Ex Parte Neftel et al

Patent Trial and Appeal Board

Nov 15, 2017

13260456 (P.T.A.B. Nov. 15, 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.
13/260,456 09/26/2011 Frederic Neftel JHN-5648-25 6842
23117 7590 11/17/2017
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
LAM, ELIZA ANNE
ART UNIT PAPER NUMBER
3686
NOTIFICATION DATE DELIVERY MODE
11/17/2017 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):
PTOMAIL@nixonvan.com
pair_nixon @ firsttofile. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FREDERIC NEFTEL, PASCAL BERNARD,
and THOMAS HERTZ
Appeal 2016-005653
Application 13/260,45 61
Technology Center 3600
Before JOSEPH L. DIXON, JOHN A. JEFFERY, and
JOHN D. HAMANN, Administrative Patent Judges.
HAMANN, Administrative Patent Judge.
DECISION ON APPEAL
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 55—82. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real parties in interest are Gambro Lundia AB
and Debiotech S.A. App. Br. 3.
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Application 13/260,456
THE CLAIMED INVENTION
Appellants’ claimed invention relates to dialysis treatment, including
“a dialysis device comprising an automated peritoneal dialysis machine or a
hemodialysis machine that, based on input of certain data, is programmed to
carry out a treatment session.” Spec. 1. Claim 55 is illustrative of the
subject matter of the appeal and is reproduced below.
55. A dialysis device receiving, via a prescriber interface, data
representing a set of therapeutic objectives and a treatment plan,
which comprises a treatment schedule for a number of
consecutive treatment sessions and a set of settings of a treatment
session, the dialysis device comprising:
a patient interface configured to be positioned proximate
to the patient and configured to receive input data inputted by the
patient wherein the input data indicates a modification to at least
one of the settings, and
a computer system receiving the input data, wherein the
computer system:
modifies at least one of the settings of the set of
settings based on the input data received via the patient
interface,
re-evaluates the treatment plan as a function of the
at least one modified setting to generate a suggestion
including at least one treatment option comprising a
suggested set of settings of a treatment session to achieve
said set of therapeutic objectives, wherein the set of
therapeutic objectives include at least one of a prescribed
value for a dry weight of a patient and a prescribed value
for a dialysis dose;
causes the dialysis device to present the suggestion
to the patient, and
modifies the treatment session based on the
suggested set of settings in response to the patient
selecting the suggestion.
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REJECTIONS ON APPEAL
(1) The Examiner rejected claims 55—82 under 35 U.S.C. § 101 as
being directed to non-statutory subject matter.
(2) The Examiner rejected claims 55—60, 64—72, 75—78, 81, and 82
under 35 U.S.C. § 103(a) as being unpatentable over the combination of
Wariar (US 2007/0175827 Al; published Aug. 2, 2007) and Biewer et al.
(US 7,988,849 B2; issued Aug. 2, 2011) (hereinafter “Biewer”).
(3) The Examiner rejected claims 61—63, 73, and 74 under
35 U.S.C. § 103(a) as being unpatentable over the combination of Wariar,
Biewer, and Blomquist (US 2008/0033402 Al; published Feb. 7, 2008).
(4) The Examiner rejected claims 79 and 80 under 35 U.S.C.
§ 103(a) as being unpatentable over the combination of Wariar, Biewer, and
Plahey et al. (US 2006/0195064 Al; published Aug. 31, 2006) (hereinafter
“Plahey”).
ANALYSIS
We have reviewed the Examiner’s rejections in light of Appellants’
contentions that the Examiner erred. In reaching our decision, we consider
all evidence presented and all arguments made by Appellants.
We disagree with Appellants’ arguments, and we incorporate herein
and adopt as our own the findings, conclusions, and reasons set forth by the
Examiner in the (1) March 3, 2015 Final Office Action (“Final Act.” 2—18)
and (2) March 10, 2016 Examiner’s Answer (“Ans.” 2—19). We highlight
and address for emphasis, however, specific findings and arguments below
relating to (1) statutory subject matter eligibility and (2) the art based
rejections.
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(1) Arguments relating to f101 rejection
Appellants contend the Examiner improperly rejected claims 55—82
under 35 U.S.C. § 101. See App. Br. 12—22; Reply Br. 1—6. As to the
specific findings and arguments we emphasize below, Appellants argue the
rejected claims as a group. Thus, we decide the appeal of the § 101 rejection
on the basis of representative claim 55, and refer to the rejected claims
collectively herein as “the claims.” See 37 C.F.R. § 41.37(c)(l)(iv) (2015);
In re King, 801 F.2d 1324, 1325 (Fed. Cir. 1986).
