Ex Parte Sikes et al

Patent Trial and Appeal Board

Jan 18, 2013

12056689 (P.T.A.B. Jan. 18, 2013)

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.
12/056,689 03/27/2008 Courtney Sikes 06-0011US2 (4010/212) 9994
106953 7590 01/18/2013
Mayer & Williams
251 North Avenue West
Suite 201
Westfield, NJ 07090
EXAMINER
CRAIGO, WILLIAM A
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
01/18/2013 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)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte COURTNEY SIKES and MARK STECKEL
____________

Appeal 2011-011358
Application 12/056,689
Technology Center 1600
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1-14 and 16-25
(App. Br. 2; Reply Br. 2; Ans. 3). We have jurisdiction under 35 U.S.C.
§ 6(b).
STATEMENT OF THE CASE
The claims are directed to a medical device. Claims 1 and 24 are
representative and are reproduced in the Claims Appendix of Appellants’
Brief.

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Application 12/056,689

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Claims 1-5, 11, 13, 14, and 16-24 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of DeWitt
1
and Pacetti.
2

Claims 6-8 and 25 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of DeWitt, Pacetti, and Middleton.
3

Claims 9, 10, and 12 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of DeWitt, Pacetti, and Kunz.
4

We affirm.

The combination of DeWitt and Pacetti:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. DeWitt suggests a biodegradable coating system for medical devices,
such as a metal stent, that comprises multiple layers, such as different first
and second biodegradable polymer layers, which form “a bioactive agent
releasing coating” (Ans. 5; DeWitt 2: ¶ [0013], 20: ¶ [0203], and 27:
¶ [0267]).
FF 2. DeWitt suggests that a “bioactive agent can be present in the first
polymer, the second polymer, or both” (id. at 5-6; DeWitt 20: ¶ [0203]).

1
DeWitt et al., US 2006/0147491 A1, published July 6, 2006.
2
Pacetti et al., US 2006/0246108 A1, published November 2, 2006.

3
John C. Middleton and Arthur J. Tipton, Synthetic biodegradable polymers
as orthopedic devices, 21 BIOMATERIALS 2335-2346 (2000).

4
Kunz et al., US 6,663,881 B2, issued December 16, 2003.

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FF 3. DeWitt suggests that the bioactive agent “release kinetics profile …
can be adjusted by [the] polymeric composition and relative position of
individual polymer layers within the coating” (DeWitt 22: ¶ [0221]; Ans. 6).
FF 4. DeWitt suggests that “[i]n some embodiments, the second
biodegradable polymer has a slower bioactive agent release rate than the first
biodegradable polymer” (DeWitt 2: ¶ [0014] (emphasis added); see
generally App. Br. 6; see also Ans. 7 (DeWitt exemplifies a device that
differs from Appellants’ “claimed invention … by the orientation of the
layers on the device”)).
FF 5. DeWitt suggests that “the order of application of the coated layers
can be modified such that the first biodegradable polymer is utilized in an
outermost coated layer, while the second biodegradable polymer is utilized
in a coated layer at the device surface” (DeWitt 2: ¶ [0019] (emphasis
added); Ans. 16).
FF 6. DeWitt suggests that “the principle [sic] mode of degradation for
many of the biodegradable polymers (particular the lactide, glycolide, and
copolymers) is hydrolysis,” which “proceeds first by diffusion of water into
the material followed by random hydrolysis, fragmentation of the material,
and finally a more extensive hydrolysis…. The hydrolysis can be affected by
the size (i.e. polymer molecular weight), hydrophilicity and crystallinity of
the polymer” (Ans. 9-10 (emphasis added); DeWitt 21: ¶ [0208]).
FF 7. DeWitt suggests the coating layers may comprise, inter alia,
“poly(L-lactide), MW=100,000-150,000” and “poly(DL-lactide-co-
glycolide), MW=50,000-75,000” (Ans. 9; DeWitt 30: ¶ [0304]).
FF 8. Examiner finds that “[w]hile DeWitt … suggests lower crystallinity
polymers to provide elasticity to accommodate device expansion, DeWitt
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does not expressly teach amorphous biodegradable polymers; however,
amorphous biodegradable polymers were well known in the art at the time
the invention was made” as suggested by Pacetti (Ans. 8).
FF 9. Pacetti suggests that “the release of polymer crystallites at a late time
point once the amorphous polymer phase has degraded is associated with
increased late term inflammatory reactions” and therefore “suggests the use
of entirely amorphous polymers …[to] improve coatings b[y] reducing the
risk of this late term inflammatory reaction” (Ans. 8; Pacetti).
ANALYSIS
Based on the combination of DeWitt and Pacetti Examiner concludes
that, at the time Appellants’ invention was made, it would have been prima
facie obvious
[T]o combine the prior art elements of DeWitt and Pacetti
according to known methods to yield the predictable result of
providing a medical device as instantly claimed because DeWitt
provides a showing that a stent with a metallic substrate and
biodegradable coatings substantially the same as instantly
claimed were known and Pacetti expressly suggests the use of
amorphous polymeric coatings would improve known devices
by reducing the risk of late term inflammatory reactions after
medical device implantation. Further, Pacetti teaches
amorphous polymeric coatings for medical devices to
implement this teaching.
(Ans. 9.)
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Appellants provide separate arguments for the following groups of
claims: (I) Claims 1-5, 11, 13, 14, and 16-23; (II) Claim 24. Claims 1 and
24 are representative.
5

