Ex Parte McDowell

Board of Patent Appeals and Interferences

Jan 10, 2008

09960020 (B.P.A.I. Jan. 10, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte CHRISTOPHER MCDOWELL
____________

Appeal 2007-4388
Application 09/960,020
Technology Center 3700
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Decided: January 10, 2008
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Before ERIC GRIMES, RICHARD M. LEBOVITZ, and FRANCISCO C.
PRATS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the final rejection of claims 1, 3, 6,
8, 9, 11, 12, and 16. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

Appeal 2007-4388
Application 09/960,020

STATEMENT OF THE CASE
The claims are directed to a tray for holding surgical fasteners.
Surgical fasteners are known in the art “for attaching sutures, bone plates,
and connective tissue” (Specification 1: 17-18).
Claims 1, 3, 6, 8, 9, 11, 12, and 16, which are all the pending claims
(App. Br. 2), stand rejected under 35 U.S.C. § 103(a) as obvious over
Nicholson (U.S. Pat. No. 5,968,044, Oct. 19, 1999) in view of Nguyen (U.S.
Pat. No. 5,873,462, Feb. 23, 1999) and Asa (U.S. Pat. No. 6,098,802, Aug.
8, 2000) (Answer 3).
We select claim 1 as representative of the appealed subject matter.
See 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 reads as follows:
A tray for holding a plurality of surgical fasteners, the
tray comprising
a base having a plurality of wells therein, at least two of
the surgical fasteners being disposed within respective ones of
the plurality of wells; and
a film over the base and the plurality of wells, a
weakness in the film over the plurality of wells whereby to
more easily allow an instrument to penetrate the film and enter
one of the wells;
wherein each of the wells and the surgical fasteners
within each well are maintained in a sterile environment
regardless if any of the other wells have been opened.

ISSUE ON APPEAL
Claim 1 is directed to a tray for holding surgical fasteners comprising
a base and a plurality of wells. Each well has a “film over” it and a
“weakness” in the film to allow an instrument “to more easily . . . penetrate
the film.” At least two of the surgical fasteners are “disposed within
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respective ones of the plurality of wells.” Each well is “maintained in a
sterile environment regardless if any of the other wells have been opened.”
The Examiner finds that the prior art teaches containers having a
plurality of wells for the sterile storage of medical devices (injection needles
and pipettes), where each well has a film covering that permits a well to be
separately entered while maintaining the sterility of the other wells (Answer
3-4). The Examiner finds that the prior art describes surgical fasteners in a
sterile tray, but not in plurality of wells (Answer 3) as required by claim 1.
The Examiner contends that it would have been obvious to persons of
ordinary skill in the art to have stored the surgical fasteners in a container (a
“tray”) having a plurality of wells (Answer 4).
Appellant contends there would have been no motivation to have
stored surgical fasteners in a container having a plurality of wells (App. Br.
4).
We frame this issue in this appeal as follows: whether persons of
ordinary skill in the art would have had reason to have stored surgical
fasteners in a prior art container having a plurality of wells like those used
for holding injection needles or pipette tips.
DISCUSSION
Scope and contents of the prior art
When making an obviousness determination, the scope and contents
of the prior art must first be ascertained. Graham v. John Deere Co., 383
U.S. 1, 17 (1966). Thus, we turn to the prior art cited by the Examiner. The
following numbered findings of fact (“FF”) summarize the prior art relied
upon the Examiner in setting forth the basis of the rejection.

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The Nicholson patent
1. Nicholson describes a bone fastener including an expandable
member (10) having an axial channel and an elongated or insertion element
(34) which is inserted into the channel (Nicholson, at col. 1, ll. 54-56; at col.
4, ll. 60-65; at col. 5, ll. 15-17; col. 8, ll. 16-20; Figs. 1 and 4; Answer 3).
2. A bone fastener is a single-use (i.e., used once) device utilized to
attach soft tissue to bone (Nicholson, at col. 12, l. 25 to col. 13, l. 15).
3. Nicholson also describes a surgical fastener kit that includes the
expandable member and the insertion element (Nicholson, at col. 3, ll. 25-
30; Answer 6).
4. “Preferably, the kit is encased in a sterile tray or other receptacle”
(Nicholson, at col. 3, ll. 37-38; Answer 3).

