Ex Parte 7897080 et al

Patent Trial and Appeal Board

Mar 27, 2015

95002170 (P.T.A.B. Mar. 27, 2015)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
95/002,170 09/10/2012 7897080 117744-00023 6418
23869 7590 03/27/2015
Hoffmann & Baron LLP
6900 Jericho Turnpike
Syosset, NY 11791
EXAMINER
DIAMOND, ALAN D
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
03/27/2015 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 2014-007671
Reexamination Control 95/002,170
Patent 7,897,080 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 APPEAL
This is a decision on appeal by the Patent Owner from the Patent
Examiner’s decision to reject pending claims in an inter partes
reexamination of U.S. Patent 7,897,080 B2 (hereinafter the “’080 patent”).1

1 The ’080 patent issued March 1, 2011, to Robert K. Yang, et al.
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The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and
315. We AFFIRM.

I. BACKGROUND
A request for inter partes reexamination under 35 U.S.C. §§ 311-318
and 37 C.F.R. §§ 1.902-1.997 for the ’080 patent was filed on
September 10, 2012, by a Third-Party Requester, BioDelivery Sciences
International, Inc. (hereinafter “Requester”). See Request for Inter Partes
Reexamination 1 (hereinafter “Request”); Requester’s Cross-Appeal Brief,
dated March 10, 2014 (hereinafter “Req. App. Br.”); Requester’s
Respondent Brief, dated April 10, 2014 (hereinafter “Req. Res. Br.”);
Requester’s Rebuttal Brief, dated May 27, 2014 (hereinafter “Req. Reb.
Br.”). The Patent Owner and Appellant is MonoSol Rx, LLC (hereinafter
“Patent Owner”). Patent Owner’s Appeal Brief 1, dated March 10, 2014
(hereinafter “PO App. Br.”); Patent Owner’s Respondent Brief, dated April
10, 2014 (hereinafter “PO Res. Br.”); Patent Owner’s Rebuttal Brief, dated
May 27, 2014 (hereinafter “PO Reb. Br.”).
The ’080 patent is the subject of a litigation proceeding in the United
States District Court for the Eastern District of North Carolina styled
BioDelivery Sciences International, Inc. v. Reckitt Benckiser
Pharmaceuticals, Inc. et al., 5-14-cv-00529 (NCED). The litigation was
filed on September 20, 2014 and was stayed on December 23, 2014.
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An oral hearing was held November 5, 2014. A transcript of the
hearing will be entered into the record in due course.2
The ’080 patent is directed to a method for forming a rapidly
dissolving film containing an active ingredient evenly or uniformly
distributed throughout the film. ’080 patent, col. 1, ll. 35-42. According to
the ’080 patent, “uniform distribution is achieved by controlling one or more
parameters, and particularly the elimination of air pockets prior to and
during film formation and the use of a drying process that reduces
aggregation or conglomeration of the components in the film as it forms into
a solid structure.” Id., col. 1, ll. 42-47.
The ’080 patent originally contained claims 1-299. During
reexamination, Patent Owner cancelled claims 12, 16, 91, 95, 173, 177, 254,
255, 257, 272, 273, 275, 290, 291, and 293 and added claims 300-318.
Claims 1-11, 13-15, 17-90, 92-94, 96-172, 174-176, 178-253, 256, 258-271,
274, 276-289, 292 and 294-318 currently are pending and rejected by the
Examiner. Patent Owner appeals the rejection of all of the claims. Requester
appeals the Examiner’s decision not to adopt rejections of all of the claims
under 35 U.S.C. § 112, first and second paragraphs, for lack of clarity, lack

2 Several new arguments were raised for the first time during the oral
hearing. The oral hearing transcript identifies some of these new arguments,
and we note others that were not necessarily identified during the hearing.
The parties are reminded that such new arguments are not proper and will
not be considered. 37 C.F.R. § 41.73(e)(1) (“At the oral hearing, each
appellant and respondent may only rely on evidence that has been previously
entered and considered by the primary examiner and present argument that
has been relied upon in the briefs except as permitted by paragraph (e)(2) of
this section.”). We will only consider arguments and evidence addressed in
the briefs of record in this appeal.
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of enablement and/or lack of written descriptive support for several
recitations within the claims.
Claims 1, 82, 161, and 315-318 are the independent claims at issue in
this appeal. Claims 1 and 82 are representative and read as follows (with
underlining showing added language and brackets showing deleted language
over the original patented claim):
1. (Twice Amended) A process for manufacturing a
resulting film suitable for commercialization and regulatory
approval, said regulatory approval including analytical
chemical testing which meets the standards of the U.S. Food
and Drug Administration relating to variation of an active in
individual dosage units, said [making a] film having a
substantially uniform distribution of components comprising a
substantially uniform distribution of said active in individual
dosage units of said resulting film, comprising the steps of:
(a) forming a masterbatch pre-mix comprising a solvent
and a polymer selected from the group consisting of water-
soluble polymers, water-swellable polymers and combinations
thereof;
(b) adding [an] said active, said active selected from the
group consisting of bioactive actives, pharmaceutical actives
and combinations thereof, to a pre-determined amount of said
masterbatch pre-mix to form a flowable polymer matrix, said
matrix having a substantially uniform distribution of said
active;
(c) casting said flowable polymer matrix, said flowable
polymer matrix having a viscosity from about 400 to about
100,000 cps;
(d) controlling drying through a process comprising
conveying said flowable polymer matrix through a drying
apparatus and evaporating at least a portion of said solvent from
said flowable polymer matrix to form a visco-elastic film,
having said active substantially uniformly distributed
throughout, within about the first [10]4 minutes [or fewer] by
rapidly increasing the viscosity of said flowable polymer matrix
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upon initiation of drying to maintain said substantially uniform
distribution of said active by locking-in or substantially
preventing migration of said active within said visco-elastic
film, wherein during said drying said flowable polymer matrix
temperature is 100°C or less; [and]
(e) forming [a] said resulting film from said visco-elastic
film, wherein said resulting film has a water content of 10% or
less and said substantially uniform distribution of active by said
locking- in or substantially preventing migration of said active
is maintained; and
(f) performing analytical chemical tests for uniformity of
content of said active in substantially equal sized individual
dosage units sampled from different locations of said resulting
film, said tests indicating that uniformity of content in the
amount of the active varies by no more than 10% and said
resulting film is suitable for commercial and regulatory
approval, wherein said regulatory approval is provided by the
U.S. Food and Drug Administration.

