Ex Parte Walak

Board of Patent Appeals and Interferences

Jan 25, 2010

10725890 (B.P.A.I. Jan. 25, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte STEVEN E. WALAK
__________

Appeal 2009-009883
Application 10/725,890
Technology Center 3700
____________

Decided: January 25, 2010
____________

Before LINDA M. GAUDETTE, KAREN M. HASTINGS, and
MICHAEL P. COLAIANNI, Administrative Patent Judges.

COLAIANNI, Administrative Patent Judge.

DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134 the final rejection of claims
1-22, 25-27, 57-70, and 73.1 We have jurisdiction over the appeal pursuant
to 35 U.S.C. § 6(b).

1 The Appeal Brief includes claim 56 as being on appeal. However, the Final
Office Action and the Status of Claims section of the Appeal Brief indicate
that claim 56 is withdrawn. Therefore, we shall not consider claim 56 on
appeal.
Appeal 2009-009883
Application 10/725,890

2
We AFFIRM.
Appellant discloses a composite medical device that includes a more
flexible inner portion and a less flexible outer portion (Spec. 1).

Claim 1 is illustrative:
1. A composite medical device produced by a process comprising:

constructing a composite elongate shaft by forming a metallic outer
portion comprising a first metallic material about a metallic inner portion
including a lumen therein, the metallic inner portion comprising a second
metallic material different from the first material, wherein the second
metallic material is more flexible than the first metallic material, and
wherein the composite elongate shaft has a distal region and a proximal
region; and

removing a segment of the metallic outer portion from the composite
shaft to expose a segment of the metallic inner portion.

The Examiner relies on the following prior art references as evidence
of unpatentability:

Viera US 6,039,699 Mar. 21, 2000
Ren US 6,045,547 Apr. 4, 2000
Rooney US 6,306,105 B1 Oct. 23, 2001
O’Brien WO 99/58184 Nov. 18, 1999

Appellant appeals the following rejection:

1. Claims 1-11, 13, 15, 16, 18-22, 25-27, 57-59, 61, 63, 64, 66-70, and
73 are rejected under 35 U.S.C. § 103(a) as being unpatentable over
Ren in view of Viera.2

2 The Examiner’s omission of claims 10, 22, 27, and 70 from the statement
of rejection (Ans. 3) is harmless error because it is clear from the body of the
rejection that claims 10, 22, 27, and 70 are rejected (Ans. 5, 6, and 8). Also,
Appeal 2009-009883
Application 10/725,890

3
2. Claims 12, 17, 60, and 65 are rejected under 35 U.S.C. § 103 as being
unpatentable over Ren in view of Viera and O’Brien.
3. Claims 14 and 62 are rejected under 35 U.S.C. § 103 as being
unpatentable over Ren in view of Viera and Rooney.3
With regard to rejection (1) Appellant traverses the rejection of claims
1, 57, and 73 with regard to the same feature. Accordingly, we select claim
1 as representative with claims 2-11, 13, 15, 16, 18-22, 25-27, 57-59, 61, 63,
64, 66-70, and 73 standing or falling therewith. Rejections (2) and (3) are
traversed for the same reasons as rejection (1). Accordingly, claims 12, 14,
17, 60, 62, and 65 stand or fall with our analysis of claim 1.

ISSUE
Has Appellant shown that the Examiner reversibly erred in construing
the “constructing a composite elongate shaft by forming a metallic outer
portion comprising a first metallic material about a metallic inner portion
including a lumen” feature of product-by-process claim 1 as including a
structure having the composite elongate shaft formed of pre-formed inner
and outer metallic portions that are subsequently bonded together by

the Examiner’s omission of claims 58 and 69 from the statement of the
rejection (Ans. 3) is harmless error because these claims contain similar
subject matter as claims 6, 7, and 27, which were rejected under § 103 over
Ren in view of Viera. Appellant does not separately argue claims 6, 7, and
27. Accordingly, it is clear that non-separately argued claims 58 and 69 are
likewise rejected under § 103 over Ren in view of Viera. Appellant does not
dispute that claims 58 and 69 are under rejection (Br. and Reply Br.
generally).
3 Appellant incorrectly states that claim 52 is rejected over Ren in view of
Viera and Rooney (Br. 3). The Examiner corrects this mistake and indicates
that claim 62 is rejected over Ren in view of Viera and Rooney, which
Appellant accepts (Ans. 2; Reply Br. 2).
Appeal 2009-009883
Application 10/725,890

4
welding or brazing, for example, such that the claimed invention would have
been obvious over Ren in view of Viera? We decide this issue in the
negative.

PRINCIPLES OF LAW
The applicant bears the procedural burden of showing error in the
Examiner’s rejections. See, e.g., In re Kahn, 441 F.3d 977, 985-86 (Fed.
Cir. 2006) (“On appeal to the Board, an applicant can overcome a rejection
[under § 103] by showing insufficient evidence of prima facie obviousness”)
(citation and internal quote omitted).
Product-by-process claims are not specifically discussed in the patent
statute. In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985). The practice and
governing law have developed in response to the need to enable an applicant
to claim an otherwise patentable product that resists definition by other than
the process by which it is made. Id. For this reason, even though product-
by-process claims are limited by and defined by the process, determination
of patentability is based on the product itself. Id. Once the Patent Office
establishes a prima facie case that the claimed and prior art products appear
to be the same or substantially the same, the burden shifts to applicant to
show that the products do not possess the same properties (i.e., the products
are different). Id. at 698.
Claims are given the broadest reasonable construction consistent with
the Specification. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). The
Patent and Trademark Office (“PTO”) determines the scope of claims in
patent applications not solely on the basis of the claim language, but upon
giving claims their broadest reasonable construction “in light of the
Appeal 2009-009883
Application 10/725,890

5
specification as it would be interpreted by one of ordinary skill in the art.”
In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).