Claim 1:
We are not persuaded by Appellants’ contention that DeWitt teaches
away from the claimed invention because “claims 1 and 23 of DeWitt …
state that the second biodegradable polymer is selected to have a slower
bioactive agent release rate relative to the first biodegradable polymer”
(App. Br. 5 and 7-8; see also id. at 6 (“DeWitt teaches multi-layer coatings
wherein the second (upper) layer has a slower release rate than the first
(lower) layer”); Cf. FF 4 and 5). Appellants’ contentions discount DeWitt’s
suggestion that “[i]n some embodiments the second biodegradable polymer
has a slower bioactive agent release rate than the first” and that “the order of
application of the coated layers can be modified such that the first
biodegradable polymer is utilized in an outermost coated layer” (FF 4 and 5;
Cf. App. Br. 7-8).

5
We recognize, but have not considered, the contentions Appellants present
in their Reply Brief relating to claims not separately argued in their Principal
Brief on Appeal (see e.g., Reply Br. 10 (“Claims 5 and 20” (emphasis
removed)); id. at 11 (“Claims 7, 8, and 25” (emphasis removed)); and id. at
11-12; Cf. App. Br. 4-10). Appellants fail to explain why these contentions
were not presented earlier. See Ex parte Borden, 93 USPQ2d 1473, 1474
(BPAI 2010) (informative) (absent a showing of good cause, the Board is
not required to address “arguments that could have been made in the
principal brief on appeal … but were not”).
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We are not persuaded by Appellants’ contention that the second layer
suggested in DeWitt’s “Table 2 … does not contain any therapeutic agent”
(App. Br. 5; Cf. FF 2).
For the foregoing reasons, we are not persuaded by Appellants’
contention that Examiner’s rejection is based on hindsight reconstruction (id.
at 5-6).
We are not persuaded by Appellants’ unsupported intimation that a
person of ordinary skill in this art would not have combined DeWitt with
Pacetti, because “there are other good reasons to employ a polymer with
some degree of crystallinity as described in DeWitt” (App. Br. 7; Cf. FF 9).

Claim 24:
Appellants’ claim 24 requires, inter alia, a first polymer that has a
number average molecular weight that is at least two times that of the second
polymer (see Claim 24). Appellants contend that the combination of DeWitt
and Pacetti fails to teach this limitation of Appellants’ claim 24. We are not
persuaded.
DeWitt suggests the coating layers may comprise, inter alia, “poly(L-
lactide), MW=100,000-150,000” and “poly(DL-lactide-co-glycolide),
MW=50,000-75,000” (FF 7). Therefore, notwithstanding Appellants’
contention to the contrary, DeWitt suggests the use of polymers that have a
number average molecular weight that differ by at least two times within a
single device (id.; Cf. App. Br. 9). As discussed above, DeWitt suggests that
the placement of particular polymer layers is determined based on the
desired bioactive agent release kinetics profile (FF 3-6). Therefore, DeWitt
suggests to a person of ordinary skill in this art a first polymer having a
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number average molecular weight that is at least two times that of the second
(outer) polymer as is required by Appellants’ claim 24 (see Ans. 9-10).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claims 1 and 24 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of DeWitt and Pacetti is
affirmed. Claims 2-5, 11, 13, 14, and 16-23 are not separately argued and
fall with claim 1.

The combination of DeWitt, Pacetti, and Middleton:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
ANALYSIS
The claims were not separately argued and therefore stand or fall
together. Claim 6 is representative.
For the reasons set forth above, we find no deficiency in the
combination of DeWitt and Pacetti. Therefore, we are not persuaded by
Appellants’ contention that Middleton, “cited for its teachings regarding
poly(d,l-lactic acid), and poly(d,l-lactide-co-glycolide) with differing
monomer contents,” fails to make up for the deficiency in the combination
of DeWitt and Pacetti (App. Br. 9).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 6 under 35 U.S.C. § 103(a) as
unpatentable over the combination of DeWitt, Pacetti, and Middleton is
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affirmed. Claims 7, 8, and 25 are not separately argued and fall with claim
6.

The combination of DeWitt, Pacetti, and Kunz:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
ANALYSIS
The claims were not separately argued and therefore stand or fall
together. Claim 9 is representative.
For the reasons set forth above, we find no deficiency in the
combination of DeWitt and Pacetti. Therefore, we are not persuaded by
Appellants’ contention that Kunz, “cited for its teachings regarding how the
rate of degradation of a biodegradable matrix may be modified,” fails to
make up for the deficiency in the combination of DeWitt and Pacetti (App.
Br. 9).
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 9 under 35 U.S.C. § 103(a) as
unpatentable over the combination of DeWitt, Pacetti, and Kunz is affirmed.
Claims 10 and 11 are not separately argued and fall together with claim 9.

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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

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