Claim 82 is also representative. Claim 82 is substantially similar to
claim 1 above and includes the additional step of forming multiple films:
82. A process for manufacturing resulting films suitable
for commercialization and regulatory approval, said regulatory
approval including analytical chemical testing which meets the
standards of the U.S. Food and Drug Administration relating to
variation of an active in individual dosage units, said [making
a]films having a substantially uniform distribution of
components comprising a substantially uniform distribution of a
desired amount of said active in individual dosage units of said
resulting films, comprising the steps of:
(a) forming a flowable polymer matrix comprising a
polymer selected from the group consisting of a water-soluble
polymer, a water swellablc polymer and combinations thereof, a
solvent and [an]said active, said active selected from the group
consisting of bioactive actives, pharmaceutical actives[, drugs,
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medicaments] and combinations thereof, said matrix having a
substantially uniform distribution of said active;
(b) casting said flowable polymer matrix, said flowable
polymer matrix having a viscosity from about 400 to about
100,000 cps;
(c) controlling drying through a process comprising
conveying said flowable polymer matrix through a drying
apparatus and evaporating at least a portion of said solvent from
said flowable polymer matrix to form a visco-elastic film,
having said active substantially uniformly distributed
throughout, within about the first [10]4 minutes [or fewer]by
rapidly increasing the viscosity of said flowable polymer matrix
upon initiation of drying to maintain said substantially uniform
distribution of said active by locking-in or substantially
preventing migration of said active within said visco-elastic
film, wherein during said drying said flowable polymer matrix
temperature is 100°C or less, and wherein uniformity of content
of said active in substantially equal sized individual dosage
units of said visco-elastic film is such that the amount of the
active varies by no more than 10%; [and]
(d) forming [a]said resulting film from said visco-elastic
film, wherein said resulting film has a water content of 10% or
less and said substantially uniform distribution of active by said
locking-in or substantially preventing migration of said active is
maintained;
(e) performing analytical chemical tests for uniformity of
content of said active in substantially equal sized individual
dosage units sampled from different locations of said resulting
film, said tests indicating that uniformity of content in the
amount of said active varies by no more than 10% and said
resulting film is suitable for commercial and regulatory
approval, wherein said regulatory approval is provided by the
U.S. Food and Drug Administration; and
(f) repeating steps (a) through (e) to form additional
resulting films, such that uniformity of content in the amount of
said active in said resulting film and said additional resulting
films varies no more than 10% from the desired amount of the
active as indicated by said analytical chemical tests.
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CLAIM INTERPRETATION AND
REJECITONS UNDER 35 U.S.C. § 112 (pre-AIA)
A. PATENT OWNER’S APPEAL OF REJECTIONS OF CLAIM 318
BASED ON SECTION 112
Claim 318 stands rejected under 35 U.S.C. § 112 (pre-AIA), first and
second paragraphs, as indefinite and lacking written descriptive support.
Patent Owner does not address the Examiner’s specific findings and
conclusions articulated in the rejections or explain why these positions are
deficient. PO App. Br. 34-35. Instead, Patent Owner requests entry of an
amendment filed September 3, 2013, which was not entered by the Examiner.
Id. Matters that are petitionable are not before a merits panel for review on
appeal. See 37 C.F.R. § 1.181; Manual of Patent Examining Procedure
§ 1002.02(c)(3) (8th ed., Rev. 2, May 2004) and § 1201 (8th ed., Rev. 3,
August 2005); see also, e.g., In re Berger, 279 F.3d 975, 984-85 (Fed. Cir.
2002) (Issues regarding whether an examiner abused his or her discretion in
matters of practice and procedure are not subject to appeal). Accordingly,
we summarily affirm the Examiner’s rejections of claim 318 under 35 U.S.C.
§ 112.

