Capitol Vial Inc.

Patent Trials and Appeals Board

Sep 1, 2020

14174252 - (D) (P.T.A.B. Sep. 1, 2020)

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.
14/174,252 02/06/2014 Michael Gooden FCAPV-06DV2 2440
26875 7590 09/01/2020
WOOD, HERRON & EVANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI, OH 45202
EXAMINER
DAVIS, ROBERT B
ART UNIT PAPER NUMBER
1743
NOTIFICATION DATE DELIVERY MODE
09/01/2020 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):
usptodock@whe-law.com
wjacobs@whe-law.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MICHAEL GOODEN and RANDALL LECROY
____________

Appeal 2019-005550
Application 14/174,252
Technology Center 1700
____________

Before CATHERINE Q. TIMM, MONTÉ T. SQUIRE, and
JEFFREY R. SNAY, Administrative Patent Judges.

SQUIRE, Administrative Patent Judge.

DECISION ON APPEAL1

Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision to finally reject claims 1–3, which are all of the claims pending in
this application. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 This Decision refers to the Specification filed Feb. 6, 2014 (“Spec.”); Final
Office Action dated May 16, 2018 (“Final Act.”); Appeal Brief filed
Apr. 16, 2019 (“Appeal Br.”); Examiner’s Answer dated May 16, 2019
(“Ans.”); and Reply Brief filed July 15, 2019 (“Reply Br.”).
2 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Capitol Vial Inc. and Thermo Fisher
Scientific Inc. as the real parties in interest. Appeal Br. 5.
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CLAIMED SUBJECT MATTER
The invention relates to containers and, more particularly, to an
apparatus and method for forming a container having a receptacle and an
integral cap. Spec. ¶ 2, Abstract. Claim 1 illustrates the subject matter on
appeal and is reproduced below from the Claims Appendix to the Appeal
Brief:
1. A sterile-by-process container having a closed sterile
internal cavity defined during manufacture of the container,
the sterile-by-process container comprising:
a receptacle having a body portion defining the sterile
internal cavity and a neck portion defining an opening to the
internal cavity, the body portion having a first cross-section
dimension and the neck portion having a second cross-section
dimension that is less than the first cross-section dimension
along the entire longitudinal length of the body portion, the
neck portion further including an outer surface having at least
one thread positioned thereon configured to provide a screw-on
connection with a separate device; and
a cap integrally formed with the receptacle and
configured to seal the opening to the sterile internal cavity so as
to define the closed sterile internal cavity when the cap is
initially closed to seal the opening during manufacture of the
container.
Appeal Br. 17 (key disputed claim language italicized and bolded).
REFERENCES
The Examiner relies on the following prior art references as evidence
in rejecting the claims on appeal:
Name Reference Date
Abrams US 4,783,056 Nov. 8, 1988
Brotz US 4,974,757 Dec. 4, 1990
Mueller US 5,008,066 Apr. 16, 1991
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Delman et al.
(“Delman”)
US 2006/0076309 Al Apr. 13, 2006
Ostrowski
(“the ’797 Patent”)
US 7,472,797 B2 Jan. 6, 2009
REJECTIONS
On appeal, the Examiner maintains (Ans. 3) the following rejections:
1. Claim 1 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Delman in view of Mueller and Abrams (“Rejection 1”).
Ans. 7.
2. Claims 2 and 3 are rejected under pre-AIA 35 U.S.C. § 103(a)
as being unpatentable over Delman in view of Mueller and Abrams as
applied to claim 1 above, and further in view of Brotz (“Rejection 2”).
Ans. 8.
3. Claim 1 is rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1–21 of the ’797 Patent in view
of Mueller and Abrams (“Rejection 3”). Ans. 4.
4. Claims 2 and 3 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1–21 of the ’797 Patent
in view of Mueller, Abrams, and Brotz (“Rejection 4”). Ans. 5.
OPINION
Having considered the respective positions the Examiner and
Appellant advance in light of this appeal record, we affirm the Examiner’s
rejections based essentially on the fact-finding and reasoning the Examiner
provides in the Answer and Final Office Action, which we adopt as our own.
We add the following primarily for emphasis.
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Rejection 1
The Examiner determines that the combination of Delman, Mueller,
and Abrams suggests a container satisfying the limitations of claim 1 and
concludes the combination would have rendered the claim obvious. Ans. 7–8
