Peter Holm. Tygesen et al.

Patent Trials and Appeals Board

Dec 18, 2019

15373022 - (D) (P.T.A.B. Dec. 18, 2019)

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.
15/373,022 12/08/2016 Peter Holm Tygesen 108221-0211 1072
22428 7590 12/18/2019
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
SONG, JIANFENG
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
12/18/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_________________

Ex parte PETER HOLM TYGESEN, KARSTEN LINDHARDT,
MARTIN REX OLSEN, GINA ENGSLEV FISCHER,
JAN MARTIN OVERGARD, GEORG BOYE,
NIKOLAJ SKAK, and TORBEN ELHAUGE

_________________

Appeal 2018-007370
Application 15/373,022
Technology Center 1600
_________________

Before RAE LYNN P. GUEST, DEBORAH KATZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL

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Application 15/373,022

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Appellant1 seeks our review2 under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 22–40. We have jurisdiction under 35
U.S.C. § 6(b). We AFFIRM.
Appellant’s Specification is directed to strategies for making
pharmaceuticals resistant to abuse. (Spec. ¶¶ 30–34.)
Appellant’s only independent claim, claim 22, recites:
An abuse-deterrent tablet formulated for oral
administration of an opioid, the tablet consisting of a tablet
composition and, optionally, a cosmetic coat, wherein:
the tablet composition comprises:
(a) about 1-60 % w/w of the opioid; and
(b) about 40-98 % w/w of a polyethylene oxide (PEO)
selected from the group consisting of (i) a single PEO having an
average molecular weight of from about 400,000 daltons to
about 900,000 daltons and (ii) two or more PEOs having a
combined average molecular weight of from about 400,000
daltons to about 900,000 daltons,
wherein the cosmetic coat, when present, covers at least a
portion of the tablet composition, and dissolves within 30
minutes after contact with aqueous media,
wherein the tablet composition exhibits a viscosity of at
least 170 mPas when measured by Viscosity Test #2, or a
viscosity of at least 46 Pas when measured by Viscosity Test
#1, such that the tablet composition, when subjected to a liquid
environment, forms a viscous hydrogel that resists passage
through a hypodermic needle.

