Fresenius Medical Care Holdings, Inc.

Patent Trials and Appeals Board

Jul 13, 2020

15157656 - (D) (P.T.A.B. Jul. 13, 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.
15/157,656 05/18/2016 Louis L. Barrett 723543 9925
86727 7590 07/13/2020
Leydig, Voit & Mayer, Ltd.
180 N. Stetson, Two Prudential Plaza
Suite 4900
Chicago, IL 60601
EXAMINER
DEJONG, ERIC S
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
07/13/2020 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):
Chgpatent@leydig.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LOUIS L. BARRETT, DAVID W. PETERSON,
BRIAN H. NATHANSON, MICHAEL J. GERMAIN, and
MICHAEL K. BLACK
__________

Appeal 2019-006876
Application1 15/157,656
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
system for hemodialysis patient data acquisition and management, which
have been rejected as being directed to patent-ineligible subject matter,
failing to comply with the written description requirement, and as being
indefinite. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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.)
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STATEMENT OF THE CASE
“When healthy, kidneys maintain the body’s internal equilibrium of
water and minerals.” (Spec. ¶ 3.) “Patients with kidney failure or partial
kidney failure typically undergo hemodialysis treatment, often at a
hemodialysis treatment center or clinic.” (Id.) “Several liters of excess fluid
can be removed during a typical multi-hour treatment session.” (Id. ¶ 4.)
“Hemodialysis has an acute impact on the fluid balance of the body due in
part to the rapid change in circulating blood volume.” (Id. ¶ 5.)
“Continuous quantitative measurement of parameters relating to the
circulating blood volume (in real-time) during hemodialysis reduces the
chance of dialysis-induced hypotension, and otherwise optimizes dialysis
therapy regimes by controlling fluid balance and aiding in achieving the
appropriate dry weight for the patient.” (Id.) Appellant’s invention “relates
to data acquisition for hemodialysis patients, and the management and
analysis of that data.” (Id. ¶ 2.)
Claims 1–4 and 6–16 are on appeal. Claims 1 and 16 are
representative and reads as follows:
1. A system for hemodialysis patient data acquisition and
management, comprising:
a plurality of hemodialysis systems, configured to
provide dialysis treatment sessions to a plurality of patients and
to transmit treatment-related information relating to the
plurality of patients to a host computer; and
the host computer, configured to:
receive the treatment-related information relating to the
plurality of patients from the plurality of hemodialysis systems;
store historical session data corresponding to the received
treatment-related information for the plurality of patients; and
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for each of the plurality of patients, determine and output
a treatment recommendation for the respective patient based on
the historical session data for the respective patient.

16. A system for hemodialysis patient data acquisition and
management, comprising:
a plurality of hemodialysis systems, configured to
provide dialysis treatment sessions to a plurality of patients and
to transmit treatment-related information relating to the
plurality of patients to a host computer; and
the host computer, configured to:
receive the treatment-related information relating to the
plurality of patients from the plurality of hemodialysis systems;
store historical session data corresponding to the received
treatment-related information for the plurality of patients; and
for each of the plurality of patients, display the historical
session data for the respective patient, predict future treatment-
related information for the respective patient based on the
historical session data for the respective patient, and display the
predicted future treatment-related information for the respective
patient to facilitate treatment for the respective patient.
(Appeal Br. 13, 15–16.)

The following grounds of rejection by the Examiner are before us on
review:
Claims 1–4 and 6–16 under 35 U.S.C. § 101 as being directed to
patent-ineligible subject matter.
Claims 1–4 and 6–16 under 35 U.S.C. § 112, first paragraph as failing
to comply with the written description requirement.
Claims 1–4 and 6–16 under 35 U.S.C. § 112, second paragraph as
being indefinite.

