Ex Parte Marchosky

Board of Patent Appeals and Interferences

Jan 23, 2009

10071490 (B.P.A.I. Jan. 23, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte J. ALEXANDER MARCHOSKY
____________

Appeal 2008-6234
Application 10/071,490
Technology Center 1600
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Decided: January 23, 2009
____________

Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the Examiner’s final rejection of
claims 97, 98, and 103-108. Jurisdiction is under 35 U.S.C. § 6(b). We
affirm the rejection.
STATEMENT OF THE CASE
The claims are directed to a composition for promoting the growth
and strengthening of bone “consisting essentially of” hyaluronic acid (or a
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salt of it), cancellous bone, demineralized bone matrix, and non-decalcified
bone matrix, where each component is present in a specific concentration.
Claims 97, 98, and 103-108 are pending and stand rejected by the
Examiner under 35 U.S.C. § 112, first paragraph, for lack of written
description (Ans. 4). The only independent claim on appeal is claim 104.
Because claims 97, 98, 103, and 105-108 depend on claim 104 and
incorporate all its limitations, we select claim 104 as representative. Claim
1041 reads as follows:
104. A composition for promoting the growth and strengthening
of bone consisting essentially of a mixture of hyaluronic acid or
a salt thereof, cancellous bone, demineralized bone matrix, and
non-decalcified bone matrix,
wherein the hyaluronic acid or salt thereof is present as a 0.5%-
5% (w/v) gel concentration at 10-80% (w/w); the cancellous
bone is milled to 0.1-1.5 mm in its longest diameter and is
present at 10-40% (w/w); the demineralized bone matrix is
present at 5-30% (w/w); and the non-decalcified bone matrix is
present at 5-30% (w/w).

ISSUE
Does the Specification provide a written description of a composition
consisting essentially of hyaluronic acid (or a salt of it), cancellous bone,
demineralized bone matrix, and non-decalcified bone matrix, where each
component is present in a specific recited concentration?

1 In an amendment (Mar. 19, 2007) denied entry by the Examiner (Apr. 24,
2007), Appellant had attempted to cancel the “wherein” clause from claim
104. Appellant indicated this cancellation by bracketing the entire clause
(Mar. 19, 2007 Amendment, page 2). In the claim appendix to their Brief
(page 20), Appellant erroneously included the brackets around the “wherein”
clause. This clause has not been deleted from the claim and we therefore list
it here without the brackets.
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PRINCIPLES OF LAW
“Consisting essentially of” is a transition phrase commonly
used to signal a partially open claim in a patent. Typically,
“consisting essentially of” precedes a list of ingredients in a
composition claim or a series of steps in a process claim. By
using the term “consisting essentially of,” the drafter signals
that the invention necessarily includes the listed ingredients and
is open to unlisted ingredients that do not materially affect the
basic and novel properties of the invention.
PPG Industries Inc. v. Guardian Industries Corp., 156 F.3d 1351, 1354
(Fed. Cir. 1998).
To satisfy the written description requirement, the inventor “must also
convey with reasonable clarity to those skilled in the art that, as of the filing
date sought, he or she was in possession of the invention.” Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). In describing the
claimed invention, there is no requirement that the wording be identical to
that used in the specification as long as there is sufficient disclosure to show
one of skill in the art that the inventor “invented what is claimed.” Union
Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir.
2000).
An applicant complies with the written description requirement “by
describing the invention, with all its claimed limitations.” Lockwood v.
American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
BACKGROUND
Claim 104, the only independent claim which is pending in this
appeal, was added by amendment during prosecution of this application.2 In
response to the amendment, the Examiner sent a Notice of Allowance to

2 Amendment (Mar. 6, 2006).
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Appellant, stating that the claims had been allowed for issuance of a patent.3
However, the Examiner later withdrew the allowance, and in a subsequent
Office Action, rejected claim 104 under 35 U.S.C. § 112, first paragraph, for
lack of written description.4 The Examiner stated that claim 104 contained
subject matter which was not described in the Specification as originally
filed.
Independent claim 104 is drawn to a composition “for promoting the
growth and strengthening of bone.” The composition “consist[s]
essentially” of a mixture of four components:
(1) hyaluronic acid or salt thereof (“HA”);
(2) cancellous bone (“CB”);
(3) demineralized bone matrix (“DBM”); and
(4) non-decalcified bone matrix (“NBM”).
The claim also specifies the concentration of each component in the
composition.
The composition of claim 104 “consisting essentially of” four specific
components was not originally claimed. The Examiner’s position is that the
claimed composition “consisting essentially” of HA, CB, DBM, and NBM
in the recited amounts “was not envisioned at filing” (Ans. 5). The
Examiner explains: “There is nothing in the specification pointing to this
specific combination of components and amounts” (id.).

