Ex Parte Mishima

Patent Trial and Appeal Board

Oct 16, 2017

14402136 (P.T.A.B. Oct. 16, 2017)

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.
14/402,136 11/19/2014 Takashi Mishima 4300.P0267US 1461
23474 7590 10/18/2017
FLYNN THIEL BOUTELL & TANIS, P.C.
2026 RAMBLING ROAD
KALAMAZOO, MI 49008-1631
EXAMINER
LEBRON, BENJAMIN L
ART UNIT PAPER NUMBER
1777
NOTIFICATION DATE DELIVERY MODE
10/18/2017 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):
DOCKET@FLYNNTHIEL.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TAKASHI MISHIMA
Applicant: SHIBUYA KOGYO CO., LTD.
Appeal 2017-003838
Application 14/402,136
Technology Center 1700
Before MICHAEL P. COLAIANNI, WHITNEY N. WILSON, and
JANE E. INGLESE, Administrative Patent Judges.
INGLESE, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 requests our review under 35 U.S.C. § 134(a) of a final
rejection of claims 5—9. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
Appellant claims a hemodialysis apparatus and a method of operating
a hemodialysis apparatus. Br. 1—3. Claims 5 and 8 illustrate the subject
matter on appeal and are reproduced below:
5. A method of operating a hemodialysis apparatus
provided with a dialyzer for performing hemodialysis,
1 The real party in interest (SHIBUYA KOGYO CO., LTD.) is the applicant,
and thus the Appellant. Appeal Brief filed July 22, 2016 (“Br.”), 1.
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Application 14/402,136
wherein a blood circuit is connected to the dialyzer, a dialysis
solution circuit is connected to the dialyzer, a replacement fluid
port is provided in the dialysis solution circuit and capable of
being opened and closed by a lid member, and a replacement
fluid passage has an end connected to the blood circuit and
another end connected to the replacement fluid port, comprising
the steps of:
performing a dialysis fluid substitution step of filling the
dialysis solution circuit with a dialysis solution;
performing a negative pressure forming step to make the
pressure in the dialysis solution circuit negative so that the
dialysis solution does not overflow when the replacement fluid
port is opened;
detaching the lid member from the replacement fluid
port;
changing the replacement fluid port from a closed state to
an open state; and
connecting the replacement fluid passage to the
replacement fluid port in the open state.
8. A hemodialysis apparatus comprising a dialyzer for
performing hemodialysis, a blood circuit connected to the
dialyzer, a dialysis solution circuit connected to the dialyzer,
dialysis solution flowing means for flowing the dialysis
solution in the dialysis solution circuit, control means for
controlling the dialysis solution flowing means, a replacement
fluid port provided in the dialysis solution circuit and capable
of being opened and closed by a lid member, and a replacement
fluid passage having an end connected to the blood circuit and
another end connected to the replacement fluid port in an open
state,
wherein the dialysis solution flowing means has a
construction capable of forming a negative pressure in the
dialysis solution circuit under the control of the control means,
and the control means makes the pressure in the dialysis
solution circuit negative by controlling the dialysis solution
flowing means from a state where the replacement fluid port is
in a closed state and the dialysis solution circuit is filled with
the dialysis solution, to thereby enable prevention of
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Application 14/402,136
overflowing of the dialysis solution when the replacement fluid
port is opened, and stands by until the replacement fluid port is
opened.
Br. Claims Appendix 1—3 (emphasis added).
The Examiner sets forth the following rejections in the Final Office
Action entered December 10, 2015 (“Final Act.”), and maintains the
rejections in the Answer entered August 11, 2016 (“Ans.”):
I. Claim 8 under 35 U.S.C. § 112, second paragraph as being
indefinite for failing to particularly point out and distinctly claim the subject
matter that the Applicant regards as the invention;
II. Claims 5—9 under 35 U.S.C. § 103(a) as unpatentable over
Sakamoto (WO 2012/017959 Al, published February 9, 2012)2 in view of
Cavani (WO 2009/074588 Al, published June 18, 2009).
