GRÜNENTHAL GMBH

Patent Trials and Appeals Board

Aug 20, 2021

2021000033 (P.T.A.B. Aug. 20, 2021)

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.
15/257,079 09/06/2016 ELISABETH ARKENAU-MARIC 107101-212 (48) KGB 3066
27384 7590 08/20/2021
Briscoe, Kurt G.
Norris McLaughlin, PA
7 Times Square, 21st Floor
New York, NY 10036-6524
EXAMINER
RIDER, LANCE W
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
08/20/2021 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):
jarcher@norris-law.com
nmanfredi@norris-law.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ELISABETH ARKENAU-MARIC and
JOHANNES BARTHOLOMÄUS
Appeal 2021-000033
Application 15/257,079
Technology Center 1600
Before DEBORAH KATZ, JOHN G. NEW, and ROBERT A. POLLOCK,
Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a process of
forming a tablet having reduced potential for abuse. Appellant1 seeks our
review of the Examiner’s decision to reject claims 2–7, 10, and 12 as
obvious in view of the prior art and for non-statutory double patenting. We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Grünenthal GmbH.
Appeal Br. 1.
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STATEMENT OF THE CASE
According to the Specification, certain pharmaceutical active
ingredients, e.g., opiates, “which are highly active in combating severe to
very severe pain, are frequently used by abusers to induce a state of narcosis
or euphoria.” Spec. 1. “[T]o make abuse possible, the corresponding dosage
forms, such as tablets or capsules are comminuted, for example ground in a
mortar, by the abuser[.] [T]he active ingredient is extracted from the
resultant powder using a preferably aqueous liquid and the resultant solution
. . . is administered parenterally.” Id.
Because pulverizing a dosage form is a common first step in
extracting a pharmaceutical active for abuse, the Specification explains that
“the object of the present invention [is] to provide a process for the
production of abuse-proofed dosage forms with which the [pulverization] of
the dosage form which precedes abuse using the means conventionally
available to the potential abuser is complicated or prevented.” Id. at 2. The
Specification describes dosage forms incorporating polymers having a
“minimum breaking strength” of at least 500 N to impede pulverization of
the dosage form using conventional means. See id. at 3, 9. The process for
preparing the dosage form includes a first step of applying force to shape a
polymer-containing formulation mixture into formed articles and a second
step of applying force to the formed articles combined with heat. See id. at
10–11.
Claims 2–7, 10, and 12 are on appeal, of which claim 12 is
independent. Appellant directs its arguments to claim 12, and sets forth no
additional arguments with respect to the dependent claims. See Appeal Br.
3–28. Claim 12 is reproduced below:
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12. A process of forming a tablet with a reduced potential for
abuse, said process comprising:

a) producing a formed tablet by shaping a formulation
mixture by application of force on a tablet press,
wherein the formulation mixture comprises:
i) at least one active ingredient with potential for
abuse;
ii) at least one polymer (C), which polymer (C) is
a polyalkylene oxide having a molecular
weight of at least 0.5 million g/mol, and
exhibiting a breaking strength of at least 500
N; and
iii) optionally, one or more auxiliary substances
(B); and

b) exposing the formed tablet to force
i) during heating at least to the softening point
of the polymer (C) or
ii) after said heating while the formed tablet is
still at a temperature at least at the softening
point of the polymer (C), said exposing the
formed tablet to force continuing until the
formed tablet has a breaking hardness of at
least 500 N, and
optionally providing the formed tablet with a cover,
and optionally mixing the formed tablet with other
formed tablets.
Id. at 30–31.
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The Examiner rejects claims 2–5, 7, and 12 under 35 U.S.C. § 103(a)
as being unpatentable as obvious over McGinity2 and Vezin.3 Final Act. 3–
9.
The Examiner rejects claim 6 under 35 U.S.C. § 103(a) as being
unpatentable as obvious over McGinity, Vezin, and Verma.4 Id. at 9–12.
The Examiner rejects claim 10 under 35 U.S.C. § 103(a) as being
unpatentable as obvious over McGinity, Vezin, Verma, and Oshlack.5 Id. at
12–14.
The Examiner also provisionally rejects claims 2–7, 10, and 12 on the
ground of nonstatutory double patenting. See id. at 14–28. Specifically, the
Examiner rejects claims 2–7, 10, and 12 as not patentably distinct from:
1) claims 16–19 of Application No. 15/061,252 (now U.S. Patent
No. 10,675,278), McGinity, Vezin, Verma, and Oshlack (id. at
15–16);
2) claims 18–28 of U.S. Patent No. 9,629,807 in view of
McGinity, Vezin, Verma, and Oshlack (id. at 16–17);
3) claims 36–37 and 55–56 of Application No. 15/265,253 (now
U.S. Patent No. 10,130,591), McGinity, Vezin, Verma, and
Oshlack (id. at 18–19);
4) claims 1 and 21–22 of U.S. Patent No. 8,420,056, McGinity,
Vezin, Verma, and Oshlack (id. at 19);

