Ex Parte Weibrecht et al

Patent Trial and Appeal Board

Apr 27, 2017

13500647 (P.T.A.B. Apr. 27, 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.
13/500,647 04/06/2012 Martin Weibrecht 2009P01439WOUS 1600
24737 7590 05/01/2017
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue ZEMAN, MARY K
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
05/01/2017 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):
marianne. fox @ philips, com
debbie.henn @philips .com
patti. demichele @ Philips, com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARTIN WEIBRECHT, CAROLINA RIBBING,
MARCO DANIEL PASCAL LIERFELD, and
FRANK WARTENA
Appeal 2016-0075011
Application 13/500,647
Technology Center 1600
Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
TAWEN CHANG, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to systems and methods for
evaluating toxicity levels of a patient undergoing a cancer treatment
protocol. The Examiner rejected the claims under 35 U.S.C. §§ 101, 102,
and 103(a). We have jurisdiction under 35 U.S.C. § 6(b). The rejections are
affirmed-in-part. A new ground of rejection under 35 U.S.C. § 103 is set
forth pursuit to 37 C.F.R. § 41.50(b).
1 The Appeal Brief (“Appeal Br.”) 2 lists Koninklijke Philips Electronics N.
V., as the real-party-in-interest.
Appeal 2016-007501
Application 13/500,647
STATEMENT OF THE CASE
Appellants appeal from the Examiner’s rejection of claims 13—29.
See Final Rej. (“Office Action Summary”). The claims stand rejected as
follows:
1. Claims 13—29 under 35 U.S.C. § 101 as being directed to subject
matter ineligible for a patent. Final Rej. 2.
2. Claims 13-16, 18-22, and 2A-28 under 35 U.S.C. § 102(b) as
anticipated by Pendergast (GB 2 437 106 A, publ. Oct. 17, 2007). Final Rej.
7.
3. Claims 17, 23, and 29 under 35 U.S.C. § 103(a) as obvious in view
of Pendergast and Rice (U.S. Pat. App. Pub. 2003/0233030 Al, publ. Dec.
18,2003). Final Rej. 11.
Representative claim 18 is reproduced below. For reference, the steps
of the claim have been numbered 1 to 4.
18. A method comprising:
[1] receiving, by a processing system, data of a patient
undergoing a cancer treatment protocol, the patient data
including biomarkers related to a level of toxicity in the patient
caused by the cancer treatment protocol,
[2] accessing, by the processing system, a database that
includes reference biomarkers present in prior patients that have
been characterized as having had acceptable toxicity levels
while undergoing the same cancer treatment protocol,
[3] determining, by the processing system, whether a
statistical difference exists between the biomarkers of the
patient and the reference biomarkers, and
[4] if a statistical difference exists, issuing, by the
processing system, an alarm that indicates this difference.
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Application 13/500,647
ANTICIPATION BY PENDERGAST
There are three independent claims rejected as anticipated by
Pendergast. Claim 13 is directed to a system; claim 18 to a method; and
claim 24 to non-transitory computer-readable medium. All three claims
have the same limitations, but in a form specific to the statutory class of
invention to which they are directed. We have selected method claim 18 as
representative.
The method of claim 18 comprises three steps and one optional step
dependent upon the outcome of step 3:
1) receiving data of a patient undergoing cancer treatment, where the
data includes “biomarkers related to a level of toxicity in the patient caused
by the cancer treatment protocol”;
2) accessing a database that contains “reference biomarkers” that are
present in patients “having had acceptable toxicity levels while undergoing
the same cancer treatment protocol”;
3) determining whether there is a statistical difference between the
patient’s biomarkers and the reference biomarker;
4) “if a statistical difference exists, issuing, by the processing system,
an alarm that indicates this difference.”
The Examiner rejected the claim as anticipated by Pendergast, finding
that all the steps recited in the claims are described by Pendergast. Final
Rej. 7—9. Appellants contend that Pendergast does not disclose a database
that includes reference biomarkers present in prior patients that have been
characterized as having had acceptable toxicity levels (see supra step 2),
performing a step of determining statistical differences (see supra step 3),
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and providing an alert signal when there is statistical difference (see supra
step 4). Appeal Br. 9—11.
