Nathan W. Levin et al.

Patent Trials and Appeals Board

Mar 3, 2020

13879220 - (D) (P.T.A.B. Mar. 3, 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.
13/879,220 04/12/2013 Nathan W. Levin 8142FMC0007 2620
121159 7590 03/03/2020
Kacvinsky Daisak Bluni PLLC-(Bos)
2601 Weston Parkway
Cary, NC 27513
EXAMINER
MCCROSKY, DAVID J
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
03/03/2020 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NATHAN W. LEVIN and FANSAN ZHU
Appeal 2018-002886
Application 13/879,220
Technology Center 3700
Before LINDA E. HORNER, BRETT C. MARTIN, and
BRANDON J. WARNER, Administrative Patent Judges.
MARTIN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 7, 8, 12–15, 24, 63, and 64. See Final
Act. 2–11. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Fresenius Medical
Care Holdings, Inc. Appeal Br. 1.
Appeal 2018-002886
Application 13/879,220
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CLAIMED SUBJECT MATTER
The claims are directed to a dry weight predictor. Claim 64,
reproduced below, is illustrative of the claimed subject matter:
64. A method for administering a dosage of a medicament to a
user having a body mass index value including a bioimpedance
measurement system, the bioimpedance measurement system
comprising a central processing unit, a stimulating system
including stimulating electrodes, and a recording system
including recording electrodes, the method comprising:
determining a resistance value of extracellular fluid
volume of a user’s calf by the stimulating and recording
electrodes, the resistance value being sent to the central
processing unit;
measuring a circumference of the user’s calf by the
stimulating and recording electrodes, the circumference
measurement being sent to the central processing unit;
the central processing unit calculating a normalized
resistivity based on the resistance value, the circumference
measurement, and a body mass index value of the user;
the central processing unit calculating an offset value
between the normalized resistivity and a reference value for the
normalized resistivity;
the central processing unit calculating an estimated dry
weight of the user, the estimated dry weight being based on the
offset value, and a weight of the user determined during the
calculation of the offset value is different from the estimated dry
weight;
determining a dosage of a medicament based on utilizing
the estimated dry weight to determine a dosage of a medicament;
and
administrating the dosage of the medicament to the user.
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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Zhu

US 2006/0122450 A1

June 8, 2006

Woo

US 2009/0062728 A1

Mar. 5, 2009

Moissl et al., “Body Fluid Volume Determination via Body Composition
Spectroscopy in Health and Disease,” Physiol. Meas. 27 (2006) (921−33)
(“Moissl”)

REJECTIONS
Claims 7, 8, 12‒15, 24, 63, and 64 stand rejected under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement. Ans. 2.
Claims 7, 8, 12–15, 24, 63, and 64 stand rejected under 35 U.S.C.
§ 101 as being directed to non-statutory subject matter. Ans. 3–5.
Claims 7, 8, 12–15, 24, and 63 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Zhu and Moissl. Ans. 5–9.2
Claim 64 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Zhu, Moissl, and Woo. Ans. 9‒11.

