Hani Awad et al.

Patent Trials and Appeals Board

Dec 16, 2021

2020003297 (P.T.A.B. Dec. 16, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/444,445 02/28/2017 Hani Awad 1903-0001CNT1 5723
28078 7590 12/16/2021
MAGINOT, MOORE & BECK, LLP
One Indiana Square, Suite 2200
INDIANAPOLIS, IN 46204
EXAMINER
FOX, ALLISON M
ART UNIT PAPER NUMBER
1633
MAIL DATE DELIVERY MODE
12/16/2021 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HANI AWAD, BRADLEY T. ESTES, and FARSHID GUILAK
Appeal 2020-003297
Application 15/444,445
Technology Center 1600
Before JOHN G. NEW, TAWEN CHANG, and RACHEL H. TOWNSEND,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–20. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Cytex
Therapeutics, Inc. Appeal Br. 2.
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STATEMENT OF THE CASE
The Specification states that prior art has shown “the potential for the
induction of bone in ectopic sites such as muscle by the implantation of
demineralized bone powder.” Spec. ¶ 3. The Specification states, however,
that “a similar approach is not available for the repair of soft tissues” and
that “[t]he current state of the art typically involves the use of autologous
tissue grafts, cryo-preserved or fresh allograft tissues, or the use of synthetic
(metal, polymer) . . . materials” as functional tissue replacements for missing
or damaged tissues. Id. ¶¶ 4–5. The Specification describes significant
drawbacks for each of the current tissue replacement materials. Id. ¶¶ 5–6.
According to the Specification, “[t]he present invention relates to the
repair, replacement and/or regeneration of diseased or traumatized soft
tissue.” Spec. ¶ 2. More particularly, the Specification states that invention
relates to
process[ing] soft tissue from specific sites in the body in a
manner that produces pulverized morsels of the soft tissue
[(Native Soft Tissue Matrix or NSTM)] devoid of immunogenic
material and pathogens but with intact aspects of the composition
of the extracellular matrix proteins including the growth factors
and cytokines that are responsible for tissue growth and cellular
infiltration and differentiation.
Id. ¶ 7. The Specification further states that the invention introduces use of
NTSM morsels “that can be used either as an acellular (non-viable) filler
material or combined with viable elements (cells) and/or bioactive molecules
to promote the repair or regeneration of diseased or traumatized soft
tissues.” Id. ¶ 9.

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CLAIMED SUBJECT MATTER
The claims are directed to a method for preparing a product for use in
repairing a lesion or defect at a tissue site in a human or animal patient body,
a product produced according to such a method, a method for repairing such
a lesion or defect, and a product for introduction within such a tissue site.
Claims 1, 13, and 20 are illustrative:
1. A method for preparing a product for use in repairing a
lesion or defect at a tissue site in a human or animal patient body, the
method comprising:
[(a)] obtaining tissue from a donor human or animal body;
[(b)] freezing the obtained tissue;
[(c)] pulverizing the frozen tissue;
[(d)] suspending the pulverized tissue in a fluid;
[(e)] homogenizing the tissue suspension using a tissue
homogenizer;
[(f)] precipitating tissue particles from the homogenized tissue
suspension;
[(g)] re-suspending the precipitated tissue particles; and
[(h)] lyophilizing the tissue re-suspension to provide the
product to be used in repairing the lesion or defect.

13. A product produced according to the method of claim 1.

20. A product for introduction within a tissue site of the
human or animal body, the product comprising:
a matrix of a substantially non-mineralized native soft tissue of
the human or animal body, the matrix including a plurality of pores,
the matrix formed by lyophilizing a tissue suspension, wherein:
the tissue suspension includes precipitated tissue particles
suspended in a fluid,
the precipitated tissue particles are tissue particles precipitated
from a homogenized tissue suspension,
the homogenized tissue suspension is a homogenization of
pulverized tissue homogenized using a tissue homogenizer and
suspended in a second fluid, and
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the pulverized tissue is frozen tissue obtained from a donor
human or animal body that has been pulverized.
Appeal Br. 33, 35, 37 (Claims App.) (bracketed alphabetical notations
added).

REJECTION(S)
A. Claims 1–20 are rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Hiles.2 Ans. 9.
B. Claims 13 and 20 are rejected under pre-AIA 35 U.S.C. § 102(b) as
being anticipated by Hiles. Ans. 7.
C. Claim 13 is rejected under each of pre-AIA 35 U.S.C. § 102(a) and 35
U.S.C. § 102(e) as being anticipated by Gertzman.3 Ans. 8.
D. Claim 13 is rejected under each of pre-AIA 35 U.S.C. § 102(a) and 35
U.S.C. § 102(e) as being anticipated by Lin.4 Ans. 9.

OPINION
A. Claim Construction
We begin our analysis with claim construction. During prosecution,
we interpret terms in a claim using the broadest reasonable interpretation in
light of the Specification. In re Morris, 127 F.3d 1048, 1055 (Fed. Cir.
1997).

2 Hiles et al., US 2002/0099448 A1, published July 25, 2002.
3 Gertzman et al., US 2003/0206937 A1, published Nov. 6, 2003.
4 Lin et al., US 2004/0091462 A1, published May 13, 2004.
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1. Claim 1 preamble
Claim 1 recites in its preamble “[a] method for preparing a product for
use in repairing a lesion or defect at a tissue site in a human or animal
patient body.” Appeal Br. 33 (Claims App.).
The Examiner and Appellant appear to agree that the preamble is
limiting, at least to a degree. However, the Examiner asserts that the
preamble encompasses any product capable of “being placed in a lesion or
defect at a tissue site in a human or animal patient body” without causing
further damage, Ans. 3, whereas Appellant asserts that the preamble limits
the claim to products capable of “being retained in a tissue defect or lesion
sufficient to repair the defect or lesion,” Appeal Br. 5. Accordingly, in the
context of claim 13 (claiming “[a] product produced according to the method
of claim 1”), the Examiner asserts that the product may be a loose powder,
Ans. 6, whereas Appellant contends that the claim excludes a loose powder,
because “there is nothing to hold the powder at the site.” Id.
We are not persuaded by either construction. We agree that the
preamble of claim 1 is limiting. However, we find the constructions
proposed by the Examiner and the Appellant to be inconsistent with the
language of the preamble. More specifically, the claim recites a method for
preparing a product for use in “repairing a lesion or defect at a tissue site in a
human or animal patient body.” The plain and ordinary meaning of
“repairing”5 requires more than not causing further damage; thus we find the
Examiner’s proposed construction to be unreasonably broad. On the other

5 “repair.” MERRIAM-WEBSTER, https://www.merriamwebster.com/
dictionary/repair (last visited Dec. 2, 2021) (“to restore to a sound or healthy
state”).
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hand, the claim does not require the product prepared by the claimed method
to be used alone: For instance, the claims do not preclude use of devices
(e.g., bandages) that would retain a loose powder at a tissue site so as to
allow it “to be used in repairing” a lesion or defect as recited in the body of
the claim. Thus, Appellant’s proposed construction, which purports to
exclude loose powder, is unduly narrow.
Accordingly, we construe the preamble of claim 1 as requiring
preparation of a product capable of being used in “repairing a lesion or
defect at a tissue site in a human or animal patient body.”
2. “Homogenizing . . . using a tissue homogenizer”
Claim 1 recites step (e), “homogenizing the tissue suspension using a
tissue homogenizer.” The Examiner concludes:
The broadest reasonable interpretation of “homogenizing” is “to
blend into a mixture that is the same throughout” . . . , based on
definition from Merriam-Webster’s dictionary: “homogenize”
1a: to blend (diverse elements) into a mixture that is the same
throughout). There is no explicit definition for “tissue
homogenizer” in the specification[;] thus, the broadest
reasonable interpretation of [“]tissue homogenizer[”] is
considered to be any machine capable of disrupting physical
material,[6] based on Sigma-Aldrich “Tissue Homogenizer”
Labware Products directory/description. Thus, the step [of]
[“homogenizing the tissue suspension using a tissue
homogenizer”] is interpreted as requiring blending a tissue
suspension into a mixture that is the same throughout using a
machine capable of disrupting the physical tissue material. It is
noted that the claim requires homogenization of a tissue
suspension (tissue is already particulated), the claim does not

