Ex Parte Hocum et al

Patent Trial and Appeal Board

Jan 24, 2018

13519843 (P.T.A.B. Jan. 24, 2018)

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.
13/519,843 11/13/2012 Craig L. Hocum 1012-017US01/ 2009-161 7826
28863 7590 01/26/2018
SHUMAKER & SIEFFERT, P. A.
1625 RADIO DRIVE
SUITE 100
WOODBURY, MN 55125
EXAMINER
BORIN, MICHAEL L
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
01/26/2018 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):
pairdocketing @ ssiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CRAIG L. HOCUM, JAMES T. McCARTHY,
DAVID P. STEENSMA, DAVID DINGLI, JAMES L. ROGERS, and
EDWARD J. GALLAHER
Appeal 2017-005738
Application 13/519,84s1
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1-7 and 14
(Final Act.2 2).3 Examiner entered a rejection under 35 U.S.C. § 101. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as “Mayo Foundation for
Medical Education and Research, of Rochester, MN” (Br. 3).
2 Examiner’s October 28, 2015 Office Action.
3 Pending claims 8-13 and 15 stand withdrawn from consideration (Final
Act. 2).
Appeal 2017-005738
Application 13/519,843
STATEMENT OF THE CASE
Appellants’ “disclosure relates to modeling of biophysical parameters
to determine pharmaceutical dosages” (Spec. ^ 1). Appellants’ claim 1 is
representative and reproduced below:
1. A system, comprising:
a biophysical simulation engine that represents a process
by which red blood cells are produced in humans, wherein the
biophysical simulation engine includes a plurality of parameters
the values of which are patient-specific; and
a processing unit configured to execute the biophysical
simulation engine, wherein the processing unit:
receives patient-specific historical hemoglobin (Hgb)
data and corresponding historical erythropoietic stimulating
agent (ESA) dosage data,
models a patient-specific response to the historical ESA
dosage data for a plurality of sets of parameter values,
selects at least one set of the parameter values such that
the modeled patient response to the historical ESA dosage data
substantially fits the patient-specific historical Hgb data,
simulates patient-specific Hgb values that would be
obtained by the patient over a predetermined period of time
based on the biophysical simulation engine, the at least one
selected set of parameter values, and a plurality of proposed
therapeutic ESA dosages, and
identifies at least one of the plurality of proposed
therapeutic ESA dosages that substantially maintains the
simulated patient-specific Hgb values within a target range
during the predetermined period of time;
wherein the plurality of parameters includes an
erythropoietin setup rate parameter having a patient-specific
value that when applied to the model raises the simulated
patient specific hemoglobin values to a level equal to the
patient-specific historical Hgb data on a first day for which the
simulation is performed, and
wherein the biophysical simulation engine takes into
account delay in increase of simulated patient-specific Hgb
values in response to delivery of the proposed therapeutic ESA
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dosages and delay in decrease of simulated patient-specific Hgb
values due to lifespan of circulating red blood cells in the
patient.
(Br. 2)
The claims stand rejected as follows:
Claims 1-7 and 14 stand rejected under 35 U.S.C. § 101 as directed to
non-statutory subject matter.
ISSUE
Does the evidence of record support Examiner’s finding that
Appellants’ claimed invention is directed to non-statutory subject matter?
FACTUAL FINDINGS
FF 1. Appellants disclose:
In [End Stage Renal Disease (ESRD)] patients, as well as
in other patient populations experiencing reduced hemoglobin
levels, the biophysical system that regulates erythropoietin
production does not function properly. [Erythropoietic
Stimulating Agents (ESAs)] are often prescribed to manage
hemoglobin levels (anemia) in ESRD patients and in other
patient populations. An ESA prescription may include, for
example, intravenous injection of darbepoetin alfa (Aranesp®)
or Recombinant Human Erythropoietin (rHuEPO). The current
protocol for developing ESA prescriptions produces patterns of
hemoglobin (Hgb) oscillation that subject patients to a cycle of
overshoot and undershoot of target Hgb values. For example,
when the patient exhibits a low Hgb, the dosage may be
dramatically increased in an attempt to quickly raise Hgb levels.
When the patient exhibits a high Hgb, interruption of ESA
therapy (by greatly reducing the dose or withholding
administration) may lead to under-dosing of the ESA, which, in
turn, leads to an undershoot of Hgb values. The result is an
undesirable fluctuation of Hgb levels above and below the
target range. The period of the High-Low-High may take up to
nine months for a complete cycle. Hgb values are often
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Application 13/519,843
measured monthly, rendering Hgb cycling practically
imperceptible.
(Spec. ^ 6; see id. 3.)
