Ex Parte Craig et al

Board of Patent Appeals and Interferences

Jan 13, 2009

10103411 (B.P.A.I. Jan. 13, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte CHARLES HORACE CRAIG, HERBERT R. RADISCH, and
THOMAS TROZERA
____________

Appeal 2008-2994
Application 10/103,411
Technology Center 1700
____________

Decided: January 14, 2009
____________

Before JENNIFER D. BAHR, LINDA E. HORNER, and STEFAN
STAICOVICI Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Charles Horace Craig et al. (Appellants) appeal under 35 U.S.C. § 134
from the Examiner’s decision rejecting claims 10-29. Claims 1-9 have been
canceled. We have jurisdiction over this appeal under 35 U.S.C. § 6 (2002).
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Application 10/103,411

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THE INVENTION
The Appellants’ invention is drawn towards an expandable medical
stent of a modified austenitic stainless steel alloy having less than or equal to
about 0.03% carbon, less than or equal to about 2% manganese, less than or
equal to about 0.75% silicon, less than or equal to about 0.023% phosphorus,
less than or equal to about 0.01% sulfur, from about 12% to about 20%
chromium, less than or equal to about 3% molybdenum, from about 10% to
about 18% nickel, from about 46.185% to about 74% iron, and from about
2% to about 10% of one or a combination of gold, osmium, palladium,
platinum, rhenium, tantalum, tungsten, or iridium (Spec. 5-6 and Table II).

Claim 10 is representative of the claimed invention and reads as
follows:
10. An expandable medical stent, comprising an alloy
comprising, in weight percent,
iron,
from about 12 to about 20 percent chromium,
from about 10 to about 18 percent nickel, and
from about 2 to about 10 percent iridium,
said stent being deliverable to and expandable in a body
lumen.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
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Application 10/103,411

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Del Corso US 4,891,080 Jan. 2, 1990
Pinchasik US 5,449,373 Sep. 12, 1995
Armini US 5,919,126 Jul. 6, 1999
Nishikawa (as translated) JP 55-131157 Oct. 11, 1980

The following rejections are before us for review:
The Examiner rejected claims 10-13, 17-23, and 27-29 under 35
U.S.C. § 103(a) as unpatentable over Pinchasik in view of Nishikawa and in
further view of Armini.1
The Examiner rejected claims 14-16 and 24-26 under 35 U.S.C. §
103(a) as unpatentable over Pinchasik in view of Nishikawa and in further
view of Armini and Del Corso.

THE ISSUES
1. Have the Appellants shown that the teachings of Pinchasik and
Nishikawa constitute non-analogous art?
2. Have the Appellants shown that the Examiner’s conclusion of
obviousness based upon the teachings of Pinchasik, Nishikawa, and Armini
is based on improper hindsight?
For the reasons set forth in our discussion below, we are not
persuaded by the Appellants’ arguments.
Accordingly, we AFFIRM the Examiner’s rejection.

1 As to claims 13 and 23 only, the Examiner mentions the teachings of
Del Corso as merely support for concluding that “it would have been
obvious to one of ordinary skill in the art to have optimized the content of Ni
in the alloy of Nishikawa to achieve the proper amount of corrosion
resistance” (Ans. 4).
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FINDINGS OF FACT
The following enumerated findings of facts (FF) are supported by at
least a preponderance of the evidence. Ethicon, Inc. v. Quigg, 848 F.2d
1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for
proceedings before the Office).
1. The general problem facing the Appellants was providing an
austenitic stainless steel alloy for making a medical stent that has both
corrosion-resistance and radiopaque characteristics (Spec. 2, ll. 8-9).
2. Pinchasik discloses an expandable medical stent of a 316L (austenitic)
stainless steel alloy (col. 2, ll. 42-46).
3. Nishikawa discloses that the addition of osmium (Os), palladium (Pd),
platinum (Pt), iridium (Ir), rhodium (Rh), or rubidium (Ru) to an
austenitic stainless steel composition provides for very good corrosion
resistance against electrolytes, such as sweat and seawater (Pages 3
and 4).
4. Nishikawa further discloses that the content of one or the sum of at
least two elements selected from osmium (Os), palladium (Pd),
platinum (Pt), iridium (Ir), rhodium (Rh), or rubidium (Ru) is set at
0.1-45% (Page 3).
5. Nishikawa further discloses a stainless steel composition including by
weight 0.03% carbon, 0.52% manganese, 0.32% silicon, 0.002%
phosphorus, 0.002 % sulfur, 18.28 % chromium, 10.38 % nickel, 5.48
% iridium, and 64.986 % iron (remainder) (Pages 2 and 5 and Table 1,
Sample 18).
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6. Armini discloses improving the radiopacity of a medical stent by
providing a gold, iridium, or platinum coating to the medical stent
(col. 1, ll. 54-59).
7. Del Corso discloses improving the corrosion resistance of a stainless
steel alloy by providing up to about 3 % molybdenum (col. 4, ll. 6-
10).

