Ex Parte Trollsas

Patent Trial and Appeal Board

Feb 21, 2018

11809059 (P.T.A.B. Feb. 21, 2018)

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.
11/809,059 05/30/2007 Mikael O. Trollsas 050623.00785 9221
45159 7590
SQUIRE PB (Abbott)
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
EXAMINER
KASSA, TIGABU
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
02/23/2018 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 MIKAEL O. TROLLSAS
Appeal 2017-002360
Application 11/809,0591
Technology Center 1600
Before DONALD E. ADAMS, DEBORAH KATZ, and DEVON
ZASTROW NEWMAN, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1 and 5—10
(App. Br. 2; see Ans. 2).2 Examiner entered a rejection under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies the real party in interest as “Abbott Cardiovascular
Systems Inc.” (App. Br. 2).
2 “[Cjlaims 4, 11, 12, and 15—22 [stand] withdrawn” (App. Br. 2; see Ans.
2).
Appeal 2017-002360
Application 11/809,059
STATEMENT OF THE CASE
Appellant’s disclosure “generally relates to a substituted
polycaprolactone for biomedical applications such as coating a stent” (Spec.
1:7-8).
Appellant’s originally filed claims 1 and 3 are reproduced below:
1. A coating on a medical device which comprises a substituted
polycaprolactone,
wherein the substituted polycaprolactone comprises units
comprising a structure selected from
Formula II
or
combinations thereof,
wherein:
x, y, and z are independent integers having values
ranging from 0-20;
n is an integer ranging from 1 to about 100,000;
Ri and R2 are independently hydrogen or C1-C20
substituents;
Ri and R2 cannot both be hydrogen; and
Ri, R2, x, y, and z are selected such that the structure of
Formulae I or II are not simultaneously a polylactic acid (PLA),
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Application 11/809,059
polyglycolic acid (PGA), polyhydroxybutyric acid (PBH),
polyhydroxyvaleric acid, valerolactone, caprolactone,
dioxanone or a copolymer thereof.
(Trollsas 20083 9-10.)
3. The coating of claim 1, wherein the substituted
polycaprolactone comprises a structure selected from
wherein R’ is hydrogen, a protective group or a short
chain alkyl group, and
wherein m is an integer independent from n ranging from
1 to about 100,000.
(Id. at 10-11.)
Examiner Restricted Appellant’s originally filed claims and required
Appellant to elect a species of coating (see January 6, 2009, Office Action).
In response, Appellant elected, inter alia,
[A] coating comprising this polymer
wherein R’ is a short chain alkyl group as the species of
coating.
(See Appellant’s January 15, 2009, Response to Restriction Requirement 11;
see Ans. 3; see generally Trollsas 2008, 10-11 (claim 3 (third structure,
wherein “n” and “m” are 1)).)
3 Trollsas, US 2008/0299164 Al, pub. Dec. 4, 2008.
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Application 11/809,059
During prosecution, however, Appellant amended the claims several
times after the foregoing species election, including amendments to claim 1
that ultimately result in the addition, as the last clause, the requirement that
“at least one Ri or R2 is a C1-C20 substituent comprising one or more
cyclohexyl, 1,4-dimethyl cyclohexyl, alkoxy, phenoxy, aryloxy, ketone,
ester, thioether, thioester, amide, amine, thiol, or phenol groups” (see
Appellant’s July 8, 2015, Response to Office Action 2; Appellant’s
September 19, 2014, Amendment; see also App. Br. 12).