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DISCUSSION
Patent-Ineligible Subject Matter
The Examiner finds that the claims “expressly recite a series abstract
data analysis steps comprising determining or receiving a patient’s data and
the output to be generated therefrom.” (Final Action 3.) The Examiner
states that “[t]he courts have clearly established that a method directed
essentially to a series of algorithmic/mathematical procedures is not a
statutory process.” (Id. (citing Digitech Image Techs., LLC. v. Elecs. for
Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014) and buySAFE, Inc. v. Google,
Inc., 765 F.3d 1350 (Fed. Cir. 2014).) The Examiner then finds that,
although the claims “recite additional elements beyond the judicial exception
set forth above[,] [t]he data collection methods and the treatment methods
recited in the claims are generic with respect to what is already employed in
the background art,” and that the “claims fail to present a significant
improvement to any experimental process or procedure encompassed by the
claims involved in sample preparation or data collection method.” (Id.) The
Examiner also finds that the “system elements of a hemodialysis system and
non-invasive blood monitor are routine and conventional devices in the
relevant arts” and their use “to collect data fail to demonstrate any
improvement to the system elements themselves.” (Id. at 4.) In light of the
foregoing, the Examiner concludes that the claims are directed to non-
statutory subject matter. (Id.)
The Supreme Court has established a two-step framework for
“distinguishing patents that claim laws of nature, natural phenomena, and
abstract ideas from those that claim patent-eligible applications of those
concepts.” Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014). “First,
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we determine whether the claims at issue are directed to” a patent-ineligible
concept. Id. If so, “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. (quoting Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 566 U.S. 66, 78–79 (2012)).
Applying the 2019 Revised Patent Subject Matter Eligibility Guidance
(“Revised Guidance”), 84 Fed. Reg. 50–57 (January 7, 2019),2 we agree
with the Examiner’s conclusion that the claims are addressed to ineligible
subject matter. Under the Revised Guidance, we first determine 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)).
See Revised Guidance, 84 Fed. Reg. at 54–55. Only if a claim (1) recites a
judicial exception and (2) does not integrate that exception into a practical
application, do we then determine whether the claim:

2 “All USPTO personnel are, as a matter of internal agency management,
expected to follow the guidance.” Id. at 51; see also USPTO, October 2019
Update: Subject Matter Eligibility 1 (the “October 2019 Update”) (available
at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_
update.pdf).
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(3) adds a specific limitation beyond the judicial exception that is not
a “well-understood, routine, conventional activity” in the field (see
MPEP § 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 Revised Guidance, 84 Fed. Reg. at 56.
Revised Guidance Step 2(A), Prong 1
The Examiner contends that the claims recite a series of abstract data
analysis steps, namely determining from patient data a treatment
recommendation and outputting that recommendation. (Final Action 2–3.)
We agree. As noted above, a mental process is an abstract idea. A mental
process is one that can be “performed in the human mind (including an
observation, evaluation, judgment, opinion).” Revised Guidance, 84 Fed.
Reg. at 52; see also CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d
1366, 1372–73 (Fed. Cir. 2011) (determining that a claim whose “steps can
be performed in the human mind, or by a human using a pen and paper” is
directed to an unpatentable mental process). This is true even if the claim
recites that a generic computer component performs the acts. See, e.g.,
Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir.
2015) (“Courts have examined claims that required the use of a computer
and still found that the underlying, patent-ineligible invention could be
performed via pen and paper or in a person’s mind.”); see also Revised
Guidance, 84 Fed. Reg. at 52 n.14 (“If a claim, under its broadest reasonable
interpretation, covers performance in the mind but for the recitation of
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generic computer components, then it is still in the mental processes
category unless the claim cannot practically be performed in the mind.”).
Claim 1
Although claim 1 recites a host computer is configured to “determine
and output a treatment recommendation for the respective patient based on
the historical session data for the respective patient,” this recitation by itself
does not distinguish the steps of the claim from mental processes. That is
because we conclude that the determining and outputting of a
recommendation are processes that can practically be performed in the mind,
or with the aid of pen and paper. The determination is based on the received
and stored information. The determination is an evaluation or judgment that
can be performed in the human mind but for the claimed computer
application. The recommendation that is output is simply the result of the
evaluation of the data and judgment as to a treatment recommendation,
which can be performed in the human mind and then verbalized but for the
computer application.