6 We understand the Examiner’s construction of “tissue homogenizer” to
also include the requirement that the machine be “capable of homogenizing
tissue particles in a suspension.” Non-Final Act. 3 (Apr. 4, 2019).
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require the homogenization to actually comminute, shear,
particulate or modify the actual tissue.
Ans. 3–4.
Citing to the Estes Declaration,7 Appellant contends that “[t]he
Examiner’s interpretation of ‘tissue homogenizer’ essentially reads this
limitation out of the claim” and “is contrary to the understanding of a ‘tissue
homogenizer’ by the person of ordinary skill in the relevant art.” Appeal Br.
6. Appellant contends that, instead,
[a] tissue homogenizer, according to the ordinary and customary
meaning given the term by persons of ordinary skill in the
relevant art, is a device used to uniformly mince or fragment a
tissue in such a manner as to disperse fragments of the tissue
evenly throughout a mixture, in which the tissue is torn with high
shear forces and is homogenized into similarly sized fragments
that are distributed uniformly throughout the solution.
Id. at 8; see also id. at 7.
We agree with the Examiner that the broadest reasonable
interpretation of “homogenizing the tissue suspension using a tissue
homogenizer” is to “blend[] a tissue suspension into a mixture that is the
same throughout using a machine capable of disrupting the physical tissue
material,” for the reasons set forth in the Answer. Ans. 4.
We acknowledge Dr. Estes states in his declaration that “[a] tissue
homogenizer is a device used to uniformly mince a tissue in such a manner
as to disperse fragments of said tissue evenly throughout a mixture.” Estes
Decl. ¶ 16. As an initial matter, however, this is uncorroborated testimony
of a named inventor, and we are inclined to give such evidence less weight.

