Ex Parte Raine et al

Board of Patent Appeals and Interferences

Nov 5, 2010

10210707 (B.P.A.I. Nov. 5, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte DENNIS RAINE
and DANETTE BOUNELIS
________________

Appeal 2009-010038
Application 10/210,707
Technology Center 1700
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Before JEFFREY T. SMITH, BEVERLY A. FRANKLIN, and
MARK NAGUMO, Administrative Patent Judges.

NAGUMO, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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A. Introduction2
Dennis Raine and Danette Bounelis (“Raine”) timely appeal under
35 U.S.C. § 134(a) from the final rejection3 of claims 3-21, 24-30, 33,
and 34. We have jurisdiction under 35 U.S.C. § 6. We AFFIRM.
The subject matter on appeal relates to methods for sterilizing large
volumes, in particular, more than 80 liters, of liquids, especially biological
liquids such as sera. According to the 707 Specification, sterilization is
typically accomplished by exposing the sample to penetrating ionizing
radiation, such as gamma rays, x-rays, or electrons. (Spec. 2, ll. 1-6.) Most
of the radiation is said to simply pass through the packaging and the product,
leaving no residue and no residual radioactivity. (Id. at ll. 7-12.)
Representative Claim 30 reads:
30. A method for sterilizing a liquid product, comprising:
(I) disposing said liquid product in a sterilization
container having a capacity of a volume of liquid equal
to or greater than about eighty liters, said container
having;
(a) a container lid;
(b) a base comprising a bottom panel, and
(c) extending from and connected to said bottom
panel so as to be upstanding and circumferentially

2 Application 10/210,707, Sterilization Containers and Methods for
Radiation Sterilization of Liquid Products, 1 August 2002, claiming the
benefit of a provisional application filed 8 April 2002. The specification is
referred to as the “707 Specification,” and is cited as “Spec.” The real party
in interest is listed as Biologos, Inc. (Appeal Brief, filed 1 August 2008
(“Br.”), 3.)
3 Office action mailed 4 February 2008 (“Final Rejection”; cited as “FR”).
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contiguous, and to terminate at a top end that
registers with said container lid and defines an
opening into an interior of said base:
(i) a first side wall and a second side wall;
said first and second side walls being
disposed opposite each other and spaced
apart, and
(ii) a front wall and a back wall; said front
and back walls being disposed opposite each
other, spaced apart, and connected to said
first side wall and said second side wall,
(II) exposing said liquid product within the sterilization
container to an amount of radiation sufficient to sterilize
said liquid product,
wherein the distance between the first and second side
walls or the distance between the front and back walls is
about 11 inches or less, and
wherein the container is filled to about 100% of capacity.
(Br., Claims App. A-4; indentation, paragraphing, and emphasis added.)
An embodiment of a container used in the process is illustrated in
Figure 2, which is reproduced from the disclosure:

{Figure 2 shows a container in which liquids are sterilized by radiation}
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To orient the reader, we note that a rectangular block having a volume of
about 80 liters (80,000 cm3) and a thickness of about 11 inches (28 cm) thick
can be, for example, about 12 inches (30 cm) wide and about 37 inches
(95 cm) long. The elevated section in the middle of the container shown in
Figure 2 is provided to permit easy handling on a portable platform such as a
pallet or dolly. (Spec. 10, ll. 8-19.) Other features, such as inner bag 100
and lip 190, are also illustrated, but need not detain us as the dependent
claims that recite these features are not argued separately.
The Examiner has maintained the following grounds of rejection:4
A. Claims 3-7, 9-16, 24, 25, 28-30, 33, and 34 stand rejected under
35 U.S.C. § 103(a) in view of the combined teachings of
Vellutato,5 Bacehowski 624,6 and Smith.7
B. Claims 8 and 21 stand rejected under 35 U.S.C. § 103(a) in
view of the combined teachings of Vellutato, Bacehowski 624,
Smith, and Fotos.8
C. Claims 17-20 stand rejected under 35 U.S.C. § 103(a) in view
of the combined teachings of Vellutato, Bacehowski 624,
Smith, and Shaw.9

4 Examiner’s Answer mailed 15 October 2008 (“Ans.”).
5 Arthur L. Vellutato, Method of Sterilization, U.S. Patent 6,333,006 B1 (25
December 2001), based ultimately on an application filed 28 October 1993.
6 David Bacehowski et al., Large Volume Flexible Containers, U.S. Patent
4,968,624 (1990).
7 Sidney T. Smith et al., Gas Permeable Sterile Closure, U.S. Patent
6,659,132 B2 (9 December 2003), based on an application filed 19 March
2001.
8 Stephen Fotos, U.S. Patent 3,362,575 (1968).
9 Mark D. Shaw et al., U.S. Patent 5,042,683 (1991).
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D. Claim 26 stands rejected under 35 U.S.C. § 103(a) in view of
the combined teachings of Vellutato, Bacehowski 624, Smith,
and Bacehowski 147.10
E. Claim 27 stands rejected under 35 U.S.C. § 103(a) in view of
the combined teachings of Vellutato, Bacehowski 624, Smith,
and Goodrich.11
B. Discussion
Findings of fact throughout this Opinion are supported by a
preponderance of the evidence of record.
Raine argues, with respect to Rejection A, that “the cited references,
alone or in combination, fail to disclose or suggest a method of sterilizing a
liquid product in a filled container having a capacity of about 80 liters or
greater, wherein the container has a width of about 11 inches or less.”
(Br. 21, last para.) Raine argues further (Br. 20-21), based on two
declarations submitted by co-inventor Mr. Dennis Raine,12 that the
dimension of 11 inches is not merely a “design choice,” but that containers
having a greater width of 12″ or 13″ that are full of sera have an effective
local density13 greater than 0.50 g/cc, thus demonstrating the criticality of
an 11″ width for ensuring adequate sterilizing irradiation of animal sera

