Ex Parte Matthews et al

Patent Trial and Appeal Board

Sep 10, 2015

13197261 (P.T.A.B. Sep. 10, 2015)

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.
13/197,261 08/03/2011 Michael A. Matthews USC-276 (803) 5419
22827 7590 09/10/2015
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
EXAMINER
MRUK, BRIAN P
ART UNIT PAPER NUMBER
1761
MAIL DATE DELIVERY MODE
09/10/2015 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MICHAEL A. MATTHEWS and PEDRO J. TARAFA1
____________

Appeal 2014-000564
Application 13/197,261
Technology Center 1700
____________

Before CHUNG K. PAK, KAREN M. HASTINGS, and
GEORGE C. BEST, Administrative Patent Judges.

PAK, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134(a) from the
Examiner’s decision2 finally rejecting claims 1‒20, which are all of the
claims pending in the above-identified application. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 The real party in interest is said to be the University of South Carolina.
Appeal Brief filed May 29, 2013 (“Br.”) at 1. However, the Specification
also states that the U.S. “government has certain rights in the invention”
because “[t]his invention was made with government support under
R01EB55201 awarded by National Institutes of Health.” Specification filed
August 3, 2011 (“Spec.”) at 1, ll. 5‒6.
2 Final Action mailed December 27, 2012 (“Final Act.”) at 1‒4 and the
Examiner’s Answer mailed July 31, 2013 (“Ans.”) at 4.
Appeal 2014-000564
Application 13/197,261

2
The subject matter on appeal is directed to a process for achieving
“safe endotoxin levels on medical devices (e.g., ≤ 20 EU/device according to
the US Pharmacopeia – Standard USP27-NF22)[,]” which comprises
cleaning the medical devices “via exposing the medical device[s] to a
compressed CO2-based mixture [containing carbon dioxide, a surfactant, and
water in the form of water-in-CO2 microemulsions having a pressure of at
least about 400 psi].” Spec. 3, ll. 7‒22. To expose the medical devices to
the highly compressed CO2-based mixture, both the medical devices and the
compressed CO2-based mixture must be loaded into a high pressure vessel
such that the compressed CO2-based mixture has a pressure of at least about
400 psi at the time the medical devices are exposed to the compressed CO2-
based mixture. See, e.g., Spec. 4, ll. 14‒22, 12, ll. 3‒8, and 15, ll. 2‒20.
Figure 2, which shows an apparatus for conducting the cleaning
process discussed above, is reproduced below:

Figure 2 shows that stainless steel plate 5 carrying medical components to be
treated and a compressed CO2-based mixture in gas cylinder 1 are loaded
into high pressure vessel 4 having heating jacket 7 and cooling coil 6 so that
Appeal 2014-000564
Application 13/197,261

3
the medical components are exposed to a highly pressured CO2-based
mixture. See, e.g., Spec. 4, ll. 14‒17 and 15, ll. 1‒20. This pressurized
cleaning for at least two hours is said to achieve safe endotoxin levels
(≤ 20 EU/device as required for medical devices). Spec. 25, ll. 14‒17.
Details of the appealed subject matter are recited in illustrative claim
1,3 which is reproduced below from the Appeal Brief’s Claims Appendix:
1. A method of cleaning a medical device, the method
comprising
loading the medical device into a chamber, and
exposing the medical device to a compressed CO2-based
mixture within the chamber, the compressed CO2-based mixture
comprising carbon dioxide, a surfactant, and water in the form
of water-in- CO2 microemulsions, wherein the compressed
CO2- based mixture has a pressure of at least 400 psi.
Br. 12 (emphasis added.)
The Examiner has maintained the rejection of claims 1‒20 under 35
U.S.C. § 102(b) as anticipated by, or under 35 U.S.C. § 103(a) as
unpatentable over, the disclosure of Hei.4 Final Act. 1‒4 and Ans. 4.
Appellants seek review of this rejection.
DISCUSSION
Upon consideration of the evidence on this record in light of the
arguments and responses advanced by Appellants and the Examiner, we find
that Appellants have identified reversible error in the Examiner’s
determination that Hei, the applied prior art, would have rendered the subject

3 For purposes of this appeal, we limit our discussion to the broadest claim
on appeal, sole independent claim 1.
4 US 2004/0033269 A1 published in the name of Hei et al. on February 19,
2004 (“Hei”).
Appeal 2014-000564
Application 13/197,261