“That purely mental processes can be unpatentable, even when
performed by a computer, was precisely the holding of the Supreme Court
in Gottschalk v. Benson[, 409 U.S. 63, (1972)].” CyberSource Corp., 654
F.3d at 1373, 1375; Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350,
1354 (Fed. Cir. 2016) (“[A]nalyzing information by steps people go through
in their minds, or by mathematical algorithms, without more, [is
characterized] as essentially mental processes within the abstract-idea
category.”).
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In light of the above, we conclude that claim 1 recites mental
processes which are abstract ideas, and thus, we proceed to the next step of
the eligibility analysis.
Revised Guidance Step 2(A), Prong 2
Following the Revised Guidance, we next consider whether “the claim
as a whole integrates the recited judicial exception into a practical
application of the exception”; i.e., whether the claim “appl[ies], rel[ies] on,
or use[s] the judicial exception in a manner that imposes a meaningful limit
on the judicial exception.” Revised Guidance, 84 Fed. Reg. at 54. This
analysis includes “[i]dentifying whether there are any additional elements
recited in the claim beyond the judicial exception(s)” and “evaluating those
additional elements individually and in combination to determine whether
they integrate the exception into a practical application.” Id. at 54–55.
Here, claim 1 requires a plurality of hemodialysis systems, and a host
computer that receives information from the system and stores data
corresponding to the received data. The host computer is a generic computer
element, “a host computer,” that performs normal computer functionality,
i.e., receive information, store information, and process information, and that
is used as a tool to perform the abstract idea. One of the examples in which
a judicial exception has been found not to be integrated into a practical
application is when “[a]n additional element . . . merely includes instructions
to implement an abstract idea on a computer, or merely uses a computer as a
tool to perform an abstract idea.” Revised Guidance, 84 Fed. Reg. at 55.
We find no indication in the Specification, nor does Appellant direct us to
any indication therein, that the operations recited in independent claim 1
require any specialized computer hardware or software or that the claimed
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invention is implemented using other than generic computer components to
perform generic computer functions. See DDR Holdings, LLC v.
Hotels.com, L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) (“[A]fter Alice, there
can remain no doubt: recitation of generic computer limitations does not
make an otherwise ineligible claim patent-eligible.”). To the contrary, the
Specification describes the “host computer” at a very high level of
abstraction, noting that it includes a database that stores historical data
regarding a large number of patients’ treatment (see, e.g., Spec. ¶ 17) and
may include “software” (id. ¶¶ 21, 23, 54, 58) as well as a graphical user
interface (id. ¶ 34) and wireless communication (id. ¶ 53). In other words,
the host computer that applies the judicial exception (i.e., “determine and
output a treatment recommendation”) does not integrate the exception into a
practical application.
As for the recitation of a “hemodialysis system” recited in the claim,
we note that the function of this system in the claim is to provide dialysis
treatment sessions and to transmit treatment-related information to the host-
computer. The Specification discloses that the system has “extracorporeal
tubing” (Spec. ¶¶ 19, 36) to which an input needle or catheter is inserted (id.
¶ 36) and which tubing is connected to a peristaltic pump and then to a
dialyzer or blood filter (id.).
The Specification indicates that blood monitors are used “in
connection with” a hemodialysis system. (Spec. ¶¶ 14, 43.) These monitors
are not part of the “hemodialysis system.” These monitors monitor patient
hematocrit, hemoglobin, and oxygen saturation. (See, e.g., id. ¶¶ 19, 26, 32,
43.) The values determined by the monitors are part of the treatment-related
information that is transmitted to the host computer. (Id. ¶¶ 19, 43, 44.) The
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Specification indicates that “[t]he system . . . allows data to be entered
manually.” (Id. ¶ 20.)