According to Appellants, the claims do not concern an abstract idea,
and even if they did, the claims would be patent eligible because the claims
amount to significantly more than an abstract idea. App. Br. 12—22; Reply
Br. 1—6. We find Appellants’ arguments unpersuasive.
Section 101 of the Patent Act provides that “[wjhoever invents or
discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may
obtain a patent therefor, subject to the conditions and requirements of this
title.” 35 U.S.C. § 101. The Supreme Court has explained that this
provision is subject to a long-standing, implicit exception: “[ljaws of nature,
natural phenomena, and abstract ideas are not patentable.” Alice Corp. Pty.
Ltd. v. CLSBankInt’l, 134 S. Ct. 2347, 2354 (2014) (internal quotation
marks and citation omitted). The Court has set forth a two-part inquiry to
determine whether this exception applies. First, we must determine if the
claim at issue is directed to one of those patent-ineligible concepts. Alice,
134 S. Ct. at 2355. Second, if the claim is directed to one of those patent-
ineligible concepts, we must consider the elements of the claim “both
individually and as an ordered combination to determine whether the
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additional elements transform the nature of the claim into a patent-eligible
application.” Alice, 134 S. Ct. at 2355 (internal quotation marks omitted)
(quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66,
72 (2012)).
(i) Abstract idea
We first consider whether the Examiner properly concluded that each
of the claims are directed to one or more abstract ideas. For example, the
Examiner concluded that the claims “are directed to the abstract idea of
comparing new and stored information and using rules to identify options
. . . . [T]he concept of ‘comparing new and stored information’ is described
by the receiving input data, re-evaluating a treatment plan, and presenting
suggestions.” Final Act. 2. In other words, claim 55 “compares input data
inputted by the patient (new information) and a set of therapeutic objectives
(stored information) and . . . performs an evaluation of the data (rules) to
identify a suggested set of settings (options).” Ans. 17.
Appellants have not persuaded us that the Examiner erred. The
Federal Circuit has explained that the abstract-idea inquiry requires “looking
at the ‘focus’ of the claims, their ‘character as a whole’” to determine if the
claims are directed to an abstract idea. Elec. Power Grp., LLC v. Alstom
S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016). Claim 55 recites “[a] dialysis
device receiving, via a prescriber interface, data representing a set of
therapeutic objectives and a treatment plan, which comprises a treatment
schedule for a number of consecutive treatment sessions and a set of settings
of a treatment session.” App. Br. 30.
Appellants argue the Examiner makes an overly broad generalization
of the claims and “ignores the specific language of the claims as a whole as
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well as Appellants’ Specification” in finding an abstract idea. App. Br. 13.
Furthermore, Appellants argue the claims do not “relate to any of the types
of activity to which ‘certain methods of organizing human activity’ applies”
(i.e., . . concepts relating to interpersonal and intrapersonal activities’”).
App. Br. 14 (citing the Office’s July 2015 Update: Subject Matter Eligibility
(hereinafter “2025 Update”) at 4 (arguing the 2015 Update explains “‘that
(1) not all methods of organizing human activity are abstract ideas, and
(2) this category description is not meant to cover human operation of
machines’”)).
In addition, Appellants try to distinguish SmartGene — a Federal
Circuit decision referenced in the 2015 Update which found claims to be
directed to an abstract idea — as being “expressly limited to circumstances
where each and every step recited in the claim is a familiar part of the
conscious process that humans (doctors) regularly perform in their heads.”
App. Br. 14—15 (citing SmartGene, Inc. v. Adv. Bio. Labs., SA, 555 Fed.
Appx. 950, 955 (Fed. Cir. 2014)).