DISCUSSION
Upon consideration of the evidence relied upon in this appeal and
each of Appellant’s contentions, we affirm the Examiner’s rejection of claim
8 under 35 U.S.C. § 112, second paragraph and rejection of claim 8 under
35 U.S.C. § 103(a), for the reasons set forth in the Final Action, the Answer,
and below, but reverse the Examiner’s rejection of claims 5—7 and 9 under
35 U.S.C. § 103(a) for the reasons set forth in the Appeal Brief and below.
2 Appellant does not contest the Examiner’s reliance on the U.S. national
phase (US 2013/0150768 Al, published June 13, 2013) of the PCT
application (WO 2012/017959 Al, published February 9, 2012), and
citations in this Decision to Sakamoto, therefore, refer to the U.S. national
phase application.
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Rejection I
The Examiner finds that the recitation in claim 8 of “control means for
controlling the dialysis solution flowing means” invokes 35 U.S.C. § 112,
sixth paragraph. Final Act. 3. The Examiner finds that Appellant’s
Specification does not specify “what the control means are,” and finds that
claim 8, therefore, fails to meet the requirements of 35 U.S.C. § 112, second
paragraph. Final Act. 3 citing Spec. Tflf 10, 13.
Appellant argues that “[u]nder U.S. Patent Law, claims using ‘means’
language is [szc] only indefinite under 35 USC 112, second paragraph, if the
function language is unclear.” Br. 3. Appellant contends that this “is not the
case in the present situation as each ‘means’ clause clearly specifies the
function.” Id.
However, a claim limitation expressed in means-plus-fimction
language “shall be construed to cover the corresponding structure, material,
or acts described in the specification and equivalents thereof.” 35 U.S.C.
112, sixth paragraph. It is well-settled that if a specification fails to disclose
structure or materials that perform a function recited in a means-plus-
function limitation, then the means-plus-fimction limitation renders the
claim indefinite because the Applicant has in effect failed to particularly
point out and distinctly claim the subject matter regarded as the invention, as
required by 35 U.S.C. § 112, second paragraph. In re Donaldson Co., 16
F.3d 1189, 1195 (Fed. Cir. 1994) (“[I]f one employs means-plus-fimction
language in a claim, one must set forth in the specification an adequate
disclosure showing what is meant.... If an applicant fails to set forth an
adequate disclosure, the applicant has in effect failed to particularly point
out and distinctly claim the invention as required by the second paragraph of
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section 112.”).
Appellant does not identify any disclosure in Appellant’s
Specification of structures or materials that perform the function of the
control means recited in claim 8 (controlling the dialysis solution flowing
means). Br. 3. Therefore, we sustain the Examiner’s rejection of claim 8 for
failing to comply with the requirements of 35 U.S.C. § 112, second
paragraph.
Rejection II
We point out initially that the Examiner addresses apparatus claim 8
and method claim 5 together (Final Act. 7—11), but we address these claims
separately in light of their differing limitations.
Claim 8
The Examiner finds that Sakamoto discloses a hemodialysis apparatus
comprising blood circuit 1 and a dialysis solution circuit formed by dialysate
introducing line LI, dialysate discharging line L2, and dialyzer 4. Final Act.
7—8; Sakamoto H 2, 71, Figure 6. The Examiner interprets the “dialysis
solution flowing means for flowing the dialysis solution in the dialysis
solution circuit” recited in claim 8 under 35 U.S.C. § 112, sixth paragraph to
cover the corresponding pumps and opening/closing valves in the dialysis
solution circuit described in paragraph 13 of Appellant’s Specification.
Final Act. 4, Spec. 113. Sakamoto discloses such dialysis solution flowing
means by indicating that the dialysis solution circuit includes valves V3, V4
and duplex pump 5 that introduce dialysate into dialyzer 4 (dialysis fluid
flowing means). Sakamoto H 71, 78, 79, Figure 6.