PRINCIPLES OF LAW
In determining whether the subject matter of a claim is obvious,
“neither the particular motivation nor the avowed purpose of the [applicant]
controls. What matters is the objective reach of the claim.” If the claim
extends to what is obvious, it is unpatentable under § 103. Moreover, while
there must be some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness, “the analysis need not seek out
precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” KSR Int’l. Co. v. Teleflex
Inc., 550 U.S. 398, _, 127 S.Ct. 1727, 1741-42 (2007).
“‘A reference is reasonably pertinent if, even though it may be in
different field from that of the inventor's endeavor, it is one which, because
of the matter with which it deals, logically would have commended itself to
an inventor's attention in considering his problem.’ In re Clay, 966 F.2d
656, 659 (Fed. Cir. 1992). In other words, ‘familiar items may have obvious
uses beyond their primary purposes.’ KSR Int’l. Co. v. Teleflex, Inc., 550
U.S. 398, _, 127 S. Ct. 1727, 1742, 167 L.Ed.2d 705 (2007).” In re Icon
Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007).
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It must be recognized that any judgment on obviousness is in a sense
necessarily a reconstruction based upon hindsight reasoning. But so long as
it takes into account only knowledge which was within the level of ordinary
skill at the time the claimed invention was made, and does not include
knowledge gleaned only from the applicant’s disclosure, such a
reconstruction is proper. In re McLaughlin, 443 F.2d 1392, 1395 (CCPA
1971).

OPINION
Rejection of Claims 10-13, 17-23, and 27-29 under 35 U.S.C. § 103(a)
based upon Pinchasik, Nishikawa, and Armini
Issue (1)
The Appellants argue claims 10-13, 17-23, and 27-29 under 35 U.S.C.
§ 103(a) together as a group. Therefore, in accordance with 37 C.F.R.
§ 41.37(c)(1)(vii) (2008), we have selected claim 10 as the representative
claim to decide the appeal of the rejection of claims 11-13, 17-23, and 27-29
standing or falling with claim 10.
The Appellants argue that the teachings of Nishikawa cannot be
combined with the teachings of Pinchasik because the teachings of
Nishikawa are not in the field of the Appellants’ field of endeavor, that is,
the medical device field (Br. 2 6), specifically, the field of medical stents (Br.
5). The general problem facing the Appellants was providing an austenitic
steel alloy for making a medical stent that has both corrosion and radiopaque
characteristics (FF 1). Pinchasik discloses the use of an austenitic stainless

2 We refer herein to the Appeal Brief (“App. Br.”), filed July 27, 2007,
and the Examiner’s Answer (“Ans.”), mailed October 11, 2007.

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steel (316L) for making an expandable medical stent (FF 2). Pinchasik is
from the Appellants’ field of endeavor and thus is analogous art to the
Appellants’ invention. Nishikawa discloses that the addition of 0.1-45%
iridium to an austenitic stainless steel composition provides for improved
corrosion resistance (FF 3 and 4). As such, Nishikawa deals with a problem
addressed by the Appellant, namely, providing an austenitic steel alloy that
exhibits corrosion resistance and, thus, would have commended itself to an
inventor’s attention in considering this problem. Therefore, Nishikawa is
analogous art to the Appellants’ invention.

