Ex Parte Craig et al

Patent Trial and Appeal Board

Oct 31, 2016

12955522 (P.T.A.B. Oct. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/955,522 11/29/2010
62058 7590 11/02/2016
PAULY, DEVRIES SMITH & DEFFNER, L.L.C.
TCF Tower-Suite 900
121 South 8th Street
MINNEAPOLIS, MN 55402-2481
Charles H. Craig
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.
l 15.0234USC1 7647
EXAMINER
MATTHEWS, WILLIAM H
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
11/02/2016 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):
docketing@pdsdlaw.com
kds@pdsdlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHARLES H. CRAIG, HERBERT R. RADISCH JR.,
THOMAS A. TROZERA, DAVID M. KNAPP, TIMOTHY S. GIRTON,
and JONATHAN S. STINSON
Appeal2014-003692 1
Application 12/955,5222
Technology Center 3700
Before JENNIFERD. BAHR, STEFAN STAICOVICI, and
KEN B. BARRETT, Administrative Patent Judges.
ST AI CO VICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The instant appeal is related to Appeal Nos. 2007-2379 (10/112,391,
mailed Jan. 31, 2008), 2008-2994 (10/103,411, mailed Jan. 15, 2009), 2010-
006353 (10/103,411, mailed June 16, 2011), and 2010-007318 (10/112,391,
mailed Sept. 28, 2010).
2 According to Appellants, the real party in interest is Boston Scientific
Scimed, Inc. Appeal Br. 1 (filed July 29, 2013).
Appeal2014-003692
Application 12/955,522
Charles H. Craig et al. (Appellants) appeal under 35 U.S.C. § 134(a)
from the Examiner's final decision rejecting claims 1-3, 5-10, and 19-26. 3
We have jurisdiction over this appeal under 35 U.S.C. § 6(b ).
SUMMARY OF DECISION
We AFFIRM.
INVENTION
Appellants' invention relates to an intra vascular stent manufactured
from a radiopaque alloy. Spec. 1, 11. 16-18.
Claims 1 and 22 are independent. Claim 22 is illustrative of the
claimed invention and reads as follows:
22. An intravascular stent consisting of an alloy comprising
about 11 to about 18 wt.% chromium, about 5 to about 12 wt.%
nickel, at least about 15 wt.% iron, and about 5 to about 50
\Vt.% platinum, the stent having a generally tubular structure
defined by a plurality of interconnected struts having interstitial
spaces therebetween, the stent being expandable from a first
position, sized for insertion into a vessel, to a second position,
where at least a portion of said stent is in contact with a vessel
wall of the vessel.
3 Claims 4 and 11-18 are canceled. Appellants' Amendment 2-3 (filed
Dec. 20, 2012).
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Application 12/955,522
REJECTIONS
The following rejections are before us for review:
I. The Examiner rejected claims 1, 3, 6, 19--22, and 24 under 35
U.S.C. § 103(a) as being unpatentable over Dang (US
6,471,721 Bl, iss. Oct. 29, 2002), Nishikawa (JP 55-131157,
pub. Oct. 11, 1980)4, and with evidentiary support from Tu (US
6,077,298, iss. June 20, 2000) and Fischell (US 5,607,442, iss.
Mar. 4, 1997).
II. The Examiner rejected claims 7, 8, 10, 25, and 26 under 35
U.S.C. § 103(a) as being unpatentable over Dang, Nishikawa,
with evidentiary support from Tu and Fischell, and Cox (US
6,273,911 Bl, iss. Aug. 14, 2001).
III. The Examiner rejected claims 2, 5, 9, and 23 under 35 U.S.C.
§ 103(a) as being unpatentable over Dang, Nishikawa, with
evidentiary support from Tu and Fischell, Cox, and Del Corso
(US 4,891,080, iss. Jan. 2, 1990). 5
4 We derive our understanding of this reference from the English
language translation. All references to the text of this document are to
portions of the translation.
5 Although the Examiner fails to mention Fischell in Rejections II and
III, as claims 7, 8, 10, 25, and 26 of Rejection II and claims 2, 5, 9, and 23 of
Rejection III depend directly or indirectly from independent claims 1 and 22,
we consider the omission a typographical error.