The Examiner finds that Sakamoto discloses that the hemodialysis
apparatus further comprises bypass line L9, substitution infusion pump 11,
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and substitution infusing port 10 (replacement fluid port), which form a
bypass portion of the dialysis solution circuit. Final Act. 8; Sakamoto 196,
Figure 6. The Examiner finds that Sakamoto discloses that the hemodialysis
apparatus further includes substitution infusing line L10 (replacement fluid
passage) having one end connected to blood circuit 1 and another end
connected to substitution infusing port 10. Final Act. 8; Sakamoto 196,
Figure 6. The Examiner finds that Sakamoto discloses performing
substitution infusion with the hemodialysis apparatus by driving substitution
infusion pump 11 so that dialysate flows from line LI through bypass line
L9, through substitution infusing line 10, and through branch lines LlOa and
LI0b into blood circuit 1. Final Act. 8; Sakamoto 197, Figure 6.
The Examiner finds that Sakamoto discloses creating a closed circuit
in the hemodialysis apparatus by closing valves VI, V2, V3, V5, and V6
when blood circuit 1 is filled with priming solution, and applying negative
pressure to the closed circuit by extracting liquid (priming
solution/dialysate) from the circuit using ultrafiltration pump 6 (liquid
supplying mechanism) while substitution infusing pump 11 is stopped.
Final Act. 8; Sakamoto 98, 99, 101, Figure 6. The Examiner finds that
this “negative pressure forming step of Sakamoto is capable of making the
pressure in the dialysis solution circuit negative so that the dialysis solution
does not overflow when the substitution infusion port is opened.” Final Act.
8-9.
The Examiner finds that Sakamoto discloses that the valves in
Sakamoto’s hemodialysis apparatus are electromagnetic, which the
Examiner finds would have suggested to one of ordinary skill in the art that
the apparatus electronically controls the valves and pumps (control means
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Application 14/402,136
for controlling the dialysis solution flowing means). Final Act. 11;
Sakamoto 75—79. The Examiner further finds that one of ordinary skill in
the art would have been led to make Sakamoto’s hemodialysis apparatus
automatic (via control means) because providing mechanical or automatic
means (control means) to replace manual activity to accomplish the same
results would have involved nothing more than employing ordinary skill in
the art at the time of Appellant’s invention. Final Act. 12 citing In re
Venner, 120 USPQ 192 (CCPA 1958); In re Rundell, 9 USPQ 220 (CCPA
1931).
The Examiner finds that Sakamoto does not disclose a lid member
that detaches from substitution infusing port 10 to open and close the port,
and the Examiner relies on Cavani for disclosing this feature. Final Act. 9.
The Examiner finds that Cavani discloses a unit for infusing a substitute
solution into a dialysis machine that has a flushing conformation (closed
state) and a dialysis conformation (open state). Final Act. 9-10; Cavani 2,1.
19—3,1. 1. The Examiner finds that Cavani discloses that when the infusion
unit is in the flushing conformation (closed state) dialysate circulates
through first external connector 13, through connecting cone 17, into
flushing chamber 9a, and through second external connector 15. Final Act.
9—10; Ans. 15; Cavani 5,1. 11—21, Figure 4. The Examiner finds that
Cavani discloses that when the infusion unit is in the dialysis conformation
(open state) cap 20 is removed from blocking portion 11, allowing dialysate
to flow from first external connector 13 to connecting cone 17, which joins
pipe 2b. Final Act. 11; Ans. 15—16; Cavani 5,1. 23—32, Figure 5.
The Examiner finds that one of ordinary skill in the art would have
been led at the time of Appellant’s invention to use the substitute solution
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Application 14/402,136
infusion unit disclosed in Cavani as the substitution infusing port of
Sakamoto to infuse a substitute solution into Sakamoto’s hemodialysis
apparatus “in a clean manner that is convenient and practical, as taught by
Cavani.” Final Act. 11; Cavani 2,11. 13—17. The Examiner further finds that
the substitute solution infusion unit disclosed in Cavani was a known device
for infusing a substitute solution in a hemodialysis apparatus at the time of
Appellant’s invention, and one of ordinary skill in the art, therefore, would
have been led to use Cavani’s unit in Sakamoto’s hemodialysis apparatus
because “it would operate equally well as the one disclosed by Sakamoto.”
