Ex Parte Orlowski

Patent Trial and Appeal Board

Oct 22, 2018

13266059 (P.T.A.B. Oct. 22, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/266,059 02/14/2012 Michael Orlowski
22876 7590 10/24/2018
FACTOR INTELLECTUAL PROPERTY LAW GROUP, LTD.
1327W. WASHINGTON BLVD.
SUITE5G/H
CHICAGO, IL 60607
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.
9843-0004 4418
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
10/24/2018 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):
jmerritt@factoriplg.com
ysolis@factoriplg.com
cschroeder@factoriplg.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL ORLOWSKI 1
Appeal2017-010145
Application 13/266,059
Technology Center 3700
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and JEFFREY N.
FREDMAN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims related to a catheter balloon comprising a
coating of Paclitaxel and shellac. The Examiner rejected the claims as
obvious under 35 U.S.C. § 103 and on the grounds of obviousness type
double-patenting. Appellants appeal the rejections pursuant to 35 U.S.C. §
134. We have jurisdiction under 35 U.S.C. § 6(b). The obviousness
rejection is reversed and the double-patenting rejection is affirmed.
1 The Appeal Brief ("Br.") 1 identifies EuroCor GmbH as the real party in
interest.
Appeal2017-010145
Application 13/266,059
STATEMENT OF THE CASE
Claims 19--22 and 36-38 stand finally rejected by the Examiner as
follows:
1. Claims 19--22 and 36-38 under pre-AIA 35 U.S.C. § I03(a) as
obvious in view of Orlowski (WO 2008/089730 A2, published July 31,
2008)2 and Schomig (WO 2008/046641 A2, published Apr. 24, 2008). Ans.
3.
2. Claims 19-21, 36, and 37 are provisionally rejected on the ground
of obviousness type "non-statutory" double patenting as obvious over claims
1, 3, and 8-14 of copending Application No. 13/978,203 in view ofFukaya
(U.S. 6,613,066 Bl, issued Sept. 2, 2003). Ans. 3.
There are two independent claims on appeal, claims 19 and 38.
Claims 19 and 3 8 are directed to a catheter balloon comprising a coating of
Paclitaxel and shellac.
Claim 19 is illustrative and reads as follows:
19. A catheter balloon comprising a coating of Paclitaxel and
shellac wherein the coating is applied directly onto a balloon
surface.
OBVIOUSNESS IN VIEW OF ORLOWSKI AND SCHOMIG
Claim 19 is directed to a catheter balloon comprising "a coating of
Paclitaxel and shellac." The claim requires that "the coating is applied
directly onto a balloon surface." Paclitaxel is a therapeutic agent used to
treat reocclusion of the blood vessel after implantation of a stent, known as
"restenosis." Spec. 1 :9--27; 3:31-38. The Specification teaches that
2 Orlowski is a German language document. A machine translation of the
German into English was relied upon by the Examiner.
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Application 13/266,059
restenosis following stent implantation is one of the major causes for further
hospitalization. Id. at 1 :29-30.
The Specification teaches that, to address this problem, a catheter
balloon, coated with a pharmacological agent, had been used in the prior art
to dilate the blood vessel and deliver the agent to the vessel wall to prevent
restenosis. Spec. 2: 15-27. The Specification further teaches that while
Paclitaxel coated balloons have been utilized in the prior art, "the
disadvantage of the prior art coated dilatable catheter balloon is the
relatively long inflation time ( 60 s) needed to achieve a measurable
Paclitaxel penetration into the arterial wall ... [which] can cause prolonged
ischemia and arterial injury." Id. at 2:32-35. The Specification describes
failed attempts reported in the literature to use Paclitaxel on catheter
balloons to treat restenosis. Id. at 2:36-3 :34.
The Specification teaches that Schomig, the same publication cited in
the obviousness rejection, discloses stents coated with rapamycin and
shellac. Spec. 5 :21-23. Shellac is a natural resin produced by certain types
of insects. Id. at 9:21-29. The Specification teaches that shellac "had a
profound impact on stent-based rapamycin by protracting drug release long-
term." Id. at 5:23-24. According to the Specification, Schomig discloses:
Shellac was deemed to be useful to modulate the release
kinetics of an implant-based, e.g. stent-based compound to slow
the release kinetic (more than 60 days) that is required to
prevent in-stent restenosis at 6-9 months follow up.
Id. at 5:26-29.
In contrast, the Specification teaches that "retardation of drug release
is not favourable for a catheter balloon, where it is the main goal, in contrast
to a stent, to release as much of the coated drug in a time frame as short as
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Application 13/266,059
possible to shorten the inflation time to an absolute minimum." Spec. 5:31-
33. The Specification discloses that, in view of the teaching in Schomig:
[I]t was surprising and unexpected that a catheter balloon
coated with Paclitaxel and shellac resulted in a profound
increase of drug release compared to a catheter balloon that was
not coated with shellac. WO 2008/046641 [Schomig] rather
implied that shellac combined with a drug leads to a stable
formulation that releases the drug very slowly over a long time
period (months) and would not be suitable for fast drug release.
