Ex Parte Vellutato

Patent Trial and Appeal Board

Nov 20, 2018

10754629 (P.T.A.B. Nov. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/754,629 01/12/2004
27557 7590 11/23/2018
BLANK ROME LLP
1825 Eye Street NW
WASHINGTON, DC 20006-5403
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Arthur L. Vellutato SR.
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
100858-00113 8071
EXAMINER
MARCHESCHI, MICHAEL A
ART UNIT PAPER NUMBER
1799
NOTIFICATION DATE DELIVERY MODE
11/23/2018 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):
W ashingtonDocketing@blankrome.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte ARTHURL. VELLUTATO, SR.
Appeal2017-002800
Application 10/754,629
Technology Center 1700
Before ROMULO H. DELMENDO, BEYERL YA. FRANKLIN, and
JENNIFER R. GUPTA, Administrative Patent Judges.
DELMENDO, Administrative Patent Judge.
DECISION ON APPEAL
The Applicant ("Appellant") 1 appeals under 35 U.S.C. § 134(a) from
the Primary Examiner's non-final decision to reject claims 1-8, 16-21, and
23--41. 23 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 The Appellant states that the real party in interest is "V eltek Associates,
Inc." (Appeal Brief filed May 31, 2016 ("Appeal Br.") at 1).
2 Appeal Br. 5-16; Reply Brief filed December 12, 2016 ("Reply Br.") 1-8;
Non-Final Office Action entered July 29, 2015 ("Non-Final Act.") 3-12;
Examiner's Answer entered October 11, 2016 ("Ans.") 2-22.
3 Oral arguments were heard from the Appellant's representative on
November 15, 2018, a written transcript of which should be entered into the
record in due course.
Appeal2017-002800
Application 10/754,629
I. BACKGROUND
The subject matter on appeal relates to a method for sterilizing two
chemical compositions, such as a concentrated composition and a diluent,
contained within two respective containers for subsequent mixing in an
aseptic or sterile environment (Specification filed January 12, 2004
("Spec."), ,r 1 and Abstract). Representative claim 1 is reproduced as
follows:
1. A method of sterilizing a chemical composition
comprising the steps of:
providing a first container with a first chemical
composition and a second container with a second chemical
composition, wherein the first container is positioned with
respect to the second container so that the first chemical
composition is maintained apart from said second chemical
composition, but can be combined with the second chemical
composition, and wherein the first and second containers are
configured to be used in a clean environment without
contaminating the clean environment;
sealing the first and second containers in a first sealing
layer to form a first sealed container enclosure;
enclosing said first sealed container enclosure in a
shipping container to form a closed shipping package; and
externally irradiating said closed shipping package at a
predetermined radiation level for a predetermined time interval
to simultaneously sterilize said first and second chemical
compositions, said first and second containers, said first sealed
container enclosure, and said closed shipping package.
(Appeal Br. 18 (Claims Appendix); emphasis added).
II. REJECTIONS ON APPEAL
On appeal, the Examiner maintains three rejections:
A. Claims 37 and 41 under pre-AIA 35 U.S.C. § 112, ,r 1, as
failing to comply with the written description requirement;
2
Appeal2017-002800
Application 10/754,629
B. Claims 1-3, 7, 8, 16, 20, 21, and 25--41 underpre-AIA
35 U.S.C. § I03(a) as unpatentable over Vellutato4 in view of
Leoncavallo; 5 and
C. Claims 4--6, 17-19, 23, and 24 under 35 U.S.C. § I03(a) as
unpatentable over Vellutato in view of Leoncavallo and
Carpenter. 6
(Ans. 2-22; Non-Final Act. 3-12.)
III. DISCUSSION
Rejection A. Claims 37 and 41 were added by an Amendment filed
July 9, 2015. Claim 3 7, which depends from claim 1, recites "the first and
second containers are not frangible or breakable" (Appeal Br. 24).
Claim 41, which depends from claim 16, recites "the container is not
frangible or breakable" (id.). 7
The Examiner finds that these added claims do not comply with the
written description requirement of 35 U.S.C. § 112, ,r 1, because the
Specification, as filed originally, does not provide adequate support for the
limitations (Ans. 3). The Appellant, on the other hand, contends that the
Drawings filed January 12, 2004 describe an exemplary embodiment in
which a user may open a lid 21 and pull upwards a pull ring 102, which
4 US 6,123,900, issued September 26, 2000.
5 US 6,305,576 Bl, issued October 23, 2001.
6 US 6,150,423, issued November 21, 2000.
7 According to the Appellant, the limitations in claims 37 and 41 were
"added to further differentiate the present invention from the prior art to
Leoncavallo, which specifically provides a container that is 'frangible or
breakable' to allow fluid to pass out of it" (id. at 6).
3
Appeal2017-002800
Application 10/754,629
would then open a nozzle cap 4 7 to release a liquid from a small container
40 into a large container 20 without the need for the smaller container 40 to
be frangible or breakable (Appeal Br. 6-7) (citing Figs. 1, 6(a}-6(c)).
