SYSMEX CORPORATION

Patent Trials and Appeals Board

Sep 24, 2021

2020004893 (P.T.A.B. Sep. 24, 2021)

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.
13/729,777 12/28/2012 Yusuke MORI 11333/579 1911
757 7590 09/24/2021
Crowell/BGL
P.O. BOX 10395
CHICAGO, IL 60610
EXAMINER
LEE, KEVIN G
ART UNIT PAPER NUMBER
1711
MAIL DATE DELIVERY MODE
09/24/2021 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 PATENT TRIAL AND APPEAL BOARD
____________

Ex parte YUSUKE MORI, KINYA UCHIHASHI, and
YUMIKO MIZUNO

Appeal 2020-004893
Application 13/729,777
Technology Center 1700
____________

Before JEFFREY T. SMITH, MICHAEL P. COLAIANNI, and
DONNA M. PRAISS, Administrative Patent Judges.

PRAISS, Administrative Patent Judge.

DECISION ON APPEAL1

Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–3, 5, 6, 8, 10–12, 15, 17, 21, and 22.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 In this Decision, we refer to the Specification filed Dec. 28, 2012
(“Spec.”), the Final Office Action dated Aug 2, 2019 (“Final Act.”), the
Appeal Brief filed Dec. 30, 2019 (“Appeal Br.”), the Examiner’s Answer
dated Apr. 16, 2020 (“Ans.”), and the Reply Brief filed June 12, 2020
(“Reply Br.”).
2 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Sysmex Corporation as the real party
in interest. Appeal Br. 1.
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Application 13/729,777

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STATEMENT OF THE CASE
The invention relates generally to a container for storing a washing
solution used for a blood analyzer. Spec. ¶ 2. According to the Specification,
rubber is generally used as a lid member for a blood collection tube because
it can be pierced with a blood collection needle, however, rubber is
deteriorated when exposed to a sodium hypochlorite washing solution. Id.
¶ 6. The Specification describes external CO2 permeating into the container
due to a deteriorated rubber lid member reduces a detergency of the washing
solution by promoting decomposition of sodium hypochlorite. Id. The
Specification describes one aspect of the invention as a multilayer film
bonded to the container body to seal the opening. Id. ¶ 7. Claim 1, the sole
independent claim involved in this appeal, is representative of the subject
matter on appeal (emphasis added).
1. In combination, a container and a washing solution
stored in the container, the combination configured for use by a
blood analyzer, the combination comprising:
a container body, having a form of a blood collection
tube, made of a thermoplastic resin resistant to corrosion by a
chlorine-based washing solution and having an opening on an
upper end, wherein the chlorine-based washing solution is
stored in the container body, the chlorine-based washing
solution having a chlorine concentration of at least 1% and not
more than 12%, and a pH of at least 9; and
a multilayer film bonded to the container body to seal the
opening,
wherein the container body is only covered by the
multilayer film,
and wherein an identification code indicating that the
container accommodates the washing solution is assigned to the
container body, and
the multilayer film consisting of:
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a non-rubber seal layer heat-sealed to the container body
thereby sealing the opening, the seal layer made of the
thermoplastic resin that is resistant to corrosion by the
chlorine-based washing solution;
a non-rubber gas barrier layer on an outer side of the
seal layer that is resistant to CO2 penetration; and
a polyamide layer between the seal layer and the gas
barrier layer,
wherein the gas barrier layer is a ceramic deposition film
including one of aluminum oxide or silica on a base film of
polyethylene terephthalate or oriented nylon and covering a
whole area of the opening, and
wherein the thickness of the non-rubber seal layer is the
largest among the layers of the multilayer film.
Appeal Br. 21 (Claims Appendix).

