Ex Parte Cheng et al

Patent Trial and Appeal Board

Jan 12, 2017

12052037 (P.T.A.B. Jan. 12, 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.
12/052,037 03/20/2008 Eric Cheng 05-01545US2 (4010/205) 1678
121974 7590 01/17/2017
K AC VINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
01/17/2017 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):
bbonneville @ kdbfirm .com
docketing @ kdbfirm. com
ndeane @ kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERIC CHENG, JIANMIN LI,
WEENA BUCAY-COUTO, SCOTT SANDERS,
JAMES F. SCHUERMANN, and MIN-SHY AN SHEU
Appeal 2015-005244
Application 12/052,037
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a
urological medical device for release of therapeutic agents. The Examiner
rejected the claims on the ground of obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Boston Scientific Scimed,
Inc. (see App. Br. 3).
Appeal 2015-005244
Application 12/052,037
Statement of the Case
Background
Appellants’ “invention relates generally to urological medical devices,
and more particularly to implantable or insertable urological medical devices
which release therapeutic agents” (Spec. 12).
The Claims
Claims 1—6, 8, 12—14, 16—27, and 50-59 are on appeal. Independent
claim 1 is representative and reads as follows (emphasis added):
1. A urological medical device comprising an alpha-
adrenergic blocker as a urologically beneficial agent, said
urological medical device being a ureteral stent adapted for
placement in a urinary tract of a subject whereupon at least a
portion of said urologically beneficial agent is released in vivo
in an amount effective to promote kidney stone expulsion.
The Issues
A. The Examiner rejected claims 1—6, 8, 12, 14, 16—23, 26, 50, 51, 53,
54, and 56—59 under 35 U.S.C. § 103(a) as obvious over Fischer2 (Ans. 2-4).
B. The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as obvious
over Fischer and Price3 (Ans. 4).
C. The Examiner rejected claim 24 under 35 U.S.C. § 103(a) as obvious
over Fischer and Liu4 (Ans. 5).
D. The Examiner rejected claims 25, 27, 52, and 55 under 35 U.S.C.
§ 103(a) as obvious over Fischer and Lawin5 (Ans. 5—6).
2 Fischer, Jr. et al., US 2007/0161967 Al, published July 12, 2007
(“Fischer”).
3 Price et al., US 2005/0074448 Al, published Apr. 7, 2005 (“Price”).
4 Liu et al., US 2004/0143209 Al, published July 22, 2004 (“Liu”).
5 Lawin et al., US 2003/0232087 Al, published Dec. 18, 2003 (“Lawin”).
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Application 12/052,037
Because the same issue is dispositive for all four rejections, we will
consider them together. Appellants do not argue the claims separately, and
we select claim 1 as representative.
The Examiner finds that Fischer teaches
a ureteral stent (several types, ]fs 43 & 55) comprising an
alpha-adrenergic blocker (167) as a beneficial agent, wherein
the ureteral stent is adapted for placement in the ureters,
which are in the urinary tract of a subject, whereupon at least
a portion of the beneficial agent is released in vivo in an
amount to promote kidney stone expulsion (167, relaxes
blood vessels, used in the urinary tract).
(Ans. 2.)
The Examiner acknowledges that Fischer “does not disclose a specific
embodiment where a ureteral stent uses alpha-blockers” but finds “Fischer
does disclose use of a ureteral stent (which is placed in the urinary tract) and
alpha blockers used in the urinary tract to enhance urinary flow” {id.). The
Examiner concludes that it would have been obvious to “utilize alpha
blockers with a ureteral stent to enhance urinary flow (which also promotes
kidney stone expulsion as the relaxed smooth muscle allows the kidney
stone to pass easier)” {id. at 2—3).
The issues with respect to these rejections are: Does the evidence of
record support the Examiner’s conclusion that Fischer renders the claims
prima facie obvious?
Findings of Fact
1. Fischer teaches “a ureteral stent which contains channels, for
example, an open pore structure,” the “channels containing a
pharmacologically active ingredient in the central, linear portion” so that
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Application 12/052,037
“only the length of the ureter into which region 63 of stent 60 is placed will
be treated with a pharmacologically active ingredient” (Fischer | 55; see
also Ans. 2).
2. Fischer teaches that
pharmacologically active ingredients may also be used in
various embodiments. Alpha-blockers are drugs that block
receptors in arteries and smooth muscles. The action of the
alpha-blocker relaxes blood vessels and leads to an increase
in blood flow and a lower blood pressure, thus helping to
control blood pressure or hyper tension. In the bladder neck
or urinary tract, alpha-blockers also relax the walls of the tract
and enhance urinary flow, especially in persons suffering
from prostatic hypertrophy (an enlarged prostate gland).
Alpha-blocker drugs include doxazosin (CARDURA®),
alfuzosin (UROXATRAL®), tamsulosin (FLOMAX®),
prazosin (MINIPRESS®), and terazosin (HYTRIN®).
(Fischer | 67; see also Ans. 2.)
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
When there is a design need or market pressure to solve a
problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her technical
grasp. If this leads to the anticipated success, it is likely the
product not of innovation but of ordinary skill and common
sense. In that instance the fact that a combination was
obvious to try might show that it was obvious under § 103.
Id. at 421.
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Application 12/052,037
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2—8; FF 1—2) and agree that claim 1
would have been obvious over Fischer. We address below Appellants’
arguments.
Appellants contend that “[t]o arrive at the invention as presently
claimed in independent claims 1 and 59, one of ordinary skill in the art
would have to, inter alia, choose a ureteral stent from the numerous devices
described in Fis[c]her” (App. Br. 7). Appellants also argue that
one of ordinary skill in the art would have to have some
reason to select an alpha-adrenergic blocker (e.g., tamsulosin
or a pharmaceutically effective salt thereof) from among “[a]
