Ex Parte Hill et al

Patent Trial and Appeal Board

Nov 14, 2016

12039214 (P.T.A.B. Nov. 14, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/039,214 02/28/2008 Ronald Stewart Hill
26158 7590 11/16/2016
WOMBLE CARLYLE SANDRIDGE & RICE, LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
P63782 1010.2 (0019.7) 7072
EXAMINER
SCHUBERG, LAURA J
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
11/16/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte RONALD STEWART HILL, RICHARD CHRIS KLANN
and FRANCIS V. LAMBERTI
Appeal2015-004374
Application 12/039,2141
Technology Center 1600
Before LORA M. GREEN, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a bioactive hydrogel matrix.
The Examiner finally rejected the claims as obvious under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 134. The Examiner's
decision is affirmed-in-part. A new grounds of rejection under 35 U.S.C.
§ 103(a) is set forth pursuant to 37 C.F.R. § 41.50(b ).
1 "The '214 Application."
Appeal2015-004374
Application 12/039,214
STATEMENT OF CASE
Appellants appeals from the Examiner's final rejection of claims 1-
12, 15-30, and 45--49. The claims stand rejected by the Examiner as
follows:
1. Claims 1-3, 5-10, 12, 15-23, 28-30, and 45--49 under 35 U.S.C.
§ 103(a) (pre-AIA) as obvious in view ofUsala '587 (U.S. Pat. No.
6,261,587 Bl, patented July 17, 2001), Liu et al., (U.S. Pat. No. 5,972,385,
patented Oct. 26, 1999), and Lin et al., (U.S. Publ. Pat. App. No.
2004/0091462 Al, publ. May 13, 2004). Ans. 2.
2. Claim 45 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view
of Usala '587, Liu, Lin, and Falchuk (U.S. Publ. Pat. App. No.
2002/0169201, publ. Nov. 14, 2002). Ans. 5.
3. Claims 1-12, 24-27, and 45 under 35 U.S.C. § 103(a) (pre-AIA) as
obvious in view of Rhee et al., (U.S. Pat. No. 5,470,911, patented Nov. 28,
1995), Usala '331 (U.S. Pat. No. 5,824,331, patented Oct. 20, 1998), and
Lin. Ans. 8.
4. Claim 45 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view
of Rhee, Usala '331, Lin, and Falchuk. Ans. 10.
Claim 1, the only independent claim on appeal, is reproduced below
(bracketed numbers added for reference to the individual components):
1. A bioactive hydro gel matrix comprising [ 1] gelatin, [2] a
polysaccharide, [3] one or more components selected from the
group consisting of polar amino acids, polar amino acid analogs
or derivatives, divalent cation chelators, and combination
thereof, [ 4] hydroxyapatite, and [ 5] demineralized bone matrix
(DBM).
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USALA '587, LIU, AND LfN
We shall reverse this rejection for the reasons stated by Appellants.
The Examiner determined that it would have been obvious to one of
ordinary skill to have combined the teachings in Usala '587 with Liu and
Lin. Final Rej. 3-6. However, as pointed out by Appellants, the purpose of
Usala '587's composition is for promoting vascularization, for preventing an
immune response, and for reducing inflammation. Appeal Br. 8 (last
paragraph). Lin describes a composition for forming bone. Id. at 5. The
Examiner did not provide a persuasive reason as to why Lin's bone
composition would be combined with Usala '587. For this reason, we
reverse the rejection of claims 1-3, 5-10, 12, 15-23, 28-30, and 45--49 as
obvious in view of Usala '587, Liu, and Lin.
Rejection
RHEE, USALA '331, AND LIN, AND
FURTHER IN VIEW OF FLACHUK
The claimed bioactive hydrogel matrix is required to have five
components: 1) gelatin; 2) polysaccharide; 3) one or more of 3a) polar
amino acids or 3b) divalent chelators; 4) hydroxyapatite; and 5)
demineralized bone matrix (DBM).
[FF 1 ]2 Gelatin is a form of denatured collagen. '214 Appl. 11: 28-30;
12: 23-31.
2 "FF" refer to findings of fact.
