LifeCell Corporation

Patent Trials and Appeals Board

Feb 7, 2020

15185280 - (D) (P.T.A.B. Feb. 7, 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.
15/185,280 06/17/2016 Patrick Leamy 128196-06104 4902
145655 7590 02/07/2020
McCarter & English, LLP/LifeCell
265 Franklin Street
Boston, MA 02110
EXAMINER
CLEVELAND, TIMOTHY C
ART UNIT PAPER NUMBER
1774
NOTIFICATION DATE DELIVERY MODE
02/07/2020 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):
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 PATRICK LEAMY, QING-QING QIU, MICHAEL S. POHLE,
JASON MICHAEL POMERLEAU, and JEROME CONNOR

Appeal 2019-003716
Application 15/185,280
Technology Center 1700
Before BEVERLY A. FRANKLIN, JEFFREY B. ROBERTSON, 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), Appellant1 appeals from the
Examiner’s decision to reject claims 1–10. 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 2019-003716
Application 15/185,280

2
CLAIMED SUBJECT MATTER2
Appellant describes the invention as relating to a packaging for a
medical device where the device is packaged prior to treating the medical
device in a supercritical carbon dioxide (SC-CO2) chamber. Spec. ¶ 7.
Claim 1 is illustrative:
1. A packaging system for a medical device, comprising an
outer package, the outer package comprising a first portion and a
second portion, wherein the first portion is permeable to supercritical
carbon dioxide (SC-CO2) and a sterilant, and wherein when the
second portion is sealed it is impermeable to moisture;
an inner structure configured to hold the second portion open
during sterilization, wherein the inner structure is separate from the
outer package; and
an inner package that is permeable to SC-CO2 and a sterilant,
wherein the inner package is positioned within the inner structure.

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

Reference
US 2005/0268573 A1
US 7,108,832 B2

WO 2009/150488 A1

Date
Dec. 8, 2005
Sep. 19, 2006

Dec. 17, 2009

2 In this Decision, we refer to the Final Office Action dated February 26,
2018 (“Final Act.”), the Appeal Brief filed August 27, 2018 (“Appeal Br.”)
(with corrected claims appendix filed January 8, 2019), the Examiner’s
Answer dated February 7, 2019 (“Ans.”), and the Reply Brief filed April 8,
2019 (“Reply Br.”).
Appeal 2019-003716
Application 15/185,280

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REJECTIONS
The Examiner maintains the following rejections on appeal:
A. Claims 1–9 under 35 U.S.C. § 103 as obvious over Yan in view of
Mermet. Ans. 3.
B. Claim 10 under 35 U.S.C. § 103 as obvious over Yan in view of
Mermet and Christensen. Id. at 5.

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.
The Appellant does not present any substantively distinct argument for
claims other than claim 1. Appeal Br. 14–15. We therefore limit our
discussion to claim 1. All other claims stand or fall with that claim.
37 C.F.R. § 41.37(c)(1)(iv) (2013).
The Examiner finds that claim 1 is obvious over Yan in view of
Mermet. Ans. 3. The Examiner finds that Yan teaches a package containing
a medical device during a sterilization process. Id. (citing Yan). The
Examiner finds that Yan’s package has gas permeable and gas impermeable
Appeal 2019-003716
Application 15/185,280