vast range of drugs, medicaments and materials [that] may be
employed as a pharmacologically active ingredient. . .” (see
paragraph [0057]) for use with the ureteral stent.
{Id.) Appellants also contend that “one of ordinary skill in the art would
have to release the alpha-adrenergic blocker in vivo in an amount effective to
promote kidney stone expulsion, even though Fischer is completely silent
regarding kidney stones” {id. at 7—8). Appellants argue that “the presently
claimed invention would not have been obvious without the hindsight gained
from Applicant’s disclosure” {id. at 9; see also Reply Br. 7).
We find these arguments unpersuasive. As the Examiner explains,
[Regarding choosing a stent from among the numerous
devices described in Fis[c]her — Fis[c]her spends an entire
paragraph (155) on ureteral stents, it is not part of a long list
of items. Regarding selecting alpha-adrenergic blockers from
a vast range, alpha blockers are explicitly disclosed for use in
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Application 12/052,037
the urinary tract (167), and one with ordinary skill in the art
would be aware that ureters are part of the urinary tract.
Regarding the amount, Fis[c]her discloses using alpha
blockers in the urinary tract to relax smooth muscle to
increase urinary flow (167), a side effect of said increased
flow is the promotion of kidney stone expulsion.
(Ans. 6; see also FF 1—2.) See KSR, 550 U.S. at 421. We further note that
claim 1 does not define “an amount effective” rendering this phrase a
functional recitation without any specific requirement. “‘Functional’
terminology may render a claim quite broad. By its own literal terms a
claim employing such language covers any and all embodiments which
perform the recited function.” In re Swinehart, 439 F.2d 210, 213 (CCPA
1971). Therefore, “[i]f the prior art structure is capable of performing the
intended use, then it meets the claim.” Id.. Here, Appellants have provided
no evidence that the device rendered obvious by Fischer would not satisfy
this functional recitation.
Appellants contend that “without reference to Applicant’s disclosure,
one of ordinary skill in the art would have had no motivation to provide a
medical device as claimed” (App. Br. 8).
We find this argument unpersuasive because Fischer provides reasons
to administer alpha blockers to the urinary tract (FF 2) and Fischer provides
reasons to use a ureteral stent to deliver drug only to desired locations (FF
1). Thus, the ordinary artisan, interested in delivering alpha blockers only to
specific locations in the ureter, would have had reason to use a ureteral stent,
both elements specifically taught by Fischer (FF 1—2). That the prior art has
a different reason or motivation to combine is of no moment as long as there
is a sufficient reason to make the combination. See In re Kemps, 97 F.3d
1427, 1430 (Fed. Cir. 1996) (“[T]he motivation in the prior art to combine
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Application 12/052,037
the references does not have to be identical to that of the applicant to
establish obviousness.”)
Appellants argue that
[b]ased on the Declaration of Jianmin Li submitted August
21, 2013, Applicant had previously argued that one of
ordinary skill in the art would not use a ureteral stent to
release an alpha blocker-drug based on the teachings of
Fischer, Price, Liu and Lawin. In this regard, Applicant had
argued, inter alia, that it is not at all apparent that local
administration of alpha-blockers in the urinary tract would be
an effective technique for relaxing the muscular portion of the
prostate and/or the bladder neck, as opposed, for example, to
systemic admiration by injection, oral administration, etc.,
and that, even assuming for the sake of argument that a person
of ordinary skill in the art wished to locally administer an
alpha-blocker to the urinary tract in order to relax the
muscular portion of the prostate and/or the bladder neck, such
a person would not elect to release the drug in the ureter.
(App. Br. 8).
We have considered the Li Declaration6 7but find it solely focused on
Dr. Li’s “opinion that one of ordinary skill in the art would not use a ureteral
stent to release an alpha blocker-drug” (Li Declaration 3). The Li
Declaration provides no factual evidence, other than the opinion of the
inventor, that addresses Examiner’s finding that it would have been obvious
to include alpha blocker in a ureteral stent “to relax the urinary tract (which
includes the ureters) to allow for increased flow” as taught by Fischer and
that “[promoting kidney stone expulsion is a side effect of the relaxed
urinary tract (including the ureters) which results in increased flow” (Ans.
8).
6 Declaration of Dr. Jianmin Li, dated July 29, 2013 (“Li Declaration”).
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However, “the Board is entitled to weigh the declarations and
conclude that the lack of factual corroborations warrants discounting the
opinions expressed in the declarations.” In re Am. Acad. ofSci. Tech Ctr.,
367 F.3d 1359, 1368 (Fed. Cir. 2004). See also In re Bulina, 362 F.2d 555,
559 (CCPA 1966) (“[A]n affidavit by an applicant or co-applicant as to the
advantages of his invention is less persuasive than one made by a
disinterested person.”). Here, we acknowledge Dr. Li’s opinion, but find
that it does not overcome the Examiner’s strong prima facie case of
obviousness based substantively on the single Fischer reference teaching all
of the elements of claim 1 and giving reasons to combine these elements (FF
1—2) as discussed by the Examiner (see Ans. 8).
SUMMARY
In summary, we affirm the rejection of claims 1 and 59 under 35
U.S.C. § 103(a) as obvious over Fischer. Claims 2—6, 8, 12, 14, 16—23, 26,
50, 51, 53, 54, and 56—58 fall with claim 1.
We affirm the rejection of claim 13 under 35 U.S.C. § 103(a) as
obvious over Fischer and Price.
We affirm the rejection of claim 24 under 35 U.S.C. § 103(a) as
obvious over Fischer and Liu.
We affirm the rejection of claims 25, 27, 52, and 55 under 35 U.S.C.
§ 103(a) as obvious over Fischer and Lawin.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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