Ex Parte Glauser et al

Patent Trial and Appeal Board

Mar 27, 2017

11171111 (P.T.A.B. Mar. 27, 2017)

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.
11/171,111 06/29/2005 Thierry Glauser 050623.00457 6446
03/29/201745159 7590
SQUIRE PB (Abbott)
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
EXAMINER
HELM, CARALYNNE E
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
03/29/2017 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):
sfripdocket @ squirepb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THIERRY GLAUSER and SYED FAIYAZ AHMED HOSSAINY
Appeal 2014-009419
Application 11/171,1111
Technology Center 1600
Before FRANCISCO C. PRATS, ELIZABETH A. LaVIER, and
KRISTI L. R. SAWERT, Administrative Patent Judges.
LaVIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner’s Final Rejections of claims 1, 5, 7—9, 11, 24, 29, and 31. We
have jurisdiction under 35 U.S.C. § 6(b). For the reasons set forth below, we
AFFIRM.
BACKGROUND
The Specification describes implantable devices, such as stents or
coatings thereon, “formed of a material that contains malolactonate derived
1 Appellants state the real party in interest is Abbott Cardiovascular Systems,
Inc. Appeal Br. 3.
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Application 11/171,111
repeating units.” Spec. 1:9—11. Claim 1, the only independent claim on
appeal, is illustrative:
1. A stent comprising:
a copolymer of formula:
wherein Z is O, S or NR1;
wherein W is absent, O, S, or NR2;
wherein R, R1 and R2 are each independently H, C1-C20
substituted or unsubstituted straight chain or branched
hydrocarbyl group, substituted or unsubstituted cyclic
hydrocarbyl group, substituted or unsubstituted
heterocyclic group, substituted or unsubstituted aromatic
group, substituted or unsubstituted heteroaromatic group,
a biobeneficial moiety, or a bioactive agent;
wherein the biobeneficial moiety is selected from the
group consisting of phosphoryl choline, poly(vinyl
pyrrolidone), heparin, heparin fragments, hyaluronic
acid, laminin, osteopontin, A, B- and C-natriuretic
peptide, CD-34 antibody, and combinations thereof;
wherein X is a positive number ranging from about 0.01
to about 0.99;
wherein Y is a positive number ranging from about 0.99
to about 0.01; and
one or more biocompatible polymers selected from the group
consisting of: polyacrylonitrile, polyvinyl ketones,
poly(hydroxypropyl methacrylate) (HPMA),
poly(hydroxypropyl methacrylamide), PEG acrylate (PEGA),
R (formula I);
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PEG methacrylate, and poly(2-methacryloyloxyethyl
phosphorylcholine) (MPC);
wherein the copolymer is provided as a coating on the stent.
Appeal Br. 10 (Claims Appendix).
REJECTIONS MAINTAINED ON APPEAL
1. Claims 1, 5, 7, 11, 24, 29, and 31 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Arnold,2 Lenz,3 Yewey,4 and
Parzuchowski.5 Final Action 3; see also Ans. 2.
2. Claims 1,8, and 9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Arnold, Lenz, Yewey, Parzuchowski, and
Rudakov.6 Final Action 7; see also Ans. 2.
DISCUSSION
Appellants focus their arguments on claim 1, and do not separately
argue any of the other claims. See Appeal Br. 8. Accordingly, we treat
claim 1 as representative, as to both rejections. See 37 C.F.R.
§ 41.37(c)(l)(iv). We agree with, and adopt, the Examiner’s reasoning and
conclusions that the claims are unpatentable as obvious over the cited prior
art references, as further described below.
2 Arnold et al., WO 2005/081752 A2, published Sept. 9, 2005.
3 Lenz et al., 4,320,753, issued Mar. 23, 1982.
4 Yewey et al., 5,744,153, issued Apr. 28, 1998.
5 Parzuchowski et al., Synthesis & Characterization of Polymethacrylate-
Based Nitric Oxide Donors, 124 J. Am. Chem. Soc. 12182 (2002).