B. CLAIM INTERPRETATION AND REQUESTER’S APPEAL OF
NON-ADOPTED REJECTIONS OF CLAIMS BASED ON
SECTION 112
“suitable for commercialization and regulatory approval . . .”
Each of the independent claims recites in the preamble a process of
manufacturing a resulting film or films that are “suitable for
commercialization and regulatory approval, said regulatory approval
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including analytical chemical testing which meets the standards of the U.S.
Food and Drug Administration relating to variation of an active in individual
dosage units,” and the body of each of the claims further recites “said
resulting film is suitable for commercial and regulatory approval, wherein
said regulatory approval is provided by the U.S. Food and Drug
Administration.”
Requester proposes the rejection of all the claims on appeal under 35
U.S.C. § 112, first and second paragraphs (pre-AIA), because the above
phrases lack written descriptive support and an enabling disclosure and are
unclear. Req. App. Br. 14-21. In particular, Requester argues that the
phrases require “films meeting all of the requirements for FDA approval.”
Id. at 17 and 20. Moreover, Requester contends that the phrases are unclear
because they are subject to at least two interpretations, the Patent Owner’s
interpretation, and the interpretation by the Examiner. Id. at 20-21.
Patent Owner contends that the phrases are clear, supported, and
enabled in light of the following portion of the ’080 patent:
Failure to achieve a high degree of accuracy with respect to the
amount of active ingredient in the cut film can be harmful to the
patient. For this reason, dosage forms formed by processes such
as Fuchs, would not likely meet the stringent standards of
governmental or regulatory agencies, such as the U. S. Federal
Drug Administration (“FDA”), relating to the variation of
active in dosage forms. Currently, as required by various world
regulatory authorities, dosage forms may not vary more than
10% in the amount of active present. When applied to dosage
units based on films, this virtually mandates that uniformity in
the film be present.
’080 patent, col. 2, ll. 36-46.
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The Examiner determined that the language is enabled and definite
and found that the language had written descriptive support in view of the
language in the claim reciting a step of “performing analytical chemical tests
for uniformity of content . . . said tests indicating that uniformity of content
in the amount of the active varies by no more than 10%.” RAN 13.
According to the Examiner,
The claims do not require commercialization and regulatory
approval, they set forth suitability for commercialization and
regulatory approval. The bright line test for such suitability is
based on performing analytical chemical tests for uniformity of
content of active, said tests showing a particular variation of
active, for example, not more than 10%.
RAN 14. In other words, the Examiner determined that the phrase “suitable
for commercialization and regulatory approval . . .” is limited in scope by
the claim language and the ’080 patent to require the film to have a property
of uniformity that varies by not more than 10%.
On its face, the phrase “suitable for commercialization and regulatory
approval . . .” suggests much more stringent requirements than merely the
degree of uniformity recited in the claims, as exemplified by Dr. Clevenger’s
Declaration. See Clevenger Declaration, executed April 12, 2013, ¶ 4 (“the
route to regulatory approval is an ongoing negotiation with the FDA through
the New Drug Application (NDA) process. In this negotiation process,
analytical testing and standards are determined for each product depending
on its particular properties and characteristics. . . . Also, standardized test
methods can change over time (e.g., USP <905> was revised in 2007 and
2011).”). We agree with the Requester that actually obtaining FDA approval
requires more than uniformity of active content.
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However, claim language is not to be read in a vacuum. “Importantly,
the person of ordinary skill in the art is deemed to read the claim term not
only in the context of the particular claim in which the disputed term
appears, but in the context of the entire patent, including the specification.”
Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). “While the
Board must give the terms their broadest reasonable construction, the
construction cannot be divorced from the specification and the record
evidence.” In re NTP, Inc., 654 F3d 1279, 1288 (Fed. Cir. 2011) (citing In
re Suitco Surface, 603 F.3d 1255, 1259 (Fed. Cir. 2010). Moreover, “the
claims themselves provide substantial guidance as to the meaning of
particular claim terms.” Phillips, 415 F.3d at 1314. “To begin with, the
context in which a term is used in the asserted claim can be highly
instructive.” Id.
The ’080 patent describes “various world regulatory authorities”
requiring that “dosage forms may not vary more than 10% in the amount of
active present.” Col. 2, ll. 43-45. Thus, our interpretation of “suitability”
must be considered in this context. The ’080 Patent discuses a prior art
patent, U.S. Patent No. 4,136,145 to Fuchs (“Fuchs”), which discloses films
having an active agent that suffer from aggregation or conglomeration of
active materials due to the process by which the films are formed. Id. at col.
2, ll. 7-26. The ’080 patent further states that Fuchs’ process “is a multi-step
process that adds expense and complexity and is not practical for
commercial use” (id. at col. 2, ll. 57-59) and that “[o]ther factors, such as
mixing techniques, also plays role in the manufacture of a pharmaceutical
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film suitable for commercialization and regulatory approval.” Id. at col. 3,
ll. 58-60.
Requester’s interpretation, i.e., requiring meeting all of the
requirements for FDA approval, is inconsistent with the limited context with
which FDA approval is described in the ’080 patent. We determine that the
phrase does not require that the process claimed actually produce a product
that meets all of the requirements of FDA approval or actually obtain FDA
approval, only a product that has uniformity that would make the product
suitable for obtaining such approval. In light of the claim language and the
’080 patent, one of ordinary skill in the art would have understood the
phrase to mean producing a film having a uniformity of active content that
may not vary by more than 10% within the film matrix, which we discuss in
further detail below.
The ’080 patent also provides written descriptive support for the
claimed phrase. See e.g., ’080 patent, col. 15, ll. 37-42 (“the uniformity of
the present invention is determined by the presence of no more than a 10%
by weight of pharmaceutical and/or cosmetic variance throughout the
matrix.”). Additionally, the ’080 patent enables one of ordinary skill in the
art to achieve such suitability using the procedures and methods described
and exemplified therein.
Patent Owner further argues, based on the requirement that the film is
“suitable for commercialization and regulatory approval . . . ,” that the
claims of the ’080 patent require “a uniformity of content in amount of
active (i) in individual dosage units sampled from a single lot of resulting
film of 10% or less (independent claims 1, 161 and 316-318, see Appendix
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A, Bogue Declaration I, EA -1), and (ii) in individual dosage units sampled
from two or more lots of resulting films of +/-10% of the pre-determined
desired amount (independent claims 82 and 315, see Appendix B, Bogue
Declaration I, EA-l).” PO App. Br. 18-19 (emphasis added). According to
Patent Owner:
the invention in U.S. Patent No. 7,897,080 (the “’080 Patent”)
is directed to novel and non-obvious processes for
manufacturing pharmaceutical and bioactive active-containing
films suitable for commercialization and regulatory approval by
the U.S. Food and Drug Administration (“FDA”). The
suitability is with respect to uniformity of content in the amount
of active in the resulting films, such that:
(i) the degree of uniformity of content of the amount of
active (e.g., where the amount of active varies by no more that
10% between equally sized dosage units) throughout a single
manufactured roll (lot) of resulting film can also be strictly
maintained through the claimed processes; and
(ii) the degree of uniformity of content in the amount of
active in individual dosage units (e.g., where the amount of
active in any equally sized dosage unit varies by no more than
10% from the expected or desired amount) taken from different
manufactured rolls (lots) of resulting films can also be strictly
maintained through the claimed processes.
Moreover, commercialization requires the ability to mass
produce the films at scale and to ensure that resulting film
products from different manufactured lots (runs) reproducibly
meet the requisite degree of uniformity in amount of drug.
PO Reb. Br. 1-2 (emphasis added). Patent Owner suggests that the phrase
“suitable for commercialization and regulatory approval . . . ” informs one of
ordinary skill in the art that the phrase “substantially uniform distribution of
active” means both “throughout a single manufactured roll (lot) of resulting
film” and “in individual dosage units . . . taken from different manufactured
rolls (lots) of resulting films.” Id. In other words, Patent Owner argues that
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this phrase requires reproducibility among dosage forms within a film matrix
and between film matrices.
In support of this interpretation, the Patent Owner again points to the
background of the ’080 patent where the process of Fuchs is discussed as
follows:
dosage forms formed by processes such as Fuchs, would not
likely meet the stringent standards of governmental or
regulatory agencies, such as the U.S. Federal Drug
Administration (“FDA”), relating to the variation of active in
dosage forms. Currently, as required by various world
regulatory authorities, dosage forms may not vary more than
10% in the amount of active present. When applied to dosage
units based on films, this virtually mandates that uniformity in
the film be present.
’080 patent, col. 2, ll. 38-46.
We disagree that the phrase “suitable for commercialization and
regulatory approval . . .” requires reproducibility among dosage forms within
a film matrix and between film matrices in claims 1, 161, 316, 317, or 318.
Claims 1, 161, 316, 317, and 318 are each directed to “A process for
manufacturing a resulting film.” While a process that produces many films
may read on these claims because such a process produces at least one
resulting film, a process that only produces one film also reads on the
claims. Thus, the requirement of suitability “for commercialization and
regulatory approval” must be a property of a single film itself. Claims 1,
161, 316, 317, and 318 do not recite any additional films. Thus, we cannot
agree that reproducibility is a requirement of claims 1, 161, 316, 317, and
318, or the claims that depend therefrom.
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This interpretation is supported by the language recited by Patent
Owner that “[w]hen applied to dosage units based on films, this virtually
mandates that uniformity in the film be present.” ’080 patent, col. 2, ll. 45-
46 (emphasis added). Accordingly, this passage is directed to uniformity
within “the film,” as is substantially all of the ’080 patent, and not between
films. For example, the ’080 patent states that
Consideration of the above discussed parameters, such as
but not limited to rheology properties, viscosity, mixing
method, casting method and drying method, also impact
material selection for the different components of the present
invention. Furthermore, such consideration with proper material
selection provides the compositions of the present invention,
including a pharmaceutical and/or cosmetic dosage form or film
product having no more than a 10% variance of a
pharmaceutical and/or cosmetic active per unit area. In
other words, the uniformity of the present invention is
determined by the presence of no more than a 10% by weight of
pharmaceutical and/or cosmetic variance throughout the
matrix. Desirably, the variance is less than 5% by weight, less
than 2% by weight, less than 1 % by weight, or less than 0.5%
by weight.
Col. 15, ll. 28-42 (emphasis added). In other words, the invention
particularly addresses a “film product” with uniform active content and
uniform active content “throughout the matrix.”
The ’080 patent states that the active material is “evenly distributed
throughout the film,” which is “achieved by . . . the use of a drying process
that reduces aggregation or conglomeration of the components in the film as
it forms into a solid structure.” ’080 patent, col. 1, ll. 37-47. An objective
of the process is “a substantially non-self-aggregating uniform heterogeneity
throughout the area of the films.” Id. at col. 4, ll. 9-11. The ’080 patent
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further describes “a substantially reduced occurrence of, i.e. little or no,
aggregation or conglomeration of components within the film as is normally
experienced when films are formed by conventional drying methods.” Id.,
col. 6, ll. 27-31. The process of the ’080 patent provides “uniform
distribution of components for any given area in the film.” Id. at col. 7, ll.
24-26 (emphasis added). Further, the ’080 patent describes three tests for
determining uniformity. Each of these tests is described with respect to unit
dosage “from the same film.” Id., col. 31, l. 37 to col. 32, l. 39; see also col.
29, ll. 33-39. The ’080 patent does not expressly describe using these tests
for uniformity with respect to more than one “resulting film.”
Claims 82 and 315, however, are directed to “[a] process for
manufacturing resulting films . . . “ and include an additional step (f) of
“repeating steps (a) through (e) to form additional resulting films . . ..”
Accordingly, only with respect to claims 82 and 315 and the claims that
depend therefrom does the phrase “suitable for commercialization and
regulatory approval . . .” include both uniformity within an individual film
and reproducibility of the process in the formation of “additional resulting
films.”
As pointed out by Patent Owner, the ’080 patent recites:
If the testing results show non-uniformity between film
samples, the manufacturing process may be altered. This can
save time and expense because the process may be altered prior
to completing an entire manufacturing run. For example, the
drying conditions, mixing conditions, compositional
components and/or film viscosity may be changed. Altering the
drying conditions may involve changing the temperature,
drying time, moisture level, and dryer positioning, among
others.
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Moreover, it may be desirable to repeat the steps of
sampling and testing throughout the manufacturing process.
Testing at multiple intervals may ensure that uniform film
dosages are continuously produced. Alterations to the process
can be implemented at any stage to minimize non-uniformity
between samples.
’080 patent, col. 29, ll. 39-53. The ’080 patent suggests that consistent
manufacturing processes can be expected to produce consistent product.
The principle that identical processes lead to identical results is pervasive in
the case law. See e.g., Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
246 F.3d 1368, 1376 (Fed. Cir. 2001) (explaining that newly discovered
results of known processes are not patentable because those results are
inherent in the known processes); In re Best, 562 F.2d 1252, 1255 (CCPA
1977) (holding that where the claimed and prior art products are produced
by identical or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily possess the
characteristics of his claimed product). In other words, one of ordinary skill
in the art would expect substantially identical results with a repetition of
substantially identical process steps. Thus, reproducibility of the film
making process has written descriptive support in the ’080 patent and is
enabled because the skilled artisan would expect substantially identical
results when merely repeating identical steps and different results using
different steps, as described therein.
For these reasons, we affirm the Examiner’s decision not to adopt the
proposed rejection of all the claims under 35 U.S.C. § 112, first and second
paragraphs (pre-AIA).