ANALYSIS
We review the appealed rejections for error based upon the issues
Appellant identifies, and in light of the arguments and evidence produced
thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential)
(cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011)
(“[I]t has long been the Board’s practice to require an applicant to identify
the alleged error in the examiner’s rejections.”)). After considering the
argued claims in light of the case law presented in this Appeal and each of
Appellant’s arguments, we are persuaded of reversible error in the appealed
rejections.
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The Examiner’s rejections are based on the following references.3
Name Reference Date
Kasai US 5,033,476 July 23, 1991
Rainen US 2006/0212020 A1 Sept. 21, 2006
Wuest US 2009/0110888 A1 Apr. 30, 2009
Kohashi JP 2591521 Dec. 25, 1998
Takashi JP 2003-246000 Sept. 2, 2003
Shibata JP 2003-254980 Sept. 10, 2003
Sysmex
Sysmex Operator’s Manual
Automated Hematology
Analyzer SF-3000
2001
The Examiner rejects claims 1–3, 5, 6, 8, 10–12, 15, 17, 21, and 22 as
follows for the reasons provided in the Final Office Action.4 Final Act. 2–
11.
Claim(s) 35 U.S.C. § Reference(s)/Basis
1–3, 5, 6, 10, 12,
15, 17, 21, 22 103(a)
Shibata, Kasai, Wuest,
Takashi, Sysmex
8 103(a) Shibata, Kasai, Wuest, Takashi, Sysmex, Rainen
11 103(a) Shibata, Kasai, Wuest, Takashi, Sysmex, Kohashi
As an initial matter, the Examiner interprets the recited claim term
“resistant” to mean “simply able to repel or ward off.” Final Act. 2. As
applied to claim 1, the Examiner determines “resistant” means “to repel or
ward off a chlorine-based washing solution or CO2.” Id.
The Examiner’s rejection of claim 1 relies on Shibata’s disclosure of a
container and a washing solution configured for use by a blood analyzer
where the container body is a test tube-like container made of material

