Ex Parte Yun

Patent Trial and Appeal Board

Aug 21, 2017

11343940 (P.T.A.B. Aug. 21, 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.
11/343,940 01/30/2006 Anthony Joonkyoo Yun PALO-010 6659
93726 7590 08/23/2017
EPA - Bozicevic Field & Francis LLP
Bozicevic, Field & Francis
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
SZNAIDMAN, MARCOS L
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
08/23/2017 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTHONY JOONKYOO YUN1
Appeal 2016-006541
Application 11/343,940
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES and RYAN H. FLAX,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating atherosclerosis, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification discloses “a method for treating or preventing
vessel disease or derangement. . . . The method involves administration of
agents whose sole objective consists of altering the biology within the
1 Appellant identifies the Real Party in Interest as Palo Alto Investors.
(Appeal Br. 3.)
Appeal 2016-006541
Application 11/343,940
adventitia, the outer layer of the blood vessel wall. These agents may be
administered or applied directly to the vessel.” (Spec. 5:28 to 6:2.)
Claims 1, 13, 41—44, 46, 48, 49, and 51—55 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A method of treating a subject for atherosclerosis, said method
consisting of:
modulating inflammatory activity of the adventitial tissue of a target
artery of said subject by direct application of a pharmacological agent from
an extravascular location to the surface of the adventitia at an affected
portion of the target artery while avoiding a disturbance of extant
derangement within the target artery, and in a manner effective to treat
atherosclerosis.
The claims stand rejected as follows:
Claims 1, 13, 43, 46, 48, 49, and 51—53 under 35 U.S.C. § 103(a) as
obvious based on Signore,2 Jukema,3 Seward,4 and Pliquett5 (Ans. 4);
Claims 41 and 42 under 35 U.S.C. § 103(a) as obvious based on
Signore, Jukema, Seward, Pliquett, and Gothoskar6 (Ans. 8);
Claim 44 under 35 U.S.C. § 103(a) as obvious based on Signore,
Jukema, Seward, Pliquett, and Holme7 (Ans. 8—9); and
2 Signore US 2003/0126758 Al, Nov. 20, 2003.
3 Jukema, “Amlodipine and atorvastatin in atherosclerosis: a review of the
potential of combination therapy, ” 5(2) Expert Opin. Phamacother. 459—
468 (2004).
4 Seward et al. US 203/0171734 Al, Sept. 11, 2003.
5 Pliquett, “Statin therapy restores sympathovagal balance in experimental
heart failure” 95 J. Appl. Physiol 700-704 (2003).
6 Gothoskar, “Pulsatile Delivery,” 4(5) Pulsatile Drug Delivery
Systems: A Review (2004).
7 Holme, US 5,296,471, Mar. 22, 1994.
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Appeal 2016-006541
Application 11/343,940
Claims 54 and 55 under 35 U.S.C. § 103(a) as obvious based on
Signore, Jukema, Seward, Pliquett, and Uhrich8 (Ans. 8—9).
DISCUSSION
The Examiner has rejected all of the claims on appeal as obvious
based on Signore, Jukema, Seward, and Pliquett, by themselves or combined
with either Gothoskar, Holme, or Uhrich. The same issue is dispositive for
all of the rejections.
The Examiner finds that “Signore describe[s] arterial patches
embedded with various agents. . . . The patches are taught to be used . . .
[by] placing the patch on the external aspect of a blood vessel to close an
incision or cut to the vessel.” (Ans. 5.) The Examiner finds that Signore
“does not teach utilizing these patches to treat atherosclerosis.” {Id. at 6.)
However, the Examiner finds that Seward “describe[s] a method for treating
atherosclerotic arteries comprising positioning a microneedle at a targeted
location (e.g. an atherosclerotic artery), piercing the arterial wall with said
microneedle, and delivering an active agent through the microneedle to
directly administer the agents to the adventitia of the target artery.” {Id. at
6—7.) The Examiner concludes that these teachings would have made the
claimed method obvious to one of ordinary skill in the art. {Id. at 7.9)
8 Uhrich, “Polymeric systems for controlled drug- release99 Chem. Rev.
3181-3198 (1999).
9 The Examiner cites Jukema for its disclosure that statins and calcium
channel blockers are effective treatments for atherosclerosis, and cites
Pliquett for its teaching that statins affect the autonomic nervous system.
(Ans. 6.) However, claim 1 does not require these specific agents and
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Appeal 2016-006541
Application 11/343,940
Appellant argues that
the only step of the recited method of treating
atherosclerosis is direct application of a pharmacological agent
from an extravascular location to the surface of the adventitia at
an affected portion of the target artery while avoiding a
disturbance of extant derangement within the target artery. The