7 Declaration of Inventor Bradley T. Estes Pursuant to 37 C.F.R. § 1.132
(Jan. 2, 2019).
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See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir.
2004) (citations omitted) (explaining that the Board is entitled to weigh
the declarations and conclude the lack of factual corroboration warrants
discounting the opinions expressed in the declarations). Moreover, it is
unclear how Dr. Estes’ definition of a tissue homogenizer differs
significantly from the Examiner’s construction (i.e., a machine capable of
disrupting the physical tissue material and blending a tissue suspension into
a mixture that is the same throughout).
We further acknowledge Dr. Estes’ testimony that the tissue
homogenizer used by the inventors is “a rotor-stator tissue homogenizer”
and that
[t]his type of tissue homogenizer utilizes a rapidly rotating blade
(rotor) within a static sleeve (stator). When spun at high
velocities, the tissue is brought into the end of the sleeve at which
time the tissue is torn with high shear forces due to the narrow
gap between the rotor and stator. The stators also have saw-tooth
end profiles to help shred the tissue apart. While spinning at high
RPMs, the tissue is sheared and then pumped out of the holes in
the stator. Since the homogenizer is working in an open
configuration, the product is recirculated until the material is
sufficiently homogenized into similarly sized fragments while
the fragments are also being distributed uniformly throughout the
solution.
Estes Decl. ¶ 16.
As evident from the paragraph reproduced above, however, Dr. Estes’
testimony does not suggest that all tissue homogenizers tear tissue with high
shear force. Estes Decl. ¶ 16. Rather, Dr. Estes merely states that a
particular type of tissue homogenizer used by the inventor (i.e., a rotor-stator
tissue homogenizer) tears the tissue with high shear force when the tissue is
spun at high velocities. Id. Appellant’s claim does not require a particular
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type of tissue homogenizer, just using “a tissue homogenizer.” It is well
settled that we will not read into the claim a limitation not present in the
claim itself. Bayer AG v. Biovail Corp., 279 F.3d 1340, 1348 (Fed. Cir.
2002). Accordingly, we are not persuaded by Appellant’s argument that the
Examiner’s construction of “tissue homogenizer” is unduly broad.
3. Steps (d)-(g) of Claim 1
The Examiner notes that
the tissue particles in suspension after step (g) are not clearly
different than the tissue particles in suspension after step (d).
Steps (e)-(g), while required as active steps in the method, do not
necessarily achieve any change or transformation in the tissue
particles vis-à-vis step (d), the particles are (d) suspended and (e)
homogenized in a fluid, (f) separated from the fluid, and then (g)
re-suspended in a fluid (the fluid may be the same or different
than the fluid of step (d)). All-in-all, in carrying out steps (d)-(g)
results in suspension of tissue particles in a fluid.
Ans. 4.
Appellant contends that “[t]he Examiner’s understanding regarding
the nature of the tissue in steps (d) and (g) is incorrect because the
Examiner’s definition of ‘tissue homogenizer’ is incorrect.” Appeal Br. 10.
We are not persuaded for the same reasons discussed above with respect to
the construction of the term “tissue homogenizer.”
B. Obviousness rejection over Hiles (claims 1–20)
1. Issue
The Examiner finds that Hiles discloses “medical products for
implantation comprising submucosa . . . in various forms, including sheets,
sponges, and fluidized.” Ans. 10. The Examiner finds that Hiles teaches
methods of preparing its implants that disclose all of the steps of the claimed
methods, except that Hiles does not teach “a step of (c) pulverizing the
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frozen tissue prior to comminuting the tissue in a blender” and also “does not
exemplify all steps together in a single embodiment.” Id. at 10–11.
The Examiner finds, however, that the pulverizing step “is a
duplication of the cutting/mincing step.” Ans. 10. The Examiner asserts
that “[t]he inclusion of an additional reduction in size step would not add
significantly more to the claim, and thus is prima facie obvious to duplicate
as much as necessary to achieve the desired size.” Id. at 10–11. The
Examiner also finds that, although Hiles does not include an embodiment
exemplifying all claimed steps together, the rejection is based on selection of
a particular comminuting method (i.e., blending a solution of SIS tissue in a
high speed blender) from various methods disclosed in Hiles “for use in
production of a solid-state article (sponge) via the method of Example 11 in
the reference.” Id. at 11. The Examiner asserts that “[s]election of any one
of the disclosed comminution methods is considered prima facie obvious, in
light of their disclosure as suitable means for comminuting tissue within the
reference.” Id.
Appellant contends that Hiles does not disclose a method comprising
all of the claimed steps in the sequence recited. Appeal Br. 27.
The issue with respect to this rejection is whether a preponderance of
evidence of record supports the Examiner’s conclusion that the claims are
obvious over Hiles.
2. Findings of Fact
1. Hiles teaches the use of “biomaterial comprising the submucosa
of a tissue” as implants and in “topical applications . . . such as wound
dressings or wound plugs.” Hiles ¶ 5; see also id. ¶¶ 19, 47 (teaching that
“[f]luidized tela submucosa of [Hiles’] invention finds use as an injectable
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heterograft for tissues . . . in need of repair or augmentation most typically to
correct trauma or disease-induced tissue defects” as well as “a filler for
implant constructs,” wherein “tela submucosa” refers to “a layer of collagen-
containing connective tissue occurring under the mucosa in most parts of the
alimentary, respiratory, urinary, integumentary, and genital tracts of
animals”), ¶ 52 (teaching “inject[ion of] . . . fluidized submucosa
composition into the locale of a tissue defect or a wound in need of healing”
to “take advantage of the biotropic properties of the tela submucosa”), ¶ 72
(teaching the use of a lyophilized small intestine submucosa (SIS) sponge
for “providing hemostasis in a large wound[,] fill[ing] a large defect[,
and/or] provid[ing] a three dimensional structure for cell culture or in vivo
growth”).
2. Hiles teaches obtaining “[a] tela submucosa implantable
collagen biomaterial according to [its] invention . . . from the alimentary,
respiratory, urinary, integumentary, or genital tracts of animals.” Hiles ¶ 25.
3. Hiles teaches that “[p]rocesses of the invention desirably
involve first rinsing the tela submucosa source one or more times with a
solvent, suitably water,” treating with a disinfecting agent, and delaminating
the tela submucosa layer from its source, e.g., intestine. Id. ¶¶ 28, 40.
4. Hiles teaches that the “[t]ela submucosa tissue of [its] invention
can also be processed to provide fluidized compositions.” Hiles ¶ 46. In
particular, Hiles teaches that
solutions or suspensions of the tela submucosa can be prepared
by comminuting and/or digesting the tela submucosa with a
protease (e.g. trypsin or pepsin), for a period of time sufficient to
solubilize the tissue and form substantially homogeneous
solution. The submucosa starting material is desirably
comminuted by tearing, cutting, grinding, shearing or the like.
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Grinding the submucosa in a frozen or freeze-dried state is
advantageous, although good results can be obtained as well by
subjecting a suspension of pieces of the submucosa to treatment
in a high speed blender and dewatering, if necessary, by
centrifuging and decanting excess waste. The comminuted tela
submucosa can be dried, for example freeze dried, to form a
powder. Thereafter, if desired, the powder can be hydrated, that
is, combined with water or buffered saline and optionally other
pharmaceutically acceptable excipients, to form a fluid tissue
graft composition, e.g. having a viscosity of about 2 to about
300,000 cps at 25EC. The higher viscosity graft compositions
can have a gel or paste consistency.
Id. ¶ 46; see also id. ¶ 49 (describing methods of comminuting tela
submucosa specimens), ¶ 50 (teaching that tela submucosa powder “can be
easily hydrated using, for example, buffered saline to produce a fluidized
tissue graft material of [Hiles’] invention at the desired viscosity”).
5. Hiles teaches that tela submucosa may first be reduced to small
pieces, e.g., by cutting before being comminuted while in the frozen state to
form a coarse tela submucosa powder. Hiles ¶ 48.
6. Hiles teaches that “[f]urther grinding of the tela submucosa
powder using a prechilled mortar and pestle can be used to produce a
consistent, more finely divided product” and that “liquid nitrogen is used as
needed to maintain solid frozen particles during final grinding.” Hiles ¶ 50.
7. Hiles teaches a method of preparing a preferred fluidized
material wherein a tela submucosa powder is “subjected to proteolytic
digestion to form a substantially homogeneous solution” and “[t]he
solubilized submucosa can then be concentrated by salt precipitation of the
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solution and separated for further purification and/or freeze drying to form a
protease-solubilized intestinal submucosa in powder shape.” Hiles ¶ 51.
8. Example 11 of Hiles teaches preparation of a lyophilized small
intestine submucosa (SIS) sponge wherein
comminuted SIS (with a mean particle size of approximately 150
μm) was centrifuged in a Beckman TJ-6 centrifuge with a speed
of 1550xg for 15 minutes. The supernatant was poured off
leaving a dough-like consistency of SIS remaining. The material
was then poured into various polycarbonate molds and frozen at
cold temperatures, preferably at -80° C. for at least 2 hours. The
material was then vacuum-dried for 6 hours in a lyophilizing
system with the condenser at -70° C. at a vacuum pressure of less
than 100 millitorr, preferably 15 millitorr. Optionally, the sponge
10 can then be sterilized using ethylene oxide. The resulting
structure was an SIS sponge 10, having a creamyish yellow-
white color.
. . . Using comminuted hydrated SIS with a possible
fragment size of 25 to 3000 μm produced a more condensed,
higher density sponge, whereas larger fragments produced a less
dense larger pore sized sponge. . . . Since the resulting sponge
can take the shape of the mold in which it is placed, modifying
the mold shape will modify the sponge shape.
Hiles ¶¶ 70–71.
9. Hiles teaches that the procedure described in Example 11 may
be varied by, e.g., using comminuted hydrated SIS with different fragment
sizes. Hiles ¶ 71.
3. Analysis
a) Claims 1–12 and 14–19
We agree with Appellant that the Examiner has not established a
prima facie case that Hiles renders obvious the methods recited in claims 1–
12 and 14–19 on appeal. In particular, although we agree with the Examiner
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that Hile’s method suggests all of the other steps of the claim,8 we agree
with Appellant that the Examiner has not established that Hiles discloses or
suggests the step in claim 1 of “lyophilizing the tissue re-suspension to