In contrast, Appellants argue the instant claims “define a specific type
of machine” addressing “therapeutic objectives and treatment plans for renal
therapy treatment sessions [which] comprise parameters that are not human
activity and cannot be calculated in one’s head.” App. Br. 15—16 (citing
Spec. 2:21—29, 4:8—11, 14:8—32 (listing parameters as including “creatinine
clearance, a given dose defined as a Kt/V ratio where K=clearance of urea
(ml/min), t=time on dialysis (min), V=volume of urea distribution in the
body (ml), an individual water removal target, a sodium elimination and
balance, the patient’s weight, total body water and blood pressure”)
(emphasis added)); see also id. (citing Spec. 3:31—4:6, 14:8—15:8 (arguing
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treatment settings “include such parameters as duration of the treatment
session, blood flow, fluid removal rate, total removed fluid volume, dialysis
fluid composition, dialysis fluid flow rate, dialysis fluid temperature,
dialyzer type, treatment session schedule, number of exchanges per session,
frequency of exchanges, fluid volume per exchange, duration of each dwell
and glucose concentration in dialysis fluid”)). Appellants contend that
“[tjhese are complex processes that (1) do not reflect human activity and (2)
cannot be performed without a specially programmed data processing
system, i.e., they cannot be performed in one’s head nor are they routinely
performed in one’s head.” App. Br. 17.
We agree with the Examiner that the claims are directed to an abstract
idea of comparing new and stored information as described above (i.e.,
comparing patient inputted data (new information) and a set of therapeutic
objectives/parameters (stored information) and performing an evaluation of
the data (rules) to identify a suggested set of settings (options)). In this
regard, the claims of the instant application are similar to the claims in
Electric Power, which did “not go beyond requiring the collection, analysis,
and display of available information in a particular field, stating those
functions in general terms, without limiting them to technical means for
performing the functions that are arguably an advance over conventional
computer and network technology.” 830 F.3d at 1351. Specifically, our
reviewing Court held that “collecting information, including when limited to
particular content (which does not change its character as information), as
within the realm of abstract ideas” and that “analyzing information by steps
people go through in their minds, or by mathematical algorithms, without
more, as essentially mental processes within the abstract-idea category.” Id.
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at 1353—54 (internal citations omitted). We are unpersuaded by Appellants’
arguments that the parameters cannot be calculated in one’s head and the
processes are complex. Although the calculations may be complex and may
lend themselves to be calculated by a person using support (e.g., paper and
pencil, calculator, generic computing device), the processes remain
essentially mental processes applying mathematical algorithms (i.e., steps
people go through in their minds). See id.
The claims of the instant application also are similar to the claims in
SmartGene, wherein the Federal Circuit found claims patent ineligible
because they did “no more than call on a ‘computing device,’ with basic
functionality for comparing stored and input data and rules, to do what
doctors do routinely.” See SmartGene, 555 Fed. Appx. at 954. Appellants’
characterization of SmartGene is too narrow. Although SmartGene limits its
ruling to circumstances where every step is a familiar part of the conscious
process that doctors can do in their heads, SmartGene should not be read to
preclude the use of a basic computing device (e.g., a calculator) to assist in
making such calculations while remaining an abstract idea. Id. at 955.
Importantly, SmartGene found (as is the case here) that those claims at issue
did not contain “any steps beyond those which doctors routinely and
consciously perform.” Id.
These cases are sufficiently analogous to establish that the instant
claims are directed to an abstract idea. See Enfish, LLC v. Microsoft Corp.,
822 F.3d 1327, 1334 (Fed. Cir. 2016) (explaining that when determining
whether claims are directed to an abstract idea, “both this court and the
Supreme Court have found it sufficient to compare [the] claims at issue to
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those claims already found to be directed to an abstract idea in previous
cases”).
(ii) Inventive concept
We next consider whether the Examiner correctly concluded the
claims do not include 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.” Alice, 134 S. Ct. at 2355 (internal quotation marks omitted) (quoting
Mayo, Inc., 566 U.S. at 72—73). The Examiner finds:
The claim[s] do[] not include additional elements that are
sufficient to amount to significantly more than the judicial
exception because the computer as recited is a generic computer
component that performs functions (i.e., receiving input data,
reevaluating a plan, and presenting suggestions). These are
generic computer functions (i.e., obtaining data, analyzing data,
and creating a recommendation) that are well-understood,
routine, and conventional activities previously known to the
industry. The claim[s] also recite[] a dialysis device, which
do[es] not add meaningful limitations to the idea of comparing
new and stored information beyond generally linking the system
to a particular technological environment, that is,
implementation via computers.
Final Act. 2—3 (emphasis omitted); see also Ans. 17—18 (finding the claims
are “directed towards data gathering and performing a mathematic[al]
analysis to determine a suggested set of settings, a human would be capable
of performing mathematical analysis on a series of data inputs, the problem
is thus not rooted in computer technology”).