4
matter recited in claims 1‒20 obvious to one of ordinary skill in the art
within the meaning of 35 U.S.C. § 103(a). Accordingly, we reverse the
Examiner’s § 103(a) rejections of the above claims substantially for the
reasons set forth in the Appeal Brief. We add the following primarily for
emphasis.
There is no dispute that Hei either teaches or would have suggested
using a CO2-based mixture containing carbon dioxide, a surfactant, and
water in the form of water-in-CO2 microemulsions in cleaning a medical
device. Compare Ans. 4‒5 with Br. 3‒11. What is disputed is the
Examiner’s finding that Hei teaches exposing the medical device to such
CO2-based mixture having a pressure of at least 400 psi as recited in claim 1.
Id.
Thus, the dispositive question raised by the Examiner and Appellants
is: Has the Examiner erred in finding that Hei teaches exposing a medical
device to a CO2-based mixture containing carbon dioxide, a surfactant, and
water in the form of water-in-CO2 microemulsions subjected to a pressure of
at least 400 psi in the manner recited in claim 1? On this record, we answer
this question in the affirmative.
According to the Specification, to expose the medical device to such
highly pressurized CO2-based mixture, both the medical device and the
compressed CO2-based mixture must be loaded into a high pressure vessel or
chamber. See, e.g., Spec. 4, ll. 14‒22, 12, ll. 3‒8, and 15, ll. 1‒20. To
achieve the objective or goal of Appellants’ invention of obtaining safe
endotoxin levels (≤ 20 EU/device as required for medical devices) on
medical devices, the Specification requires exposing the medical device to
the highly pressurized CO2-based mixture in a pressure chamber for a
Appeal 2014-000564
Application 13/197,261

5
prolonged period. Spec. 3, ll. 7‒14 and 25, ll. 14‒17. When the
Specification specifies an object or goal of the invention, as here, we
interpret the claims in the manner that would allow the claimed invention to
meet such objective or goal, i.e., exposing a medical device to a highly
pressurized CO2-based mixture in a pressure chamber for a prolonged period
to achieve a safe endotoxin level on such medical device. In re Rambus,
Inc., 694 F.3d 42, 50 (Fed. Cir. 2012) (stating that when the Specification
specifies an object or goal of the invention, any claim construction or
interpretation that would have rendered the claimed invention incapable of
meeting that objective or goal is incorrect) (citing Lisle Corp. v. A.J. Mfg.
Co., 398 F.3d 1306, 1314 (Fed. Cir. 2005).)
Having interpreted the claims in this manner, we evaluate the content
of Hei relied upon by the Examiner. We find that the passages, Examples,
and Tables of Hei relied upon by the Examiner teach venting a CO2-based
mixture containing an antimicrobial agent densified at a pressure of 15‒
10,000 psi in an applicator or a vessel so that a medical device is exposed to
the vented CO2-based mixture in a room, rather than in a high pressure
chamber. Compare Br. 4‒9 with Ans. 4‒7; see also Hei ¶¶ 54, 124, 125, and
215‒257. Upon venting the densified or compressed CO2-based mixture in
the applicator or vessel, Hei teaches that such densified or compressed CO2-
based mixture expands “from a high pressure to ambient pressure[,]” i.e.,
changing the densified or compressed CO2-based mixture “quickly” into the
gaseous phase due to the pressure drop associated with leaving the applicator
or vessel, during the application of such mixture to a soiled or contaminated
surface, e.g., a contaminated medical device. Br. 4‒9 and Hei ¶¶ 124‒125
and 215‒257 (Examples 1‒7 and Table 1‒5). Thus, on this record, the
Appeal 2014-000564
Application 13/197,261

6
Examiner has not shown that Hei teaches exposing a medical device to a
CO2-based mixture under a pressure of at least 400 psi, especially for a
sufficient time period for achieving a safe endotoxin level on the medical
device. Ans. 4‒7. Nor has the Examiner explained why one of ordinary
skill in the art would have been led to expose the medical device to the CO2-
based mixture under a pressure of at least 400 psi for a sufficient time period
for achieving a safe endotoxin level on the medical device as required by
claim 1from the teaching of Hei. Id.
ORDER
In view of the foregoing, the decision of the Examiner to reject claims
1‒20 under 35 U.S.C. § 102(b) as anticipated by, or under 35 U.S.C.
§ 103(a) as unpatentable over, the disclosure of Hei is REVERSED.

REVERSED
cdc