Ex Parte DeVries et al

Patent Trial and Appeal Board

Sep 20, 2012

10659490 (P.T.A.B. Sep. 20, 2012)

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.
10/659,490 09/10/2003 Robert B. DeVries 1001.1602101 3452
11050 7590 09/20/2012
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
HUGHES, SAMUEL T
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
09/20/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ROBERT B. DEVRIES,
KRISTIAN DIMATTEO, and STEVEN WALAK
__________

Appeal 2011-005981
Application 10/659,490
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a medical
device, such as a stent. The Examiner entered rejections for indefiniteness,
anticipation, and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1-10 and 65-69 stand rejected and appealed (see App. Br. 3).
Claim 1, the only independent claim, illustrates the appealed subject matter
and reads as follows:

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1. A composite medical device, comprising:
a first composite elongated member formed from an outer
member comprising a first material and an inner member comprising a
second material different from the first material, the outer member
surrounding and encasing the inner member, wherein the second
material is more elastic than the first material; and
at least one flexibility region formed on said first composite
elongated member, said flexibility region formed by selectively
removing a portion of the outer member to expose the inner member,
wherein, when the composite medical device is deformed about the
exposed inner member from a first position to a second position, the
exposed inner member tends to bias the medical device toward the
first position, wherein said first composite elongated member has a
solid cross-section.

The following rejections are before us for review:
(1) Claim 67, under 35 U.S.C. § 112, second paragraph, as indefinite
(Ans. 3-4);
(2) Claims 1-4, 6-10, and 65-69, under 35 U.S.C. § 102(b), as
anticipated by Tomonto
1
(Ans. 4-7); and
(3) Claim 5, under 35 U.S.C. § 103(a), as obvious over Tomonto and
Moore
2
(Ans. 7-8).
INDEFINITENESS
In rejecting claim 67 as indefinite, the Examiner noted that “[c]laim
67 first recites wherein the first end of the medical device and first
composite elongated member are „in a first direction from the second end of
the‟ medical device or first composite elongated member, respectively”
(Ans. 3.) The Examiner concluded, however, that “it is unclear what is

