Ex Parte 7897080 et al

Patent Trials and Appeals Board

Mar 27, 2015

95002170 - (S) (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.
95/002,170 09/10/2012 7897080 117744-00023 6418
23869 7590 01/31/2017
Hoffmann & Baron LLP
6900 Jericho Turnpike
Syosset, NY 11791
EXAMINER
DIAMOND, ALAN D
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
01/31/2017 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
____________

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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 UNDER 37 C.F.R. § 41.77(f)

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This is a decision under 37 C.F.R. § 41.77(f) addressing the request to
reopen prosecution under 37 C.F.R. § 41.77(b)(1), filed December 9, 2015
(“Request”) by Patent Owner, Monosol Rx, LLC (“Patent Owner”),
Comments filed under 37 C.F.R. § 41.77(c) on December 23, 2015
(“Comments”) by Third Party Requester, BioDelivery Sciences
International, Inc. (“Requester”), and the Examiner’s Determination under
37 C.F.R. § 41.77(d) mailed July 7, 2016 (“Determination”).
In a Decision on Appeal entered March 27, 2015 (“Decision”), the
Board affirmed the Examiner’s rejection of all the claims on appeal,
including the rejections of claims 82 and 315 and the claims that depend
therefrom, under 35 U.S.C. § 103(a) as unpatentable over Chen, either alone
or further in view of Staab. Decision 43. The Board further affirmed the
rejection of claim 318 under 35 U.S.C. § 112, first and second paragraphs.
Id. The Board further entered 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) pursuant to our authority under 37 C.F.R.
§ 41.77(b). Decision 27–32, 43.
In particular, the new ground of rejection was entered because the
language of claims 82 and 315 that recites “varies by no more than 10%
from the desired amount” is indefinite and lacks written descriptive and
enabling support in the ’080 patent. Decision 32. The remaining claims
were rejected only because of their dependency on claim 82.
In its Request, Patent Owner submitted an amendment to claims 82
and 315 and canceled claims 93 and 304–307. Request 62. Patent Owner
further submitted new evidence in the form of a Declaration of Dr. Garry L.
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Myers (“Myers Decl.”) and a Declaration of Dr. David T. Lin (“Lin Decl.”).
Request 66.
In the Comments, Requester asserts that Patent Owner’s amendment
and evidence do not overcome the new ground of rejection under 35 U.S.C.
§ 112 set forth in the Decision. Comments 2. Requester’s Comments
include new evidence in the form of a Declaration of Dr. Jason O. Clevenger
(“Clevenger Decl.”).
The proceeding has been returned to the Board under 37 C.F.R.
§ 41.77(f) for a new decision. Our new Decision is deemed to incorporate
the earlier Decision, except for those portions specifically withdrawn herein,
if any. 37 C.F.R. § 41.77(f).
Patent Owner amends claims 82 and 315 in three primary ways.
1. The preamble of the claims recite that the process is for
manufacturing both “resulting films” and “individual dosage units of
substantially uniform surface area and thickness cut from said
resulting films, said individual dosage units containing an amount of
active varying no more than 10% from a dosage amount of said active
for said individual dosage units as required by the U.S. Food and Drug
Administration (FDA) for said active.” Request 76-81.
2. A step is added of “cutting from said resulting film individual dosage
units of substantially equal areas and of substantially equal
thicknesses, said individual dosage units containing a dosage amount
of said active, wherein the dosage amount of said active is from 1
microgram up to 150 [or 300] milligrams.” Id.
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3. The step of “performing analytical chemical tests” was amended from
the testing the “uniformity of content of said active” to testing “to
determine the amount of said active in said individual dosage units”
and that “said tests indicating that the amount of said active in said
sampled individual dosage units varies by no more than 10% from
said dosage amount of said active for said individual dosage units as
required by the FDA for said active.” Id.
In other words, the claims are amended to assert a particular amount of
active in “individual dosage units,” “substantially equal sized samples” and
“sampled individual dosage units” in addition to the uniformity of active in a
resulting film. Thus, the “amount of active” varies by no more than 10%
between samples and/or individual dosage units and varies by no more than
10% from “a dosage amount of said active for said individual dosage units
as required by the FDA for said active.”
Patent Owner asserts that these amendments render the claims definite
and enabled and have proper written descriptive support. Request 68. The
Requester and the Examiner disagree. See generally Comments and
Determination, respectively.