8 Hiles teaches using biomaterial that comprises the submucosa of a tissue
from, e.g., the alimentary, respiratory, urinary, integumentary, and/or genital
tracts of animals in its method, FF2, which meets step (a) of claim 1, i.e.,
“obtaining tissue from a donor human or animal body.” Hiles also teaches
comminuting the submucosa starting material “by subjecting a suspension of
pieces of the submucosa to treatment in a high speed blender and
dewatering, if necessary, by centrifuging and decanting excess waste.” FF4.
We agree with the Examiner that this teaching reads on step (d) “suspending
. . . tissue in a fluid” (i.e., “suspension of pieces of the submucosa”); step (e)
“homogenizing the tissue suspension using a tissue homogenizer” (i.e.,
“treatment in a high speed blender”); and step (f) “precipitating tissue
particles from the homogenized tissue suspension” (i.e., “dewatering, if
necessary, by centrifuging and decentering excess waste”). Ans. 10.
Finally, Example 11 of Hiles teaches using comminuted hydrated SIS to
prepare its lyophilized SIS sponge, which suggests re-suspension of the
precipitated tissue particles (step (g)). FF8. Likewise, although Hiles does
not explicitly provide an example where the tissue was frozen and
pulverized (i.e., steps (b) and (c) of claim 1) before being suspended in a
fluid and homogenized, Hiles teaches that tela submucosa “may first be
reduced to small pieces, e.g., by cutting before being comminuted while in
the frozen state to form a coarse . . . powder,” and then further grounded in a
frozen state to “produce a consistent, more finely divided product.” FF5,
FF6; see also FF4 (teaching that “[g]rinding the submucosa in a frozen or
freeze-dried state” is an advantageous way of comminuting the “submucosa
starting material”). Thus, Hiles suggests a method wherein submucosa is
pulverized (i.e., reduced to fine particles) in a frozen state, and further
teaches that multiple iterations of comminution may be performed on its
submucosa starting material. Accordingly, we agree with the Examiner that
a skilled artisan would have found it obvious, based on the teaching in Hiles,
to freeze donor tissue and pulverize the frozen tissue, prior to suspending the
tissue and homogenizing the suspension, as recited in claim 1.
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provide the product to be used in repairing the lesion or defect.” Appeal Br.
27.
The Examiner asserts
Example 11 teaches that to produce a sponge, the comminuted
SIS is hydrated (See Hiles et al, ¶0071), which reads on claimed
step g) re-suspending the precipitated tissue particles, placed
into a mold, and then vacuum-dried, which reads on claimed step
h) lyophilizing the tissue resuspension.
Ans. 21. However, while we agree that Hiles teaches using comminuted
hydrated SIS in Example 11, FF9, Hiles also teaches that the comminuted
SIS was centrifuged and the supernatant poured off before the remaining
“dough-like” SIS is poured into molds and vacuum-dried. FF8. The
Examiner has not persuasively explained why the comminuted SIS, after
being centrifuged and with the supernatant removed, would still read on a
suspension.
Accordingly, we reverse the Examiner’s rejection of claim 1 as
obvious over Hiles. We reverse the rejection of claims 2–12, which depend
from claim 1, for the same reason. In re Fritch, 972 F.2d 1260, 1266 (Fed.
Cir. 1992) (explaining that “dependent claims are nonobvious if the
independent claims from which they depend are nonobvious”).
Claim 14 recites “[a] method for repairing a lesion or defect at a tissue
site in a human or animal patient body, the method comprising” the steps of
claim 1 and the additional steps of “reconstituting the dry formulation
[resulting from lyophilizing the tissue re-suspension] to form a slurry” and
“implanting the slurry into the lesion or defect at the tissue site in the human
or animal patient body.” Appeal Br. 35 (Claims App.). We therefore
reverse the Examiner’s rejection of claim 14 as obvious over Hiles for the
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same reason discussed above. We likewise reverse the rejection of claims
15–19, which depend from claim 14. In re Fritch, 972 F.2d at 1266.
b) Claims 13, 20
As the Examiner points out, claims 13 and 20 are product-by-process
claims or product claims comprising product-by-process limitations. Ans. 5,
6–7. The Examiner considered these product-by-process limitations “only
insofar as the method of production imparts distinct structural or chemical
characteristics or properties to the product.” Id. The Examiner determines
that, as for claim 13, such characteristics or properties include:
human or animal tissue particles being of a size smaller than the
starting tissue (given the tissue is pulverized); . . . contain a
plurality of tissue particles (i.e. it cannot be a single tissue
particle); . . . lyophilized; . . . physically capable of being placed
at a lesion or defect site in a human or animal patient body; and
upon placement at the lesion or defect site, . . . not detrimental to
the human or animal patient body.
Id. at 6.
As for claim 20, the Examiner interprets the claim as being directed to
“a product which comprises a matrix of a substantially non-mineralized
native soft tissue (which covers all tissue except bone and teeth).” Ans. 7.
The Examiner further concludes that
the matrix must be a unitary structure (it cannot be a loose
powder), and must be capable of containing or embedding other
substances, such as cells; however, no cells are required (nor
excluded). The matrix must also include a plurality of pores, it
must also be lyophilized. From the product-by-process
limitations, the matrix must also be formed of a plurality of
pulverized particles, it cannot be a single particle of naturally
occur[r]ing tissue.
Id.
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With regard to the obviousness rejection of claims 13 and 20 over
Hiles, the Examiner states as an initial matter that, “[f]ollowing the
discussion of claim 1, . . . the sponges created by the method of Hiles . . .
will necessarily meet the structural limitations of claims 13 and 20 by virtue
of being made by the same method.” Ans. 13. The Examiner further
determines that “[u]ltimately the products of claims 13 and 20 are
considered obvious over the sponge disclosed in Example 11 of Hiles,” and
“Appellants have not persuasively pointed out structural differences between
the products of claims 13 and 20 and the sponge of Hiles.” Id. at 22.
As discussed above, we find the Examiner has not established a prima
facie case that Hiles renders obvious the method of claim 1. Nevertheless,
we determine that the Examiner has established a prima facie case that the
products of claims 13 and 20 are obvious over the product of Hiles and that
Appellant has not produced evidence showing, or persuasively argued, that
the Examiner’s determinations with respect to these product-by-process
claims are incorrect. Only those arguments made by Appellant in the Briefs
have been considered in this Decision. Arguments not presented in the
Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv).
Appellant contends that “the method of Hiles is not the same method
recited in Independent claims 1 and 20” and that, thus, “there is no
foundation for the rejection of claims 13 and 20 as obvious in view of
Hiles.” Appeal Br. 30. While we agree that the Examiner has not
established that the method of Hiles is identical to the method of claim 1 or
includes all of the process limitations of claim 20, this does not end the
inquiry, because “[t]he patentability of a product does not depend on its
method of production. If the product in a product-by-process claim is the
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same as or obvious from a product of the prior art, the claim is unpatentable
even though the prior product was made by a different process.” In re
Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985).
Moreover, the predecessor of our reviewing court has explained that
the “Patent Office bears a lesser burden of proof in making out a [prima
facie] case . . . for product-by-process claims because of their peculiar
nature,” In re Fessmann, 489 F.2d 742, 744 (CCPA 1974). We determine
that the Examiner has met this burden by explaining how the sponge in
Example 11 of Hiles meets the respective structural limitations in claims 13
and 20 outlined in the Answer and recited in this decision. This is
particularly the case given that claim 13 itself recites no express structural
limitations at all — although claim 1 implies certain structural limitations
such as the inclusion of lyophilized tissue particles — and claim 20 recites
only the express structural limitations of “a matrix of a substantially non-
mineralized native soft tissue of the human or animal body . . . including a
plurality of pores.”
In this regard, we note that, while the Examiner has not shown how
Hiles teaches step (h) of claim 1 (i.e., lyophilizing a re-suspension of
precipitated tissue particles), Hiles teaches preparing a lyophilized small
intestine submucosa sponge by taking comminuted SIS, centrifuging it,
removing the supernatant, pouring the remaining dough-like SIS into various
molds, and freezing and lyophilizing the material. FF8. Appellant has not
provided any persuasive evidence that the product prepared according to
Appellant’s claim 1 that includes a step of re-suspending precipitated tissue
particles and then lyophilizing the re-suspension is structurally different
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from the lyophilized small intestine submucosa sponge prepared as disclosed
in Hiles.
Appellant contends that the Examiner’s interpretation of claim 13
ignores the statement of Dr. Estes in the Estes Declaration
describing the nature of the product resulting from the method of
claim 1. As specifically stated by Dr. Estes, “Unexpectedly, after
using a tissue homogenizer to homogenize non-mineralized soft
tissue, lyophilizing the re-suspension did not generate a loose
powder. We expected to produce a powder, but instead got a
solid, unitary structure.” Estes Declaration, Para. 21. The
Examiner has selected product characteristics that are
deliberately at odds with the statement of Dr. Estes, who actually
prepared the product according to the method steps of claim 1.
Appeal Br. 13.
We are not persuaded. As an initial matter, although Dr. Estes states
that he “prepared a composition according to the claims of the current
application,” it is unclear exactly how each step was performed. Neither
does Dr. Estes explain how he comminuted the tissue in attempting to create
the product of Hiles’ Example 11, other than that he collected particles that
were in the 150 µm range. Estes Decl. ¶¶ 8, 14.
In response to similar points made by the Examiner (Non-Final Act. 7;
Ans. 17), Appellant contends that,
unless the Examiner is questioning the veracity of Dr. Estes
assertion that he “prepared a composition according to the claims
of the current application”, that statement must be accepted as
fact; and if that statement is fact, then all of the method steps
recited in claim 1 were performed by Dr. Estes to produce the
results set forth in the Estes Declaration.
Reply Br. 9; see also Appeal Br. 14–15. Appellant also contends that “Hiles
does not indicate how the comminuted SIS is obtained in Example 11,
suggesting that whether the tissue is comminuted by ‘tearing, cutting,
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grinding, shearing or the like’ set forth in ¶[0046] is not relevant, provided
the particle size is approximately 150 µm as in Example 11.” Appeal Br. 18.
Appellant further contends that “[t]he Examiner . . . has not set forth any
foundation for the criticality of how the SIS is comminuted.” Id.
We are not persuaded. Contrary to Appellant’s reasoning,
[t]he Board has broad discretion as to the weight to give to
declarations offered in the course of prosecution. See Velander
v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (“[A]ccord[ing]
little weight to broad conclusory statements [in expert testimony
before the Board] that it determined were unsupported by
corroborating references [was] within the discretion of the trier
of fact to give each item of evidence such weight as it feels
appropriate.”).
In re Am. Acad. of Science Tech Ctr., 367 F.3d at 1368 (alterations in
original). Furthermore, “It is well established that the objective evidence of
nonobviousness must be commensurate in scope with the claims.” In re
Lindner, 457 F.2d 506, 508 (CCPA 1972). Thus, where declaration
testimony is conclusory or otherwise not commensurate in scope with the
claims, we have broad discretion as to the weight to give to that testimony.
To the best of our understanding, it appears that Dr. Estes used a
rotor-stator tissue homogenizer to both break down the tissue initially
provided into the homogenizer into smaller particles and to mix those tissue
particles in the suspending fluid to “prepare[] a composition according to the
claims of the current application.” Estes Decl. ¶¶ 14, 17–21.
As an initial matter, we note that the Estes Declaration is unclear as to
