Ex Parte Davis

Board of Patent Appeals and Interferences

Feb 9, 2011

10442220 (B.P.A.I. Feb. 9, 2011)

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.
10/442,220 05/20/2003 Phillip Davis 63634(48996) 3170
21874 7590 02/09/2011
EDWARDS ANGELL PALMER & DODGE LLP
P.O. BOX 55874
BOSTON, MA 02205
EXAMINER
CONLEY, SEAN EVERETT
ART UNIT PAPER NUMBER
1773
MAIL DATE DELIVERY MODE
02/09/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte PHILLIP DAVIS
____________

Appeal 2010-002562
Application 10/442,220
Technology Center 1700
____________

Before CHUNG K. PAK, BEVERLY A. FRANKLIN, and
MICHAEL P. COLAIANNI, Administrative Patent Judges.

PAK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1 through 16, 22 through 25, and 27, all of the claims
pending in the above-identified application.1 An oral hearing was held on
January 20, 2011. We have jurisdiction under 35 U.S.C. § 6.

1 See generally the Appeal Brief filed October 21, 2008 (“App. Br.), the
Answer dated December 23, 2008 (“Ans.”), and the Reply Brief filed
February 13, 2009 (“Reply Br.”).
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STATEMENT OF THE CASE
The subject matter on appeal is directed to a “[a] system for reducing
tears in a sterilization wrap surrounding a sterilization tray” containing
surgical instruments (See, e.g., claims 1, 10, 15, and 25 and Spec. 1, ll. 9-
11). The system is said to include a sterilization wrap protector made of a
foam plastic material, a sterilization tray, a sterilization wrap and at least one
surgical instrument (App. Br. 7-16 and Spec. 3, ll. 2-4). Figure 4 of the
above-identified application illustrates such system as shown below:

Elements 10, 34, and 36 of Figure 4 are identified as corner protectors (i.e.,
sterilization wrap protectors), a sterilization tray, and a sterilization wrap,
respectively at pages 7 and 8 of the Specification. According to pages 1 and
2 of the Specification, such system provides corner protectors (sterilization
wrap protectors) which completely cover the sharp corners of the
sterilization tray unlike a conventional system. The conventional system is
described at pages 1 and 2 of the Specification as follows:
Sterilization of surgical tools including scalpels, scissors
and clamps may be accomplished in a known manner by
placing the tools in a sterilization tray, wrapping the tray with a
sterilization wrap to form a sterilization pack and then placing
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the pack into a sterilizer. Once a sterilization pack has
completed a sterilization cycle, it may be removed from the
sterilizer and stored for future use during surgery.
One long and continuing problem encountered with
sterilization packs includes tearing and ripping open of the
sterilization wrap prior to use of the sterilized surgical
equipment. Of course, once a pack is torn, the entire contents
are deemed contaminated with bacteria and the like and,
therefore, must be re-wrapped and then re-sterilized. A typical
location where a rip may occur is at a corner of a sterilization
pack.
On prior art corner protector for protecting rips in a
sterilization wrap of a sterilization pack is shown at 100 in
Figure 1. The corner protector 100 is composed of reticulated
plastic foam and has a rectangular, block-like shape. …

Details of the appealed subject matter are recited in representative claims 1,
10, 15, and 25 reproduced from the Claims Appendix to the Appeal Brief as
shown below:

1. A system for reducing tears in a sterilization wrap surrounding a
sterilization tray comprising:

a) at least one generally corner-shaped sterilization wrap protector
including:

i) an inside engagement area for accommodating a comer
portion of a sterilization tray, the inside engagement area being
bounded by a first inside portion that is generally planar, a
second inside portion that is generally planar and which extends
in a direction that is generally perpendicular to the first inside
portion and a third inside portion which defines a plane that
extends in a direction that is generally perpendicular to
the first inside portion and to the second inside portion; and

ii) an outside engagement area for accommodating a
sterilization wrap, the outside engagement area being bounded
by a first outside portion that is generally planar, a second
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outside portion that is generally planar and which extends in a
direction that is generally perpendicular to the first outside
portion and a third outside portion which defines a plane that
extends in a direction that is generally perpendicular to the first
outside portion and to the second outside portion; and

b) a gas permeable sterilization wrap surrounding the sterilization tray
and engaged with the outside engagement area.