Id. at 5:34--39.
The Specification also discloses:
The use of a catheter balloon coated with Paclitaxel and shellac
resulted in an up to 20-fold higher tissue concentration as
compared with balloon types coated only with Paclitaxel,
reaching an optimal tissue concentration for inhibition of
smooth muscle cell proliferation. The balloon inflation time-
dependency study showed maximum tissue Paclitaxel
concentration after balloon inflation times of 30 s, with minimal
further increase in tissue drug concentration after 45 s, and
release of the drug into the circulation after a I -min inflation
time. The balloon inflation time of 30 s causes less arterial
injury and is better tolerated by patients in a clinical scenario.
Id. at 6:22-30.
Rejection
The Examiner found that Orlowski describes a balloon catheter coated
with paclitaxel, but not comprising shellac in the coating as required by all
the rejected claims. Final Act. 3. The Examiner found that Schomig, the
same publication discussed in the Specification, describes implants to be
used as depots for drugs to be released into surrounding tissues when
implanted into a subject. Id. The Examiner found that Schomig discloses
that the implant can be coated with shellac to provide superior durability and
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Application 13/266,059
hardness. Id. The Examiner determined that it would have been obvious to
one of ordinary skill in the art to have utilized shellac on Orlowski's balloon
catheter because shellac has "the advantage of improved efficacy and safety
of the device, and yields a coating which provides superior durability and
hardness." Id. at 4.
Discussion
Appellant argues, as discussed in the Specification and described
above, that Schomig teaches "that the use of shellac in conjunction with the
delivery system taught therein protracts and extends the delivery time of a
drug coated thereon," while a balloon catheter "requires delivery of a full
dosage of a drug at a very fast rate." Br. 11. For this reason, Appellant
argues that one of ordinary skill in the art would not have had reason to used
shellac on a balloon catheter because it slows down the release of drug
which is opposite to what is desired when a balloon catheter is used. Id. at
13.
As evidence that a short release of drug is desired on a balloon
catheter, Appellant cited disclosure from Orlowski:
To avoid these problems, it is also possible only by means of a
coated catheter balloon without stent a so-called "biological
stenting" perform, ie to make the vessel widening the narrowed
point by dilation of a coated catheter balloon, wherein during a
short Dilatationszeit [ dilation time of] the catheter balloon
sufficient pharmacological agent is transferred to the vessel
wall, due to the expansion vessel and the active substance
remains at a new transmission or a re-narrowing of the vessel
closure.
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Application 13/266,059
Paclitaxel as applied to a balloon catheter that [ c ]oating is
formed which is easily detached from the balloon, and can be
effectively transferred to the vessel wall.
Orlowski 1.
In contrast, Appellant cites disclosure in Schomig that the properties
of a preferred coating agent is one which is "slowly degraded in the human
body over several weeks, months or years." Schomig 5:31-33 (cited in
Appeal Brief at 14). Appellant also cited Figure 2 of Schomig which is said
to show:
. . . in a stent without a shellac coating, nearly 80% of the
rapamycin on the stent is released in about 12 days. In a stent
with a shellac coating, 80% of the rapamycin coating is not
released until about 28 days. According to this embodiment in
Schomig, utilizing a shellac coating more than doubles the
delivery time of the drug - a feature that is clearly undesirable
in view of the known requirements of balloon catheter delivery
systems.
Br. 14. The Examiner did not dispute Appellant's interpretation of Figure 2
of Schomig.
Appellant argues that Schomig "aims to create an implant which acts
as a drug delivery device which has a prolonged delivery time since the
implant will be permanently left in a patient." Br. 15. For this reason,
Appellant contends that one of ordinary skill in the art would not have
looked to Schomig' s teachings "when trying to develop a coating for a
balloon catheter which is only inserted into and dilated within a patient for a
very short period of time and therefore needs an almost instantaneous
transfer of a full dosage of a drug." Id. Citing Figures 1 and 2 of the
Specification, Appellant argues that the Specification provides evidence of
"the speed with which Paclitaxel is absorbed when coated on a balloon along
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Application 13/266,059
with shellac as required by claims 19, 3 6 and 3 8 in the present application."
Id. at 17.
The Examiner does not dispute Appellant's contentions that balloon
catheters are inflated for a short period of time during which a therapeutic
agent must be released rapidly in contrast to a stent which delivers an agent
for an extended period of time. Ans. 5. Rather, the Examiner responds that
the "cited prior art meets the structural limitations of the instant claims and it
is unclear how paclitaxel with shellac as disclosed in the prior art which
prolongs release of paclitaxel, has an opposing property of an immediate
release mechanism by simply coating another medical device." Id. at 4. The
Examiner states that Appellant is "arguing a release condition which is
immaterial because the instant claims do not recite any release conditions."