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“analytical chemical tests”
All the claims on appeal recite a process step that includes
“performing analytical chemical tests for uniformity of content of said active
in substantially equal sized individual dosage units sampled from different
locations of said resulting film.”
Requester proposes the rejection of all the claims on appeal under 35
U.S.C. § 112, first and second paragraphs (pre-AIA), because the above
phrase lacks written descriptive support and is unclear. Req. App. Br. 22-23.
According to Requester, the term “analytical chemical tests” is not used in
the ’080 patent, and the ’080 patent fails to describe any testing methods that
are “chemical” in nature. Id. In particular, the Requester argues that the
’080 patent describes only a “dissolution” test generally, with no associated
procedure, and a light absorption test for determining the specific amount of
dye content in a film, which is not a “chemical” analysis. Id.
The Examiner determined that the phrase “analytical chemical tests”
means “analytical tests for determining the amount of active content in the
recited sample.” RAN 8 and 16. The Examiner reached this interpretation
because the ’080 patent describes “testing films of the present invention for
chemical and physical uniformity.” RAN 8 (citing ’080 patent, col. 28, l. 66
to col. 29, l. 1). The ’080 patent then describes testing by visual
examination for agglomerations, weighing identically sized individual
dosages cut from the film, and “dissolving individual doses and testing for
the amount of active therein.” RAN 8-9 (citing col. 29, ll. 3-47 and col. 31,
l. 37 to col. 32, l. 39). According to the Examiner, “physical” uniformity
refers to uniformity in appearance and physical properties, such as weight,
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while “chemical” uniformity refers to the actual amount of active material
dispersed within the film matrix. Id. Patent Owner agrees with the
Examiner’s interpretation. PO Res. Br. 16-18.
The additional claim language reveals that the results of “performing
chemical analytical tests for uniformity of content” is an indication “that
uniformity of content in the amount of the active varies by no more than
10%.” It is only through a test that determines the actual amount of active
content within the film matrix that it can be determined whether or not the
“amount of the active” varies by no more than 10%. The ’080 patent does
not suggest that “amount of active” can be determined by visual inspection
or by weight measurements alone, although these methods nonetheless may
be used to determine whether or not the active amount within a film matrix
is “substantially uniform.” Accordingly, we find the Examiner’s
interpretation reasonable in light of the claim language and ’080 patent
disclosure.
Further, it is particularly relevant that the ’080 patent states that “[a]ny
conventional means for examining and testing the film pieces may be
employed, such as, for example, visual inspection, use of analytical
equipment, and other suitable means known to those skilled in the art.” ’080
patent, col. 29, ll. 35-39. In other words, the term “analytical chemical tests”
are not limited to a dissolution test or a light absorption test, as described in
the ’080 patent. Rather, any test known in the art for determining the actual
amount of active content within samples of a film matrix would fall within
the scope of the phrase “analytical chemical tests.”
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We determine that the phrase “analytical chemical tests,” in light of
the claim language and the ’080 patent, would have been clear to one of
ordinary skill in the art, and would mean analytical tests for determining the
actual amount of active content in a sample of the film matrix. We find the
’080 patent also provides written descriptive support based on the passages
identified by the Examiner as discussed above.
Accordingly, we affirm the Examiner’s decision not to adopt the
proposed rejection of all the claims under 35 U.S.C. § 112, first and second
paragraphs (pre-AIA).

“amount of active varies by no more than 10%” and “amount of said active
varies by less than 5%”
All of the claims on appeal recite that the “uniformity of content in the
amount of the active varies by no more than 10%,” with the exception of
claim 318, which recites a “uniformity of content in the amount of said
active varies by less than 5%,” and certain dependent claims, which narrow
the range to no more than 2%, 1% or 0.5%.
Requester proposes rejections of all the claims on appeal under 35
U.S.C. § 112, first and second paragraphs (pre-AIA), because the
requirement that these ranges of uniformity are determined by “performing
analytical chemical tests” lacks written descriptive support and an enabling
disclosure and is unclear. Req. App. Br. 25-32.
With respect to written descriptive support, Requester argues that “the
’080 patent discloses no method that results in a film that it states satisfies
the new variation/uniformity recitation verified by analytical chemical
testing.” Id. at 30.
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As discussed above, “analytical chemical tests” encompasses any test
known in the art for determining the actual amount of active content within
samples of a film matrix, including known dissolution tests and known light
absorption tests for determining the specific amount of content in a film.
Considering this meaning of the term “analytical chemical tests,” we find
written descriptive support in the ’080 patent’s description that “the
uniformity of the present invention is determined by the presence of no more
than a 10% by weight of pharmaceutical and/or cosmetic variance
throughout the matrix. Desirably, the variance is less than 5% by weight,
less than 2% by weight, less than 1% by weight, or less than 0.5% by
weight.” ’080 patent, col. 15, ll. 37-42.
With respect to a lack of enablement, Requester contends that
“[d]espite over 100 examples and 150 pages of specification, the ‘080 patent
discloses no method that results in a film that it states satisfies the new
variation/uniformity recitation or which is actually verified by analytical
chemical testing as doing so.” Req. App. Br. 28.
The test for compliance with the enablement requirement in the first
paragraph of 35 U.S.C. § 112 (pre-AIA) is whether the disclosure, as filed, is
sufficiently complete to enable one of ordinary skill in the art to make and
use the claimed invention without undue experimentation. In re Wands, 858
F.2d 731, 737 (Fed. Cir. 1988). The analysis must consider the evidence
related to each of the so-called Wands factors, and any conclusion of non-
enablement must be based on the evidence as a whole. Id. at 736-37.
“A threshold issue is whether the PTO met its burden of proof in
calling into question the enablement of appellant’s disclosure. This burden
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required that the PTO advance acceptable reasoning inconsistent with
enablement. Thereupon, the burden would shift to appellant to show that one
of ordinary skill in the art could have practiced the claimed invention
without undue experimentation.” In re Strahilevitz, 668 F.2d 1229, 1232
(CCPA 1982). The Examiner must present sufficient reasons or evidence to
doubt the truth or accuracy of any statement in Appellant’s supporting
disclosure. See In re Marzocchi, 439 F.2d 220, 224 (CCPA 1971).
Requester fails to put forth persuasive evidence on which the
Examiner could have relied as evidence that preparing films having the
claimed variation in active content would have required undue
experimentation on the part of the skilled artisan.3 Thus, Requester has
provided no persuasive evidence that the ’080 patent is not enabling for
films having the claimed variation in active content.
Requester’s arguments directed to indefiniteness are directed also to
lack of clarity as to the determination of variation by “analytical chemical
tests.” We disagree with Requester that the claims are unclear to one of
ordinary skill in the art. As discussed above, the step of “performing
analytical chemical tests for uniformity of content of said active in
substantially equal sized individual dosage units sampled from different
locations of said resulting film, said tests indicating that uniformity of

3 We agree with the Requester and the Examiner that the evidence in
Bogue’s Declarations directed to testing of 2,000,000 individual doses for
content uniformity “lacks specific details about the film production” to
ascertain whether or not the claimed steps were performed. See RAN 74;
Req. App. Br. 28. Accordingly, Bogue’s Declarations contribute little
weight to either Patent Owner’s contention of enablement or Requester’s
contention of lack of enablement.
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content in the amount of the active varies by no more than 10%” would have
been understood by a skilled artisan to mean a step of determining that the
actual content of active varies by no more than 10% in substantially equal
sized individual dosage units sampled from different locations of a resulting
film.
However, we agree with Requester that Patent Owner has proposed
several different meanings to the phrase “amount of the active varies by no
more than 10%.” For example, Patent Owner at various times argues that
the term “varies by no more than 10%” means +/- 10%, or an actual range of
20% variation, or varying by no more than 10% from any particular amount.
However, these meaning for the phrase are not supported by the ’080 patent,
which is consistent in its meaning as to variation of active content. For
example, the ’080 patent states: “Currently, as required by various world
regulatory authorities, dosage forms may not vary more than 10% in the
amount of active present.” ’080 patent, col. 2, ll. 42-45. The ’080 patent
further states that
a pharmaceutical and/or cosmetic dosage form or film product
having no more than a 10% variance of a pharmaceutical and/or
cosmetic active per unit area. In other words, the uniformity of
the present invention is determined by the presence of no more
than a 10% by weight of pharmaceutical and/or cosmetic
variance throughout the matrix.
Id., col. 15, ll. 34-40 (emphasis added). The ’080 patent further describes
three tests for determining uniformity in a film matrix. None of the
described tests measure uniformity with respect to any particular amount.
Instead each of these tests describes measuring equally sized areas of a
single film with respect to each other. See col. 31, l. 37 to col. 32, l. 39.
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Thus, the ’080 patent considers only the amount of variation between
individual dosage samples per unit area of the film matrix. The ’080 patent
does not support an interpretation of the phrase “amount of the active varies
by no more than 10%” to mean a variation of +/- 10%, or a total variation of
20%, or variation with respect to any particular dosage. Therefore, we are
not persuaded by Patent Owner’s argument that we should interpret the
limitation in a manner that is inconsistent with the interpretation we adopted
above in light of the ’080 Patent.
Accordingly, we affirm the Examiner’s decision not to adopt the
proposed rejection of all the claims under 35 U.S.C. § 112, first and second
paragraphs (pre-AIA).