whether the tissue homogenizer used in fact homogenizes the tissue
suspension. Dr. Estes states, for example, that “[n]o matter what speeds or
volumes of suspensions, [the inventors] could not make a homogeneous
suspension containing only small particles of the cartilage” and that,
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“[w]hile many of the particles were sheared and broken down by the
homogenizer, many more of the particles were not being broken down in the
process.” Estes Decl. ¶ 19. Dr. Estes does not explain whether the inventors
were eventually able to make a homogeneous suspension, saying only that,
“[i]nstead, unexpectedly, during processing of the tissues[] the tissue
homogenizer was also acting as a high speed blender or mixer, intertwining
the tissue fragments and collagenous matrices together.” Id. ¶ 20. We note
that Appellant urges in the claim construction of tissue homogenizer that
homogenizing is the dispersion of similarly sized fragments evenly
throughout a mixture. Appeal Br. 8. However, Appellant also appears to
suggest that claim 1 does not require all of the tissue suspension to be
homogenized. Appeal Br. 9 (stating that “simply because all of the tissue
was not sheared and broken down does not mean that the tissue homogenizer
did not create the product described by Dr. Estes that results from
performing the steps of Applicant’s claim 1” and that, “[t]o the contrary, the
product that had ‘incomplete’ processing of some tissue particles is the very
product that resulted from the process and . . . exhibited the surprising
characteristics identified by Dr. Estes that distinguishes this product from all
of the prior art cited by the Examiner”). We note that such a construction
improperly reads out the limitation of “homogenizing the tissue suspension
using a tissue homogenizer.” (Emphasis added.) Thus, Dr. Estes’
declaration evidence does not establish that the product he made is one that
is made according to all of the requirements of claim 1.
It further appears that the alleged unexpected structural properties of
the product result specifically from the use of the particular type of tissue
homogenizer (i.e., a rotor-stator tissue homogenizer) to both pulverize and
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mix the variously sized particles of tissue in the suspension. Estes Decl.
¶¶ 14, 17–21. The claim, however, neither requires the use of a particular
kind of tissue homogenizer to homogenize the tissue suspension, nor
requires the use of any tissue homogenizer to pulverize the frozen tissue.
Thus, to the extent the Estes Declaration suggests that the products made
using the specific tissue homogenizer that is not required by Appellant’s
claim may have different structural characteristics from the sponge of Hiles’
Example 11, the evidence is not persuasive that the sponge of Hiles’
Example 11 does not have structure identical to the products required by
claims 13 and 20.
Similarly, as the Examiner points out and Appellant has not disputed,
the Estes Declaration appears to only address a method using cartilage,
whereas claim 13 encompasses any human or animal tissue. Non-Final Act.
6; Appeal Br. 14. Thus, the Estes Declaration does not suggest that the
sponge of Hiles’ Example 11 would not have structure identical to products
encompassed by claim 13 and produced using non-cartilage tissues.
Appellant contends that cartilage falls within the scope of claim 1 and
all of the examples described in the original Specification refer to cartilage.
Appeal Br. 14. Appellant contends that “[i]t is irrelevant to establishing the
nature of the structural changes in the tissue whether that tissue is only
cartilage, rather than every other possible type of tissue” and that “[t]he
Examiner has . . . not provided any evidence that any other tissue obtained
from a donor human or animal will not exhibit the same properties as
described in the Estes Declaration.” Id. We are not persuaded because,
once the Examiner has established a prima facie case with respect to the
obviousness of claim 13, the burden shifts to Appellant to “demonstrate the
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unobvious character of his claimed invention over the cited references,” In
re Fessmann, 489 F.2d at 745. As the Examiner explains, the evidence
produced in the Estes Declaration, to the extent it relates only to cartilage, is
not commensurate with the scope of the claims. Non-Final Act. 6.
Accordingly, we are not persuaded that Dr. Estes’ declaration shows
that the sponge of Hiles’ Example 11 is structurally different from the
products required by claims 13 and 20, and we affirm the Examiner’s
rejection of claims 13 and 20 as obvious over Hiles.
C. Anticipation rejection over Hiles (claims 13, 20)
1. Issue
The Examiner interprets claims 13 and 20 as product-by-process
claims having the characteristics discussed above in connection with the
obviousness rejection of claims 13 and 20 over Hiles.
The Examiner finds that Hiles teaches “biomaterial comprising
purified submucosal tissue treated so as to have shape memory and a shaped
configuration” and that Example 11 of Hiles describes “a lyophilized sponge
of small intestinal submucosa (SIS)” produced by lyophilizing, in pre-
formed molds, a mixture having a “dough-like consistency” (i.e., slurry) of
comminuted SIS having mean particles size 150 μm. Ans. 7.
The Examiner finds that the lyophilized SIS sponge of Hiles meets all
of the structural limitations of claim 13 recited above because (1) SIS is
animal tissue; (2) the sponge is “comprised of a plurality of comminuted SIS
particles, each particle being smaller than the native SIS tissue”; (3) the
sponge is lyophilized; and (4) the sponge “can be placed in a tissue defect”
to “help facilitate tissue repair.” Ans. 8.
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The Examiner similarly finds that the lyophilized SIS sponge of Hiles
meets the structural limitations of claim 20 recited above. Ans. 8. The
Examiner finds that SIS is non-mineralized animal tissue and that the sponge
is a “unitary structure” comprising “a plurality of comminuted tissue
particles.” Id. The Examiner finds that a “‘sponge’ structure will have a
plurality of pores” and that the porous structure of Hiles’ sponge is further
evidenced by Hiles’ teaching that “the sponge ‘provides three-dimensional
structure for cell culture or in vivo growth.’” Id. at 7. Finally, as already
discussed, the Examiner finds that Hiles’ sponge is lyophilized and “can be
introduced into a tissue site in a human or animal body.” Id. at 8.
Appellant contends that the rejection is improper as to claim 13
because the Examiner disregarded step (e) of claim 1, i.e., “homogenizing
the tissue suspension using a tissue homogenizer” and “fail[ed] to consider
the factual evidence provided in the Estes Declaration.” Appeal Br. 16–17,
20. Appellant contends that “the manner in which the starting material is
homogenized imparts critical structural properties to the final product.” Id.
at 19. Appellant contends that the rejection of claim 20 “suffers from the
same errors . . . so . . . should be reversed for the same reasons.” Id. at 20.
The issues with respect to this rejection are (1) whether the Examiner
has provided a rationale tending to show that the claimed product appears to
be the same or similar to the prior art product and, if so, (2) whether
Appellant has provided evidence establishing differences between the
claimed and prior art products.
2. Analysis
Unless otherwise noted, we adopt the Examiner’s findings of fact and
reasoning regarding the rejection of claims 13 and 20 as anticipated by Hiles
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(Final Act. 2–3, 4–10; Ans. 3–4, 5–8, 15–16, 17–19). We address
Appellant’s arguments below. Only those arguments timely made by
Appellant in the briefs have been considered; arguments not so presented in
the briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015); see also Ex
parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) (“Any
bases for asserting error, whether factual or legal, that are not raised in the
principal brief are waived.”).
Appellant contends that “[i]t is undeniable that Hiles does not disclose
homogenizing with a tissue homogenizer” and that the Examiner’s rejection
“eliminate[s] the homogenizing step (e) of parent claim 1.” Appeal Br. 17.
Even assuming this to be true, we are not persuaded by such a statement
standing alone, because, as discussed above, “[t]he patentability of a product
does not depend on its method of production.” In re Thorpe, 777 F.2d at
697. In this case, we find that the Examiner has established a prima facie
case that Hiles anticipates claim 13 by articulating why the sponge of Hiles’
Example 11 has the same structure as a product encompassed by claim 13.
Thus, it is not relevant to the anticipation rejection that Hiles does not teach
any particular step in Appellant’s product-by-process claims, unless
Appellant provides evidence that the step imparts a structural difference to
the product of claim 13 that is not present in Hiles’ prior art product. As
already discussed above in the context of the obviousness rejection of claim
13 over Hiles, we are not persuaded that Appellant’s proffered evidence
shows such a structural difference.
Appellant contends that
the Examiner’s improper and incorrect interpretation of “tissue
homogenizer” recited in the homogenizing step (d) of claim 1
infects the interpretation of product-by-process claim 13. Again,
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the Examiner’s interpretation of “tissue homogenizer” is that it
simply mixes or blends components without imparting any
structural modification to the tissue being homogenized. . . .
[T]his interpretation is at odds with the ordinary and customary
meaning of this term to a person of ordinary skill in this art.
Appeal Br. 13–14, 17 (contending that the Examiner’s rejection is based on
the erroneous assertion that “homogenizing suspended tissue particle does
not alter the tissue composition or produce any structural change in the
tissue composition (not just the tissue particles), regardless of how the tissue
composition is homogenized”).
We are not persuaded for the reasons discussed above in the claim
construction section of the opinion. Accordingly, we are not persuaded that
the sponge of Hiles’ Example 11 would not have the same structure as a
product encompassed by claims 13 and 20 merely because Hiles does not
disclose homogenization via a “tissue homogenizer” as Appellant defines
that term.
Appellant contends that the Estes Declaration shows that “the
resulting product [of Hiles’ Example 11] is ‘a powder conglomerate made up
of non-unified particles,’” which is “very different [from] the product
produced according to the present invention, which is an ‘interconnected
unitary scaffold or matrix having entangled particulate fibers and an
intertwined structure having a cotton candy-like appearance.’” Appeal Br.
17–18.
We are not persuaded. As discussed above, the claims are not limited
to products prepared using a “rotor-stator” tissue homogenizer, which the
Estes Declaration states imparts specific structural characteristics to the
tissue that was processed with the rotor-stator tissue homogenizer. Estes
Decl. ¶¶ 16–21. Furthermore, as also discussed above, we find that Hiles
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teaches specific methods of comminuting the tela submucosa for purposes of
preparing its product. FF4. Thus, the Estes Declaration, which does not
describe how the SIS particles were comminuted in allegedly preparing a
product according to the method described in Hiles’ Example 11, and which
appears to have used only a rotor-stator tissue homogenizer in preparing a
product according to the claims, does not persuaded us that the products
produced by the processes recited in claims 13 and 20 are different than the
product of Hiles’ Example 11.9
Appellant disputes the Examiner’s assertion that “the declaration is
not commensurate in scope with the method/product of the instant claims”
by pointing to its arguments above. Appeal Br. 18. We understand
Appellant to be referring to its arguments that the declaration is
commensurate with the scope of the claims because “tissue homogenizer”
should be construed as Appellant proposes. We are not persuaded for the
same reasons discussed above, namely that we agree with the Examiner that
Appellant’s construction of “tissue homogenizer” is unduly narrow.
Appellant also contends that “[t]here is no basis to conclude that how
the starting material is comminuted to the requisite 150 µm is critical in any
matter.” Appeal Br. 18. More particularly, Appellant contends that
the comminuted SIS starting material in Example 11 of Hiles
corresponds to steps (a)-(d) of parent claim 1. Thus, whether or
not the comminuted SIS starting material of Hiles Example 11 is
comminuted by a high-speed blender is irrelevant to the
subsequent steps of Applicant’s invention. Second, as explained
above, a high-speed blender is not a tissue homogenizer to a