1
U.S. Patent No. 6,425,855 B2 (issued July 30, 2002).
2
U.S. Patent App. Pub. No. 2004/0024444 A1 (filed July 31, 2002).
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meant by „in a first direction.‟ Does that infer they are on opposite sides of
the device?” (id.).
The Examiner further noted that “[c]laim 66 [sic, 67] also recites
wherein „the axis of the first composite elongated member at the first end ...
is offset from the axis of the composite medical device.‟ However, it is
unclear as to which axis is referred to” (id. at 3-4).
Despite its presence in the Final Rejection (see Final Rejection 2
(entered November 30, 2009)), this indefiniteness rejection is not addressed
in the Appeal Brief. The Reply Brief explains, however, that “the Examiner
has failed to clarify that rejection in response to Appellants‟ communication
after the Final Office Action. The Examiner incorrectly quoted claim 66 in
the rejection of claim 67” (Reply Br. 2).
Further, Appellants contend, “it is believed that the amendment of
claim 67 and the discussion in the communication of January 26, 2010
removed any ambiguity regarding the designation of a first direction. The
lack of further discussion has been interpreted as acceptance of the
amendment” (id.). Appellants note that the “restatement of the rejection in
the Examiner‟s Answer apparently indicates that the issue is being raised
again, but again incorrectly quotes claim 66. Appellants believe that the
rejection has been rendered moot by the amendment and respectfully request
that the rejection be overruled” (id.).
We note that the Examiner‟s rejection at one point refers to “[c]laim
66” (Ans. 3). However, the language quoted by the Examiner in that
sentence appears in claim 67 (see App. Br. 25). Thus, given that the
Examiner rejected claim 67 and quoted language in that claim, we are not
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persuaded that the Examiner‟s inadvertent reference to claim 66 undermines
the substance of the rejection.
Moreover, other than the alleged error in referring to claim 66,
Appellants present no specific substantive argument in the Reply Brief, or
the Appeal Brief for that matter, explaining why the Examiner‟s conclusion
of indefiniteness with respect to claim 67 is erroneous or why the
amendment referred to overcomes the rejection. We note that the Advisory
Action of February 18, 2010 did not contain any specific response directed
to Appellants‟ arguments regarding the indefiniteness rejection (see
Advisory Action 2 (entered February 18, 2010; see also Amendment After
Final 12-13)). The Advisory Action did not, however, state that the
indefiniteness rejection had been withdrawn.
Thus, as Appellants‟ Appeal and Reply Briefs do not present any
specific convincing argument explaining why the Examiner‟s conclusion of
indefiniteness as to claim 67 is erroneous, we affirm the Examiner‟s
rejection of claim 67 under 35 U.S.C. § 112, second paragraph.
ANTICIPATION
Appellants contend that the Examiner erred in finding that Tomonto
anticipates claim 1 because an ordinary artisan would reasonably interpret
“the claim phrase „the outer member surrounding and encasing the inner
member‟ in view of the specification and drawings as the outer member
contacting the inner member on all sides” (App. Br. 6; see also Reply Br. 2-
4). In contrast, Appellants urge, the struts of Tomonto‟s stent identified by
the Examiner as corresponding to claim 1‟s elongated member are not
completely contacted on all sides by the outer covering material (see App.
Br. 8-9; also Reply Br. 4).
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Appellants also contend that the Examiner erred in finding that
Tomonto inherently describes a device in which the inner second material is
more elastic than the outer first material (see App. Br. 12-14; also Reply Br.
6-7).
The Examiner responds:
If complete enclosure [of the inner member of the composite
elongated member of claim 1] is required by the claims before
the flexibility regions are formed then the claim is merely
limited to a device wherein the outer layer completely
surrounds the inner but specific portions of the outer layer are
then subsequently removed to expose the inner member. This
removal is a product by process limitation so Tomonto meets
the final product and therefore overlaps the claims.

(Ans. 9.)
Moreover, the Examiner argues, Appellants‟ Specification supports
the Examiner‟s finding that Tomonto inherently describes a device
composed of an elongate member that has an inner material that is more
elastic than an overlying outer material, as claim 1 requires (see id. at 11).
We find that a preponderance of the evidence favors the Examiner‟s
position.
It is well settled that “[t]o anticipate a claim, a prior art reference must
disclose every limitation of the claimed invention, either explicitly or
inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
As to product-by-process claims, as stated in In re Thorpe, 777 F.2d
695, 697 (Fed. Cir. 1985) (citations omitted):
[E]ven though product-by-process claims are limited by and
defined by the process, determination of patentability is based
on the product itself. The patentability of a product does not
depend on its method of production. If the product in a
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product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though
the prior product was made by a different process.