2 McGinity et al., US 6,488,963 B1, issued Dec. 3, 2002.
3 Vezin, W. R. et al., “Adjustment of precompression force to reduce
mixing-time dependence of tablet tensile strength,” 35 J. Pharm. Pharmacol.
555–558 (1983).
4 Verma et al., US 6,322,811 B1, issued Nov. 27, 2001.
5 Oshlack et al., US 2004/0170680 A1, publ. Sept. 2, 2004.
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5) claims 1 and 21–22 of U.S. Patent No. 8,722,086, McGinity,
Vezin, Verma, and Oshlack (id. at 19–20);
6) claims 1 and 5–6 of U.S. Patent No. 8,114,383, McGinity,
Vezin, Verma, and Oshlack (id. at 20–21);
7) claims 1–14 of U.S. Patent No. 8,114,384, McGinity, Vezin,
Verma, and Oshlack (id. at 21–22);
8) claims 19–26 of U.S. Patent No. 8,075,872, McGinity, Vezin,
Verma, and Oshlack (id. at 22–23);
9) claims 17–26 of U.S. Patent No. 8,192,722, McGinity, Vezin,
Verma, and Oshlack (id. at 24–25);
10) claims 1–13 of U.S. Patent No. 8,323,889, McGinity, Vezin,
Verma, and Oshlack (id. at 25–26);
11) claims 19–30 of U.S. Patent No. 8,420,056, McGinity, Vezin,
Verma, and Oshlack (id. at 26–27); and
12) claims 25–26 of U.S. Patent No. 8,309,060, McGinity, Vezin,
Verma, and Oshlack (id. at 27–28).
ANALYSIS
To establish a prima facie case of obviousness, the Examiner must
show that each and every limitation of the claim is described or suggested by
the combination of prior art references or would have been obvious based on
the knowledge of those of ordinary skill in the art. In re Fine, 837 F.2d 1071,
1074 (Fed. Cir. 1988). “[R]ejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006),
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quoted with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007).
The Examiner finds that that McGinity teaches a method of forming a
tablet by compressing an extrudate containing a drug with potential for
abuse and a polyalkylene oxide having a molecular weight of at least 0.5
million g/mol that is heated to the softening point of the polyalkylene oxide.
Final Act. 3–4. The Examiner finds that McGinity “does not teach pre-
compressing the extrudate with a tablet press.” Id. at 4. The Examiner finds
that “Vezin teaches using precompression of tablet mixtures in tablet presses
prior to a main compression to increase the tablet tensile strength, remove
trapped air from the mixtures before compaction, and decrease lamination
and capping occurring during tablet manufacture.” Id. The Examiner finds
that a person of ordinary skill in the art would have had a reason to apply
Vezin’s precompression step to McGinity’s process to reduce capping and
lamination made by the “extrusion and tableting of McGinity by eliminating
the air in the extrudate and tablet punch dies by pre-compressing the
mixtures being tableted as well as increasing the final tablet strength.” Id.
Appellant does not generally dispute the Examiner’s findings as to
McGinity’s and Vezin’s individual teachings. See Appeal Br. 3–14. Rather
Appellant argues that the Examiner has failed to show that a person of
ordinary skill in the art would have had a reason to combine Vezin’s
precompression step with McGinity’s extrusion process. See id. We find
Appellant’s arguments persuasive and, for the reasons set forth below, we
reverse the Examiner’s rejection.
McGinity teaches controlled-release drug delivery preparations which
have been prepared by hot-melt extrusion of mixtures containing high
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molecular weight polyethylene oxide (“PEO”) and a therapeutic compound.
McGinity 1:9–19. McGinity teaches that PEO is a hot-melt extrudable
polymer “that is sufficiently rigid at standard ambient temperature and
pressure but is capable of deformation or forming a semi-liquid state under
elevated heat or pressure.” Id. at 7:45–50. McGinity teaches formulations,
including tablets, “may be shaped as needed,” using hot-melt extrusion or
“other equivalent[] processes such as . . . compressing molding.” Id. at 7:54–
60.
McGinity generally describes a hot-melt extrusion process. First, “[a]n
effective amount of a powdered therapeutic compound is mixed with a high
molecular weight PEO.” Id. at 8:9–10. Next, “[t]he mixture is [] placed in
the extruder hopper and passed through the heated area of the extruder at a
temperature which will melt or soften the PEO . . . to form a matrix
throughout which the therapeutic compound is dispersed.” Id. at 8:17–22.
Finally, the molten or softened mixture is extruded via a die to form an
extrudate. Id. at 8:22–24. McGinity teaches that the warm extrudate is
“easily shaped, molded, chopped, ground, molded, spheronized into beads,
cut into strands, tableted or otherwise processed to the desired physical
form.” Id. at 8:25–28. In specific examples, McGinity teaches that “[t]he
extrudate may then be ground to a powder or molded to a caplet” (id. at
12:54–56 (Example 2)) and “the extrudate may be chopped to form tablets”
(id. at 13:10–11 (Example 3)).
Vezin teaches that tablet tensile strength may deteriorate due to
lubricant overmixing when compressing some formulations into tablets. See
Vezin 555. Vezin teaches that “[t]he phenomenon appears to arise from
ordered mixing by adsorption of lubricant multi-layers to formulation or
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excipient particles.” Id. Vezin teaches that adding a precompression step to
the process increases tablet strength and reduces lamination and capping. Id.