“rapidly increasing the viscosity of said flowable polymer matrix”
All of the claims on appeal recite a step of “controlling drying . . .
comprising conveying said flowable polymer matrix through a drying
apparatus and evaporating at least a portion of said solvent from said
flowable polymer matrix to form a visco-elastic film, having said active
substantially uniformly distributed throughout, within about the first 4
minutes by rapidly increasing the viscosity of said flowable polymer matrix
upon initiation of drying to maintain said substantially uniform distribution
of said active by locking-in or substantially preventing migration of said
active within said visco-elastic film.”
Requester proposes the rejection of all the claims on appeal under 35
U.S.C. § 112, second paragraph (pre-AIA), because the term “rapidly” is a
term of degree, the scope of which cannot be determine. Req. App. Br. 35-
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37. We disagree with Requester’s reasoning because it ignores the
remaining language recited in the claims.
In particular, the remaining language defines the phrase “rapidly” in
terms of the resulting product film. In other words, the viscosity of the
flowable polymer matrix is rapidly increased during drying if, when solvent
is at least partially evaporated while being conveyed through a drying
apparatus, the active in the resulting film is locked in or substantially
prevented from migrating within the first 4 minutes. According to the
language of the claim, this property is demonstrated by the formation of a
visco-elastic film, having the active substantially uniformly distributed
throughout.
The ’080 patent supports this interpretation of the claim language. In
the ’080 patent, uniformity is characterized with respect to the lack of
agglomeration and migration of active material in any part of the film matrix
during drying. For example, the ’080 patent states that the active material is
“evenly distributed throughout the film,” which is “achieved by . . . the use
of a drying process that reduces aggregation or conglomeration of the
components in the film as it forms into a solid structure.” ’080 patent, col. 1,
ll. 37-47. An objective of the process is “a substantially non-self-
aggregating uniform heterogeneity throughout the area of the films.” Id. at
col. 4, ll. 9-11. The ’080 patent further describes “a substantially reduced
occurrence of, i.e. little or no, aggregation or conglomeration of components
within the film as is normally experienced when films are formed by
conventional drying methods.” Id., col. 6, ll. 27-31; see also col. 12, ll. 47-
49 (“The films are controllably dried to prevent aggregation and migration
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of components.”). Further, the first test described in the ’080 patent was a
visual inspection by “either the naked eye or under slight magnification. By
viewing the films it was apparent that they were substantially free of
aggregation, i.e. the carrier and the actives remained substantially in place
and did not move substantially from one portion of the film to another.” Id.
at col. 31, ll. 37-45. Thus, the objective to maintain the uniformity and
prevent the aggregation or conglomeration of components due to particle
migration within the films during drying provides sufficient information to
one of ordinary skill in the art regarding the term “rapidly” to ascertain the
scope of the claims.
Accordingly, we affirm the Examiner’s decision not to adopt the
proposed rejection of all the claims under 35 U.S.C. § 112, second paragraph
(pre-AIA).

“controlling drying ... to form a visco-elastic film ... wherein during said
drying said flowable polymer matrix temperature is 100 °C or less.”
All of the claims on appeal recite a step of “controlling drying ... to
form a visco-elastic film ... wherein during said drying said flowable
polymer matrix temperature is 100 °C or less.”
Requester proposes the rejection of all the claims on appeal under 35
U.S.C. § 112, second paragraph (pre-AIA), because it is unclear when the
100°C or less temperature limit no longer applies. According to Requester,
the Examiner concluded that the temperature limitation applied to the entire
drying step until the matrix is no longer a flowable polymer matrix, as
determined by its viscosity exceeding the range recited in the previous step.
Req. App. Br. 37-38.
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The Examiner interprets this step such that the film becomes “visco-
elastic” only when the matrix dries to a viscosity outside of the previously
recited viscosity range of “about 400 to about 100,000 cps” for the “flowable
polymer matrix.” See RAN 23. Initially, we disagree with the Examiner’s
interpretation that a visco-elastic film is only formed when a viscosity
outside of the recited “about 400 to about 100,000 cps” is reached. The
viscosity is recited only during the “casting” step. The claims do not require
any particular viscosity during any of the additional steps of the claims.
Further, one of ordinary skill in the art would not find the temperature
recitation unclear. The temperature is recited as “during said drying of said
flowable polymer matrix”. Thus, the temperature is directed to the time
frame during which the flowable polymer matrix is being dried. The
temperature of the matrix during the drying step is independent of
establishing when the drying step is completed and/or when a visco-elastic
film is formed. The phrase merely identifies a parameter for the drying step.
This interpretation is consistent with the ’080 patent which sets 100 °C as a
preferred maximum temperature because “[t]emperatures that approach 100
°C. will generally cause degradation of proteins as well as nucleic acids.”
’080 patent, col. 12, ll. 20-25; col. 27, ll. 53-55. Thus, it would be
detrimental to certain active material for the film to reach temperatures over
100 °C.
To the extent that Requester cannot identify solvents and/or oven
temperatures that are excluded by the language (see RAN 23 (citing
Requester’s Comments of April 12, 2013)), we decline to determine the
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language indefinite on this basis. “[B]readth is not indefiniteness.” In re
Gardner, 427 F.2d 786, 788 (CCPA 1970).
Accordingly, we affirm the Examiner’s decision not to adopt the
proposed rejection of all the claims under 35 U.S.C. § 112, second paragraph
(pre-AIA).

