University of Florida Research Foundation, Inc.

Patent Trials and Appeals Board

Jun 1, 2020

14363538 - (D) (P.T.A.B. Jun. 1, 2020)

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.
14/363,538 06/06/2014 Peter S. McFetridge T13458 (222108-1780) 3252
154717 7590 06/01/2020
THOMAS|HORSTEMEYER, LLP - UF
UNIVERSITY OF FLORIDA (UF)
3200 WINDY HILL ROAD, SE
SUITE 1600E
ATLANTA, GA 30339
EXAMINER
CHONG, STEPHEN M
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
06/01/2020 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):
docketing@thomashorstemeyer.com
ozzie.liggins@thomashorstemeyer.com
uspatents@thomashorstemeyer.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PETER S. MCFETRIDGE
__________

Appeal 2019-005413
Application1 14/363,538
Technology Center 1600
__________

Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of forming a temporomandibular joint disc, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Fibrocartilage is a specialized tough and flexible tissue found in the
TMJ [(temporomandibular joint)] disc of the jaw.” (Spec. 1.) These discs
“have a unique combination of tensile strength, compressive resistance, and

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 University of
Florida Research Foundation, Inc. (Appeal Br. 3.)
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elastic deformability that cushion the articulating skeletal structures
surrounding them.” (Id.) “Neither the wide range of disc size and contour
nor the complex mechanical abilities of fibrocartilage has yet to be
replicated using synthetic matrix materials.” (Id.) Appellant’s invention is
directed at a method of making a TMJ disc for implantation. (Id.)
Claims 18–28 and 30–33 are on appeal.2 Claim 18 is representative
and reads as follows:
18. A method of forming a temporomandibular joint (TMJ)
disc, comprising the steps of:
obtaining a precursor TMJ scaffold structure comprising
a fibrocartilage tissue from a subject animal;
decellularizing the precursor TMJ scaffold structure to
produce a decellularized TMJ scaffold structure;
freeze drying the decellularized TMJ scaffold structure to
form a freeze-dried TMJ scaffold structure, such that the freeze-
drying process produces a decellularized, freeze-dried
fibrocartilage tissue having a compressive modulus and a peak
stress value less than that of a corresponding sodium dodecyl
sulfate (SDS) decellularized fibrocartilage tissue that has not
been freeze-dried; and
after freeze drying, drilling a plurality of drilled holes in
the decellularized, freeze-dried TMJ scaffold structure.
(Appeal Br. 24.)

2 Claims 10 and 11 are pending but have been withdrawn from
consideration.
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The prior art relied upon by the Examiner is:
Name Reference Date
Lin US 2008/0195211 A1 Aug. 14, 2008
Badylak US 2010/0222882 A1 Sept. 2, 2010
S. B. Lumpkins et al., A mechanical evaluation of three decellularization
methods in the design of a xenogeneic scaffold for tissue engineering the
temporomandibular joint disc, 4 Acta Biomaterialia 808–16 (2008).