at 556. Vezin teaches that “[s]uch effects, where present, appear to involve
relatively long-term events (e.g. stress relaxation and escape of air) within
the compact occurring largely between the two separate compaction events.”
Id. at 557–558.
Appellant argues that “Vezin’s solutions are intended for tablets
prepared by a fundamentally different process from McGinity’s extrusion
processes.” Appeal Br. 6. Specifically, Appellant argues that Vezin’s
precompression process relates to problems caused by “ordered mixing” of
lubricants in powder excipient mixtures. See id. at 7. Appellant argues that
the Examiner has not shown that McGinity’s extrudates suffered from any of
the same problems as Vezin’s powder mixtures, and has not provided a
rationale as to why the benefits of Vezin’s direct compression process apply
to McGinity’s extrusion process. Id. at 8.
We are persuaded by Appellant’s argument. The Examiner has not
shown that the problem solved by Vezin—reduced tablet tensile strength due
to overmixing of lubricants in direct compression mixtures—applies to
McGinity’s extrudates. See In re Kahn, 441 F.3d at 988 (“[T]he problem
examined is not the specific problem solved by the invention but the general
problem that confronted the inventor before the invention was made.”).
The Examiner finds that McGinity teaches combining powder
materials for extrusion, and that the extrusion process may merely soften
rather than dissolve the materials. See Ans. 11–12. The Examiner thus finds
that “McGinity clearly indicates that the materials in the extruded mixtures
may be in powdered forms and thus even if Vezin were restricted to
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powdered mixtures McGinity provides for the use of them.” Id. at 12. We
find the record evidence does not support this interpretation of McGinity,
which teaches that the powder materials are combined in an extruder at a
temperature that will melt or soften the PEO to form a matrix throughout
which the therapeutic compound is dispersed. See McGinity 8:3–22.
Accordingly, the record evidence does not support the finding that McGinity
would suffer from the problem of overmixing powder excipients leading to a
decrease of tensile strength.
The Examiner further finds that both Vezin and McGinity teach the
use of lubricants, e.g., magnesium stearate, in the compositions. Ans. 12.
The Examiner finds that a person of ordinary skill in the art “would have
expected an improvement in the dosage forms of McGinity that include
these same lubricants, provide for powdered materials in the extruded
materials, and subsequently compress them into tablet shapes.” Id.
Additionally, the Examiner finds that Vezin’s precompression would remove
trapped air from McGinity’s formulations “even beyond the issues with the
lubricant alone as well as in non-powdered materials as long as the extruders
are not provided in an air free environment to avoid any air getting into the
mixtures.” Id. at 12–13. However, the Examiner does not provide evidence
to support either of these rationales. See In re Warner, 379 F.2d 1011, 1017
(CCPA 1967) (“The Patent Office has the initial duty of supplying the
factual basis for its rejection. It may not . . . resort to speculation, unfounded
assumptions or hindsight reconstruction to supply deficiencies” in the cited
references.). For example, the Examiner does not provide evidence that
extruded formulations would retain powdered lubricants in the heated
mixture, nor that extruded formulations contain trapped air.
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In sum, the Examiner’s rationales to combine the references are not
supported by the evidence of record. Thus, on the record before use, we
agree with Appellant that the Examiner erred in rejecting the claims as
obvious.
The Examiner’s rejections of claims 2–7, 10, and 12 for obviousness-
type double patenting also rely on the combination McGinity and Vezin. For
the reasons set forth above, we reverse the Examiner’s rejections on the
grounds of obviousness-type double patenting.
CONCLUSION
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
2–5, 7, 12 103(a) McGinity, Vezin 2–5, 7, 12
6 103(a)
McGinity, Vezin,
Verma
6
10 103(a)
McGinity, Vezin,
Verma, Oshlack
10
2–7, 10, 12

Nonstatutory
double patenting
Appl. No.
15/061,252,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
US 9,629,807,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
Appl. No.
15/265,253,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
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Application 15/257,079

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2–7, 10, 12

Nonstatutory
double patenting
US 8,420,056,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
US 8,722,086,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
US 8,114,383,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
US 8,114,384,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
US 8,075,872,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
US 8,192,722,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
US 8,323,889,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
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2–7, 10, 12

Nonstatutory
double patenting
US 8,420,056,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
2–7, 10, 12

Nonstatutory
double patenting
US 8,309,060,
McGinity, Vezin,
Verma, Oshlack
2–7, 10, 12
Overall
Outcome
2–7, 10, 12

REVERSED