Ex Parte Craig et al

Board of Patent Appeals and Interferences

Feb 23, 2009

10112390 (B.P.A.I. Feb. 23, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte CHARLES H. CRAIG, THOMAS A. TROZERA
and HERBERT R. RADISCH, JR.
____________________

Appeal 2008-2691
Application 10/112,390
Technology Center 3700
____________________

Decided:1 February 23, 2009
____________________

Before: WILLIAM F. PATE III, JENNIFER D. BAHR and
STEVEN D.A. McCARTHY, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing a response, as recited in 37 C.F.R.
§ 41.50(b) (2008) begins to run from the Decided Date shown on this page
of the decision. The time period does not run from the Mail Date (paper
delivery) or Notification Date (electronic delivery).

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STATEMENT OF THE CASE 1
The Appellants appeal under 35 U.S.C. § 134 (2002) from the final 2
rejection of claims 27-30 and 32 under 35 U.S.C. § 102(b) (2002) as being 3
anticipated by Eckert (US 5,858,556, issued Jan. 12, 1999); from the final 4
rejection of claims 27, 29, 30 and 32 under 35 U.S.C. § 102(e) (2002) as 5
being anticipated by Dang (US 6,471,721 B1, issued Oct. 29, 2002); and 6
from the final rejection of claim 28 under 35 U.S.C. § 103(a) (2002) as being 7
unpatentable over Dang and Eckert. We have jurisdiction under 35 U.S.C. 8
§ 6(b) (2002). 9
We AFFIRM. Pursuant to 37 C.F.R. § 41.50(b) (2008), we designate 10
our affirmance a NEW GROUND OF REJECTION. 11
The claims on appeal relate to intravascular stents fabricated from 12
alloys that provide better radiopaque characteristics for fluoroscopic 13
observations than is provided by the known austenitic stainless steels, yet 14
maintains preferred physical properties of austenitic stainless steel. (Spec. 4, 15
ll. 1-3). Claim 27 is the sole independent claim on appeal: 16
17
27. An intravascular stent, comprising 18
A stent body having a generally tubular 19
shape and capable of maintaining patency in a 20
blood vessel, the stent body being formed of a 21
metal alloy in the form of a mixture of elements, 22
the alloy comprising, in weight percent, 23
a maximum of about 0.030 carbon; 24
a maximum of about 2.000 manganese; 25
a maximum of about 0.750 silicon; 26
a maximum of about 0.023 phosphorus; 27
a maximum of about 0.010 sulfur; 28
about 12.000 to about 20.000 chromium; 29
about 0.000 to about 3.000 molybdenum; 30
31
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about 10.000 to about 18.000 nickel; 1
iron; and 2
a first element selected from the group 3
consisting of gold, osmium, palladium, iridium, 4
rhenium, tantalum, tungsten, and ruthenium. 5
6
Eckert and Dang each disclose both radiopaque stents and tubular 7
metallic structures for use in making such stents. (Eckert, col. 3, ll. 37-48; 8
Dang, col. 6, ll. 18-20). 9
ISSUES 10
The Appellants’ sole contention directed against the rejections of 11
claims 27-30 and 32 is that neither Eckert nor Dang discloses or suggests a 12
stent including a stent body formed of a metal alloy in the form of a mixture 13
of elements. The Appellants contend that both Eckert and Dang disclose 14
stents formed from tubular structures containing a series of individual layers 15
of stainless steel and radiopaque metal bonded to each other. The 16
Appellants assert that the combination of such layers is not a mixture. (App. 17
Br. 4-5) 18
The Appellants do not argue any of claims 27, 29, 30 and 32 19
separately with respect to either rejection under § 102 and therefore group 20
these claims. (App. Br. 4-5). Independent claim 27 is representative of the 21
group. See 37 C.F.R. § 41.37(c)(1)(vii) (2008). The Appellants do not 22
direct any arguments against the rejection of claim 28 under § 103(a) other 23
than the contention that neither Eckert nor Dang discloses or suggests a stent 24
including a stent body formed of a metal alloy in the form of a mixture of 25
elements. (See App. Br. 6). 26
The Examiner finds that the ordinary usage of the term “alloy” is 27
sufficiently broad to include “a substance composed of two or more 28
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metals . . . intimately united” and that the ordinary usage of the term 1
“mixture” is sufficiently broad to include any combination (see Ans. 6, 2
citing MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY at 31 and 744 (10th 3
ed. 2002)(“alloy,” def. 2 and “mixture,” def. 2)). Based on these definitions, 4
the Examiner finds that the layered structures disclosed in Eckert and Dang 5
are metal alloys in the form of mixtures of elements because each of the 6
layered structures includes “two or more metals intimately united (or alloy) 7
in the form of a mixture (or combination) of elements.” (Ans. 6-7). 8
Therefore, this appeal turns on one issue: 9
Have the Appellants shown that the Examiner erred in 10
finding that Eckert and Dang disclose stents including stent 11
bodies formed of metal alloys in the form of mixtures of 12
elements? 13
14
FINDINGS OF FACT 15
The record supports the following findings of fact (“FF”) by a 16
preponderance of the evidence. 17
1. Eckert’s multilayer composite tubular structure has an outer 18
layer of a biocompatible material such as stainless steel; a middle layer of a 19
radiopaque material such as gold; and an inner layer of a biocompatible 20