We agree with Appellants that the Examiner’s anticipation rejection is
not supported by a preponderance of the evidence. Specifically, there is no
mention in Pendergast of step 2) of accessing a database that contains
“reference biomarkers” that are present in patients “having had acceptable
toxicity levels while undergoing the same cancer treatment protocol”; and
step 3) of determining whether there is a statistical difference between the
patient’s biomarkers and the reference biomarker. The Examiner relied
upon teachings in Pendergast of an outcome history relating to patient
mortality/morbidity rate (Pendergast 3:1—10) as a teaching of reference
markers relating to toxicity levels present in patients undergoing cancer
treatment, but we find such disclosure deficient because it is not a specific
disclosure of toxicity levels, biomarkers, or cancer treatment. Anticipation
requires a showing that each element of the claim is identifiable in a single
reference. Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375—77
(Fed. Cir. 2005). “The identical invention must be shown in as complete
detail as is contained in the . . . claim.” Richardson v. Suzuki Motor Co., 868
F.2d 1226, 1236 (Fed. Cir. 1989). Because each element of the claim is not
described by Pendergast, we are compelled to reverse the rejection of claims
13—16, 18—22, and 24—28 under 35 U.S.C. § 102(b) as anticipated by
Pendergast.
OBVIOUSNESS REJECTION OVER PENDERGAST AND RICE
The Examiner did not make findings that Rice had teachings that meet
the deficiencies in Pendergast cited above. Consequently, the rejection of
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claims 17, 23, and 29 under 35 U.S.C. § 103(a) as obvious in view of
Pendergast and Rice is reversed.
101 REJECTION
The Examiner found that the claims are directed to an abstract idea
and a natural phenomenon, judicial exceptions to patentability under 35
U.S.C. § 101. Final Rej. 2-3.
To determine whether a claim is eligible for patent under 35 U.S.C.
§ 101, a two-step analysis is necessary. As set forth in Alice Corp. Party.
Ltd. v. CLS Bank International, 134 S. Ct. 2347, 2355 (2014):
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,
“[w]hat 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.”
Alice, 134 S. Ct. at 2355 (second and fourth alterations in original) (citations
omitted).
In this case, the steps of 1) receiving a biomarker of a patient, 2)
accessing a database of reference biomarkers, and 3) determining the
differences between the patient and reference biomarkers are conventional.
To put this in simple terms, the aforementioned steps are the same as those
of a patient who gets blood drawn by a doctor to determine whether the
biomarkers in it, such as blood cell count, glucose concentration, and
cholesterol levels, are normal as compared to a database of a known standard
reference values.
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The central purpose of the claim is to compare the biomarkers of a
patient undergoing chemotherapy with a biomarker database of patients who
underwent the same treatment to determine whether the patient is exhibiting
acceptable toxicity levels. The relationship between the biomarkers and
toxicity levels is natural phenomenon because it represents the body’s
natural response to chemotherapy. A claim that merely describes a
relationship that is a consequence of natural processes is ineligible for a
patent because it is a natural law. Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 132 S. Ct. 1289, 1296—97 (2012). For these reasons, we
conclude claim 18 is directed to patent ineligible subject matter under the
first part of the Alice test.
The second step of the analysis requires a determination of whether
the claims do significantly more than simply describe the abstract idea or
natural law. Mayo, 132 S. Ct. at 1297. The claim limitations must be
scrutinized to determine whether the claims contain an “inventive concept”
to “transform” the claimed abstract idea or natural law into patent-eligible
subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at 1294,
1298).
The transformation of an abstract idea into patent-eligible subject
matter “requires more than simply stat[ing] the [abstract idea]
while adding the words ‘apply it.’” Id. (quoting Mayo, 132 S.Ct.
at 1294) (alterations in original). “A claim that recites an abstract
idea must include ‘additional feature’ to ensure ‘that the [claim]
is more than a drafting effort designed to monopolize the
[abstract idea].”’ Id. (quoting Mayo, 132 S.Ct. at 1297)
(alterations in original). Those “additional features” must be
more than “well-understood, routine, conventional activity.”
Mayo, 132 S.Ct. at 1298.
Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014).
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In this case, claim 18 simply instructs the practitioner to implement
the natural law using routine and conventional activity. The recited steps
involve receiving biomarker data, accessing a database containing biomarker
data on patients who have been administered chemotherapy, determining
differences between the patient’s biomarkers and those of the database. As
already discussed, these steps correspond to the same conventional steps in
the art when a patient’s blood is examined to determine whether the cells
and chemicals present in it fall within normal ranges to assess the patient’s
health status. The step of issuing an alarm when there is a difference
between the patient biomarkers does not add anything significantly more to
the ineligible natural phenomenon because it is conventional to alert the
health care provider when a patient’s biomarkers are different from
acceptable values as evidenced by Pendergast who teaches such an alert.