Indefiniteness
The test for definiteness is whether one skilled in the art would
understand the bounds of the claim when read in light of the
specification. If the claims read in light of the specification
reasonably apprise those skilled in the art of the scope of the
invention, § 112 demands no more.
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Miles Lab., Inc. v. Shandon, Inc., 997 F.2d 870, 875 (Fed. Cir. 1993)
(citation omitted); see also In re Moore, 439 F.2d 1232, 1235 (CCPA 1971)
(the indefiniteness inquiry asks whether the claims “circumscribe a
particular area with a reasonable degree of precision and particularity. It is
here where the definiteness of the language employed must be analyzed––
not in a vacuum, but always in light of the teachings of the prior art and of
the particular application disclosure as it would be interpreted by one
possessing the ordinary level of skill in the pertinent art.”).
Patent Owner contends that the new term “dosage amount” “indicates
the amount of drug active intended to be in an individual dosage unit.”
Request 66. Patent Owner also contends that “the claims clearly refer to
tests to determine the amount of active in individual dosage units.” Id. at 67.
Patent Owner asserts that the “dosage amount” is equivalent to a “labeled
amount” or “target amount,” which is “the amount of drug active the FDA
requires drug manufacturers to show on the drug packaging or on inserts in
the packaging for each individual dosage unit.” Id. 83–84; see also id. at
86–87.
The Examiner determined that the amendments to claims 82 and 315
remain unpatentable under 35 U.S.C. § 112, second paragraph, as being
indefinite based on the reasoning set forth in our Decision. Determination
8–10. The Examiner found persuasive the Requester’s assertion that
throughout the reexamination Patent Owner has conflated the term “desired
amount” and “dosage amount.” Id. 8–9. Thus, amending claims 82 and 315
so that instead of the language “varies by no more than 10% from the
desired amount,” the claims now recite “varies by no more than 10% from
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said dosage amount” is a distinction without a difference. Request 79, 81
(emphasis added).
Factually, we agree with the Examiner and Requester that the Patent
Owner has used the phrases “desired amount,” “target amount,” “labeled
amount,” and “dosage amount,” interchangeably throughout this
reexamination. See Comments 6–7; Determination 9; see also Patent Owner
Appeal Brief 39–40 (referring to the “desired/label amount”); Second Bogue
Declaration, dated March 13, 2013, ¶ 10 (referring to “a ‘target’ or ‘desired’
amount” as a “Label Claim”); Request 59 (referring to “the FDA labeled
dosage amount”), 67 (“the intended or target dosage amount appearing on
the drug ‘label’.”). Thus, the use of “dosage amount” over the term “desired
amount” is a distinction without a clearly identified difference.
Yet, the use of the phrase “dosage amount” alone is not dispositive for
a determination of indefiniteness. The language of claim 82 addressed in the
Decision stated 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.” Thus, the indefiniteness determination was
based on characterizing “uniformity of content” in terms of an FDA
recognized desired amount. The Decision reasoned that the ’080 patent had
not expressly characterized uniformity with respect to an FDA recognized or
labeled dosage. Decision 28.
We agree with the Patent Owner that the claims as amended overcome
the specific problem of characterizing uniformity in terms of an FDA
recognized desired or dosage amount. In the claims as amended, reference
to the “amount of active varying no more than 10% from a dosage amount of
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said active for said individual dosage units” is as a separate requirement of
the claims that is divorced from the further requirement of uniformity of
active of the resulting films. In other words, the claims no longer
characterize uniformity in terms of a “desired amount” or a “dosage
amount.” Thus, the reasons the Examiner and Requester rely on for
maintaining the indefiniteness rejection are not sound solely on the basis that
the amendments substituted “dosage amount” for “desired amount.”
The Decision did not indicate that a FDA recognized “desired,”
“dosage” or “target” amount would not have been understood and
recognized by the skilled artisan. To the contrary, the Decision stated that
“[w]e 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 degree of accuracy and reproducibility in large
scale pharmaceutical manufacturing.” Decision 31. Thus, we agree with
Patent Owner that the skilled artisan would have understood what a “dosage
amount of said active for said individual dosage units as required by the
FDA for said active” means.
The Examiner also determined that the recitation of actual dosage
amounts of “1 microgram to 150 milligrams” in claim 82 and “1 microgram
to 300 milligrams” in claim 315 and the recitation of “as required by the
FDA for said active” in claims 82 and 315 do not provide definiteness
because the Decision stated that the ’080 patent does not expressly
characterize uniformity with respect to an FDA recognized or labeled
dosage. Determination 9 (quoting Decision 28).
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Although the claims only limit the dosage amount of said active in an
individual dosage unit, to “from 1 microgram to 150 [or 300] milligrams,”
which allows for the actual dosage amount in an individual dosage unit to
vary based on the size and thickness of the individual dosage unit cut from
the film, we decline to determine the language indefinite on this basis.
Rather, the limitations only illustrate the breadth of the claims, and
“[b]readth is not indefiniteness.” In re Gardner, 427 F.2d 786, 788 (CCPA
1970).
Requester further contends that the phrases “substantially uniform
surface area and thickness,” “substantially equal areas” and “substantially
equal thicknesses” are not clearly defined terms. Comments 19–22.
Requester argues that it is unclear the amount of variation in thickness or
area would fall within the term “substantially” and the ’080 patent does not
explain qualifying or quantifying film thicknesses or specifically a step of
cutting the film to any particular thickness. Id. at 20–21.
Words of degree, such as “substantially,” can be definite where the
specification provides a general guideline and examples sufficient to enable
a person of ordinary skill in the art to determine whether something is within
the scope of the claim. Seattle Box Co. v. Indus. Crating & Packing, Inc.,
731 F.2d 818, 826 (Fed. Cir. 1984) (holding that “[w]hen a word of degree is
used the district court must determine whether the patent’s specification
provides some standard for measuring that degree.”); Amgen, Inc. v. Chugai
Pharm. Co., Ltd., 927 F.2d 1200, 1218 (Fed. Cir. 1991) (holding that the
term “at least about” was indefinite because the patent provided no guidance
as to where the line should be drawn between the numerical value of the
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prior art cited in the prosecution history and the close numerical value in the
patent); see also Verve, LLC v. Crane Cams, Inc., 311 F.3d 1116, 1119–20
(Fed. Cir. 2002) (recognizing that guidance as to measurement of a term of
degree can come from the intrinsic record or from the knowledge of a person
of ordinary skill in the art).
We disagree that these terms are indefinite. The ’080 patent states
that “[f]urthermore, the films of the present invention have a substantially
uniform thickness, which is also not provided by the use of conventional
drying methods used for drying water-based polymer systems.” ’080 patent,
col. 6, ll. 40–45. The ’080 patent further explains how to achieve a desired
thickness by “reverse roll coating” (id., col. 7, ll. 53–55) and in describing:
Monitoring and control of the thickness of the film also
contributes to the production of a uniform film by providing a
film of uniform thickness. The thickness of the film may be
monitored with gauges such as Beta Gauges. A gauge may be
coupled to another gauge at the end of the drying apparatus, i.e.
drying oven or tunnel, to communicate through feedback loops
to control and adjust the opening in the coating apparatus,
resulting in control of uniform film thickness.
’080 patent, col. 14, ll. 46–54. Further, the ’080 patent states that
when the films are cut into individual dosage forms, the amount
of the active in the dosage form can be known with a great deal
of accuracy. This is achieved because the amount of the active in
a given area is substantially identical to the amount of active in
an area of the same dimensions in another part of the film.
Id., col. 19, ll. 34–39. The patent further describes that the additive weight
test discussed on page 30 of the Decision is based on the principle that
“individual dosages forms from the same film of substantially equal
dimensions, will contain the same mass.” Id., col. 32, ll. 32–33.
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Thus, the ’080 patent, as well as the claim language itself, makes clear
that the uniformity and consistent dosage amount is a function of the
thickness and size of the film when cut into individual samples or dosage
units. Even if the content active is dispersed uniformly in a film, the
additive weight test will not be capable of demonstrating such uniformity
unless the samples weighed are of substantially equal thickness and size.
Similarly, the actual amount of active within various samples will not be
consistent if the sample sizes are substantially different. Thus, an acceptable
degree of deviation from uniformity and amount of active within a sample or
individual dosage unit, consistent with the language of the claims, may be a
function of some allowable degree of aggregation or by slight variations in
size or thickness of the sample. Thus, the skilled artisan would have
understood the acceptable degrees of variation in size and thickness as a
function of overall variations in uniformity and amount of content active, as
recited in the claims. i.e., such that the amount of active in the samples
varies by no more than 10%.
Requester also argues that the amended claims are indefinite because
the claims separately recite “substantially equal sized samples” or “sampled
individual dosage units” and “individual dosage units of substantially
uniform surface area and thickness” and the difference between the two are
unclear. Comments 22. We disagree with the Requester.
The language of the claim recites “individual dosage units of
substantially uniform surface area and thickness cut from said resulting
films” and “individual dosage units sampled from different locations of said
resulting film.” Thus, the language is clear that “sampled individual dosage
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units” are cuts of substantially uniform surface area and thickness that are
pulled from different locations of said film, as opposed to individual dosage
units that are cut, for example, adjacent one another, and thus in the same
general location, within a resulting film. Requester has provided no
explanation as to why this would have been unclear to the skilled artisan.
All of Requester’s arguments regarding lack of clarity were
considered and not found to be persuasive. Accordingly, Patent Owner’s
amendments to claims 82 and 315 overcome the rejection under 35 U.S.C. §
112, second paragraph, as being indefinite, and said rejection is hereby
withdrawn.

Lack of Written Description
The Examiner determined that the amendments to claims 82 and 315
remain unpatentable under 35 U.S.C. § 112, first paragraph, for lack of
written descriptive support based on the reasoning set forth in our Decision.
Determination 10. We agree with the Examiner, and maintain the rejections
under 35 U.S.C. § 112, first paragraph, set forth in our Decision. See
Decision 27–32.
The test for written description is that it “must clearly allow
persons of ordinary skill in the art to recognize that [the inventor]
invented what is claimed.” The disclosure must “convey[] to
those skilled in the art that the inventor had possession of the
claimed subject matter as of the filing date.”
Q.I. Press Controls, B.V. v. Lee, 752 F.3d 1371, 1380 (Fed. Cir. 2014)
(alterations in original) (citations omitted) (quoting Ariad Pharm., Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)). As discussed in the
Decision (Decision 28–32), the portions of the ’080 patent relied upon by the
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Patent Owner are insufficient to show that Patent Owner was in possession
of the invention now claimed.
We are not persuaded that reference to the requirements of the FDA or
“various world regulatory authorities,” in the ’080 patent, provides for
sufficient written description for a variation of up to 20% (± 10% around a
“desired amount” or a “dosage 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., Request 83. Contrary to Patent Owner’s
contention, the ’080 patent is directed to the lack of agglomeration of active
material in any part of the film matrix. Patent Owner has not persuasively
shown that the ’080 patent is also directed to maintaining an amount of
materials within ±10% of an FDA recognized or labeled dosage, to the
extent the amount of variation is greater than the amount of variation (10%
variation between individual dosage samples per unit area of a film matrix)
described in the remainder of the ’080 patent as uniformity of active content
in a film.
The first paragraph relied upon by Patent Owner (Request 64) as
supporting the language of the amended claims states that “various 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. As
stated in our Decision “[t]his sentence of the ’080 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.” Decision 28–29.
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We decline to deviate from the reasoning discussed in detail in the
Decision, despite the change in language focusing on the amount of active in
each individual dosage unit. We find insufficient evidence that the skilled
artisan would have understood the phrase “dosage forms may not vary more
than 10% in the amount of active present” in the ’080 patent as describing
steps of measuring the amount of active within an individual dosage form
and comparing it to an FDA recognized dosage in light of the remainder of
the ’080 patent and the lack of supported evidence that such a requirement
by the FDA exists.
Patent Owner further relies on the testimony of Dr. Lin and Dr.
Myers1 submitted with the Patent Owner’s Request. Request 93–96 (citing
Myers Decl. ¶¶ 10, 12–16; Lin Decl. ¶¶ 13–14.)
Dr. Myers testifies that
It is common knowledge that Pharmaceutical products fall under
the purview of the FDA and thus must meet the requirements of
the FDA in order to be “suitable for commercialization and
regulatory approval.” If too little of the active is contained in the
individual dosage unit, then the intended therapeutic effect will
not be realized. If too much of the active is present in the
individual dosage unit, then the patient is at risk for adverse
effects and potential death. Hence, the FDA's stringent
requirement relating to how much the amount of active in the
individual dosage units may vary from the dosage amount and
still be acceptable. Patients must be able to rely on individual
dosage units containing an accurate amount of drug, as labeled

1 As pointed out by the Requester (Comments 12), Dr. Myers is an inventor
of the ’080 patent and cannot be considered an uninterested and entirely
objective declarant. We weigh the probative value of Dr. Myers’ testimony
accordingly.
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and with the variation allowed by the FDA, i..e. [sic] no more
than 10% from the labeled dosage amount for that active.
Myers Decl. ¶ 12. Dr. Myers also states that “[t]hese individual dosage units
must contain, within safe limits, the amount of drug active, i.e., the dosage
amount of the drug active for the particular individual unit dose. The FDA
sets this requirement, among others.” Id. ¶ 15 (emphasis added).
Dr. Lin testifies that, in 1993, “the FDA’s standard practice was to
accept, in drug applications in connection with the manufacture of individual
dosage units, a range in the amount of drug active of +/- 10% from the
labeled dosage amount of active.” Lin ¶ 15. Dr. Lin testifies that this is the
range he personally used “in recommending approval of [New Drug
Applications (NDA)] since at least as early as 1997.” Id. Dr. Lin testifies
that “this standard range was not formally published at the time of the filing
of the ’080 Patent.” Id. ¶ 16. As supporting evidence, Dr. Lin cites to a
2010 FDA Advisory Committee transcript and 2009 information relating to
levothyroxine sodium as stating that “the NDA or ANDA specifications
typically mirror the USP monographs, which call for a 90 to 110 percent
strength or label claim” and, specifically to levothyroxine sodium as “an
exception to this standard.” Lin Decl. 7 n.4, 8 n.5, ¶¶ 18–20.
The testimony of Dr. Myers lacks underlying evidentiary support and
is conclusory. Although Dr. Lin’s testimony is allegedly based on his
personal experience, Dr. Lin’s testimony is not sufficient to show by a
preponderance of evidence that, at the time of the invention, the language in
the ’080 patent that “various 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) would have conveyed to the skilled artisan
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that Patent Owner had possession of an invention in which the amount of
active in a dosage form may not vary by more than 10% from an amount
recognized by the FDA as a dosage or labelled amount. As pointed out by
the Requester (Comments 10–11), Dr. Lin does not present contemporary
supporting evidence that the skilled artisan would have understood that the
FDA required a dosage amount within a 20% range around a labeled dosage
amount.2 To the contrary, Dr. Lin admits that such a standard was “not

2 U.S. Application 12/614,928, which became the ’080 patent was filed
November 9, 2009, but claims priority to provisional applications filed as
early as October 12, 2001. ’080 patent, Related U.S. Application Data. To
show written descriptive support as of the earliest filing date, the evidence
should demonstrate what the skilled artisan would have understood as of
October 2001. The FDA Advisory Committee Meeting Transcript
(Appendix 3) and the Levothyroxine Official Bulletin (Appendix 4) from
2010, the FDA Questions and Answers on Levothyroxine Sodium Products
document (dated October 3, 2007, “Page Last Updated” August 27, 2013,
and printed August 16, 2015)(Appendix 5), and 21 C.F.R. § 31.450 (as of
April 1, 2011)(Appendix 1) are not contemporary with the earliest filing
date. The “Guidance for Industry: Q6A Specifications: Test Procedures and
Acceptance Criteria for New Drug Substances and New Drug Products,”
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucml34966.htm (downloaded August 16, 2015) (Appendix 2),
which appears to be 65 Fed. Reg. 83041 (December 29, 2000), is contemporary
with the earliest filing date, but is insufficient to show that the skilled artisan
would have understood the FDA (or any regulating authority) had a known
practice of finding an acceptable variation of ±10% from a dosage amount, as
this document evinces no such practice. See 65 Fed. Reg. 83041, 83047-8
(Sections 3.3.2.1(d) (Uniformity of dosage units for tablets and capsules) and
3.3.2.2(a) (Uniformity of dosage units for oral liquids)(“The dosage unit is
considered to be the typical dose taken by the patient. If the actual unit dose,
as taken by the patient, is controlled, it may either be measured directly or
calculated, based on the total measured weight or volume of drug divided by
the total number of doses expected. . . . For powders for reconstitution,
uniformity of mass testing is generally considered acceptable.”).
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formally published.” Lin ¶ 16. Dr. Lin has not shown that such a standard
was commonly known and provides no persuasive evidence that it existed at
the time of the invention. The lack of supporting evidence is consistent with
Requester’s expert testifying that “[t]here is no one standard attributable to
‘various would regulatory authorities” and that “the United States Food and
Drug Administration (“FDA”) has declined to adopt any particular set
standard.” Clevenger Decl. ¶ 7. Accordingly, we decline to give much, if
any, weight to the Patent Owner’s evidence. Rohm & Haas Co. v. Brotech
Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997) (“Nothing in the rules or in our
jurisprudence requires the fact finder to credit the unsupported assertions of
an expert witness.”).
Patent Owner further directs us to Examples X, Y, and Z of the ’080
patent, as evidence of written descriptive support. Request 85–91, 98–101.
Example X is described as the formation of a 30 micron thick mix of a base
formula and Loratadine (80% active). ’080 patent, col. 36, l. 45 to col. 37, l.
19. The film was cut, and “a 1”x0.75” piece weighed 70 mg and contained
10 mg of Loratadine.” Id., col. 37, ll. 17–19. The ’080 patent reports that for
Examples Y and Z, flexible films were produced by the same method with
“the target weight of 70 mg containing 5 mg of Zomig and 70 mg containing
10 mg of Paxil, respectively.” Id., col. 37, ll. 20–23.
The ’080 patent states that “[a]fter 5 min. of stirring, the total mix was
added to the pan of a three roll coater set (reverse roll coater) at 30 micron
coating thickness.” Id., col. 37, ll. 10–12. The ’080 patent does not identify
the size of the pan, the total size of the film, or whether more than a single 1
inch by 0.75 inch piece was cut from the film. Id. The ’080 patent also does
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not identify whether the 10 mg or 5 mg active amounts were confirmed or
merely calculated from the initial amounts of Loratadine, Zomig, and Paxil in
the films of Examples X, Y, and Z, respectively, and the 70 mg weight of the
100% dried piece of film. See id., col. 36, ll. 53–55. The ’080 patent states
only that “10 mg of drug 12.5 mg of the final dry product must be weighed.”
Id., col. 37, ll. 2–3 (emphasis added).3
Patent Owner argues that 10 mg of Loratadine, 5 mg of Zomig, and 10
mg of Paxil are “FDA labeled amounts” of these three drugs. Request 86. To
support this argument, Patent Owner directs us to paragraphs 6–9 of the Myers
Declaration and images of exterior packaging of a Loratadine product and
product inserts for Zomig and Paxil that are said to be “taken from FDA
documents on the FDA’s website.” See Request 87–91; Myers Decl. ¶¶ 6–9.
Patent Owner contends that “Examples X, Y, and Z met their goal in obtaining
individual dosage units cut from the films . . . containing an FDA dosage
amount for the drug active.” Request 98. Patent Owner asserts that the dosage
would be within a +/- 10% range of the 10 mg or 5 mg amounts even if the

3 Dr. Myers provides calculations showing a desired weight of 70 mg for a
unit dosage that would contain 10 mg of active Loratadine given the starting
material recited for Example X, if the active was uniformly dispersed therein
and the materials completely dried. Myers Decl. ¶¶ 23–29. Dr. Myers’
testimony draws into question whether the amounts of active reported in the
’080 patent were merely calculated from the starting materials described
therein and merely reported what was the expected dosage, in light of the
lack of written descriptive support of any actual testing on the cut sample in
Example X. See ’080 patent, col. 36, ll. 50–59, col. 37, l. 9.
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films were not completely dried but rather included a water content of up to
10%. Id. at 99–100 (citing Myers Decl. ¶¶ 32–35).
Examples X, Y, and Z and the FDA approved packaging and inserts
are not sufficient to show by a preponderance of evidence that, at the time of
the invention, the language in the ’080 patent that “various 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) would have shown
that the skilled artisan had possession of an invention in which the amount of
active in a dosage form may not vary by more than 10% from an amount
recognized by the FDA as a dosage or labelled amount.
It is not disputed that Examples X, Y, and Z are not expressly
described in the ’080 patent as representing “dosage amounts” for the
various pharmaceuticals or that the FDA accordingly recognized such
amounts as a “dosage amount.” Moreover, Dr. Myers does not testify and
the evidence does not show that the skilled artisan would have known, at the
time of the invention, that 10 mg of Loratadine, 5 mg of Zomig, and 10 mg
of Paxil were FDA recognized dosage amounts. As pointed out by
Requester (Comments 15–16), FDA approved dosage amounts as of 2015
for particular tablet formulations are not probative of what a skilled artisan
would have known regarding FDA recognized dosing of these
pharmaceuticals by sublingual film, if any existed, at the time of the
invention.
Even if the skilled artisan would have known that these amounts were
recognized dosages by the FDA at the time of the invention, Examples X, Y,
and Z does not describe a step of “performing analytical chemical tests to
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determine the amount of said active in said individual dosage units sampled
from different locations of said resulting film.” The ’080 patent does not
describe cutting the films of Examples X, Y, or Z “from different locations”
but only described cutting “a 1”x0.75” piece” and does not describe
performing an analytical chemical test to confirm the amount active in the
single cut piece. As discussed above, at best the disclosure describes
weighing a 1”x0.75” piece to confirm that it weighed 70 mg, which would
contain the calculated 10 mg of Loratadine if the active was uniformly
dispersed in the matrix.4
Finally, even if additional testing was performed, only exact amounts
of active expected are described. Examples X, Y, and Z do not describe that
+/- 10% from that expected dosage amount would have also been
acceptable. The ’080 patent does not show that Patent Owner had
possession of an invention in which the amount of active in a dosage form
may not vary by more than 10% from an amount recognized by the FDA as
a dosage or labelled amount.
Accordingly, we maintain the rejection of claim 82 and 315 under 35
U.S.C. § 112, first paragraph, as lacking written descriptive support.

Enablement
In light of our finding that claims 82 and 315, as amended, fail to
overcome the new grounds of rejection based on 35 U.S.C. § 112, first

4 Examples X, Y, and Z are described as being “taste mask coated” products.
’080 patent, col. 36, l. 65 to col. 37, l. 3. The reported results of such
coating is that “[t]he products were sweet without any noticeable drug
aftertaste.” Id., col. 37, ll. 24–25.
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paragraph, for lacking written descriptive support, we need not further
address the enablement rejection also based on 35 U.S.C. § 112, first
paragraph.

Summary
For the reason discussed above, in amending claims 82 and 315,
Patent Owner has overcome the Decision’s new ground of rejection based on
35 U.S.C. § 112, second paragraph, but has not overcome the Decision’s
new ground of rejection based on the written description requirement of 35
U.S.C. § 112, first paragraph.
The rejection of claims 82–92, 94–160, 261–271, 274, 276–278, 298,
and 315 under 35 U.S.C. § 112, first paragraph, as lacking written
descriptive support is maintained.
In the event neither party files a request for rehearing within the time
provided in 37 C.F.R. § 41.79, and this Decision becomes final and
appealable under 37 C.F.R. § 41.81, a party seeking judicial review must
timely serve notice on the Director of the United States Patent and
Trademark Office. See 37 C.F.R. §§ 90.1, 1.983.

cda

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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