Fresenius Medical Care Holdings, Inc.

Patent Trials and Appeals Board

Jun 9, 2021

2020003269 (P.T.A.B. Jun. 9, 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.
15/429,583 02/10/2017 Ross Peter Jones 18196-0183002 1002
26216 7590 06/09/2021
FISH & RICHARDSON P.C. (FRESENIUS)
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
BREWSTER, HAYDEN R
ART UNIT PAPER NUMBER
1779
NOTIFICATION DATE DELIVERY MODE
06/09/2021 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):
PATDOCTC@fr.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROSS PETER JONES, PRANAV CHOPRA, RUPERT MENZIES,
MARK DAVID TUCKWELL, MARTIN JOSEPH CRNKOVICH, LYNN
JENSEN, and SHASHIKANT DATTATRAYA KALASKAR

Appeal 2020-003269
Application 15/429,583
Technology Center 1700
____________

Before CATHERINE Q. TIMM, MICHAEL P. COLAIANNI, and
BRIAN D. RANGE, Administrative Patent Judges.

COLAIANNI, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–19. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party in interest as Fresenius Medical Can Holdings Inc.
Appeal Br. 1.
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Application 15/429,583

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Appellant’s invention is directed to a method of detecting the
concentration of a substance (e.g., sodium or hydrogen) in a medical fluid
(e.g., blood or dialysate) using nuclear magnetic resonance (NMR) (Claim 1;
Spec. 38:12–15).
Claim 1 is representative of the subject matter on appeal:
1. A method comprising:
measuring a quantity of a first substance in a reference fluid in a
reference fluid cartridge using a nuclear magnetic resonance
sensor assembly;
measuring, using the nuclear magnetic resonance sensor
assembly, a quantity of a second substance in the reference fluid
in the reference fluid cartridge;
measuring, using the nuclear magnetic resonance sensor
assembly, a quantity of the first substance in a medical fluid in a
medical fluid cartridge;
measuring, using the nuclear magnetic resonance sensor
assembly, a quantity of the second substance in the medical fluid
in the medical fluid cartridge; and
determining a concentration of the second substance in the
medical fluid based on the measured quantities of the first and
second substances in the reference fluid and the medical fluid,
wherein the first substance is different from the second
substance, and
wherein the concentration of the first substance in the reference
fluid is known.

Appellant appeals the following rejections:
1. Claims 1–5 are rejected under 35 U.S.C. §§ 102(b)/103(a) as
unpatentable over Rapoport (US 4,875,486; Oct. 24, 1989).
2. Claims 6–8, 10–12, 14, 17, and 19 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Rapoport in view of Lee (US
2010/0072994 A1; Mar. 25, 2010).
3. Claims 9 and 13 are rejected under 35 U.S.C. § 103(a) as
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Application 15/429,583

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unpatentable over Rapoport in view of Lee and de Rooij (US
2008/0136415 A1; June 12, 2008).
4. Claims 15 and 16 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Rapoport in view of Lee and Keenan (US
2008/0077074 A1; Mar. 27, 2008).
5. Claim 18 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Rapoport in view of Lowery (US 2012/0100546 A1; Apr.
26, 2012).
Appellant’s arguments focus on the subject matter of claim 1 under
rejection (1) (Appeal Br. 3–6). Claims 2 to 19 are not argued separately and
will stand or fall with claim 1.