2 The statement of the rejection on page 5 of the Answer omits claim 24, but
the detailed explanation of the rejection includes an analysis of the
obviousness of claim 24 on page 9 of the Answer.
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Application 13/879,220
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OPINION
Written Description
The Examiner rejects independent claims 63 and 64, and by extension
their dependent claims, for failing to comply with the written description
requirement. According to the Examiner, the specification is insufficiently
specific in describing the CPU as that which does the calculating of the
claimed values. Ans. 2. We first note that original claim 57 specifically
stated that the computer system is programmed to perform the step of
calculating a difference value, which is equivalent to the claimed offset
value of claims 63 and 64. Claim 42 likewise recited a computer program
for executing the method of claim 26, which means the computer performs
the various steps contained therein. For this reason alone, the claims find
sufficient written description support. Furthermore, we agree with Appellant
that “[t]he specification provides sufficient description to a person having
ordinary skill in the art to understand that the central processing unit is
utilized for executing commands, including mathematical operations.”
Reply Br. 2 (citing Spec. ¶¶ 37‒41, 51). The Examiner appears to be
looking for an ipsis verbis description of the computer specifically
performing the steps as claimed, when all that is required is that one of
ordinary skill in the art understand that the CPU performs the various
operations, which the Specification adequately establishes. Accordingly, we
do not sustain the Examiner’s rejection.
Subject Matter Eligibility
Standard for Patent Eligibility
In issues involving subject matter eligibility, our inquiry focuses on
whether the claims satisfy the two-step test set forth by the Supreme Court in
Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). The Supreme Court
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5
instructs us to “first determine whether the claims at issue are directed to a
patent-ineligible concept,” id. at 216–18, and, in this case, the inquiry
centers on whether the claims are directed to an abstract idea. If the initial
threshold is met, we then move to the second step, in which we “consider the
elements of each claim both individually and ‘as an ordered combination’ to
determine whether the additional elements ‘transform the nature of the
claim’ into a patent-eligible application.” Id. at 217 (quoting Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79, 78 (2012)).
The Supreme Court describes the second step as a search for “an ‘inventive
concept’—i.e., an element or combination of elements that is ‘sufficient to
ensure that the patent in practice amounts to significantly more than a patent
upon the [ineligible concept] itself.’” Id. (quoting Mayo, 566 U.S. at 72–
73).
The USPTO recently published revised guidance on the application of
§ 101. USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent
Subject Matter Eligibility Guidance (“Memorandum”). Under that
guidance, we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
human activity such as a fundamental economic practice, or
mental processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
“well-understood, routine, conventional” in the field (see MPEP
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§ 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See Memorandum.