claim excludes steps not specifically recited in the claims.
(Appeal Br. 5.) Appellant argues that both Signore and Seward disclose
methods that include steps in addition to application of a pharmacological
agent to the adventitia of a blood vessel. {Id. at 5—6.)
We agree with Appellant that the Examiner has not persuasively
shown that the claimed method would have been obvious based on the cited
references. Specifically, the Examiner has not pointed to disclosures in the
cited references of a method “consisting of’ directly applying a
pharmacological agent to the adventitia of an artery “while avoiding a
disturbance of extant derangement within the target artery,” as required by
claim 1.
Signore discloses “methods of making and using surgical patches
which release agents that prevent inflammatory reactions, thrombus
formations and/or intimal hyperplasia.” (Signore 110.) Signore states that
patch angioplasty is a technique for “arteriotomy closure used by surgeons
after vascular procedures.” {Id. 15.) “Patch angioplasty can be performed
with . . . synthetic material. . . . However, synthetic materials implanted in
the vasculature induce thrombogenic, inflammatory and hyperproliferative
responses.” {Id. ]Hf 6—7.) Signore states that the active agent(s) in its patch
therefore we need not discuss Jukema or Pliquett with regard to the issue on
appeal.
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Appeal 2016-006541
Application 11/343,940
“will effectively prevent or inhibit local inflammatory reaction, prevent
thrombus material from building up on the patch and stop cells from
proliferating onto the patch.” {Id. 110.) Thus, Signore describes
administering an active agent to a blood vessel via a patch after a surgical
procedure, in order to prevent adverse effects when closing the blood vessel.
Seward states that coronary artery disease, including atherosclerosis,
can be treated with balloon angioplasty, the effectiveness of which is
increased with the use of stents. (Seward H 4—5.) However, “patients who
have undergone angioplasty procedures with subsequent stenting still suffer
from a high incidence of restenosis resulting from hyperplasia.” {Id. 1 6.)
Seward discloses “methods and kits for distributing pharmaceutical
agents in the adventitial tissue surrounding a blood vessel.” {Id. 13.)
Seward states that its “methods for distributing pharmaceutical agents will
be most often used in coronary arteries, typically for the treatment of
hyperplasia or vulnerable plaque.” {Id. 121.) Seward discloses
“[ejxemplary pharmaceutical agents for treating restenosis and hyperplasia,”
or for treating arrhythmia, congestive heart failure, vulnerable (unstable)
plaque, or vasospasm. {Id. 123.)
Thus, Seward describes using its method to treat a variety of
cardiovascular disorders, including some resulting from atherosclerosis or
the treatment of it, such as hyperplasia, restenosis, and vulnerable plaque,
but it does not describe treating a subject with atherosclerosis itself. In
addition, as the Examiner noted, “while the microneedle minimizes
disturbing the extant derangement of the target artery, it does not avoid the
disturbance altogether.” (Ans. 7.)
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Appeal 2016-006541
Application 11/343,940
In summary, Signore’s method is disclosed for use in order to close a
blood vessel after a vascular procedure, while Seward’s method is disclosed
for use to treat disorders that are seemingly unrelated to atherosclerosis (e.g.,
arrhythmia, congestive heart failure, or vasospasm) or that result from other
treatments for the consequences of atherosclerosis (e.g., hyperplasia and
restenosis), but does not disclose a method that consists o/treating “a subject
for atherosclerosis” itself, as recited in claim 1 on appeal.
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.” In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In this case, we conclude
that the Examiner has not carried the initial burden of showing that the
claimed method—consisting of direct application of a pharmacological agent
to the adventitia of an artery, without disturbing the extant derangement
within the artery, to treat atherosclerosis—would have been obvious to a
person of ordinary skill in the art based on the cited references. We therefore
reverse the rejection of claim 1 under 35 U.S.C. § 103(a) based on Signore,
Jukema, Seward, and Pliquett. All of the pending claims depend from claim
1, and all of the rejections on appeal are based on Signore, Jukema, Seward,
and Pliquett, in combination with Gothoskar, Holme, or Uhrich. The
Examiner has not pointed to any teachings in Gothoskar, Holme, or Uhrich
that would make up for the deficiency of Signore and Seward discussed
above. We therefore reverse all of the rejections on appeal.
REVERSED
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