4
portions corresponding to the portions claim 1 recites. Id. The Examiner
finds that Yan is silent in regard to claim 1’s recited inner structure. Id. The
Examiner finds, however, that Mermet also teaches a sterile packaging for a
medical device and that Mermet discloses a rigid part (6) that is capable of
maintaining an opening during a sterilization process. Id. at 3–4 (citing
Mermet). The Examiner determines it would have been obvious to combine
the rigid, porous part of Mermet into the package of Yan because doing so,
among other things, would “optimiz[e] the exposure of the medical device to
the sterilant composition” and “provid[e] another barrier to further protect
the device from microbial contamination.” Id. at 4.
Appellant argues that a person of skill in the art would not have
combined the rigid part of Mermet into the Yan package because Yan
requires flattening. Appeal Br. 8; Reply Br. 4. Appellant argues that if
someone flattened Yan’s package while Mermet’s rigid part were in it, the
rigid portion would break and leave plastic fragments in the package. Appeal
Br. 8; Reply Br. 5. Appellant also argues that failure to flatten Yan prior to
sealing it would force air into the container. Reply Br. 4.
The Examiner, however, finds that Yan’s flattening is optional. Ans.
5–6. The preponderance of the evidence supports the Examiner’s position.
Yan indicates that the flattening that Appellant emphasizes is optional by
using the word “may.” In particular, Yan states, “the container may be
flattened.” Yan ¶ 36 (emphasis added). After removing sterilizing gas and
optionally flattening the container, Yan’s partition line 46 may be flattened
and sealed using “heat sealing, adhesive bonding, ultrasonic welding, and
the like.” Id. After sealing and severing the permeable portion 14 from the
impermeable portion 12, the impermeable portion 12 “is then ready for
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Application 15/185,280

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transportation and storage.” Id. While skipping flattening might make Yan’s
package more bulky for shipping, Yan does not indicate that there would be
a problem with, for example, heat sealing without first flattening the
impermeable portion 12. Appellant does not identify evidence to the
contrary. Reply Br. 4. “[A]rguments of counsel cannot take the place of
evidence lacking in the record.” Estee Lauder Inc. v. L’Oreal, S.A., 129
F.3d 588, 595 (Fed. Cir. 1997) (internal quotes and citation omitted).
Appellant further argues that a person of skill in the art would have no
reason to modify Yan because Yan is already an effective sterilization
package. Appeal Br. 13. The Examiner, however, finds that inclusion of the
rigid part of Mermet can help protect the packaged device from damage and
also results in improved sterilization by allowing a homogenous exposure to
sterilization fluid. Ans. 6–7. The Examiner’s findings are supported by the
preponderance of the evidence. Mermet explains the benefit of its rigid part
(container 6) as follows:
The rigidity of container 6 makes it possible to preserve the
integrity of the objects 5 during the evacuation operation. . . .
This rigidity also has the advantage of granting a fixed shape to
the assembly formed by these objects, optimized for a
homogenous exposure to the sterilization fluid. . . . The rigid of
the container 6 also has the advantages of making it possible to
increase the capacity of a packing relative to the maximum
capacity which a known flexible packing can have.
Mermet 7:24–8:2. A person of skill in the art would have weighed the
advantages of the rigid part that Mermet teaches against any disadvantages
(e.g., not being able to fully flatten for compact shipping) and make a choice
that best suits the needs of the person’s particular application. See
Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“a
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Application 15/185,280

6
given course of action often has simultaneous advantages and disadvantages,
and this does not necessarily obviate motivation to combine”).
Appellant also argues that claim 1 provides unexpected results for
sterilization because Appellant’s Specification shows that sterilization is
more effective when the inner structure holds open a portion of the package
during sterilization. Appeal Br. 14; Reply Br. 5. Superior results alone,
however, are not sufficient to show that the results is unexpected. Pfizer,
Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007) (“[A]ny superior
property must be unexpected to be considered as evidence of non-
obviousness.” (emphasis in original)). Here, the Examiner correctly
determines that Appellant lacks evidence that this result is unexpected.
Ans. 7. Indeed, the preponderance of the evidence indicates superior
sterilization is not unexpected because Mermet teaches that its rigid part
provides the same benefit. Mermet 7:27–29.
Because Appellant’s arguments do not identify error, we sustain the
Examiner’s rejections.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–9 103 Yan, Mermet 1–9
10 103 Yan, Mermet,
Christensen
10
Overall
Outcome
1–10

Appeal 2019-003716
Application 15/185,280

7
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