Lieven Elvire Colette. Baert et al.

Patent Trials and Appeals Board

Dec 17, 2019

14300607 - (D) (P.T.A.B. Dec. 17, 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.
14/300,607 06/10/2014 Lieven Elvire Colette Baert TIP0217USDIV1 4213
27777 7590 12/17/2019
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
CONIGLIO, AUDREA JUNE BUCKLEY
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
12/17/2019 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):
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PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte LIEVEN ELVIRE COLETTE BAERT,
IKSOO CHUN, GUENTER KRAUS,
DEBORAH M. SCHACHTER, and QIANG ZHANG
____________

Appeal 2018-002233
Application 14/300,6071
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and
DAVID COTTA, Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a
degradable, removable, pharmaceutical subcutaneous implant for the
sustained release of one or more drugs. The Examiner rejected the claims on
appeal as obvious under 35 U.S.C. § 103(a). We reverse.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. According to Appellant, the real party in interest is Janssen
Sciences Ireland UC, an affiliate of Johnson & Johnson. Appeal Br. 1.

Appeal 2018-002233
Application 14/300,607

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STATEMENT OF THE CASE
The Specification states that “[i]mplantable drug delivery devices
have been known in the art.” Spec. 1. “In the art-known implantable drug
delivery systems the active ingredient is embedded in a matrix material that
is shaped in a cylindrical form of sufficient small size to allow subcutaneous
implantation via a hollow needle.” Id. This delivery form has the
disadvantage that “there is a lag time between implantation and delivery of
the drug because the bodily fluids have to penetrate the implant and start
decomposing the polymeric matrix” leading to “irregularities in the release
pattern.” Id. In addition, the Specification asserts that no such delivery
system has been designed to simultaneously deliver two or more drugs. Id.
According to the Specification “[t]he present invention relates to an
implantable depot polymeric device that is easily introduced into the
subcutaneous space, removed if the necessity arises, and degrades when
drug delivery function is complete.” Id. The implant is “composed of a tube
. . . made of a degradable polymer . . . [having] a plurality of openings.”
Within the tube are “micro-particles contain[ing] an active agent or a
combination of two or more active agents . . . size[d] . . . such that the
majority of the microparticles cannot pass through the openings.” Id. at 3–4.
Claims 1, 2, 8, 9, and 13–15 are on appeal. Claim 1 is representative
and reads as follows:
1. A degradable, removable, pharmaceutical subcutaneous
implant for the sustained release of one or more drugs in a
subject, comprising
a tube that is defined by an outer wall,
wherein the outer wall is fabricated from
poly(dioxanone); has a plurality of openings on its surface;
and completely surrounds a cavity,
and wherein the cavity contains one or more sets of
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Application 14/300,607

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microparticles embedded in a hydrogel, wherein at least
one set of the microparticles comprises rilpivirine and a
copolymer of lactide and glycolide, and
wherein the size of the microparticles is selected
such that the majority of the microparticles cannot pass
through the openings.
Appeal Br. 7.
The Examiner rejected claims 1, 2, 8, 9, and 13–15 as obvious over
the combination of Priewe,2 Harbeson,3 and Porjazoska.4
ANALYSIS
Each of the rejected claims requires a “tube” having an outer wall that
“completely surrounds a cavity” and “has a plurality of openings on its
surface.” Appeal Br. 7. In finding the claimed subcutaneous implant
obvious, the Examiner relies on Priewe as disclosing the claimed tube. Ans.
3–4. Appellant argues that Priewe does not disclose this limitation. Appeal
Br. 4–5; Reply Br. 3. We find that Appellant has the better position.
We begin by construing the claims. We understand the term “tube,”
as used in claim 1, to mean a hollow, cylindrical body. This is consistent
with the way the term “tube” is used in the Specification. Spec. 3
(describing the tube as having an “internal diameter” and an “inner
diameter”); id. at 4 (describing the tube as having an “outer wall . . .
completely surrounding a cavity”); id. at 5 (describing the tube as having
openings through which fluid may penetrate); id. at 6 (describing the tube as

2 Priewe et al., WO 02/30482 A1, published Apr. 18, 2002 (“Priewe”).
3 Harbeson et al., US 2009/0036357 A1, published Feb. 5, 2009
(“Harbeson”).
4 Porjazoska et al., Poly(lactide-co-glycolide) Microparticles as Systems for
Controlled Release of Proteins – Preparation and Characterization, 54 Acta
Pharm. 215–229 (2004) (“Porjazoska”).
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Application 14/300,607

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“cylindrical”); id. at 8 (describing the tube as having an internal and an outer
diameter); Fig. 2 (depicting a hollow cylindrical body). It is also consistent
with the plain and ordinary meaning of the term “tube.” See
https://dictionary.cambridge.org/dictionary/english/tube (accessed
12/5/2019) (defining tube as “a long, hollow cylinder of plastic, metal,
rubber, or glass, used for moving or containing liquids or gases”).
The Examiner relies on Figure 5 of Priewe as disclosing this
limitation. Ans. 3–4.5 Figure 5 of Priewe is reproduced below.
Figure 5 is “a section from the filament prepared according to example 8,
seen in side view.” Priewe, 21. Example 8 describes the preparation of
“[e]chogenic propylene filaments with pressure-sensitive glass hollow
bodies.” Id. at 25–26. According to Example 8, a mixture of polypropylene
granules and glass hollow bodies (22) was melted, and a thread

5 The Examiner also cites: Priewe’s abstract; page 4, line 1 to page 8, line
30; page 14, lines 9–20; Example 8; and page 26, lines 9–12. However, the
Examiner does not specifically identify anything in the cited material other
than Figure 5 as disclosing structure corresponding to the claimed tube. Nor
do we find anything in the cited material corresponding to the claimed tube.
Accordingly, we focus our discussion on Priewe’s Figure 5.
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Application 14/300,607

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approximately 1 meter long was pulled out with a glass rod. Id. The glass
hollow bodies (22) remained “intact” and could be seen under a microscope.
In Figure 5, the glass hollow bodies (22) are shown “partially surrounded by
[the] polypropylene” of the filament (20). Id.
We do not discern anything in Priewe to suggest that the filament in
Figure 5 meets the requirement of claim 1 for a “tube.” To the contrary, the
method by which the filament (20) of Figure 5 was prepared — by pulling
the filament out of a melted mixture of polypropylene with a glass rod —
suggests that the filament is a solid structure. While the glass bodies (22)
embedded within the filament are described as “hollow” (id. at 26), the
Examiner does not direct us to any evidence to suggest that the filament (20)
is hollow or would otherwise meet the definition of a “tube.” Accordingly,
we reverse the Examiner’s rejection of claims 1, 2, 8, 9, and 13–15 as
obvious over the combination of Priewe, Harbeson, and Porjazoska.
SUMMARY
In summary:

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1, 2, 8, 9,
13–15
103(a) Priewe, Harbeson,
Porjazoska
1, 2, 8, 9,
13–15

REVERSED