The following ground of rejection by the Examiner is before us on
review:
Claims 18–28 and 30–33 under 35 U.S.C. § 103(a) as unpatentable
over Lumpkins, Lin, and Badylak.
DISCUSSION
The Examiner finds that Lumpkins teaches methods in which porcine
temporomandibular joint disc scaffolds were obtained, decellularized using
SDS, and analyzed. (Final Action 3–4.) The Examiner finds that it was
known in the art that “the goal of decellularization is to effectively remove
immunogenic cellular material while maintaining the biological activity and
mechanical integrity of the extracellular matrix,” but that it was also “well
known in the art that decellularization can alter the mechanical properties of
resulting engineered scaffolds.” (Id. at 3.)
The Examiner notes that Lumpkins does not teach freeze-drying the
decellularized TMJ scaffold or “drilling a plurality of drilled holes in the
decellularized TMJ scaffold.” (Id. at 4.) The Examiner finds that both of
those processing steps would have been obvious from the teachings of Lin
and Badylak. (Id. at 4–5.) The Examiner finds that the “methods taught by
Lin et al., Badylak et al., and Lumpkins et al., which are methods derived
and employed for the same and/or similar purposes, would thus, give rise to
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the expectation that when combined, would also produce similar, if not
enhanced, results.” (Id. at 6.)
The Examiner finds that Badylak teaches “a method for engineering
and preparing joint bioscaffolds for temporal mandibular joints having
decellularized matrix structures that may be additionally processed with
freeze drying. See Badylak et al. at [0014] and [0062].” (Id. at 4.)
The Examiner finds that Lin teaches a “method for engineering a disc
scaffolding designed with porous microstructured scaffolding, made from
biodegradable polymers, having screw holes, and utilized for
temporomandibular joint repair. See Lin et al. at Abstract and [0080].” (Id.)
The Examiner points out that Lin teaches “a design that allows permeability
and allows nutrients or (stem) cells to be delivered or migrate into the disc.
See Lin et al., entire document and especially at [0028], [0048], [0087], and
[0088].” (Id.) The Examiner further finds that Lin teaches that “advantages
of the method include the ability to create designed microstructures that can
mimic intervertebral load carrying capability, and the capability of creating
disc structures that can regrow natural tissue. See Lin et al. at [0012].” (Id.)
The Examiner finds that Lin also teaches “an advantage over artificial discs,
such as synthetic materials are subject to wear and fatigue failure and thus
seeding the disc that are loaded (e.g. embedded in the through-holes) with
cells and materials that facilitate regrowth of natural tissues is highly
desirable. See Lin et al. at [0012].” (Id. at 5.)
The Examiner concludes that one of ordinary skill in the art “would
have been motivated to add the porous microstructure scaffolding and freeze
drying decellularized matrices . . . because Badylak et al. and Lin et al. teach
methods and compositions that provide advantages in the materials having
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less wear and fatigue. See Lin et al. at [0012].” (Id.) The Examiner notes
“that the order of decellu[l]arizing and freeze-drying before drilling holes in
the scaffold, to achieve the method as instantly claimed is generally not
deemed inventive when the same results are expected upon performing the
noted sequence in any or even reverse order.” (Id. at 7.) The Examiner also
concludes that the structure as modified would inherently have the
compressive modulus and peak stress requirements of the claim because
freeze-drying necessarily produces those requirements. (Id. at 5–6.)
We do not agree that the Examiner has made out a prima facie case of
obviousness. In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011)
(“An examiner bears the initial burden of presenting a prima facie case of
obviousness.”). First, we agree with Appellant that the TMJ scaffold
material of Badylak is substantially different than that of Lumpkins and the
teachings therein would not have been considered applicable to the
Lumpkins material. (Appeal Br. 14–15.) In particular, Lumpkins teaches a
fibrocartilage TMJ disc material obtained from a pig jaw as the scaffold
material that is decellularized. (Lumpkins 809.) Although Badylak teaches
tailoring an implant device to “replace[] fibrocartilagenous meniscuses in the
temporomandibular joint” (see, e.g., Badylak ¶¶ 9, 66), Badylak does not
teach the scaffold material is fibrocartilage material. Rather, Badylak
discloses creating a three dimensional tissue scaffold from extracellular
matrix (ECM) material that has been decellularized or is acellular. (See,
e.g., id. ¶¶ 8, 41, 54, 103–4.) The ECM material that is taught to be of use in
Badylak is obtained from soft tissue such as “urinary bladder, intestine,
liver, heart, esophagus, spleen, stomach and dermis.” (Id. ¶¶ 55, 103.) That
tissue is processed in such a way as to obtain “mainly . . . epithelial
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basement membrane and subjacent tunica propria” or “mainly of the tunica
submucosa” (id. ¶¶ 56–57, 103–104), or it is “snap frozen . . . [so that it] can
then be comminuted so that particles are small enough to be placed in a
