Ex Parte 6607695 et al

Board of Patent Appeals and Interferences

Feb 13, 2012

90009290 (B.P.A.I. Feb. 13, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte Veltek Associates, Inc.,
Patent Owner and Appellant
____________

Appeal 2011-010491
Reexamination Control 90/009,290
Patent 6,607,695 B2
Technology Center 3900
____________

Before ROMULO H. DELMENDO, JEFFREY B. ROBERTSON, and
ROBERT A. CLARKE, Administrative Patent Judges.

ROBERTSON, Administrative Patent Judge.

DECISION ON APPEAL
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Veltek Associates, Inc., the owner of the patent under reexamination
(hereinafter the “‘695 Patent”), appeals under 35 U.S.C. §§ 134(b) and 306
from a final rejection of claims 1-4, 8-37, and 39-44 (Appeal Brief filed July
21, 2010, hereinafter “App. Br.,” at 2; Final Office Action mailed March 15,
2010). We have jurisdiction under 35 U.S.C. §§ 134(b) and 306.
We REVERSE.

STATEMENT OF THE CASE
This reexamination proceeding arose from a third-party request for ex
parte reexamination filed by Peter S. Weissman of Blank Rome LLP on
behalf of Steris Corporation (Request for Ex Parte Reexamination filed
October 1, 2008). We understand that the ‘695 Patent is the subject of
litigation styled Veltek Associates, Inc. and Arthur Vellutato v. Steris
Corporation, Civil Action No. 2:07-cv-03433 (E.D. Pa.) (Request 1).
We heard Patent Owner’s oral arguments on November 2, 2011, a
written transcript of which was entered into the record on December 9, 2011.
The ‘695 Patent states involves methods of optimizing the sterilization
process for chemical compositions. (Col. 1, ll. 10-11.)
Claim 1 on appeal reads as follows:
1. A method of sterilizing, under non-sterile conditions,
a chemical [composition] disinfectant contained in a sealed
container comprising the steps of[, under non-sterile
conditions]:
providing a container having an internal volume;
charging the internal volume of the container with a
quantity of said chemical [composition] disinfectant suitable for
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being discharged under pressure from said container and
effective for use in a decontamination procedure in a controlled
environment;
pressurizing the internal volume of the container;
sealing the internal volume of the container to form a
sealed container;
hermetically heat sealing the container in a first sealing
layer to form a first hermetically heat-sealed container
enclosure;
hermetically heat sealing said first hermetically sealed
container enclosure in a second sealing layer to form a second
hermetically heat-sealed container enclosure;
enclosing said second hermetically heat-sealed container
enclosure in a shipping carton to form a closed shipping
package the contents of which include said chemical
[composition] disinfectant, said sealed container, and said first
and second hermetically heat-sealed container enclosures;
transferring said closed shipping package with its
contents in a non-sterile condition to an irradiation plant; and
externally irradiating said closed shipping package and
its contents at the irradiation plant at a predetermined radiation
level for a predetermined time interval to simultaneously
sterilize said chemical [composition] disinfectant, said sealed
container, and said first and second hermetically heat-sealed
container enclosures, said radiation level and time interval
being controlled so as to retain the effectiveness of said
chemical disinfectant.

(Claims App’x, App. Br. 43-44.)

The Examiner relied upon the following as evidence of
unpatentability (Examiner’s Answer mailed February 4, 2011, hereinafter
“Ans.,” 3):
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American Cyanamid UK 942,374 Nov. 1963
Schweigl US 4,899,914 Feb. 1990
Abplanalp UK 2,216,422 Oct. 1989

Clean Rooms Magazine Reader Service Nos. 498 and 419, March 1992.

Sidney Jefferson, “Sterilization of Medical Equipment and Pharmaceutical
Product”, Chapter 3, Massive Radiation Techniques, Consulting Editor,
Leader of the Technological Irradiation Group, Isotope Research Division,
A.E.R.E. Wantage, 1964, pp. 61-97.