(relying on Delman, Figs. 1–5, ¶¶ 2–5, 15–18; Mueller, Fig. 1; Abrams, Fig.
5, 1:12–22, 1:36–46).
Appellant argues the Examiner’s rejection of claim 1 should be
reversed because Mueller teaches away from a “sterile-by-process container
having a closed sterile internal cavity defined during manufacture of the
container,” as recited in the claim. Appeal Br. 13; Reply Br. 5 (arguing
“Mueller is not a proper reference . . . because it teaches away from the
invention”). Appellant contends that, in contrast to the claimed invention,
Mueller teaches forming a preform by injection molding and then
transferring the preform to a conventional blow molding apparatus with the
closure cover (closure cover 20) kept in the open position. Appeal Br. 13
(citing Mueller, Figs. 1, 5, 7, 8, 5:17–67); see also id. at 14 (“Mueller not
only does not contemplate producing a sterile-by-process container, it
expressly teaches away from it.”).
Appellant further argues Mueller is completely silent with respect to a
“sterile-by-process container having a closed sterile internal cavity defined
during manufacture of the container,” as recited in the preamble of claim 1,
and that Mueller does not describe how the container is sterilized before it
reaches the filling mechanism to be filled. Id. at 13.
Appellant also argues the Examiner’s rejection should be reversed
because a person of ordinary skill in the art would not have been motivated
to combine Delman with Mueller and Abrams to arrive at the claimed
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invention as recited in claim 1. Id. at 15. In particular, Appellant contends
“the Examiner fails to provide a sound rationale for modifying Delman with
the disclosure of Mueller.” Id. at 14; see also Reply Br. 7 (arguing “the
Examiner has not provided a sufficient rationale to combine the references”).
Rather, Appellant argues the Examiner’s proposed combination of Delman
with Mueller and Abrams is improper because
such a combination would fail to achieve Appellants
claimed sterile-by-process container having a closed
sterile internal cavity that is defined when the cap is
initially closed to seal the opening to the internal cavity
during manufacture of the container, in combination with
the particular shape as claimed.
Appeal Br. 15.
We do not find Appellant’s arguments persuasive of reversible error
in the Examiner’s rejection in view of the fact-finding and reasons the
Examiner provides at pages 7–13 of the Answer and pages 5–7 of the Final
Office Action, which a preponderance of the evidence supports. As the
Examiner finds (Ans. 7), Delman discloses a breast milk container having
upper opening 13, shoulder/lip 15, circumferential threaded outer
arrangement 17, body portion 7, and integral cap 9, which snaps onto the
upper opening when closed. Delman, Figs. 1–3, ¶¶ 15, 17. As the Examiner
further finds (Ans. 7), Delman teaches that the container can be any suitable
structure sufficient to receive and retain breastmilk and there is a need to
seal the container for easy closure and to keep sterile the interior of the
container upon closing the container with the cap. Delman ¶ 3 (disclosing
“[c]ontamination of breastmilk can present health hazards to an infant” and
“to prevent contamination, breastmilk should be stored only in clean
containers . . . and immediately sealed and stored if the breastmilk is to be
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fed to an infant”), ¶ 4 (cautioning that “[g]iven the health implications for an
infant, the cleanliness and sterilization are of significant concern”), ¶ 5
(disclosing “there is a need for a closure assembly that can be formed with . .
. the container mouth in a non-screw-on fashion for easy closure”).
As the Examiner further finds (Ans. 8), Mueller discloses a container
(container 10) having an integral cap (cover 20) and a main hollow section
(receptacle 12) that is larger in cross-section than the container’s neck
portion (neck 14) along the entire longitudinal length of the main hollow
section. Mueller, Fig. 1, 3:30–35 (disclosing “container 10 includes a main
hollow portion or receptacle 12 having reduced cross-sectional dimensions
at neck 12”).
As the Examiner also finds (Ans. 8), regarding the
“sterile-by-process-container” recitation of claim 1, Abrams discloses a
container (vial 12) having an integral cap (cap 14) and describes a process
for making wherein the cap and vial are sealed closed within the mold to
maintain the sterility of the interior of the vial prior to use. Abrams, Fig. 5,
1:7–11 (describing “a process for making the vial in the mold . . . wherein