rotary knife mill, where the ECM is powdered” (id. ¶¶ 58, 94–96, 104), or it
is processed to make an ECM-derived gel by comminuting the ECM,
solubilizing it, raising the pH of the solution, and gelling the solution (id.
¶ 59). It is this ECM material that Badylak teaches “can be sterilized by any
of a number of standard methods without loss of function,” whose “protein
material” can be cross-linked, which “material may be further processed by
optional drying, desiccation, lyophilization, freeze drying, and/or
glassification,” and/or “optionally can be further digested.” (Id. ¶ 62.)
Badylak further describes how this ECM material is used to construct
a scaffold that can be either planar or three-dimensional. (See, e.g., id.
¶¶ 76–77, 97, 105 (two hydrated sheets of decellularized urinary bladder
matrix-ECM (“UBM-ECM”) cut to size are placed in a mold, pressed to
create a pocket into which particulate UBM-ECM is packed, and over which
two additional decellularized hydrated sheets of UBM-ECM are positioned,
all of which is subjected to vacuum pressurization thereby forming a
multilamanate structure).)
Although Lumpkins and Badylak are in the same field of endeavor,
we do not agree that one of ordinary skill in the art would have been
motivated to freeze dry the fibrocartilagenous TMJ scaffold structure that is
taught in Lumpkins simply because Badylak teaches that ECM material that
can be used to construct a scaffold for replacing fibrocartilagenous meniscus
in the temporomandibular joint can be freeze-dried. That is especially true
where, as Appellant notes (Appeal Br. 15), Badylak does not even teach any
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benefit to freeze drying ECM materials for use in building its structures. In
other words, we are not presented with a situation where “a technique has
been used to improve one device, and [thus] a person of ordinary skill in the
art would recognize that it would improve similar devices in the same way.”
See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Furthermore, we disagree with the Examiner that Lin would have
suggested to one of ordinary skill in the art to drill holes in the Lumpkins
scaffold with a reasonable expectation of success. As Appellant explains
(Appeal Br. 19–20), Lin teaches porous, synthetic scaffolding that is formed
ab initio from biocompatible polymers. Lin explains that “[a]dvantages of
the method” is “the ability to create designed microstructures,” such as by
using direct or indirect casting solid free form techniques. (Lin ¶¶ 12, 47,
51–53, 77, 80–81, 87.) The scaffold material that Lin teaches to use to
design or form the scaffolds is “biodegradable polymers, biodegradable
ceramics, non-biodegradable metals, non-biodegradable metal alloys, or
mixtures thereof.” (Id. ¶¶ 29, 47, 58.) Regarding the “microstructure
design” “to provide load bearing capability similar to a natural human
intervertebral disc, along with pathways for nutrient nutrition,” Lin explains
that it
may comprise, but is not limited to, the following: (1) an
interconnected system of spherical pores with varying diameter;
(2) an interconnected system of straight or curved struts with
varying diameter; (3) topology optimized microstructures; or
(4) wavy fibered structures.
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(Id. ¶ 52.)3 None of the foregoing suggests that the microstructure is
provided after the scaffold three dimensional structure is built, such as by
drilling holes. Nor does Lin provide any reason to think that drilling holes
after the fact into such a structure would reasonably be expected to achieve
the result of “effective elastic and permeability properties, . . . load bearing
capability similar to a natural human intervertebral disc, along with
pathways for nutrient nutrition” (Lin ¶ 52). Furthermore, there is nothing in
Lin’s teaching of using biodegradable polymers, biodegradable ceramics,
non-biodegradable metals, non-biodegradable metal alloys, or mixtures
thereof to fabricate scaffold structures that would reasonably suggest to one
of ordinary skill in the art that holes could be drilled into fibrocartilage
tissue, the material of Lumpkins, with a reasonable expectation of success in
achieving the functions provided by the microstructure design built into the
Lin material scaffold. Here again, we are not presented with a situation
where “a technique has been used to improve one device, and [thus] a person
of ordinary skill in the art would recognize that it would improve similar
devices in the same way.” See KSR, 550 U.S. at 417.
Thus, for the foregoing reasons, we do not find the Examiner has set
forth a prima facie case of obviousness. And, we, therefore, do not affirm

3 We recognize that Lin also discusses the formation of screw holes, which
the Examiner notes are used after the scaffolding is made to fasten the
scaffold structure in place. (Ans. 14.) However, Lin describes these holes
as being designed ab initio. (See, e.g., Lin ¶ 80:
Note that this scaffold has features created uniquely from
image-based design, including a wrap-around ramus collar that
allows surgical fixation, as shown with the screw holes.)

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the Examiner’s rejection of claims 18–28 and 30–33 under 35 U.S.C.
§ 103(a) as unpatentable over Lumpkins, Lin, and Badylak.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
18–28, 30–
33
103(a) Lumpkins, Lin,
Badylak
18–28, 30–
33

REVERSED