Appellant relied on certain parts of the following (App. Br. 55):1
Ex. 1: Decl. of Arthur L. Vellutato, Jr. dated January 19, 2010 (“the
Vellutato Declaration”);
Ex. 2: Decl. of Edward A. Fitzgerald, Ph.D. dated November 13, 2009
(“the Fitzgerald Declaration”);
Ex. 3: Letter from Andrew Witter dated February 27, 2001;
Ex. 4: C. Artandi, Sutures, Manual on Radiation Sterilization of
Medical and Biological Materials, IAEA, Technical Reports Series No. 149,
Chapter 10, © 1973, pp. 171-186; and
Ex. 5: R.S.M. Frohnsdorff, Experience Derived from the Operation of
a Large Cobalt-60 Irradiation Plant, presented IAEA Working Group
Meeting on Revision of the Recommended Code of Practice for the
Radiation Sterilization of Medical Products, June 3-9, 1972, pp. 145-151.

1 Appellant also attempts to rely on a Declaration of Dr. Edward Fitzgerald
filed April 15, 2010. However, this Declaration was not made of record in
this reexamination. (See Ans. 9.) Accordingly, we do not consider the
views expressed therein in deciding this appeal.
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The Examiner rejected claims 1-4, 8-37, and 39-44 as follows:
I. Claim 1 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement (Ans. 4);
II. Claim 1 under 35 U.S.C. § 112, second paragraph, for failing to
point out and distinctly claim the subject matter which applicant
regards as the invention (Ans. 4); and
III. Claims 1-4, 8-37, and 39-44 under 35 U.S.C. § 103(a) as
unpatentable over the combined teachings of Clean Rooms,
American Cyanamid, Schweigl, Abplanalp, and Jefferson (Ans.
5-7).

ISSUES
35 U.S.C. §112 Rejections
35 U.S.C. § 112, 1st Paragraph Rejection
The Examiner found that the original disclosure of the ‘695 Patent
does not provide support for the limitation in claim 1, which states: “said
radiation level and time interval being controlled so as to retain the
effectiveness of said chemical disinfectant.” (Ans. 4.)
Appellant contends that the purpose of the invention is to provide
alcohol which can disinfect surfaces in a clean room, and therefore while the
Specification does not use the exact wording of the claims, one of ordinary
skill in the art would have appreciated that Appellant was in possession of
the invention as claimed. (App. Br. 10-11.)

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35 U.S.C. § 112, 2nd Paragraph Rejection
The Examiner concluded that claim 1 is vague and indefinite because
it is unclear what characteristics would be required in order to meet the
terms “suitable” or “effective” recited in the claim, because the
“decontamination procedure” and the “controlled environment” have not
been defined. (Ans. 4.)
Appellant argues the terms “suitable” and “effective” are used to
modify the quantity of chemical disinfectant in the container, and not the
decontamination procedure and the controlled environment, which are well
known to a skilled artisan. (App. Br. 12-13.) Appellant contends that
relative terminology may be broad, but is not necessarily indefinite and that
the terms used in the claims distinguish miniscule amounts of alcohol.
(App. Br. 12-13.)