“repeating steps (a) through (e) to form additional resulting films[, which]
varies no more than 10% from the desired amount of said active as indicated
by said analytical chemical tests”
Claims 82 and 315 include an additional step of “repeating steps (a)
through (e) to form additional resulting films, such that uniformity of
content in the amount of said active in said resulting film and said additional
resulting films varies no more than 10% from the desired amount of said
active as indicated by said analytical chemical tests.”
Requester proposes the rejection of claims 82 and 315 and the claims
that depend therefrom under 35 U.S.C. § 112, first and second paragraph
(pre-AIA), because the “[t]he ’080 patent discloses no method involving a
‘repeating’ step and verification of a resulting variation/uniformity.” Req.
App. Br. 34. According to Requester, “[t]here is simply no support in the
’080 patent for a method that achieves one variation percentage within a
resulting film, and a second variation percentage between resulting films.”
Id. We disagree with the Requester’s reasoning and find written description
support and an enabling disclosure in the ’080 patent for reproducibly
producing films.
As discussed above, reproducibility between films can be expected
when identical steps are repeated. See ’080 patent, col. 29, ll. 39-53.
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Accordingly, the language in claim 82 and 315 allows for some variation in
process conditions provided that the uniformity of content “varies no more
than 10% from the desired amount of said active.”
However, Requester further argues that the claim language lacks
clarity because “a variation of up to 20% (± 10% around a target) in active
content [] is a much larger variation than the claims indicate are produced
each individual time the method is carried out (‘varies by no more than 10%,
5%, etc.’).” Req. App. Br. 35. Patent Owner contends that the ’080 patent
supports the concept that a film may not vary by more than 10% from a
particular or “desired” dosage. See PO App. Br. 24-25, 39-40, 49-52. We
agree with the Requester that the claim language “varies by no more than
10% from the desired amount” does not meet the requirements of 35 U.S.C.
§ 112.
Patent Owner gives no evidence or reasons for its contention that the
requirements of the FDA or “various world regulatory authorities,” as
specifically mentioned in the ’080 patent, reference a variation of up to 20%
(± 10% around a “desired amount”) as opposed to a variation between
various dosage forms of no more than 10%, consistent with the remainder of
the ’080 patent. See e.g., PO App. Br. 10-12, 19, and 25; PO Res. Br. 27-28
and 35; PO Reb. Br. 1-4. Contrary to Patent Owner’s contention, the ’080
patent does not expressly characterized uniformity with respect to an FDA
recognized or labeled dosage, even in the paragraph relied upon by the
Patent Owner. The paragraph states that “world regulatory authorities”
require that “dosage forms may not vary more than 10% in the amount of
active present.” ’080 patent, col. 2, ll. 43-45. This sentence of the ’080
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patent can be interpreted to mean that each dosage unit does not vary from
one to another by more than 10%. Only this interpretation is consistent with
the rest of the language of the ’080 patent.
The FDA standards identified by Patent Owner in the portion of the
’080 patent reproduced supra, is not again referenced. In the remaining
parts of the ’080 patent, uniformity is characterized not with respect to a
recognized or labeled dosage, but with respect to the lack of agglomeration
of active material in any part of the film matrix. For example, the ’080
patent states that the active material is “evenly distributed throughout the
film,” which is “achieved by . . . the use of a drying process that reduces
aggregation or conglomeration of the components in the film as it forms into
a solid structure.” ’080 patent, col. 1, ll. 37-47. An objective of the process
is “a substantially non-self-aggregating uniform heterogeneity throughout
the area of the films.” Id. at col. 4, ll. 9-11. The ’080 patent further
describes “a substantially reduced occurrence of, i.e. little or no, aggregation
or conglomeration of components within the film as is normally experienced
when films are formed by conventional drying methods.” Id., col. 6, ll. 27-
31. The process of the ’080 patent provides “uniform distribution of
components for any given area in the film.” Id. at col. 7, ll. 24-26 (emphasis
added).
Requiring a particular film to have an amount of active relative to a
labeled dosage, such as an FDA labeled dosage, or any “desired dosage”
disregards whether or not the active is provided in an agglomerated form.
Rather, such a requirement considers only the total amount of active material
in a dosage sized film. In Patent Owner’s interpretation, a dosage sized film
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may include substantial agglomerations of active material provided that the
total amount of active material in the dosage sized film is within 10% of the
dosage that is labelled.
Further, the ’080 patent describes three tests for determining
uniformity, none of which seek confirmation with respect to any particular
dosage. The first test was a visual inspection by “either the naked eye or
under slight magnification. By viewing the films it was apparent that they
were substantially free of aggregation, i.e. the carrier and the actives
remained substantially in place and did not move substantially from one
portion of the film to another.” Id. at col. 31, ll. 37-43. This first test does
not measure the actual amount active content or compare an actual amount
to any particular “desired” amount.
The second test involved cutting out “dosage forms” “from random
locations throughout the film” and additively weighing the randomly
selected dosage forms. Id. at col. 31, ll. 46-50. Table 2 shows that with
each additional dosage form, the weight increased by exactly 0.04g. Id. at
col. 32, ll. 25-29. The ’080 patent explains that “each component has a
unique density. Therefore, when the components of different densities are
combined in a uniform manner in a film, as in the present invention,
individual dosages forms from the same film of substantially equal
dimensions, will contain the same mass.” Id. at col. 32, ll. 30-34. This
second test also does not measure the actual amount active content within
any particular unit area or compare an actual amount to any particular
“desired” amount.
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The third test involved dissolving “individual doses” and testing for
the amount of active in films of identical size. Id. at col. 32, ll. 35-38. The
’080 patent states that “[t]his demonstrates that films of substantially similar
size cut from different locations on the same film contain substantially the
same amount of active.” Id. at col. 32, ll. 38-40. Although the third test
determines the actual amount of active within a dosage sized film, the third
test does not compare an actual amount to any particular “desired” amount.
Rather, the third test is directed towards comparing the active content at
various locations “on the same film.” Id. at col. 32, ll. 38-39.
We understand that the FDA requires accuracy with respect to dosage
labelling and the amount of active content actually within a product and has
requirements that ensure a degree of accuracy and reproducibility in large
scale pharmaceutical manufacturing. See Lin Decl. ¶12-154 (discussing
“current good manufacturing practice (cGMP) regulations” and citing to 21
C.F.R. §§ 210 and 211 and the FDA Guideline for Submitting
Documentation for the Manufacture and Controls for Drug Products,
February 1987); Bogue Decl. II, ¶¶ 10-15.5 The only substantiated evidence
regarding accepted testing practices for uniformity of dosage units in the art
suggest that the FDA requirement is far more complex and, thus, is
inconsistent with the simple “no more than 10%” language allegedly
required by “world regulatory authorities” in the ’080 patent. See Lin Decl.,
¶ 16 (citing USP General Chapter <905> Uniformity of Dosage Units).

4 Declaration of Dr. David T. Lin, executed March 13, 2013.
5 Declaration of Dr. B. Arlie Bogue, executed August 29, 2013.
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Accordingly, the language “varies by no more than 10% from the
desired amount” is indefinite, and lacks written descriptive and enabling
disclosure in the ’080 patent, because the ’080 patent does not provide any
information as to what is meant by the term “desired amount” and fails to
describe or enable a method with the objective of meeting any particular
amount of active content by no more than 10%. The ’080 patent is entirely
directed to an objective of maintaining uniformity with respect to a lack of
agglomeration of active content for any given area in a film.
On this basis, we enter a new ground of rejection of claims 82-160,
261-271, 274, 276-278, 298, 304-307 and 315 under 35 U.S.C. § 112, first
and second paragraphs (pre-AIA), as being indefinite, lacking written
descriptive support, and lacking an enabling disclosure of a method for
preparing multiple films having “uniformity of content in the amount of said
active in said resulting film and said additional resulting films varies no
more than 10% from the desired amount of said active,” as recited in claims
82 and 315. The remaining claims are rejected as depending from claim 82,
which is unpatentable under 35 U.S.C. § 112, first and second paragraphs
(pre-AIA).

REJECTIONS BASED ON CHEN
All of the claims on appeal stand rejected under 35 U.S.C. § 103(a)
(pre-AIA) as being unpatentable over Chen6 either alone or further in view
of Staab.7

6 WO 00/42992, published July 27, 2000, naming Li-Lan Chen et al. as
inventors.
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Patent Owner contends that Chen fails to disclose the controlling
drying step (step (d) in claim 1), in which a visco-elastic film is formed
“having said active substantially uniformly distributed throughout, within
about the first 4 minutes by rapidly increasing the viscosity of said flowable
polymer matrix upon initiation of drying to maintain said substantially
uniform distribution of said active by locking-in or substantially preventing
migration of said active within said visco[-]elastic film.” PO App. Br. 37;
see PO App. Br. 18. With respect to all of the claims on appeal, Patent
Owner further contends that Chen fails to disclose the recited “performing
chemical analytical test” step (step (f) in claim 1), in which the test indicates
“uniformity of content in the amount of the active varies by no more than
10% and said resulting film is suitable for commercial and regulatory
approval, wherein said regulatory approval is provided by the U.S. Food and
Drug Administration.” Id.
The Examiner found that “Chen controls drying and evaporates water
from the cast matrix in 9 minutes of drying in a hot air circulating oven at
50°C (see p. 17, lines 13-15 and Fig. 2).” RAN 34. The Examiner found
that Chen’s matrix has the same viscosity range and uses the same
hydrocolloid (HPMC) and water ratio. Id. Further, the Examiner finds that
Chen is dried at the same temperature range for the same amount of time as
in the ’080 patent. Id. We note that the example in Chen of drying for only
9 minutes (Chen, p. 17, ll. 13-15) is consistent with the description in the
’080 patent of “the drying of the film will occur within about ten minutes or
fewer, or more desirably within about five minutes or fewer.” ’080 patent,