9 In this regard, we also note that, in contrast to the description in Estes
Declaration of “a powder conglomerate,” Estes Decl. ¶ 13, Hiles’ Example
11 teaches that its process produced a “sponge,” FF8.
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person of ordinary skill according to the only evidence of record
- the Estes Declaration. Third, as noted above, Hiles does not
describe a homogenization step in Example 11 that is distinct
from the comminution step used to prepare the starting material.
The Examiner cannot dismiss the comparative study
undertaken by Dr. Estes by arbitrarily declaring that a data point
not provided by Hiles (how the comminuted SIS of Example 11
is obtained) is a result-critical piece of information. Moreover,
even considering how the initial comminuted SIS starting
material is produced fails to consider that the homogenizing step
of claim 1 is separate from and subsequent to a comminution
step, such as the step used to prepare the comminuted SIS in
Hiles Example 11.
Id. at 19–20.
We are not persuaded. We have explained why we agree with the
Examiner’s construction of the term “tissue homogenizer.” Similarly, as we
have explained above, for purposes of a product-by-process claim, it is the
product, not the method of its production, that must be different from the
prior art product. In re Thorpe, 777 F.2d at 697. In this case, the Examiner
has pointed to Example 11 of Hiles, which teaches a lyophilized SIS sponge
that appears to be “identical with or only slightly different than a product
claimed” in Appellant’s product-by-process claims. In re Brown, 459 F.2d
531, 535 (CCPA 1972). Thus, the burden shifts to Appellant to come
forward with evidence establishing a difference between the claimed product
and the prior art product. In re Marosi, 710 F.2d 799, 803 (Fed. Cir. 1983).
Appellant has not produced persuasive evidence to meet this burden.
Appellant also contends that “Hiles[’] only mention of homogeneity
concerns the use of protease digestion of tela submucosa ‘to solubilize the
tissue and form substantially homogeneous solution’” and that, even if
“Hiles does disclose using a blender and dewatering to produce a powder,”
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“the method for producing the product of Hiles Example 11 does not refer to
homogenizing or the use of the high-speed blender described in other
excerpts.” Appeal Br. 17.
We are not persuaded. Hiles’ Example 11 teaches using comminuted
SIS to prepare a lyophilized sponge. FF8. Hiles also teaches producing
solutions or suspensions of SIS by “comminuting and/or digesting the tela
submucosa with a protease . . . , for a period of time sufficient to solubilize
the tissue and form substantially homogeneous solution.” FF4. Hiles
further teaches comminuting the SIS by “tearing, cutting, grinding, shearing
or the like,” especially “[g]rinding the submucosa in a frozen or freeze-dried
state” or “subjecting a suspension of pieces of the submucosa to treatment in
a high speed blender and dewatering, if necessary, by centrifuging and
decanting excess waste.” FF4. Thus, these disclosures are directly related to
each other by Hiles’ teachings.
Accordingly, for the reasons discussed above, we affirm the
Examiner’s rejection of claim 13 as anticipated by Hiles. Appellant does not
separately argue claim 20, which falls with claim 13.