FINDINGS OF FACT & ANALYSIS
The Examiner finds that Rapoport anticipates or, alternatively, would
have rendered obvious the method of claim 1 (Final Act. 4–6). The
Examiner finds that Rapoport teaches determining the glucose level in a
patient’s blood by using the relationship in peak heights of the glucose and
water in a standard solution and the peak heights of glucose and water in a
patient sample (Final Act. 4–5). The Examiner finds that the normalized
water peak height is analogous to a water concentration (i.e., the first
substance in claim 1) in the reference fluid (Final Act. 5).
Alternatively, the Examiner finds that Rapoport teaches the method of
claim 1, except for the concentration of the first substance (i.e., water in
Rapoport) in the reference fluid is known (Final Act. 5). The Examiner
finds that the more information that is known about one of the substances,
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such as the first substance, and its relationship with the other substance (i.e.,
the second substance), the more likely one could determine information
about the second substance (Final Act. 6). The Examiner concludes that it
would have been obvious to measure the a quantity of the first substance in
the medical fluid in a medical fluid cartridge and determine a concentration
of the second substance in the reference fluid and medical fluid, where the
concentration of the first substance is also known, as an alternate or
simplifying means of garnering the concentration of the second reference
(Final Act. 6).
Appellant argues the Examiner errs in finding that Rapoport teaches
water is a known concentration in the standard sample (Appeal Br. 4).
Appellant argues that the Examiner conflates “quantity” and “concentration”
in finding that Rapoport’s disclosure of water peak height in the standard is a
disclosure of concentration (Reply Br. 4). Appellant contends that
concentration is the amount of a dissolved substance (solute) contained per
unit of volume (solvent) (Reply Br. 2, 4). Based on this definition of
concentration, Appellant contends that the concentration of water cannot be
ascertained because the concentration would be based on the amount of
water (solute) dissolved in water (solvent) (Reply Br. 4). Appellant argues
Rapoport’s normalized water peak is derived based on measured water peaks
of the standard sample and blood and is not a known quantity (Reply Br. 3).
Appellant argues that a measured quantity is different than a known quantity
(Reply Br. 3). Appellant argues the calibration data in Rapoport may not be
considered as relating to a reference fluid, but even if the calibration data
may be considered to relate to a reference fluid, Appellant contends the
calibration data does not include quantities of first and second substances
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that are measured by a nuclear magnetic sensor assembly that is also used to
measure quantities of those first and second substances in a medical fluid in
a medical fluid cartridge (Appeal Br. 6).
Contrary to Appellant’s arguments, Rapoport teaches using nuclear
magnetic resonance (NMR) to analyze body fluid samples (col. 2, ll. 37–39).
Rapoport teaches the analysis is done in phases that include a patient reading
cycle where NMR is applied to the patient’s blood underneath a fingernail
(col. 5, ll. 4–24; col. 6, ll. 22–26). Rapoport’s next phase includes a standard
sample reading cycle (col. 6, l. 27). Rapoport discloses the standard sample
contains predetermined amounts of the constituent material or materials
being tested for and acts as a reference level (col. 6, ll. 65–67). Rapoport
discloses that the NMR analysis of the standard sample and the patient
sample include peak height data (col. 7, ll. 1–5; col. 8, ll. 1–34; Fig. 5a). As
shown in Rapoport’s Figure 5a, the NMR spectrum includes peaks for H2O
and glucose. The x-axis for each of these peaks is labelled as “PPM” or
parts per million (Rapoport, Fig. 5a). We find that parts per million is a
measure of concentration. Rapoport’s equation that is used to calculate the
patient’s glucose concentration is based on using the standard solution’s
known glucose concentration (K) multiplied by the ratio of water peak
heights in the standard sample and patient sample and the ratio of glucose
peak heights in the standard sample and patient sample (col. 7, ll. 6–68; col.
8, ll. 1–8).
Based upon Rapoport’s disclosures, we agree with the Examiner that
Rapoport’s water standard peak height includes within it an indication of the
concentration of water in the standard sample. As shown in Figure 5a, the
NMR spectrum shows that water peak is at about 5 ppm. In other words, the
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concentration of water (i.e., the first substance) in Rapoport’s standard
sample was known as required by claim 1. Appellant’s arguments about
conflating quantity and concentration are not persuasive in light of
Rapoport’s Figure 5a disclosure. Appellant’s definition of concentration is
narrow in that it is limited to the amount of solute dissolved in a solvent
(Reply Br. 2, 4). There are other measures of concentration such as
molarity2, which is a measure of the molar concentration of a solution,
expressed as the number moles of solute per liter of solution (emphasis
added). The concentration of water may be determined as the moles of
water per volume of solution (i.e., glucose and water combined).
We find that the Examiner has established that Rapoport anticipates
the method recited in claim 1. Accordingly, we are unpersuaded by
Appellant’s arguments regarding lack of motivation to use water
concentration to determine glucose concentration in a patient’s blood
because no motivation is needed for an anticipation rejection. Indeed,
Rapoport’s use of the water peak height standard indicates that the
concentration of water in the standard was known along with the
concentration of glucose in the standard. Moreover, the use of the water
peak height and glucose peak height in the standard is part of the data used
in the equation to determine the glucose level in the patient (Rapoport,
equation bridging cols. 7 and 8).
We affirm the Examiner’s § 102(b) rejection and the § 103 rejection
over Rapoport. For the same reasons, we affirm the following rejections: (1)
§ 103 rejection of claims 6–8, 10–12, 14, 17, and 19 over Rapoport and Lee,

2 https://www.dictionary.com/browse/molarity last accessed May 27, 2021.
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(2) § 103 rejection of claims 9 and 13 over Rapoport, Lee, and De Rooij, (3)
§ 103 rejection of claims 15 and 16 over Rapoport, Lee, and Keenan, and (4)
§ 103 rejection claim 18 over Rapoport and Lowery.

DECISION
In summary:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5 102(b) Rapoport 1–5
6–8, 10–
12, 14, 17,
19
103(a) Rapoport, Lee 6–8, 10–12,
14, 17, 19

9, 13 103(a) Rapoport, Lee, De Rooij 9, 13
15, 16 103(a) Rapoport, Lee, Keenan 15, 16
18 103(a) Rapoport, Lowery 18
Overall
Outcome
1–19

TIME PERIOD FOR RESPONSE

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED