Ex Parte Bays et al

Board of Patent Appeals and Interferences

May 17, 2010

10682289 (B.P.A.I. May. 17, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte F. BARRY BAYS and BRIAN R. HARRIS
____________

Appeal 2009-013738
Application 10/682,289
Technology Center 1600
____________

Decided: May 17, 2010
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
LORA M. GREEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 23-44, the only
claims pending in this application. We have jurisdiction under 35 U.S.C.
§ 6(b).

Appeal 2009-013738
Application 10/682,289

STATEMENT OF THE CASE
The claims are directed to an apparatus for preparing a bone graft
composite. Claim 23, the only independent claim, is reproduced below:
23. An apparatus for preparing a bone graft composite comprising a
bone graft material and a bone marrow aspirate, the apparatus comprising:
a tube having a first open end and a second open end;
a first end cap removably coupled to said first open end, said first end
cap having a passage therethrough to allow fluid communication between a
bone marrow aspirate delivery member and said tube, a trailing end of said
first end cap configured for selective attachment to a bone marrow aspirate
delivery member;
a second end cap removably coupled to said second end, said second
end cap having a passage therethrough to allow fluid communication
between said tube and a filter, a leading end of said second end cap
configured for selective attachment of a filter;
a filter member removably coupled to said leading end of said second
end cap;
a filter in said filter member, said filter configured to prevent bone
marrow aspirate from passing therethrough while permitting air to pass
therethrough, said filter in fluid communication with said tube via said
passage of said second end cap; and
a bone graft material in the tube.

The rejections presented by the Examiner follow:
1. Claims 23-44 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Muschler1 and Wironen.2
2. Claims 23-29, 32, and 35-40 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Muschler, Wironen, and Erbe.3
3. Claims 23-27, 30-33, 36-38, and 40-43 stand rejected under 35 U.S.C.

1 Muschler, US 6,723,131 B2, issued April 20, 2004.
2 Wironen et al., US 2003/0180262 A1, published September 25, 2003.
3 Erbe et al., US 6,736,799 B1, issued May 18, 2004.
2
Appeal 2009-013738
Application 10/682,289

§ 103(a) as unpatentable over the combination of Muschler, Wironen, and
Willard.4
4. Claims 23-44 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Muschler, Wironen, Erbe, and Willard.
We reverse.

ISSUE
Does the evidence relied upon by the Examiner suggest an apparatus
that comprises a filter configured to prevent bone marrow aspirate from
passing therethrough while permitting air to pass therethrough?

ANALYSIS
Independent claim 23 is drawn to an apparatus that comprises, inter
alia, a filter configured to prevent bone marrow aspirate from passing
therethrough while permitting air to pass therethrough (Claim 23). Since
claims 24-44 depend directly or indirectly from claim 23, we focus our
analysis on independent claim 23.
The Examiner has rejected claim 23 over the combination of Muschler
and Wironen, with or without Erbe and/or Willard. In making these
combinations, the Examiner finds that Muschler teaches the apparatus of
claim 23 with the exception of a “filter membrane [that] prevents aspirate
passage while allowing air to pass through” (Ans. 5). To make up for this
deficiency in Muschler, the Examiner relies on Willard to teach an apparatus
“for making bone graft composites . . . wherein one end has a filter

4 Willard et al., US 4,846,174, issued July 11, 1989.
3
Appeal 2009-013738
Application 10/682,289

membrane attached to prevent passage of bone past components . . . while
expelling air from the tube” (id.).
Based on the combined teachings of Muschler and Willard, the
Examiner concludes that “[a]t the time of the claimed invention, it would
have been obvious to one of ordinary skill in the art to use the filter of
Wironen in the apparatus of Muschler for the disclosed desirability for
removing air from the bone graft composite material during mixing” (Ans.
5). We are not persuaded.
Muschler teaches a “method of preparing composite bone marrow
graft material having an enriched population of progenitor cells” (Muschler,
col. 2, ll. 29-31; App. Br. 9 and 10). In performing this method, Muschler
utilized an apparatus comprising a column containing a biocompatible
implantable matrix and two loading syringes (Muschler, col. 6, l. 62 - col. 7,
l. 42). In operation, aspirate5 is loaded into a first loading syringe, the first
and second syringes are attached to opposite ends of the column, and then
the first loading syringe is plunged to deliver aspirate into the column where
the aspirate flows through or contacts the matrix prior to being collected at
the opposite end of the column in the second loading syringe (Muschler, col.
7, ll. 39-42; see also App. Br. 10-11). “In this manner, the progenitor cells
present in the aspirate volume are preferably concentrated in the matrix
volume, providing an enriched matrix” (Muschler, col. 7, ll. 56-58; see also
App. Br. 11). “[T]he initial effluent from [the] column . . . delivered to [the]
second loading syringe . . . can be discarded prior to continuing the method”

5 Muschler defines aspirate as comprising “progenitor cells . . . and other
nucleated cells,” in addition to, “platelets, red blood cells and serum
(including molecules which are soluble or suspended in serum)” (Muschler,
col. 7, ll. 23-27).
4
Appeal 2009-013738
Application 10/682,289

or “caused to flow back and forth through [the] matrix . . . by alternately
plunging the first and second loading syringes” (Muschler, col. 8, ll. 9-14).
Following this procedure the loading syringes are detached from the column
and the matrix, enhanced with progenitor cells, that resides in the column is
further processed (see, e.g., Muschler, col. 8, l. 26 - col. 9, l. 3).
In summary, Muschler’s apparatus is designed to allow the aspirate to
flow directly from a first syringe residing on a first side of the column,
through the matrix, into a second syringe residing on the second side of the
column. In doing so, only a specific population of cells contained in the
aspirate is intended to be retained in the matrix residing in the column, the
remainder of the aspirate is required to be removed from the column.
Therefore, while Muschler teaches that the endcaps of the column “can be
provided with a screen or membrane”; the screen/membrane is used to retain
the matrix within the column while allowing aspirate to pass through and out
of the column (Muschler, col. 7, ll. 15-17; App. Br. 10). Accordingly, the
modification suggested by the Examiner, wherein Wironen’s filter is
incorporated into Muschler’s apparatus, would defeat the purpose of
Muschler’s apparatus.
Accordingly, we agree with Appellants’ contention that “the cited
references cannot be combined without destroying the stated objective of
Muschler” (App. Br. 9). “A reference may be said to teach away when a
person of ordinary skill, upon reading the reference . . . would be led in a
direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). On this record, Muschler teaches
away from its combination with Wironen as relied upon by the Examiner.
5
Appeal 2009-013738
Application 10/682,289

The Examiner relies on Erbe to teach “an apparatus for making bone
composite materials wherein the end caps are closed (or sealed)” (Ans. 9)
and on Willard to teach “columnar tubes wherein a threaded end has a
removable cap and washer placed in between to secure the assembly” (id. at
12). Neither reference, alone or in combination makes up for the deficiency
in the combination of Muschler and Wironen.

CONCLUSION OF LAW
The evidence relied upon by the Examiner fails to suggest an
apparatus that comprises a filter configured to prevent bone marrow aspirate
from passing therethrough while permitting air to pass therethrough
We reverse all the rejections of record.

REVERSED

cdc

WRIGHT MEDICAL TECHNOLOGY, INC.
LEGAL DEPARTMENT
5677 AIRLINE ROAD
ARLINGTON TN 38002-9501
6