Ex Parte DiMatteo

Board of Patent Appeals and Interferences

Nov 1, 2010

10264920 (B.P.A.I. Nov. 1, 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.
10/264,920 10/04/2002 Kristian DiMatteo 706214-2001 6191
7590 11/01/2010
Bingham McCutchen LLP
2020 K Street, NW
Washington, DC 20006
EXAMINER
LUCCHESI, NICHOLAS D
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
11/01/2010 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 KRISTIAN DIMATTEO
____________________

Appeal 2009-009433
Application 10/264,920
Technology Center 3700
____________________

Before: LINDA E. HORNER, WILLIAM F. PATE III, and
FRED A. SILVERBERG, Administrative Patent Judges.

PATE III, 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 2009-009433
Application 10/264,920
2
STATEMENT OF CASE
Appellant appeals under 35 U.S.C. § 134 from a rejection of claims 1,
2, 4, 5, 7, 10-17, 19, 22 and 25-30. App. Br. 2. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm-in-part.

The claims are directed to a venous access device with detachable
suture wings. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A medical device for percutaneous access to a body
comprising:
a housing;
an entry site for one of the administration, withdrawal, and
exchange of fluids; and
a first detachable suture wing selectively coupleable to
the medical device via a first attachment arrangement.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Johnston
Speckman
Schultz
Kovacs
US 4,886,501
US 5,792,104
US 5,897,528
US 5,941,856
Dec. 12, 1989
Aug. 11, 1998
Apr. 27, 1999
Aug. 24, 1999
Tollini
Biolink2
US 2003/0216694 A1
WO 00/16844
Nov. 20, 2003
Mar. 30, 2000

2 Referred to by first named inventor, Estabrook, on page 4 of the Answer,
as Biolink, the applicant, thereafter and by Appellant.
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REJECTIONS
Claims 1, 2, 5 and 13-17 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Kovacs. Ans. 4.
Claims 1, 10-12, 28 and 30 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Johnston. Ans. 5.
Claims 1, 2, 4, 10-14, 17, 19 and 25-27 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Schultz. Ans. 5.
Claims 1, 12-14 and 27 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Biolink. Ans. 6.
Claims 1, 2, 13, 14, 17, 27 and 29 stand rejected under 35 U.S.C.
§ 102(e) as being anticipated by Tollini. Ans. 7.
Claims 7 and 22 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Biolink and Speckman. Ans. 7.

OPINION
The rejections of claims 1, 2 and 5 as being anticipated by Kovacs; and
claims 1, 2 and 29 as being anticipated by Tollini are reversed.
Appellant makes essentially the same argument regarding the
rejection of claim 1 as being anticipated by Kovacs and as being anticipated
by Tollini. Appellant argues that the Examiner’s interpretation of “suture
wing” as including Kovacks’ strap portions 42, 46 and the base portion 23’
and tab 26’ of Tollini’s tape is unreasonably broad. App. Br. 4-5, 11-12;
Reply Br. 2-4; see also Ans. 4-5, 7. We agree.
[W]here the Patent Office has reason to believe that a
functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the authority
to require the applicant to prove that the subject matter shown
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Application 10/264,920
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to be in the prior art does not possess the characteristic relied
on.
In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). Nevertheless, before an
appellant can be put to this burdensome task, the examiner must provide
sufficient evidence or scientific reasoning to establish the reasonableness of
the examiner’s belief that the functional limitation is an inherent
characteristic of the prior art. The fact that a certain result or characteristic
may occur or be present in the prior art is not sufficient to establish the
inherency of that result or characteristic. In re Rijckaert, 9 F.3d 1531, 1534
(Fed. Cir. 1993) (citation omitted). “‘Inherency . . . may not be established
by probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.’” In re Robertson, 169
F.3d 743, 745 (Fed. Cir. 1999) (citations omitted). “In relying upon the
theory of inherency, the examiner must provide a basis in fact and/or
technical reasoning to reasonably support the determination that the
allegedly inherent characteristic necessarily flows from the teachings of the
applied prior art.” Ex parte Levy, 17 USPQ2d 1461, 1464 (BPAI 1990)
(citations omitted).
The Examiner’s argument that Kovacks’ strap portions are capable of
receiving sutures and are therefore suture wings because they accept
threaded stitching 45 (Ans. 9) is unpersuasive. The Examiner has not
provided any scientific evidence or technical reasoning to establish that the
method of applying stitching 45, which may include using some mechanical
device, is sufficiently similar to a surgeon’s method of applying suturing to
establish that Kovacks’ strap portions 42, 46 are, in fact, penetrable by a
surgeon’s suturing instrument. No specific materials or thicknesses are
discussed for these elements of Kovacks. Thus, the Examiner has not
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established that the penetrability, upon which the Examiner’s argument is
based, is a characteristic that necessarily flows from the teachings of the
applied prior art.
The Examiner’s basis for concluding that the base portion 23’ and tab
26’ of Tollini’s tape is penetrable by a surgeon’s suturing implement also
lacks factual support or technical reasoning to reasonably support this
determination. The fact that the material may be “thin” (Ans. 13) is not
sufficient to establish that the material is necessarily penetrable by a
surgeon’s suturing implement. Furthermore, even if the portions of Kovacks
and Tollini relied upon by the Examiner were penetrable, there is no
indication they would suffice to hold the device in place by suturing without,
for example, ripping or tearing. Further, Tollini expressly states that his
device is intended to avoid using this type of attachment. P. 3, para. [0058].
Thus, the rejections of claim 1, and of those claims depending
therefrom, as being anticipated by either Kovacs or Tollini, must be
reversed.