material such as stainless steel. (Eckert, col. 3, ll. 37-45 and 50-54). 21
2. Eckert discloses that the bond formed between the stainless 22
steel and tantalum layers is critical to the proper function of the stent. 23
(Eckert, col. 4, ll. 25-29). Eckert further discloses forming a metallurgical 24
bond, where diffusion of the material elements takes place, to bond the 25
biocompatible and radiopaque layers together. (Eckert, col. 4, ll. 30-31). 26
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3. Eckert also discloses a method for fabricating a stent which 1
includes arranging tubes of the biocompatible and radiopaque materials 2
coaxially; reducing the diameters of the tubes by swaging or tube drawing; 3
annealing the tubes to bond the materials into a composite tubular structure; 4
and etching and machining the composite tubular structure to form a stent. 5
(Eckert, col. 3, ll. 46-48; col. 5, ll. 2-8; and col. 5, ll. 31-36). 6
4. Dang discloses a method for making a stent. (Dang, col. 5, ll. 7
6-8). 8
5. Dang’s method begins with machining a series of grooves in a 9
piece of 316L stainless steel tube stock. (Dang, col. 5, ll. 12-14, 17-20 and 10
24-26). 11
6. Dang further discloses inserting strips of radiopaque material 12
such as gold into the grooves by press-fitting, diffusion bonding or laser 13
bonding. (Dang, col. 5, ll. 41-46). 14
7. Dang next discloses sputtering a thin layer of 316L stainless 15
steel over the tube stock. (Dang, col. 5, l. 65 – col. 6, l. 3 and col. 6, ll. 9-16
11). 17
8. Dang then discloses cutting the tube stock to form the stent. 18
(Dang, col. 6, ll. 18-20). 19
20
PRINCIPLES OF LAW 21
“To anticipate a claim, a prior art reference must disclose every 22
limitation of the claimed invention, either explicitly or inherently.” In re 23
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). When the Patent and 24
Trademark Office has a sound basis for believing that a product claimed by 25
an applicant and a product disclosed in the prior art are inherently the same, 26
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the applicant has the burden of showing that the products are not the same. 1
In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). 2
A claim is unpatentable for obviousness under 35 U.S.C. § 103(a) if 3
“the differences between the subject matter sought to be patented and the 4
prior art are such that the subject matter as a whole would have been obvious 5
at the time the invention was made to a person having ordinary skill in the 6
art to which said subject matter pertains.” In Graham v. John Deere Co., 7
383 U.S. 1 (1966), the Supreme Court set out factors to be considered in 8
determining whether claimed subject matter would have been obvious: 9
10
Under § 103, the scope and content of the prior art 11
are to be determined; differences between the prior 12
art and the claims at issue are to be ascertained; 13
and the level of ordinary skill in the pertinent art 14
resolved. Against this background, the 15
obviousness or nonobviousness of the subject 16
matter is determined. 17
18
Id., 383 U.S. at 17. 19
A claim under examination is given its broadest reasonable 20
interpretation consistent with the underlying specification. In re American 21
Acad. of Science Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In the 22
absence of an express definition of a claim term in the specification, the 23
claim term is given its broadest reasonable meaning in its ordinary usage as 24
the term would be understood by one of ordinary skill in the art. In re ICON 25
Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007); In re Morris, 26
127 F.3d 1048, 1054 (Fed. Cir. 1997). Limitations not explicit or inherent in 27
the language of a claim cannot be imported from the specification. E-Pass 28
Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369 (Fed. Cir. 2003). 29
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ANALYSIS 1
The ordinary usage of the term “alloy” is sufficiently broad to include 2
a homogeneous mixture of two or more metals. The Free Dictionary, 3
http://www.thefreedictionary.com/alloy (last visited February 18, 2009). A 4
homogeneous mixture is a mixture in which the atoms of the constituents are 5
interspersed. DICTIONARY OF CHEMISTRY at 327 (Oxford Univ. Press, 3d ed. 6
1996). 7
Diffusion bonding is a process for joining two metals in which the 8
principal mechanism for joining the metals is interdiffusion of atoms across 9
the interface. Shirzadi, “Diffusion Bonding,” http://www.msm.cam.ac.uk/ 10
phase-trans/2005/Amir/bond.html (last visited February 18, 2009). One 11
source defines “diffusion” as “[t]he process by which different substances 12
mix as a result of the random motions of their component atoms . . . .” 13
DICTIONARY OF CHEMISTRY at 158-59 (“diffusion,” def. 1). 14
Both Eckert and Dang disclose stents fabricated from tubular metallic 15
structures. (FF 3-8). Both Eckert and Dang disclose fabricating the tubular 16
metallic structures by forming diffusion bonds between layers of stainless 17
steel and of a radiopaque metal such as gold. (FF 2, 3 and 6). When the 18
diffusion bonds are formed between the layers of stainless steel and 19
radiopaque metal, the atoms of the stainless steel and the radiopaque metal 20
would interdiffuse across the bond interface so that the radiopaque metal and 21