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[FF2] The '214 Application teaches that the gelatin and
polysaccharide can be cross-linked, such as gelatin cross-linked to dextran.
Id. at 32: 6-31.
[FF3] The Examiner found that Rhee describes a composition for soft
and hard tissue augmentation comprising (Final Rej. 8-10) (numbered
according to claim 1):
[FF4] 1) Collagen, a gelatin (Abstract; col. 4, 11. 26-31; col. 13, 11. 60-
67);
[FF5] 2) Glycosaminoglycan, a polysaccharide (Abstract; col. 4, 11.
26-31 col. 7, 11. 14-15);
Id.
[FF6] 4) Hydroxyapatite (col. 12, 11. 39--43).
Compositions comprising conjugates with ceramic particles,
preferably hydroxyapatite and/or tricalcium phosphate, are
particularly useful for the repair of stress-bearing bone due to
its high tensile strength.
The Examiner found that it would have been obvious to have included
hydroxyapatite in Rhee's composition because it is "particularly useful for
the repair of stress-bearing bone due to its high tensile strength." Final Rej.
9.
[FF7] The collagen and glycosaminoglycan3 are covalently bound.
Rhee, col. 4, 11. 25-32.
The conjugate comprising a glycosaminoglycan covalently
bound to a hydrophilic synthetic polymer may be further bound
to collagen to form a three component conjugate having
different properties.
3 "Useful glycosaminoglycans include hyaluronic acid, the chondroitin
sulfates, keratan [sic, keratin] sulfate, chitin and heparin." Rhee, Abstract.
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Id. at Abstract.
One (1) milliliter of 35 mg/ml collagen in solution (pH 2) is
mixed with 1 ml of a 2% (w/v) acidified solution of
difunctionally activated S-PEG. The S-PEG-collagen solution is
immediately mixed with 2 ml of a 10 mg/ml solution of
deacetylated hyaluronic acid (pH 13), neutralizing the pH of the
mixture and causing the difunctionally activated S-PEG to
covalently bond with both the collagen and the hyaluronic acid.
Id. at col. 30, 11. 916 (Example 3)
[FF8] Rhee also describes including cytokines and growth factors,
such as bone morphogenic protein, in its composition. Id. at Abstract; col. 4,
11. 36-41; col. 12, 11. 66.
[FF9] The material described by Rhee can be used in the repair and
replacement of bone. Id. at col. 4, 11. 41--45.
[FFlO] Rhee does not describe the presence of 3) one or more of 3a)
polar amino acids or 3b) divalent chelators; and 5) DBM in its composition.
[FF 11] The Examiner found that Ursala '3 31 describes a matrix with
collagen based gelatin (Ursala '331, col. 3, 11. 41-44; col. 17, 11. 8-23) which
can include dextran (id. at col. 17, 11. 8-23) (, 3a) polar amino acids (col. 3,
11. 41-44), and 3b) divalent cation chelators (id. at col. 3, 11. 47-50).
[FF12]
Depending on the desired physical properties, these substrates
can have their resistance to force (firmness) increased or
decreased by addition of other chemicals. As described in the
example below, such firmness is increased by addition of amino
acid moieties with polar R groups or accessible
hydrogen/hydroxyl groups to increase dipole moment
attractions and hydrogen bonds as the enhanced substrate cools.
Id. at col. 13, 11. 36--43.
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[FF13]
The resistance of the matrix to force can be increased by the
addition of chelators that remove divalent cation interference
from the hydrogen bond and dipole moment interactions.
Id. at col. 3, 11. 47-50.
The storage matrix can benefit by the addition of a divalent
chelator, such as citrate, EDTA or EGTA, which can increase
the rigidity of the matrix ...
Id. at col. 12, 16-18.
[FF14]
The Examiner found that it would have been obvious to one of
ordinary skill in the art to add 3) one or more of 3a) polar amino acids or 3b)
divalent cation chelators to Rhee's bone growth composition to increase
firmness and resistance to force as taught by Ursala '331. Final Rej. 10.
Id.