7 US 5,393,528, issued February 28, 1995, to Staab.
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col. 7, ll. 30-32, col. 13, ll. 23-35 (“the films of the present invention
desirably are dried for 10 minutes or less”), col. 43, ll. 23-24; see RAN 97.
Accordingly, the Examiner finds that the claimed uniformity, the
locking in and lack of substantial migration, and the claimed percent
variation of the amount of active are inherent in Chen’s films based on the
evidence that Chen uses the same criteria exemplified in the ’080 patent for
evaluating uniformity, namely weighting unit dosage of equal size. RAN
36. The Examiner acknowledges that Chen does not describe a step of
performing “analytical chemical tests,” but determines that “it would have
been obvious to one of ordinary skill in the art at the time the invention was
made to have performed known analytical chemical tests on Chen’s dosages
so as to determine the actual amount of active in the dosages and thus, assure
active content uniformity.” RAN 38.
According to Patent Owner, although Chen’s Example 7 teaches a
process with conditions identical to those claimed and disclosed in the ’080
patent, and confirmation of uniformity by weight measurements, Patent
Owner argues that “there is no disclosure at all in Chen of the ‘locking-in’
element within the first 4 minutes necessary to achieve the recited desired
degree of uniformity of content of pharmaceutical active as verified by the
only methods capable of actually ascertaining the amount of active present -
analytical chemical testing.” PO App. Br. 37; see also PO App. Br. 17-19.
Initially, we are not persuaded that the ’080 patent supports that the
uniformity of content of a pharmaceutical active can only be verified by
analytical chemical testing. Such a position is contrary to the teachings of
the ’080 patent, which expressly identifies weight testing and analytical
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chemical testing as equivalent methods for establishing uniformity. ’080
patent, col. 29, ll. 35-39 (“Any conventional means for examining and
testing the film pieces may be employed, such as, for example, visual
inspection, use of analytical equipment, and any other suitable means known
to those skilled in the art.”).
The ’080 patent describes three specific tests for determining
uniformity – a test by visual inspect, a test by additive weighing, and a test
by dissolution. Id. at col. 31, l. 37 to col. 32, l. 39.
Although the third test determines the actual amount of active within a
particular sized film, the claims do not require any particular amount of
active – only that the active material present be uniformly distributed within
the film. As discussed above, the term “uniform” in the claims is not
directed to uniformity with respect to a particular dosage, as proposed by
Patent Owner, but rather non-agglomerated and evenly dispersed active
content for any area of a given film. Thus, the additive weight test described
in the ’080 patent, which is substantially identical to the additive weight test
described for Example 7 of Chen, is sufficient evidence that the film product
of Chen inherently has the recited uniformity of active material to meet the
requirements of the claims.
According to Patent Owner, the only way to have achieved
“uniformity” as identified in the ’080 patent, is to have “locked in” the
uniformity within the first 4 minutes of the drying process. PO App. Br. 37-
38. Patent Owner has not explained how the Chen process achieves the
recited uniformity as demonstrated by additive weight results that are
consistent with those described in the ’080 patent yet would not achieve the
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step of “locking-in” the active within the first 4 minutes of drying. In light
of the additive weight analysis described in Chen, we are not persuaded that
the locking in feature is not inherently met by the otherwise uniform product
of Chen.
We agree with the Examiner that there is sufficient evidence to find
that Chen inherently discloses a film with a uniform content of therapeutic
active composition per unit of film. Accordingly, Chen’s substantially
identical process includes locking in the uniformity at 4 minutes, based on
the substantially identical results with respect to uniformity.
Patent Owner further argues that Figure 5 of Chen demonstrates that
“in 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 39. Initially, Patent Owner’s arguments with respect to Figure 5
are exclusively related to release of an amount of active being more than
110% of “the expected/desired amount of pharmaceutical active for that
drug.” Id. However, as discussed in detail above, the claims do not require
any particular amount or any “expect/desired” amount of active material.
Accordingly, we do not find Patent Owner’s arguments, including those
regarding the release data over time in Figure 5 of Chen, to be compelling of
a lack of uniformity.
Moreover, Figure 5 does not suggest agglomerated or unevenly
dispersed active content for any area of a given film. Figure 5 merely
indicates that different amounts of active material releases from the Chen
films at various times for films of Examples 5-8, which is not shown to be
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37

an indicator that the active material is not uniformly distributed. See Chen,
p. 16, ll. 27-29.
We agree with the Examiner that the step of performing analytical
tests for uniformity of content would have been obvious to the skilled artisan
based on the Patent Owner’s own admissions in the ’080 patent that the FDA
required testing that determines actual amounts of materials in random
samples (col. 2, ll. 42-46) and that dissolution tests are an example of
“conventional means for examining and testing the film pieces” for
uniformity (col. 29, ll. 33-39). Moreover, the Bogue Declaration I,8 which
describes testing of millions of samples of a particular drug containing film
manufactured using a particular undisclosed process that allegedly falls
within the scope of at least claim 1 (see ¶¶ 4 and 6), is evidence that such
testing is routine in the art. See ¶ 7 (“samples were analyzed by a validated
method, in compliance with FDA guidelines and regulations regarding
same.”).
In a case such as this where patentability rests upon a property of the
claimed material not disclosed within the art, the PTO has no reasonable
method of determining whether there is, in fact, a patentable difference
between the prior art materials and the claimed material. Therefore, where
the claimed and prior art products are identical or substantially identical, or
are produced by identical or substantially identical processes, the PTO can
require an applicant to prove that the prior art products do not necessarily
possess the characteristics of his claimed product. In re Spada, 911 F.2d
705, 708 (Fed. Cir. 1990); In re Best, 562 F.2d 1252, 1255 (CCPA 1977).

8 Declaration of Dr. B. Arlie Bogue, executed March 13, 2013.
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However, the initial burden of presenting a case of unpatentability remains
with the Requester and Examiner. If that burden is met, only then does the
burden of coming forward with evidence or argument shift to the Patent
Owner. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
The evidence does not support Patent Owner’s contention that the
processes disclosed in Chen and in the ’080 patent are distinguishable. The
’080 patent describes its drying process generally and does not clearly
identify how a drying step can vary from a conventional drying process to
lock in uniformity in the first 4 minutes. For example, the ’080 patent states
that agglomerations form from “conventional drying methods such as a
high-temperature air-bath using a drying oven, drying tunnel, vacuum drier,
or other such drying equipment.” Col. 6, ll. 24-33. However, the
description of non-agglomerating drying methods in the ’080 patent does not
clearly distinguish such drying equipment. See col. 14, ll. 20-21 (“the
inventive process is not limited to any particular apparatus for the above-
described desirable drying.”). The ’080 patent is not limited to any
particular drying methods but rather includes a variety of drying methods.
Id. col. 6, ll. 52-60; col. 7, ll. 1-22; col. 27, ll. 26-27 (“When a controlled or
rapid drying process is desired, this may be through a variety of methods.”).
The only process clearly distinguished by the ’080 patent is “uncontrolled air
currents, either above or below the film” which “can create non-uniformity
in the final film product.” Id., col. 7, ll. 17-19; see also col. 6, ll. 49-52; col.
12, ll. 47-57 (“The films are controllably dried to prevent aggregation and
migration of components, as well as preventing heat build up within.”); col.
10, l. 50-63; col. 13, ll. 6-7; col. 27, ll. 13-19. The ’080 patent does not
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with minimal deviation as evidence that substantially uniform content of
therapeutic active is inherent in the films described by Chen. RAN 35 and
71; see Chen p. 20, Table 4. The measured weight per dosage film as
described in Chen is consistent with the additive weight test described in the
’080 patent for determining uniformity. Specifically, the ’080 patent states:
“when the components of different densities are combined in a uniform
manner in a film, as in the present invention, individual dosages forms from
the same film of substantially equal dimensions, will contain the same
mass.” ’080 patent, col. 32, ll. 30-33. A weight deviation of ± 0.001 is well
within a 10% variation per film unit requirement of the claims. Patent
Owner does not persuasively show a distinction between the additive weight
test of the ’080 patent and the consistent weight measurements of Chen.
Accordingly, the Examiner’s finding of inherency based on the
processes of Chen and the ’080 patent being “substantially identical” is
supported by the evidence of record, as well as the Examiner’s finding that
Chen teaches films with consistent weight per unit film. Accordingly, the
burden was properly shifted to Patent Owner to demonstrate that the process
of Chen does not, in fact, teach a film having a substantially uniform content
of therapeutic active composition per unit of film by chemical analytical
testing. Patent Owner did not meet this burden.

