Ex Parte Santini et al

Board of Patent Appeals and Interferences

Sep 16, 2010

11041161 (B.P.A.I. Sep. 16, 2010)

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.
11/041,161 01/21/2005 John T. Santini JR. 17648-0028 6137
29052 7590 09/16/2010
SUTHERLAND ASBILL & BRENNAN LLP
999 PEACHTREE STREET, N.E.
ATLANTA, GA 30309
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
09/16/2010 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)
1

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte JOHN T. SANTINI, JR., MICHAEL J. CIMA,
ROBERT S. LANGER, and ACHIM GOPFERICH
____________________

Appeal 2009-009438
Application 11/041,161
Technology Center 3700
____________________

Before: LINDA E. HORNER, WILLIAM F. PATE III, and
FRED A. SILVERBERG, Administrative Patent Judges.

PATE III, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2009-003755
Application 11/041,161
2
STATEMENT OF CASE
This is an appeal from the final rejection of claims 27-49. These are
the only claims in the application. We have jurisdiction under 35 U.S.C.
§§ 134 and 6. The claimed subject matter is directed to a method of
implanting a structure having reservoirs of drugs which are released into the
body. The drugs are contained in a reservoir and dispersed in a matrix
therein. Claim 27, reproduced below, is further illustrative of the claimed
subject matter:
27. A method for local delivery of drug molecules in a
patient, the method comprising:
implanting at a site in a patient a drug delivery device
which comprises a support structure, at least two discrete
reservoirs provided in spaced positions across at least one
surface of the support structure, and a release system loaded in
each of the reservoirs, the release system including drug
molecules dispersed in a degradable matrix material; and
allowing the matrix material to disintegrate in vivo to
release the drug molecules from the reservoirs to the site in a
controlled manner.

REFERENCES
The references of record relied upon by the Examiner as evidence of
anticipation and obvious are:
Currie US 5,366,454 Nov. 22, 1994
Cima
Friedman
US 5,490,962
US 5,648,399
Feb. 13, 1996
Jul. 15, 1997
Cleland US 5,753,219 May 19, 1998
Langley US 5,801,140 Sep. 1, 19982

2 The Examiner includes Friedman, Cleland, and Langley in his
statement of Evidence Relied Upon, but these do not appear in the
statements of the rejections. We note that where a reference is relied on to
support a rejection, whether or not in a “minor capacity,” there would appear
Appeal 2009-003755
Application 11/041,161
3

REJECTIONS
Claims 27-29, 31-40, 42, 43 and 45-48 stand rejected under 35 U.S.C.
§ 102 as anticipated by Currie.
Claims 30 and 41 stand rejected under 35 U.S.C. § 103 as
unpatentable over Currie.
Claim 44 stands rejected under 35 U.S.C. § 103 as unpatentable over
Currie in view of Cima.
Claim 49 stands rejected under 35 U.S.C. § 103 as unpatentable over
Currie.

OPINION
We will not sustain the § 102 rejection on appeal. We are in
agreement with Appellants that Currie does not disclose a matrix material as
the term “matrix” is commonly understood. The medicine containing
compartment 16 of Currie is not disclosed as containing anything other than
the medicine. See, e.g., col. 1, l. 62 and col. 5, ll. 40-46. We acknowledge
the Examiner’s argument on page 3 of the Answer that the medicine could
be hormones or enzymes. However, it is our finding that the hormones or
enzymes are merely the medicine that is to be delivered by the implantable
device of Currie. The presence of a hormone or enzyme in the chamber
cannot satisfy the claim limitation directed to a matrix. Since Currie does
not disclose delivery of the medicine by disintegration, dispersion or
diffusion from a matrix inside the reservoir, as claimed, Currie lacks an

to be no excuse for not positively including the reference in the statement of
the rejection. In re Hoch, 428 F.2d 1341, 1342 n.3 (CCPA 1970).

Appeal 2009-003755
Application 11/041,161
4
essential element of independent claims 27 and 39 and cannot anticipate
these claims under § 102. For the same reason, Currie does not anticipate
dependent claims 28, 29, 31-38, 40, 42, 43, and 45-48 under § 102.
With respect to the rejection of claims 30, 41, and 49 under § 103, we
will not affirm these rejections either. Appellants’ argument that Currie
does not disclose the claimed matrix, and would not have rendered the
matrix prima facie obvious, convinces us that the rejections under § 103 are
not sustainable.
Likewise, the rejection of claim 44 under § 103 cannot be sustained.
The Examiner argues, on the one hand, that the use of the polymeric material
for the matrix is merely the selection of a known material for its intended
purpose and is an obvious matter of design choice. On the other hand, the
Examiner argues that the polymeric material disclosed in Currie would be
suitable as an adhesive. Neither of these contentions provides a reasonable
basis with rational underpinnings that would have suggested to one of
ordinary skill that the references be combined. The former is merely a per
se rule of obviousness, which rules are disdained by our reviewing court.
See In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). The latter reason
offered by the Examiner has no explanation attached, and it is therefore
difficult to determine the underlying basis for the rational underpinnings of
this rejection. Accordingly, the Examiner has not made a prima facie case of
obviousness with respect to the rejection of claim 44 under 35 U.S.C. § 103.

DECISION
The rejection of claims 27-29, 31-40, 42, 43, and 45-48 under 35
U.S.C. § 102 is reversed.
Appeal 2009-003755
Application 11/041,161
5
The rejections of claims 30, 41, 44, and 49 under 35 U.S.C. § 103 are
reversed.

REVERSED

nlk

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