Ex Parte LAGUNA et al

Board of Patent Appeals and Interferences

Oct 20, 2010

09384900 (B.P.A.I. Oct. 20, 2010)

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.
09/384,900 08/27/1999 ALVARO J. LAGUNA MP/147 8440
28596 7590 10/21/2010
GORE ENTERPRISE HOLDINGS, INC.
551 PAPER MILL ROAD
P. O. BOX 9206
NEWARK, DE 19714-9206
EXAMINER
MENDEZ, MANUEL A
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
10/21/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ALVARO J. LAGUNA and CAREY V. CAMPBELL
____________

Appeal 2009-011003
Application 09/384,900
Technology Center 3700
____________

Before LINDA E. HORNER, JENNIFER D. BAHR, and
STEVEN D.A. McCARTHY, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2009-011003
Application 09/384,900

2
The Appellants appeal under 35 U.S.C. § 134 of the Examiner’s final 1
decision rejecting claims 24-42. More specifically, the Examiner rejects: 2
claims 24-26 under 35 U.S.C. § 102(b) as being anticipated by 3
Daneshvar (US 5,728,066, issued Mar. 17, 1998); 4
claims 24, 25, 29, 32-34, 37 and 40-42 under § 102(b) as being 5
anticipated by Kraus (US 5,718,680, issued Feb. 17, 1998); 6
claims 28, 30, 31, 36, 38 and 39 under 35 U.S.C. § 103(a) as 7
being unpatentable over Daneshvar and Crocker (US 5,843,116, 8
issued Dec. 1, 1998); and 9
claims 27 and 35 under § 103(a) as being unpatentable over 10
Daneshvar and Ravenscroft (US 5,766,201, issued Jun. 16, 1998). 11
Claims 1-23 are cancelled. We have jurisdiction over the appeal under 35 12
U.S.C. § 6(b). 13
We REVERSE. 14
Claim 24 is the sole independent claim on appeal: 15
24. A sleeve adapted to be mounted on a 16
catheter shaft so as to be formed into an inflatable 17
balloon comprising 18
the sleeve having a first end, a second end, 19
and a middle section; 20
wherein prior to being formed into the 21
balloon by mounting on the catheter shaft at least 22
one of the ends is non-distensible while the middle 23
section of the sleeve is distensible. 24
Appeal 2009-011003
Application 09/384,900

3
Rejections of claims 24-26 under § 102(b) as being anticipated by 1
Daneshvar; and of claims 24, 25, 29, 32-34, 37 and 40-42 under § 102(b) as 2
being anticipated by Kraus 3
The analysis of these rejections begins with claim construction. See 4
Medichem, S.A. v. Rolabo, S.L., 353 F.3d 928, 933 (Fed. Cir. 2003). Claim 5
24 recites a “sleeve.” The sleeve is “adapted to be mounted on a catheter 6
shaft so as to be formed into an inflatable balloon.” The latter recitation 7
implies that the inflatable balloon into which the sleeve is formed is not the 8
claimed sleeve itself. Furthermore, “prior to being formed into the balloon 9
by mounting on the catheter shaft at least one of the ends [of the sleeve] is 10
non-distensible while the middle section of the sleeve is distensible.” As the 11
Appellants point out, “[i]n order to be perfectly clear that [claim 24 is] 12
defining the sleeve itself and not a completed catheter balloon device, [the 13
Appellants have] included the limitation that these properties exist ‘prior to 14
being formed into the balloon.’” (Reply Br.2 2.) Claim 24 claims a sleeve 15
and not an inflatable balloon or a completed catheter of which the inflatable 16
balloon may be a component. 17
The Appellants correctly contend that “the pending claims do not 18
define a product-by-process[.]” (Reply Br. 1.) A product-by-process claim 19
“is one in which the [claimed] product is defined at least in part in terms of 20
the method or process by which it is made.” Bonito Boats, Inc. v. Thunder 21
Craft Boats, Inc., 489 U.S. 141, 158 n. (1989). Although claim 24 recites 22
that the sleeve is adapted to be mounted on a catheter shaft so as to be 23
formed into an inflatable balloon, the claim does not recite any step of a 24
method or process by which the sleeve itself is made. The term “prior to 25