The Nguyen patent
5. Nguyen describes a pen needle dispenser for storing and
dispensing sterile injection needles (Nguyen, at col. 1, ll. 5-8; col. 2, ll. 30-
34; Answer 4).
6. Each pen needle assembly (100) comprises a plurality of cavities
or wells, each of which contains a sterile injection needle (Nguyen, at col. 3,
ll. 37-67; Fig. 2; Answer 4).
7. Each cavity (31) is sealed “using a label or sterility barrier 150 that
is attached to an upper surface 32 of container 30, which provides sterility
for the unused pen needle assemblies in each cavity 31” (Nguyen, at col. 3,
ll. 45-50; Fig. 2).
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Application 09/960,020

8. The label or sterility barrier can also be scored to allow for
controlled breaking of the scored area (Nguyen, at col. 3, ll. 57-67; Answer
4).
9. The needle dispenser provides a convenient way to safely and
sterilely store needles which can be individually accessed prior to use, e.g.,
by persons who must periodically inject doses of medication (Nguyen, at
col. 2, ll. 8-13 and 60-65).
10. The needle dispenser also provides a way of disposing of and
preventing needles from being reused (Nguyen, at col. 2, ll. 54-59).

The Asa patent
11. Asa describes a rack for pipette tips which comprises a plurality
of wells, each well containing one pipette tip, and having a cover to prevent
cross-contamination between the wells (Asa, at col. 2, ll. 13-26; Answer 4).
The pipette rack can be covered by a combination of pierceable films that
ensure the sterility of the individual pipette tips when they are dispensed
(Asa, at col. 6, ll. 55-64).
12. “Pipette tips are often disposable” (Asa, at col. 1, l. 17).

Differences between the prior art and the claimed invention
Once the scope and contents of the prior art have been determined, the
differences between the prior art and the claimed invention must be
identified. Graham, 383 U.S. at 17. The following facts are relevant to this
determination:
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13. Each of Nguyen and Asa describe containers which comprise a
plurality of wells or cavities for the sterile storage of disposable medical
devices (FF 5-8, 10-12; Answer 3-4).
14. In Nguyen’s container for injection needles, each needle is
individually stored in a cavity and sealed with a label or sterility barrier that
“provides sterility for the unused pen needle assemblies in each cavity 31”
(FF 6-7; Nguyen, at col. 3, ll. 37-67; Fig. 2; Answer 4).
15. Nguyen’s label or sterility barrier (FF 7, 14) meets the limitations
of claim 1 of “a film over the base and plurality of wells”, where the film
maintains “a sterile environment regardless if any of the other wells have
been opened” (Answer 4).
16. The label or barrier can be scored to allow for controlled breakage
and access to the sterile needle (FF 8; Nguyen, at col. 3, ll. 57-67; Answer 4)
– and thus is “a weakness in the film . . . to more easily allow an instrument
to penetrate the film” as recited in claim 1.
17. Nicholson describes a surgical kit comprising a bone fastener
encased in a sterile tray or receptacle (FF 2-3; Nicholson, at col. 3, ll. 25-30
and 37-38), but does not describe the tray structure, and in particular, does
not describe a tray with a plurality of wells (Answer 3, 6) as required by
claim 1.
18. Thus, the difference between the prior art and the claimed
invention is that the prior art does not teach surgical fasteners in container
having a plurality of wells (FF 17) (Answer 4).