35 U.S.C. § 103 Rejection
The Examiner found that Clean Rooms discloses an aerosol spray
including alcohol, where the disclosure of and aerosol spray “clearly and
intrinsically requires appropriate containment to provide such a spray.”
(Ans. 5.) The Examiner found that the method recited in claim 1 with the
exception of how terminal sterilization is achieved and the placement of
bagged containers in shipping boxes for terminal sterilization. (Ans. 5.) The
Examiner found that American Cyanamid discloses gamma sterilization of
pre-packaged heat-sealed surgical sutures packaged in isopropyl alcohol,
which are packed into cardboard shipping boxes and sterilized. (Ans. 5.)
The Examiner states that Schweigl, Abplanalp and Jefferson all disclose
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pressurized containers. (Ans. 6, 10.) The Examiner found that Schweigl
and Abplanalp disclose that it was known in the art to terminally sterilize
aerosol cans containing saline and propellant with gamma radiation. (Ans.
6.) The Examiner additionally found that Jefferson discloses that sterilizing
pharmaceutical preparations in pressurized aerosol cans with gamma
radiation is desirable because gamma radiation is a penetrating cold method
of sterilization. (Ans. 6.)
The Examiner concluded that it would have been obvious to box the
aerosol spray containers of Clean Rooms in the final shipping containers and
terminally sterilize then through gamma radiation, because American
Cyanamid, Schweigl, Abplanalp, and Jefferson disclose such as an effective
means of providing terminal sterilization of a pressurized product in a single
step. (Ans. 6.)
Appellant contends that the Examiner has mischaracterized the
teachings of Clean Rooms because Clean Rooms does not disclose any
particular method of sterilizing, an aerosol container, or a pressurized
product. (App. Br. 15-16.) Appellant argues that one or ordinary skill in the
art would not have known that alcohol could be sterilized without destroying
the stability of the alcohol. (App. Br. 18.) Appellant also argues that
American Cyanamid does not teach alcohol sterilization, but rather
sterilizing surgical sutures containing miniscule amounts of alcohol, which
could not be discharged from a pressurized container. (App. Br. 21, 23.)
Thus, Appellant contends that there is no teaching in American Cyanamid to
support the Examiner’s statement that the alcohol would remain effective for
disinfecting, and that even if the alcohol in American Cyanamid were to
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remain effective, such a benefit would be an unrecognized accident. (App.
Br. 23-25.) Regarding Schweigl, Abplanalp, and Jefferson, Appellant
contends that the saline solutions used therein are not flammable, are not
used in clean rooms, and that Abplanalp and Jefferson teach away from the
use of irradiation to sterilize the saline solution in a pressurized aerosol can.
(App. Br. 26, 36.) Appellant argues that there is no expectation of success
for irradiation to sterilize alcohol based on the irradiation of conditioning
fluid or saline in a pressurized container, such that the Examiner has
engaged in impermissible hindsight in concluding the claims on appeal
would have been obvious. (App. Br. 31, 37.)

Thus, the principal issues in this appeal are:
Did the Examiner err in finding that the original disclosure of the ‘695
Patent does not provide support for the limitation in claim 1, which states:
“said radiation level and time interval being controlled so as to retain the
effectiveness of said chemical disinfectant”?
Did the Examiner err in concluding the terms “suitable” or “effective”
recited in claim 1 render the claim vague and indefinite?
Did the Examiner err in concluding that the claims would have been
obvious over the combination of Clean Rooms, American Cyanamid,
Schweigl, Abplanalp, and Jefferson?