Issue (2)
The Appellants argue that the Examiner’s conclusion of obviousness
is based on improper hindsight (Br. 7). The general problem facing the
Appellants was providing an austenitic stainless steel alloy for making a
medical stent that has both corrosion resistance and radiopaque
characteristics (FF 1). Pinchasik discloses the use of an austenitic stainless
steel (316L) for making an expandable medical stent (FF 2). Nishikawa
discloses that the addition of 0.1-45% iridium to an austenitic stainless steel
composition provides for very good corrosion resistance (FF 3 and 4).
Therefore, we agree with the Examiner that it would have been obvious for a
person of ordinary skill in the art to use the austenitic stainless steel material
of Nishikawa to make the stent of Pinchasik because Nishikawa specifically
teaches that the addition of iridium provides for improved corrosion
characteristics, hence providing for a medical stent having “improved
corrosion resistance” (Ans. 5).
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Armini discloses that the addition of a gold, iridium, or platinum
coating to a medical stent improves the radiopacity of the medical stent (FF
5). The Appellants argue that because iridium is added as a coating to the
stent of Armini, a person of ordinary skill in the art “would not have been
motivated to use the alloy of Nishikawa to produce a stent, but would have
instead have [sic.] been motivated to apply a coating of gold, platinum, or
iridium to the outside stent” (Br. 7). We disagree with the Appellants’
position because 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). The teachings of Armini were
used by the Examiner merely to show that the element iridium is known to
improve radiopacity. Hence, a person of ordinary skill would have
understood that the iridium in the austenitic stainless steel of Nishikawa
would likewise improve the radiopaque characteristics of the austenitic
stainless steel of Nishikawa. In conclusion, we agree with the Examiner that
a person of ordinary skill in the art would have recognized that the addition
of iridium, as taught by Nishikawa, to a stainless steel composition for
making the medical stent of Pinchasik, in addition to improving corrosion
characteristics, would also have “the additional benefit of improving the x-
ray visibility” (Ans. 5).
Lastly, the Appellants argue that corrosion resistance to sweat, as
addressed by the teachings of Nishikawa, is different than the corrosion
resistance that a medical stent requires once implanted within an internal
body lumen, hence “not every corrosion resistant material is suitable for
producing a stent” (Br. 6). In other words, the Appellants appear to argue
that because Nishikawa's stainless steel is for a wristwatch band, and not a
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stent for implantation in an internal body lumen, a skilled artisan would not
have had reason to believe it was suitable for the environment within an
internal body lumen. Nishikawa discloses that the addition of 0.1-45% Ir to
an austenitic stainless steel composition provides very good corrosion
resistance against electrolytes, such as sweat (FF 3 and 4). Armini discloses
that the addition of a gold, iridium, or platinum coating to a medical stent
improves the radiopacity of the medical stent (FF 6). Since the iridium
coating is applied to a medical stent, which is implanted in an internal body
lumen, a person of ordinary skill in the art would expect that iridium does
not induce adverse reactions in the human anatomy, hence is a
biocompatible element. In conclusion, we find that the combined teachings
of Nishikawa and Armini would readily suggest to a person of ordinary skill
in the art that a stainless steel containing Ir would be advantageous for
making a medical stent because it provides: (1) very good corrosion
resistance, and (2) the additional benefit of improved X-ray visibility.
For the reasons discussed above, the Appellants’ arguments do not
demonstrate error in the Examiner’s rejection of claim 10 and claims 11-13,
17-23, and 27-29 standing or falling with claim 10. Accordingly, the
rejection of claim 10 and claims 11-13, 17-23, and 27-29 standing or falling
with claim 10, is sustained.

Rejection of Claims 14-16 and 24-26 under 35 U.S.C. § 103(a) based upon
Pinchasik, Nishikawa, Armini, and Del Corso
With respect to claims 14-16 and 24-26 the Appellants point out that
Del Corso does not overcome the perceived deficiencies of Pinchasik,
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Nishikawa, and Armini (App. Br. 9). For the reasons discussed above this
argument is not persuasive.
For the foregoing reasons, the Appellants’ argument does not
persuade us that the Examiner erred in rejecting claims 14-16 and 24-26.
Accordingly, the rejection of claims 14-16 and 24-26 is sustained.

DECISION
The rejection of claims 10-13, 17-23, and 27-29 under 35 U.S.C. §
103(a) as unpatentable over Pinchasik in view of Nishikawa and in further
view of Armini is affirmed.
The rejection of claims 14-16 and 24-26 under 35 U.S.C. § 103(a) as
unpatentable over Pinchasik in view of Nishikawa and in further view of
Armini and Del Corso 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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2008).

AFFIRMED

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