10. A system for reducing tears in a sterilization wrap surrounding a
sterilization tray comprising:

a) at least one sterilization wrap protector including:

i) a tray comer engagement surface comprising a first comer
engagement surface that is generally planar, a second comer
engagement surface that is generally planar and which extends
in a direction that is generally perpendicular to the first comer
engagement surface and a third comer engagement surface that
is generally planar and which extends in a direction that is
generally perpendicular to the first comer engagement surface
and to the second comer engagement surface wherein the first,
second and third comer engagement surfaces intersect to define
an inside comer point; and

ii) a sterilization wrap engagement surface comprising a first
sterilization wrap engagement surface that is generally planar, a
second sterilization wrap engagement surface that is generally
planar and which extends in a direction that is generally
perpendicular to the first sterilization wrap engagement surface
mad a third sterilization wrap engagement surface that
is generally planar and which extends in a direction that is
generally perpendicular to the first sterilization wrap
engagement surface and to the second sterilization wrap
engagement surface wherein the first, second and
third sterilization wrap engagement surfaces intersect to define
an outside comer point; wherein the tray comer engagement
surface and the sterilization wrap engagement surface axe
separated by a generally constant thickness of the material; and
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b) a gas permeable sterilization wrap surrounding the sterilization tray
and engaged with the sterilization wrap engagement surface.

15. A system for reducing tears in a sterilization wrap surrounding a
sterilization tray comprising:

a) at least one sterilization wrap protector including:

i) a tray comer engagement surface comprising a first comer
engagement surface that is generally planar, a second comer
engagement surface that is generally planar and which extends
in a direction that is generally perpendicular to the first comer
engagement surface and a third comer engagement surface that
is generally planar and which extends in a direction that is
generally perpendicular to the first comer engagement surface
and to the second comer engagement surface wherein the first,
second and third comer engagement surfaces intersect to define
an inside comer point; and

ii) a sterilization wrap engagement surface comprising a first
sterilization wrap engagement surface that is generally planar, a
second sterilization wrap engagement surface that is generally
planar and which extends in a direction that is generally
perpendicular to the first sterilization wrap engagement surface
and a third sterilization wrap engagement surface that is
generally planar and which extends in a direction that is
generally perpendicular to the first sterilization wrap
engagement surface and to the second sterilization wrap
engagement surface wherein the first, second and third
sterilization wrap engagement surfaces intersect to define an
outside comer point; and

iii) wherein the tray comer engagement surface and the
sterilization wrap engagement surface are separated by a
generally constant thickness of the material, the first and second
comer engagement surfaces have a surface area that is
substantially less than that of the third comer engagement
surface, the first and second sterilization wrap engagement
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surfaces have a
surface area that is substantially less than that of the third
sterilization wrap engagement surface and wherein the
sterilization tray comprises a sterilization tray side surface, a
sterilization tray front surface and a sterilization tray bottom
surface and wherein each of the first, second and third corner
engagement surfaces each have a surface area that is
substantially less than that of the sterilization tray side surface,
the sterilization tray front surface and the sterilization tray
bottom surface, respectively and;

b) a gas permeable sterilization wrap surrounding the sterilization tray
and engaged with the sterilization wrap engagement surface.