the elements constituting the stainless steel mix. In other words, the atoms 22
of the radiopaque metal and the elements constituting the stainless steel 23
would be interspersed near the diffusion bond interface, forming a 24
homogeneous mixture. These considerations provide a sound basis for 25
belief that the material of the tubular metallic structures in the regions near 26
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the diffusion bond interfaces are metal alloys in the form of mixtures of 1
elements. 2
Both Eckert and Dang disclose fabricating the stents from the tubular 3
metallic structures by cutting or etching the tubular metallic structures. (FF 4
3 and 8). It is unlikely that such a cutting or etching step would disturb the 5
metallurgical structure of the material of the stent near the diffusion bond 6
interfaces. Therefore, there is sound reason to believe that the stents 7
disclosed by Eckert and Dang include stent bodies formed of metal alloys in 8
the form of mixtures of elements. Since the Appellants do not contend 9
before us that either Eckert or Dang fails to disclose any limitation of claim 10
27 other than a stent body formed of a metal alloy in the form of a mixture 11
of elements, Eckert suffices to establish a prima facie case of anticipation of 12
the subject matter of claims 27-30 and 32 and Dang suffices to establish a 13
prima facie case of anticipation of the subject matter of claims 27, 29, 30 14
and 32. 15
The Appellants point to no evidence in this appeal which might rebut 16
the sound basis for belief that the stents disclosed by Eckert and Dang 17
include stent bodies formed of metal alloys in the form of mixtures of 18
elements. The evidence as whole supports the rejection of claims 27-30 and 19
32 under § 102(b) as being anticipated by Eckert and the rejection of claims 20
27, 29, 30 and 32 under § 102(e) as being anticipated by Dang. 21
The Appellants do not appear to contend that the Examiner has failed 22
to articulate reasoning having rational underpinning to support combining 23
the teachings of Dang and Eckert in rejecting claim 28 under § 103(a). 24
Since the Appellants do not contend before us that either Eckert or Dang 25
fails to disclose any limitation of claim 28 other than a stent body formed of 26
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a metal alloy in the form of a mixture of elements and since there is a sound 1
basis for belief that both Eckert and Dang disclose this feature, Dang and 2
Eckert suffice to establish a prima facie case of obviousness of claims 27-30 3
and 32 and Dang suffices to establish a prima facie case of obviousness of 4
the subject matter of claim 28. 5
The Appellants point to no evidence in this appeal which might rebut 6
the sound basis for belief that the stents disclosed by Eckert and Dang 7
include stent bodies formed of metal alloys in the form of mixtures of 8
elements. The Appellants also point to no objective evidence which might 9
tend to prove secondary considerations bearing on the patentability of claim 10
28. The evidence as whole supports the rejection of claim 28 under § 103(a) 11
as being anticipated by Dang and Eckert. 12
13
CONCLUSIONS 14
The Appellants have not shown that the Examiner erred in finding that 15
Eckert and Dang disclose stents including stent bodies formed of metal 16
alloys in the form of mixtures of elements. 17
The Appellants have not shown that the Examiner erred in rejecting 18
claims 27-30 and 32 under § 102(b) as being anticipated by Eckert; that the 19
Examiner erred in rejecting claims 27, 29, 30 and 32 under § 102(e) as being 20
anticipated by Dang; or that the Examiner erred in rejecting claim 28 under 21
§ 103(a) as being unpatentable over Dang and Eckert. Since the reasoning 22
underlying our affirmance differs from the reasoning articulated by the 23
Examiner, the affirmance is designated a new ground of rejection under 24
§ 41.50(b). 25
26
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DECISION 1
We AFFIRM the rejection of claims 27-30 and 32. Since the 2
reasoning underlying our affirmance differs from the reasoning articulated 3
by the Examiner, the affirmance is designated a NEW GROUND OF 4
REJECTION under § 41.50(b). 5
Under 37 C.F.R. § 41.50(b) a new ground of rejection has been 6
entered. 37 C.F.R. § 41.50(b) provides that, “[A] new ground of rejection 7
pursuant to this paragraph shall not be considered final for judicial review.” 8
Regarding the new ground of rejection, Appellant must, WITHIN 9
TWO MONTHS FROM THE DATE OF THE DECISION, exercise one of the 10
following options with respect to the new ground of rejection, in order to 11
avoid termination of the appeal as to the rejected claims: 12
(1) Reopen prosecution. Submit an appropriate amendment of the 13
claims so rejected or new evidence relating to the claims so rejected, 14
or both, and have the matter reconsidered by the examiner, in which 15
event the proceeding will be remanded to the examiner. . . ; or 16
17
(2) Request rehearing. Request that the proceeding be reheard under 18
§ 41.52 by the Board upon the same record. . . . 19
20
No time period for taking any subsequent action in connection 21
with this appeal may be extended under 37 C.F.R. § 1.136(a). 22
23
24
AFFIRMED; 37 C.F.R. § 41.50(b) 25
26
27
vsh 28
29
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