See infra Finding of Fact 14 (“FF”).
Appellants contend that the claimed “technique ... is not the mere
application of a known technique using a computer.” Appeal Br. 10.
Appellants contend that the claims differ from those considered by the Mayo
court because in this case “there is no known technique for determining
whether a patient will receive an ‘acceptable’ level of toxins when
undergoing chemotherapy, other than 'trial-and-error', particularly when a
combination of chemicals is infused over a course of time.” Id. Appellants
acknowledge that the recordation of biomarkers is routine, but argues that
substantially more is added because
in addition to this routine recording of each patient’s biomarkers,
the recordings of the patients that experienced “acceptable” toxic
effects (e.g. upset stomach, but no vomiting; drop in temperature,
but not shock; etc.) are distinguished from those patients that
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experienced “unacceptable” toxic effects (vomiting, shock,
etc.).
... If the biomarkers of the current patient begin to differ
significantly from the biomarkers of the patients that experienced
“acceptable” toxic effects, an early-warning alert signal can be
issued. Potentially, because this alert signal is issued based on
the current biomarkers of the patient, it is likely to provide more
advanced notice than waiting for the toxins to have a
noticeable/“unacceptable” effect on the patient, and remedial
actions will be more effective.
Id. at 11.
Appellants’ argument is not persuasive because it attempts to
distinguish Mayo based on a “discovery” of a natural principle, namely, the
appearance of biomarkers in patient in response to administration of a
chemotherapeutic agent. The biomarker response is entirely a natural
phenomenon because it reflects the biological response of the patient’s body
to the chemotherapeutic agent.
Accordingly, we affirm the rejection of claims 13—29 under 35 U.S.C.
§ 101 as being directed to subject matter ineligible for a patent.
NEW GROUND OF REJECTION
Pursuant to 37 C.F.R. § 41.50(b), we set forth the following new
ground of rejection of independent claims 13, 18, and 24 under 35 U.S.C.
§ 103(a) as obvious in view of Pendergast and Dranitsaris (WO
2006/113987 Al, publ. Nov. 2, 2006).
We begin with the teachings in Pendergast to establish that Pendergast
describes the same steps of claim 18, but not with respect to biomarkers
related to toxicity levels in a patient caused by cancer treatment. For the
latter limitation, we cite Dranitsaris, a published PCT application cited in a
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search report for the PCT application to which the instant application claims
benefit. See Information Disclosure Statement dated Apr. 6, 2012;
International Search Report in PCT/IB2010/054332 (mailing date Apr. 2,
2011)
Pendergast
The following findings of fact (“FF”) from Pendergast are pertinent to
the obviousness determination:
FF1. Pendergast describes performing real-time monitoring of patient
parameters through sensors positioned on a patient. Pendergast 4:6—11.
Parameters include ECG, heart rate, blood pressure, blood oxygen
saturation, EEG, etc. Id. at 4:11—20.
FF2. Pendergast describes storing the real-time monitoring
parameters as a real-time medical record in a hospital information system.
Id. at 5:6—20.
FF3. The patient parameters (FF1) collected in Pendergast are
“biomarkers” as recited in the instant claims.
FF4. The transmitting and storing of the patient parameters in
hospital information system (FF2) is “receiving, by a processing system,
data of a patient. . . including biomarkers” as in step 1 of claim 18.
FF5. Although Pendergast doesn’t describe the biomarkers as related
to toxicity in a patient caused by a cancer treatment protocol, if the patient
were experiencing cancer treatment, such collected biomarkers would be
related to the toxicity of the cancer treatment.
FF6. Pendergast describes an “historical reference database” with
historical patient records which include “all of the medical record data,
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monitoring parameters, treatments and outcome information for a large
number of patients.” Id. at 6:18—23.
FF7. The database includes “monitoring parameters . . . taken from
the patient during the course of the patient’s history or treatment.” Id. at
6:27-29.
FF8. Pendergast further teaches:
[T]he historic patient record 34 includes a listing of the
treatments utilized with the patient. These treatments may
include the type of drugs taken by the patient, caregiver
documentation regarding the patient treatment, medical
procedures performed on the patient, tests given during the
treatment as well as diagnosis information for the patient.
Finally, the historic patient record includes outcome information
44 that provides information as to the ultimate outcome obtained
for the patient based upon the treatment, monitoring parameters
and medical record data.
