Ex Parte Baumgartner

Board of Patent Appeals and Interferences

Jun 19, 2009

10168294 (B.P.A.I. Jun. 19, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LUDWIG BAUMGARTNER
__________

Appeal 2008-0062731
Application 10/168,294
Technology Center 1600
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Decided:2 June 19, 2009
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Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of making bone growth factor enriched bone material and to an enriched

1 Heard June 9, 2009.
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
Appeal 2008-006273
Application 10/168,294

bone material. The Patent Examiner rejected the claims as anticipated. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

STATEMENT OF THE CASE
Bone morphogenetic proteins (BMPs) are said to be growth factors
that play a role in the growth of bones. (Spec. 1:8-9.) According to the
Specification, bone material enriched with growth factors is used in surgery
to promote bone growth at defective areas and to accelerate bone healing.
(Id. at 1:12-14.) Appellant claims a method of manufacturing bone growth
factor enriched bone material and an enriched bone material manufactured
by the method.
Claims 1-4, 6, 7 and 9-15, which are all the pending claims, are on
appeal. The claims have not been argued separately and they will stand or
fall together as grouped in the two rejections. See 37 C.F.R.
§ 41.37(c)(1)(vii). Claim 1 is representative and reads:
1. A method of manufacturing a bone material enriched with bone
growth factors, comprising

charging a surface and/or an interior of the bone material with at least
one bone growth factor (BMP) and
wherein the bone material is initially charged by
spraying on, trickling on or drawing in of a solution or
suspension of the at least one bone growth factor or
by immersing into a solution or suspension of the bone growth
factor; and

sheathing thereafter the bone material with a resorbable material to
yield the enriched bone material.

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Application 10/168,294

The Examiner rejected the claims as follows:
• claims 1-4, 6, 7, 9, 11, 12 and 14 under 35 U.S.C. § 102(e) as
anticipated by Lindholm;3 and
• claims 1-4, 6, 7, 9, 11-13 and 15 under 35 U.S.C. § 102(b) as
anticipated by Jefferies.4

ANTICIPATION
The Issues
A. The rejection over the Lindholm publication
The Examiner’s position is that Lindholm taught manufacturing a
BMP enriched bone material in the form of a BMP and collagen carrier
block, and then coating the carrier block with “resuspended precipitate
containing BMP-impregnated collagen (which is a resorbable material).”
The Examiner found that Lindholm’s “coating” step was the same as
Appellant’s “sheathing” step. (Ans. 5-6.)5
Appellant contends that Lindholm’s coating precipitate did not
contain collagen, and could only have contained BMP. (App. Br. 6-7.)6
“Since BMP by itself is not a ‘resorbable material,’” Lindholm did not
disclose Appellant’s step of “sheathing . . . with a resorbable material.” (Id.
at 7.)

3 U.S. Patent Application Publication No. US 2005/0142164 A1, filed by
Lindholm et al., claiming an effective filing date of Feb. 29, 1996, published
Jun. 30, 2005.
4 U.S. Patent No. 4,394,370, issued to Steven R. Jefferies, Jul. 19, 1983.
5 “Supplemental Examiner’s Answer,” mailed Aug. 13, 2008.
6 “Reply Brief As A Substitute Appeal Brief,” filed Sept. 26, 2007.
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Application 10/168,294

Appellant also argues that even if Lindholm’s precipitate contained
collagen and BMP, and the precipitate were used as the sheathing material,
the outer surface would comprise both collagen and BMP. (Id. at 7-8).
“Thus, BMP is not sheathed with resorbable material by such a process.”
(Id. at 8.)
The issues with respect to this rejection are:
whether BMP is a resorbable material, and
if Lindholm’s coating step used a precipitate containing both collagen
and BMP, would it meet the claim limitation “sheathing thereafter the bone
material with a resorbable material to yield the enriched bone material.”

B. The rejection over the Jefferies patent
The Examiner found that Jefferies taught a method of making an
implant in which BMP was mixed with demineralized bone particles (DBP)
and then with collagen. The Examiner’s position is that when BMP and
DBP were mixed, the DBP surface was charged with BMP. (Ans. 6.)
“Because DBP has a porous structure, when mixed with BMP protein, it will
be ‘charged’ with BMP protein on the surface and interior of the particles.”
(Id. at 12.) Mixing with collagen would then sheath the charged bone
material with a resorbable material.
Appellant contends that Jefferies does not explicitly or implicitly
disclose that BMP and DBP are first mixed and then added to a collagen
dispersion. (App. Br. 9.) Appellant interprets Jefferies to mean that the
mixing of BMP and DBP is “during” complexing with collagen, not prior to
complexing. (Id. at 9-10.)
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The issue with respect to this rejection is whether Jefferies explicitly
or inherently taught a step of charging DBP with BMP.