[FF 15] The Examiner determined:
One of ordinary skill in the art would have had a reasonable
expectation of success [in adding polar amino acids and
divalent cation chelators to Rhee] because Rhee et al teach that
one of their embodiments is intended for hard tissue
augmentation and would therefore benefit from these properties
for increased strength.
[FF 16] The Examiner found that Lin describes a composition for
repairing bone which includes osteotherapeutic materials, such as 5) DBM
(Lin, Abstract; present in Examples (id. at i-fi-f 133-140, 150-152, 170).
[FFl 7] Lin's composition can also include BMP (id. at i-fi-13, 4), 3)
hydroxyapatite (id. at i15), and 1) gelatin (id. at i1 42), and 2)
polysaccharides (id.)
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[FF 18] The Examiner found that it would have been obvious to one
of ordinary skill in the art to have included 5) DBM into Rhee's composition
because Lin teaches that DBM is desirable and beneficial for bone repair, the
same purpose of Rhee's composition. Final Rej. 11.
Issue
Appellants contend that Rhee does not describe a single embodiment
with the "presently claimed" materials. Appeal Br. 10. Appellants argue
that the "mere disclosure of a number of materials is insufficient to provide
the level of predictability required to make a prima facie case of
obviousness." Id. at 11. Appellants contend that the Examiner did not
provide "any evidence that a person of ordinary skill in the art would find
reason to pick and choose elements from Rhee that are included in the
specifically claimed composition." Id. With respect to the addition of polar
amino acids, chelators, and DBM, Appellants argue that the Examiner did
not establish that "a person of ordinary skill in the art would predict that a
composition as presently claimed would provide for excellent bone
regeneration." Id.
Appellants provided evidence to establish the non-obviousness of the
claimed invention, namely experimental results purported to show
"surprising results arising from the presently claimed combination of
specific materials." Id. at 12.
The issue in this rejection is whether the Examiner established that
one of ordinary skill in the art would have had reason to make a composition
comprising the components 1) through 5) as recited in claim 1, and whether
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such composition has unexpected results when compared to the closest prior
art.
Discussion
The Examiner provided explicit reasons as to why one of ordinary
skill in the art would have utilized 3) one or more of 3a) polar amino acids
or 3b) divalent chelators; 4) hydroxyapatite; and 5) demineralized bone
matrix (DBM) in Rhee's matrix comprising 1) gelatin and 2) the
polysaccharide glycosaminoglycan. Final Rej. 8-10. Specifically, the
Examiner found that components 3) through 5) are each described as
beneficial to bone growth and repair, providing a reason to have utilized
them in Rhee's gelatin/ glycosaminoglycan matrix which is useful for the
same purpose. FF6, FF14, FF15. FF18. The Examiner's reasoning is
supported by a preponderance of the evidence in the record. FF6, FF9, FF12,
FF 13, FF 16, FF 17. Appellants did not identify a persuasive error in the
Examiner's reasoning nor fact-finding.
Unexpected results
A showing of "unexpected results" can be used to demonstrate the
non-obviousness of a claimed invention. Soni, 54 F.3d 746, at 750 ("One
way for a patent applicant to rebut a prima facie case of obviousness is to
make a showing of 'unexpected results,' i.e., to show that the claimed
invention exhibits some superior property or advantage that a person of
ordinary skill in the relevant art would have found surprising or
unexpected."). These results must be "surprising or unexpected" to one of
ordinary skill in the art when comparted to closest prior art. In re Soni, 54
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F.3d 746, 750 (Fed. Cir. 1995). Unexpected results must also be
"commensurate in scope with the degree of protection sought by the claimed
subject matter." In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005).
Appellants provided a declaration under 37 C.F.R. § 1.132 by Ronald
Stewart Hill, Ph.D., a co-inventor of the '214 Application (Hill Deel.
(2012)). Dr. Hill describes test results obtained with "the presently claimed
hydrogel matrix with a bone morphogenetic protein (BMP). Hill Deel.