3 Citations to the text of Shibata, Takashi, and Kohashi are to their English
language translations made of record.
4 Claims 18–20 are withdrawn from consideration. Final Act. 1.
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resistant to corrosion by a chlorine-based washing solution, has an opening
at an upper end, a cap to seal the opening, and an identification code
indicating the container accommodates the washing solution. Final Act. 3.
The Examiner determines Shibata does not explicitly disclose the details or
materials of the container body or a covering. Id.
The Examiner determines it would have been obvious to modify
Shibata with Kasai’s disclosure that a container body in the blood collection
tube art can be made of thermoplastic resin, including PET, which is
inherently resistant to corrosion by a chlorine-based washing solution. Id. at
3–4. The Examiner also finds it would have been obvious to modify
Shibata’s cap with Kasai’s disclosure of a multi-layer film comprising a non-
rubber seal layer made of thermoplastic resin capable of heat fusing with the
PET tubular body, a non-rubber gas barrier layer (aluminum foil film), and a
polyamide layer (a nylon film) between the seal layer and the gas barrier
layer. Id. at 4. The Examiner’s rationale is that it would have been obvious
to use common and well-known materials in the test tube and multilayer
sealing film art and for the reasons that Kasai’s heat-sealing seal layer
having the same thermoplastic resin material as the container securely seals
a test tube to prevent leaking and provide air-tightness. Id. at 7.
The Examiner acknowledges the combination of Shibata and Kasai
does not disclose the close ended structure of the multilayer film required by
claim 1. Id. at 5. Specifically, the Examiner finds the combination does not
disclose a gas barrier layer that is a ceramic deposition film including one of
aluminum oxide or silica on a base film of PET or oriented nylon. Id. The
Examiner turns to Wuest and Takashi for disclosing multilayer films which
include a ceramic deposition film. Id. at 5–6. The Examiner acknowledges,
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however, that Wuest combined with Shibata and Kasai is not clear that the
intermediate polyamide layer of Kasai is maintained. Id. at 5. The Examiner
also acknowledges that Takashi discloses a non-rubber seal layer consisting
of a layer of sealing film and a layer of the same material as the sealing film
containing oxygen absorbing material beneath the intermediate polyamide
layer, making it two distinct layers that the Examiner acknowledges does not
read on the close-ended “seal layer” of claim 1. Id. at 6. The Examiner’s
reason for combining Wuest is to include an aluminum oxide on a base film
to provide a barrier against transmission of air and/or moisture. Id. at 7. The
Examiner further finds that Takashi discloses the thickness of the seal layer
may be larger than the thickness of the gas barrier layer (id. at 6) and
provides as a reason to combine Takashi the increased durability of the seal
layer to prevent cracks and leaks from external shock (id. at 7). Sysmex is
relied upon for the chlorine containing washing solution recited in claim 1.
Id. at 8.
During examination, the Examiner bears the initial burden of
establishing a prima facie case of obviousness. In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992). “[R]ejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)); see also,
Ball Aerosol & Specialty Container, Inc. v. Ltd. Brands, Inc., 555 F.3d 984,
993 (Fed. Cir. 2009) (“[T]he analysis that ‘should be made explicit’ refers
not to the teachings in the prior art of a motivation to combine, but to the
court’s analysis.”).
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We agree with Appellant that the Examiner does not adequately
explain why a person having ordinary skill in the art would have modified
Kasai’s rubber seal with Wuest and Takashi’s film structures. Appeal Br. 14.
Appellant correctly points out that Kasai’s multilayer film includes a rubber
seal layer 26. Id. at 16; Kasai 5:55–60, 6:16–23. The Examiner’s finding that
Kasai discloses a broad class of elastomeric materials that are not limited to
rubber, but inclusive of “simply rubber-like materials” is not supported by
the cited record in this appeal. Ans. 5; see Ans. 10 (“the ‘seal 26’ of Kasai is
not necessarily rubber.”). Kasai’s disclosure of “thermoplastic elastomer” at
line 58 in column 5 is at the end of a sentence that begins “[f]rom this
viewpoint, the sealing element 26 is made of rubber material.” Kasai 5:55–
60. The viewpoint the sentence alludes to is the explanation why rubber is
used for a blood-collecting tube and that is because rubber “stop[s] up the
needle hole.” Id. at 5:51. Because Kasai’s tube contains blood and not a
chlorinated cleaning solution, Appellant asserts that a skilled artisan would
not be motivated to replace Kasai’s multilayer film with a non-rubber seal
layer based on the contents of Kasai’s container. Appeal Br. 17.
The Examiner’s determination that a skilled artisan viewing Kasai’s
multilayer film would logically look to Wuest and Takashi’s multilayer
films based on the structural similarities and functional overlap does not
have a rational underpinning because the function of Kasai’s multilayer film
is to seal a container that is accessed by a needle because it contains blood.
Ans. 13. As Appellant correctly points out, both Wuest and Takashi are
directed to the packaging of food and non-food products, rather than blood,
and neither are directed to packaging chlorine-based washing solutions as
required by claim 1. Appeal Br. 12. Moreover, the rejection is not simply a
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substitution of Kasai’s film for either Wuest or Takashi’s film structures
because the Examiner acknowledges that neither structure meets claim 1’s
closed structure for “the multilayer film consisting of” only the recited
elements for the multilayer film. Wuest lacks the intermediate polyamide
layer (Final Act. 5) and Takashi discloses two distinct layers for the non-
rubber seal layer (Final Act. 6). When the transitional phrase “consists of”
appears in a clause in the body of a claim, it limits the element set forth in
that clause to the exclusion of materials other than those recited.
Mannesmann Demag Corp. v. Engineered Metal Prods. Co., 793 F.2d 1279,
1282 (Fed. Cir. 1986). Here, Wuest lacks the intermediate polyamide layer
(Final Act. 5) and Takashi discloses two distinct layers for the non-rubber
seal layer (Final Act. 6).
In sum, we agree with Appellant that the rejection of claim 1 over
Shibata, Kasai, Wuest, Takashi, and Sysmex is based on impermissible
hindsight. Because the Examiner’s rejections of dependent claims 2, 3, 5, 6,
8, 10–12, 15, 17, 21, and 22 under 35 U.S.C. § 103(a) are based on the same
rationale for combining Shibata, Kasai, Wuest, Takashi, and Sysmex, and
the additional references relied upon for rejecting claims 8 and 11 do not
cure the deficiencies discussed above, we reverse the rejections of the
dependent claims for the same reason.

CONCLUSION
For these reasons, we reverse the Examiner’s rejections of claims 1–3,
5, 6, 8, 10–12, 15, 17, 21, and 22 under 35 U.S.C. § 103(a).
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In summary:
Claim(s)
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 5, 6,
10, 12, 15,
17, 21, 22
103(a)
Shibata, Kasai,
Wuest, Takashi,
Sysmex
1–3, 5, 6,
10, 12, 15,
17, 21, 22

8 103(a)
Shibata, Kasai,
Wuest, Takashi,
Sysmex, Rainen
8
11 103(a)
Shibata, Kasai,
Wuest, Takashi,
Sysmex, Kohashi
11
Overall
Outcome
1–3, 5, 6, 8,
10–12, 15,
17, 21, 22

REVERSED