Also, once the Examiner establishes that a product recited in terms of
its process of making is prima facie unpatentable due to anticipation,
Appellants bear the burden of proving “that the prior art products do not
necessarily or inherently possess the characteristics of his claimed product.”
Id. at 698 (quoting In re Fitzgerald, 619 F.2d 67, 70 (CCPA 1980); In re
Best, 562 F.2d 1252, 1255 (CCPA 1977)).
Here, claim 1 recites a composite medical device that has “a first
composite elongated member formed from an outer member comprising a
first material and an inner member comprising a second material different
from the first material, the outer member surrounding and encasing the inner
member” (App. Br. 17 (emphasis added)). The elongated member must
have “at least one flexibility region formed on said first composite elongated
member, said flexibility region formed by selectively removing a portion of
the outer member to expose the inner member” (id. (emphasis added)).
Thus, rather than requiring the elongated member to have an inner
member that is surrounded and encased by an outer member, claim 1
encompasses devices in which the elongated member is formed from a
composite member in which the outer member surrounds the inner member,
but where a portion of the outer member has been removed to expose the
inner member. Of note, claim 1 does not impose any limitation on the
proportion of outer member that may be removed.
As the Examiner points out, Tomonto discloses a stent that includes
“at least one elongate member, each strut” (Ans. 4 (citing Tomonto, Fig. 1)).
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As the Examiner also points out, Tomonto discloses one embodiment in
which its stent “could be made of a superelastic material, such as Nitinol,
sandwiched between two layers of a plastically deformable, such as stainless
steel” (Tomonto, col. 4, ll. 52-55).
Thus, as required by claim 1, Tomonto discloses a composite device
that has an elongated member with an outer material, stainless steel, which is
different from an inner material, nitinol. The struts of Tomonto‟s device
include portions corresponding to the claimed flexibility region, in which the
inner material (reference numbers 80 and 90) is entirely exposed (see, e.g.
id. at Figs. 1 and 2).
Appellants provide an annotated version of Tomonto‟s Figure 3,
reproduced below, to show that the sandwich embodiment of Tomonto does
not anticipate claim 1 (see Reply Br. 4):

Appellants‟ annotated Figure 3 is a cross sectional view of a strut of
Tomonto‟s stent, and shows the elements of Tomonto‟s sandwich
embodiment, with element 110, which corresponds to the inner nitinol layer,
lying between outer layer 110 and a layer denoted by broken lines, which
correspond to the outer stainless steel layers. Appellants argue that, since
the outer member only encloses the inner member on two sides, Tomonto‟s
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sandwich embodiment does not meet claim 1‟s requirement that the outer
member surround and encase the inner member (see Reply Br. 4).
As noted above, however, claim 1 is a product-by-process claim and
does not limit the amount of outer material which may be removed to expose
the inner member. Thus, while claim 1 requires the elongate member to be
formed from a composite member that has an outer member that fully
surrounds and encases an inner member, because claim 1 does not limit the
amount of outer material that may be removed to form the final product,
claim 1 encompasses devices having elongate members in which the
overlying outer material is removed to an extent that not all sides of the
inner member are covered by the outer member. That is, claim 1 does not
require the inner member of the non-flexibility regions to be completely
surrounded and encased by the outer member.
Thus, Tomonto discloses a composite device that has an elongated
member in which an inner material, nitinol, is sandwiched by a different
outer material, stainless steel (Tomonto, col. 4, ll. 52-55). As seen in
Appellants‟ annotated Figure 3 of Tomonto, reproduced above, the
elongated member in the sandwich embodiment has a solid cross section, as
required by claim 1. Moreover, due to the exposed sections of the inner
material, Tomonto meets claim 1‟s requirement that the flexibility region be
formed by removal of a portion of the outer member.
We note that Tomonto‟s devices are made by producing a laminated
tube having multiple layers, with the stent‟s structures, including the struts,
being formed by cutting into the laminated tube, thereby exposing the inner
layers of material (see id. at col. 4, l. 57, through col. 5, l. 19). While
Tomonto‟s production methods may be different from those claimed,
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however, Appellants point to no clear or specific evidence suggesting that
the elongate member described in Tomonto‟s sandwich embodiment fails to
meet any structural feature of a device made by the process steps recited in
claim 1. We are therefore not persuaded that the Examiner erred in finding
that Tomonto discloses a device with a composite elongated member that
meets the structural relationship of the inner and outer members required by
claim 1.
We are also not persuaded that the Examiner erred in finding that the
inner second material of Tomonto‟s sandwich embodiment, nitinol, is more
elastic than the first material. Appellants argue:
[N]either “stainless steel” nor “Nitinol” would be understood
by one of ordinary skill in the art to specify a single chemical
composition and further one of ordinary skill in the art would
appreciate that the mechanical properties of any given
composition of those materials depend upon both the
mechanical and thermal history to which the sample has been
subjected. This is especially true of Nitinol where the art relies
upon processing to greatly alter the mechanical properties of an
article fabricated therefrom.
There are over 150 grades of stainless steel as well as a
variety of measures of “elasticity”. For example, it is relatively
easy to find literature values for modulus, “elasticity”, for
stainless steels which vary by a factor of 3. The Examiner has
not cited any portion of Tomonto which discloses that the
disclosed generic superelastic material is necessarily more
elastic than a generic plastically deformable material, or even
that the unspecified Nitinol is more elastic than the unspecified
stainless steel for any given measure of elasticity.

