Ex Parte Ferree

Board of Patent Appeals and Interferences

Dec 2, 2009

10987919 (B.P.A.I. Dec. 2, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BRET A. FERREE
__________

Appeal 2009-006043
Application 10/987,919
Technology Center 1600
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Decided: December 2, 2009
__________

Before DONALD E. ADAMS, ERIC GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for activating latent TGF-β. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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Statement of the Case
The Claims
Claims 1-13 are on appeal. We will focus on claim 1, which is
representative and reads as follows:
1. A method of activating latent TGF-β, comprising the
steps of:
providing platelet-rich plasma (PRP); and
using one or more activators to activate latent TGF-β
in the PRP.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Hood III US 5,733,545 Mar. 31, 1998

Grainger et al., Release and activation of platelet latent TGF-β in
blood clots during dissolution with plasmin, 1(9) NATURE MEDICINE 932-
937 (1995).
Okamoto et al., Dermatopontin interacts with transforming growth
factor β and enhances its biological activity, 337 BIOCHEMICAL J. 537-541
(1999).
Mu et al., The integrin αvβ8 mediates epithelial homeostasis through
MT1-MMP-dependent activation of TGF-β1, 157(3) J. CELL BIOLOGY 493-
507 (2002).
Chu et al., Plasmin, Subtilisin-like Endoproteases, Tissue
Plasminogen Activator, and Urokinase Plasminogen Activator are involved
in Activation of Latent TGF-β1 in Human Seminal Plasma, 253
BIOCHEMICAL BIOPHYSICAL RESEARCH COMMUNICATIONS 128-134 (1998).
Dennis et al., Cellular activation of latent transforming growth factor
β requires binding to the cation-independent mannose 6-phosphate/insuline-
like growth factor type II receptor, 88 PROC. NATL. ACAD. SCI. USA 580-
584 (1991).
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Kojima et al., Requirement for Transglutaminase in the Activation of
Latent Transforming Growth Factor-β in Bovine Endothelial Cells, 121 J.
CELL BIOLOGY 439-448 (1993).
Dubois et al., Evidence that Furin is an Authentic Transforming
Growth Factor-B1-Converting Enzyme, 158(1) AM. J. PATHOLOGY 305-316
(2001).
Abe et al., Cell-Associated Activation of Latent Transforming Growth
Factor-β by Calpain, 174 J. CELLULAR PHYSIOLOGY 186-193 (1998).
Lee et al., New Use of a Three-Dimensional Pellet Culture System for
Human Intervertebral Disc Cells, 26(21) SPINE 2316-2322 (2001).

