Ex Parte Lee et al

Patent Trials and Appeals Board

Jun 5, 2019

12601518 - (D) (P.T.A.B. Jun. 5, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/601,518 11/23/2009
26530 7590 06/07/2019
LADAS & PARRY LLP
224 SOUTH MICHIGAN A VENUE
SUITE 1600
CHICAGO, IL 60604
FIRST NAMED INVENTOR
Heeyoung Lee
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
CU-9893 8136
EXAMINER
PYLA, EVELYN Y
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
06/07/2019 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):
ChicagoUSPTO@ladas.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HEEYOUNG LEE, HYUNJIN YANG,
JUN SEOK LEE, and JI SUK CHOI1
Appeal 12/601,518
Application 2018-007 633
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for preparing a scaffold for transplanting fat tissue, which have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
1 Appellants identify the Real Party in Interest as Heeyoung Lee. Appeal Br. 3.
Appeal2018-007633
Application 12/601,518
STATEMENT OF THE CASE
Claims 17-30 are on appeal. Claim 17 is illustrative and reads as
follows ( emphasis added):
17. A method for preparing a scaffold for transplantation of
fat tissue for the correction of contour deformities in the skin
and/or regeneration of deformed sites throughout the human
body or cell culture, the method comprising the steps of:
(a) fragmenting fat tissue by physical treatments without
using any chemical treatment to obtain isolated lipids in a liquid
state, a first fragmented fat tissue containing lipids in a liquid
state, and a second fragmented fat tissue free of lipids in a
liquid state;
(b) removing the isolated lipids in a liquid state;
( c) removing only the first fragmented fat tissue
containing lipids in a liquid state to isolate the second
fragmented fat tissue free of lipids in a liquid state; and
( d) sterilizing the second fragmented fat tissue to obtain a
scaffold,
wherein a volume and a three-dimensional structure of
the scaffold are partially maintained, and
wherein a microstructure of the scaffold comprising
connective tissue is partially maintained.
Claims 18, 24, and 25 are also independent and are directed to
methods similar to that of claim 1 7. The differences from claim 1 7 are as
follows: claim 18 recites "fragmenting fat tissue by sonication or high
pressure nozzle spray," claim 24 recites "fragmenting fat tissue by physical
treatments ... to obtain isolated lipid droplets in a liquid state," and claim
25 recites "fragmenting fat tissue by sonication or high pressure nozzle spray
to obtain isolated lipid droplets in a liquid state." Appeal Br. 17-19
( emphases added).
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Appeal2018-007633
Application 12/601,518
The claims stand rejected as follows:
Claims 17-19, 21-26, and 28-302 under 35 U.S.C. § 103(a) as
obvious based on Zocchi3 and Chu4 (Ans. 3) and
Claims 20 and 27 under 35 U.S.C. § 103(a) as obvious based on
Zocchi, Chu, and Simpson5 (Ans. 9).
DISCUSSION
The Examiner has rejected claims 17-19, 21-26, and 28-306 as
obvious based on Zocchi and Chu. The Examiner has rejected claims 20 and
27 as obvious based on Zocchi, Chu, and Simpson. The same issue is
dispositive for both rejections.
The Examiner finds that Zocchi teaches most of the limitations of the
claimed method but does not teach a step of sterilizing its collagen scaffold.
Ans. 5-6. The Examiner finds that Chu teaches "methods of sterilizing
dermal fillers and injectable collagen" to reduce contamination, and
concludes that it would have been obvious to modify Zocchi' s method to
include Chu's sterilization step. Id. at 6-7.
2 The statement of the rejection does not include claim 29, but claim 29 is
expressly addressed in the body of the rejection. Ans. 8. Thus, we conclude
that the omission of claim 29 from the statement of the rejection was a
typographical error.
3 Zocchi, EP 0418979 A2, published Mar. 27, 1991.
4 Chu et al., US 7,902,145 B2, issued Mar. 8, 2011.
5 Simpson et al., US 7,615,373 B2, issued Nov. 10, 2009.
6 The statement of the rejection does not include claim 29, but claim 29 is
expressly addressed in the body of the rejection. Ans. 8. Thus, we conclude
that the omission of claim 29 from the statement of the rejection was a
typographical error.
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Appeal2018-007633
Application 12/601,518
With respect to the three components recited in the claims ("isolated
lipids in a liquid state, a first fragmented fat tissue containing lipids in a
liquid state, and a second fragmented fat tissue free of lipids in a liquid
state"), the Examiner finds that Zocchi's centrifugation step produces
different layers that meet those limitations. See id. at 4-6. Specifically, the
Examiner finds that
the method disclosed by Zoochi [sic] produces three distinct
layers. The surface layer, i.e. uppermost layer, is the less dense
oily layer comprising fat/oil components such as the liquid
lipids released from burst adipocytes and fragmented lipid
matrix, which is separated from the middle layer. The oily/fat
layer reads on "isolated lipids in a liquid state" and ''first
fragmented fat tissue containing lipids in a liquid state".
Id. at 6.
Appellants argue that
Zocchi obtains a middle layer, comprising cellular residues (the
wall of the burst adipocytes and intercellular substances)
