SMITHS MEDICAL ASD, INC.

Patent Trials and Appeals Board

Mar 13, 2020

14495934 - (D) (P.T.A.B. Mar. 13, 2020)

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.
14/495,934 09/25/2014 Kristin Finberg 0109/0048 1007
135866 7590 03/13/2020
LAW OFFICE OF LOUIS WOO
717 NORTH FAYETTE STREET
ALEXANDRIA, VA 22314
EXAMINER
AHMED, TASNIM M
ART UNIT PAPER NUMBER
3783
MAIL DATE DELIVERY MODE
03/13/2020 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 KRISTIN FINBERG, CAL AARON HOOPLE,
AMY KUBAS, RONALD GENE TRAVIS, and LOUIS WOO

Appeal 2019-004885
Application 14/495,934
Technology Center 3700
____________

Before JENNIFER D. BAHR, MICHAEL L. HOELTER, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
final decision rejecting claims 8–11 and 21–24. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.

1 We use “Appellant” in reference to the “applicant” as the latter term is
defined in 37 C.F.R. § 1.42. Appellant identifies Smiths Medical ASD, Inc.
as assignee and sole real party in interest. Appeal Br. 3.
Appeal 2019-004885
Application 14/495,934

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STATEMENT OF THE CASE
The Specification
The Specification’s disclosure “relates to implantable medical devices
and more particularly to portals having an indicia bearing septum that can
readily be identified after being implanted into a patient, and methods of
manufacturing the indicia bearing septum.” Spec. ¶1.
The Claims
Claims 8–11 and 21–24 are rejected. Final Act. 1. The only other
pending claims, namely claims 1–7 and 12–20, have been withdrawn from
consideration. Id. Claims 8 and 9 are the independent claims on appeal.
Appeal Br. 19–20. Claim 8 is illustrative and reproduced below.
8. A port implantable into a patient, comprising:
a housing having a chamber with an opening and an
outlet, the opening having fitted therein a one piece unitary
septum made of an elastomeric material having
at least one continuous cavity of a given
configuration formed by a depression on the top surface
of the septum,
a one piece solid radiopaque insert injection
molded from a liquid radiopaque material having the
given configuration fittingly mounted to the cavity to
present a visual indicia,
the septum sealing the opening of the chamber to form a
reservoir in the housing adapted to store a fluid,
a catheter adapted to be connected to the outlet to be in
fluid communication with the reservoir so that the fluid is
conveyable between the reservoir and the patient when the port
is implanted into the patient;
wherein, after the port is implanted in the patient, the
radiopaque insert at the septum provides at least one
Appeal 2019-004885
Application 14/495,934

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identification indicia of the port under x-ray or computer
tomography imaging.
Id. at 19 (paragraphing added).
The Examiner’s Rejection
The following rejection before us is claims 8–11 and 21–24, under 35
U.S.C. § 102(a)(1), as anticipated by US 2011/0288503 A1, published
Nov. 24, 2011 (“Magalich”).
DISCUSSION
Magalich discloses a medical imaging septum and access port device.
Magalich, Title. The Examiner found that Magalich discloses all of the
limitations of claim 8. Final Act. 3–4 (citing Magalich ¶¶2, 4, 5, 8, 54, 74,
85, 89 and Figs. 2, 5D, 6, 7, 9). To meet the “one piece unitary septum”
limitation, the Examiner relies exclusively on the embodiment of Figure 5D.
See Ans. 8 (“For clarification, the embodiment of the device being relied on
is that of Fig. 5D only, where the device as a whole comprises distinct
elements of a first elastomer region 30d, a second elastomer region 20d, and
an insert 36d; other figures are only referred to for labels or other
perspectives of the exemplary device.”). Figure 5D of Magalich is
reproduced below.

Appeal 2019-004885
Application 14/495,934

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Figure 5D of Magalich shows a cross-sectional view of septum 103.
Magalich ¶¶18, 86. The Magalich septum comprises two elastomeric
regions 20d and 30d. ¶¶72, 89. Region 20d includes former voids that have
been “filled” in by indicia 36d. See id. ¶89 (“As illustrated in FIG. 5D,
region 36d, which may comprise the indicia, is shown as a solid material,
often an elastomeric region.”). The indicia 36d “may include radiopacity
additive. Alternatively region 36d may lack, or have less, radiopacity
additive or other attributes as compared to other regions, such as for example
region 20d.” Id.
The Examiner finds that region 20d is “one piece unitary septum
made of an elastomeric material” within the meaning of claim 8. Final
Act. 3. Appellant argues that the Magalich septum 103 is not a one piece
unitary septum because it is explicitly described as consisting of multiple
elastomeric regions, i.e., 20d and 30d in the asserted embodiment of Figure
5D. Appeal Br. 10–11. The Examiner responds that region 20d alone is
asserted as a one piece unitary septum. See Ans. 8 (“[O]nly the second
elastomer region 20d is being considered as the claimed septum.”). The
Examiner is free to do this as the claim is open-ended and does not exclude
additional structure. See Appeal Br. 19 (Claim 8 reciting: “A port
implantable into a patient, comprising: . . .” (emphasis added)). However,
region 20d, although “one piece” and “unitary,” is not a septum, given the
voids that extend fully therethrough. In other words, region 20d is incapable
of “sealing the opening of the chamber to form a reservoir in the housing
adapted to store a fluid,” as further recited in claim 8. And, even if indicia
36d effectively plugs those voids, indicia 36d cannot be considered as part of
the septum, because the septum must be “one piece unitary.”
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Application 14/495,934

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Accordingly, based on the record established by the Examiner
focusing exclusively on Figure 5D of Magalich, we reverse the rejection of
independent claim 8. We likewise reverse the rejection of claim 9, which
similarly recites “a one piece unitary resealable elastomer septum having a
top surface sealingly fitted to the top opening to establish a reservoir in the
housing.” Appeal Br. 19. We also reverse the rejection of claims 10, 11,
and 21–24, all of which depend from either claim 8 or claim 9. See In re
Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988) (“Dependent claims are
nonobvious under section 103 if the independent claims from which they
depend are nonobvious.”).

SUMMARY
Claims
Rejected
35 U.S.C. § References/Basis Affirmed Reversed
8–11, 21–24 102(a)(1) Magalich 8–11, 21–24

REVERSED