TERUMO KABUSHIKI KAISHA

Patent Trials and Appeals Board

Dec 8, 2020

2020002650 (P.T.A.B. Dec. 8, 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.
14/435,331 04/13/2015 Hiroshi Nishitani 1011350-000571 1072
21839 7590 12/08/2020
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA, VA 22313-1404
EXAMINER
KLEIN, BENJAMIN JACOB
ART UNIT PAPER NUMBER
3781
NOTIFICATION DATE DELIVERY MODE
12/08/2020 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):
ADIPDOC1@BIPC.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte HIROSHI NISHITANI, HIROKAZU USAMI,
YOSHIHIKO KOYAMA, and TSUYOSHI ARIIZUMI

Appeal 2020-002650
Application 14/435,331
Technology Center 3700
____________

Before BIBHU R. MOHANTY, MICHAEL C. ASTORINO, and
KENNETH G. SCHOPFER, Administrative Patent Judges.

ASTORINO, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 6–9 and 16.2 We have jurisdiction
under 35 U.S.C. § 6(b). We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies the real party in interest as
Terumo Kabushiki Kaisha. Appeal Br. 2.
2 In an Advisory Action, mailed September 6, 2019, the Examiner entered an
amendment, filed August 22, 2019, cancelling claims 1–4, 14, and 15.
Claims 5 and 10–13 were previously cancelled during prosecution. See
Amendment 2–3 (filed Oct. 9, 2018).
Appeal 2020-002650
Application 14/435,331

2

STATEMENT OF THE CASE
Claimed Subject Matter
Claim 6, the sole independent claim, is representative of the subject
matter on appeal and is reproduced below.
6. A sterile peritoneal dialysis fluid, comprising:
an acidic first liquid containing only water, icodextrin,
and sodium chloride, the acidic first liquid containing sodium
chloride in an amount up to 2.34 g/L;
an alkaline second liquid containing an alkaline pH
regulator; and
the first liquid after sterilization having a pH of 4.7 to
5.5, the second liquid after sterilization having a pH of 6.5 to
7.5, and a mixture of the first liquid and the second liquid after
sterilization having a pH of 6.0 to 7.5.
Rejection
Claims 6–9 and 16 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Faict et al. (US 5,092,838, iss. Mar. 3, 1992) (“Faict”) in
view of Martis et al. (US 2004/0121982 A1, pub. June 24, 2004) (“Martis”).

ANALYSIS
The Examiner rejects independent claim 6 based on the combined
teachings of Faict and Martis. Final Act. 4–7. The Examiner finds Faict
teaches a sterile peritoneal dialysis fluid including an acidic first liquid and
an alkaline second liquid, wherein the acidic first liquid “contain[s] only
water, and glucose or a related molecule.” Id. at 4–5. The Examiner also
finds Faict fails to teach an “acidic first liquid containing sodium chloride in
an amount up to 2.34 g/L,” as recited in claim 6. See id. at 5. To remedy
this deficiency, the Examiner turns to Martis. The Examiner determines:
Martis teaches a number of examples of suitable 2 part
solutions and specifically teaches an example having sodium
Appeal 2020-002650
Application 14/435,331

3

chloride only in the second solution, and also teaches an
example having sodium chloride in both solutions including
(4.22g/L) in the first solution. . . . Therefore it would have been
obvious to a person having ordinary skill in the art . . . the
sodium chloride concentration in the first solution could be
adjusted from between zero to up to at least 4.22g/L with the
reasonable expectation that such a modification would produce
the predictable result of providing a combined solution having
the desired sodium chloride concentration while still providing
a first solution which is thermally stable.
Id. at 6 (citing Martis ¶¶ 32, 43, 46–49) (emphasis added). The Examiner
bolsters this determination with additional reasoning, such as an “obvious to
try” rationale. See Ans. 4–5. The Examiner’s additional reasoning is
supported solely on the finding the Martis teaches a sodium chloride
concentration in the first solution having a range from zero to up to at least
4.22g/L. See id.
The Appellant points out that “Martis’s disclosure of a single value
(4.22 g/L) of sodium chloride in one example and the absence of sodium
chloride in another example, does not constitute a disclosure of a range of
between zero to up to at least 4.22 g/L.” Reply Br. 2; see Appeal Br. 5–8.
We agree. The Appellant further points out that “Martis merely discloses
the use of sodium chloride in a specific amount, i.e., 4.22 g/L” and “[t]his
amount is outside the claimed range of up to 2.34 g/L.” Appeal Br. 6 (citing
Martis ¶ 48). We agree.
The Appellant argues that “[t]he Examiner does not explain why a
person of ordinary skill in the art would have been somehow led to modify
the cited art to arrive at the ‘desired’ sodium chloride concentration (i.e., the
claimed range) without resorting to improper hindsight.” Appeal Br. 7–8.
The Appellant’s argument is persuasive.
Appeal 2020-002650
Application 14/435,331

4

The Examiner’s rejection of claim 6 relies on the finding that Martis
teaches a sodium chloride concentration in a first solution having a range
from zero to up to at least 4.22g/L. However, as discussed above, we agree
with the Appellant that Martis does not teach a two part solution with a first
liquid including sodium chloride in a range of zero to up to at least 4.22g/L.
Although Martis does teach a first solution having sodium chloride at
4.22 g/L (Martis ¶ 48), this amount of sodium chloride is above the claimed
range, i.e., “in an amount up to 2.34 g/L.” In view of the foregoing, we
determine that the Examiner’s reasoning lacks the necessary rational
underpinning to support the conclusion that a person having ordinary skill in
the art would have modified Faict’s acidic first liquid to contain an amount
of sodium chloride in the claimed range. See in re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006) (“[R]ejections on obviousness grounds . . . [require] some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.”) (cited with approval in KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007)). Thus, we do not sustain the
Examiner’s rejection of claim 6 and claims 7–9 and 16, which depend
therefrom.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
6–9, 16 103(a) Faict, Martis

6–9, 16

REVERSED