10 David V. Bacehowski et al., U.S. Patent 4,910,147 (1990).
11 Raymond P. Goodrich et al., U.S. Patent 5,587,490 (1996).
12 Affidavit filed 13 February 2006 (“Raine 1”), and Declaration filed 8 May
2007 (“Raine 2”), included in the Evidence Appendix attached to the Brief.
13 Effective local density (“ELD”), is said to be a measure of effective
penetration by gamma radiation. A value of 0.50 g/cc is said to indicate that
“radiation penetrates only one-half way through the container.” (Raine 2
at 2, ¶ 8.)
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samples (Raine 2 at 3, ¶¶ 10-11), which is said to be between about 25
to 40 kiloGrays (kGy), as recited in claim 29 (Br. 20, 1st full para.).
Raine does not argue for the separate patentability of any other claims
subject to Rejection A. Although Raine presents arguments for the
patentability of the remaining claims under separate headings corresponding
to Rejections B through E, the arguments are not substantially distinct from
the arguments for the patentability of independent claim 30. In particular,
Raine does not dispute the Examiner’s findings as to the secondary
references, or the propriety of the combinations of teachings. Accordingly,
all claims stand or fall with claim 30. 37 C.F.R. § 41.37(c)(1)(vii) (2007),
second sentence.
The Examiner finds that Vellutato describes a method of sterilizing a
liquid product in a container that meets all the limitations of claim 1 but for
the volume (80 liters or more), being filled to capacity, and the distance
between the front and back walls being 11″ or less. (FR 2-4; Ans. 5-7.)
Moreover, the Examiner finds that Vellutato describes exposing the liquid in
the container to 25 to 35 kGy of gamma radiation, sufficient to sterilize the
liquid product. (FR 3; Ans. 7; both citing Vellutato, col. 5, ll. 25-32 and
col. 6, ll. 32-38.) The Examiner relies on Bacehowski 624 and especially on
Smith for teachings of liquid-filled container suitable for holding larger
volumes of liquids. (FR 4-7; Ans. 7-9.) The Examiner argues in particular
that the different dimensioned box-like containers described by Smith in
Figures 1-3 to contain large amounts of liquids [200, 500, and 1500 liters,
respectively] would have suggested to the ordinary worker that variations of
length, height, and depth, including the recited 11 inches, would have been
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obvious. (FR 6-7; Ans. 10-11; both citing Bacehowsky 624 col. 6,
ll. 10-18.) The Examiner also finds that it was well known that the thickness
(“width”) of a sample correlates with the effectiveness of radiation
penetration and sterilization. (FR 16-17; Ans. 20-21.) The Examiner
concludes that optimizing the thickness of a sample to obtain proper
sterilizing radiation doses would have been prima facie obvious, and that the
results presented in the Raine 2 Declaration were not unexpected. (FR 17;
Ans. 21.)
Raine’s arguments fail to prove harmful error in the Examiner’s
rejections. In particular, Raine has not provided any credible evidence that
the relation between sample thickness, radiation penetration, and
effectiveness of sterilization was not known to persons having ordinary skill
in the art. That much is taught by Vellutato in the passages at column 5,
lines 25-32, teaching sterilizing doses generally in the range of 25-35
kilogray, and at column 6, lines 32-38, teaching irradiation at a
predetermined level for a predetermined time for sterilizing the liquid in the
container. If any further instruction were needed—and we have not been
presented with any credible evidence that those of ordinary skill in the art
would have needed such instruction—Vellutato also teaches that “obviously
the face of carton 36 facing the source or radiation will receive a higher
dosage than the side facing away from the source.” (Vellutato, col. 5,
ll. 33-35.) Vellutato teaches further that the amount of radiation impinging
on the container should be monitored with dosimeters “[t]o insure
appropriate dose levels between 20-40 kilograms,” and to thus apply
appropriate radiation levels to the entire package. (Id. at ll. 36-38.) Thus,
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Vellutato shows that such considerations were well-known to persons having
ordinary skill in the art.
C. Order
We AFFIRM the rejection of claims 3-7, 9-16, 24, 25, 28-30, 33,
and 34 under 35 U.S.C. § 103(a) in view of the combined teachings of
Vellutato, Bacehowski 624, and Smith.
We AFFIRM the rejection of claims 8 and 21 under 35 U.S.C.
§ 103(a) in view of the combined teachings of Vellutato, Bacehowski 624,
Smith, and Fotos.
We AFFIRM the rejection of claims 17-20 under 35 U.S.C. § 103(a)
in view of the combined teachings of Vellutato, Bacehowski 624, Smith, and
Shaw.
We AFFIRM the rejection of claim 26 under 35 U.S.C. § 103(a) in
view of the combined teachings of Vellutato, Bacehowski 624, Smith, and
Bacehowski 147.
We AFFIRM the rejection of claim 27 under 35 U.S.C. § 103(a) in
view of the combined teachings of Vellutato, Bacehowski 624, Smith, and
Goodrich.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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