D. Anticipation rejection over Gertzman (claim 13)
1. Issue
Gertzman’s Example 1 teaches “[a] malleable putty of hyaluronic acid
4% with 100-800 micron sized demineralized cortical allograft bone powder
having a residual calcium weight of 0.95% constituting approximately @
32% total weight percentage of the composition.” Gertzman ¶ 71.
Gertzman further teaches that
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[t]he example was formulated with 66 grams of freeze dried
demineralized cortical allograft bone of particle size of 100-800
microns mixed into 140.3 grams of a 4% solution of hyaluronic
acid (mol. wt, approximately 700,000 Daltons) in phosphate
buffered saline. The bone component is added to achieve a bone
concentration of approximately 32% (w/w). The solution is well
mixed and allowed to stand for 2-3 hours at room temperature.
This provides a malleable putty with a penetration unit of 61 and
excellent formability properties and a pH of 7.2.
Id. ¶ 72.
The Examiner finds that Gertzman teaches the application of the
malleable putty to a bone defect site and further finds that the bone powder
used to create the putty reads on instant claim 13 as construed above. Ans.
8–9.
Appellant contends that the rejection is based on an “improper
interpretation of claim 13 as only requiring a loose powder.” Appeal Br. 22.
Appellant further contends that “Gertzman does not disclose a product that
results from homogenizing a tissue suspension using a tissue homogenizer.”
Id. Appellant contends that “[t]he Examiner has not suggested, nor is it
possible, that the product disclosed in Gertzman, achieves the product of the
present invention ‘having entangled particulate fibers and an intertwined
structure.’” Id.
The issue with respect to this rejection is whether a preponderance of
the evidence of record supports the Examiner’s finding that the bone powder
disclosed in Gertzman’s Example 1 reads on the product recited in claim 13.
2. Findings of Fact
10. Gertzman teaches
a malleable bone putty and a flowable pastel composition for
application to a bone defect site to promote new bone growth at
the site which comprises a new bone growth inducing compound
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of partially demineralized lyophilized allograft bone material
having a residual calcium content ranging from 4 to 8% dry
weight.
Gertzman Abstract.
11. Gertzman teaches that the bone powders used in its composition
“has a particle size ranging from about 100 to about 800 microns.”
Gertzman Abstract.
12. Gertzman teaches an example of “[a] malleable putty of
hyaluronic acid 4% with 100-800 micron sized demineralized cortical
allograft bone powder having a residual calcium weight of 0.95%
constituting approximately @ 32% total weight percentage of the
composition.” Gertzman ¶ 71 (Example 1).
13. Gertzman teaches that Example 1 “was formulated with 66
grams of freeze dried demineralized cortical allograft bone of particle size of
100-800 microns mixed into 140.3 grams of a 4% solution of hyaluronic
acid (mol. wt, approximately 700,000 Daltons) in phosphate buffered
saline.” Gertzman ¶ 72.
14. Gertzman teaches that, in the preferred embodiment,
[t]he bone segments are milled and placed in a sieve to size the
milled bone to 100-800 microns or coarse ground to achieve
cortical/cancellous chips in the form of irregularly shaped
polyhedra with an edge dimension up to 5 mm. The milled bone
material is placed in mixing container and cleaned with a 5:1
ratio of 3% Hydrogen Peroxide and stirred for 15 minutes,
removed and rinsed with a minimum of 3000 ml of sterile water.
The rinsed bone powder is placed back into the cleaned mixing
container and at least 1000 ml of 70% sterile ethanol is added
and the solution is mixed for 30 minutes. The bone powder is
then transferred into a No. 70 sieve and an open vacuum is
applied to the bottom of the sieve and the bone powder is dried
for 20 minutes. The dried bone powder is transferred to the
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demineralization process where it is weighed. The bone weight
in grams is compared to a chart which determines the acid
volume to be applied which is approximately 1 gram equals
approximately 16 ml of acid. The bone powder is mixed with
0.6N HCl for about 2½ hours to achieve maximum bone powder
surface engagement with the HCl to remove most of the mineral
content.
Gertzman ¶ 42. Gertzman teaches a slightly different demineralization
process when cortical/cancellous bone chips are used. Id. ¶ 43 (treating
bone chips with 0.6N HCl at a different ratio and/or for different length of
time). Gertzman further teaches rinsing the bone material with water,
adding buffer solution, then rinsing the buffered bone powder with sterile
water. Id. ¶ 44.
15. Gertzman teaches that “[d]emineralized allograft bone is
usually available in a lyophilized or freeze dried and sterile form to provide
for extended shelf life.” Gertzman ¶ 11.
3. Analysis
Unless otherwise noted, we adopt the Examiner’s findings of fact and
reasoning regarding the rejection of claim 13 as anticipated by Gertzman
(Final Act. 10–11; Ans. 8–9, 19). We address Appellant’s arguments below.
Only those arguments timely made by Appellant in the briefs have been
considered; arguments not so presented in the briefs are waived. See 37
C.F.R. § 41.37(c)(1)(iv); see also Ex parte Borden, 93 USPQ2d at 1474.
Appellant contends that the rejection is based on an “improper
interpretation of claim 13 as only requiring a loose powder.” Appeal Br. 22.
Appellant contends “[a] loose powder with no structure or form is not
capable of repairing a lesion or defect at a tissue site,” as required by the
preamble of claim 1 to which claim 13 refers, “in part because there is
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nothing to hold the powder at the site.” Appeal Br. 5. We are not persuaded
because, as discussed above, the claims do not preclude use of devices (e.g.,
bandages) that would retain a loose powder at a tissue site so as to allow it to
repair a lesion or defect at a tissue site.
Appellant further contends that “Gertzman does not disclose a product
that results from homogenizing a tissue suspension using a tissue
homogenizer.” Appeal Br. 22. Appellant contends that, “[n]otably,
Gertzman makes no mention of homogenization in any respect” and that,
“[i]nstead, in Example I relied on by the Examiner, the freeze-d[r]ied
[demineralized bone matrix (DBM)] is ‘mixed into’ a solution of hyaluronic
acid, and ‘well mixed and allowed to stand for 2-3 hours at room
temperature.’” Id.
We are not persuaded. Claim 13 recites a product produced according
to the method of claim 1, which includes a step of homogenizing a
suspension of pulverized tissue using a tissue homogenizer. However, as
discussed above, “[t]he patentability of a product does not depend on its
method of production.” In re Thorpe, 777 F.2d at 697. Instead, “[i]f the
product in a product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though the prior
product was made by a different process.” Id.
In this case, after the homogenizing step, claim 1 recites precipitating
the particles from the homogenized suspension and re-suspending the
precipitated tissue particles without further homogenizing the re-suspension.
For reasons similar to those discussed above with respect to the rejection
over Hiles and reiterated below, we are not persuaded by Appellant’s
argument that a re-suspension of particles precipitated from a homogenized
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suspension of tissue pulverized using a tissue homogenizer, which is then
lyophilized, would result in a product having a different structure than the
demineralized bone powder of Gertzman.
Appellant contends that “[t]he Examiner has not suggested, nor is it
possible, that the product disclosed in Gertzman, achieves the product of the
present invention ‘having entangled particulate fibers and an intertwined
structure.’” Appeal Br. 22. We are not persuaded because Appellant relies
on the Estes Declaration as evidence that the claimed product will have
entangled particulate fibers and an intertwined structure, and, as discussed
above, the Estes Declaration at most suggests that homogenizing the tissue
using a particular type of tissue homogenizer (i.e., a rotor stator) would
result in products having entangled particulate fibers and an intertwined
structure. Claim 1, however, is not limited as to the particular type of rotor
stator used.
Accordingly, we affirm the Examiner’s rejection of claim 13 as
anticipated by Gertzman.