2 The abbreviation “Reply Br.” refers to the Reply Brief filed April 13,
2005.
Appeal 2009-011003
Application 09/384,900

4
being formed into the balloon by mounting on the catheter shaft” says 1
nothing about any method or process by which the sleeve is made. 2
Therefore, claim 24 is not a product-by-process claim. 3
Any reasonable interpretation of claim 24 is limited to a sleeve 4
“wherein prior to being formed into the balloon by mounting on the catheter 5
shaft at least one of the ends is non-distensible while the middle section of 6
the sleeve is distensible.” The Appellants correctly contend that “each of the 7
references cited by the Examiner describes sleeves that do not have non-8
distensible ends prior to mounting on a catheter shaft.” (Reply Br. 3.) 9
Daneshvar describes a catheter with an inflatable balloon 4, where the 10
balloon may have fixed ends 5 and 6. (Daneshvar, col. 3, ll. 8-10 and 19-24; 11
fig. 1.) Similarly, Kraus describes a catheter with sheath 22 sealed around 12
an internal tubular member 21 to form an inflatable cavity 23, that is, a 13
balloon. (Kraus, col. 3, ll. 51-53; fig. 2.) 14
The Examiner does not appear to find that either Daneshvar or Kraus 15
discloses a sleeve “wherein prior to being formed into the balloon by 16
mounting on the catheter shaft at least one of the ends is non-distensible 17
while the middle section of the sleeve is distensible.” Instead, the Examiner 18
finds that Daneshvar and Kraus each disclose a “balloon catheter having a 19
sleeve forming a balloon wherein at least one of the ends is non-distensible 20
while the middle section of the sleeve is distensible.” (Ans.3 5 (internal 21
quotation marks suppressed).) The Examiner’s finding is insufficient to 22
show that either Daneshvar or Krause anticipates the subject matter of claim 23
24 under a reasonable construction of claim 24. 24

3 The abbreviation “Ans.” and the term “Answer” refer to the Answer
mailed February 9, 2005.
Appeal 2009-011003
Application 09/384,900

5
Claim 24, when properly construed, claims a sleeve wherein prior to 1
being formed into a balloon by mounting on a catheter shaft, at least one of 2
the ends is non-distensible and not a balloon catheter which may have at 3
least one non-distensible end only after being mounted on the catheter shaft. 4
Neither Daneshvar nor Kraus describes a sleeve wherein prior to being 5
formed into the balloon by mounting on the catheter shaft at least one of the 6
ends is non-distensible while the middle section of the sleeve is distensible. 7
We do not sustain the Examiner’s rejection of claims 24-26 under § 102(b) 8
as being anticipated by Daneshvar; or of claims 24, 25, 29, 32-34, 37 and 9
40-42, under § 102(b) as being anticipated by Kraus. 10
11
Rejections of claims 28, 30, 31, 36, 38 and 39 under § 103(a) as being 12
unpatentable over Daneshvar and Crocker; and of claims 27 and 35 under 13
§ 103(a) as being patentable over Daneshvar and Ravenscroft 14
Crocker discloses a catheter 10 including an elongate tubular body 15
12. (Crocker, col. 3, ll. 56-58.) A distal end 16 of the elongate tubular body 16
12 is provided with a balloon 18 including an inner balloon 36 and an outer 17
balloon 38. The inner balloon 36 is disposed coaxially within the outer 18
balloon 38. (Crocker, col. 4, ll. 46-48 and col. 5, ll. 20-21.) Substantially 19
nondistensible expansion limiting bands 40, 44 are disposed between the 20
inner and outer balloons 36, 38. (Crocker, col. 5, ll. 21-27.) Figure 3 of 21
Crocker depicts the substantially nondistensible expansion limiting bands 22
40, 44 as being positioned between the ends of the inner and outer balloons 23
36, 38 and not at the ends of the balloons. Crocker teaches that the 24
substantially nondistensible expansion limiting bands 40, 44 “may be coated 25
or mounted on the exterior surface of the balloon 18, the interior surface of 26
Appeal 2009-011003
Application 09/384,900

