist, considering that Chen has not
described the testing procedure used for determining the release profiles
shown in Figure 5, such as a sample’s access to the dissolving solution, or an
artifact of the test method, as noted by the Requester. Comments 8.
Patent Owner has not shown that the reasoning provided in the
Decision to be untenable or that a change in the Decision is warranted.

OBVIOUSNESS BASED ON CHEN IN VIEW OF STAAB
Patent Owner further contends that the Board’s brief discussion of
Staab fails to show “a clear indication of the specific section(s) in Staab on
which the Board relies” such that “the CAFC will not be able to review the
bases for the Board’s Decision.” Request 22.
As stated in the Decision, we affirmed the Examiner’s rejection of
dependent claims 39-44 and 77 over Chen and Staab. Decision 37 and 38.
Claims 39-44 and 77 have additional limitations relating to the presence of
an additional film layer that were not argued separately by Patent Owner in
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its appeal brief (see PO App. Br. 48). These limitations were found by the
Examiner to have been met by Staab. See RAN 40-42 and 97-98. Although
not expressly stated in our Decision, we reviewed the Examiner’s findings,
concluded they are reasonable and fact-based, and adopted the Examiner’s
findings and conclusions with respect to the application of Staab as our own.
See Comments 10-11 (citing case law indicating the Federal Circuit would
consider the grounds stated by the Examiner when the Board affirms without
comment). We continue to adopt the Examiner’s findings and conclusions
on rehearing. As also stated in the Decision, we did not reach the additional
rejections on appeal, including the additional rejection of claims 39-44 and
77 as obvious based on Staab alone (RAN 52-53). As a result, the Decision
did not discuss the other aspects of Staab relied on by the Examiner and
argued by Patent Owner. See Decision 38; PO App. Br. 49-55; RAN 42-51.

COMMERCIAL SUCCESS
Patent Owner contends that the Board erred in basing its decision, in
part, on the fact that “Patent Owner fails to show actual sales data” when
actual sales data was “contained within Exhibit 5.” Request 23; See Exhibit
5 to Patent Owner’s Response to the Action Closing Prosecution (hereinafter
“Exhibit 5”). We find no error in our Decision directed to the evidence of
Suboxone sublingual film sales data. Exhibit 5 merely shows overall sales
data from Q1 2011 to Q2 2013. Id. For each quarter, Exhibit 5 provides the
“Sales Rank”, the amount of sales, and the number of units sold. Id. As
indicated by Requester (Comments 14), this data does not reflect only the
sales of Suboxone film. Rather, the data reflects the sales of the drug
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Suboxone in all dosage forms. Patent Owner arrives at a $1 billion sales
figure based on an additional finding that “[b]y the end of 2012 . . . the film
product had a 64% market share of the total Suboxone® drug products
market” and “assuming a 64% share of the $1,491,597,000 market [the total
of all sales for all of 2012]” to arrive at about $954 million in sales for 2012.
PO App. Br. 32, n. 3. However, Patent owner contends that the tablet form
of Suboxone was not discontinued until September of 2012 (see Request
24), calling into question whether Patent Owner had 64% of the market
share for all of 2012.1 Yet, Patent Owner’s figure includes all the sales from
2012 without clearly distinguishing which of those sales were film product
and not tablet product.
Moreover, even if we take the Patent Owner’s assertion that the
Suboxone film has had nearly $1 billion dollar in sales, we do not find that
information probative that the film is not obvious over Chen, which is also
directed to drug films that are demonstrably uniform in active content.
Proof of commercial success is not simply a matter of producing sales
figures. Commercial success “is relevant in the obviousness context only if
there is proof that the sales were a direct result of the unique characteristics
of the claimed invention—as opposed to other economic and commercial
factors unrelated to the quality of the patented subject matter.” In re Huang,