(2012) i-f 4. The hydrogel matrix tested was "E-Matrix," a commercial
product comprising "a combination of a polypeptide and a polysaccharide
according to the claims of the present patent application." Id. Dr. Hill did
not identify the polypeptide or polysaccharide present in E-Matrix. Dr. Hill
also did not state whether the polypeptide and polysaccharide were cross-
linked or not.
Dr. Hill performed a first experiment in which low and high
concentrations of BMP were utilized in E-Matrix to promote bone growth in
a rat spinal fusion model. Id. at i-fi-1 4, 5. Dr. Hill also performed the
experiment using different concentrations of BMP. Id. at i-f 6.
Dr. Hill testified:
It was surprising to find that, although the lower doses of BMP-
2 were ineffective for achieving maximum possible bone
growth, combination of the impractically low dose BMP-2 with
a hydrogel matrix according to the present claims still achieved
bone growth performance that matched or exceeded that seen
with high dose BMP-2 treatment.
Id. at i-f 5.
Dr. Hill's statement was accompanied by the experimental data upon
which he based this opinion. Id. at i-fi-1 5, 6, 7.
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We agree with the Examiner that the showing described by Dr. Hill in
these first experiments is not adequate to demonstrate that the claimed
invention is not obvious over the cited prior art because it was not compared
to the closest prior art. A showing of "new and unexpected results" must be
"relative to prior art." Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392
F.3d 1317, 1322 (Fed. Cir. 2004). To establish unexpected results, the
claimed subject matter must be compared with the closest prior art. In re
Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
In this case, Rhee describes a composition useful for bone growth that
comprises collagen (gelatin) covalently bound to the polysaccharide
glycosaminoglycan. FF3, FF4, FF7, FF9. Both components are the same as
those recited in the claims, namely, 1) gelatin and 2) polysaccharide. Rhee
also teaches that BMP can be added to its composition. FF8. Appellants did
not compare E-Matrix to Rhee's composition. Rather, Appellants used a
composition to demonstrate unexpected results that was like Rhee's
composition, namely, a bone growth composition comprising 1) gelatin and
2) polysaccharide. All that Appellants have demonstrated is that a prior art
composition facilitates the effect of BMP on bone growth. "Mere
recognition of latent properties in the prior art does not render nonobvious
an otherwise known invention." In re Baxter Travenol Labs., 952 F.2d 388,
392 (Fed. Cir. 1991).
Even if Appellants experiment is proper for demonstrating unexpected
results, the showing is still deficient because it represents only a single
embodiment of claim 1. Specifically, claim 1 recites "a polysaccharide."
Appellants did not establish that any polysaccharide within the scope of the
claim would enhance the bone-promoting activity of BMP. Appellants have
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not even identified the specific components of E-Matrix to determine what
polysaccharide was utilized and whether the protein in it was, in fact,
gelatin.
Appellants contend that the Examiner mischaracterized Rhee, and that
Rhee does not disclose a hydrogel formed of gelatin and polysaccharide.
Reply Br. 5; Appeal Br. 16. We do not agree. Rhee specifically mentions
the polysaccharide glycosaminoglycan "conjugated to a synthetic
hydrophilic polymer such as polyethylene glycol (PEG), which is optionally
conjugated to collagen as well." Rhee, col. 1, 11. 20-26. Appellants appear
to take the position that a "working" example is necessary in order for the
disclosure to serve as the closest prior art. Again, we do not agree. Rhee's
disclosure of a composition with both gelatin and the polysaccharide
glycosaminoglycan is concrete and specific. There is no picking and
choosing as alleged by Appellants (Reply Br. 5, 6); Rhee says to make it,
even if the collagen is optional. Moreover, Example 3 in Rhee makes a
polymer of collagen and hyaluronic acid (a polysaccharide) along with PEG.
Id. a col. 30, 11. 9-16; FF7.
Dr. Hill also conducted additional experiments "to evaluate the effect
of various bone graft Materials" when implanted into the vertebral bodies of
rats. Hill Deel. (2012) i-f 10. Dr. Hill performed the experiments using five
treatment groups (id.):
1) Absorbable collagen sponge (ACS).
2) Absorbable collagen sponge and BMP.
3) Test material 1: "hydrogel matrix encompassed by the present
claims, hydroxyapatite (HA), and demineralized bone matrix (DBM)."