25. A system for preventing tears in a sterilization wrap, comprising:

a) a generally rectangular surgical sterilization tray including at least
one surgical instrument, the tray having a plurality of corners
proximate the bottom of the tray, each corner being defined by three
generally orthogonal faces, the tray being adapted and configured for
permitting the sterilization of the instrument;

b) a plurality of wrap protectors, each wrap protector surrounding
each corner proximate the bottom of the tray, the wrap protector
having an inside surface having three generally orthogonal faces that
axe adapted and configured to receive the three generally orthogonal
faces of each corner of the surgical sterilization tray; and
c) a gas-permeable sterilization wrap surrounding the surgical
sterilization tray and engaging the plurality of wrap protectors, the
plurality of wrap protectors separating the sterilization tray from the
sterilization wrap.
As evidence of unpatentability of the claimed subject matter, the
Examiner relies on the following references at page 3 of the Answer:
Maurice US 4,851,286 Jul. 25, 1989
Griffiths US 4,961,502 Oct. 9, 1990
Kroeckel US 5,370,222 Dec. 6, 1994
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Watanabe JP407187247 A Jul. 25, 1995
Rilley US 5,882,612 Mar. 16, 1999

“Clysar® Shrink and Overwrap Films,” Bemis Europe Flexible Packaging,
http://www.bemis-europe.com (unknown publication date) (hereinafter
referred to as “Bemis”).

“Shrink film prevents fogging-Clysar polyolefin film from E.I. du Pont de
Nemours and Company Inc – Applied Technologies,” Bob Swientek,
http://findarticles.com/p/articles/mi_m3289/is_n11_v162/ali_14605228
(Oct. 1993)(hereinafter referred to as “due Pont”)

As evidence of patentability of the claimed subject matter, Appellant
relies on the following evidence attached as pages 32 through 190 of the
Appeal Brief:
Glowezewskie, Jr. US 4,844,259 Jul. 4, 1989
Davis US 6,440,375 B1 Aug. 27, 2002
Curnow WO 2007/019233 A2 Feb. 15, 2007

“Comprehensive guide to steam sterilization and sterility assurance in health
care facilities,” AAMI, ANSI/AAMI ST79:2006, p. 54 (unknown
publication date)

Health Care Purchasing News, “CS Questions & Answers,” Ray Taurasi,
(2006).

Cygnus Wrap Protector Product (unknown page number and publication
date).

AveeoMedix, “AveeoMedix Wrap Protector Product,” (unknown page
numbers and publication date).

“STOPPER: Velmed Wrap Protector Product,” Reorder # 5100 (unknown
page numbers and publication date).

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Declaration of Jordan Barnes under 37 C.F.R. § 1.132 executed on
September 14, 2007.

Second Declaration of Jordan Barnes under 37 C.F.R. § 1.132 executed on
January 24, 2008.

Declaration of Phillip Davis under 37 C.F.R. § 1.132 executed on March 26,
2007.

Declaration of Larry Kelly under 37 C.F.R. § 1.132 executed on August 3,
2007.

Declaration of Michael Davis under 37 C.F.R. § 1.132 executed on August
7, 2007.

Declaration of Tony Clarke under 37 C.F.R. § 1.132 executed on August 20,
2007.

Declaration of Karen Baker under 37 C.F.R. § 1.132 executed on September
13, 2007.

Appellant seeks review of the following grounds of rejection set forth
in the Answer (App. Br. 6):
1) Claim 25 under 35 U.S.C. § 102(b) as anticipated by the
disclosure of Kroeckel;
2) Claim 27 under 35 U.S.C. § 103(a) as unpatentable over the
combined disclosures of Kroeckel and Maurice;
3) Claims 1 through 16 under 35 U.S.C. § 103(a) as unpatentable
over the combined disclosures of Kroeckel and Watanabe; and
4) Claims 22 through 24 under 35 U.S.C. § 103(a) as unpatentable
over the combined disclosures of Kroeckel, Watanabe, and Maurice.