1 We use the word “Appellant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party-in-interest as Egalet Ltd. (Appeal Br. 3.)
2 We consider the Final Office Action issued September 27, 2017 (“Final
Act.”), the Appeal Brief filed February 20, 2018 (“Appeal Br.”), the
Examiner’s Answer issued on May 18, 2018 (“Ans.”), the Reply Brief filed
July 9, 2018 (“Reply Br.”).
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(Appeal Br. 21, Claims App.) The structural limitations of claim 22
encompass a tablet that comprises (a) about 1–60 % w/w of the opioid; and
(b) about 40–98 % w/w of a single PEO having an average molecular weight
of from about 400,000 daltons to about 900,000 daltons.
The Examiner rejected claims 22–40 as being obvious under 35
U.S.C. § 103(a) as being unpatentable over Downie (International
Application Publication WO 2008/086804 A2, published July 24, 2008).
(Final Act. 3–7.)
Findings of Fact
1. Downie is directed to abuse resistant pharmaceutical
compositions that include one or more polyglycols and one or more active
substances and is resistant to crushing. (See Downie abstract; Final Act. 4.)
2. Downie teaches that polyethylene glycols or polyethylene
oxides with molecular weights in a wide range of molecular weights,
including from about 100,000 to about 900,000 daltons, are suitable as
polymers in the compositions provided. (See Downie 12:22; Final Act. 4.)
3. Downie specifically teaches that polyethylene oxides with
molecular weight of about 400,000 daltons are suitable as a polymer in the
compositions provided. (Downie 12:4–16.)
4. Downie also teaches that a mixture of polyethylene oxides with
different average molecular weights can be used to obtain a polyethylene
oxide with the desired average molecular weight. (See Downie 13:12–13;
Final Act. 4.)
5. Downie teaches that the drug may be present in a concentration
from about 0.01% to about 40% in the compositions provided. (See Downie
19:1–5; Final Act. 4.)
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6. Downie teaches that the polymers can be in the compositions
provided at concentrations of from about 10 to 90% in the compositions
provided. (Downie 14:8; Final Act. 4.)
7. Downie teaches that the drug substance can be opioids, such as
hydrocodone, morphine, or oxycodone. (Downie 15–17; Final Act. 4.)
8. Downie teaches that the pharmaceutical compositions provided
by be used in the preparation of tablets. (See Downie 10:30–32.)
Analysis
The Examiner finds that Downie teaches a pharmaceutical
composition having 10 to 90% polymer and 0.01% to about 40% drug,
wherein the polymer can be PEO with a molecular weight of about 400,000
daltons and the drug can be an opioid. (See Ans. 4.) The Examiner finds
further that the limitations in claim 22 to a range of viscosity as measured by
certain tests (“a viscosity of at least 170 mPas when measured by Viscosity
Test #2, or a viscosity of at least 46 Pas when measured by Viscosity Test
#1”) and the limitation to the forming “a viscous hydrogel that resists
passage through a hypodermic needle” are inherent properties of the tablets
taught in the prior art because those tablets are the same or substantially the
same as the claimed tablets. (See Ans. 5–6.) The Examiner cites Atlas
Powder Co. v. lreco, Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999), to
determine that Appellant is merely claiming an unappreciated property of a
prior art composition. (See Ans. 6.) We agree with the Examiner.
Appellant argues that the Examiner fails to identify any reason that
would have led one of ordinary skill in the art to make the selections of the
claimed PEO molecular weights and percentages of opioid from the broad
genus taught in Downie to obtain an abuse-deterrent tablet as claimed. (See
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Appeal Br. 11.) Specifically, Appellant argues that Downie does not discuss
the viscosity of its compositions, does not discuss any hydrogel-forming
properties of its compositions, and does not discuss the preparation of tablets
that deter abuse by injection. (See Appeal Br. 13.) We are not persuaded by
these arguments.
A tablet as recited in claim 22 encompasses a tablet comprising (a)
about 1–60 % opioid and (b) about 40–98 % w/w of a PEO having an
average molecular weight of about 400,000 daltons. Downie teaches
compositions that can be in tablet form can comprise PEO having an average
molecular weight of about 400,000. (See Downie 12:4–11; see FFs 3 and
8.) Downie also teaches that such tablets can comprise 0.01– 40% drug,
including several opioids, and about 10–90% polymer. (Downie 14:8 and
18:1–5; see FFs 5 and 6.) Thus, although Downie does not present a single
embodiment that encompasses all of the limitations of claim 22, if one of
ordinary skill in the art had followed the express guidance in Downie to use
a PEO of average molecular weight of about 400,000 in a tablet, he or she
would also know that opioids could be included at a concentration up to 40%
and that the PEO polymer could be included at concentrations up to 95%.
“The law is replete with cases in which the difference between the
claimed invention and the prior art is some range or other variable within the
claims. . . . These cases have consistently held that in such a situation, the
applicant must show that the particular range is critical.” In re Woodruff,
919 F.2d 1575, 1578 (Fed. Cir. 1990). Accordingly, in the absence of
evidence that the concentration of opioid or PEO recited in claim 22 is
critical, we are persuaded that a tablet with PEO of average molecular
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weight 400,000, as expressly taught in Downie, with the recited
concentrations of opioid and PEO would have been obvious.
Appellant argues that “[t]he rejection on appeal is based on unguided
selections and combinations of individual disclosures in Downie that are
pieced together in hindsight in an attempt to arrive at a tablet as claimed.”
(Appeal Br. 10.) This argument is unpersuasive because Downie expressly
teaches PEO of average molecular weight 400,000 daltons as a polymer for
use in tablets. Although the teachings of PEO size, polymer concentration,
drug concentration, and tablet form are found in different places within the
text of Downie, they express alternate embodiments of the subject matter
taught. Given that PEO having an average molecular weight of 400,000 is
expressly taught, one need only select a concentration of polymer and opioid
that falls within a very large portion of the ranges taught in Downie to arrive
at the claimed tablet. Downie teaches that each of these limitations can be
selected for a drug formulation, providing a reason for their selection,
contrary to Appellant’s argument. (See Appeal Br. 11.)
Appellant argues further that the closest prior art to the tablets recited
in claim 22 would have to be selected from Downie’s examples, but that
each of Examples 1–7 provide compositions with PEO having a lower
average molecular weight than recited in the claims (100,000, 200,000,
and/or 300,000 daltons), not PEOs within the claimed range of 400,000 to
900,000 daltons. (See Appeal Br. 11.)
We disagree that the closest prior art to Appellant’s claim 22 are the
examples of Downie. “All the disclosures in a reference must be evaluated,
including nonpreferred embodiments, . . . and a reference is not limited to
the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651
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(CCPA 1972) (citation omitted). Downie expressly teaches using PEO of
average molecular weight 400,000 daltons. Thus, we disagree that the
closest prior art is found only in the examples of Downie. Appellant’s
argument that the only comparison that the Examiner should have made is
between the examples of Downie and the claimed composition is based on a
misapprehension of the law. (See Appeal Br. 11–13.)
Appellant argues further that Downie does not provide a reasonable
expectation of success in obtaining a tablet that exhibits the recited viscosity
limitations as abuse-deterrent properties. (See Appeal Br. 13–14.)
Appellant argues that Downie does not discuss viscosity, hydrogel-forming
properties, or deterrence of abuse through injection for the compositions it
teaches. Appellant notes that Downie is directed to a different mode of
abuse-deterrence, which is addressed by adjusting the relative solubilities of
a composition in water and alcohol. (See id.)
We are not persuaded by this argument because one of ordinary skill
in the art would have had a reasonable expectation of success in formulating
a tablet with (a) about 1–60 % w/w of the opioid; and (b) about 40–98 %
w/w of PEO having an average molecular weight of about 400,000 daltons
from the teachings of Downie. Appellant has not directed us to persuasive
evidence that such a tablet would not inherently possess the other properties,
such as viscosity, recited in claim 22.
Appellant cites In re Stephan Co., 868 F.3d 1342 (Fed. Cir. 2017), but
we do not find that case to be informative of the facts before us now. (See
Appeal Br. 13–14.) In Stephan, the claims at issue recited a surfactant with
a cloud point above at least 70°C, whereas the prior art taught a surfactant
component with an ideal cloud point above only 60°C. See Stephan, 868
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F.3d at 1346. In contrast, the facts of the current case are that Downie
expressly teaches embodiments within the scope of limitations of claim 22.
Thus, unlike the facts of Stephan, the actual teachings of Downie would
have provided a reasonable expectation that a tablet as claimed could be
formulated successfully.
Appellant presents a declaration under 37 C.F.R. § 1.132 by inventor
Nikolaj Skak, which reportedly presents experimental data from the
compositions of the examples in Downie. (See Appeal Br. 14–17; see
Declaration under 37 C.F.R. § 1.132, executed June 28, 2017 by Nikolaj
Skak (“Skak Decl.”).) Appellant argues that Mr. Skak’s declaration shows
that the compositions of Downie’s examples do not exhibit the viscosity
properties recited in claim 22. (See Appeal Br. 14–17.)
We agree with the Examiner that the data presented by Mr. Skak does
not address the compositions for which Downie was cited. (See Ans. 7 and
19.) Contrary to Appellant’s arguments, compositions with PEO having an
average molecular weight of 400,000 daltons as taught in Downie are the
closest prior art, not the examples, which include polymers of different
average molecular weight. Appellant’s argument that “the Skak Declaration
presents experimental data on the closest examples of Downie, which use
PEO with an average molecular weight outside of the claimed range” (see
Appeal Br. 16), is unpersuasive because Downie actually teaches PEO
within the claimed range. Downie does not merely provide a suggestion
about compositions with PEO of average molecular weight about 400,000
daltons – it expressly teaches it.
Appellant argues further that the Examiner improperly relied on
inherency to meet the viscosity properties recited in claim 22. (See Appeal
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Br. 17–19.) Although the use of inherency in the obviousness context is
limited, if a claim limitation is necessarily present, or the natural result of a
combination of elements explicitly disclosed by the prior art, inherency may
be properly implemented. See PAR Pharm., Inc. v. TWI Pharm., Inc., 773
F.3d 1186, 1195–96 (Fed. Cir. 2014). Under the facts of this case, the
Examiner properly relied on inherency because Downie expressly teaches
PEO having an average molecular weight of about 400,000 daltons in drug
compositions. Appellant does not argue or direct us to persuasive evidence
that any feature other than the average molecular weight of the PEO, such as
the concentration of opioid or PEO, is responsible for the viscosity and other
abuse-deterrent characteristics recited in claim 22. To the contrary,
Appellant argues that the compositions recited in the examples in Downie do
not exhibit viscosities as recited in claim 22 because
PEO having an average molecular weight of 100,000, 200,000
and/or 300,000 daltons (as used in the Examples of Downie)
and PEO (or two or more PEOs) having an average molecular
weight of from about 400,000 daltons to about 900,000 daltons
(as recited in the claims) have structural and functional
differences that impact their viscosity and hydrogel-forming
properties.