In light of the foregoing, we understand the hemodialysis system
recited by the claims to be a generic, typical hemodialysis system for
filtering a patient’s blood that is connected in some manner to a computer
that can accept data input thereto and transmit data therefrom. While it is
the case that the elements of such a system are tangible, such tangibility is
not sufficient to convert the subject matter claimed into a patent eligible
claim. As the Supreme Court indicated in Alice, whether a device is “a
tangible system (in § 101 terms, a ‘machine’)” is not dispositive. See 573
U.S. at 224. Resolving the § 101 inquiry based on such an argument “would
make the determination of patent eligibility ‘depend simply on the
draftsman’s art.”’ Id. (quoting Parker v. Flook, 437 U.S. 584, 593 (1978));
see also CyberSource, 654 F.3d at 1372 (“[E]ven if some physical steps are
required to obtain information from the database (e.g., entering a query via a
keyboard, clicking a mouse), such data-gathering steps cannot alone confer
patentability.”). The hemodialysis system as claimed does not apply or
otherwise use the judicial exception in any manner. Rather it is an element
that enables the transmission of data input to it to the host computer, which
computer determines and outputs a treatment recommendation. The data
gathering itself is insignificant pre-solution activity, see MPEP § 2106.05(g)
(“[a]n example of pre-solution activity is a step of gathering data for use in a
claimed process.”)), that does not apply the abstract idea in a meaningful
way, but instead simply “generally link[s] the use of a judicial exception to a
particular technological environment or field of use.” Revised Guidance, 84
Fed. Reg. at 55 (citing MPEP § 2016.05(h)); see also In re Grams, 888 F.2d
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835, 840 (Fed. Cir. 1989) (“The presence of a physical step in the claim to
derive data for the algorithm will not render the claim statutory.”).
Claim 1 does not require the hemodialysis system do anything with
the determined and outputted treatment recommendation, i.e., the claim does
not use the information generated by the judicial exception to effect any type
of change. Compare Claim 1 with October 2019 Update: Subject Matter
Eligibility Appendix 1 20, 27–29 (Example 45: claim 4 “A controller for an
injection molding apparatus”) (explaining that (i) limitation (d) does not just
link the judicial exception of observing/evaluating obtained temperatures to
a target temperature recited in limitation (c) to a technical field of injection
molding temperature control “but instead adds a meaningful limitation in
that it employs the information provided by the judicial exception (the
comparison of the mold temperature with the target temperature) to control
the operation of the injection molding apparatus,” and (ii) by maintaining the
temperature within the claimed two degree range “avoids the technical
problems associated with undercure and overcure, which would otherwise
negatively affect the cured polyurethane’s strength and wear performance”
and “thus improves upon previous controllers used in this technical field of
injection molding”).
In light of the foregoing, we disagree with Appellant that “[t]he
features of claim 1 . . . provide technical improvements with respect to
treatment of patients using hemodialysis systems and are integrated into a
practical application.” (Appeal Br. 4.) That there are a number of
hemodialysis systems connected to a single host computer, allowing for a
“single host computer to be able to support a large number of patients served
by a plurality of hemodialysis systems” (Appeal Br. 4; Reply Br. 3) does not
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render the claim a “technical improvement[].” And Appellant’s argument
that a single host computer is able to “perform various operations with
respect to the treatment-related information of multiple patients” (Reply Br.
3) does not persuasively identify a technical improvement. As the Federal
Circuit made clear in Two-Way Media Ltd. v. Comcast Cable
Communications, the improvement must be a technical one. See Two-Way
Media Ltd. v. Comcast Cable Commc’ns, LLC, 874 F.3d 1329, 1338–39
(Fed. Cir. 2017) (reciting an abstract idea performed on generic computer
and network components that operate according to their ordinary functions
does not contain an inventive concept). Here, Appellant’s claim does not
recite a technical improvement that solves a technical problem. Instead, the
claim, as a whole, relates to management and analysis of blood condition
data of multiple patients undergoing dialysis treatment which is said to be
“quite helpful to attending staff administering the treatment to the patient”
because the database can “provide the attending physician and/or nurse with
historical information on the patient to facilitate therapeutic care for the
patient.” (Spec. ¶¶ 2, 9, 17; see also id. ¶ 71 (“use of the system allows the
attending staff to easily analyze the long-term trend of the patient and
facilitate informed decision making”).) Such does not describe a technical
improvement that provides an improvement in computer functionality or in
any other technology or technical field.
