Ex Parte Ruane et al

Patent Trial and Appeal Board

Mar 17, 2016

11958090 (P.T.A.B. Mar. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111958,090 12/17/2007
48004 7590 03/17/2016
EGL/Cook - Indianapolis
BRINKS GILSON & LIONE
CAPITAL CENTER, SUITE 1100
201 NORTH ILLINOIS STREET
INDIANAPOLIS, IN 46204-4220
FIRST NAMED INVENTOR
Patrick H. Ruane
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.
12730-328 (PA-6079-RFB) 1499
EXAMINER
SHARMA, YASHITA
ART UNIT PAPER NUMBER
3774
MAILDATE DELIVERY MODE
03/17/2016 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 parte1 PA TRICK H. RUANE, PRISCILLA REYES,
BLAYNE A. ROEDER, and AMY M. VIBBERT
Appeal2012-000553
Application 11/958,090
Technology Center 3700
Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge MITCHELL.
Opinion Concurring filed by Administrative Patent Judge ADAMS.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134 from the Examiner's
decision finally rejecting claims 10-17. We have jurisdiction over the
appeal under 35 U.S.C. § 6(b).
We reverse,
1 Appellants identify the Real Party in Interest as MED Institute, Inc. App.
Br. 1.
Appeal2012-000553
Application 11/958,090
STATEMENT OF THE CASE
The Specification is directed to implantable medical devices adapted
to release a therapeutic agent. Spec. i-f 2.
Claims 10-1 7 are on appeal, and are set forth in a Claims Appendix to
the Appeal Brief. App. Br. 26-27. Claim 10, the sole independent claim at
issue, is illustrative and reads as follows (emphasis added):
10. A coated tubular stent graft having an abluminal surface
with a surface area and a luminal surface defining a drainage
lumen, the coated stent graft comprising: a graft material
attached to a radially expandable support frame to form at least
a portion of both the luminal surface and the abluminal surface
of the coated tubular stent graft and a coating including a glycol
polymer on the portion of the graft material forming the
abluminal surface, the graft material containing about 5 - 100
micrograms of a taxane therapeutic agent per mm2 of the
surface area of the abluminal surface and a polyurethane
polymer comprising a polymer including polydimethylsiloxane
and a polyurethane, the stent graft having a weight ratio of the
taxane therapeutic agent to the glycol of between about 0.10
and 3.50.
The Examiner has rejected the claims as follows:
I. Claims 10-12, 14, 15, and 17 under 35 U.S.C. § 103(a) as
unpatentable over Dimatteo,2 Hunter,3 and Raze;4
2 Kristian Dimatteo and Robert C. Thistle, US 2003/0093141 Al, published
May 15, 2003.
3 William L. Hunter et al., US 2004/0260318 Al, published Dec. 23, 2004.
4 Brian Raze and David Tseng, US 2006/0020329 Al, published Jan. 26,
2006.
2
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Application 11/958,090
II. Claim 13 under 35 U.S.C. § 103(a) as unpatentable over
Dimatteo, Hunter, Raze, and Shakushiro; 5 and
III. Claims 16 and 17 under 35 U.S.C. § 103(a) as unpatentable
over Dimatteo, Hunter, Raze and Udipi. 6 Ans. 4--9.
I. Obviousness over Dimatteo, Hunter, and Raze
Addressing independent claim 10, the Examiner asserts that Dimatteo
teaches all the limitations except for "a polyurethane polymer comprising a
polymer including polydimethylsiloxane and a polyurethane" and "the stent
graft having a weight ratio of the taxane therapeutic agent to the glycol of
between about 0.10 and 3.50." Ans. 4--5. The Examiner relies on Raze for
teaching a graft "comprising a polyurethane polymer comprising a polymer
including polydimethylsiloxane and polyurethane." Id. at 7.
The Examiner relies on Hunter for teaching "the stent graft having a
weight ratio of the taxane therapeutic agent to the glycol of between about
0.10 and 3.50," stating because
Hunter teaches the polymer and drug agent ratio can be
controlled by controlling the combination of the two elements
(pg. 48, par. 0309), it would have been an obvious matter of
design choice to modify the teaching of the Hunter reference, to
have a weight ratio of the taxane therapeutic agent to the glycol
of between about 0.10 and 3.50, since appellant has not
disclosed that having this particular ratio[] of0.10 and 3.50
solves any stated problem or is for any particular purpose and it
appears that the device would perform equally well with [ o ]ther
designs.
