Ex Parte Duerschinger

Patent Trial and Appeal Board

Sep 6, 2016

12265409 (P.T.A.B. Sep. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/265,409 11105/2008
23389 7590 09/08/2016
SCULLY SCOTT MURPHY & PRESSER, PC
400 GARDEN CITY PLAZA
SUITE 300
GARDEN CITY, NY 11530
FIRST NAMED INVENTOR
Guenter DUERSCHINGER
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
23547 2084
EXAMINER
COUGHLIN, DANIEL F
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
09/08/2016 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):
Docket@SSMP.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GUENTER DUERSCHINGER
Appeal2015-001396
Application 12/265,409
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
TA WEN CHANG, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1, 4--8, and 10
(Final Act. 2).2 Examiner entered rejections under 35 U.S.C. § 103. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
Appellant discloses "a medical capsule, having a capsule shape and
size capable of being introduced into a subject body, at least a part of the
medical capsule being dissolved over time by remaining in a predetermined
1 Appellant identifies "[t]he real party of interest [as] Olympus Medical
Systems Corporation" (Br. 2).
2 Examiner's December 2, 2013 Final Office Action.
Appeal2015-001396
Application 12/265,409
time or more in a lumen" (Spec. 2). Claim 1 is representative and
reproduced below:
1. A medical capsule, having a capsule shape and size
capable of being introduced into a subject body, at least a part
of the medical capsule being dissolvable by remaining in a
lumen of the subject body for at least a given period of time, the
medical capsule comprising:
an outer casing having the capsule shape and a
substantially uniform thickness;
an inner casing provided inside the outer casing and
having discharge outlets at both ends of the inner casing and
having an inner space similar to an outline of the outer casing;
and
a filling provided within the inner space of the inner
casmg,
wherein the inner space of the inner casing and an
outside of the medical capsule are configured to
communicatively connect with each other through the discharge
outlets by dissolution of the outer casing so that the filling
flows outside the medical capsule through the discharge outlets.
(Br. 10 (Claims Appendix).)
Claims 1, 4, 6-8, and 10 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Schestopol, 3 Siadat, 4 and Drake. 5
Claims 1 and 5 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Schestopol, Siadat, and Ayer. 6
3 Schestopol et al., US 2005/0201974 Al, published Sept. 15, 2005.
4 Siadat et al., Double Walled Polymeric Drug Delivery Systems Containing
Nanoparticle Drug Intendedfor Colon-Specific Delivery, 19 ASIAN J. CHEM.
1875-1882 (2007).
5 Drake et al., US 4,793,997, issued Dec. 27, 1988.
6 Ayer et al., US 6,283,953 Bl, issued Sept. 4, 2001.
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Appeal2015-001396
Application 12/265,409
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellant's Figures 1 and 3 are reproduced below:
FIG.1
15
lQ
.,. .. /
FIG.3
"Fig. 1 shows a medical capsule 10 [that] includes an inner casing 12 [that
has a filling 15 and] has two discharge outlets 13 which face each other, and
a sealed outer casing 14" (Spec. 11: 6-10). "Fig. 3 shows a medical capsule
30 [that] includes an inner casing 32 [that has a filling 35 and has] two
discharge outlets (openings) facing each other and an outer casing formed by
two cup-shaped members 36 and 37," wherein "[t]he wall thickness of the
outer casing at both ends may be designed to thin by shaping the interior
(shaped portion 38) as shown in Fig. 1" (id. at 12: 3-13).
FF 2. Schestopol discloses "drug delivery systems with increased
residence times in the GI tract, nasal mucosa, pulmonary mucosa, and other
mucosa in a cost-effective manner" (Schestopol i-f 10; see generally Final
Act. 4).
3
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Application 12/265,409
FF 3. Schestopol's Figure 7 is reproduced below:
FIG.7
ll
20 /
28 . .,,..._ _ 28
.. , ' 14
' '·
12
,,_.
~ ... _,. ··~
·.,,, ' ..
• ~· ,. • .. :-., t : • ~- •••
"As shown in [Schestopol's] FIG. 7, [Schestopol's] system [(11)] contains a
core (14), a semi-permeable coating (28) and a bioadhesive polymer cylinder
(12)," which may "[o]ptionally, []contain one or two restricted release
openings (20) at the top and bottom of the bioadhesive cylinder" (Schestopol
i-fi-183, 86, FIG. 5; see generally Final Act. 4; Ans. 3; see Br. 7 ("Schestopol
discloses that a capsule casing contains two release openings")).
FF 4. Examiner finds that Schestopol's "outer cylinder [12] contains walls
of uniform thickness (Final Act. 4; Ans. 3; see e.g., Schestopol i193
("cylinders (typically with an internal diameter of 7 mm and a wall thickness
of 1 mm) are typically cut into 1 cm long cylinders")).