Therefore, Appellant’s amended claim 1, as it appears in Appellant’s
Brief, is representative and reproduced below:
1. A coating on a medical device which comprises a substituted
polycaprolactone; wherein the substituted polycaprolactone
comprises units comprising a structure selected from
combinations thereof;
wherein:
x, y, and z are independent integers having values
ranging from 0-20;
n is an integer ranging from 1 to about 100,000;
Ri and R2 are independently hydrogen, C1-C20
substituents, or C1-C20 substituents comprising one or more
cyclohexyl, 1,4-dimethyl cyclohexyl, alkoxy, phenoxy, aryloxy,
ketone, ester, thioether, thioester, amide, amine, thiol, or phenol
groups;
Ri and R2 cannot both be hydrogen;
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Appeal 2017-002360
Application 11/809,059
Ri, R2, x, y, and z are selected such that the substituted
polycaprolactone is not a polylactic acid (PLA), polyglycolic
acid (PGA), polyhydroxybutyric acid (PBH),
polyhydroxyvaleric acid, valerolactone, caprolactone, or
dioxanone or where the substituted polycaprolactone is a
copolymer, the structure of Formulae I or II are not both a
polylactic acid (PLA), polyglycolic acid (PGA),
polyhydroxybutyric acid (PBH), polyhydroxyvaleric acid,
valerolactone, caprolactone, or dioxanone; and
at least one Rj or R2 is a C1-C20 substituent comprising
one or more cyclohexyl, 1,4-dimethyl cyclohexyl, alkoxy,
phenoxy, aryloxy, ketone, ester, thioether, thioester, amide,
amine, thiol, or phenol groups.
(App. Br. 12 (emphasis added).) Appellant’s claims 5—10 depend directly or
indirectly from Appellant’s claim 1 (see id. at 12—13; see also Reply Br. 6).
The claims stand rejected as follows:
Claims 1 and 5—10 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Chen,4 Trollsas 1999,5 Malmstrom,6
Grube,7 and Campbell.8
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
4 Chen et al., US 2007/0264307 Al, published Nov. 15, 2007.
5 Mikael Trollsas et al., Highly Branched Block Copolymers: Design,
Synthesis, and Morphology, 32 Macromolecules 4917 4924 (1999).
6 Eva Malmstrom et al., The effect of terminal alkyl chains on
hyperbranchedpolyesters based on 2,2-bis(hydroxymethyl)propionic acid,
197 Macromol. Chem. Phys. 3199-3207 (1996).
7 Eberhard Grube et al., Rapamycin Analogs for Stent-Based Local Drug
Delivery, 29 Herz 162—166 (2004).
8 Campbell et al., US 2005/0095267 Al, published May 5, 2005.
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Application 11/809,059
ANALYSIS
According to Examiner, Appellant’s claim 1, as presented in this
Appeal, requires:
R1 and R2 are independently hydrogen, [Cl]-C20
substitutes, or [C1J-C20 substituents comprising one or more
cyclohexyl, 1,4-dimethyl cyclohexyl, alkoxy, phenoxy, aryloxy,
detone, ester, thioether, thioester, amide, amine, thiol, or phenol
groups which . . . [reads on Appellant’s] elected species.
(Ans. 13; see id. (“[Appellant’s] elected species ... is still a structure
encompassed by [Appellant’s] claim 1[, as presented in this Appeal]”).)
We are not persuaded.
Examiner’s interpretation of Appellant’s claim 1 fails to account for
the last clause of the claim that requires:
at least one Ri or R2 is a C1-C20 substituent comprising
one or more cyclohexyl, 1,4-dimethyl cyclohexyl, alkoxy,
phenoxy, aryloxy, ketone, ester, thioether, thioester, amide,
amine, thiol, or phenol groups.
(App. Br. 12.)
As Appellant explains, “Chen does not teach or suggest using a
substituted polycaprolactone which has at least one C1-C20 substituent that
comprises one or more cyclohexyl, 1,4-dimethyl cyclohexyl, alkoxy,
phenoxy, aryloxy, ketone, ester, thioether, thioester, amide, amine, thiol, or
phenol groups, as recited in [Appellant’s] claim 1” and the combination of
Trollsas 1999, Malmstrom, Grube, and Campbell does “not cure the
deficiency of Chen” (App. Br. 8—9; see Reply Br. 5).