Findings of Fact
Lindholm
1. Lindholm described an osteogenic device comprising a bone
morphogenetic protein (BMP) and collagen impregnated in and/or
adsorbed on a bioceramic carrier. (Abstract.)
2. Lindholm taught mixing BMP with collagen. (Spec. at [0125].)
3. Lindholm taught adsorbing the BMP-impregnated collagen to a
porous block material such as human demineralized cortical bone.
(Id. at [0126] & [0133].)
4. In Lindholm’s Example 7, entitled “The Preparation of the Osteogenic
Device,”
(1) a carrier block was immersed in BMP impregnated collagen
under vacuum (Id. at [0134]),
(2) the mixture including the block was dialyzed (Id. at [0135]),
(3) the dialyzed solution was centrifuged (Id. at [0136]),
(4) the supernatant was discarded and the block was thereafter
coated with precipitate “which contains some remnants or
debris of BMP impregnated” from the centrifuging step (Id. at
[0137]), and
(5) the device was freeze dried (Id. at [0138]).

Jefferies
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5. Jefferies described complexes of collagen and demineralized bone
particles (DBP), or of collagen and solubilized bone morphogenetic
protein (BMP), fabricated in a sponge suitable as an implant for
reconstructive surgery. (Abstract.)
6. Jefferies’ Example I described making DBP, and then adding the DBP
to a collagen dispersion, and processing the mixture to prepare a
sponge. (Col. 3, l. 45 – col. 4, l. 43.)
7. Jefferies’ Example II described making BMP, and then adding the
BMP to a collagen dispersion, in a procedure “identical with the
procedure followed in Example I.” (Col. 4, l. 45 – col. 5, l. 11.)
8. Jefferies taught that “[a]lternatively, one may mix the BMP and DBP
sources in complexing with the reconstituted collagen.” (Col. 5, ll.
11-13.)

Principles of Law
To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or
inherently. Anticipation is an issue of fact, and the question of
whether a claim limitation is inherent in a prior art reference is
a factual issue.

In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
“Under the principles of inherency, if the prior art necessarily functions in
accordance with, or includes, the claimed limitations, it anticipates.”
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999).

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Application 10/168,294

Analysis
A. The rejection over the Lindholm publication
We agree with the Examiner that BMP is a resorbable material.
Lindholm taught that “BMP without a carrier rapidly dissolves and diffuses
in the body fluids after implantation.” (Lindholm at [0007].)7 Therefore,
when Lindholm taught coating the BMP-collagen block with a BMP
containing precipitate (FF4), it described coating with a resorbable material.
Appellant argues that even if BMP is resorbable, “BMP is not
sheathed with resorbable material by [Lindholm’s coating] process.” The
claim reads “sheathing thereafter the bone material.” It does not read
“sheathing thereafter the BMP.” That is, the claim does not require all the
BMP to be under the coating or sheathing. There is no dispute that
Lindholm charged bone material with BMP to make a block (FF4), and
thereafter coated the block. As the claim requires only that the coating or
sheathing material be “resorbable,” we agree with the Examiner that
Lindholm taught a method comprising both of Appellant’s claimed steps.

B. The rejection over the Jefferies patent
The dispute turns on how one of ordinary skill in the art would have
understood Jefferies’ disclosure that “[a]lternatively, one may mix the BMP
and DBP sources in complexing with the reconstituted collagen.” (FF8.) A
plain reading would be simultaneous mixing of BMP and DBP with

7 Lindholm was not alone in describing BMP in terms indicating it is
resorbable. Jefferies also disclosed “slow resorption of the [collagen-BMP]
graft” at col. 5, ll. 27-28. That is, the whole graft, BMP included, was
resorbable.
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reconstituted collagen. There is no evidence that Jefferies meant first mix
BMP and DBP under conditions where the BMP could charge “a surface
and/or an interior” of the DBP, and thereafter combine that mixture with
reconstituted collagen. We find that Jefferies did not expressly teach a
sequence of charging then sheathing. We do not find that Appellant’s
claimed sequence of steps is a necessary interpretation of Jefferies’
disclosure, and therefore do not find that the two steps inherently occurred in
Jefferies’ process.
Appellant’s claim 12 defines a product made by the two step charging
and sheathing process recited in claim 1. In Jefferies’ alternative process of
mixing BMP and DBP in complexing with reconstituted collagen, it might
be possible that some DBP would become charged with BMP. However, the
mere fact that a certain thing may result from a given set of circumstances is
not sufficient to support a finding of inherent anticipation. See
MEHL/Biophile, 192 F.3d at 1365.

CONCLUSIONS OF LAW
BMP is a resorbable material, and Lindholm’s step of coating with
BMP anticipated the claimed step of “sheathing . . . with a resorbable
material;” and
Jefferies did not explicitly or inherently describe a step of charging
DBP with BMP.

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SUMMARY
We affirm the rejection of claims 1-4, 6, 7, 9, 11, 12 and 14 under
35 U.S.C. § 102(e) as anticipated by Lindholm; and
We reverse the rejection of claims 1-4, 6, 7, 9, 11-13 and 15 under
35 U.S.C. § 102(b) as anticipated by Jefferies.

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-IN-PART

dm

GIFFORD, KRASS, SPRINKLE, ANDERSON
& CITKOWSKI. P.C.
PO BOX 7021
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