The Appellant's argument is insufficient to identify any reversible
error in the Examiner's rejection. In re Jung, 637 F.3d 1356, 1365 (Fed. Cir.
2011).
The written description requirement does not require in haec verba
support. In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996). Nevertheless,
"the test for sufficiency is whether the disclosure of the application relied
upon reasonably conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date." Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).
Here, the Appellant does not dispute the Examiner's finding (Ans. 10-
11) that the original disclosure does not contain any description that would
have indicated to one skilled in the relevant art that the smaller second
container 40 is made of a material that is not frangible or breakable (Appeal
Br. 6-7). Instead, the Appellant relies on the exemplary embodiment shown
in Figures 1 and 6(a}-6(c), as we recounted above. That exemplary
embodiment, however, features a lid and pull ring mechanism to release the
smaller container's contents. At most, the exemplary embodiment would
have supported a method that uses such a lid and pull ring mechanism, but
neither claim 3 7 nor 41 specifies such a method. We have not been directed
to sufficient support in the original disclosure providing any hint-much less
a description----of the breaking strength of the container materials. The
Specification states that the containers are "preferably round plastic bottles"
4
Appeal2017-002800
Application 10/754,629
but fails to provide any details on the mechanical or breaking strength of the
plastic material that are used to make the bottles (Spec. ,r 20).
Because the Appellant does not direct us to any description that
supports a method in which a fluid may be released from an unbreakable8
container that does not use such a lid and pull ring mechanism, we sustain
the Examiner's rejection. Ex parte Grasselli, 231 USPQ 393, 394 (Bd. App.
1983) ("[T]he negative limitations recited in the present claims, which did
not appear in the specification as filed, introduce new concepts and violate
the description requirement of the first paragraph of35 U.S.C. [§] 112."),
aff'd mem., 738 F.2d 453 (Fed. Cir. 1984).
Rejection B. Except for claim 37 and 41 collectively, the Appellant
relies on the same arguments for all claims subject to this ground of rejection
(Appeal Br. 8-15). Therefore, we confine our discussion to claims 1 and 37,
which we select as representative pursuant to 37 C.F.R. § 4I.37(c)(l)(iv).
As provided by this rule, claims 2, 3, 7, 8, 16, 20, 21, 25-36, and 38--40
stand or fall with claim 1, and claim 41 stands or falls with claim 3 7.
The Examiner finds that Vellutato describes a sterilization method
including every limitation recited in claim 1 except for "a second container
with a second chemical composition" (Ans. 3--4). To resolve this difference,
the Examiner relies on Leoncavallo (id. at 4). Specifically, the Examiner
finds that "it is generally known in the art ... to utilize a first container that
is positioned with respect to the second container so that the first chemical
composition is maintained apart from said second chemical composition, but
[subsequently] can be combined with the second chemical composition," as
8 The Appellant does not even identify what materials would be
"unbreakable."
5
Appeal2017-002800
Application 10/754,629
evidenced by Leoncavallo (id.). Finding further that Leoncavallo teaches
that the disclosed two-container system is suitable for use in laboratory,
scientific, or medical environments, the Examiner concludes that the claimed
subject matter would have been obvious to a person having ordinary skill in
the art because that person would have expected success in applying
Vellutato's sterilization method to Leoncavallo's two-container system (id.
at 5---6).
The Appellant contends that the Examiner failed to make out a prima
facie case of obviousness against claim 1 because "the Examiner's entire
rejection is based on the analysis that if Leoncavallo can mix the liquids
without being exposed to the external environment, then the liquids cannot
contaminate the clean environment" (Appeal Br. 10). According to the
Appellant, the Examiner "completely ignor[ es] the possibility of the
container itself being a contaminant" (id.). The Appellant urges that
"Leoncavallo is not suitable for use in a clean environment" (id.). The
Appellant also argues that Leoncavallo is non-analogous to Vellutato, and,
therefore, cannot be combined (id. at 11-12). The Appellant argues that
even if these references are combined, "it would destroy the Vellutato
teaching since the resulting product would contaminate the clean
environment" (id. at 12). Furthermore, the Appellant argues that the
Examiner failed to give proper weight to the recitation "configured to be
used in a clean environment" in claim 1 (id. at 13). As for claims 37 and 41,
the Appellant argues that Leoncavallo teaches away from the recited
limitations (id. at 11 ).
The Appellant's arguments fail to identify any reversible error in the
Examiner's rejection. Jung, 637 F.3d at 1365.
6
Appeal2017-002800
Application 10/754,629
V ellutato describes a sterilization method that is identical to the
Appellant's claimed method except that it is applied to a single container
system rather than a two-container system (Vellutato col. 2, 1. 28---col. 5, 1.