5 Kiyoski Shakushiro et al., US 5,227,043, issued Jul. 13, 1993.
6 Kishore Udipi et al., US 6,918,929 B2, issued Jul. 19, 2005.
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Application 11/958,090
Furthermore, absent a teaching as to criticality that a
weight ratio of the taxane therapeutic agent to the glycol has to
be between about 0.10 and 3.50, this particular arrangement is
deemed to have been known by those skilled in the art since the
instant specification and evidence of record fail to attribute any
significance (novel or unexpected results) to a particular
arrangement.
Ans. 6 (citing In re Kuhle, 526 F.2d 553, 555 (CCPA 1975)).
Appellants counter that the Examiner admits that the combination of
references fails to teach or suggest a stent graft having the claimed weight
ratio of a taxane therapeutic agent to glycol, and has failed to establish that
this claimed ratio is merely a design choice. App. Br. 8, 11-15. According
to Appellants, the Specification explains
the ratio of taxane therapeutic agent to the glycol is important to
successful loading of the stent graft device on the deployment
system and successful deployment of the stent graft within the
body vessel while maintaining its intended elution rate for
optimal therapeutic purposes.
Id. at 9-10 (citing Spec. i-f 151 ). Appellants conclude as follows:
As Table 13 clearly shows, with stent grafts having the
ratio of the claimed invention, large amounts of the therapeutic
agent can be loaded into the device for delivery to the treatment
sites without undesirable consequences to loading, deployment
or elution rates as found with stent grafts having similar
amounts of the therapeutic agent but lacking the claimed ratio.
Id. at 10 (emphasis omitted).
The Examiner responds that the claimed "weight ratio of the taxane
therapeutic agent to the glycol of between about 0.10 and 3.50" would be
obvious because "Hunter teaches the polymer and drug agent ratio can be
controlled by controlling the combination of the two elements." Ans. 10
4
Appeal2012-000553
Application 11/958,090
(citing Hunter, 48 i-f 309). The Examiner further responds that the data
contained in Table 13 of Appellants' Specification "does not disclose
criticality" of the "very broad range of 'about 0.10-3.50"' as recited in claim
10. Ans. 10.
In response, Appellants contend that because none of the cited
references recognize that the claimed weight ratio of taxane therapeutic
agent to glycol polymer is a result-effective variable, the Examiner has
improperly shifted the burden of demonstrating the criticality of the claimed
range. Reply Br. 8-9. Specifically, Appellants note that the Examiner has
not demonstrated that Hunter, or other prior art references "recognize that
the ratio of taxane therapeutic agent to glycol polymer was important in
preventing damage to the stent graft to avoid possible loss of the therapeutic
agent during deployment and/or alteration of the elution rate of the agent
after deployment." Id.
We agree with Appellants that the obviousness rejection should be
reversed. As correctly expressed by Appellants, the Examiner "has not
shown that the claimed weight ratios would be discovered by one of
ordinary skill in the art by routine experimentation." Reply Br. 8. "[\V]hile
it may ordinarily be the case that the detennination of optimum values for
the parnrneters of a prior art process would be at least prima facie obvious,
that conclusion depends upon what the prior art discloses with respect to
those parameters." in re Sebek, 465 F.2d 904, 907 (CCPA 1972). On this
recon..1, the prior art fails to disclose the claimed weight ratio of the taxane
therapeutic agent to the glycol~ let alone suggest that this ratio is important
to consider when one is interested in preventing physical damage to the stent
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Appeal2012-000553
Application 11/958,090
graft, resulting in the possible loss of the therapeutic agent during
deployment and/or alteration of the agent's elution rate after deployment, i.e)
that the ratio of the taxane therapeutic agent to the glycol is a result-etlective
variable. Thus, the Exarniner failed to establish an evidentiarv basis to ' v
support a conclusion that the claimed ratio would have been obvious. See In
re Antonie, 559 F.2d 618, 620 (CCPA 1977) (finding an exception to "the
rule that the discovery of an optirnum value of a variable in a known process
is nonna11y obvious" when "the parameter optimized was not recognized to
be a result-effective variable").
Further, even if the Examiner properly shifted the burden to
Appellants to demonstrate the criticality of the claimed range, the Examiner
has not demonstrated on this record how Appellants' proffered data fails to
do so. Specifically, the Examiner states that "[c]laim 10 requires a very
broad range of 'about 0.10-3.50' and the specification does not disclose
[the] criticality of such a broad range." Ans. 10. We disagree with the
Examiner. Referring to Table 13, the Specification describes the successful
deployment of coated stent grafts having a ratio of paclitaxel to polyethylene
glycol (PEG) of 0.74--3.28, with grafts at ratios higher than about 3.6 being
more difficult to deploy without damage to the graft material. Spec. i-f 151;
see also Appeal Br. 9-10. In other words, as Appellants have correctly
asserted, the Specification provides a weight-ratio range that encompasses
the range recited by claim 10, and further explains the importance or
criticality of that range to achieve successful deployment without damaging
graft material.