4) Test material 2: Grafton by Osteotech.
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5) Test material 3: DBX by Synthes. "The DBX® product provides
DBM combined with hyaluronate." Id. at i-f 23
Dr. Hill describes how the experiments were performed and how the
results were quantified to determine the effect of the test material on bone
growth. Id. at i-fi-110-13. Dr. Hill reported the result of the experiments.
Table 5 summarized bone fusion and manual palpitation of the bone in all
the test groups. Dr. Hill testified that the bone fusion scores "in the Group
using Test Material 1 [said to be a matrix of claim 1] were significantly
higher than the two Groups using Test Material 2 and Test Material 3." Id.
at i-f 15. Dr. Hill further explained that while the group with ACS and BMP
showed 100% fusion, the new bone formation was less than Test Material 1.
Id. at i-f 16.
Dr. Hill further testified, citing experimental data shown in Figs. 1-3:
Using a quantification protocol, animals in the Group using
Test Material 1 demonstrated significantly greater new bone
formation than all other treatment Groups, including the
rhBMP-2 Group (1070 mm3 vs. 475 mm3, p < 0,05).
Id. at i-f 1 7.
Based this and other data, Dr. Hill concluded:
The above data illustrates the surprisingly efficacious results
when using the material according to the present invention
formed of the hydro gel matrix, DBM, and HA. We believe the
excellent results arise from the osteoinductivity of the DBM,
the mechanical properties of the HA, and the biocompatibility
and structural effects of our specific hydrogel matrix i.e. ability
to maintain the full implant volume for new bone formation at
the implant site.
Id. at i-f X.
We do not find that the evidence, when considered as part of all the
evidence in the record, establishes the non-obviousness of the claimed
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invention. Transocean Oj]shore Deepwater Drilling, Inc. v. Maersk Drilling
USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012).
To begin, we have not been directed to information that identifies the
components of the hydro gel matrix of Test Material 1, said to be
representative of the claims. This is troubling since the claims require both
gelatin and a polysaccharide, and we have not been able to confirm that
gelatin is present in the hydrogel matrix nor what polysaccharide was
utilized. In our opinion, such information should have been divulged since
one of ordinary skill in the art, would have wanted to know the specific
components of the matrix, e.g., to know whether such matrix was known in
the art at the time of the invention, and, to determine whether the results
were due to the merits of the invention, rather than something already known
in the art. See J.T. Eaton & Co. v. Atlantic Paste & Glue Co., 106 F.3d 1563
(Fed. Cir. 1997).
Even without this information, we find the showing defective for the
full scope of the claims. Ans. 19. While Dr. Hill has provided factual
support for his testimony about the results exhibited by a "material
according to the present invention formed of the hydro gel matrix, DBM, and
HA," he did not demonstrate that other embodiments within the scope of the
claim would show such "surprisingly efficacious" results. Hill Deel. (2012)
i-f 21. For example, the claimed matrix comprises a polysaccharide, which is
reasonably understood to be a genus of polysaccharide molecules with
different structures. However, only one matrix was used in the experiments.
We have not been told whether the matrix contained only one type of
polysaccharide, whether multiple types of polysaccharide were present, and
what specific polysaccharide was used. We also have not been told the form
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of the matrix. For example, the Application teaches that the gelatin and
polysaccharide can be cross-linked. FF2. The claims cover both a cross-
linked and non-cross-linked matrix, but Appellants have not disclosed
whether the two components in the matrix are linked or not.