Examiner’s Findings and Conclusion
In the first step of the Alice inquiry, the Examiner rejects claims 7, 8,
12−15, 24, 63, and 64 “because the claimed invention is directed to a
judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract
idea) without significantly more.” Ans. 3. The Examiner identifies the
claimed series of steps for calculating a patient’s dry weight as the abstract
idea. Id. At Alice step 2, the Examiner additionally finds that the claims do
not add a meaningful limitation to the abstract idea so as to amount to
significantly more than the judicial exception. Id.
Analysis According to the Guidelines
Step One: Do Claims 63 and 64 Fall Within a Statutory Category of § 101?
We first examine whether the claims recite one of the enumerated
statutory classes of subject matter, i.e., process, machine, manufacture, or
composition of matter, eligible for patenting under 35 U.S.C. § 101. Claims
63 and 64 are directed to a method, which is one of the statutory classes (i.e.,
a process) under 35 U.S.C. § 101.
Step 2A, Prong One: Do Claims 63 and 64 Recite a Judicial Exception?
We next look to whether the claims recite any judicial exceptions,
including certain groupings of abstract ideas, i.e., mathematical concepts,
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certain methods of organizing human activity such as a fundamental
economic practice, or mental processes.
Claim 63
In this instance, claim 63, for example, recites the steps of
determining a resistance value, measuring a circumference of the user’s calf,
calculating a normalized resistivity, calculating an offset value, and
calculating an estimated dry weight of the user. Specifically, the claims
recite:
determining a resistance value of extracellular fluid
volume of a user’s calf by the stimulating and recording
electrodes, the resistance value being sent to the central
processing unit;
measuring a circumference of the user’s calf by the
stimulating and recording electrodes, the circumference
measurement being sent to the central processing unit;
the central processing unit calculating a normalized
resistivity based on the resistance value, the circumference
measurement, and a body mass index value of the user;
the central processing unit calculating an offset value
between the normalized resistivity and a reference value for the
normalized resistivity; and
the central processing unit calculating an estimated dry
weight of the user, the estimated dry weight being based on the
offset value, and a weight of the user determined during the
calculation of the offset value is different from the estimated dry
weight.
Although these steps are claimed as being done by a processor or
computer, the activities themselves are all capable of being performed in the
human mind and, as such, each step of selecting, forming, and storing in the
claim falls into the abstract idea of mental processes. See, e.g., CyberSource
Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir. 2011) (“That
purely mental processes can be unpatentable, even when performed by a
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computer, was precisely the holding of the Supreme Court in Gottschalk v.
Benson.”). Claim 64 recites steps similar to those discussed above. We
therefore determine that claims 63 and 64 recite the abstract idea of mental
processes, which is a judicial exception to patent-eligible subject matter.
Step 2A, Prong Two: Do Claims 63 and 64 Recite Additional Elements that
Integrate the Judicial Exceptions into a Practical Application?
Claim 63
Following our Office guidance, having found that claim 63 recites a
judicial exception, we next determine whether the claim recites “additional
elements that integrate the exception into a practical application” (see MPEP
§§ 2106.05(a)–(c), (e)–(h)). See Revised Guidance, 84 Fed. Reg. at 54. As
noted above, each of the claimed steps is merely recited as being performed
by a computer or processor. As used in the claims, the computer and
processor are merely generic components of a computer system that do not
result in an improvement in the functioning of a computer or other
technology or technological field. The recitations of the generic structures
with which the recited steps are performed are merely instructions to use a
computer system as a tool to perform the abstract idea. Thus, the claims do
not apply, rely on, or use the mental process steps in a manner that imposes a
meaningful limit on those steps. Rather, the claim is simply a drafting effort
designed to monopolize the mental process steps of claim 63.
The additional elements do not add meaningful limits to the mental
process steps recited in claim 63. Instead, the generic computer system
limitations are no more than instructions to apply the judicial exception (i.e.,
a mental process) using generic computer elements. See MPEP § 2106.05(f)
(“Use of a computer or other machinery in its ordinary capacity for . . . tasks
(e.g., to receive, store, or transmit data) or simply adding a general purpose
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computer or computer components after the fact to an abstract idea . . . does
not provide significantly more.”).
In short, the additional elements discussed above: (1) do not improve
the functioning of a computer or other technology; (2) are not applied with
any particular machine; (3) do not effect a transformation of a particular
article to a different state; and (4) are not applied in any meaningful way
beyond generally linking the use of the judicial exception to a particular
technological environment. See MPEP §§ 2106.05(a)–(c), (e)–(h).
Consequently, the claimed invention does not integrate the abstract idea into
a “practical application.”
For these reasons, the additional elements of claim 63 do not integrate
the judicial exception into a practical application. Thus, claim 63 is directed
to an abstract idea, which is a judicial exception to patent eligible subject
matter under 35 U.S.C. § 101.
Claim 64
Claim 64 contains limitations similar to claim 63, but adds the steps of
determining a dosage and then administering said dosage. These two
additional steps, considered collectively, integrate the judicial exception into
a practical application. According to claim 64, one would perform all of the
steps to determine a proper dosage according to the method, but then would
actually administer such a dosage to a user. We agree with Appellant that
“administering a more accurate dosage of a medicament to a patient”