FINDINGS OF FACT (“FF”)
1. The ‘695 Patent states that the invention is directed to improved
sterilization methods for isopropyl alcohol used in
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decontamination procedures. (Col. 1, ll. 10-13, 19-21; see also
col. 3, ll. 5-13, col. 6, ll. 5-15.)
2. The ‘695 Patent discloses that the chemical composition
container “may be a standard aerosol can,” where when using
isopropyl alcohol as the chemical composition, it is inserted
under pressure with a propellant such as nitrogen. (Col. 4, ll.
12-18.)
3. Clean Rooms discloses an “isopropyl alcohol aerosol spray”
used in decontamination procedures, which is in a “double bag”
and “terminally sterilized.” (Clean Rooms, Reader Service No.
498.)
4. Clean Rooms is silent as to the container for the aerosol spray
or the method employed for terminal sterilization. (See Clean
Rooms in its entirety.)
5. American Cyanamid discloses that sutures are packaged in
alcohol, where the packages containing alcohol and sutures are
not disclosed as being under pressure. (P. 4, ll. 9-26.)
6. American Cyanamid discloses that the packaged sutures are
sterilized via gamma radiation. (P. 4, ll. 26-34.)
7. Schweigl discloses irradiation of an aerosol saline solution that
has been packaged in a pressurized container. (Col. 4, ll. 18-
68.)
8. Schweigl discloses that saline solution is employed to wash
away chemicals used as part of a disinfecting regimen for the
contact lens. (Col. 1, ll. 23-26.)
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9. Schweigl discloses that radiation will cause some chemicals to
break down. (Col. 2, ll. 11-17.)
10. Abplanalp discloses irradiation of an aerosol saline solution that
has been packaged in a pressurized container. (P. 1, ll. 5-16.)
11. Abplanalp discloses that after radiation treatment, the saline
solutions do not possess any residual bacteria killing or bacteria
controlling activity. (P. 2, ll. 1-4.)
12. Dr. Fitzgerald declared that an aerosol spray in the form of a
stream spray or a mist spray may be generated from a number
of different spray bottles, including spray bottles, squeeze
bottles, or other non-pressurized bottles. (Fitzgerald Dec. para.
13b.)
13. Dr. Fitzgerald declared that chemical disinfectants, such as
alcohol, are flammable, particularly as the volume or
concentration increases, and that the temperature of alcohol
increases during irradiation. (Fitzgerald Dec. para. 32a.)
14. Dr. Fitzgerald declared that when alcohol is placed in a
pressurized container with a propellant, it is potentially
explosive. (Fitzgerald Dec. paras. 32b, 41.)
15. Mr. Vellutato declared that alcohol is flammable and that when
alcohol is irradiated, the temperature of alcohol increases.
(Vellutato Declaration. para. 8, 14.)
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PRINCIPLES OF LAW
To satisfy the written description requirement, a patent applicant must
“convey with reasonable clarity to those skilled in the art that, as of the filing
date sought, he or she was in possession of the invention.” Vas-Cath Inc. v.
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991) (emphasis omitted). “It
is not necessary that the application describe the claim limitations exactly . .
. but only so clearly that persons of ordinary skill in the art will recognize
from the disclosure that appellants invented processes including those
limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA 1976) (internal
citation omitted). That is, the mere absence of literal support for a claim
limitation “does not, in and of itself, establish a prima facie case for lack of
adequate descriptive support under the first paragraph of 35 U.S.C. 112.” Ex
parte Parks, 30 USPQ2d 1234, 1236 (BPAI 1993) (citations omitted).
The test for compliance for 35 U.S.C. § 112, second paragraph, is
whether the claims set out and circumscribe a particular area with a
reasonable degree of precision and particularity when read in light of the
application disclosure as they would be interpreted by one of ordinary skill
in the art. In re Moore, 439 F.2d 1232, 1235 (CCPA 1971).
The Examiner bears the initial burden, on review of prior art or on any
other ground, of presenting a prima facie case of unpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In order to establish a prima
facie case of obviousness, the Examiner must show that each limitation of
the claim is described or suggested by the prior art or would have been
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obvious based on the knowledge of those of ordinary skill in the art. See,
e.g., In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988).

ANALYSIS
35 U.S.C. § 112, 1st Paragraph Rejection
We agree with Appellant, that the ‘695 Patent provides sufficient
support that the inventor was in possession of a method of sterilizing a
chemical disinfectant as recited in claim 1, where the effectiveness of the
chemical disinfectant is retained after the irradiation process is complete.
Specifically, as Appellant points out, the ‘695 Patent is directed to sterilizing
a chemical disinfectant that is used for decontamination procedures. (FF 1.)
Thus, one of ordinary skill in the art would have immediately understood
from reading the Specification of the ‘695 Patent, that after the sterilization
procedure has been performed, the chemical disinfectant must retain the
disinfecting function. Otherwise, the invention could not fulfill its intended
purpose.
Regarding the Examiner’s position that the ‘695 Patent does not
disclose any post-irradiation testing to determine whether the chemical
disinfectant is effective (Ans. 8), the Examiner has not directed our attention
to any persuasive authority that such testing is necessary to determine
whether there is written description support in the Specification. As
discussed above, the ‘695 Patent describes that the chemical disinfectant is
used for disinfection purposes after the irradiation procedure has been
performed. Thus, the written description in the ‘695 Patent shows that the
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inventor was in possession of the method recited in claim 1, where the
chemical disinfectant is effective post irradiation.
Further, we agree with Appellant that the Examiner’s position that the
Specification fails to provide guidance with respect to controlling the
radiation parameters to maintain effectiveness, does not reflect the test for
written description support, but rather relates to whether the claims are
enabled. (Ans. 4; App. Br. 11.) The ’695 Patent provides an adequate
disclosure to satisfy the written description requirement as discussed above.
In addition, the Examiner has not provided a sufficient analysis from which
to conclude that a person of ordinary skill in the art would not have been
able to make and use the invention without undue experimentation.
Accordingly, we reverse the Examiner’s rejection of claim 1 under 35
U.S.C. § 112, first paragraph.