(App. Br. 13; see also Reply Br. 6-7.)
We are not persuaded. Appellants point to no clear or specific
evidence in the record in support of the argument that an ordinary artisan
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would fail to understand that the inner nitinol material of Tomonto‟s
sandwich embodiment (Tomonto, col. 4, ll. 52-55) would be more elastic
than the outer stainless steel material. It is well settled that argument by
counsel does not constitute actual evidence. See In re Geisler, 116 F.3d
1465, 1471 (Fed. Cir. 1997).
Moreover, as the Examiner points out, Appellants specifically list
nitinol and stainless steel as materials which are relatively elastic and
relatively stiff, respectively:
The outer member 26 may comprise a relatively stiff material,
whereas the inner core member 28 may comprise a relatively
elastic material. In certain embodiments, for example, the inner
core member 28 may be formed of a material having
superelastic or pseudo-elastic characteristics such as nickel-
titanium alloy (Nitinol), beta titanium alloy, titanium-palladium
alloy (Ti-Pd), titanium-platinum alloy (Ti-Pt), or nickel-
titanium-copper alloy (Ni-Ti-Cu), whereas the outer member 26
may be formed of a relatively stiff material such as stainless
steel, gold, molybdenum, platinum, titanium, tungsten, Elgiloy,
L605, MP35N, Ta-10W, 17-4PH, Aeromet 100, cobalt-chrome
alloy or cobalt alloys, metal glass alloys, and refractory metal
alloys.

(Spec. 8.) Thus, as the sandwich embodiment of Tomonto contains inner
and outer layers composed of precisely the materials described in
Appellants‟ Specification as being useful for those components, we are not
persuaded that the Examiner‟s finding, that the nitinol in Tomonto‟s
sandwich embodiment is inherently more elastic than the outer stainless
steel, lacks an adequate evidentiary basis.
Accordingly, as Appellants‟ arguments do not persuade us that the
preponderance of the evidence fails to support the Examiner‟s finding of
anticipation as to claim 1, and as we are not persuaded that the anticipation
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finding is based on an unreasonable claim interpretation, we affirm the
Examiner‟s rejection of claim 1 as anticipated by Tomonto. As they were
not argued separately, claims 2-4, 6-10, and 65-69 fall with claim 1. See 37
C.F.R. § 41.37(c)(1)(vii).
OBVIOUSNESS
In rejecting claim 5, which depends from claim 1, over Tomonto and
Moore, the Examiner cited Moore as evidence that an ordinary artisan would
have considered it obvious to provide Tomonto‟s stent with a polymeric
outer coating, as the claim requires (Ans. 7-8). Appellants urge that, since
Moore does not remedy the deficiencies of Tomonto as to claim 1, claim 5 is
necessarily unobvious over the combination of Tomonto and Moore (see
App. Br. 15).
As discussed above, however, we are not persuaded that claim 1 fails
to encompass the device described by Tomonto. Therefore, as Appellants
point to no specific deficiency as to the Examiner‟s combination of Tomonto
and Moore, and as we detect none, we affirm this rejection as well.
SUMMARY
We affirm the Examiner‟s indefiniteness rejection of claim 67.
We also affirm the Examiner‟s anticipation rejection of claims 1-4, 6-
10, and 65-69 over Tomonto.
We also affirm the Examiner‟s obviousness rejection of claim 5 over
Tomonto and Moore.

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TIME PERIOD
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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