Appellant’s argument that Example 40 of the USPTO’s “Subject
Matter Eligibility Examples” supports finding independent claim 1 patent-
eligible (Appeal Br. 4) is not persuasive. Claim 1 of that Example was
determined to be patent eligible because it integrated the judicial exception
of “comparing at least one of the collected traffic data to a predefined
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threshold,” a mental process, into a practical application. (Subject Matter
Eligibility Examples: Abstract Ideas, Example 40 11–12.) In the analysis of
the eligible claim, it is stated that “[a]lthough each of the collecting steps
analyzed individually may be viewed as mere pre- or post-solution activity,”
the method limits collection of additional Netflow protocol data
to when the initially collected data reflects an abnormal
condition, which avoids excess traffic volume on the network
and hindrance of network performance.
(Subject Matter Eligibility Examples: Abstract Ideas Example 40 at 11.)
The invention claimed was directed at varying the amount of network data
collected based on monitored events in the network, i.e., an abnormal
condition, thereby avoiding excess traffic volume on the network which
hinders network performance. Appellant’s claim 1 does not have a similarly
recited practical application of the mental process of determining and
outputting of a treatment recommendation. Data is received by the host
computer from the hemodialysis systems, it is stored, and the treatment
recommendation is determined and output; nothing more is recited.
We find that claim 1 is much more akin to claim 2 of Example 40 that
was found not to be patent eligible. In claim 2 of the Example, network data
is collected and a comparison to a predefined threshold, the judicial
exception, is made. (Subject Matter Eligibility Examples: Abstract Ideas
Example 40 at 12.) In the analysis of the claim, it is stated that the
collecting step is recited at a high level of generality and is insignificant
extra-solution activity, and that “[t]he network appliance that performs the
comparison step is also recited at a high level of generality, and merely
automates the comparison step.” (Id.) It is then stated that:
[e]ach of the additional limitations is no more than mere
instructions to apply the exception using a generic computer
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component (the network appliance) . . . even in combination,
these additional elements do not integrate the abstract idea into
a practical application because they do not impose any
meaningful limits on practicing the abstract idea.
(Id. at 12–13.) Here too, there is no meaningful limit on practicing the
abstract idea; the use of a generic host computer to determine and
output is no more than mere instructions to apply the exception using
a generic computer component.
Revised Guidance Step 2(B)
Finally, the Revised Guidance directs us to consider whether claim 1
includes “additional elements . . . [that] provide[] ‘significantly more’ than
the recited judicial exception.” Revised Guidance, 84 Fed. Reg. at 56. The
Revised Guidance states that an additional element that “simply appends
well-understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception, . . .
is indicative that an inventive concept may not be present.” Id.
The host computer is nothing more than a general purpose computer.
Using generic computer components to perform abstract ideas does not
provide the necessary inventive concept. See Alice, 573 U.S. at 223 (“[T]he
mere recitation of a generic computer cannot transform a patent-ineligible
abstract idea into a patent-eligible invention.”); see also SAP Am., Inc. v.
InvestPic, LLC, 898 F.3d 1161, 1163, 1170 (Fed. Cir. 2018) (finding that the
invocation of such computers for use in carrying out improved mathematical
calculations amounts to recitation of what is well-understood, routine, and
conventional).
Moreover, as discussed above, the hemodialysis system that provides
the data to the generic host system is recited at a high level of abstraction
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and can be “a conventional hemodialysis system” (Spec. ¶ 35). Thus, we
conclude that there are no “additional elements . . . [that] provide[]
‘significantly more’ than the recited judicial exception.” Revised Guidance,
84 Fed. Reg. at 56.
For the foregoing reasons, we do not find Appellant’s argument that
there is not a “proper basis for rejection in accordance with the requirements
of the USPTO’s Berkheimer memo” (Appeal Br. 6) persuasive.
