Kibalo, Benjamin T.

Patent Trials and Appeals Board

Dec 27, 2019

14676289 - (D) (P.T.A.B. Dec. 27, 2019)

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.
14/676,289 04/01/2015 Benjamin T. Kibalo 128196-05702 1032
145655 7590 12/27/2019
McCarter & English, LLP/LifeCell
265 Franklin Street
Boston, MA 02110
EXAMINER
KIPOUROS, HOLLY MICHAELA
ART UNIT PAPER NUMBER
1799
NOTIFICATION DATE DELIVERY MODE
12/27/2019 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):
docket@mccarter.com
mvaneman@mccarter.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BENJAMIN T. KIBALO
Appeal 2019–003943
Application 14/676,289
Technology Center 1700
Before MONTÉ T. SQUIRE, AVELYN M. ROSS, and
BRIAN D. RANGE, Administrative Patent Judges.
RANGE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s decision to reject claims 59–70, 72, and 74.1 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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 LifeCell
Corporation. Appeal Br. 1.
Appeal 2019–003943
Application 14/676,289

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CLAIMED SUBJECT MATTER2
Appellant describes the invention as relating to processing of human
or animal tissue for patient issue. Spec. ¶ 2. In particular, tissues are
processed to remove certain components or destroy pathogens while
maintaining desired biologic properties of the tissue. Id. ¶¶ 2, 23. Claim 59
is the only independent claim on appeal and is illustrative of the claimed
subject matter:
59. A method for reducing the bioburden in a soft tissue
sample, said method comprising:
providing a tissue comprising mammalian skin;
removing an epidermal layer from the skin; and
applying a sustained pressure to the tissue by placing the tissue
in a liquid and applying sustained elevated pressure to the liquid for a
time sufficient to cause at least a 5 log reduction in the bacterial
concentration within the tissue, wherein the pressure is applied at a
rate to control the temperature of the tissue such that the temperature
of the tissue does not exceed 30°C.
Appeal Br. 13 (Claims App.) (emphasis added to certain key recitations).

2 In this Decision, we refer to the Final Office Action mailed May 1, 2018
(“Final Act.”), the Appeal Brief filed October 29, 2018 (“Appeal Br.”), the
Examiner’s Answer mailed February 25, 2019 (“Ans.”), and the Reply Brief
filed April 23, 2019 (“Reply Br.”).
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Application 14/676,289

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REFERENCES
The Examiner relies upon the prior art below in rejecting the claims
on appeal:
Mills et al.
(“Mills”)

Ngo et al.
(“Ngo”)

Kibalo

Kishida et al.
(“Kishida”)
US 2006/0228252 A1

US 2010/0323440 A1

US 9,023,273 B2

WO 2008/111530 A1
Oct. 12, 2006

Dec. 23, 2010

May 5, 2015

Sept. 18, 2008

REJECTIONS
The Examiner maintains (Ans. 3) the following rejections on appeal:
A. Claims 59–70 and 72 on the ground of nonstatutory double patenting
type obviousness as being unpatentable over claims 1–14 of Kibalo.
Final Act. 4–5.3
B. Claims 59–65 and 74 under 35 U.S.C. § 103(a) as obvious over Ngo
in view of Kishida. Id. at 5–9.
C. Claims 66–70 under 35 U.S.C. § 103(a) as obvious over Ngo in view
of Kishida and Mills. Id. at 9–11.
D. Claim 72 under 35 U.S.C. § 103(a) as obvious over Ngo in view of
Kishida and Sun. Id. at 11.

3 The rejection does not address claim 74. In the event of further
prosecution, we leave application of nonstatutory double patenting to claim
74 for the Examiner to address in the first instance.
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OPINION
We review the appealed rejections for error based upon the issues
identified by Appellant and in light of the arguments and evidence produced
thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential),
cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t
has long been the Board’s practice to require an applicant to identify the
alleged error in the examiner’s rejections.”). After considering the evidence
presented in this Appeal and each of Appellant’s arguments, we are not
persuaded that Appellant identifies reversible error. Thus, we affirm the
Examiner’s rejections for the reasons expressed in the Final Office Action
and the Answer. We add the following primarily for emphasis.
Rejection A, non-statutory double patenting. Appellant does not
address this rejection. We, therefore, summarily affirm the rejection.
Rejections B, C, and D, obviousness. Appellant does not present
substantively separate arguments for these rejections and does not argue any
claim recitations other than those of independent claim 59. Appeal Br. 7–12.
We therefore limit our discussion to claim 59. All other claims stand or fall
with that claim. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Ngo teaches providing a tissue sample
comprising mammalian skin, removing an epidermal layer from the skin,
applying sustained pressure for time sufficient to sterilize the tissue, and
maintaining the temperature below 30ºC during application of the elevated
pressure. Final Act. 5–6 (citing Ngo). The Examiner finds that Ngo does
not teach applying the elevated pressure by placing the tissue in liquid. Id.
at 7. The Examiner finds, however, that Kishida teaches preparing a soft
tissue sample for transplantation by applying sustained elevated pressure by
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Application 14/676,289