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Application 12/955,522
ANALYSIS
Rejection I
The Examiner finds that Dang discloses, inter alia, a 316L stainless
steel intravascular stent including an expandable tubular body of
interconnected struts with interstices there between. Final Act. 2-3 (citing
Dang, Fig. 4) (transmitted Feb. 15, 2013). The Examiner further finds that
because Dang discloses that "conventional metal stents are insufficiently
radiopaque for fluoroscopic visualization," Dang includes "radiopaque
materials into grooves of a conventional stainless steel stent." Id. at 3 (citing
Dang, col. 1, 11. 42-67, col. 2, 11. 1-58, and col. 5, 11. 6---64). However, the
Examiner finds that Dang's stent material does not have the composition of
each of independent claims 1 and 22. Id. Nonetheless, the Examiner finds
that Nishikawa discloses a sweat and/or seawater corrosion resistant 316L
stainless steel-platinum alloy having the composition of independent claims
1 and 22. Id. at 3--4. The Examiner further notes Tu's disclosure of
"vascular stents ... formed from a biocompatible alloy of stainless steel and
platinum" and Fischell' s disclosure that "[ e ]lectrolytic corrosion of metals is
also a well known problem for implantable metals in the bloodstream." Id. at
3. Thus, in view of the disclosures of Tu and Fischell, the Examiner
concludes that it would have been obvious for a person of ordinary skill in
the art to use the corrosion resistant 316L stainless steel-platinum alloy of
Nishikawa to make the stent of Dang to "provide[] improved radiopacity and
improved corrosion resistance as desired by stent manufacturers." Id. at 4.
Appellants argue that because "Dang ... discloses a composite body
portion," the stent of Dang does not "consist[] of a single alloy," as per
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Application 12/955,522
independent claim 22, or include a "body portion that consists of a single
alloy," as per independent claim 1. 6 Appeal Br. 3. Appellants also maintain
that Nishikawa's plated wristwatch band, like Dang, is a composite
structure. Id. at 4; see also Nishikawa 2. Appellants further argue that based
on the disclosures of Nishikawa, Tu, and Fischell, "[ o ]ne having ordinary
skill in the art would not have had any reason to modify Dang's stent to
include only the claimed metal," and thus "consist of a single alloy." Id. at
3--4.7 Thus, according to Appellants, the Examiner's "modification of
Dang's stent to use Nishikawa's alloy alone, eliminating Dang's radiopaque
material, represents a wholesale redesign of Dang' s stent" and thus, it
"would change the principle of operation of' Dang's stent. Id. at 5.
We appreciate that the stent of Dang is not manufactured from a single
alloy, as called for by independent claims 1 and 22, and that Nishikawa
discusses plating the disclosed alloy relied upon by the Examiner. However,
obviousness does not require that all of the features of the secondary
reference be bodily incorporated into the primary reference. In re Keller,
642 F.2d 413, 425 (CCPA 1981). In this case, we do not agree with
Appellants that a person of ordinary skill in the art would not have been
prompted to modify Dang's stent with Nishikawa's alloy, as the Examiner
proposes. An improvement that is nothing more than the predictable use of
prior art elements according to their established functions is likely to be
6 The transitional phrase "consisting of' excludes any element, step, or
ingredient not specified in the claim. In re Gray, 53 F.2d 520 (CCPA 1931).
7 According to Appellants, (1) Tu discloses a stainless steel-platinum
alloy for making stents (see col. 3, 11. 21-24); and (2) Fischell discloses a
gold plated stainless steel stent (see col. 2, 11. 61---67).
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obvious. KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007). Here, the
Examiner's modification is an improvement to the stent of Dang to use the
alloy of Nishikawa to lead to a predictable result, namely, to provide
improved radiopacity and corrosion resistance. See Final Act. 4. This
modification is well within the skill of one having ordinary skill in this art.
See KSR, 550 U.S. at 417 ("[I]f a technique has been used to improve one
device, and a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill."). Given that: ( 1)
Dang discloses using platinum as a radiopaque material in combination with
a 316L stainless steel stent; (2) Nishikawa discloses a 316L stainless steel-
platinum alloy that provides improved electrolytic corrosion resistance when
compared to a 316L stainless steel material; (3) Tu discloses that stainless
steel-platinum alloys can be used to manufacture a stent; and (4) Fischell
discloses that electrolytic corrosion of metals is a well-known problem for
implantable metals in the bloodstream, the Examiner's reasoning has
rational underpinnings. See Dang, col. 5, 11. 17-19 and 38--44; Nishikawa, p.
2; Tu, col. 3, 11. 21-24, and Fischell, col. 2, 11. 54---67.