Final Act. 11.
Appellant argues that “the blood filling line (L10) of Sakamoto et al
does not show the ‘replacement fluid port’ and the ‘replacement fluid
passage’” recited in claim 8. Br. 4.
However, Sakamoto does not disclose that substitution infusing line
L10 is a “blood filling line” as Appellant asserts. Rather, as discussed
above, Sakamoto discloses that the hemodialysis apparatus described in the
reference includes substitution infusing line L10 (replacement fluid passage)
having one end connected to blood circuit 1 and another end connected to
substitution infusing port 10 (replacement fluid port). Therefore, contrary to
Appellant’s arguments, Sakamoto’s apparatus includes structural features
corresponding to the replacement fluid port and replacement fluid passage
recited in claim 8.
Appellant argues that Sakamoto does not disclose performing a
negative pressure forming step after performing a dialysis fluid substitution
step to make the pressure in the dialysis solution circuit negative so that
dialysis solution will not overflow when Sakamoto’s substitution infusing
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port (replacement fluid port) is opened. Br. 5. Appellant further argues that
Sakamoto does not disclose performing a negative pressure forming step
before changing the substitution infusing port (replacement fluid port) from
the closed state to the open state, and before connecting the substitution
infusing port (replacement fluid port) to substitution infusing line L10
(replacement fluid passage). Br. 5—6.
However, claim 8 recites a hemodialysis apparatus rather than a
hemodialysis method, and, therefore, does not recite the method steps
implied by Appellant’s arguments. In other words, claim 8 does not require
performing a negative pressure forming step after performing a dialysis fluid
substitution step, and does not require performing a negative pressure
forming step before changing the substitution infusing port (replacement
fluid port) from the closed state to the open state, and before connecting the
substitution infusing port (replacement fluid port) to substitution infusing
line L10 (replacement fluid passage). Accordingly, Appellant’s arguments
are directed to subject matter that is not recited in claim 8, and, therefore
lack persuasive merit. In re Self, 671 F.2d 1344, 1348 (CCPA 1982)
(“[Ajppellant’s arguments fail from the outset because . . . they are not based
on limitations appearing in the claims.”).
Moreover, with respect to the functional language recited in claim 8, it
is well-settled that language in an apparatus claim directed to a function or
intended use that does not structurally limit the claimed apparatus
components or patentably differentiate the claimed apparatus from an
apparatus suggested by the prior art, will not support patentability. See, e.g.,
In re Schreiber, 128 F.3d 1473, 1477—79 (Fed. Cir. 1997) (“Schreiber’s
contention that his structure will be used to dispense popcorn does not have
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Application 14/402,136
patentable weight if the structure is already known” and “the Board
[correctly] found that the Harz dispenser [for dispensing lubricating oil]
would be capable of dispensing popcorn in the manner set forth in claim 1 of
Schreiber’s application.”); see also In re Rishoi, 197 F.2d 342, 344^45
(CCPA 1952); In re Otto, 312 F.2d 937, 940 (CCPA 1963); In reLudtke,
441 F.2d 660, 663-64 (CCPA 1971); In re Yanush, All F.2d 958, 959
(CCPA 1973).