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placing the tissue in liquid. Id. (citing Kishida). The Examiner also finds
that Kishida teaches that its method disrupts bacteria in the tissue while also
advantageously preventing unwanted swelling of the tissue. Ans. 5–6 (citing
Kishida). The Examiner determines that a person of skill in the art would
have applied the teachings of Kishida (use of a liquid) to achieve the
elevated pressure of Ngo teaches because Kishida’s method “is recognized
in the art to be effective in reducing bioburden while avoiding damage to the
tissue.” Final Act. 8.
Appellant argues that a person of skill in the art would not have
modified Ngo with Kishida because Ngo requires use of supercritical carbon
dioxide during its application of pressure. Appeal Br. 7–11. The Examiner
disagrees by finding that Ngo teaches two distinct methods. Ans. 4. The
Examiner explains that the rejection is based only on Ngo’s second
method—a method that does not require supercritical carbon dioxide.
As summarized below, the preponderance of the evidence supports the
Examiner’s position that Ngo teaches two methods and that the second
method does not require supercritical carbon dioxide. Ngo’s title,
“PROCESS FOR STERILIZING ACELLULAR SOFT TISSUE UNDER
PRESSURE,” does not reference supercritical carbon dioxide. Ngo’s
abstract likewise does not reference supercritical carbon dioxide. Ngo’s
Figure 1 is a schematic flow chart of Ngo’s process (Ngo ¶ 23), and Figure 1
indicates that “SUPER CRITICAL CO2” and “ULTRA HIGH PRESSURE”
are distinct alternative final steps of the Ngo process. Ngo’s Summary of
the Invention also does not reference supercritical carbon dioxide. Id. ¶¶
12–22.
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Ngo’s more detailed explanation of its two examples indicates the
examples are distinct. Ngo example 1 is entitled “Sterilization of Dermis
with Supercritical CO2 Under Pressure,” and example 1’s final step states
“[t]he dermis is then treated with supercritical CO2 under pressure from
about 1400 to 2000 psi.” Id. ¶¶ 33–42 (emphasis added). In contrast, Ngo
example 2 is entitled “Sterilization of Dermis with Ultra High Pressure,”
and example 2’s final step states “[t]he dermis is then sterilized under ultra
high pressure.” Id. ¶¶ 43–53 (emphasis added). Ngo’s second example does
not reference supercritical carbon dioxide. The different language of these
two examples suggests that the “Ultra High Pressure” example (example 2)
does not make use of supercritical carbon dioxide.
Appellant emphasizes Ngo paragraph 32. Appeal Br. 10–11; see also
Reply Br. 3. That paragraph states the “dermis is [then] sterilized with
supercritical CO2 at a temperature ranging from 10 º C–80º C at a pressure
ranging from 1200–2200 psi for a period ranging from about 10 to about 200
minutes or is alternatively sterilized under ultra high pressure ranging from
65,000–125,000 psi at a temperature ranging from -10º C–30º C for a period
ranging from 1–30 minutes.” Ngo ¶ 32 (emphasis added). In view of the
other context Ngo provides, as discussed above, this paragraph is best
understood as stating that “supercritical carbon dioxide” and “ultra high
pressure” are alternative and distinct sterilization methods. Id.
Because Ngo teaches an “ultra high pressure” method (i.e., method 2)
that does not involve supercritical CO2, a person of skill in the art would
naturally look to other references to ascertain how to implement the ultra
high pressure method. Id. The teachings of Kishida provide such an
implementation with the advantage of, for example, preventing swelling of
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the tissue. Ans. 6. Appellant’s argument, therefore, does not identify error
in the Examiner’s rejections, and we sustain the rejections.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
59–70, 72 Obviousness-type
double patenting,
Kibalo
59–70, 72
59–65, 74 103 Ngo, Kishida 59–65, 74

66–70 103 Ngo, Kishida, Mills 66–70

72 103 Ngo, Kishida, Sun 72

Overall
Outcome
59–70, 72,
74

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