When unexpected results are demonstrated, it must be established that
such results would be obtained by other embodiments with the claim scope,
i.e., other polysaccharides, and cross-linked and uncross-linked forms of the
hydrogel matrix.4 Dr. Hill attributed the unexpected results, in part, on "the
biocompatibility and structural effects of our specific hydrogel matrix i.e.
ability to maintain the full implant volume for new bone formation at the
implant site." Hill Deel. (2012) i-f 21 (emphasis added). Consequently, the
composition and structural state of the hydro gel would be reasonably
expected to affect the outcome in the bone material experiments. For this
reason, we are not persuaded that the results obtained from the single
4 ("Even assuming that the results were unexpected, Harris needed to show
results covering the scope of the claimed range. Alternatively Harris needed
to narrow the claims."); In re Greenfield, 571F.2d1185, 1189 (CCPA 1978)
("Establishing that one (or a small number of) species gives unexpected
results is inadequate proof, for 'it is the view of this court that objective
evidence of non-obviousness must be commensurate in scope with the
claims which the evidence is offered to support."') (quoting In re Tiffin, 448
F.2d 791, 792 (CCPA 1971)); (Finding the claim scope broad, and the
"probative value of appellants' evidence ... quite narrow," the court in In re
Clemens, 622 F.2d 1029, 1036 (CCPA 1980) concluded this "is not a case in
which the probative value of a narrow range of data can be reasonably
extended to prove the unobviousness of a broader claimed range." Cf In re
Kollman, 595 F.2d 48, 56 (CCPA 1979) (where it was held that the
nonobviousness of a broader claimed range was proven by a narrower range
of data, when one having ordinary skill in the art could "ascertain a trend in
the exemplified data which would allow him to reasonably extend the
probative value thereof.").
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embodiment of one hydro gel is indicative of the full scope of hydro gel
embodiments covered by the claim. Indeed, Dr. Hill appears to attribute the
unexpected results to the "specific hydrogel matrix" utilized in the
experiments, but the claims are not limited to such a specific hydrogel
matrix.
In addition to this, it is not evident to us that the comparison made by
Dr. Hill represented the closest prior art. Ans. 21. Rhee described a
composition comprising collagen cross-linked with glycosaminoglycan.
FF7. However, Dr. Hill did not compare the material said to be within the
scope of claim 1 (Test Material 1) to Rhee's material. Treatments 1) and 2)
were performed with only collagen; treatment 5) was performed with DBX
that comprises DBM and hyaluronate, but no collagen. Hill Deel. (2012)
i-f 23. The complete composition of Grafton in treatment 4) was not
disclosed.
Appellants argue that DBX in treatment 5) is closer, because it
comprises hyaluronate and DBM. Reply Br. 2. Hyaluronate is a
glycosaminoglycan which is a polysaccharide. Thus, DBX comprises two of
the components recited in claim 1, a polysaccharide and DBM. The
Examiner disputed this.
Inin re Merchant, 575 F.2d 865, 868 (CCPA 1978), the court
acknowledged that "no all-encompassing principle or test can be delineated
for determining the closest prior art." However, the court stated that a
"comparison of the claimed invention with the disclosure of each cited
reference to determine the number of claim limitations in common with each
reference, bearing in mind the relative importance of particular limitations,
will usually yield the closest single prior art reference." Id. In In re
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Johnson, 747 F.2d 1456, 1461 (Fed. Cir. 1984), the court further held that
"an applicant must compare to the closest prior art, even if that art was not
relied on by the examiner." Moreover, the court stated that "[w]here two
references were equally close to the claimed invention there is no reason for
insisting that applicant compare with one reference, the one relied upon by
the examiner, instead of another." Id. The court noted, however, that such a
determination is "premised on the notion that the teachings of the closest
prior art references are sufficiently similar so that the testing of one
compound showing unexpected results would provide the same information
as to the relevant teachings of the other equally close references." Id.
In this case, even if DBX is considered to be the closest prior art
because it comprises two of the five components, 5 the showing is still not
persuasive.
First, as already explained, the showing is not commensurate in scope
with the claim. The comparison was made with only one embodiment
within the scope of claim 1.
Secondly, and independently, we note that the claimed composition
has five components. It has not been established by adequate evidence that
the composition tested by Dr. Hill contained all five components. Dr. Hill
stated: "Test material 1 (a material comprising a hydrogel matrix
5 The Examiner found that Rhee also describes the presence of gelatin beads
and hydroxyapatite. Ans. 21. Appellants take the position that the Examiner
"require Appellant to review Rhee, pick and choose variously disclosed
elements therefrom and reconstruct a composition that is as close as possible
to the claimed composition" which is adverse [to] the prevailing law."