35 U.S.C. § 112, 2nd Paragraph Rejection
We also agree with Appellant that the terms “suitable” and “effective”
do not render claim 1 indefinite. (App. Br. 12-14.) As Appellant points out,
the ‘695 Patent discloses that the containers may be a standard aerosol can,
such that the quantity of chemical disinfectant, for example, alcohol, is only
required to be an amount that is enough to be used in a decontamination
procedure, which is not critical and has a clear meaning to one of ordinary
skill in the art. (App. Br. 13-14; FF 2.) In the instant case, the novel
concept of claim 1 involves the sterilizing procedure disclosed therein, and
not the particular amounts of chemical disinfectant recited in the claims.
Accordingly, although the ‘695 Patent does not specify actual suitable or
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effective quantities of chemical disinfectant, in light of acknowledgement by
Appellant that such quantities are well known in the art, we cannot agree
with the Examiner’s position that it is unclear whether one of ordinary skill
in the art can determine the quantities that are suitable or effective in order
to appreciate the metes and bounds of claim 1. See In re Halleck, 422 F.2d
911 (1970) (35 U.S.C. § 112, 2nd paragraph rejection reversed because
“effective amount” for improved growth stimulation was not critical and
determination of such amounts would not be beyond one skilled in the art
and would not have involved undue experimentation).

35 U.S.C. § 103 Rejection
We agree with Appellant that the combination of the prior art as set
forth in the Examiner’s rejection to arrive at the method of the present
claims would not have been predictable application of the sterilizing
methods of the prior art. (App. Br. 26, 31, 35-36.) Specifically, while Clean
Rooms discloses the terminal sterilization of an alcohol aerosol spray, Clean
Rooms is silent as to whether the aerosol spray is contained in a pressurized
container or the method of terminal sterilization employed. (FF 4.) As
pointed out by Appellant, an aerosol spray may be generated from a number
of different spray bottles, such that an aerosol spray is not necessarily
contained in a pressurized container. (App. Br. 16; FF 12.)
Although both Schweigl and Abplanalp disclose irradiation of an
aerosol saline solution that has been packaged in a pressurized container (FF
7 & 10), we agree with Appellant, that in light of the chemical differences
between the saline solutions in Schweigl and Abplanalp and the alcohols
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disclosed in Clean Rooms and American Cyanamid vis-à-vis, the
flammability of alcohol (see FF 8, 9, 11, 13-15), one of ordinary skill in the
art would not have been led to apply the techniques disclosed in Schweigl
and Abplanalp for packaging and sterilizing the alcohol aerosol spray
disclosed in Clean Rooms. In this regard, we also observe that the saline
solutions in Schweigl and Abplanalp do not appear to have any disinfecting
functions after application of the irradiation treatment. (See FF 8 and 11.)
While American Cyanamid discloses that gamma radiation is applied
in order to sterilize sutures packaged in alcohol, the packages containing
alcohol are not disclosed as being under pressure. (FF 5, 6.) Appellant has
provided evidence that one of ordinary skill in the art would have
understood that when alcohol is placed in a pressurized container with a
propellant, it is potentially explosive. (FF 14.) Appellant has also provided
evidence that when alcohol is irradiated, the temperature of alcohol
increases. (FF 13, 15.) Accordingly, one of ordinary skill in the art would
not have had an adequate reason in applying a sterilizing procedure that
relied on irradiation to a flammable chemical such as alcohol in a
pressurized container. Therefore, we do not sustain the Examiner’s rejection
of the claims.

CONCLUSION
On this record, we find that:
the Examiner erred in finding that the original disclosure of the ‘695
Patent does not provide support for the limitation in claim 1, which states:
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“said radiation level and time interval being controlled so as to retain the
effectiveness of said chemical disinfectant”;
the Examiner erred in concluding the terms “suitable” or “effective”
recited in claim 1 render the claim vague and indefinite; and
the Examiner erred in concluding that the claims would have been
obvious over the combination of Clean Rooms, American Cyanamid,
Schweigl, Abplanalp, and Jefferson.

DECISION
The Examiner’s decision to reject claims 1-4, 8-37, and 39-44 under
35 U.S.C. §§ 112 and 103(a) is reversed.
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).

REVERSED

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