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Reason to combine the prior art
Having established the differences between the prior art and the
claimed invention, the next step is to identify a reason why persons of
ordinary skill in the art would have been prompted to combine the prior art
to have made the claimed invention. KSR Int’l Co. v. Teleflex Inc., 127 S.
Ct. 1727, 1741 (2007).
In this case, the Examiner contends that it “would have been obvious
to one of ordinary skill in the art at the time the invention was made to
provide the disposable surgical fastener assemblies of Nicholson . . . in a
tray as taught by either Asa . . . or Nguyen . . . in order to provide
independent dispensing of the fasteners” (Answer 4).
We agree with the Examiner’s reasoning and conclusion. The
following findings of fact are relevant to this determination:
19. Nicholson teaches that its bone fasteners are preferably stored in a
sterile tray (FF 4; Nicholson, at col. 3, ll. 37-38; Answer 3).
20. Nicholson does not describe the structure of the tray (FF 17;
Answer 3).
21. However, Nguyen teaches that a multi-cavity container facilitates
the sterile storage of injection needles, each held in separate sterile cavity
that can be individually accessed through a film barrier without
compromising the sterility of the other cavities (FF 5-9).
22. Asa’s multi-well pipette rack shares similar characteristics and
advantages for sterile storage with Nguyen’s container (FF 11; Asa, at col. 2,
ll. 13-23; Answer 4).
23. Thus, for medical devices which require sterility – such as the
bone fasteners of Nicholson (FF 4; Nicholson, at col. 3, ll. 37-38; Answer 3)
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– the prior art reasonably suggests to persons of skill in the art storing the
devices in a plurality of wells, so that one device can be used without
comprising the sterility of the other devices (see FF 21-22).
Appellant argues that “there is no need to provide a plurality of wells
as all of these devices are going to be used during the surgical operation”
(App. Br. 5). We are not persuaded by this argument that the Examiner
erred.
24. The prior art teaches that disposable single-use medical devices –
injection needles in Nguyen (see FF 10; Nguyen, at col. 2, ll. 54-59) and
pipette tips in Asa (see FF 11; Asa, at col. 1, l. 17 and col. 6, ll. 55-64;
Answer 4) – are typically stored sterilely in individual wells to permit one
device to be used without contaminating devices in neighboring wells.
25. Like injection needles and pipettes, bone fasteners are single-use
medical devices (see FF 2; Nicholson, at col. 12, l. 25 to col. 13, l. 15;
Answer 3).
26. The prior art teaches that it is conventional to package single-use
medical devices in multi-well containers, where each well has a sterility
barrier to keep its contents sterile (see FF 24).
In sum, it is not patentable to use a prior art structure for its known
and expected benefits. When “a patent ‘simply arranges old elements with
each performing the same function it had been known to perform’ and yields
no more than one would expect from such an arrangement, the combination
is obvious.” KSR, 127 S. Ct. at 1740. A suggestion, teaching, or motivation
to combine the relevant prior art teachings does not have to be found
explicitly in the prior art. In re Kahn, 441 F. 3d 977, 987 (Fed. Cir. 2006).
See also KSR, 127 S. Ct. at 1741 (The obviousness analysis “can take
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Application 09/960,020

account of the inferences and creative steps that a person of ordinary skill in
the art would employ.”).
Appellant also argues that “there is no mention whatsoever of the
cartridge holding the bone fasteners” (App. Br. 5). We do not agree. As
pointed out by the Examiner (Answer 6), Nicholson describes the cartridge
comprising an expandable member and an insertion element (Nicholson, at
col. 16, ll. 14-29). The bone fastener is described by Nicholson as
comprising an expandable member and an insertion element (34) (FF 1;
Nicholson, at col. 1, ll. 54-56; at col. 4, ll. 60-65; at col. 5, ll. 15-17; col. 8,
ll. 16-20; Figs. 1 and 4; Answer 3).
For the foregoing reasons, we affirm the rejection of claim 1. Claims
3, 6, 8, 9, 11, 12, and 16 fall with claim 1 because separate reasons for their
patentability were not provided. See 37 C.F.R. § 41.37(c)(1)(vii).

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

Ssc:

PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
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