32; col. 6, 1. 47---col. 7, 1. 6 (claim 1)). In particular, Vellutato teaches that
the method is suitable for containers for chemical compositions used in clean
room-type atmospheres (e.g., pharmaceutical industry) (id. at col. 2, 11. 53-
60; col. 3, 11. 1-9).
Leoncavallo teaches a two-container system for storing liquids that
are subsequently mixed in various environments such as laboratories and
other scientific or medical environments (Leoncavallo col. 1, 11. 13-33; col.
1, 1. 66-col. 2, 1. 9; Fig. 2, 3, 4A, and 4B). In particular, Leoncavallo teaches
a cartridge 80, which communicates with an interior 64, including a
cartridge body 82 defining a sealed, but frangible or breakable end 92 (id.
Fig. 2; col. 5, 11. 8-37). A person having ordinary skill in the art would have
drawn a reasonable inference from Leoncavallo's disclosure that certain
medical or laboratory environments would require clean, sterile conditions
(id. at col. 1, 11. 24--27 ("Especially in the case of laboratory, scientific or
medical situations, aseptic conditions are often required for the fluid
material or materials during storage, shipping, handling and use.") ( emphasis
added)). Therefore, that person having ordinary skill in the art would have
understood from no more than common sense and ordinary creativity that
sterilization of Leoncavallo's system would have been desirable. In re
Preda, 401 F.2d 825, 826 (CCPA 1968) ("[I]n considering the disclosure of
a reference, it is proper to take into account not only specific teachings of the
reference but also the inferences which one skilled in the art would
reasonably be expected to draw therefrom.").
7
Appeal2017-002800
Application 10/754,629
Where Leoncavallo's two-container system is to be used in a clean,
sterile environment, a person having ordinary skill in the art would have
found it obvious to implement an advantageous, well-known sterilization
technique such as that shown in Vellutato in order to maintain the chemical
compositions in a sterilized state over an extended period of time (V ellutato
col. 2, 11. 28---60). KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,417 (2007)
("[I]f a technique has been used to improve one device, and a person of
ordinary skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its actual
application is beyond his or her skill.").
The Appellant's argument that Leoncavallo is non-analogous to
Vellutato is unpersuasive because it is not accompanied by any reasonably
specific discussion on the tests used by courts for determining whether a
reference is not analogous. Here, Vellutato does not limit the container or
chemical composition that requires sterilization, although it illustrates the
technique on a one-container system. To the extent that Leoncavallo's two-
container system requires sterilization (such as in a laboratory or medical
environment), a person having ordinary skill in the art would have
considered all suitable sterilization techniques including Vellutato 's
technique, as we found above. On this point, our reviewing court has stated
that the Supreme Court of the United States instructed the scope of
analogous art must be looked at broadly. Wyers v. Master Lock Co., 616
F.3d 1231, 1238 (Fed. Cir. 2010); KSR Int'! Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007) ("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.") (emphasis added); In re ICON Health &
8
Appeal2017-002800
Application 10/754,629
Fitness, Inc., 496 F.3d 1374, 1380-81 (Fed. Cir. 2007) (a reference is
analogous if it addresses the same or similar problem).
The Appellant's argument (Appeal Br. 12-13) that Leoncavallo does
not teach a container system for use in a "clean environment" is plainly
incorrect. As the Examiner points out (Ans. 13), the limitation at issue is
broad. Leoncavallo teaches two-container systems suitable for various
environments including laboratory and medical environments (Leoncavallo
col. 1, 11. 7-10, 22-27). The Appellant offers no explanation why such
environments would not be "clean" given Leoncavallo's explicit teaching
that such environments often require aseptic or clean, sterile conditions.
As for claims 3 7 and 41, we are constrained to agree with the
Appellant. Although claims 3 7 and 41 contain new matter not included in
the original disclosure, that new matter must be considered in analyzing
obviousness. 9 Leoncavallo teaches a system in which the small container
includes a sealed but frangible or breakable end 92 (Leoncavallo Fig. 2, 4A,
and 4B; col. 5, 11. 15-16). The Examiner does not explain why a person
having ordinary skill in the art would make Leoncavallo's smaller container
not frangible or unbreakable.
For these reasons, we sustain the rejection as to claims 1-3, 7, 8, 16,
20, 21, 25-36, and 38--40 but not as to claims 37 and 41.
Rejection C. The Appellant argues merely that "Carpenter does not
cure the deficiencies of Vellutato and Leoncavallo" (Appeal Br. 16). As we
discussed above, the Examiner's rejection is not deficient as to claim 1.
Therefore, we also uphold the rejection of claims 4--6, 17-19, 23, and 24.
9 Grasselli, 231 USPQ at 394.
9
Appeal2017-002800
Application 10/754,629
IV. SUMMARY
Rejections A and Care sustained. Rejection Bis sustained as to
claims 1-3, 7, 8, 16, 20, 21, 25-36, and 38--40 but not as to claims 37 and
41. Therefore, the Examiner's final decision to reject claims 1-8, 16-21,
and 23--41 is affirmed.
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
10