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RELEVENT FACTS, PRINCIPLES OF LAW, ISSUE, ANALYSIS, AND
CONCLUSIONS
The Examiner’s §§ 102(b) and 103(a) rejections are based on the
Examiner’s finding that Kroeckel teaches the claimed sterilization tray,
sterilization wrap, and surgical instrument.2 On the other hand, Appellant
contends, inter alia, that Kroeckel does not teach the claimed sterilization
tray, sterilization wrap, and surgical instrument.
Thus, the dispositive question raised is: Has the Examiner
demonstrated that Kroeckel teaches the claimed sterilization tray,
sterilization wrap and surgical instrument? On this record, we answer this
question in the negative.
As correctly argued by Appellant at pages 12 through 14, the
Examiner has not established that Kroeckel’s box for fragile articles and
CLYSAR® Shrink film (identified by Bemis and du Pont as a clear
packaging film) are capable of functioning as a sterilization tray and a
sterilization wrap, respectively for sterilizing surgical instruments. Although
the Examiner has taken an official notice of a particular fact3 to show that
the clear packaging film and box taught by Kroeckel are capable of the
claimed functionalities, such official notice is improper. It is well settled
that the Examiner cannot take an official notice of such specific knowledge

2Appellant does not dispute the Examiner’s finding that Watanabe and
Maurice teach particular corner protectors corresponding to the claimed
corner-shaped sterilization wrap protectors.
3 The Examiner has taken an official notice that “it is well known and
conventional in the sterilization art to utilize ultraviolet light to sterilize
items that are sealed in a tray wrapped with a shrink wrap plastic material”
at page 9 of the non-final Office action dated November 28, 2007 and pages
13 and 19 of the Answer.
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peculiar to a particular art as correctly argued by Appellant at page 14 of the
Appeal Brief. In re Ahlert, 424 F.2d 1088, 1091 (CCPA 1970).
Consequently, the Examiner’s assertion of the claimed capabilities of the
clear packaging film and box taught by Kroeckel is not supported by any
factual findings of record.
Moreover, as asserted by Appellant at page 11 of the Appeal Brief,
the Examiner has incorrectly interpreted the claimed “surgical instrument”
as including Kroeckel’s fragile products, such as x-ray cassettes, since such
interpretation is not consistent with the Specification. As indicated supra,
the Specification identifies only scalpels, scissors and clamps as surgical
instruments in a sterilization tray subject to sterilization prior to their use in
surgeries. Implicit in this description in the Specification is that the claimed
surgical instruments are limited to those surgical tools which come into
contact with patients during surgeries and which require sterilization to
avoid infecting the patients. SciMed Life Sys., Inc. v. Advanced
Cardiovascular Sys., Inc., 242 F.3d 1337, 1344 (Fed. Cir. 2001) (“[T]he
written description can provide guidance as to the meaning of the claims,
thereby dictating the manner in which the claims are to be construed, even if
the guidance is not provided in explicit definitional format.”); See also In re
Fout, 675 F.2d 297, 300 (CCPA 1982) (“Claims must always be read in light
of the specification. Here the specification makes plain what the appellants
did and did not invent….”).
Accordingly, we reverse the Examiner’s decision rejecting claim 25
under § 102(b) and claims 1 through 16, 22 through 24, and 27 under
§ 103(a).

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NEW GROUND OF REJECTION
Pursuant to 37 C.F.R. § 41.50(b), we enter the following new ground
of rejection.
Claims 1 through 16, 22 through 25, and 27 are rejected under 35
U.S.C. § 103(a) as unpatentable over the combined teachings of the admitted
prior art (Appellant’s admission at pages 1 and 2 of the Specification),
Davis, Kroeckel, Watanabe4, and Maurice. Appellant acknowledges at
pages 1 and 2 of the Specification that:
Sterilization of surgical tools including scalpels, scissors
and clamps may be accomplished in a known manner by
placing the tools in a sterilization tray, wrapping the tray with a
sterilization wrap to form a sterilization pack and then placing
the pack into a sterilizer. Once a sterilization pack has
completed a sterilization cycle, it may be removed from the
sterilizer and stored for future use during surgery.
One long and continuing problem encountered with
sterilization packs includes tearing and ripping open of the
sterilization wrap prior to use of the sterilized surgical
equipment. Of course, once a pack is torn, the entire contents
are deemed contaminated with bacteria and the like and,
therefore, must be re-wrapped and then re-sterilized. A typical
location where a rip may occur is at a corner of a sterilization
pack.
One prior art corner protector for protecting rips in a
sterilization wrap of a sterilization pack is shown at 100 in
Figure 1. The corner protector 100 is composed of reticulated
plastic foam and has a rectangular, block-like shape. …