6
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Application 11/958,090
Therefore, for the reasons expressed in the Appeal and Reply Briefs,
and as outlined above, we do not sustain the Examiner's rejection of
independent claim 10 as obvious over Dimatteo, Hunter and Raze. For the
same reasons, we also do not sustain the Examiner's rejection of dependent
claims 11, 12, 14, 15 and 17. "[D]ependent claims are nonobvious if the
independent claims from which they depend are nonobvious." In re Fritch,
972 F.2d 1260, 1266 (Fed. Cir. 1992).
II. Obviousness over Dimatteo, Hunter, Raze, and Shakushiro I Udipi
Addressing claim 13, the Examiner finds that Dimatteo, Hunter and
Raze teach all the limitations "except for the glycol polymer is poly( ethylene
glycol) with a weight average molecular weight in the range from 100 to
about 10,000." Ans. 8. To address this deficiency, the Examiner relies on
the Shakushiro reference. Id.
Addressing claims 16 and 17, the Examiner finds that Dimatteo,
Hunter and Raze teach all the limitations except for those that require the
graft material to comprise 5-100 milligrams of poly( ethylene glycol), and
about 1--40 micrograms poly( ethylene glycol) per mm2 of the abluminal
surface area. Ans. 9. The Examiner relies on the Udipi reference to remedy
this deficiency. Id.
Claims 13, 16 and 17 depend either directly or ultimately from
independent claim 10, and neither Shakushiro nor Udipi is relied on by the
Examiner for what we find lacking in the Examiner's rejection of claim
10---a teaching for the stent graft to have a weight ratio of the taxane
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Appeal2012-000553
Application 11/958,090
therapeutic agent to the glycol between about 0.10 and 3.50, or some
suggestion that the ratio is a result-effective variable.
Accordingly, for the reasons expressed above in our discussion of the
rejection of independent claim 10, we also reverse the Examiner's rejections
of claims 13, 16 and 17.
SUMMARY
We reverse the rejection of claims 10-12, 14, 15 and 17 under 35
U.S.C. § 103(a) as unpatentable over Dimatteo, Hunter, and Raze.
We reverse the rejection of claim 13 under 35 U.S.C. § 103(a) as
unpatentable over Dimatteo, Hunter, Raze, and Shakushiro.
We reverse the rejection of claims 16 and 17 under 35 U.S.C. § 103(a)
as unpatentable over Dimatteo, Hunter, and Raze, and Udipi.
APJ Initials:
SLCM
EAF
PL Initials:
kmm
REVERSED
8
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PA TRICK H. RUANE, PRISCILLA REYES,
BLAYNE A. ROEDER, and AMY M. VIBBERT
Appeal2012-000553
Application 11/958,090
Technology Center 3700
Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.
ADAMS, Administrative Patent Judge, concurring.
DECISION ON APPEAL 7
This appeal under 35 U.S.C. § 134(a) involves claims 10-17 (see
App. Br. 3).8 Examiner entered rejections under 35 U.S.C. § 103(a). This
Panel has jurisdiction over the appeal under 35 U.S.C. § 6(b ).
7 Appellants identify the Real Party in Interest as "MED Institute, Inc."
(App. Br. 1.)
8 Claims 1-9 and 18-20 stand withdrawn from consideration (App. Br. 3).
Appeal2012-000553
Application 11/958,090
STATEMENT OF THE CASE
Appellants' "invention relates to medical devices for implantation in a
body vessel. More particularly, ... to implantable medical devices adapted
to release a therapeutic agent" (Spec. i-f 2). Claim 10 is representative and
reproduced in the Claims Appendix of Appellants' Brief.
Claims 10-12, 14, 15, and 17 under 35 U.S.C. § 103(a) as
unpatentable over Dimatteo,9 Hunter, 10 and Raze. 11
Claim 13 under 35 U.S.C. § 103(a) as unpatentable over Dimatteo,
Hunter, Raze, and Shakushiro. 12
Claims 16 and 17 under 35 U.S.C. § 103(a) as unpatentable over
Dimatteo, Hunter, Raze and Udipi. 13
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Examiner finds that Dimatteo fails to disclose, inter alia, a coated
tubular stent graft, but fails to suggest, inter alia, "a weight ratio of [] taxane
therapeutic agent to[] glycol of between about 0.10 and 3.50" (see Ans. 4--
5).