Furthermore, even though we appreciate Appellants' position that
there is no support in either Tu or Fischell to replace a composite material
structure, such as Dang's stent, with a single alloy, as taught by Nishikawa
(see Reply Br. 1-2 (filed Feb. 5, 2014)), we note that The Supreme Court
has rejected the rigid requirement that the rationale for the proposed
combination come from within the references. See KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007). Here, in view ofTu's disclosure that
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stainless steel-platinum alloys can be used to manufacture a stent and
Fischell's disclosure that electrolytic corrosion of metals is a well-known
problem for implantable metals in the bloodstream, the Examiner's
modification is merely the use ofNishikawa's stainless steel-platinum alloy
to make the stent of Dang. See Final Act. 4. The Examiner is correct in that
such a modification provides improved corrosion resistance, while also
providing radiopaque properties. See Ans. 8.
We also do not agree with Appellants that the Examiner's
modification "would change the principle of operation of' Dang's stent. See
Appeal Br. 5. Rather, we agree with the Examiner that the modification
"results in a stent that remains suitable for implantation and addresses the
issue of increasing radiopacity with platinum as desired in Dang, and further
provides enhanced corrosion resistance." Ans. 8. We further agree with the
Examiner that a person of ordinary skill in the art "would look to the specific
alloys taught in Nishikawa because they would be expected to be
biocompatible (as evidenced by Fischell) and provide enhanced radiopacity
as desired in each of Dang and Tu." Id. (emphasis omitted).
Lastly, Appellants reference our Decision in related Appeal No. 2010-
007318 (hereafter "Decision") and state that "[ t ]he BP AI never ruled that
one having ordinary skill in the art would have found it obvious to eliminate
Dang' s radiopaque material" and further request that we "evaluate the
pending claims with fresh eyes." Appeal Br. 5. Appellants note that in
contrast to the claims presented in related Appeal No. 2010-007318, "the
pending claims exclude the possibility of a device having Dang's composite
structure." Reply Br. 1.
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We do not agree with Appellants' assessment because we stated in our
Decision that, "when the platinum-alloyed 316L stainless steel material of
Nishikawa is used to make the stent of Dang ... both corrosion resistance
and radiopaque properties of the stent are improved." Decision 6 (emphasis
added). Hence, as we refer to the "stent of Dang," we are referring to the
entire stent, which includes both 316L stainless steel body 11 and platinum
strips 13. As such, in contrast to Appellants' position, we did take into
consideration in our Decision that the Examiner's modification replaces
Dang's 316L stainless steel body 11 and platinum strips 13 with Nishikawa's
stainless steel-platinum alloy. Nonetheless, even assuming arguendo that we
were to accept Appellants' assertions, we are not persuaded because we
agree with the Examiner that the "claim language 'consisting of' does not
differentiate the claimed invention from the [combined] teachings of Dang,
Nishikawa, Tu, and Fischell." Ans. 7. The Examiner's stated rejection sets
forth that "the separate platinum layer and stainless steel layer [of Dang's
stent] would be eliminated and replaced with [Nishikawa's] single material
(an alloy of the stainless steel and platinum) to address the problems [of
radiopacity and corrosion] noted in the prior art." Id. It is quite clear that
when the platinum-alloyed 316L stainless steel material of Nishikawa isused
to make the stent of Dang, as the Examiner proposes, the resulting stent does
not require platinum strips 13 because the alloy already includes platinum
for providing radiopaque properties.
In conclusion, for the foregoing reasons, we sustain the rejection
under 35 U.S.C. § 103(a) of claims 1, 3, 6, 19--22, and 24 as unpatentable
over Dang, Nishikawa, and with evidentiary support from Tu and Fischell.
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Rejections II and III
As to the remaining rejections, Appellants rely on the same arguments
presented supra. See Appeal Br. 5-6. Accordingly, for the same reasons as
discussed above, we sustain the rejection under 35 U.S.C. § 103(a) of claims
7, 8, 10, 25, and 26 under 35 U.S.C. § 103(a) as being unpatentable over
Dang, Nishikawa, with evidentiary support from Tu and Fischell, and Cox.
We also sustain the rejection of claims 2, 5, 9, and 23 as being unpatentable
over Dang, Nishikawa, with evidentiary support from Tu and Fischell, Cox,
and Del Corso.
SUMMARY
The Examiner's decision to reject claims 1-3, 5-10, and 19-26 is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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