1 In fact, Exhibit 4 to Patent Owner’s Response to the Action Closing
Prosecution, Reckitt Benckiser Group’s Annual Report and Financial
Statement of 2012, states at page 4 that “[c]onversion from tablets to film in
the US continued to increase with market volume share at the end of 2012 of
64%, up from 48% at the end of 2011, creating a significantly more
sustainable business.” Accordingly, Patent Owner’s calculation relying on
64% market share for sales during all of 2012 is suspect.
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100 F.3d 135, 140 (Fed. Cir. 1996). In order to be probative of
non-obviousness, the commercial success must be attributed to the material
difference between the claimed invention and the closest prior art. Asyst
Technologies, Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008)
(“[T]here was no evidence that the success of the commercial embodiment
. . . was attributable to the . . . only material difference between [the prior
art] and the patented invention.”); J.T. Eaton & Co., Inc. v. Atlantic Paste &
Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997) (“the asserted commercial
success of the product must be due to the merits of the claimed invention
beyond what was readily available in the prior art”); Richdel, Inc. v.
Sunspool Corp., 714 F.2d 1573, 1580 (Fed. Cir. 1983) (Patentee failed to
show that “such commercial success as its marketed system enjoyed was due
to anything disclosed in the patent in suit which was not readily available in
the prior art.”); see also In re Caveney, 386 F.2d 917, 923 (CCPA 1967)
(“[T]he failure of those in the trade to make appellant’s invention in no way
bears on its nonobviousness. . . . It seems to us that appellant’s commercial
success may well be due to those features of his ducts which are covered by
the [prior art] patent. . . . Commercial success, in such circumstances, is no
indication of patentability over the [prior art] device.”).
The evidence of 2012 sales is not adequately probative of commercial
success of invention beyond what was readily available in the prior art.
Patent Owner argues that its sales are directly related to the fact that
Suboxone was provided in an orally administered film product. However,
orally administered film products having uniformity of content were
described in Chen. As determined by the Examiner the novelty of the
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claimed invention over Chen is that the process further includes “performing
analytical chemical tests for content uniformity of said pharmaceutical active
. . . indicating said substantially uniform distribution . . . in that the amount
of pharmaceutical active varies by no more than 10%.” The processes are
otherwise indistinguishable. See Decision 33-34. Patent Owner has not met
its burden of demonstrating that the film product’s commercial success was
directly related to confirming uniformity by analytical testing. As we
discuss in the Decision, there is substantial evidence that analytical testing of
film content was conventional. See Decision 31-32.
Moreover, as stated in our Decision, Requester has rebutted the
evidence of commercial success being solely the result of the novel aspects
of the process claimed in the patent by pointing out that the Suboxone film
product was the only film product with FDA approval and for a time was the
only form of Suboxone commercially available and that Suboxone was sold
at a price less than the tablet form. See Decision 36-37, Req. Res. Br. 14;
Comments 14-15; Exhibit 4, p. 4, col. 2 (explaining that the film product is a
lower priced product than the tablet form of Suboxone, that the European
markets have “government price reductions,” and that advertising and
marketing programs increased in 2012).2
Patent Owner further contends that the Board overlooked the
significance of the FDA approval of the Suboxone film because it was “the first

2 We also cannot rule out the possibility that large overall sales are due to the
desirability of Suboxone’s particular drug combination or that such a drug
combination may have a particularly large market (drug addiction
treatment), which has nothing to do with the drug being provided in a film
made in accordance with the claimed invention.
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sublingual oral dosage delivery film of any kind on the market and the first film
to successfully combine buprenorphine and naloxone” and the large sales of the
product “is clear evidence of a long felt but unsolved need in the general
public.” Request 25-26. To the extent Patent Owner is arguing that the only
reason FDA approval was met, and thus the Suboxone film could have been
sold at all, was the step of confirming uniformity of content by analytical
testing, we disagree that this evidence is persuasive evidence of non-
obviousness. While it is true that analytical testing was necessary to obtain
FDA approval, the fact that a known process provided for uniformly active
content as taught by the product art was confirmed in a conventional way is
insufficient evidence to show non-obviousness.
The holding of Leo Pharmaceutical Products, Ltd. v. Rea, 726 F. 3d
1346 (Fed. Cir. 2013), is distinguishable on this point. In Leo, the court states
that “FDA approval highlights that Leo Pharmaceutical's formulation is truly
storage stable, something that the prior art formulations did not achieve.” Leo,
726 F.3d at 1358 (emphasis supplied). Here, however, Chen did achieve
uniformity of active content, as evidenced by the weight additive test described
in the ’337 patent. Confirming this uniformity using other known and
conventional chemical analytical tests for the purpose of FDA approval does
not render the process patentable. Moreover, we disagree with Patent Owner
that evidence of large sales data is sufficient to establish a long felt but unmet
need in the art.3