FF 2. Appellants disclose that their
system includes a patient-specific biophysical simulation model
that, based on a patient’s historical response to ESA therapies,
determine a target dosing level which can be translated to a
dosing regimen titrated to available commercial doses. The
dosing regimen thus obtained can be configured to
simultaneously achieve and sustain adequate and stable Hgb
values for extended periods of time as well as minimize or
eliminate Hgb oscillations (commonly known as Hgb cycling).
The total amount (and cost) of ESA administered may also be
reduced or minimized. If the patient’s overall medical
condition remains stable, Hgb values have been shown, using
the techniques described herein, to remain stable at a given
target level. If the patient's underlying medical condition
changes, the system includes a diagnostic system which can be
used to establish a new target dosing level that may restore Hgb
values to a desired target level in a minimum of time.
(Spec. T| 53.)
FF 3. Appellants disclose:
Due to its longer half[-]life, darbepoetin alfa requires
approximately five days for complete elimination from the
serum, and has a prolonged period of pharmacological activity.
This allows providers to administer the drug less frequently.
But the extended half-life of darbepoetin alfa, in combination
with red blood cell dynamics, creates a physiological
consequence. After an administration of darbepoetin alfa, [red
blood cell (RBC)] production is enhanced for up to 26 days.
This delay, if not factored into the design of the prescription,
sets up Hgb cycling. It is not uncommon for patients to
experience 12-18 months of Hgb “overshoot” and “undershoot”
as providers try to establish an adequate and stable Hgb level
following existing protocols. The system accounts for feedback
and delay in the erythropoietic process by establishing a target
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Application 13/519,843
dosing level, assisting with the design of a dosing regimen, and
monitoring results over time.
(Spec. T| 64; see id. ^ 2.)
ANALYSIS
The system of Appellants’ claim 1 comprises: (1) a biophysical
simulation engine that represents a process by which red blood cells are
produced in humans that includes a plurality of patient-specific parameter
values and (2) a processing unit configured to execute the biophysical
simulation engine (Br. 2).
The biophysical simulation engine of Appellants’ system: (a) takes
into account delay in increase of simulated patient-specific Hgb values in
response to delivery of the proposed therapeutic ESA dosages and delay in
decrease of simulated patient-specific Hgb values due to lifespan of
circulating red blood cells in the patient and (b) includes an erythropoietin
setup rate parameter, among the plurality of parameters, that has a patient-
specific value that when applied to the model raises the simulated patient-
specific hemoglobin values to a level equal to the patient-specific historical
Hgb data on a first day for which the simulation is performed (id.).
The processing unit of Appellants’ system: (i) models a patient-
specific response to historical ESA dosage data for a plurality of sets of
parameter values; (ii) selects at least one set of parameter values such that
the modeled patient response to the historical ESA dosage data substantially
fits the patient-specific historical Hgb data; (iii) simulates patient-specific
Hgb values that would be obtained by the patient over a predetermined
period of time based on the biophysical simulation engine, the at least one
selected set of parameter values, and a plurality of proposed therapeutic ESA
dosages; and (iv) identifies at least one of the plurality of proposed
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therapeutic ESA dosages that substantially maintains the simulated patient-
specific Hgb values within a target range during the predetermined period of
time {id.).
Alice Corp. Pty. Ltd. v. CLSBank Inti, 134 S. Ct. 2347, 2355 (2014)
sets forth the following two-step analysis for determining patent eligibility
under Section 101:
First, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts [e.g., a law of nature,
natural phenomenon, or abstract idea]. If so, we then ask, what
else is there in the claims before us? . . . We have described
step two of this analysis 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. (alterations, citations, and quotation marks omitted).
With respect to Alice's first step, Examiner finds that, when
considered as a whole, Appellants’ claimed system “simply describes the
concept of gathering and combining data by reciting steps of organizing
information through mathematical relationships to generate additional
information” (Final Act. 3). Thus, Examiner finds that the system of
Appellants’ claim 1 is directed to non-statutory subject matter, specifically,
an abstract idea (Final Act. 3; see also id. at 3-5; Ans. 2).
With respect to Alice's second step, the search for an inventive
concept, Examiner finds that the “processing unit” of Appellants’ claim 1,
represents “generic hardware that nearly every computer will include” and a
series of processing steps (Final Act. 4). With respect to the hardware,
Examiner finds that “[n]one of the hardware offers a meaningful limitation
beyond generally linking the system to a particular technological
environment, that is, implementation via computers” (Final Act. 4). With
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respect to the processing steps, Examiner finds that these steps represent
nothing more than data gathering and manipulation steps (Final Act. 4).