3 Notice of Allowance (May 24, 2006).
4 Office Action (Aug. 25, 2006).
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FINDINGS OF FACT (FF)
1. In the Summary of the Invention, a composition for promoting growth and
strengthening of bone is described that comprises: 1) a mixture of HA, 2)
CB, and, 3) DBM (Spec. 5:27 to Spec. 6:3). This composition was claimed
in the original Specification (Spec. 43; claim 56).
2. A composition is described in the Summary of the Invention having an
osteoinductive material (b) that comprises: 1) DBM, 2) NBM, and 3) “with
or without” HA (Spec. 4:9-10; 5:7-9). This composition is also described on
page 16, lines 6-9, of the Specification (see FF4 below).
3. In addition to DBM, NBM, and HA, the composition (FF2) can comprise
CB (Spec. 4:12) and growth factors (id. at 4:1-9).
4. The Specification states
Certain complex materials can also conveniently serve as
sources of osteoinductive molecules. Such molecules are
known to be provided by demineralized bone matrix (“DBM”),
which is prepared by grinding cortical bone tissues . . . , then
treating the ground tissues with hydrochloric acid . . . It is
believed, however, that the acid treatment process used in
preparing DBM denatures and/or solubilizes some of the
osteogenic molecules present in untreated bone, destroying the
osteogenic nature of the denatured molecules or allowing them
to leach out of the DBM preparation. Therefore, a preferred
source of osteogenic molecules is non-decalcified bone matrix
(“NBM”), which is ground cortical bone tissues which are not
acid-treated. A combination of [NBM] protein and DBM is
also useful in the invention compositions as a source of
osteoinductive molecules. The addition of [HA] may further
enhance the osteoinductivity of the mixtures.
(Spec. 15:15 to 16:9.) Osteoinductive materials act as bone growth factors
(id. at 9:14-22).

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5. The compositions explicitly described in the Specification are
summarized in the table below, where “+” indicates the presence of the
component and a blank, its absence.
HA CB DBM NBM
FF1 + + +
FF2 + + +

6. There is no word-for-word description of a composition consisting
essentially of: 1) HA, 2) CB, 3) DBM, and 4) NBM as required by claim
104.
ANALYSIS
The issue in this case is whether the Specification contains a written
description of the composition of claim 104 “for promoting the growth and
strengthening of bone” which consists essentially of HA, CB, DBM, and
NBM. A composition consisting essentially of all four recited components
is not explicitly disclosed in the Specification (see FF1-6). Instead, the
Specification describes a three-component composition of HA, CB, and
DBM (FF1). Citing the Specification at page 16, lines 5-8, Appellant
contends that “the use of the combination of NBM and DBM, as an
alternative [for] DBM alone” is “expressly provided for” (App. Br. 18).
Appellant’s position is apparently that persons of ordinary skill in the art
would have recognized the description of the claimed four-component
composition when DBM and NBM is substituted for DBM in the three-
component composition summarized in FF1 (id.).
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According to the Specification, DBM is a source of osteoinductive
molecules that serve as bone growth factors (FF4). The Specification states
that there is a loss in the osteoinductive molecules when DBM is prepared
(FF4). Consequently, the Specification states that “a preferred source” of
the osteoinductive factors is NBM, rather than DBM (FF4; Spec. 16:3-5).
For this reason, the Specification concludes – as Appellant noted – “[a]
combination of [NBM] protein and DBM is also useful in the invention
compositions as a source of osteoinductive molecules” (FF4; Spec. 16:5-8).
This disclosure is not sufficient to establish that the inventor invented
the claimed four-component composition. To satisfy the written description
requirement, the Specification must convey to persons of ordinary skill in
the art that the inventor was in possession of the claimed invention. Vas-
Cath Inc. v. Mahurkar, 935 F.2d at 1563-64. In this case, the Specification
describes a three-component composition of HA, CB, and DBM in the
Summary of the Invention and claims it (FF1). However, there is no explicit
statement in the written description that the inventor invented this same
composition with NBM. Appellant provides a reason as to why NBM might
be added to the three-component composition: because the Specification is
said to teach that the combination of NBM and DBM is an alternative for
DBM, alone (FF4; App. Br. 18). However, this was stated in the context of
describing an osteoinductive material (FF3). There is no statement in the
Specification that this substitution should be made in a different composition
having only HA, CB, and DBM (FF1).
Appellant appears to be relying an improper standard for complying
with the written description requirement for a claim which was not disclosed
in the original application - as is the here. The question is not whether the
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Specification provides a reason to have made the invention which is now
claimed, but whether the invention, with all its claimed limitations, is
described in it. See Lockwood v. American Airlines, Inc., 107 F.3d 1565,
1572 (1997). In the Summary of the Invention, a composition for promoting
growth and strengthening of bone is described that contains: 1) HA, 2) CB,
and, 3) DBM (FF1). The inventor therefore expressly summarized what he
believed the invention to be: a composition of HA, CB, and DBM. This
express statement of the invention should be taken at face value. To find
otherwise, would improperly extend the scope of the invention beyond what
was actually described as in the Specification.

CONCLUSION OF LAW
The Specification does not describe a composition consisting
essentially of hyaluronic acid (or a salt of it), cancellous bone, demineralized
bone matrix, and non-decalcified bone matrix, where each component is a
specific concentration. We affirm the rejection of claim 104, and dependent
claims 97, 98, 103, and 105-108 which incorporate all its limitations and
which were not separately argued. 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

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