Although Examiner may be correct in finding that Trollsas 1999
teaches a previously claimed species of Appellant’s claimed invention,
Examiner failed to establish that the combination of Chen, Malmstrom,
Grube, and Campbell makes obvious a coating on a medical device that
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Application 11/809,059
comprises a substituted polycaprolactone, within the scope of Appellant’s
claimed invention as presented in this Appeal (see Ans. 13 (citing Trollsas
1999 4920: Table 2, sample entry 13 and 4918: Table 1, sample entry 10);
see generally Ans. 3—19). Therefore, we are not persuaded by Examiner’s
assertion that “[i]t would have been prima facie obvious to one of ordinary
skill in the art at the time the claimed invention was made to modify the
teachings of Chen et al. by specifically choosing the elected substituted
polycaprol[a]ctone because the specific elected caprolactone is taught by
[Trollsas 1999]” (Ans. 15—16 (emphasis added)).
Further, although Examiner asserts that Trollsas 1999 discloses “other
species that are encompassed by the structures recited in [Appellant’s] claim
1,” Examiner failed to identify a specific structure in Trollsas 1999 that
when applied in combination with Chen, Malmstrom, Grube, and Campbell
suggests a coating on a medical device that comprises a substituted
polycaprolactone, within the scope of Appellant’s claimed invention as
presented in this Appeal (see Ans. 16; see generally id. at 3—19).
The same is true of Examiner’s assertion that
[i]t should be clear [from Chen] that upon polymerization and
ring opening the modified caprolactone will convert into
polymers that contain a branched or linear alkyl, alkenyl or
alkynyl chain from Cl to Cl8, cyclic moieties having C3 to C8
including heterocycles of nitrogen, oxygen and sulfur and
combinations thereof which are substituent groups that are
recited in claim 1 for R1 and R2,
which fails to account for the last clause of Appellant’s claim 1 on Appeal
(see Ans. 18 (emphasis omitted)). As Appellant explains,
the claims as amended in the submission filed on September 19,
2014 no longer include the elected substituted polycaprolactone
copolymer because the definition of Ri and R2 has been
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Application 11/809,059
amended to further require “at least one Ri or R2 is a C1-C20
substituent comprising one or more cyclohexyl, 1,4-dimethyl
cyclohexyl, alkoxy, phenoxy, aryloxy, ketone, ester, thioether,
thioester, amide, amine, thiol, or phenol groups,” while the
previously elected substituted polycaprolactone does not have
any of the substituents.
[Thus,] even though claim 1 still recites Ri and R2 are
independently hydrogen, C1-C20 substituents, C1-C20
substituents comprising one or more cyclohexyl, 1,4-dimethyl
cyclohexyl, alkoxy, phenoxy, aryloxy, ketone, ester, thioether,
thioester, amide, amine, thiol, or phenol groups, the claim 1
further requires that "at least one Ri or R2 is a C1-C20
substituent comprising one or more cyclohexyl, 1,4-dimethyl
cyclohexyl, alkoxy, phenoxy, aryloxy, ketone, ester, thioether,
thioester, amide, amine, thiol, or phenol groups,” which
excludes the previously elected species.
(Reply Br. 5—6; see App. Br. 8.)
To be complete, we recognize Examiner’s finding that the
combination of Chen, Trollsas 1999, Malmstrom, Grube, and Campbell
suggests a compound comprising an alkoxyl group (see Ans. 19). As
Appellant makes clear, however, Examiner failed to establish that this prior
art suggests placing an alkoxyl group at an RI and/or R2 position, as is
required by Appellant’s claimed invention (App. Br. 9—10; see Reply Br. 6).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1 and 5—10
under 35 U.S.C. § 103(a) as unpatentable over the combination of Chen,
Trollsas 1999, Malmstrom, Grube, and Campbell is reversed.
REVERSED
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