Taken together, Examiner finds that “mere data gathering in
conjunction with an abstract idea is not enough to qualify as ‘significantly
more’” and Appellants’ claimed system does “not recite inventive steps
outside of data manipulation^ or [steps that] improve[] ... the functioning
of the computer itself’ (Final Act. 4; see Ans. 2 (“Other than manipulation
of data, there is no evidence for an improvements to another technology or
to the functioning of the computer itself, or for applying the judicial
exception with, or by use of, a particular machine”)). Therefore, Examiner
finds that, when “[vjiewed as a whole, th[e] additional claim elements do not
provide meaningful limitations to transform the abstract idea into a patent
eligible application of the abstract idea such that the claims amount to
significantly more than the abstract idea itself’ (Final Act. 4).
We find no error in Examiner’s finding that Appellants’ claim 1 is
directed to non-statutory subject matter.
Appellants contend that the selection, simulation and identification
steps performed by the processing unit “are not conventional steps that those
in the field would have routinely practiced, in that application of the recited
claim limitations was not widely prevalent at the time the application was
filed” (Br. 8). In this regard, Appellants contend that “[tjhese claim
limitations are significant because the resulting invention solves the Hgb
cycling problem by ‘identifying] at least one of the plurality of proposed
therapeutic ESA dosages that substantially maintains the simulated patient-
specific Hgb values within a target range during the predetermined period of
time’” and, thereby, “[t]he dosing regimen thus obtained can be configured
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to simultaneously achieve and sustain adequate and stable Hgb values for
extended periods of time as well as minimize or eliminate Hgb oscillations
(commonly known as Hgb cycling)” (Br. 9 (citing Spec. 6 and 53)
(alteration original)).
Appellants further contend that accounting for “delay in increase of
simulated patient-specific Hbg values in response to delivery of the
proposed therapeutic ESA dosages and delay in decrease of simulated
patient-specific Hgb values due to lifespan of circulating red blood cells in
the patient,” as is required by the system of Appellants’ claim 1, “furthers
the goal of the claimed invention to ‘identify] at least one of the plurality of
proposed therapeutic ESA dosages that substantially maintains the simulated
patient-specific Hgb values within a target range during the predetermined
period of time’” (Br. 9-10 (citing Spec. ^ 64) (alteration original)).
Therefore, Appellants contend that the system set forth in their claim
1 provides “additional elements” that “go[] beyond merely ‘processing
information, converting one form of numerical representation into another,
and correlating information” and, thus, represent “more than mere [well-
understood, routine, or conventional techniques in the field, or] instructions
to ‘apply’ the so-called abstract idea” (Br. 10; see id. at 10-11).
We are not persuaded.
Instead, we agree with Examiner’s finding that Appellants’ claimed
invention, which is performed on a generic computer, does no more than
collect and manipulate data to generate additional information. “[SJimply
implementing a mathematical principle on a physical machine, namely a
computer, [is] not a patentable application of that principle.” Mayo
Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289,
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1301 (2012). Further, “an invention directed to collection, manipulation,
and display of data [is] an abstract process.” Intellectual Ventures ILLC v.
Capital One Financial Corp., 850 F.3d 1332, 1340 (Fed. Cir. 2017); see
generally id. at 1340-41.
Without additional limitations, a process that employs
mathematical algorithms to manipulate existing information to
generate additional information is not patent eligible. “If a
claim is directed essentially to a method of calculating, using a
mathematical formula, even if the solution is for a specific
purpose, the claimed method is nonstatutory.” Parker v. Flook,
437 U.S. 584, 595[] (1978) (internal quotations omitted).
Digitech Image Techs., LLC v. Flees. For Imaging, Inc., 758 F.3d 1344,
1351 (Fed. Cir. 2014). See also Fair Warning Ip, LLC v. Iatric Systems,
Inc., 839 F.3d 1089, 1093 (Fed. Cir. 2016) (“analyzing information by steps
people go through in their minds, or by mathematical algorithms, without
more,” are “essentially mental processes within the abstract-idea category”);
Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1146 (Fed. Cir.
2016) (“Methods which can be performed entirely in the human mind are
unpatentable . . . because [they] embody the ‘basic tools of scientific and
technological work’ that are free to all men and reserved exclusively to
none”). Cf. FF 1. Thus, when the elements of Appellants’ claim 1 are
considered as a whole, the claim elements fail to add enough to “‘transform
the nature of the claim’ into a patent-eligible application.” Intellectual
Ventures, 850 F.3d at 1338; see id. at 1341-1342. See also CyberSource
Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir. 2011) (“The
mere manipulation or reorganization of data . . . does not satisfy the
transformation prong”).
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CONCLUSION OF LAW
The evidence of record fails to support Examiner’s finding that
Appellants’ claimed invention is directed to patent ineligible subject matter.
The rejection of claim 1 under 35 U.S.C. § 101 as directed to non-statutory
subject matter is affirmed. Claims 2-7 and 14 are not separately argued and
fall with claim 1.
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).
AFFIRMED
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