6 Rudakov et al., US 6,451,050 Bl, issued Sept. 17, 2002.
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Application 11/171,111
1. Rejection 1
The Examiner relies on Arnold as teaching stents coated with a
polymer, to which a nitric oxide donor,7 specifically diazeniumdiolate, is
covalently attached along the backbone. Final Action 3 (citing Arnold
13, 57). Arnold discloses that the nitric oxide donor inhibits platelet
aggregation and smooth muscle cell proliferation. Id. (citing Arnold 1 62).
Arnold notes that “[a]ny of a wide variety of polymers can be used,” insofar
as “[i]t is only necessary that the polymer selected is biologically
acceptable.” Arnold 125. Arnold’s illustrative polymers include poly(D, L-
lactide), polyacrylonitrile, and poly(vinyl methyl ketone). Final Action 3
(citing Arnold 125). However, the Examiner notes that Arnold does not
provide “details of the attachment of a diazeneiumdiolate to a poly(D, F-
lactide) polymer,” nor does Arnold “explicitly teach the copolymerization of
malic acid with lactide in order to yield a polymer to which the
diazeniumdiolate can be covalently bound.” Id.
The Examiner turns to Fenz for teaching biodegradable copolymers
with units derived from malolactonate or malolactonic acid. Final Action 4
(citing Fenz 3:26—60). Fenz further describes attachment of
pharmaceuticals as pendant groups from the carboxylic acid side chains. Id.
(citing Fenz 1:54—2:8, Example 3). The Examiner also finds that Fenz
discloses that:
[ljactide can be included as a comonomer along with a mole
percentage of 5% to 90% malolactonate or malolactonic acid
which meets the limitations for X and Y (see column 3 lines 26-
30, 40, and 47-49; instant claim 1). Fenz et al. et al. teach the
7 The Specification lists nitric oxide donors among a set of exemplary
bioactive agents. Spec. 3:21—22.
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Application 11/171,111
instantly claimed Z and W moieties to be oxygen and the R
moiety to be a bioactive agent (see column 1 line 54—column 2
line 20; instant claims 1 and 5).
Id. In addition, Lenz’s polymers can be bound to therapeutic agents and
implanted into the body, where they are slowly released. Id. (citing Lenz
4:43—47, 4:60-62).
For further support, the Examiner relies on Yewey as “explicitly
envision[ing]” the use of poly(lactide-co-malolactonic acid) as a polymer
conjugated to a drug in solid implants (Final Action 4 (citing Yewey 14:46—
67)), and on Parzuchowski for teaching a process of attaching
diazeniumdiolate compounds to methyl acrylate monomers (id. at 4—5
(discussing Parzuchowski Schemes 1 and 2)).
The Examiner provides an extensive discussion to support the
rationale to combine the references as claimed. See Final Action 5—7. In
part, the Examiner states:
It would have been obvious to one of ordinary skill in the
art at the time of the invention to select a polymer of Lenz et al.
for the stent coating of Arnold et al. because both teach release
of therapeutic agents from a polymer that is facilitated by the
covalent binding of a bioactive to a polylactide polymer.
Further, Yewey et al. also teach such a copolymer for drug
delivery and to reduce drug burst from polymer vehicles (see
column 14 lines 46-50). In addition, the inclusion of malic acid
in the preparation of the poly(D, L-lactide) polymer of Arnold
et al. provides a simple avenue for attaching the
diazeniumdiolate of Arnold et al. along the polymer backbone
via the acid side chain provided by the malic acid monomers.
This would then facilitate the procedure taught by
Parzuchowski et al. where their diazeniumdiolate precursor is
protected reacted with the acid side chains of the malic acid,
then deprotected and exposed to nitric oxide which the yields a
carbon chain bound diazeniumdiolate as detailed by Arnold et
al. In light of the teachings of Lenz et al. and Yewey et al. it
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Application 11/171,111
would have been obvious to follow their direction and prepare a
copolymer of D, L-lactide and malolactonate monomer ffo[m]
the coating of Arnold et al., where the instantly claimed Z and
W moieties are oxygen and the R moiety is a bioactive agent.
Id. at 5—6.
Appellants present several arguments, none of which persuasively
demonstrates reversible error by the Examiner.