We consequently affirm the Examiner’s rejection that claim 1 is
directed to patent-ineligible subject matter.
Claims 2–4 and 6–15
Appellant argues the fact that specific structural components in claims
2 and 3 such as optical blood monitors and sensor assemblies with blood
chambers and photo emitters and photodetectors, “as well as the other
features recited in claims 4 and 6–15” are sufficient additional features that
integrate “the claimed concepts into practical applications.” (Appeal Br. 6.)
We do not find this persuasive. None of the recited structural elements of
these dependent claims integrate the abstract idea of determining and
outputting. Rather, they are elements that are part of the data gathering,
which data is transmitted to the host computer for its use in carrying out the
abstract idea. Moreover, the Specification teaches that an optical blood
monitoring system that can be used is in the prior art and marketed by the
assignee and has the elements recited in the dependent claims. (Spec. ¶¶ 9–
14.)
We, consequently, affirm the Examiner’s rejection that dependent
claims 2–4 and 6–15 are directed to patent-ineligible subject matter.

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Claim 16
Appellant argues independent claim 16 separately as well. This claim,
rather than reciting “determine and output a treatment recommendation . . .
based on the historical session data for the respective patient” as in claim 1,
requires that the host computer be configured to “display the historical
session data” and “predict future treatment-related information . . . based on
the historical session data . . . and display the predicted future treatment-
related information.” (Appeal Br. 16.) The “predict” recitation like the
determine recitation is a mental process because, but for the recitation that
the “host computer” is configured to predict, this is an act that people can
perform using their minds or pen and paper. See, e.g., CyberSource, 654
F.3d at 1372–73; Versata, 793 F.3d at 1335; Revised Guidance, 84 Fed.
Reg. at 52 n.14. Appellant’s Specification states that “[a] keyboard 100 and
display 102 are also provided with the host computer 90, as is well known.”
(Spec. ¶ 54.) Thus, we find that the addition of the two display requirements
are insignificant pre-solution and post-solution activity, respectively. See
SAP, 898 F.3d at 1167 (quoting Elec. Power Grp., 830 F.3d at 1353–54
(“[M]erely presenting the results of abstract processes of collecting and
analyzing information, without more (such as identifying a particular tool for
presentation), is abstract as an ancillary part of such collection and
analysis.”)). In SAP, our reviewing court found claims directed to “the
selection and mathematical analysis of [investment] information, followed
by reporting or display of the results” using “off-the-shelf computer
technology” not directed to patent-eligible subject matter. SAP, 898 F.3d at
1167–68. Here, as in claim 1, there is no technical improvement providing
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an improvement to computer functionality including display of data. Thus,
there is no change in our analysis set forth above with respect to claim 1.
Accordingly, we also affirm the Examiner’s rejection of claim 16 as
being directed to patent-ineligible subject matter.
II
Written Description and Indefiniteness
The Examiner finds that neither the claims nor the Specification
“provides for a definition that meaningfully limited the manner in which
an[y] of the recited device elements have actually been ‘configured’ to
achieve the special purpose functions defined in the instant claims.” (Final
Action 5.) The Examiner concludes that the generic elements therefor
invoke means-plus-function interpretation and that the disclosure in the
Specification “fails [to] specify any structure corresponding to the means as
instantly claimed” and thus Appellant “has failed to demonstrate that they
were in possession of the full scope of the claimed invention.” (Id. at 6.)
Additionally, the Examiner finds that “the functionally defined adapted
processor or other computer system causes the metes and bounds of the
instant claims to be indefinite” for the same reasons, i.e., “because there is
no corresponding disclosure of what structures are encompassed by said
means.” (Id. at 7–8.)