Appellant contends that the admittedly known prior art corner
protector 100 does not correspond to the claimed corner protector used in the
claimed sterilization system (Spec. 2).

4 Our reference to Watanabe is to the corresponding English translation of
record.
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Thus, the dispositive question is: Does one of ordinary skill in the art
have a reason, suggestion or motivation to employ the claimed corner-
shaped sterilization wrap protectors, in lieu of known corner protectors made
of plastic foam, in the admittedly known sterilization system taught at pages
1 and 2 of the Specification within the meaning of 35 U.S.C. § 103(a). On
this record, we answer this question in the affirmative.
As indicated supra, Appellant acknowledges that “[a] typical location
where a rip may occur is at a corner of a sterilization pack” and the use of a
plastic foam material in such corner to prevent rips in a sterilization wrap is
known. From the known plastic foam corner protector shown in Figure 2 of
the present application, one of ordinary skill in the art would have also
readily noticed through simple observation that the admittedly known plastic
foam corner protectors 100 do not completely cover the corners of a
sterilization tray, which typically cause rips in a sterilization wrap. In re
Ludwig, 353 F.2d 241, 244 (CCPA 1965) (Discovery of a problem readily
noticeable via simple observation is well within the ambit of one of ordinary
skill in the art.)
Moreover, Davis discloses using a highly absorbent trayliner made of
a polymeric foam material in a sterilization tray to provide a dry condition at
the completion of sterilization and to further cushion “the instrumentation,
thus minimizing the potential for instrumentation damage during post-
sterilization handling” (col. 2, ll. 31-43 and col. 3, ll. 40-57). It can be
inferred from this disclosure of Davis that providing any additional
cushioning effect for surgical instruments in the sterilization tray for the
purpose of further minimizing “the potential for instrumentation damage
during post-sterilization handling” is desirable. KSR Int’l. Co. v. Teleflex
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Inc., 550 U.S. 398, 418 (2007) (“[A]nalysis [of whether the subject matter of
a claim would have been obvious under § 103] need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ. (Emphasis added.)”);
We note that Appellant does not dispute the Examiner’s finding that
Kroeckel, Watanabe, and/or Maurice teach or would have suggested using
the claimed corner-shaped sterilization wrap protectors made of plastic foam
materials to cover the sharp corners of a container prior to wrapping to
provide a cushioning effect to minimize the potential damage to articles
therein, including fragile articles, such as x-ray cassettes used in the medical
field. We also note that one of ordinary skill in the art would have readily
noticed through simple observation that the corner-shaped sterilization wrap
protectors taught or suggested by Kroeckel, Watanabe, and/or Maurice
would completely cover the sharpe corners of a sterilization tray, which
typically cause rips in the sterilization wrap. Ludwig, 353 F.2d at 244.
Given the above circumstances, we determine that one of ordinary
skill in the art would have been led to employ the claimed known plastic
foam corner protectors taught or suggested by Kroeckel, Watanabe, and/or
Maurice as the corner protectors of the admittedly known sterilization
system, with a reasonable expectation of successfully minimizing rips in the
sterilization wrap employed and/or successfully minimizing the potential
damage to surgical instruments in the sterilization tray during post-