First, Appellants assert that the level of ordinary skill in the art “has
not been resolved by the Examiner.” Appeal Br. 6. The Examiner responds
that the rejections “implicitly resolved the level of ordinary skill via the prior
art that was cited and discussed.” Ans. 4. We agree, especially as
Appellants fail to articulate how this implicit finding is deficient, or present
evidence to that effect. See Okajima v. Bourdeau, 261 F.3d 1350, 1355
(Fed. Cir. 2001).
Appellants argue that Yewey, which describes nonaqueous liquid
polymer-drug conjugates that solidify to form solid implants when placed in
aqueous solution, fails to teach or suggest the use of such conjugates as
coatings for implants. Appeal Br. 7 (discussing Yewey 3:35—37).
According to Appellants, “envisioning the polymer in solid implants formed
in situ falls short of suggesting a coating on a stent.” Id. at 8; see also Reply
Br. 3. Appellants’ argument that Yewey fails to suggest coating stents is not
itself persuasive because it does not account for the Examiner’s combination
of Yewey with the other references, namely Arnold. See In re Keller, 642
F.2d 413, 426 (CCPA 1981) (“But one cannot show non-obviousness by
attacking references individually where, as here, the rejections are based on
combinations of references.”). Further, as the Examiner explains, “[t]he
rejection does not suggest employing the entire liquid composition of Yewey
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Application 11/171,111
et al. as a stent coating.” Ans. 4. Rather, Yewey highlights that “a
copolymer of malolactonic acid and lactide” and its drug conjugate, having
the structure of Appellants’formula I, can be implanted. Ans. 4. In other
words, Yewey demonstrates that a copolymer of formula I can be used
internally, for therapeutic purposes. And as discussed above, Arnold
broadly teaches a method of coating a stent with any “biologically
acceptable” polymer, expressly listing poly(D, L-lactide) as an illustrative
polymer. Arnold 125. This would have provided a reasonable expectation
of success in using a lactide-containing copolymer of Yewey for drug
delivery for a stent coating, as described in Arnold. See Ans. 5; cf. In re
O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988) (“Obviousness does not
require absolute predictability of success.”). Finally, we note that the
Examiner does not rely solely on Yewey as teaching polymers within the
scope of the instant formula I. Lenz, as discussed above, also describes such
polymers. See Final Action 4; see also Ans. 2—3.
As to Lenz specifically, Appellants argue only that “[t]he disclosure in
Lenz is similarly deficient [as Yewey’s], as this reference provides no
disclosure related to the coating of an implant with any polymer.” Appeal
Br. 7. The Examiner acknowledges that “a stent is not explicitly named as
an envisioned implant” in Lenz. Ans. 3. However, the Examiner explains
that Lenz is cited for its teaching of “local delivery of drugs from their
polymers in solid form via implantation of their polymers with bound
medication (see column 4 lines 51—54 and column 5 lines 29-40).” Id. As
explained above, Arnold, not Yewey or Lenz, provides the teaching of
coating a stent with a polymer, as well as a reasonable expectation in doing
so for a wide variety of polymers.
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Appellants maintain Parzuchowski fails to remedy the deficiencies of
Arnold, Lenz, and Yewey, but otherwise present no arguments regarding
Parzuchowski. See Appeal Br. 8. As we do not find the combination of
Arnold, Lenz, and Yewey to be deficient, this argument fails.
Accordingly, we are unpersuaded by Appellants’ arguments in favor
of the patentability of claim 1, and we affirm the rejection of claim 1.
Claims 5,1, 11, 24, 29, and 31 fall with claim 1.
2. Rejection 2
Appellants do not argue this rejection separately, except to state that
the teachings of the additional reference, Rudakov, do not cure the
deficiencies of Arnold, Lenz, and Yewey. See Appeal Br. 8. As we do not
find Arnold, Lenz, or Yewey to be deficient, this argument fails, and we
affirm the rejection of claim 1. Claims 8 and 9 fall with claim 1.
CONCLUSION
The rejections of claims 1, 5, 7—9, 11, 24, 29, and 31 are affirmed.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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