Reply Br. 6. Because we find the showing defective, we have not reached
the issue of whether Rhee comprises at least three of the five components of
claim 1, making it closer prior art than DBX which has only two.
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encompassed by the present claims, hydroxyapatite (HA), and demineralized
bone matrix (DBM)." Hill Deel. (2012) i-f 10. Claim 1 also requires
component 3) of "one or more components selected from the group
consisting of polar amino acids, polar amino acid analogs or derivatives,
divalent cation chelators, and combination thereof." Dr. Hill did not
mention which of components 3), if any, are present in the matrix.
Appellants, in the Reply Brief, assert component 3) is present. Reply Br. 4.
However, an argument made by counsel in a brief does not substitute for
evidence lacking in the record. Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d
588, 595 (Fed. Cir. 1997).
In our opinion, the requirement that there be a nexus between the
evidence and the merits of the claimed invention (see In re GPAC, Inc., 57
F.3d 1573, 1580 (Fed. Cir. 1995)) demands that the embodiment said to be
representative of the claimed subject matter is coextensive with all the
recited limitations of the claim. Such a requirement has been made in cases
where commercial success was at issue. Ormco Corp. v. Align Technology
Inc., 463 F.3d 1299, 1311-1312 (Fed. Cir. 2006). It is logical that all the
components of the claimed invention must be present in the embodiment
relied upon to establish unexpected results because each claimed component,
absent evidence to the contrary, would be reasonably expected to impact the
performance of the claimed invention. Accordingly, we find the showing
independently defective for the failure to establish the presence of
component 3).
Third, while we do not base our decision on this reason, we are wary
of relying on test results to establish non-obviousness of a claimed invention
when the exact ingredients (polysaccharide, polar amino acid, chelator),
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Application 12/039,214
concentrations, and structure (e.g., matrix is cross-linked or not) of the
embodiment said to exhibit the unexpected results have not been disclosed.
Dependent claims
Because dependent claims 2-12, 24-27, and 45 were not argued
separately, these claims fall with claim 1. 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv).
RHEE, USALA '331, LIN, AND USALA '587
We set forth the following new ground of rejection pursuant to
37 C.F.R. § 41.50(b):
Claims 15-23, 28-30, and 46--49 are rejected under 35 U.S.C.
§ 103(a) (pre-AIA) as obvious in view of Rhee, Usala '331, Lin, and Usala
'587.
Claims 15, 18
Claims 15 and 18 recite specific polar amino acids. Polar amino acids
were known in the art at the time of the invention, e.g., as evidenced by
Usala '587. Consequently, the selection of a specific polar amino acid
would have been obvious to one of ordinary skill in the art.
Claims 16, 17, and 19
Claims 16, 17, and 19 recite specific concentrations of polar amino
acids. As found by the Examiner, Usala '587 describes the addition of polar
amino acids to increase rigidity of the matrix (Final Rej. 4 ), the same
function disclosed by Lin at column 4, 11. 24-29. The Examiner found that
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the amounts of polar amino acids disclosed in Usala '587 reasonably suggest
the claimed amounts (Final Rej. 4), a finding undisputed by Appellants.
Claims 20, 21
Claim 20 depends from claim 1, and further recites that the chelator is
ethylenediaminetetraacetic acid ("EDT A"). As found by the Examiner,
Usala '331 teaches the addition of a chelator to increase matrix rigidity.
FF13. Usala '331 also discloses that the chelator can be EDTA as recited in
the claim. FF 13.
In regard to the recited amounts of 0.01 to 10 mM of EDTA in claim
21, such amounts would be routinely determinable as evidenced by U sala
'5 87 which teaches such amounts for the same purpose in increasing matrix
rigidity. Usala '587, col. 3, 1. 66 to col. 4, 1. 9.
Claim 22
Claim 22 depends from claim 1, and further recites a list of
medicaments that can be included in the bioactive hydrogel matrix.
Lin teaches that various osteotherapeutic, drugs, and therapeutic
agents can be added to its bone composition, reasonably suggesting
therapeutics with the specific activities recited in the claim. Lin i-fi-13, 9, 105,
117.