The rejections of claims 1, 10-12, 28 and 30 as being anticipated by
Johnston; claims 1, 2, 4, 10-12 as being anticipated by Schultz; claims 1 and
12 as being anticipated by Biolink; and claim 7 as being unpatentable over
Biolink and Speckman are reversed.
Appellant makes essentially the same argument regarding the
rejections based upon Johnston, Schultz and Biolink. Appellant argues that
the Examiner’s interpretation of a suture wing that is “detachable” and
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“selectively coupleable” as including Johnston’s tie-down 523 (Ans. 5),
Schultz’s suture loops 34 (Ans. 5-6), or Biolink’s suture attachment structure
40 (Ans. 6), is unreasonable. App. Br. 6-10; Reply Br. 3-4. We agree.
Regarding Johnston, the Examiner argues that claim 1 is met by a
suture wing that is not yet attached to the device, i.e., before assembly.
Ans. 5, 10. It has long been held that an intermediate product or article can
anticipate a claimed article even if the intermediate product is merely a stage
in the final production of a non-anticipatory article. See In re Mullin, 481
F.2d 1333, 1335-36 (CCPA 1973). However, claim 1 is not anticipated
during the making of the device because at that point there exists only a
collection of parts and not a medical device comprising the claimed elements
as required by claim 1. “A claim is anticipated only if each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference.” Verdegaal Bros. v. Union Oil Co.
of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987). “These elements must be
arranged as in the claim under review.” In re Bond, 910 F.2d 831, 832 (Fed.
Cir. 1990) (citation omitted). Thus, the Examiner’s argument regarding the
assembly stage is unpersuasive.
Regarding Schultz and Biolink, the Examiner contends that since the
suture loops 34 of Schultz and the suture attachment structure 40 of Biolink
may be cut or torn from the device, they are “detachable” and “selectively
coupleable.” Ans. 10-12. Appellant contends that cutting, tearing or
otherwise destroying the device is not within the meaning of the terms
“detachable” and “selectively coupleable” as they would be understood by

3 Johnston refers to tie-down 50 as comprising body portion 52 and base
portion 54.
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one of ordinary skill in the art when read in light of the Specification. App.
Br. 7-10; Reply Br. 4.
[T]he PTO applies to the verbiage of the proposed claims
the broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in applicant’s specification.
In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). “[R]eading a claim in
the light of the specification, to thereby interpret limitations explicitly
recited in the claim, is a quite different thing from reading limitations of the
specification into a claim, to thereby narrow the scope of the claim by
implicitly adding disclosed limitations which have no express basis in the
claim.” In re Prater, 415 F.2d 1393, 1395 (CCPA 1969) (quotation marks
omitted).
The Specification does not clearly indicate whether cutting or tearing
should be included within the meaning of “detachable” and “selectively
coupleable.” The procedure most similar to these acts described in the
Specification involves a “breakaway feature.” The Specification states that
the suture wings can be integrally molded with a breakaway feature that
allows them to be removed by snapping them off. However, the
Specification further provides that where a breakaway feature is employed,
the suture wings are generally not mechanically reattachable. Para. [0031].
Various mechanical snapping and unsnapping methods are preferred when
the suture wings are to be attached, detached and reattached to the medical
device. Paras. [0037]-[0039]. The Specification also states that adhesives
can be used to attach the suture wings but they should not be used where the
suture wings are to be removed and subsequently reattached to the device.
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Para. [0040]. Thus, it is clear from the Specification that the provision of a
breakaway feature or the ability to attach a suture wing via an adhesive does
not make the suture wing “selectively coupelable.” Since the Examiner
concludes the claim terms are met with even less structure, or no structure at
all, we cannot agree with the Examiner’s interpretation that the meaning of
“detachable” and “selectively coupelable” includes any suture wing that can
potentially be cut or torn off. Thus, even assuming the Examiner’s finding,
that the cited structures of the prior art could, in fact, be cut or torn, this
would not make them “detachable” and “selectively coupelable” within the
broadest reasonable interpretation of these terms read in light of the
Specification.
Accordingly, the rejection of claim 1, and those claims depending
therefrom, as being anticipated by Johnston, Schultz, or Biolink must be
reversed. Speckman, as applied by the Examiner, does not cure the
deficiencies noted. The rejection of claim 7 must, therefore, also be reversed.