FF 5. Examiner finds that Schestopol's core (14), or filling, comprises a
drug that "may be in powder form" (Final Act. 5; Schestopol i1 99).
FF 6. Examiner finds that Schestopol "does not disclose an outer casing
comprising a material that dissolves in a subject's body, or an outer casing
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Appeal2015-001396
Application 12/265,409
with at least two portions thinner than the remaining portions of the casing"
(Final Act. 4).
FF 7. Siadat discloses a"[ d]ouble walled polymer [drug delivery system]
with a [ c ]ore ... for colon-specific drug delivery" (Siadat, Abstract; Final
Act. 4; see Br. 7 ("Siadat discloses a double walled drug delivery system
intended for colon-specific delivery")).
FF 8. Siadat discloses: "Colon-specific drug delivery needs to protect the
drug during transit through the stomach and small intestine before allowing
rapid release on entry into the colon" (Siadat 1876; see Final Act. 4--5; see
Br. 7).
FF 9. Examiner finds that Siadat's device comprises "an external coat
comprising cross-linked copolymers ... wherein the degree of cross-linking
is controlled to tailor drug release from the dosage form[] ... , wherein the
external coat is a pH-sensitive hydrogel tailored to release the active
ingredient to the colon of a patient following oral ingestion" (Final. Act. 4--
5, citing Siadat 1876: third paragraph; 1879: lastparagraph-1880: first
paragraph, and 1881: last paragraph; see Ans. 4).
FF 10. Drake discloses "[a] device for the controlled release of an active
material into an aqueous medium, e.g. body fluids, compris[ing] ... a region
of reduced thickness which region dissolves before the remainder of the
container wall to release the active material" contained therein (Drake,
Abstract; Final Act. 5).
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Appeal2015-001396
Application 12/265,409
FF 11. Drake's Figures la and 6 are reproduced below:
Fig. 1a. Fig. 6.
12
Drake's FIG. la illustrates a
controlled release device compris[ing] a tubular capsule 11
formed from a water soluble glass composition and containing a
quantity of an active material 12. The wall of the capsule is
provided with a longitudinal groove 13 whereby a region 14 of
reduced wall thickness, i.e. of reduced resistance to solution
attack, is provided.
(Drake 1: 59---65; see generally Final Act. 5; Br. 7-8.) Drake's FIG. 6
illustrates a
device [wherein] the wall of the capsule comprises a first glass
48 of relatively low dissolution rate and a second glass 49,
forming a sector of the wall, of relatively high dissolution rate.
When the device is exposed to an aqueous medium the sector
comprising the high solubility glass 49 dissolves preferentially
to release the capsule contents.
(Drake 2: 27-34; Final Act. 5; see generally Br. 7-8.)
FF 12. Examiner finds that the combination of Schestopol and Siadat fails
to "disclose a capsule with a casing formed by two cup-shaped members"
(Final Act. 6).
6
49
Appeal2015-001396
Application 12/265,409
FF 13. Ayer "relates to a noninvasive monitoring system for monitoring the
release of a beneficial agent from an implanted osmotic drug delivery
system" (Ayer 1: 9-13; see generally Final Act. 6-7).
FF 14. Ayer's Figure 3 is reproduced below:
' . • • >
l •
/
42
FIG. 3
Ayer's "drug delivery system 40 shown in FIG. 3 includes [a]
housing having a single interior chamber 42 containing a
beneficial agent which is osmotically active or includes an
osmotic agent incorporated into the beneficial agent. The drug
delivery system housing includes at least one fluid permeable
wall 44 which allows fluid to pass into the chamber 42 but does
not allow the beneficial agent and osmotic agent to pass out
through the wall. The system 40 also includes a drug delivery
or exit passage 46 through which the beneficial agent it
delivered to the patient.
(Ayer 5: 2-12; see Final Act. 6-7.)
FF 15. Examiner finds that "the external cylinder of [Ayer's] delivery
system comprises separate first and second wall segments, wherein the wall
segments are telescopically joined to form the external cylinder and to define
an internal, beneficial agent-containing compartment" (Final Act. 7, citing
Ayer 3: 48-53; see generally Ayer, Fig. 3).
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Appeal2015-001396
Application 12/265,409
ANALYSIS
The rejection over the combination of Schestopol, Siadat, and Drake:
Based on the combination of Schestopol, Siadat, and Drake, Examiner
concludes that, at the time Appellant's invention was made, it would have
been prima facie obvious
to fabricate a capsule with inner and outer casings, wherein the
inner casing comprises a space filled with a powder, according
to the teachings of Schestopol [], wherein the outer casing
comprises a material capable of dissolving within a subject's
body as taught by Siadat [], and wherein the outer casing
comprises one or more thin portions capable of dissolving
before the remaining portions of the casing, as taught by Drake
... [for the reasonably expected benefit of] controlling release
of active species from a capsule drug form into the intestines[,
as suggested by Siadat, and] ... the added measure of control
of release from a dosage form achieved through the use of
thinner wall portions[, as suggested by Drake].