sterilization handling. See, e.g., See KSR, 550 U.S. at 420 (“One of the ways
in which a patent's subject matter can be proved obvious is by noting that
there existed at the time of invention a known problem for which there was
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an obvious solution encompassed by the patent's claims.”); In re O’Farrell,
853 F.2d 894, 903-04 (Fed. Cir. 1988) (“For obviousness under § 103, all
that is required is a reasonable expectation of success.”).
In reaching this determination, we have considered the relevance of
Kroeckel, Watanabe, and Maurice. As is apparent from our obviousness
analysis, we find that Kroeckel, Watanabe, and Maurice are from analogous
art. See KSR, 550 U.S. at 417 (“When a work is available in one field of
endeavor, design incentives and other market forces can prompt variations of
it, either in the same field or a different one.”); Agrizap, Inc. v. Woodstream
Corp., 520 F.3d 1337, 1342 (Fed. Cir. 2008) (Analogous art is not limited to
references in the field of endeavor of the invention, but also includes
references that would have been recognized by those of ordinary skill in the
art as useful for applicant’s purpose). We find that Kroeckel, Watanabe, and
Maurice are broadly from the same field of endeavor as the claimed
invention since the claimed system and the system taught by Kroeckel,
Watanabe, and Maurice are broadly from the packaging art, inclusive of the
packaging of a sterilization tray. (See Appellant’s Exhibit A,
Comprehensive guide to steam sterilization and sterility assurance in health
care facilities, “Packaging, preparation, and sterilization” (emphasis
added.)). Even if Kroeckel, Watanabe, and Maurice are not from the same
field of endeavor as the claimed system, they, as recognized by one of
ordinary skill in the art, are at least concerned with solving the needs of the
claimed sterilization system as discussed supra.
Appellant contents that the declarations relied upon provide “clear and
convincing evidence that the claimed invention is commercially successful,
meets a long-felt need, and has been copied by another in a relatively short
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period of time” (App. Br. 16-21). However, we are not persuaded by
Appellant’s declarations or arguments for the reasons articulated by the
Examiner at pages 26 and 27 of the Answer and set forth infra.
First, we find that Appellant has not provided sufficient proof to
establish that the claimed sterilization system comprising at least a
sterilization tray, a sterilization wrap and at least one particular corner
protector is commercially successful and that their sales are directly resulted
from the merits of the claimed invention. In re Huang, 100 F.3d 135, 139-
40 (Fed. Cir. 1996). In this regard, we note that the declarations relied upon
by Appellant do not evince the number of the claimed systems sold and the
actual market share of the claimed systems in a given market. Id. The
declaration of Philip Davis, the inventor, for example, indicates only the
number of the corner protectors5 sold, not the claimed systems. The
declaration Philip Davis also does not specify the extent of the advertisement
employed, i.e., below, above, or identical to a given industry norm.
Nowhere do the declarations demonstrate that the claimed system is
commercially successful or that any commercial success is due to the merits
of the claimed system.
Secondly, we find that Appellant has not demonstrated that the
claimed invention meets a long-felt, but unsolved need in the sterilization
art. See Monarch Knitting Machinery Corp. v. Sulzer Moral GmbH, 139
F.3d 877, 884 (Fed. Cir. 1998) (“The relevant secondary consideration is
‘long-felt but unsolved need,’ not long-felt need in isolation.”). In