9 Kristian Dimatteo and Robert C. Thistle, US 2003/0093141 Al, published
May 15, 2003.
10 William L. Hunter et al., US 2004/0260318 Al, published Dec. 23, 2004.
11 Brian Raze and David Tseng, US 2006/0020329 Al, published Jan. 26,
2006.
12 Kiyoaki Shakushiro et al., US 5,227,043, issued July 13, 1993.
13 Kishore Udipi et al., US 6,918,929 B2, issued July 19, 2005.
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Application 11/958,090
FF 2. Hunter discloses the incorporation of "an anti-scarring agent (e.g.,
paclitaxel) ... into a carrier[, or stent graft coating,] that includes a
polyurethane" (see Hunter i-f 313; Ans. 5).
FF 3. Hunter discloses the application of the taxane paclitaxel to a "device
surface at a dose of about 0.25 µg/mm2 to about 5 µg/mm2" (Hunter i-f 385;
see generally Ans. 5---6 and 10).
FF 4. Hunter discloses that
active agents can be imbibed into a surface hybrid polymer
layer, or incorporated directly into the hybrid polymer coating
solutions. Imbibing drugs into surface polymer layers is an
efficient method for evaluating polymer-drug performance in
the laboratory, but for commercial production it may be
preferred for the polymer and drug to be premixed in the
casting mixture. Greater efficacy can be achieved by
combining the two elements in the coating mixtures in order to
control the ratio of active agent to polymer in the coatings.
Such ratios are important parameters to the final properties of
the medicated layers, i.e., they allow for better control of active
agent concentration and duration of pharmacological activity.
(Hunter i-f 309; see Ans. 6 and 10.)
FF 5. Examiner finds that Appellants' Specification "disclose[s] the ratios
[of] ... 'about 1.34 to 3.28,' and, '0.74-3.28"' and "the criticality of these
ranges and the advantages and purposes of these ranges when loading the
stent graft with [a] therapeutic agent to prevent undesirable consequences to
loading, deployment or elution rates" (Ans. 10 and 12; see Spec. i-f 151).
FF 6. Examiner finds that the combination of Dimatteo and Hunter fails to
suggest a "graft comprising a polyurethane polymer comprising a polymer
including polydimethylsiloxane and a polyurethane" and relies on Raze to
make up for this deficiency in the combination of Dimatteo and Hunter
(Ans. 7).
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Appeal2012-000553
Application 11/958,090
FF 7. Examiner finds that the combination of Dimatteo, Hunter, and Raze
fails to suggest a "glycol polymer [that] is poly( ethylene glycol) with a
weight average molecular weight in the range from 100 to about 10,000" and
relies on Shakushiro to make up for this deficiency in the combination of
Dimatteo, Hunter, and Raze (Ans. 8 and 13).
FF 8. Examiner finds that the combination of Dimatteo, Hunter, and Raze
fails to suggest a "graft material [that] comprises a total of 5 - 100
milligrams of[] poly( ethylene glycol) and about 1-40 micrograms
poly( ethylene glycol) per mm2 of the abluminal surface area" (Ans. 8-9).
FF 9. Udipi discloses
[a] drug-polymer coated stent, comprising: a stent framework;
and a drug-polymer coating disposed on the stent framework,
wherein the drug-poymer coating comprises a styrenic block
copolymer grafted with polyethylene glycol; and a bioactive
drug dispersed within the drug-polymer coating, wherein the
grafted styrenic block copolymer comprises a chain length of
the styrenic block copolymer, a chain length of the polyethylene
glycol grafts, and a polyethylene glycol based on a
predetermined elution rate of the bioactive drug.
(Udipi 12:37--44 and 47-51 (claim 30); cf Ans. 9.)
FF 10. Udipi discloses that a "polymeric coating includes between 0.5
percent and 50 percent of the bioactive agent of drug by weight" (Udipi
5:26-29; see Ans. 9; see also Ans. 13 ("Udipi is[] relied on for the teaching
of the total weight ratio of about 0.1-1.50 since Udipi discloses polyethylene
glycol graft including 0.50-50 % or 0.5 total drug by weight or total
paclitaxel to total polyethylene glycol weight ratio")).
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Application 11/958,090
ANALYSIS
The rejection over the combination of Dimatteo, Hunter, and Raze:
Based on the combination of Dimatteo, Hunter, and Raze, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious
to modify the teaching of the Hunter reference, to have a weight
ratio of the taxane therapeutic agent to the glycol of between
about 0.10 and 3.50, since appellant has not disclosed that ...
th[ e] particular ratio[] of 0.10 and 3 .50 solves any stated
problem or is for any particular purpose and it appears that the
device would perform equally well with either [a ratio of0.10
or 3.50].