without an uppermost layer and a lower part. However, the
middle layer comprises a lipidic matrix containing lipids in a
liquid state and a lipid matrix free of lipids in a liquid state.
Thus, Zocchi fails to disclose only obtaining a lipid matrix free
of lipids in a liquid state without obtaining a lipidic matrix
containing a lipid matrix in a liquid state in the middle layer.
Appeal Br. 14.
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case ofunpatentability." In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "In rejecting an
application, factual determinations by the PTO must be based on a
preponderance of the evidence." In re Oetiker, 977 F.2d 1443, 1449 (Fed.
Cir. 1992) (J. Plager, concurring). "What the prior art teaches ... is a
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Appeal2018-007633
Application 12/601,518
determination of fact." Para-Ordnance Mfg., Inc. v. SGS Importers Int'!,
Inc., 73 F.3d 1085, 1088 (Fed. Cir. 1995).
Thus, the issue presented is whether a preponderance of the evidence
supports the Examiner's finding that Zocchi discloses a method that includes
a step of "removing only the first fragmented fat tissue containing lipids in a
liquid state to isolate the second fragmented fat tissue free of lipids in a
liquid state"-that is, a step of separating fragmented fat tissue containing
liquid lipids from fragmented fat tissue free of liquid lipids-as required by
the claims on appeal. We conclude that a preponderance of the evidence
does not support the Examiner's finding.
Zocchi discloses a method "for producing collagen without removing
the treated tissues from the harvesting syringes used for the harvesting
allowing in this way to complete the whole procedure in a sealed sterile
cycle." Zocchi 1:10-14. Zocchi's method comprises "harvesting of fat tissue
from the patient with the use of aspirating syringes, subjecting the syringes
containing the harvested material to ultrasonic energy until the thorough and
complete destruction of the fat cells is accomplished, and separating the
resultant material in the syringe in a centrifuge." Id. at 2: 17-23.
Zocchi teaches that, after centrifugation,
it is possible [to] distinguish in the syringes, from below to
high, three different layers;
1) in the lower part the blood, the physiological saline and
anaesthetic solution used for the harvesting and the rinsing;
2) in the middle, the auto-collagen formed by all cellular
residues, the wall of the burst adipocytes and intercellular
substances, very isolated;
3) on the surface, a very important oily layer coming from the
lipidic matrix of the burst cells.
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Application 12/601,518
Id. at 2:25-36.
Zocchi teaches that "only the middle layer, formed by the autologous
collagen[,] interests us for the reinjection. It is very simple by a needle to
remove all parasitic [sic] layers and so to obtain in all syringes a pure
collagen substance." Id. at 2:37-41.
Thus, Zocchi teaches that the oil from the burst cells-"isolated lipids
in a liquid state," in the language of the claims-forms the top layer in its
syringes and can be removed using a needle. Zocchi also teaches that the
blood, physiological saline, and anaesthetic solution form the bottom layer
in its syringes, and can also be removed using a needle.
Zocchi teaches that the middle layer in its syringes contains "auto-
collagen [ sic, autologous collagen?] formed by all cellular residues [ and] the
wall of the burst adipocytes." Zocchi 2:31-33 (emphasis added). This
teaching would seem to contradict the Examiner's finding that Zocchi's oily
layer also contains "fragmented lipid matrix" or in the claims' words, "first
fragmented fat tissue containing lipids in a liquid state." Ans. 6.
Zocchi also teaches that its middle layer is "formed by the autologous
collagen" and that removal of the other layers yields "a pure collagen
substance." Zocchi 2:37-41. Zocchi thus teaches that its process yields all of
the oil from the fat cells in the upper layer and all of the cellular residues and
collagen in the middle layer. Zocchi does not disclose the presence of, or any
need to remove, "fragmented fat tissue containing lipids in a liquid state"
(claims 17, 18, 24, and 25) in its process.
We therefore conclude that the Examiner's finding that Zocchi
discloses a process that includes a step of "removing only the first
fragmented fat tissue containing lipids in a liquid state to isolate the second
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Application 12/601,518
fragmented fat tissue free of lipids in a liquid state," as required by the
claims, is not supported by a preponderance of the evidence.
The Examiner responded to Appellants' argument on this point by
reiterating her position that Zocchi's "oily layer would include the less dense
fatty/oily portions of the lipoaspirate tissue including lipids released from
the cells (free-lipids) and portions of the lipid matrix also released from the
burst cells, which would have been fragmented by the application of
ultrasonic cavitation." Ans. 11. For the reasons discussed above, however,
we conclude that the Examiner's finding on this point is not adequately
supported by the evidence.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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