(Final Act. 5-6; see Ans. 4--5.)
As Examiner explains; "the rejection was based on modifying the
structure of Schestopol [] with a gastric-resistant material as the outer
coating for delivery of colon-specific drugs, as taught by Siadat" (Ans. 4--5;
see Final Act. 5---6; FF 2-9). Appellant fails to provide persuasive argument
or evidence to support a conclusion that the combination of Schestopol and
Siadat fails to make obvious the subject matter of Appellant's claim 1. See
In re Kronig, 539 F.2d 1300, 1302 (CCPA 1976) (the Board may rely upon
less than all the references cited by the Examiner).
Nevertheless, to be complete, we recognize Examiner's reliance on
Drake to provide a suggestion to modify the device suggested by the
combination of Schestopol and Siadat to further include "thin and/or quicker
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Appeal2015-001396
Application 12/265,409
dissolving regions, as taught by Drake" (Ans. 4--5; see Final Act. 5---6; FF 2-
11 ). Appellant contends that
[i]f the region of reduced thickness of Drake or the release
openings of Schestopol is applied to the drug delivery system of
Siadat, the drug may be released before entry into the colon,
and thus the drug may not be protected during the transit
through the stomach and small intestine.
(Br. 8.) In this regard, Appellant contends that "Siadat teaches away from
employing the region of reduced thickness or the release opening in the
colon-specific drug delivery system disclosed therein," because, "the colon-
specific drug delivery of Siadat needs to protect the drug during transit
through the stomach and small intestine before allowing rapid release on
entry into the colon" (id., citing Siadat 1876: 8-10). We are not persuaded.
Appellant fails to provide persuasive argument or evidence to support
a conclusion that the incorporation of a thin and/or quicker dissolving region
in the outer coating of a device suggested by the combination of Schestopol
and Siadat would result in the release of an active agent from the device
suggested by the combination of Schestopol, Siadat, and Drake prior to the
device reaching the colon. To the contrary, we find that the evidence of
record supports a conclusion that the combination of Schestopol, Siadat, and
Drake suggests a device for the specific delivery of active agent to the colon,
wherein the device comprises: (1) an outer coating designed prevent the
device from releasing the active agent, contained therein, until the device
reaches the colon and (2) thin and/or quicker dissolving regions in the outer
coating designed to facilitate the release of active agent from the device,
once it is in the colon (see Ans. 4--5; see Final Act. 5---6; FF 2-11 ).
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Appeal2015-001396
Application 12/265,409
We recognize Appellant's separate grouping of claims 4, 6-8, and 10,
but find that Appellant contends that these claims stand or fall with their
arguments regarding Appellant's claim 1 (see Br. 8).
The rejection over the combination of Schestopol, Siadat, and Ayer:
Based on the combination of Schestopol, Siadat, and Ayer, Examiner
concludes that, at the time Appellant's invention was made, it would have
been prima facie obvious
to fabricate a capsule with an outer casing according to
Schestopol [], wherein the casing is formed by two cup-shaped
members connected to each other . . . with a reasonable
expectation of success in so doing, by the simplicity of
manufacture and assembly offered by two-piece, cup-shaped
capsule segments.
(Final Act. 7.)
While Appellant recognizes the rejection over the combination of
Schestopol; Siadat; and Ayer; Appellant does not specifically address the
rejection (see Br. 3, 6, and 7; see generally id. at 1-9). Instead, Appellant
appears to rely upon the foregoing contentions regarding to the rejection
over the combination of Schestopol, Siadat, and Drake (see Br. 7-8; see
generally Br. 8 ("Based on the above arguments and remarks, [which
specifically address the combination of Schestopol, Siadat, and Drake,]
Appellant[] respectfully submit[ s] that the claims ... on appeal are not
obvious in light of the combination of Schestopol in view of Siadat and
Drake or Ayer")).
For the reasons discussed above, we are not persuaded by Appellant's
contentions with regard to the rejection over the combination of Schestopol,
Siadat, and Drake. In addition, for the reasons set forth above, Appellant
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Appeal2015-001396
Application 12/265,409
fails to establish that the combination of Schestopol and Siadat fails to make
obvious the subject matter of Appellant's claim 1. Appellant does not
separately argue Appellant's claim 5 (see Br. 8).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Schestopol, Siadat, and Drake is affirmed. Claims
4, 6-8, and 10 are not separately argued and fall with claim 1.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Schestopol, Siadat, and Ayer, is affirmed. Claim 5
is not separately argued and falls with claim 1.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
11