The issues
A. The Examiner rejected claims 1, 3, 5, 6, and 9 under 35 U.S.C. §
103(a) as obvious over Hood and Grainger (Ans. 3-6).
B. The Examiner rejected claims 4 and 8 under 35 U.S.C. § 103(a) as
obvious over Hood, Grainger, and Okamoto (Ans. 6).
C. The Examiner rejected claims 2 and 7 under 35 U.S.C. § 103(a) as
obvious over Hood, Grainger, Mu, Chu, Dennis, Kojima, Dubois, and Abe
(Ans. 7-8).
D. The Examiner rejected claims 10 and 12 under 35 U.S.C. § 103(a) as
obvious over Hood, Grainger, and Lee (Ans. 8-9).
E. The Examiner rejected claim 11 under 35 U.S.C. § 103(a) as obvious
over Hood, Grainger, Lee, Mu, Chu, Dennis, Kojima, Dubois, and Abe
(Ans. 9-10).
F. The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as obvious
over Hood, Grainger, Lee, and Okamoto (Ans. 10-11).
A. 35 U.S.C. § 103(a) over Hood and Grainger
The Examiner finds that Hood “teaches the use of the plasma-buffy
coat concentrate as a wound sealant to seal leaks of cerebrospinal fluid
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through cut dura” (Ans. 4). The Examiner finds that “Grainger et al. teach
that, upon degranulation of platelets by the active thrombin from
prothrombin present in the plasma, latent TGF-β is released and is activated
by plasmin. Also taught is the use of active TGF-β in wound healing and
matrix formation” (Ans. 5). The Examiner concludes that it would have
been obvious to combine the plasma-buffy concentrate of Hood with the
latent TGF-β activator of Grainger since Grainger teaches that “TGF-β is
used in wound healing and matrix formation as well as the use of the
plasma-buffy concentrate by Hood” (Ans. 6).
Appellant argues that “although the Examiner states that the ‘plasma-
buffy coat concentrate’ described in the Hood reference is ‘equivalent to the
PRP of the instant application,’ Appellant submits that the ‘plasma-buffy
coat concentrate’ of Hood and the ‘platelet-rich plasma’ of the present
application are not equivalent.” (App. Br. 3). Appellant argues that “the
Hood patent appears to teach away from the use of a product including
normal plasma” (App. Br. 4).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
Has Appellant demonstrated that the Examiner erred in finding that
the combination of Hood and Grainger teach the use of “platelet-rich
plasma” as required by claim 1?
Findings of Fact (FF)
1. The Specification teaches that proteases “are added to the
Platelet Rich Plasma (PRP)” but provides no definition of “Platelet Rich
Plasma” (Spec. 4, ll. 1-2).
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2. The Specification teaches that “blood is centrifuged to obtain
platelets and the platelets release the soluble regulators/growth factors by
adding a mixture of calcium chloride and topical bovine thrombin” (Spec. 4,
ll. 16-18).
3. Hood teaches “Preparation of a Plasma-Buffy Coat Mixture” in
which “[a]nticoagulated blood is then subjected to a centrifugal separation
process to produce a plasma-buffy coat mixture that contains buffy coat
components of the whole blood in plasma and removes red cells” (Hood,
col. 7, ll. 35-39).
4. Hood teaches that the process continues where “the less dense
platelets, monocytes and lymphocytes, the so called ‘buffy coat’ are forced
into the central plasma column which becomes cloudy. Lower RPMs may
not exert sufficient force to maintain separation between red cells and
plasma, which would prevent collection of the buffy coat free of red cells”
(Hood, col. 8, ll. 16-22).
5. Hood teaches that its “invention provides a plasma-buffy coat
concentrate that includes plasma and concentrated platelets and fibrinogen”
(Hood, col. 3, ll. 56-58).
6. Hood teaches that “[w]ater is removed from the plasma-buffy
coat mixture to prepare a plasma-buffy coat concentrate. This step is
conveniently performed using a conventional hemoconcentrator” (Hood, col.
9, ll. 16-19).
7. Hood teaches that “[j]ust prior to application to a wound, the
plasma-buffy coat concentrate is mixed with a fibrinogen activator” (Hood,
col. 12, ll. 2-3).
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8. Hood teaches that “[f]ibrinogen activators are well known and
commercially available, and include thrombin and batroxobin” (Hood, col.
12, ll. 6-7).
9. Grainger teaches that the “platelet α-granules contain PDGF
and TGF-β, which modulate the subsequent wound-healing process.
However, the TGF-β in human platelets, which is exclusively the β1
isoform, is stored as a latent form” (Grainger 932, col. 1).
10. Grainger teaches that “activation can be effected in vitro by
extremes of pH or proteases” (Grainger 932, col. 1).
11. Grainger teaches that “TGF-β1 was released from intact human
platelets by the action of thrombin” (Grainger 933, col. 1).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has recently emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int'l v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Claim terms are interpreted using the broadest reasonable
interpretation in light of the Specification. See, e.g., In re Hyatt, 211 F.3d
1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are
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given their broadest reasonable interpretation consistent with the
specification.”). Also see In re Morris, 127 F.3d 1048, 1054-56 (Fed. Cir.
1997). (“Absent an express definition in their specification, the fact that
appellants can point to definitions or usages that conform to their
interpretation does not make the PTO's definition unreasonable when the
PTO can point to other sources that support its interpretation.”)
It is well settled that argument by counsel cannot take the place of
evidence. In re Cole, 326 F.2d 769, 773 (CCPA 1964); In re Geisler, 116
F.3d 1465, 1471 (Fed. Cir. 1997).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii)