Claim 23
Claim 23 depends from claim 1, and further recites "wherein the
bioactive hydrogel matrix further comprises cells selected from the group
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consisting of stem cells, progenitor cells, and mixtures thereof." Lin
discloses that its matrix can comprise stem cells. Lin i-fi-13, 105.
Claims 28, 29
Claim 28 depends from claim 1, and further recites that the bioactive
hydrogel matrix is in dehydrated form.
Claim 29 depends from claim 1, and further recites that the
dehydrated bioactive hydrogel matrix is in particulate form.
Rhee teaches both features:
The conjugates can be dehydrated to form a relatively solid
implant for use in hard tissue augmentation. The dehydrated,
solid implant can further be ground into particles which can be
suspended in a non-aqueous fluid and injected into a living
being (preferably human) for soft tissue augmentation. Once in
place, the solid implants or particles rehydrate and expand in
size approximately three- to five-fold.
Rhee, Abstract.
Claim 30
Claim 30 depends from claim 1, and further recites "at least a portion
of the bioactive hydro gel matrix is in crosslinked form, the polysaccharide
being covalently crosslinked to the gelatin." This feature is described by
Rhee. FF7.
Claim 46
Claim 46 depends from claim 1, and further recites "wherein the
gelatin is present at a concentration of about 0.01 to about 40 mM.
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The Examiner found that these recited concentrations are described in
Usala '587. Final Rej. 4. Because Usala '587 describes a hydrogel, we find
that it would have been obvious to have utilize the amounts of gelatin in
Usala '587 for the hydrogel of Rhee.
Claims 47--49
Claims 47--49 recite that the polysaccharide of claim 1 is dextran,
"wherein the dextran has a molecular mass of about 300,000 to about
600,000 Da, and the polydispersity of the molecular mass of the dextran is
about 1 to about 3 (claim 48) and "wherein the dextran is present at a
concentration of about 0. 01 to about 1 mM" (claim 49).
The Examiner made findings in the Final Rejection that Lin and Rhee
teach a matrix with dextran with recited molecular weights or that one of
ordinary skill in the art would have had reason to select such weights. Final
Rej. 9, 10, 11. It therefore appears to have been an oversight by the
Examiner in not including claims 4 7 and 48 in the rejection.
With regard to the concentrations recited in claim 49, the Examiner
found that such concentrations are described in Usala '587. Final Rej. 4.
Because Usala '587 describes a hydrogel, we find that it would have been
obvious to have utilize the amounts of dextran in Usala 587 for the hydrogel
of Rhee.
SUMMARY
1. The rejection 1-3, 5-10, 12, 15-23, 28-30, 45--49 as obvious in
view ofUsala '587, Liu, and Lin is reversed.
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2. The rejection of claim 45 as obvious in view of Usala '587, Liu,
Lin, and Falchuk is reversed.
3. The rejection of claim 1-12, 24-27, and 45 as obvious in view of
Rhee, Usala '331, and Lin is affirmed.
4. The rejection of claim 45 as obvious in view of Rhee, Usala '331,
Lin, and Falchuk is affirmed.
5. Claims 15-23, 28-30, and 46--49 are rejected as obvious in view of
Rhee, Usala '331, Lin, and Usala '587. This is a new ground of rejection.
NEW GROUNDS OF REJECTION
This decision contains new grounds of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21(September7,
2004)). 37 C.F.R. § 41.50(b) provides that "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial
review."
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
( 1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the Examiner, in which
event the proceeding will be remanded to the Examiner. ...
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record ...
The amendment and/or new evidence under 37 C.F.R. § 41.50(b)(l),
or the request for rehearing under 37 C.F.R. § 41.50(b)(2), must be filed
within 2 months from the date of the Board's decision. In accordance with
37 C.F.R. § 41.50(f), this 2-month time period may not be extended by the
filing of a petition and fee under 37 C.F.R. § 1.136(a), but only under the
provisions of37 C.F.R. § 1.136(b).
AFFIRMED-IN-PART;§ 41.50(b)
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