the vial is sealed closed within the mold”), 1:17–21 (disclosing “[i]t is
important to maintain the sterility of the interior of the vial prior to use” and
“in order to maintain the sterility . . . the cap must be closed onto the vial
while the vial is in an aseptic environment”), 1:36–41 (disclosing “the heat
of the molding process could be utilized to maintain sterility during
closing”), 3:67–4:8. In describing the process, Abrams explains that
[b]ecause the interior of the vial 12 is preferably
maintained in a sterile condition, the mold 10 is adapted to
seat the cap 14 onto the vial 12 in a sealing manner while
the vial 12 is still in the mold 10.
Id. at 4:5–8.
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The Examiner also provides a reasonable basis to evince why one of
ordinary skill in the art would have had reason to combine the teachings of
the cited art to arrive at the claimed invention. See Ans. 5 (explaining it
would have been obvious to one of ordinary skill in the art to modify
Delman’s container to have a main hollow section (body portion) with a
cross-section larger than the container’s neck portion, as taught by Mueller,
for the purpose of increasing the volume capacity of the container); see also
id. at 5 (explaining it would have also been obvious to one of ordinary skill
in the art to modify Delman’s container by sealing the container within the
mold, as taught by Abrams, to maintain the sterility of the inside of the
container and avoid a separate sterilizing step); KSR Int’l Co. v. Teleflex,
Inc., 550 U.S. 398, 420 (2007) (explaining that any need or problem known
in the art can provide a reason for combining the elements in the manner
claimed).
Appellant’s arguments do not reveal reversible error in the
Examiner’s factual findings, analysis, and conclusions in this regard.
Appellant’s contention that Mueller teaches away from the
“sterile-by-process container” limitation of the claim (Appeal Br. 13–14) is
not persuasive of reversible error in the Examiner’s rejection because
Appellant does not identify evidence sufficient to support it, and we will not
read into the references a teaching away where no such language exists. Cf.
DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed.
Cir. 2006). Appellant’s contention that “Mueller is completely silent with
respect to a sterile-by-process container” (Appeal Br. 13) is equally
unpersuasive because “silence does not imply teaching away.” Allergan, Inc.
v. Apotex Inc., 754 F.3d 952, 964 (Fed. Cir. 2014).
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Rather, as the Examiner finds and explains at pages 10–12 of the
Answer, the fact that Mueller describes, as an embodiment, a process where
an injection molded preform is transferred from a first injection mold to a
second blow mold (Mueller, Fig. 8, 5:17–25, 5:29–31), without more, does
not teach away from, discredit, criticize, or discourage a “sterile-by-process
container having a closed sterile internal cavity,” as recited in claim 1, which
is a product claim. In re Fulton, 391 F.3d 1195, 1201 (finding that there is
no teaching away where the prior art’s disclosure “does not criticize,
discredit, or otherwise discourage the solution claimed”).
Mueller’s disclosure in this regard also does not negate or take away
from Mueller’s broad disclosure regarding a container having a main hollow
receptacle with reduced cross-sectional dimensions at the neck portion
(Mueller, Fig. 1, 3:30–35), which the Examiner relies upon in the rejection.
See In re Susi, 440 F.2d 442, 445–46 (CCPA 1971) (explaining that
disclosure of particular preferred embodiments does not teach away from a
prior art reference’s broader disclosure); see also In re Applied Materials,
Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012) (“A reference must be considered
for everything that it teaches, not simply the described invention or a
preferred embodiment.”).
Appellant’s arguments in this regard are also misplaced because, as
the Examiner explains (Ans. 11–12), the “sterile-by-process” recitation of
claim 1 is a product-by-process type limitation, and Appellant has not
established, either by persuasive technical reasoning or evidence, that the
claimed product is patentably distinct from the product of the prior art. “The
patentability of a product does not depend on its method of production. If the
product in a product-by-process claim is the same as or obvious from a
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product of the prior art, the claim is unpatentable even though the prior
product was made by a different process.” In re Thorpe, 777 F.2d 695, 697