(“Any arguments or authorities not included in the brief or a reply brief …
will be refused consideration by the Board, unless good cause is shown.”).
Analysis
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope cannot be compared to the
prior art.
In this case, Appellant challenges the Examiner's interpretation that
Hood’s “plasma-buffy coat concentrate” is equivalent to the “Platelet-Rich
Plasma” required by claim 1, arguing that the “‘plasma-buffy coat
concentrate’ of Hood and the ‘platelet-rich plasma’ of the present
application are not equivalent.” (App. Br. 3).
Thus, to address the rejection at issue in this appeal, we must
determine the proper meaning of the phrase “Platelet-Rich Plasma” required
by claim 1. During prosecution, claim terms are given their broadest
reasonable interpretation as they would be understood by persons of
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ordinary skill in the art in the light of the Specification. We therefore first
turn to the Specification to determine what light it sheds on the meaning of
the phrase “Platelet-Rich Plasma.”
The Specification teaches that proteases “are added to the Platelet
Rich Plasma (PRP)” but provides no definition of “Platelet-Rich Plasma”
(Spec. 4, ll. 1-2; FF 1). The only disclosure in the Specification regarding
the “Platelet-Rich Plasma” is that “blood is centrifuged to obtain platelets
and the platelets release the soluble regulators/growth factors by adding a
mixture of calcium chloride and topical bovine thrombin” (Spec. 4, ll. 16-18;
FF 2).
Therefore, the only disclosure found in the Specification for “Platelet-
Rich Plasma” is that it can be the product of blood being centrifuged to
obtain the platelets (FF 2). Based upon the language of the phrase “Platelet-
Rich Plasma” itself, we also interpret the phrase to require some level of
purification or enrichment of the platelets in the plasma, relative to the initial
starting platelet concentration in blood starting material.
Hood teaches that the “plasma-buffy coat concentrate” is “subjected
to a centrifugal separation process to produce a plasma-buffy coat mixture
that contains buffy coat components of the whole blood in plasma and
removes red cells” (Hood, col. 7, ll. 35-39; FF 3). Thus, Hood prepares the
“plasma-buffy coat concentrate” using the same (and only) step disclosed for
preparation of the “Platelet-Rich Plasma” in the Specification.
Hood further teaches that the “plasma-buffy coat concentrate” is
separated from the red blood cells of blood and concentrated, resulting in an
enrichment of platelets in the plasma concentrate relative to the initial
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amount of platelets found in blood (FF 4-6). Hood specifically teaches that
the “present invention provides a plasma-buffy coat concentrate that
includes plasma and concentrated platelets and fibrinogen” (Hood, col. 3, ll.
56-58)(emphasis added).
We therefore agree with the Examiner that the broadest reasonable
interpretation of the term “Platelet-Rich Plasma” encompasses the plasma-
buffy coat concentrate of Hood.
We are not persuaded by Appellant’s argument that Hood “achieves
the ‘plasma-buffy coat concentrate’ by altering the composition of normal
plasma . . . In contrast, the present application discloses platelet-rich plasma,
that is, normal plasma enriched in platelets” (App. Br. 3-4). In fact, the
present Specification provides no specific description of the specific and
complete process by which the “Platelet-Rich Plasma” is produced (FF 1-2).
More importantly, there is no limitation in the claim (or definition in the
Specification) which imposes a requirement that the “Platelet-Rich Plasma”
is not altered by concentration as performed by Hood. “[L]imitations are not
to be read into the claims from the specification.” In re Van Geuns, 988 F.2d
1181, 1184 (Fed. Cir. 1993) (citing In re Zletz, 893 F.2d 319, 321 (Fed. Cir.
1989)).
We also do not find persuasive Appellant’s argument that “the Hood
patent appears to teach away from the use of a product including normal
plasma” (App. Br. 4). Hood provides no specific teaching that normal
plasma would not work, but rather indicates a preference for concentrated
plasma (FF 6-7). Like our appellate reviewing court, “[w]e will not read
into a reference a teaching away from a process where no such language
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exists.” DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356,
1364 (Fed. Cir. 2006).
Conclusion of Law
Appellant has not demonstrated that the Examiner erred in finding that
the combination of Hood and Grainger teach the use of “platelet-rich
plasma” as required by claim 1.
B.- F. 35 U.S.C. § 103(a) Rejections
Appellant does not separately argue the additional rejections under 35
U.S.C. § 103(a) which depend upon the primary rejection over Hood and
Grainger. Instead, Appellant states with regard to each of these rejections
that “[i]n view of Appellant’s belief as to the allowability of independent
claims 1 and 6, rejected dependent claims . . . should be deemed allowable
as well” (see, e.g., App. Br. 5). The Examiner has found specific evidence
and reasoning to support the rejections (see Ans. 6-11). Appellant has not
provided any reason to doubt the correctness of the Examiner’s rejections.
On appeal to this Board, Appellant must show that the Examiner has not
sustained the required burden. See Ex parte Yamaguchi, 88 USPQ2d 1606,
1608 and 1614 (BPAI 2008) (precedential); Ex parte Fu, 89 USPQ2d 1115,
1118 and 1123 (BPAI 2008) (precedential). Therefore, we affirm the
Examiner’s rejections.
SUMMARY
In summary, we affirm the rejections of claim 1-13 under 35 U.S.C. §
103(a).

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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED

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