E. Anticipation rejection over Lin (claim 13)
1. Issue
The Examiner finds that Lin teaches “compositions for delivering
osteotherapeutic materials . . . containing demineralized bone matrix
(DBM)” and “methods of applying the compositions to defective bone tissue
and/or other viable tissue to promote formation of new bone.” Ans. 9. The
Examiner finds that, “[i]n Example 16 Lin . . . teach[es] forming a
DBM/Bone-chip/Hydrogel matrix by mixing DBM[] having particle size of
<0.5 mm, bone chips and macromers into a solution,” pouring the resulting
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“thick slurry” into a mold and freezing, lyophilizing, and crosslinking it to
form “a cohesive flexible matrix.” Id. The Examiner finds that “[t]he
DBM/Bone-chip/hydrogel matrix of Example 16 of Lin” reads on claim 13
because it is “from animal tissue (bone, . . . comprised of a plurality of
particles, each particle being smaller than the native bone tissue, and is
lyophilized.” Id.
Appellant contends that “[t]his rejection is improper for the same
reasons as the other improper prior art rejections of claim 13 and because the
Examiner’s interpretation of claim 13 is improper.” Appeal Br. 22. In
particular, Appellant contends that “Lin makes no mention of
homogenization in any respect” and that, because the matrix of Lin results
from the cross-linking or polymerization of the constituents rather than the
DMB/bone-chip component, “there is no need for a homogenization step as
recited in [Appellant’s] claims.” Id. at 22–23.
The issue with respect to this rejection is whether a preponderance of
the evidence of record supports the Examiner’s finding that the bone powder
disclosed in Lin’s Example 16 reads on the product recited in claim 13.
2. Findings of Fact
16. Lin teaches that demineralized bone matrix (DBM) is “the
protein component of bone,” “prepared from donated bone tissue by first
grinding the cortical bone to desired particle size, then removing minerals
from the bone particles in hydrochloric acid, and finally lyophilizing
demineralized particles to eliminate water.” Lin ¶ 18.
17. Lin teaches that
[d]emineralized allograft bone powder is typically available in a
lyophilized or freeze dried and sterile form to provide for
extended shelf life. The demineralized bone component of the
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composition herein is a known type of pulverized or powdered
material and is prepared in accordance with known procedures.
It should be understood that the term “demineralized bone
matrix” includes bone particles of a wide range of average
particle size ranging from relatively fine powders to coarse
grains and even larger chips. So, for example (which example is
intended to be illustrative and not restrictive), the bone powder
present in the composition of this invention may range in average
particle size from about 100 to about 1,200 μm or from about 125
to 850 μm.
Id. ¶ 20.
18. Example 16 of Lin teaches:
Other manners of polymerization may be used for grafts
containing DBM. For example (which example is intended to be
illustrative and not restrictive), polymerization may be initiated
by thermal initiation. A 0.700 g solution of macromer with 0.147
g solids, containing 5.88 mg of benzoyl peroxide, was prepared.
Then 0.1039 g (10.4% by weight) of bone chips with a particle
size of >0.5-<1.18 mm, and 0.1959 g (19.6% by weight) of DBM
(demineralized bone material) with a particle size of <0.5 mm
was incorporated into the solution. The resulting thick slurry was
shaped into a 12 mmx2.5 mm disc, frozen and lyophilized. Once
lyophilized, crosslinking of macromer in the shaped disks was
initiated at 50° C. over a 10-hour time period under vacuum. The
resulting material had formed a single, cohesive flexible matrix.
The matrix was able to be rehydrated in water and was easily
manipulated without fragmenting or disrupting. Re-drying and
rewetting of the DBM/Bone-chip/Hydrogel matrix at room
temperature was feasible.
Lin ¶ 150.
3. Analysis
Unless otherwise noted, we adopt the Examiner’s findings of fact and
reasoning regarding the rejection of claim 13 as anticipated by Lin (Final
Act. 11–12; Ans. 9, 19–20). We address Appellant’s arguments below.
Only those arguments timely made by Appellant in the briefs have been
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considered; arguments not so presented in the briefs are waived. See 37
C.F.R. § 41.37(c)(1)(iv); see also Ex parte Borden, 93 USPQ2d at 1474.
Appellant contends that the rejection of claim 13 over Lin “is
improper for the same reasons as the other improper prior art rejections of
claim 13 and because the Examiner’s interpretation of claim 13 is
improper.” Appeal Br. 22. We are not persuaded for the reasons already
discussed above.
Appellant contends that “Lin makes no mention of homogenization in
any respect.” Appeal Br. 22. Appellant contends that, because “[t]he matrix
of Lin is not due to the [DBM]/bone chip component,” “there is no need for
a homogenization step as recited in Applicant’s claims,” and “the
DBM/Bone chip/hydrogel matrix in Example 16 of Lin does not meet the
limitations of Applicant’s claim 13 and parent claim 1.” Id. at 23.
We are not persuaded because, as discussed above, the patentability of
a product-by-process claim does not depend on the process by which the
product is made. Appellant has not provided persuasive evidence that a
product prepared by precipitating tissue particles from a homogenized
suspension and then re-suspending the precipitated particles (without further
homogenizing the re-suspension) would result in a product that is
structurally different from a product that is not homogenized in the first
instance.
Accordingly, for the reasons discussed above, we affirm the
Examiner’s rejection of claim 13 as anticipated by Lin. Appellant does not
separately argue claim 20, which falls with claim 13.

CONCLUSION
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In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–20 103(a) Hiles 13, 20 1–12, 14–19
13, 20 102(b) Hiles 13, 20
13 102(a),
102(e)
Gertzman 13
13 102(a),
102(e)
Lin 13
Overall
Outcome
13, 20 1–12, 14–19

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

AFFIRMED IN PART