Vivex Biomedical Inc.

Patent Trials and Appeals Board

Nov 24, 2021

2021001396 (P.T.A.B. Nov. 24, 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.
15/236,807 08/15/2016 Wendy W. Weston DN0291CIP 1062
119489 7590 11/24/2021
Vivex Biologics Group, Inc.
David L. King
5131 NE County Road 340
High Springs, FL 32643
EXAMINER
DABKOWSKI, ERINNE R
ART UNIT PAPER NUMBER
1654
NOTIFICATION DATE DELIVERY MODE
11/24/2021 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
following e-mail address(es):
davidlkingsr@windstream.net
uspto@dockettrak.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WENDY W. WESTON, SILVIA DANIELA GONZALES, and
EDGAR S. MALDONADO

Appeal 2021-001396
Application 15/236,807
Technology Center 1600
____________

Before DONALD E. ADAMS, TINA E. HULSE, and RACHEL H.
TOWNSEND, Administrative Patent Judges.

HULSE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3, 5, and 7–9 as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
CLAIMED SUBJECT MATTER

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 Vivex
Biologics Group, Inc. Appeal Br. 3.
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The claimed invention relates to a bone gel composition consisting of
freeze-dried demineralized cortical bone and sterile water that is formed as a
gel and shaped into flat sheets for use in bone repair. Spec. ¶ 2. Bone
allografts from bone tissue are well known. Id. ¶ 3. But to keep the bone
repair composition in place, the prior art teaches various formulations made
into a malleable paste or putty by adding collagen or other gelatinous
material. Id. ¶¶ 3–4. “The present invention provides an improvement over
those prior art materials by providing a bone gel that is conformable into
sheets and configured to be shaped so it can be added to autograft or
allograft bone particles to make a moldable bone product.” Id. ¶ 5.
Claims 1, 3, 5, and 7–9 are on appeal.
Claim 1, the only independent claim on appeal, is illustrative and is
reproduced below:
1. A bone gel composition consisting of cortical bone made from
cut pieces of cortical bone which has been freeze dried, the freeze
dried cut pieces are then ground into particles of a size up to 125
microns and then demineralized by the addition of 20 ml of 0.6
HCL to 1 gram of bone, decanted, then addition of plain sterile
water at a 20:1 ratio and decanted and stored at -80 degrees C,
the ground demineralized particles are then freeze-dried, wherein
a volume of the freeze-dried demineralized particles is placed in
a solution of only or exclusively sterile water to create a mixture,
the water volume being at least twice the volume of the particles,
the mixture consisting of sterile water and the freeze dried
demineralized particles is autoclaved under heat and pressure to
form a gelatin, the resulting bone gel is formed into sheets having

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a thickness (t) in the range of 1 to 10 mm and formed into a
circular, round or a polygonal shape and frozen for later use.
Claims App’x.
REJECTION
Claims 1, 3, 5, and 7–9 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Missos2 in view of Talton.3,4
OPINION
A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
differences between the claimed subject matter and the prior art are such that
the subject matter, as a whole, would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which the
subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). “[A] patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art.” Id. at 418. “[I]t can be important to identify a
reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does.”
Id.
The Examiner rejected claims 1, 3, 5, and 7–9 as unpatentable for
being obvious over Missos and Talton. Missos teaches that various bone
repair compositions prepared from demineralized bone matrix (DBM) are