Id. at 5. The Examiner also states that Appellant "has not distinguished in
the claims how the same coating of paclitaxel with shellac as provided in the
prior art functions differently to get immediate release when the only
difference is coating another medical device with the same structure." Id.
In making an obviousness determination, "it can be important to
identify a reason that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the claimed new invention
does." KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 398,418 (2007). In this case,
the Examiner's reasoning is deficient because, as argued by Appellant, the
shellac coating described by Schomig is "slowly degraded in the human
body over several weeks, months or years" (Schomig 5:31-33) and
"retarded" drug release (id. at 26:5-10), while balloon catheters are used to
immediately release a drug (Spec. 2:7-13; Schomig 1 (see disclosure
reproduced above)). Thus, the Examiner did not provide adequate evidence
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that one of ordinary skill in the art would have sought to use shellac as
coating for a catheter balloon.
The Examiner questions the operability of the claim, namely, how
does the claimed catheter balloon using a shellac coating achieve a fast
release of paclitaxel over a short period when the same shellac coating used
in Schomig achieved a slow rate of drug release? The Examiner states that
"some essential subject matter" is missing from the claim. Ans. 4.
The Examiner did not establish by a preponderance of the evidence
that the claim is missing essential subject matter. As explained in the
Specification, and discussed above, the inventors found it was "very
surprising that a combination of Paclitaxel and shellac leads to a highly
useful catheter balloon" which had a rapid release of paclitaxel after a
balloon inflation time of only 30 seconds. Spec. 4: 37-5:8. The
Specification discloses:
It was highly surprising that by using a catheter balloon having
a catheter balloon coated with Paclitaxel and shellac effective
tissue Paclitaxel concentration were achieved after balloon·
inflation times of only 30 seconds (s), which causes less arterial
injury and is better tolerated by the patients in clinical scenario.
Id. at 5:5-8. The examples in the Specification describe a balloon catheter
coated with Paclitaxel and shellac. Id. at 26-28. The Examiner did not
direct us to evidence that anything other than Paclitaxel and shellac is
required by the claim to achieve the short release time.
With respect to the differences in release described in the
Specification and in Schomig, the structure which is claimed is not the same
as the structure described in the prior art, as asserted by the Examiner,
because none of the cited references describe a balloon catheter coated with
shellac and use it to deliver Paclitaxel as required by all the rejected claims.
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Application 13/266,059
The Examiner has not provided sufficient evidence to believe that a catheter
balloon coated with shellac and Paclitaxel, when rapidly dilated in a vessel,
would be expected to behave the same respect to drug release_as the
implanted stent described in Schomig which is coated with shellac and a
different drug. The Specification expressly discussed Schomig in its
disclosure (see above) and distinguished it. Spec. 5:21-6:16.
The evidence in the Specification of the "surprising" difference in
properties of the shellac and Paclitaxel coating on a balloon catheter (see
disclosure from Specification at 4:37-5:8 and 5:5-8 reproduced above) is
further evidence of the non-obviousness of the claimed subject matter. As
held in Leo Pharmaceutical v. Rea, 726 F.3d 1346, 1349-50 (Fed. Cir.
2013), "the objective indicia-taken in sum-are the most 'probative
evidence of nonobviousness ... enabl[ing] the court to avert the trap of
hindsight.' [Croes, Inc. v. Int'! Trade Comm'n, 598 F.3d 1294, 1310 (Fed.
Cir. 2010)]."
For the foregoing reasons, the rejection of independent claims 19 and
38, and dependent claims 20-22, 36, and 37 as obvious in view of Orlowski
and Schomig is reversed.
OBVIOUSNESS-TYPE DOUBLE PATENTING REJECTION
The Examiner identified the differences between the claimed subject
matter and the claims of the co-pending application 13/978,203. 3 Final Act.
9. The Examiner explained why the claimed subject matter would have been
obvious to one of ordinary skill in the art based on the claims of the co-
3 The '203 application issued as U.S. Patent 9,981,203 on May 29, 2018.
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pending application and the additionally cited Fukaya publication. Id. at 9--
10.
Appellant does not identify a defect in the Examiner's findings nor
provide reasoning as to why the rejected claims would not have been
obvious over the co-pending application. Rather, Appellant states "the
present application pre-dates application 13/978,203, Applicant submits ...
that the present invention belongs to the Applicant." Br. 18.
Appellant's argument is not persuasive. 35 U.S.C. § 101 has been
interpreted to permit only one patent to an inventor on the same invention.
The so-called "non-statutory" obviousness type double patenting rejection is
based on § 101, but the courts have interpreted the statute to prohibit a
second (or third, etc.) patent on inventions which are obvious based on the
claims of a first patent. The Examiner gave a reasoned explanation as to
why the rejected claims would have been obvious in view of the co-pending
application claims. Consequently, the rejection of claims 19--21, 36, and 37
is affirmed for the reasons set forth by the Examiner.
TIME 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). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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