FACTUAL FINDINGS (FF)
We adopt the Examiner’s findings on page 4 of the Answer as our
own. We add the following primarily for completeness.
1. Appellant does not dispute the Examiner’s construction of claim 1
as a product-by-process claim (Ans. 4-5; Br. 11-14).
2. The Specification discloses:
The elongate shaft 110 can be formed in several
different ways. For example, the inner portion 112
and the outer sleeve 114 can be co-drawn, co-
extruded, or otherwise processed, for example,
over a mandrel or other such structure or device to
form the elongate shaft 110 in which the outer
portion 114 is of unitary construction with the
inner portion 112. In some embodiments, such
unitary construction allow the formation of a
composite shaft 110 that can be co-drawn and
straightened such that the inner portion 112 and the
outer portion 114 are formed together as one
unitary construction. In other embodiments, the
inner portion 112 and the outer portion 114 may be
separately manufactured, and thereafter, the outer
portion 114 can be disposed about and securely
connected to inner portion 112. Some examples of
suitable attachment techniques can include,
soldering, welding, adhesive bonding, heat
bonding, or shrinking techniques, mechanical
bonding or fitting, heat crimping, or the like, or
combinations thereof.

(Spec. 8-9). In other words, forming the elongate shaft includes
forming a unitary construction by either coextruding the inner and
Appeal 2009-009883
Application 10/725,890

6
outer portions or separately forming the inner and outer portions
and subsequently joining them by welding, for example.
3. Ren discloses a catheter made of layers of polymeric material, the
thickness of the layers vary to provide control of the flexibility of
the catheter (col. 2, ll. 7-16; col. 3, ll. 11-31; col. 4, ll. 40-59).
4. Ren discloses that the catheter may be formed by an extrusion
process (col. 4, ll. 60-62).

ANALYSIS
Appellant argues that a claim feature is missing from the combined
teachings of Ren and Viera (Br. 11). Specifically, Appellant contends that
the product-by-process feature, “forming an elongate shaft,” of claim 1
produces an elongate shaft having an unitary construction, which requires a
coextrusion process that bonds the inner and outer portions together along
their entire length of the elongated shaft and excludes separately forming
and attaching the inner and outer portions via adhesive, welding, brazing or
soldering (Br. 11-12).
The Examiner correctly construes the “forming” feature as including a
product made by separately forming the inner and outer portions and
subsequently bonding them together to form a unitary structure (Ans. 12).
The Specification indicates that the elongate shaft may be formed by
coextrusion of the inner and outer portions, or separately forming the inner
and outer portions and bonding them together to form the shaft (FF 2).
Therefore, the structure of the composite medical device implied by the
broadest reasonable interpretation of product-by-process feature “forming an
elongated shaft” includes separately forming the parts and subsequently
Appeal 2009-009883
Application 10/725,890

7
bonding the parts together to form a unitary structure (i.e., separate parts
bonded together to form a unified single shaft).
Appellant further contends that separately forming and subsequently
bonding the layers together does not form a unitary structure as claimed.
However, the claim does not require that a unitary structure is formed by
coextrusion. Rather, the claim merely recites “forming an elongated shaft,”
which, as indicated above, the Specification teaches may include separately
forming the individual parts with subsequent bonding of the parts.
Accordingly, Appellant's argument that the claims are limited to an
elongated shaft having a unitary structure formed by coextrusion is without
persuasive merit.
Appellant further argues that one of ordinary skill would look to
Ren’s coextrusion method of making the catheters that only refers to
forming polymer to form a metallic composite medical device as claimed
only in view of Appellant's disclosure (i.e., impermissible hindsight) (Br.
12).
However, the Examiner’s stated case of obviousness does not
necessarily rely on using Ren’s coextrusion method to form the metallic
materials. Rather, the Examiner finds that Ren and Viera both disclose
devices (i.e., guidewires or catheters) that perform nearly the same function
(i.e., the ability to guide through the ducts, cavities, and vessels of a person’s
body), with the exception that guidewires do not have lumens (Ans. 4).
Based on these findings the Examiner concludes that it would have been
obvious to one of ordinary skill in the art to make the catheter of Ren using
the metal materials of Viera (Ans. 4).
Appeal 2009-009883
Application 10/725,890

8
The Examiner further explains that the product as claimed could be
made by creating the first metallic layer as a loose tube that is then fit over
the second metallic layer and then using the bonding methods of Ren or
Viera to form the elongated shaft of the composite medical device (Ans. 12).
In other words, the Examiner takes the position that the teachings of Ren and
Viera as a whole would have suggested forming the claimed metallic
elongated shaft having a lumen using the metal forming techniques of Viera.
Appellant's impermissible hindsight argument does not show
reversible error in the Examiner’s stated case and findings related thereto.
Instead, Appellant narrowly focuses the arguments on using Ren’s
coextrusion method to make a metallic composite medical device as taught
by Viera. Accordingly, we are unpersuaded by Appellant's argument.
For the above reasons, we affirm the Examiner’s § 103 rejections of
claims 1-11, 13, 15, 16, 18-22, 25-27, 57-59, 61, 63, 64, 66-70, and 73 over
Ren in view of Viera; claims 12, 17, 60, and 65 over Ren in view of Viera
and O’Brien; and claims 14 and 62 over Ren in view of Viera and Rooney.
DECISION
The Examiner’s decision 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)(1)(iv).

AFFIRMED

cam

Appeal 2009-009883
Application 10/725,890

9
CROMPTON, SEAGER & TUFTE, LL.
1221 NICOLLET AVENUE
SUITE 800
MINNEAPOLIS MN 55403-2420