2 Nicholas Missos, US 2008/0281431 A1, published Nov. 13, 2008.
3 Talton et al., US 2008/0008766 A1, published Jan. 10, 2008.
4 Appellant canceled claims 11–22 before filing the Appeal Brief. Appeal
Br. 5. Moreover, the Examiner withdrew the rejection of claims 1, 3, 5, and
7–9 over Missos alone. Ans. 6. Therefore, the above-referenced rejection is
the only rejection pending on appeal.
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known in the art. Id. ¶ 3. Missos teaches, however, that DBM “is dry and
can be difficult to manipulate, handle and shape.” Id. The DBM may be
hydrated and made malleable and then molded to fit into the proper
configuration. Id. Missos teaches that “[i]f the composition is not
immediately placed in the defect site, however, it may begin to dry and
become brittle.” Id. Missos further teaches that “depending on the
formulation, some demineralized bone matrix compositions may not retain
their shape upon drying (i.e. crumble) and thereby may lose structural
integrity prior to application at the defect site.” Id. Missos states “[i]t would
be advantageous to provide a material for bone repair that promotes rapid
and complete bone repair, yet is easy to use during surgical techniques.” Id.
Accordingly, Missos provides “a porous ceramic scaffold having a
bioresorbable coating, and a carrier comprising denatured demineralized
bone.” Id. ¶ 4.
The Examiner states that “Missos teaches a carrier made by
combining water and demineralized bone material and . . . autoclaving the
mixture which results in the formation of a gel.” Ans. 7 (citing Missos
¶ 34). The Examiner finds Missos teaches each limitation of claims 1, 3, 5,
and 7–9 except that “Missos is silent to wherein the bone gel alone (the
demineralized bone matrix and water carrier) is formed into these[] shapes
and sizes.” Id. at 8. According to the Examiner, it would have been obvious
to form the bone gel of Missos into the claimed shapes because Missos
teaches shaping its composition into sheets and various shapes. Id. The
Examiner explains that “[a]ll of the shapes taught by Missos . . . would be
inclusive to the bone gel itself given that the bone gel is part of the
composition of Missos. There is a reasonable expectation of success given
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that bone gels and bone forming compositions are routinely formed into
different shapes depending on the site of the bone defect.” Id.
Appellant argues that an ordinary artisan reading Missos would not
have been motivated to make the gel without the scaffold and coating
because those elements are an integral part of the Missos composition.
Appeal Br. 13–14. Appellant asserts that its claims “distinguish from
Missos et al[.] in that the gelatin of the claimed invention requires no
scaffolding of ceramic.” Id. at 14.
On this record, we agree with Appellant. As an initial matter, we note
that each of the claims recites a bone gel composition “consisting of” sterile
water and freeze-dried demineralized particles made of cortical bone. See
Claims App’x. We, therefore, understand that the use of the closed
transition phrase “consisting of” “exclude[s] any elements, steps or
ingredients not specified in the claim.” AFG Industries, Inc. v. Cardinal IG
Co., Inc., 239 F.3d 1239, 1245 (Fed. Cir. 2001). Thus, the claims require
that the bone gel composition consisting only of water and demineralized
bone be formed into sheets and frozen for later use. Moreover, as the
Examiner notes, the claims recite product-by-process limitations. Ans. 5.
We agree with the Examiner that the “determination of patentability is based
on the product itself (the bone gel) and does not depend on the method of
production.” Id.
The Examiner recognizes that neither Missos nor Talton teaches the
bone gel composition of the claims. But the Examiner appears to argue that
if it was known to shape the Missos composition with the ceramic
scaffolding into sheets and various shapes, it would have been obvious to
shape the bone gel carrier without the ceramic scaffolding into sheets and
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shapes, as well. See Ans. 8. It is unclear from the Examiner’s reasoning,
however, why a person of ordinary skill in the art reading Missos would
form the recited shapes with the bone gel carrier without the ceramic
scaffolding. As Appellant notes, Missos explains that compositions formed
from DBM are “dry and can be difficult to manipulate, handle, and shape.”
Missos ¶ 3. Missos addresses the problems with DBM compositions by
adding the ceramic scaffold and bioresorbable coating. Id. ¶¶ 3-4. Taken as
a whole, the Examiner has not sufficiently explained why a person of
ordinary skill in the art—reading Missos—would have forgone the benefits
of the ceramic scaffolding and formed the recited shapes without it.5
Accordingly, we find that a preponderance of the evidence does not
support the Examiner’s finding that a person of ordinary skill in the art
would have had a reason to modify Missos by forming shapes with a gel
composition consisting only of demineralized bone and water, as required by
each of the claims. We, therefore, reverse the rejection of claims 1, 3, 5, and
7–9 over Missos and Talton.

CONCLUSION
The Examiner’s rejection of claims 1, 3, 5, and 7–9 as unpatentable as
obvious over Missos and Talton is reversed.

5 We do not suggest that a person of ordinary skill in the art would
understand that ceramic scaffolding is required to form the recited shapes.
Our decision is limited by the Examiner’s rejection relying on the teachings
of Missos and Talton.
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 5, 7–9 103 Missos, Talton 1, 3, 5, 7–9
Overall
Outcome
1, 3, 5, 7–9

REVERSED