Appellants argue the claims amount to significantly more than an
abstract idea in that they “provide a technical solution to a technical problem
presented at least in the area of dialysis devices.” App. Br. 19. More
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specifically, Appellants argue the claims “are directed to solving problems
related to prior computerized dialysis devices having a patient interface,”
including by adding programming to define therapeutic or clinical objectives
to be achieved. App. Br. 19-20. In other words, the claims “improve upon
conventional dialysis devices that carry out renal therapy treatments by
providing a dialysis device that ensures a therapeutic objective is reached in
such treatments while allowing patient modification to a treatment setting
and thus flexibility in the individual treatment sessions performed by a
dialysis device.” App. Br. 20.
Appellants also argue the claims “recite particular structures and
processes or steps[, and] ... are rooted in computer technology in order to
overcome problems specifically arising in the realm of computerized dialysis
devices for carrying out renal therapy treatments, similar to the claims found
patent eligible in DDR Holdings.” App. Br. 20 (citing DDR Holdings, LLC
v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014)).
We agree with the Examiner that the claims do not amount to
significantly more than the abstract idea. We agree the claims “perform
activities that are well-understood, routine, and conventional activities
previously known to the industry,” rather than being an inventive concept.
See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716 (Fed. Cir. 2014)
(internal quotation marks omitted) (quoting Alice, 134 S. Ct. at 2357)
(finding using known elements to perform “conventional steps, specified at a
high level of generality, which is insufficient to supply an inventive
concept”). We are unpersuaded that the claims contain any recited steps
beyond those which doctors routinely and consciously perform.
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Furthermore, the claims do not specify a special purpose computer,
but rather describe routine and conventional steps to be carried out by a
generic computer (i.e., “apply it with a computer”), and, thus, fail to provide
an inventive concept. See Versata Dev. Grp., Inc. v. SAP Am., Inc., 793 F.3d
1306, 1332 (Fed. Cir. 2015) (quoting Alice, 134 S. Ct. at 2358) (finding an
inventive concept “requires more than simply stating an abstract idea while
adding the words ‘apply if or ‘apply it with a computer’”). The fact that a
generic computer requires relevant programming (which essentially is what
the dialysis device provides) does not change the programmed generic
computer into a special purpose computer. See id. DDR Holdings similarly
is inapposite, in that the claimed dialysis device is better characterized as a
generic computer with relevant programming.
For the above reasons, we sustain the Examiner’s rejection of claims
55-82 under 35 U.S.C. § 101.
(2) Arguments relating to § 103 rejections
(i) Patient inputting modification data
Appellants argue the combination of Wariar and Biewer fails to teach
or suggest “receiv[ing] input data inputted by the patient wherein the input
data indicates a modification to at least one of the settings,” as recited in
claim 55. App. Br. 22—23. More specifically, Appellants argue Wariar
teaches that a patient can only input subjective data (e.g., “‘feelings of
happiness, nominalness and sadness’”), which is “not a modified setting for
a treatment plan,” in accordance with the claims. App. Br. 23 (citing Wariar
140). Appellants argue “[t]he caregiver is the only person who modifies
treatment plan settings.” App. Br. 23 (citing Wariar || 25, 60); Reply Br. 7—
8. According to Appellants, “[t]he patient only modifies the therapy if the
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dialysis device determines that ‘urgent changes to the renal therapy’ are
required,” (i.e., suggesting only that the patient can reduce the blood pump
speed). App. Br. 23—24 (citing Wariar | 63).
The Examiner finds the combination of Wariar and Biewer teaches or
suggests the disputed limitation. Ans. 18; Final Act. 4. More specifically,
the Examiner finds Biewer teaches or suggests “a patient modifying a
treatment session” — Biewer’s automated peritoneal dialysis (“APD”)
“device allows the patient to set the fill, dwell and drain times for a
[peritoneal dialysis (“PD”)] session.” See Ans. 18 (citing 2:49—55; 6:4—10).
The Examiner finds that Biewer also teaches allowing a patient to set a
desired time of completion for devices having fixed dwell times. Id. (citing
Biewer Fig. 1).
We are not persuaded of Examiner error. The combined teachings of
Wariar and Biewer teach or suggest the disputed limitation. See, e.g.,
Biewer 2:49-55; 6:4—10, Fig. 1. Biewer teaches or suggests receiving from
a patient input data which seeks to modify a setting for a treatment session.