3 Patent Owner contends that Leo supports a conclusion that, with respect to
showing secondary considerations of non-obviousness, “[t]he fact that the
need for a film may not have been previously recognized does not matter.”
Request 25. We strongly disagree with this interpretation of Leo. It is well-
established law that, to show a long felt, but unmet, need in the art, evidence
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Patent Owner further argues that the Board’s finding that the
Suboxone film was “the only product that [had received] FDA approval, and
thus was the only product on the U.S. market for Suboxone” is in error
because “the two forms [film and tablet] were on the market at the same
time for approximately 2 years” and that “in the time span encompassed by
the concurrent marketing . . . SUBOXONE® film had sales of
approximately $2.3 billion.” Request 24. Again, Patent Owner has not
provided probative evidence of commercial success.
Although Patent Owner argues that Suboxone film and tablet were on
the market at the same time between August 30, 2010, when the film product
first acquired FDA approval,4 and September of 2012, when the tablet
dosage form was discontinued (see Request 24), Exhibit 5, which shows
quarterly sales of both tablet and film Suboxone product, does not

must show that the need was a persistent one that was recognized by those of
ordinary skill in the art. See In re Gershon, 372 F.2d 535, 538 (CCPA 1967)
(“Since the alleged problem in this case was first recognized by appellants,
and others apparently have not yet become aware of its existence, it goes
without saying that there could not possibly be any evidence of either a long-
felt need in the dentifrice art for a solution to a problem of dubious existence
or failure of others skilled in the art who unsuccessfully attempted to solve a
problem of which they were not aware.”); Orthopedic Equipment Co., Inc. v.
All Orthopedic Appliances, Inc., 707 F.2d 1376 (Fed. Cir. 1983) (finding “no
evidence of any previous, unsuccessful attempts”). To the contrary, in Leo,
the Court found that “[t]he record also shows evidence of long felt but
unsolved need, i.e., the need for a single formulation to treat psoriasis.” Leo,
726 F.3d at 1359.
4 We agree with Requester that, despite the attorney argument, Patent Owner
has not presented sufficient evidence to establish that a Suboxone film
product was commercially available as of the first date of FDA approval.
Comment 14.
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distinguish between the product in order to persuasively demonstrate the
sales of the film product as compared to the tablet form of the product. See
Exhibit 5.
Further, as stated in the Decision, “Patent Owner has not presented
sufficient evidence to evaluate whether the commercial product embodies all
the claimed features of the invention.” Decision 37. Patent Owner does not
produce persuasive evidence that the Suboxone film product was made by
the process recited in the claims of the ’337 patent.
Patent Owner contends that the Board erred in failing to assign
significant weight to the testing data of Dr. Bogue because Dr. Bogue’s
opinion testimony “is entitled to consideration and some weight so long as the
opinion is not on the ultimate legal conclusion at issue.” Request 24-25
(quoting MPEP § 716.01(c)(III)). We agree with the Examiner that Dr.
Bogue’s declaration is entitled to some, but little, weight as evidence of being
commensurate in scope with all of the claims on appeal, considering that no
details of the manufacturing process were provided. See RAN 68-69.
However, even taking Dr. Bogue’s testimony that the FDA approved Suboxone
film product was manufactured “in accordance with the invention disclosed in
the ’337 patent” at face value, we are still not persuaded that any commercial
success of the FDA approved product overcomes the evidence of obviousness
based on Chen for the reasons discussed above and in our Decision.

DENIED

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PATENT OWNER:
Hoffmann & Baron, LLP
6900 Jericho Turnpike
Syosset, NY 11791

THIRD-PARTY REQUESTER:

McCarter & English, LLP
265 Franklin Street
Boston, MA 02110