The rejections of claims 13-17 as being anticipated by Kovacs; claims 13, 14
and 27 as being anticipated by Biolink; claims 13, 14, 17 and 27 as being
anticipated by Tollini; and claim 22 as being unpatentable over Biolink and
Speckman are reversed.
Appellant contends that none of Kovacs, Biolink or Tollini discloses
“a housing adapted to receive a suture wing at a plurality of receiving
positions disposed about the medical device” as required by claim 13. App.
Br. 5-6, 10-12.
Regarding the rejection of claim 13 as being anticipated by Kovacs,
the Examiner contends that the limitation of “a housing adapted to receive a
suture wing” does not require any specific structure of the housing. Ans. 9.
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Application 10/264,920
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We disagree. Claim 13 at least requires a housing capable of receiving suture
wings. If the Examiner opines that this capability is an inherent
characteristic of Kovacs’ conduit 12, read as the claimed “housing,” this
finding must be supported by some factual evidence or scientific reasoning
to support this position. Since the Examiner has not provided sufficient
support for this finding we are constrained to reverse the rejection of claim
13, and dependent claims 14-17, as being anticipated by Kovacs.
Regarding the rejection of claim 13 as being anticipated by Biolink,
the Examiner contends that by virtue of pivot 50, Biolink’s housing 10 is
“adapted to receive a suture wing at one of a plurality of receiving positions
disposed about the medical device.” Ans. 12. The Examiner improperly
interprets the “plurality of receiving positions” to include a plurality of
orientations of the suture wing. This is an unreasonable interpretation
because the Examiner does not give weight to the portion of the limitation
requiring the receiving positions to be “disposed about the medical device.”
When this term is given weight, it is clear that the “plurality of receiving
positions” means a plurality of locations about the housing and not a
plurality of orientations of the suture wing. Since the Examiner relied upon
an erroneous claim construction in rejecting claim 13 as being anticipated by
Biolink, the rejection of claim 13, along with dependent claims 14 and 27, as
anticipated by Biolink, must be reversed. Speckman, as applied by the
Examiner, does not cure the deficiencies noted. The rejection of claim 22
must therefore also be reversed.
Regarding the rejection of claim 13 as being anticipated by Tollini,
the Examiner contends that by turning the catheter 10, read as the claimed
“housing,” one skilled in the art doubles the amount of receiving positions.
Ans. 7, 13. This interpretation is based upon the presumption that Tollini’s
Appeal 2009-009433
Application 10/264,920
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catheter could be turned upside down and still receive base 23’ and tab 26’
portions of Tollini’s tape, read as the claimed “suture wings.” Since, as
discussed above, it was unreasonable to regard these structures of Tollini as
“suture wings,” even if the Examiner’s presumption is correct, it does not
suffice to establish that Tollini’s catheter is adapted to receive “suture
wings.” Accordingly, the rejection of claim 13, along with dependent claims
14, 17 and 27 as being anticipated by Tollini, must be reversed.

The rejection of claims 13, 14, 17, 19 and 25-27 as being anticipated by
Schultz is affirmed.
Appellant contends that Schultz does not disclose or suggest “a
housing adapted to receive a suture wing at a plurality of receiving positions
disposed about the medical device” as required by claim 13. App. Br. 9.
Appellant contends that Schultz provides no description regarding the
method of attaching the suture loops 34, read as the claimed “suture wings”
to the access port 2. While Appellant’s reading of Schultz may be correct,
we fail to see how the lack of such a description in Schultz has any bearing
on whether the housing 4 is adapted to receive a suture wing at a plurality of
receiving positions disposed about the medical device since, as shown in
figure 2of Shultz, a suture loop is received at a plurality of receiving
positions disposed about the medical device. The claim does not require that
the housing is adapted to receive the same suture wing at a plurality of
receiving positions disposed about the medical device. The rejection of
claim 13 as being anticipated by Schultz is, therefore, affirmed. Since
separate arguments are not presented regarding the dependent claims, the
rejection of claims 14, 17, 19 and 25-27 as being anticipated by Schultz is
also affirmed.
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11
DECISION
The rejection of claims 1, 2, 5, and 13-17 as being anticipated by
Kovacs is reversed.
The rejection of claims 1, 10-12, 28 and 30 as being anticipated by
Johnston is reversed.
The rejection of claims 1, 2, 4, and 10-12 as being anticipated by
Schultz is reversed.
The rejection of claims 13, 14, 17, 19, and 25-27 as being anticipated
by Schultz is affirmed.
The rejection of claims 1, 12-14 and 27 as being anticipated by
Biolink is reversed.
The rejection of claims 1, 2, 13, 14, 17, 27 and 29 as being anticipated
by Tollini is reversed.
The rejection of claims 7 and 22 as being unpatentable over Biolink
and Speckman is reversed.
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).

AFFIRMED-IN-PART

nlk

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