We disagree with the Examiner’s conclusion that the claims lack
adequate written description support and are indefinite.
A means-plus-function interpretation of a claimed element is proper
under 35 U.S.C. § 112(f), when claim language recites “means for” followed
by a functional limitation. By contrast, a claim limitation that does not use
the term “means” will trigger the rebuttable presumption that 35 U.S.C.
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§ 112(f) or pre-AIA 35 U.S.C. § 112, sixth paragraph, does not apply.
Phillips v. AWH Corp., 415 F.3d 1303, 1310 (Fed. Cir. 2005) (en banc). The
presumption is overcome when “the claim term fails to ‘recite [ ] sufficiently
definite structure’ or else recites ‘function without reciting sufficient
structure for performing that function.”’ Williamson v. Citrix Online, LLC,
792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc) (quoting Watts v. XL Sys.,
Inc., 232 F.3d 877, 880 (Fed. Cir. 2000). Instead of using “means” in such
cases, a substitute term acts as a generic placeholder for the term “means”
and would not be recognized by one of ordinary skill in the art as being
sufficiently definite structure for performing the claimed function. Id. “The
standard is whether the words of the claim are understood by persons of
ordinary skill in the art to have a sufficiently definite meaning as the name
for structure.” Id. at 1349.
However, 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112, sixth
paragraph, will not apply if persons of ordinary skill in the art reading the
Specification understand the term to have a sufficiently definite meaning as
the name for the structure that performs the function, even when the term
covers a broad class of structures or identifies the structures by their function
(e.g., “filters,” “brakes,” “clamp,” “screwdriver,” and “locks”). MPEP §
2181(I)(A); Apex Inc. v. Raritan Computer, Inc., 325 F.3d 1364, 1372–73
(Fed. Cir. 2003).
Claims 1 and 16 require a plurality of hemodialysis systems
configured to provide dialysis treatment sessions, as well as to provide
treatment-related information relating to the plurality of patients to a host
computer. This term is not recited in “means for” language, and thus,
triggers the rebuttable presumption that sections 112(f)/112, sixth paragraph,
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does not apply. We agree with Appellant that one of ordinary skill in the art
would understand this term to include certain definite structure. (Appeal Br.
8.) As discussed above in the section 101 analysis, the Specification
describes a hemodialysis system as having “extracorporeal tubing” (Spec.
¶¶ 19, 36) to which an input needle or catheter is inserted (id. ¶ 36) and
which tubing is connected to a peristaltic pump and then to a dialyzer or
blood filter (id.). With regard to the configuration to provide information to
a host computer, we note that Figure 1 of the Specification demonstrates the
tubing, filtration, and pump elements connected to a computer. One of
ordinary skill in the art would thus understand that the system which
operates the blood filtration would have the ability to provide information to
a host computer, such as by a wireless communication device or other
network communication. (See, e.g., Figure 7 and Spec. ¶¶ 53, 57, 58.)
These claims further require a host computer to perform various
function including receiving information, storing information and analyzing
the information to determine or predict a treatment recommendation and
output/display that recommendation. We agree with Appellant that the
Specification and figures provide sufficient description corresponding to
these functions including the use of software and predictive algorithms.
(Appeal Br. 10; Spec. ¶¶ 54, 60–64, 66–70.)
Consequently, the determination that Appellant failed to provide
sufficient written description of “means-plus-function” claim elements
cannot be a basis for a finding of insufficient written description under 35
U.S.C. § 112, first paragraph or indefiniteness under 35 U.S.C. § 112,
second paragraph. Thus, we reverse the Examiner’s rejection of claims 1–4
and 6–16 under 35 U.S.C. § 112, first paragraph as failing to comply with
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the written description requirement and under 35 U.S.C. § 112, second
paragraph as being indefinite.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–4, 6–16 101 1–4, 6–16
1–4, 6–16 112, 1st Written
Description
1–4, 6–16
1–4, 6–16 112, 2nd Indefinite 1–4, 6–16
Overall
Outcome
1–4, 6–16

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