(Fed. Cir. 1985) (citations omitted); see also In re Pilkington, 411 F.2d
1345, 1348 (CCPA 1969) (“[The] patentability of a claim to a product does
not rest merely on a difference in the method by which that product is made.
Rather, it is the product itself which must be new and unobvious.”). Indeed,
as the Examiner finds (Ans. 11), Appellant does not provide or direct us to
any persuasive evidence in the record that the container of claim 1 has any
unexpected properties or is otherwise not the same as or obvious from the
container of the prior art. Thorpe, 777 F.2d at 697.
Appellant’s contentions that the Examiner “fails to provide a sound
rationale for modifying Delman with the disclosure of Mueller” (Appeal Br.
14) and “has not provided a sufficient rationale to combine the references”
(Reply Br. 7) are not persuasive because, as we previously discuss above,
the Examiner does provide articulated reasoning with rational underpinning
sufficient to explain why one of ordinary skill in the art would have had
reason to combine the teachings of Delman, Mueller, and Abrams to arrive
at the claimed invention. See Ans. 5, 12–13. Appellant’s disagreement as to
the Examiner’s factual findings and reasons for combining the references,
without more, is insufficient to establish reversible error. SmithKline
Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1320 (Fed. Cir. 2006)
(“[M]ere statements of disagreement . . . as to the existence of factual
disputes do not amount to a developed argument.”).
Accordingly, we affirm the Examiner’s rejection of claim 1 under
pre-AIA 35 U.S.C. § 103(a) as obvious over Delman, Mueller, and Abrams.
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Rejection 2
The Examiner rejects claims 2 and 3 under § 103 as obvious over the
combination of Delman, Mueller, Abrams, and Brotz. Ans. 8–9. In response
to the Examiner’s rejection, Appellant does not present any additional
substantive arguments. Rather, Appellant relies on the same arguments
Appellant presents above in response to the Examiner’s rejection of claim 1.
See Appeal Br. 10.
Thus, based on the fact-finding and reasoning the Examiner provides
in the record, and for principally the same reasons we discuss above for
affirming the Examiner’s rejection of claim 1 (Rejection 1), we affirm the
Examiner’s rejection of claims 2 and 3 under pre-AIA 35 U.S.C. § 103(a) as
obvious over Delman, Mueller, Abrams, and Brotz (Rejection 2).
Rejections 3 and 4
The Examiner rejects claim 1 (Rejection 3) and claims 2 and 3
(Rejection 4) on the ground of nonstatutory double patenting as being
unpatentable over claims 1–21 of the ’797 Patent in view of Mueller and
Abrams. Ans. 4–6.
In response, Appellant argues the Examiner’s rejections should be
reversed because the ’797 Patent is “silent with respect to a sterile-by-
process container having the particular shape as recited in Claim 1” (Appeal
Br. 15) and “Mueller teaches away from the claimed invention” (id. at 16).
We do not find these arguments persuasive of reversible error in the
Examiner’s rejections because they are conclusory and unsupported by
persuasive evidence in the record. Attorney argument is not evidence. In re
De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984); see also In re Geisler, 116
F.3d 1465, 1470 (Fed. Cir. 1997) (explaining that mere lawyer’s arguments
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or conclusory statements, which are unsupported by concrete factual
evidence, are entitled to little probative value).
Also, because Appellant’s arguments in this regard are analogous to
and/or rely on essentially the same arguments Appellant presents above in
response to the Examiner’s obviousness rejection of claim 1 (Rejection 1),
we do not find them persuasive of reversible error in the Examiner’s
nonstatutory double patenting rejections (Rejections 3 and 4) in view of the
fact-finding and reasoning the Examiner provides in the record, and for
essentially the same reasons we discuss above for affirming the Examiner’s
Rejection 1.
Accordingly, we affirm the Examiner’s rejections of claim 1
(Rejection 3) and claims 2 and 3 (Rejection 4) on the ground of nonstatutory
double patenting as being unpatentable over claims 1–21 of the ’797 Patent
in view of Mueller and Abrams.
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CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1 103(a) Delman, Mueller,
Abrams
1
2, 3 103(a) Delman, Mueller,
Abrams, Brotz
2, 3
1 Nonstatutory double
patenting
1
2, 3 Nonstatutory double
patenting
2, 3
Overall
Outcome
1–3

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).
AFFIRMED