6
the balloon 18 or within the wall of the balloon 18.” (Crocker, col. 5, ll. 55-1
59.) 2
The Examiner finds that, “[i]n figures 2 and 3, Crocker, et al., shows a 3
balloon catheter having a sleeve forming a balloon wherein at least one of 4
the ends is non-distensible (37, 39) while the middle section of the sleeve is 5
distensible (30).” (Ans. 8.)4 The Examiner does not appear to find that 6
Crocker discloses a sleeve “wherein prior to being formed into the balloon 7
by mounting on the catheter shaft at least one of the ends is non-distensible 8
while the middle section of the sleeve is distensible.” 9

4 On page 8 of both the Answer and the Supplemental Answer mailed
May 19, 2006, the Examiner states that, “[i]n view of these observations,
Crocker, et al., anticipates the subject matter in claim 24.” The Appellant
calls this statement a new ground of rejection and seeks to distinguish the
subject matter of claim 24 from the disclosure of Crocker. (Reply Br. 4.)
Several facts indicate that the Examiner did not intend this statement to
constitute a separate ground for rejecting claim 24, however. The
Examiner’s listing of the Grounds of Rejection on page 3 of both the Answer
and the Supplemental Answer does not include a rejection under § 102 of
any claim as anticipated by Crocker. The statements on page 8 of both the
Answer and the Supplemental Answer, as well as the Examiner’s response
on page 9 of the Supplemental Answer, fail to state that claim 24 is rejected
as anticipated by Crocker. The Examiner does not provide notice to the
Appellant in either the Answer or the Supplemental Answer that a new
ground of rejection is being entered. Although a Technical Center Director
signed the Supplemental Answer (Supp. Ans. 10), it appears that the
Technical Center Director’s signature was intended to approve the filing of a
supplemental answer rather than to approve a new ground of rejection (see
Order Returning Undocketed Appeal to Examiner mailed March 16, 2006).
In view of these facts, it appears that the statements on page 8 of both the
Answer and the Supplemental Answer were intended to “briefly comment
on the teachings of Crocker, et al.” (see Ans. 7; Supp. Ans. 7) and not to
enter a new ground of rejection against claim 24.
Appeal 2009-011003
Application 09/384,900

7
Ravenscroft describes the use of a strip 18 providing resistance via 1
wrapping the strip around an inflatable balloon 28 over a flexible shaft 14 of 2
a catheter 12. The strip facilitates sequential expansion of the inflatable 3
balloon as expansion force is increased. (Ravenscroft, col. 1, l. 67 – col. 2, l. 4
3 and col. 3, ll. 44-49.) The Examiner does not appear to find that 5
Ravenscroft discloses a sleeve “wherein prior to being formed into the 6
balloon by mounting on the catheter shaft at least one of the ends is non-7
distensible while the middle section of the sleeve is distensible.” 8
The Examiner does not articulate persuasive reasoning to explain how 9
the teachings of either Crocker or Ravenscroft might remedy the deficiency 10
in the disclosure of Daneshvar pointed out in connection with the rejection 11
of claim 24. Since the Examiner’s conclusion of obviousness lacks rational 12
underpinning, we do not sustain the Examiner’s rejections under § 103(a) 13
either of claims 28, 30, 31, 36, 38 and 39 as being unpatentable over 14
Daneshvar and Crocker; or of claims 27 and 35 as being unpatentable over 15
Daneshvar and Ravenscroft. 16
17
DECISION 18
We REVERSE the Examiner’s decision rejecting claims 24-42. 19
20
REVERSED 21
22
Klh 23
24
GORE ENTERPRISE HOLDINGS, INC. 25
551 PAPER MILL ROAD 26
P. O. BOX 9206 27
NEWARK, DE 19714-9206 28