(Ans. 6.) I am not persuaded. "[R]ejections on obviousness grounds cannot
be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
On this record, Examiner recognizes that Appellants' disclosure
establishes that the weight ratio of taxane therapeutic agent to glycol on a
coated tubular stent provides advantages and "prevents undesirable
consequences to loading, deployment or elution rates" (FF 5; see App. Br.
9-10; Reply Br. 5---6). Therefore, I am not persuaded by Examiner's
unsupported conclusion that even though the combination of Dimatteo,
Hunter, and Raze fails to suggest a "stent graft having a weight ratio of the
taxane therapeutic agent to the glycol of between about 0.10 and 3.50," such
a range would have been obvious to a person of ordinary skill in this art
because Appellants fail to establish that the ratio of polymer-to-drug is
critical, or otherwise important (Ans. 6 and 10-11; see App. Br. 10 (the
combination of Dimatteo, Hunter, and Raze fails to "suggest a stent graft
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Application 11/958,090
having a weight ratio of a taxane therapeutic agent to glycol of between
about 0.1 and 3.50")).
In addition, I am not persuaded by Examiner's attempt to bridge the
evidentiary void on this record by relying on Hunter's generic disclosure that
polymer-to-drug "ratios are important parameters to the final properties of
the medicated layers, i.e., they allow for better control of active agent
concentration and duration of pharmacological activity" (FF 4; see Reply Br.
3). In this regard, while it may be true that "it is not inventive to discover
the optimum or workable ranges by routing experimentation" when "the
general conditions of a claim are disclosed in the prior art," on this record,
Examiner failed to establish an evidentiary basis to support a conclusion that
the general conditions (i.e. ratios) were disclosed in the art relied upon by
Examiner (see generally App. Br. 14--15; Reply Br. 3--4 and 8-9). See In re
Aller, 220 F.2d 454, 456 (CCPA 1955); cf In re Sebek, 465 F.2d 904, 907
(CCP A 1972). Therefore, I am not persuaded by Examiner's unsupported
assertion that "[a]ny ratio chosen in Hunter would be 'about' 0.1-3.5 since
the about limitation allows for ratios outside of the range to be selected"
(Ans. 11 ). In my opinion, the term "about" does not, on this record, open
the claimed range so far as to read on any polymer-to-drug ratio that may
fall within Hunter's broad disclosure (see FF 4).
Lastly, Examiner recognizes that the ratio of polymer-to-drug on the
stent graft is important (FF 5). Therefore, I am not persuaded by Examiner's
assertion that the combination of Dimatteo, Hunter, and Raze suggests a
stent graft as required by Appellants' claimed invention, because
Appellants' fail to specifically disclose the importance of a polymer-to-drug
ratio of0.10 and 3.50 (see Ans. 6; see also id. at 10-11).
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Application 11/958,090
The rejection over the combination ofDimatteo, Hunter, Raze, and
Shakushiro:
Based on the combination of Dimatteo, Hunter, Raze, and Shakushiro,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious "to modify the graft" suggested by the
combination of Dimatteo, Hunter, and Raze "to include poly( ethylene
glycol) with a weight average molecular weight in the range from 100 to
about 10,000, for the purpose of a polymer with sufficient molecular weight
to allow for proper delivery of therapeutic agents" (Ans. 8). I am not
persuaded. Examiner failed to establish an evidentiary basis on this record
to support a conclusion that Shakushiro makes up for the foregoing
deficiency in the combination of Dimatteo, Hunter, and Raze (FF 7; App.
Br. 19).
The rejection over the combination of Dimatteo, Hunter, Raze, and Udipi:
Based on the combination of Dimatteo, Hunter, Raze, and Udipi,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious to modify the graft suggested by the
combination of Dimatteo, Hunter, and Raze "to include a total of 5 - 100
milligrams of the poly( ethylene glycol) and about 5 - 100 micrograms
poly( ethylene glycol)[, or alternatively about 1 - 40 micrograms
poly( ethylene glycol),] per mm2 of the abluminal surface area, for the
purpose of providing sufficient polymer to allow for proper elution of the
drug" (Ans. 9). Examiner fails, however, to identify an evidentiary basis on
this record to support Examiner's conclusion (see FF 1-6 and 8-10; see
App. Br. 20-21 ).
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CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
Therefore, I agree that the rejections of record should be reversed.
REVERSED
8