See id. Appellants incorrectly focus on Wariar individually instead of
addressing persuasively the combined teachings of Wariar and Biewer to
one of ordinary skill in the art. See In re Merck & Co., Inc., 800 F.2d 1091,
1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references”); In re Keller, 642 F.2d 413, 425 (CCPA 1981)
(finding the relevant inquiry is whether the claimed subject matter would
have been obvious to those of ordinary skill in the art in light of the
combined teachings of the references).
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(ii) Re-evaluatins the treatment plan
Appellants argue the combination of Wariar and Biewer fails to teach
or suggest
re-evaluat[ing] the treatment plan as a function of the at
least one modified setting to generate a suggestion including at
least one treatment option comprising a suggested set of settings
of a treatment session to achieve said set of therapeutic
objectives, wherein the set of therapeutic objectives include at
least one of a prescribed value for a dry weight of a patient and a
prescribed value for a dialysis dose,
as recited in claim 55. App. Br. 24—26. More specifically, Appellants argue
(i) “Biewer does not disclose a dialysis device that presents a suggested new
set of treatment settings to the patient, as a result of a setting being modified
by the patient, or that is configured to modify the treatment plan based on a
new set of treatment settings selected by the patient”; (ii) Biewer’s “dialysis
device does not display suggested treatment settings or allow the patient to
select from suggested treatment settings”; and (iii) Biewer’s APD machine
“does not generate a suggested new set of treatment settings based on a re-
evaluation of the treatment plan to achieve a desired dry weight of a patient
or a dialysis dose to be delivered to the patient.” App. Br. 25.
Appellants argue Biewer’s “device allows the patient to set the fill,
dwell and drain times for a PD session” and to set a desired time of
completion for devices operating with fixed dwell times — the device
“adjusts the dwell times to meet the patient’s desired time of completion.”
App. Br. 25 (citing Biewer 2:49-55, 6:4—10, 6:46-49, 6:61—64, 7:32—35,
Figs. 1—2). According to Appellants, Biewer’s device also can alert the
patient when it is time to start the treatment, based on the patient’s input,
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display the end time entered by the patient, and inform the patient when to
start the treatment. App. Br. 25 (citing Biewer Figs. 2, 4; 7:61—8:2).
The Examiner finds the combination of Wariar and Biewer teaches or
suggests the disputed limitation. Ans. 18; Final Act. 4. More specifically,
the Examiner finds Wariar teaches or suggests “reevaluating a treatment
plan based on the modified setting inputted by the caregiver . . . and a
suggestion including at least one treatment option comprising a suggested
set of settings of a treatment session to achieve said set of therapeutic
objectives.” Ans. 18 (citing Wariar | 60 (teaching ‘“revised renal therapy
regimen’”), claim 9 (teaching ‘“c. modifying the renal therapy the patient
receives in response to the data representative of patient physiological
parameters’”)).
We are not persuaded of Examiner error. The combined teachings of
Wariar and Biewer teach or suggest the disputed limitation. See, e.g.,
Wariar | 60, claim 9. For example, Wariar teaches or suggests reevaluating
a treatment plan based on a modified setting and providing a suggestion
including a treatment option comprising a suggested setting of a treatment
session to achieve therapeutic objectives. See id. The Examiner relies on
Biewer (as discussed above) for the patient input. Supra (2)(i). Appellants
incorrectly focus on Biewer instead of addressing persuasively the combined
teachings of Wariar and Biewer to one of ordinary skill in the art. See
Merck, 800 F.2d at 1097 (“Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references”); Keller, 642 F.2d at 425.
We also are unpersuaded by Appellants’ argument (App. Br. 26) that
the combined teachings fail to teach or suggest “the set of therapeutic
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objectives include at least one of a prescribed value for a dry weight of a
patient and a prescribed value for a dialysis dose,” as recited in claim 55.
Biewer teaches estimating “the amount of excess water or ultrafiltrate that is
removed from the patient” (which can be a therapeutic objective under the
broadest reasonable interpretation) using, inter alia, “the patient’s dry
weight.” Biewer 7:10—25. One of ordinary skill in the art would have found
it obvious in light of the combined teachings to substitute a prescribed value
of a patient’s dry weight as a therapeutic objective — the treatment
parameters are inter-related with multiple parameters available to express
therapeutic benefits and objectives. See id.', KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007) (“[T]he [obviousness] analysis need not seek out
precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.”); see also In re Preda, 401
F.2d 825, 826 (CCPA 1968) (“[I]t is proper to take into account not only
specific teachings of the references but also the inferences which one skilled
in the art would reasonably be expected to draw therefrom.”).