determined according to the method “provides a real improvement to
dialysis patients at risk for overhydration.” App. Br. 15. By taking the data
and calculations from the rest of the claim and then actually administering
that calculated dosage to a patient, claim 64 goes beyond the abstract idea
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itself, and integrates the idea into a practical application. Accordingly, we
do not sustain the Examiner’s rejection of claim 64.
Step 2B: Does Claim 63 Recite an Inventive Concept?
We next consider whether claim 63 recites any elements, individually
or as an ordered combination, that transform the abstract idea into a patent-
eligible application, e.g., by providing an inventive concept. Alice, 573 U.S.
at 217–18. As noted above, the only additional elements in claim 63 are a
processor and computer used for routine computer functionality to enact the
method steps and use of electrodes for data collection. These additional
elements do not provide, either individually or as a combination,
improvements to another technology or technical field or the functioning of
the computer itself.
According to Office guidance, under Step 2B, “examiners should . . .
evaluate the additional elements individually and in combination . . . to
determine whether they provide an inventive concept (i.e., whether the
additional elements amount to significantly more than the exception itself).”
See Guidance 84 Fed. Reg. at 56 (emphasis added). Thus, the second step of
the inquiry (Step 2B) looks at the additional elements in combination. See,
e.g., Examples accompanying Guidance (Example 37 (claim 3 analysis) and
Example 40 (claim 2 analysis)). See also BSG Tech LLC v. BuySeasons,
Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018) (“It has been clear since Alice
that a claimed invention’s use of the ineligible concept to which it is directed
cannot supply the inventive concept that renders the invention ‘significantly
more’ than that ineligible concept.”)
As noted above, the computer and processor are invoked as
conventional tools. Apart from being used to perform the abstract idea
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itself, these generic computer system components only serve to perform
well-understood functions (e.g., storing, selecting, analyzing, and outputting
data). See FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1096
(Fed. Cir. 2016) (“the use of generic computer elements like a
microprocessor or user interface do not alone transform an otherwise
abstract idea into patent-eligible subject matter”). The electrodes likewise
are used in a conventional manner to obtain data necessary for the ultimate
calculation of dry weight. In our view, claim 63 fails to add a specific
limitation beyond the judicial exception that is not “well-understood,
routine, conventional” in the field, but instead “simply appends well-
understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception.”
See Guidance, 84 Fed. Reg. at 56. That is, we are not persuaded that claim
63 is directed to a specific application designed to achieve an improved
technological result, as opposed to being directed to merely ordinary
functionality of the above-recited additional elements to apply an abstract
idea. For the reasons discussed above, we find no element or combination of
elements recited in claim 63 that contains any “inventive concept” or adds
anything “significantly more” to transform the abstract concept into a patent-
eligible application. See Alice, 573 U.S. at 221.
Appellant’s Contentions
Appellant first asserts that the present claims constitute an
“improvement of estimating a dry weight,” but the only alleged
improvement is in the automation of the data collection and calculation.
Reply Br. 3. Appellant also attempts to analogize the claims at issue to
those in Thales Visionix v. United States, 850 F.3d 1343 (Fed. Cir. 2017).
Reply Br. 4. As Appellant points out, it was the “unique configuration of
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sensors” in Thales that amounted to improvement in the data gathering. Id.
Appellant’s claims, however, merely recite using known sensors in a known
way to collect data and then process it with a computer. The improvement
lies in the administration of a better dosage of medicament, which is
encompassed in claim 64, not in the mere collection and processing of data
found in claim 63. Accordingly, we sustain the Examiner’s rejection of
claim 63, as well as those claims dependent therefrom, for which Appellant
offers no separate arguments.
Obviousness
Appellant points out that “Moissl is cited in the Office Action merely
to support the proposition that it would have been known that the
‘determination being made at a time when the individual’s actual weight is
different from the predicted/estimated value for the individual’s dry
weight,’” and that “none of Zhu, Moissl, and Woo, alone or in combination,
disclose, or even suggest, all of the features included in claim 63.” App. Br.
16−17 (making the same argument for claim 64). Although Appellant
provides scant argument on this point, we still must look to the sufficiency
of the cited evidentiary support for this claim limitation. In Moissl, the
Examiner points us to Table one and the related description of “Subjects.”
Ans. 7 (citing Moissl p. 923). The Examiner provides no explanation as to
how this portion of Moissl meets the alleged limitation. The portions of
Moissl cited by the Examiner merely describe average characteristics for
various subject groups across three locations and provide ranges of various
characteristics. This says nothing about any particular subject, nor does it
support the claimed comparison/difference between actual weight and
predicted/estimated dry weight. The Examiner did not have a high bar given
the lack of argument by Appellant, but we see no correlation between Moissl
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and the claim language at issue such that we could affirm this rejection.
Accordingly, we do not sustain the Examiner’s obviousness rejection of the
claims.
CONCLUSION
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
63, 64 112 ¶ 1 63, 64
7, 8, 12–15,
24, 63, 64
101

7, 8, 12–
15, 24, 63
64
7, 8, 12–15,
24, 63
103(a) Zhu, Moissl 7, 8, 12–
15, 24, 63
64 103(a) Zhu, Moissl, Woo 64
Overall
Outcome:
7, 8, 12–
15, 24, 63
64

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 IN PART