As discussed above, the Examiner correctly finds that the
hemodialysis apparatus suggested by the combined disclosures of Sakamoto
and Cavani having Sakamoto’s substitution infusing port 10 replaced with
Cavani’s substitute solution infusion unit, and having control means for
controlling valves V3, V4 and duplex pump 5 of Sakamoto’s apparatus
(dialysis solution flowing means), would include all the structural features
recited in claim 8.3 Accordingly, the suggested apparatus would be capable
of making the pressure in Sakamoto’s dialysis solution circuit negative by
controlling valves and pumps in Sakamoto’s dialysis solution circuit when
cap 20 of Cavani’s substitute solution infusing unit engages blocking portion
11 in a flushing configuration (replacement fluid port is in a closed state) to
prevent dialysis solution from overflowing when Cavani’s cap 20 is
removed from blocking portion 11 (opening replacement fluid port) to
change the unit to dialysis configuration.
Therefore, because the claimed hemodialysis apparatus is not
3 The Examiner interprets the “control means for controlling the dialysis
solution flowing means” recited in claim 8 as “anything capable of
controlling the means for flowing the dialysis solution” in view of the lack
of description in Appellant’s Specification of the recited control means.
Final Act. 3.
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structurally distinct from the apparatus suggested by the combined
disclosures of Sakamoto and Cavani, the preponderance of the evidence
relied upon in this appeal supports a finding that the suggested apparatus
would be capable of performing the recited functions. Schreiber, 128 F.3d
at 1477-79.
Appellant further argues that Cavani’s substitute solution infusing unit
is not configured to make pressure in a dialysis solution circuit negative by
controlling dialysis solution flowing means from a state where a replacement
fluid port is in a closed state and the dialysis solution circuit is filled with a
dialysis solution to thereby enable prevention of overflowing of the dialysis
solution when the replacement fluid port is opened, and to stand by until the
replacement fluid port is opened, as recited in claim 8. Br. 6—7. Appellant
contends that configuring Cavani’s substitute solution infusing unit to act in
this manner “would go against the express teachings of Sakamoto et al such
that it is respectfully submitted that Sakamoto et al is not properly
combinable with Cavani.” Br. 7.
However, as the Examiner correctly finds, one of ordinary skill in the
art would have been led at the time of Appellant’s invention to use the
substitute solution infusion unit disclosed in Cavani as the substitution
infusing port 10 of Sakamoto’s hemodialysis apparatus to allow a substitute
solution to be infused into Sakamoto’s apparatus cleanly and conveniently,
as disclosed in Cavani. Final Act. 11. As discussed above, Sakamoto’s
hemodialysis apparatus modified in this manner would be capable of
performing the functions recited in claim 8. Appellant’s conclusory
argument that configuring Cavani’s substitute solution infusing unit to act
according to the functional language recited in claim 8 “would go against the
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express teachings of Sakamoto” does not identify any such “express
teachings” in Sakamoto. Nor does Appellant’s argument explain with a
sufficient degree of particularity why one of ordinary skill in the art would
not have reasonably expected that the relied-upon disclosures of Sakamoto
and Cavani could have been successfully combined. It follows that
Appellant’s conclusory arguments are unpersuasive of reversible error in the
Examiner’s proposed combination of the relied-upon features of Sakamoto’s
and Cavani’s apparatuses. See In re Baxter Travenol Labs., 952 F.2d 388,
391 (Fed. Cir. 1991) (“It is not the function of this court to examine the
claims in greater detail than argued by an appellant, looking for nonobvious
distinctions over the prior art.”).
We accordingly sustain the Examiner’s rejection of claim 8 under
35U.S.C. § 103(a).
Claims 5—7 and 9
We decide the appeal as to claims 5—7 and 9 based on claim 5 alone
because claims 6, 7, and 9 each depend from claim 5 and thus include all the
limitations of claim 5.
To address claims 5—7 and 9, Appellant repeats arguments that
Appellant provides for apparatus claim 8. Compare Br. 5—6, with Br. 7.
Specifically, Appellant argues that Sakamoto does not disclose performing a
negative pressure forming step after performing a dialysis fluid substitution
step to make the pressure in the dialysis solution circuit negative so that
dialysis solution will not overflow when Sakamoto’s substitution infusing
port (replacement fluid port) is opened. Br. 7. Appellant further argues that
Sakamoto does not disclose performing a negative pressure forming step
before changing the substitution infusing port (replacement fluid port) from
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the closed state to the open state, and before connecting the substitution
infusing port (replacement fluid port) to substitution infusing line L10
(replacement fluid passage). Id.
In contrast to the analysis discussed above for apparatus claim 8 in
which Appellant’s arguments were directed to method steps not recited in
claim 8, Appellant’s arguments for claim 5 are based on method steps
recited in the claim. Appellant disputes in essence that Sakamoto would
have suggested performing the method steps in the recited order, which
Appellant implicitly asserts to be required by claim 5. We therefore begin
our analysis by determining whether claim 5 requires the recited method
steps to be performed in the order indicated in the claim.
Claimed method steps are not ordinarily construed to require a
particular order of performance unless they expressly or implicitly require
performance in that order. Altiris v. Symantec Corp., 318 F.3d 1363, 1369
(Fed. Cir. 2003) (citing Interactive Gift Express, Inc. v. CompuServe Inc.,
256 F.3d 1323 (Fed. Cir. 2001)). “First, we look to the claim language to
determine if, as a matter of logic or grammar, [the method steps] must be
performed in the order written.” Altiris, 318 F.3d at 1369. If the claim
language itself does not require performing the steps in that order, we then
look to the Specification “to determine whether it ‘directly or implicitly
requires such a narrow construction.’” Id. at 1370.
Looking first to the language of claim 5, logic dictates that the step of
“performing a negative pressure forming step to make the pressure in the
dialysis solution circuit negative so that the dialysis solution does not
overflow when the replacement fluid port is opened” must be performed
before the step of “changing the replacement fluid port from a closed state to
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an open state.” Logic also dictates that language of claim 5 requires the step
of “detaching the lid member from the replacement fluid port” to be
performed before the step of “changing the replacement fluid port from a
closed state to an open state,” and requires the step of “connecting the
replacement fluid passage to the replacement fluid port in the open state” to
be performed after the step of “changing the replacement fluid port from a
closed state to an open state.” Accordingly, the language of claim 5 requires
the steps of
performing a negative pressure forming step to make the
pressure in the dialysis solution circuit negative so that the
dialysis solution does not overflow when the replacement fluid
port is opened; detaching the lid member from the replacement
fluid port; changing the replacement fluid port from a closed
state to an open state; and connecting the replacement fluid
passage to the replacement fluid port in the open state
to be performed in the order recited in the claim.
With respect to the step of “performing a dialysis fluid substitution
step of filling the dialysis solution circuit with a dialysis solution,” claim 5
appears to require performance of this step before the next recited step of
“performing a negative pressure forming step to make the pressure in the
dialysis solution circuit negative so that the dialysis solution does not
overflow when the replacement fluid port is opened” because the negative
pressure forming step relies on the previous step to provide antecedent basis
for “the” dialysis solution. Specifically, by reciting “the dialysis solution,”
the negative pressure forming step refers to the immediately preceding step
in which “a dialysis solution” fills the dialysis solution circuit. Therefore,
the language of claim 5 appears to require performance of the dialysis fluid
substitution step before performance of the negative pressure forming step.
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We look to Appellant’s Specification for further guidance to determine
whether the Specification directly or implicitly supports this construction.
Appellant’s Specification explains that at the time of dialysis
treatment, replacement fluid passage 6 is connected to replacement fluid port
31 and dialysis solution is supplied into replacement fluid passage 6. Spec.
16,11. 1—5; Figure 1. Appellant’s Specification further explains that after
completion of dialysis treatment, the interior of the dialysis solution circuit 4
is cleaned with a cleaning liquid in a process involving, inter alia, detaching
replacement fluid passage 6 from replacement fluid port 31 and filling the
interior of dialysis solution circuit 4 with a cleaning liquid. Spec. 123;
Figure 5. Appellant’s Specification indicates that following this cleaning
treatment, the cleaning liquid contained in the dialysis solution circuit 4 is
replaced with fresh dialysis solution using a dialysis fluid substitution
procedure. Id. Appellant’s Specification describes conducting this
substitution procedure by filling dialysis solution circuit 4 with dialysis
solution when replacement fluid passage 6 is still disconnected from
replacement fluid port 31 and lid member 44 closes replacement fluid port
31. Spec. 123; Figure 5. Appellant’s Specification described performing a
negative pressure forming step after the dialysis solution substitution step to
make the pressure in dialysis solution circuit 4 negative. Spec. Tflf 24, 27;
Figure 6. Appellant’s Specification indicates that the negative pressure
forming step prevents dialysis solution in replacement fluid port 31 from
overflowing when opening replacement fluid port 31 to reconnect
replacement fluid passage 6 with replacement fluid port 31 so as to
configure the apparatus for another dialysis treatment. Spec. Tflf 26, 27;
Figure 8.
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Therefore, Appellant’s Specification explicitly indicates that dialysis
fluid substitution is performed following dialysis treatment when
replacement fluid passage 6 is disconnected from replacement fluid port 31,
and Appellant’s Specification indicates that the negative pressure forming
step is performed after dialysis fluid substitution so that dialysis solution
will not overflow when replacement fluid passage 6 is reconnected to
replacement fluid port 31 to ready the apparatus for another dialysis
treatment. Accordingly, under a broadest reasonable interpretation of claim
5 consistent with Appellant’s Specification, claim 5 requires
performing the dialysis fluid substitution step before performing the negative
pressure forming step, and therefore requires the method steps to be
performed in the order recited in the claim.
As mentioned above, the Examiner addresses method claim 5 and
apparatus claim 8 together in the Final Action, and the Examiner’s findings
of fact for claim 5 are set forth above in the discussion of claim 8. In
addressing the limitations of claim 5 in the Answer in response to
Appellant’s arguments, the Examiner asserts that the negative pressure
forming step disclosed in Sakamoto “is capable of making the pressure in
the dialysis solution circuit negative so that the dialysis solution does not
overflow when the substitution infusion port is opened.” Ans. 14. The
Examiner further asserts in the Answer that Cavani’s disclosures meet the
limitations recited in claim 5 of “a replacement fluid port... capable of being
opened and closed by a lid member,” and “detaching the lid member from
the replacement fluid port; changing the replacement fluid port from a closed
state to an open state; and connecting the replacement fluid passage to the
replacement fluid port in the open state.” Ans. 15.
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However, the Examiner does not provide a sufficient factual basis to
establish that the combined disclosures of Sakamoto and Cavani would have
suggested performing a negative pressure forming step in Sakamoto’s
apparatus modified to include Cavani’s substitute solution infusing unit after
performing a dialysis fluid substitution step to make the pressure in
Sakamoto’s dialysis solution circuit negative so that dialysis solution would
not overflow when cap 20 of Cavani’s substitute solution infusing unit
(replacement fluid port) is removed from blocking portion 11 (opened), as
required by method claim 5 as we have interpreted it. Nor does the
Examiner provide a sufficient factual basis to establish that the combined
disclosures of Sakamoto and Cavani would have suggested performing a
negative pressure forming step before changing Cavani’s substitute solution
infusing unit (replacement fluid port) from the flushing conformation to the
dialysis confirmation (closed state to open state), and before connecting
Cavani’s substitute solution infusing unit (replacement fluid port) to pipe 2b
(replacement fluid passage), as also required by claim 5 as we have
interpreted it.
Therefore, we reverse the Examiner’s rejection of claims 5—7 and 9
under 35 U.S.C. § 103(a).
DECISION
In view of the reasons set forth above and in the Final Action and the
Answer, we affirm the Examiner’s rejection of claim 8 under 35 U.S.C.
§ 103(a), but we reverse the Examiner’s rejection of claims 5—7 and 9 under
35 U.S.C. § 103(a) for the reasons set forth in the Appeal Brief and above.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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