(Hi) Dialysis dose
Appellants argue the combination of Wariar and Biewer fails to teach
or suggest that “the set of therapeutic objectives] includes both the
prescribed value for the dry weight of the patient and the prescribed for the
dialysis dose,” as recited in claims 81 and 82. App. Br. 27. More
specifically, Appellants argue that the combination fails to teach or suggest
that the therapeutic objectives include dialysis dose, which Appellants assert
“is a measure of how well a dialysis treatment removes waste from the blood
of a patient” (i.e., “a measure of adequacy (effectiveness) of dialysis
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treatment”). App. Br. 27; Reply Br. 9. Appellants submit that the
Specification provides examples of how dialysis dose is measured. See
Reply Br. 9 (citing Spec. 2:25—29, 14:8—20 (“‘[T]he dialysis dose may be
specified for each treatment, e.g. as URR (Urea Reduction Ratio) or spKt/V
(Single Pool Kt/V) or similar, or for a longer time, e.g. weekly stdKt/V
(Weekly Standard Kt/V)’.”)); see also App. Br. 27. According to
Appellants, Biewer simply teaches fill and drain times for a PD session.
App. Br. 27 (citing Biewer 7:10-25); see also Reply Br. 10 (citing Biewer
7:21-25).
The Examiner finds that the combination teaches or suggests the
disputed limitation. Ans. 19. As to the meaning of dialysis dose, the
Examiner finds that “one of ordinary skill in the art would have recognized
that a ‘dialysis dose’ has no accepted meaning in the art and encompasses
many different methods of calculation.” Id. (citing J. Mehta et al., Dialysis
Dosage in Acute Kidney Injury: Still a Conundrum? 19 J. Am. Soc.
Nephrol 1046-48 (2008)). Accordingly, the Examiner finds that the
broadest reasonable interpretation, in light of the Specification, of dialysis
dose encompasses clinician prescribed settings for treatment. Id. The
Examiner finds Biewer teaches clinician prescribed settings for treatment
(e.g., drain time, fill time, dwell time, fill volume, drain volume, pump rate)
in accordance with the broadest reasonable interpretation of dialysis dose.
Id. (citing Biewer 6:1—17, 7:10-25); see also Final Act. 4, 12 (citing Biewer
7:10-25).
We are not persuaded that the Examiner errs. Appellants argue that
the broadest reasonable interpretation of dialysis dose encompasses
measures of how well a dialysis treatment removes waste from the blood of
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a patient. The Specification provides non-limiting examples of such
measures (e.g., URR, spKt/V, stdKt/V). See Spec. 2:25—29, 14:8—20; see
also Spec. 20:25—29 (“[Djialysis dose . . . may be measured using blood
samples analyzed for BUN (Blood Urea Nitrogen), or estimated using on­
line clearance estimating technology.”). One of ordinary skill in the art
would have found the disputed limitation obvious in light of the
combination’s teachings. For example, the Examiner cited portions of
Biewer teach, or at least suggest, a measure of dialysis treatment
effectiveness via its teaching that “some estimation of the amount of excess
water or ultrafiltrate that is removed from the patient” is made. See Biewer
7:10-25; see also id. (teaching that “the total drain volume is the fill volume
of dialysate plus amounts of the patient’s [ultrafiltrate (“UF”)], which can be
calculated knowing the patient’s initial weight, the patient’s dry weight[,]
and the average density of ultrafiltrate”); Wariar 14 (“Ultrafiltration is the
removal of water and small-to-medium solutes.”). A measure of the amount
of excess water or ultrafiltrate that is removed from a patient is a measure of
the effectiveness of dialysis. See Biewer 1:18—20 (“Dialysis removes waste,
toxins and excess water from the body that normal functioning kidneys
would otherwise remove.”).
CONCLUSION
Based on our findings and reasoning above, we sustain the
Examiner’s (i) § 101 rejection of claims 55—82; (ii) § 103 rejection of claims
55, 81, and 82, as well as claims 56—60, 64—72, and 75—78, as Appellants do
not provide separate, substantive arguments for their patentability; (iii) § 103
rejection of claims 61—63, 73, and 74, as Appellants do not provide separate,
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Appeal 2016-005653
Application 13/260,456
substantive arguments for their patentability; and (iv) § 103 rejection of
claims 79 and 80, as Appellants do not provide separate, substantive
arguments for their patentability.
DECISION
We affirm the Examiner’s decision rejecting claims 55—82.
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
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