5 As is apparent from the disclosures of Watanabe, and Maurice, the claimed
corner protectors can be used in a system different from the claimed system.
Thus, the number of the corner protectors sold does not necessarily translate
into the demand for the claimed system.
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particular, Appellant has not supplied sufficient evidence to demonstrate that
there was a problem (others have failed to solve) existed over a long period
of time and that the claimed “invention actually provided a long-awaited,
widely-accepted, and promptly-adopted solution to the problem extant in the
art.” In re Mixson, 470 F.2d 1374, 1377 (CCPA 1973). The declaration of
Larry Kelly, for example, states that the use of corner protectors made of a
plastic foam material, inclusive of the admittedly known plastic foam corner
protector, solved the lint problem associated with towels used to prevent
wrap tear typically occurring at sterilization tray corners.6 The declarations
of Larry Kelly, Toney Clarke, Philip Davis, and Michael Davis do not
discuss the sufficiency of the solution already provided by the admittedly
known corner protecting sterilization system and/or the particularly designed
sterilization tray corners taught by Riley (See Spec. 1-2 and Riley, col. 1, ll.
37-40). Although the declarations of Karen Baker and Jordan Barnes
denigrate the performance of either the admittedly known corner protecting
sterilization system or the particularly designed sterilization tray corners
taught by Riley, there is no factual or objective evidence to support such
assertions. In other words, Appellant has not shown that the admittedly
known corner protecting sterilization system or the particularly designed

6 The declarations relied upon by Appellant indicates that wrap tears
occurring at sterilization tray corners were known at the time of the
invention. See, e.g., paragraphs 3-5 of the declaration of Toney Clarke. The
declarations also state that surgical towels, for example, were used on the
corners of a sterilization tray to prevent wrap tears, but were problematic
because they introduce lint into the sterilization system. See, e.g.,
paragraphs 8-12 of the declaration of Larry Kelly, paragraphs 10-11 of the
declaration of Michael Davis, paragraph 5 of the declaration of Karen Baker,
paragraph 7 of the declaration of Phillip Davis, and paragraph 6-8 of the
declaration of Toney Clarke.
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sterilization tray corners taught by Riley fails to address the known wrap tear
problem.
In addition, the declarations relied upon by Appellant do not show that
the claimed invention was a “widely-accepted and promptly-adopted
solution to the problem extant in the art.” The declarations of Jordan Barnes
indicate that the six companies either copied or independently derived corner
protectors within the broadly described corner protectors of the claimed
system, while the declaration of Philip Davis shows the number of the corner
protectors sold. As is apparent from the claims on appeal and the prior art of
record, there is no novelty in the corner protectors themselves. The prior art
of record, namely Watanabe and Maurice, also show that the claimed corner
protectors, one component of the claimed system, are useful for packaging
systems different from that claimed. Thus, it is not clear from the
declarations relied upon what extent of the claimed system was accepted and
promptly adopted to alleviate the sterilization wrap tear problem.
Finally, Appellant has not shown that there was the widespread
acceptance and adoption of the claimed subject matter to demonstrate
copying of the claimed invention for the reasons indicated supra. Cable
Electric. Prods. v. Genmark, Inc., 770 F.2d 1015, 1028 (Fed. Cir. 1984). In
addition to the findings set forth in the Answer, we also want to emphasize
that the claimed subject matter is directed to a system comprising a
sterilization tray, a sterilization wrap and at least one corner protector. We
find that the manufacture or sale of the corner protectors used in the claimed
system alone does not establish a wide acceptance of the claimed system
since the corner protectors have various uses, including in systems which are
different from that claimed as is apparent from the applied prior art.
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Accordingly, we determine that the preponderance of evidence
weighs most heavily in favor of obviousness within the meaning of 35
U.S.C. § 103(a).
ORDER
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner to reject claim 25 under
§ 102(b) and claims 1 through 16, 22 through 24, and 27 under 35 U.S.C.
§ 103(a) is REVERSED; and
FURTHER ORDERED that the new ground of rejection against
claims 1 through 16, 22 through 25, and 27 under 35 U.S.C. § 103(a) as
unpatentable over the combined teachings of the admitted prior art, Davis,
Kroeckel, Watanabe, and Maurice is ENTERED.
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provide that the Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected, or both,
and have the matter reconsidered by the Examiner, in which event the
proceeding will be remanded to the Examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record. . . .
Appeal 2010-002562
Application 10/442,220

19
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2007).

REVERSED/ § 41.50(b)

sld

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