(Appeal Br. 12.) Thus, the teaching in Downie of a drug composition
including PEO having an average molecular weight of about 400,000 daltons
inherently teaches a drug composition with the viscosity and other abuse-
deterrent features recited in claim 22.
Appellant has not persuaded us that the Examiner erred in rejecting
claim 22 as being obvious over Downie. Accordingly, we affirm the
rejection of claim 22 and the claims that depend on it.
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Appellant argues separately for the patentability of claims 33 and 34.
(See Appeal Br. 19–20.) We are not persuaded by these arguments. Claim
33 depends from claim 22 and recites an abuse-deterrent tablet “wherein the
tablet composition comprises a single PEO having an average molecular
weight of about 400,000 daltons.” (See Appeal Br. 22.) Because, as
explained above, Downie expressly teaches using PEO of average molecular
weight about 400,000 daltons, the Examiner did not err in determining that
claim 33 would have been obvious over Downie. Appellant’s arguments,
which are similar to those discussed above, are not persuasive.
Appellant also provides similar arguments against the rejection of
claim 34. (See Appeal Br. 20.) Claim 34 depends on claim 22 and recites an
abuse-deterrent tablet “wherein the tablet composition comprises a single
PEO having an average molecular weight of about 600,000 daltons.” (See
Appeal Br. 22.) Downie expressly teaches that PEO having a molecular
weight of about 600,000 daltons is suitable for the drug formulations it
provides. (See Downie 12:4–7.) Therefore, for the reasons discussed above,
the Examiner did not err in determining that claim 34 would have been
obvious over Downie.
Conclusion
Upon consideration of the record and for the reasons given, we affirm
the Examiner’s rejection.
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
22–40 103(a) Downie 22–40
Overall
Outcome
22–40
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.

AFFIRMED