Secondary Considerations of Non-obviousness
Patent Owner argues that the FDA approval of and commercial
success of Patent Owner’s manufacture of Suboxone sublingual unit dosage
film product for Reckitt Benckiser Pharmaceuticals Inc. PO App. Br. 28 and
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32-33. Patent Owner presents evidence of FDA approval of Reckitt
Benckiser’s Suboxone film product. See Bogue Decl. II, ¶¶ 5-7.
Commercial success or other secondary considerations may
presumptively be attributed to the claimed invention only where “the
marketed product embodies the claimed features, and is coextensive with
them.” Ormco Corp. v. Align Tech. Inc., 463 F.3d 1299, 1311-12 (Fed. Cir.
2006) (quoting Brown & Williamson Tobacco Corp. v. Phillip Morris, Inc.,
229 F.3d 1120, 1130 (Fed. Cir. 2000)).
An affidavit fails if it recites conclusions without reciting the
underlying facts to support those conclusions. See, e.g., In re Thompson,
545 F.2d 1290, 1295 (CCPA 1976) (affidavit related to secondary
consideration of nonobviousness, notably copying, “sets forth no specifics
and falls far short of constituting probative evidence.”); In re Am. Acad. of
Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is
entitled to weigh the declarations and conclude that the lack of factual
corroboration warrants discounting the opinions expressed in the
declarations.”).
While Patent Owner provide some evidence of commercial success of
the Suboxone product (see PO App. Br. 33, n. 4 (citing Exhibits 5&6 to
Patent Owner’s Response to the Action Closing Prosecution), Patent Owner
fail to show actual sales data for the product, calculating only proposed sales
numbers from known market share and total market sales for the Suboxone
product. Further, Patent Owner directly attributes the commercial success of
the Suboxone product to the “processes which achieve the uniformity of
content as claimed, [and without which] these products would not have been
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approved by the FDA, and no sales would be possible.” Id. However, the
commercial success of the Suboxone product could just as likely be directly
attributable to the fact that it was the only product with FDA approval, and
thus was the only product on the U.S. market for Suboxone, the tablet form
having been discontinued. See Req. Res. Br. 13 (citing Exhibit 5 to Patent
Owner’s Response to the Action Closing Prosecution). Finally, Patent
Owner has not presented sufficient evidence to evaluate whether the
commercial product embodies all the claimed features of the invention.
Ormco, 463 F.3d at 1311-12. In particular, we decline to assign any
significant weight to Dr. Bogue’s unsupported testimony that “[e]ach of the
73 lots of resulting films (Lots 1-73) containing approximately 2,000,000
individual dosage units per lot discussed herein were manufactured . . . in
accordance with the invention disclosed in the ’080 Patent, and as claimed
by the ’080 Patent both as issued and as amended in the Patentee’s Reply to
the Office Action, by: [steps (a)-(e) as recited in claim 1].” See Bogue Decl.
I, ¶ 4. Patent Owner provided no corroborating evidence of the
manufacturing process by which to evaluate if the recited steps of the
claimed invention were in fact used to manufacture all 73 lots of the
Suboxone product.
Considering the evidence as a whole, we affirm the Examiner’s
rejection of all the claims on appeal under 35 U.S.C. § 103(a) (pre-AIA) as
unpatentable over Chen alone or further in view of Staab.

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REMAINING REJECTIONS ON APPEAL
In affirming the rejection of all the claims on appeal on other grounds,
it is unnecessary to address the additional rejections maintained by the
Examiner based on other references. See In re Gleave, 560 F.3d 1331, 1338
(Fed. Cir. 2009) (holding that obviousness rejections need not be reached
upon affirming a rejection of all claims as anticipated); cf. Beloit Corp. v.
Valmet Oy, 742 F.2d 1421, 1423 (Fed. Cir. 1984) (having decided a single
dispositive issue, the ITC was not required to review other matters decided
by the presiding officer).

SUMMARY
For the reasons discussed above, we affirm the Examiner’s rejections
of (pre-AIA):
1. Claims 318 under 35 U.S.C. § 112, first and second paragraphs;
2. Claims 1-11, 13-15, 17-71, 82-90, 92-94, 96-150, 161-172, 174-
176, 178-232, 243-253, 256, 258-271, 274, 276-289, 292 and 294-
318 under 35 U.S.C. § 103(a) as obvious over Chen;
3. Claims 2, 3, 32, 55, 72-81, 111, 134, 151-160, 193, 216 and 233-
242 under 35 U.S.C. § 103(a) as being unpatentable over Chen and
Staab.
We enter new grounds of rejection of claims 82-160, 261-271, 274,
276-278, 298, 304-307 and 315 under 35 U.S.C. § 112, first and second
paragraphs (pre-AIA). Since we affirm rejections of each claim on appeal,
we decline to address the merits of additional grounds of rejection
maintained by the Examiner and appealed by the Patent Owner.
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NEW GROUND OF REJECTION
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.77(b) which provides that “[a]ny decision which includes a new ground
of rejection pursuant to this paragraph shall not be considered final for
judicial review.” Correspondingly, no portion of the decision is final for
purposes of judicial review. A requester may also request rehearing under
37 C.F.R. § 41.79, if appropriate, however, the Board may elect to defer
issuing any decision on such request for rehearing until such time that a final
decision on appeal has been issued by the Board.
For further guidance on new grounds of rejection, see 37 C.F.R.
§ 41.77(b)-(g). The decision may become final after it has returned to the
Board. 37 C.F.R. § 41.77(f).
37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN
ONE MONTH FROM THE DATE OF THE DECISION, must exercise one
of the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. The owner may file a response requesting
reopening of prosecution before the examiner. Such a response must be
either an amendment of the claims so rejected or new evidence relating to
the claims so rejected, or both.
(2) Request rehearing. The owner may request that the proceeding be
reheard under § 41.79 by the Board upon the same record. …
Any request to reopen prosecution before the examiner under 37
C.F.R. § 41.77(b)(1) shall be limited in scope to the “claims so rejected.”
Accordingly, a request to reopen prosecution is limited to issues raised by
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the new ground(s) of rejection entered by the Board. A request to reopen
prosecution that includes issues other than those raised by the new ground(s)
is unlikely to be granted. Furthermore, should the patent owner seek to
substitute claims, there is a presumption that only one substitute claim would
be needed to replace a cancelled claim.
A requester may file comments in reply to a patent owner response.
37 C.F.R. § 41.77(c). Requester comments under 37 C.F.R. § 41.77(c) shall
be limited in scope to the issues raised by the Board's opinion reflecting its
decision to reject the claims and the patent owner's response under
paragraph 37 C.F.R. § 41.77(b)(1). A newly proposed rejection is not
permitted as a matter of right. A newly proposed rejection may be
appropriate if it is presented to address an amendment and/or new evidence
properly submitted by the patent owner, and is presented with a brief
explanation as to why the newly proposed rejection is now necessary and
why it could not have been presented earlier.
Compliance with the page limits pursuant to 37 C.F.R. § 1.943(b), for
all patent owner responses and requester comments, is required.
The examiner, after the Board's entry of a patent owner response and
requester comments, will issue a determination under 37 C.F.R. § 41.77(d)
as to whether the Board's rejection is maintained or has been overcome. The
proceeding will then be returned to the Board together with any comments
and reply submitted by the owner and/or requester under 37 C.F.R.
§ 41.77(e) for reconsideration and issuance of a new decision by the Board
as provided by 37 C.F.R. § 41.77(f).

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AFFIRMED; NEW GROUNDS OF REJECTION UNDER 41.77(b)

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

THIRD-PARTY REQUESTER:

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