Id. at 7:6—13.
FF9. Pendergast teaches:
[T]he monitoring device 16 is in two-way communication with
the historic reference database 32. The monitoring device 16
delivers medical record data 46, which may include demographic
data, treatment schedule information and outcome information,
and real-time monitoring parameters 48 for comparison to the
historic patient records within the historic reference database 32.
Id. at 7:26-29.
FF10. Pendergast teaches:
Once the historic reference database identifies one or more
historic patient records that closely correspond to the real-time
monitoring parameters 48 and medical record data 46 received
from the monitoring device 16, the historic reference database 32
communicates the treatment history and outcome history from
the identified historic patient records to the monitoring device
16. If the historic reference database 32 identifies more than one
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historic patient record that closely corresponds to the medical
record data 46 and the real-time monitoring parameters 48 from
the monitoring device 16, the historic reference database 32 will
correlate the information and provide compiled information
relating to the outcome history 52 and treatment history 50 to the
monitoring device 16.
Id. at 8:9-18.
FF11. Pendergast describes step 2 of “accessing, by the processing
system, a database that includes reference biomarkers present in prior
patients” (“the monitoring device 16 is in two-way communication with the
historic reference database 32. The monitoring device 16 delivers medical
record data 46 . . . for comparison to the historic patient records within the
historic reference database 32.” (FF9)). The historic patient records
represent the database of “prior patients” required by the instant claims.
FF12. Pendergast also describes “determining, by the processing
system, whether a . . . difference exists between the biomarkers of the
patient and the reference biomarkers” as recited in step 3) because searching
for records that “closely correspond” to historical records in the historical
record database involves identifying records that correspond to, and also
records that do not correspond to, the patient biomarkers in which a
“difference exists.” FF10.
FF13. Pendergast teaches an alarm sounds when there is an adverse
event. Pendergast 8—9.
FF14. Pendergast further teaches:
[I]f the real-time monitoring parameters received from the
patient begin to change such that the historic reference database
32 identifies a significant immediate risk to the patient, the
monitoring device 16 can generate the information packet alert
54 to the physician indicating the worsening of the patient's
condition. Once again, the monitoring device 16 is able to relay
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the real-time monitoring parameters 48 to the historic reference
database 32, where the real-time monitoring parameters 48 can
be compared to historic patient records.
Id. at 9:3—10.
FF15. Pendergast thus issues an alarm as recited in step 4) of claim
18 when “monitoring parameters received from the patient begin to change
such that the historic reference database 32 identifies a significant immediate
risk to the patient.”
FF16. While Pendergast does not expressly state that the alarm issues
when there is a “difference” between the reference database parameters and
those of the patient, such step is encompassed by Pendergast’s disclosure of
monitoring parameters for a significant risk, or obvious therefrom to
determine such risk. In other words, a risk can be detected, e.g., 1) when the
biomarkers match a patient with known adverse event or 2) when the
biomarkers deviate from acceptable values.
Dranitsaris
As explained in the findings of fact, Pendergast describes a method
that involves all four steps of the claimed method. However, Pendergast
does not expressly teach receiving data from a patient of biomarkers related
to toxicity caused by cancer treatment as in step 1) and accessing biomarkers
from a database of patients who had acceptable toxicity levels undergoing
the same cancer treatment as in step 2) of the claim. Dranitsaris, however,
teaches biomarkers associated with toxicity that results from cancer
treatments. The following findings of fact from Dranitsaris are pertinent:
FF17. Dranitsaris teaches cancer-specific toxic event prediction
associated with chemotherapy. Dranitsaris 24:19.
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FF18. Dranitsaris teaches assembling clinical data from a cancer
patient population. Id. 24:32—33. Dranitsaris teaches collecting various
clinical parameters including cellular, biochemical, blood, etc. Id. at 29:24—
31:11.
FF19. Dranitsaris teaches identifying toxic events associated with
chemotherapy in the patient population. Id. at 25:21—27.
FF20. Dranitsaris teaches determining the risk of a toxic event
associated with chemotherapy and that determining a risk factor can be
accomplished by statistical analysis. Id. at 28—33.
FF21. Dranitsaris teaches
[t]he system can be utilized as part of the initial consultation
between a patient and physician, before the precise treatment
decision is made when contemplating alternatives; and/or it can
be used during the course of treatment, for example, cycle by
cycle to decide whether any other interventions need to be made
to minimize toxicity, such as dose reduction, institution of
supportive care, medication, and the like. Thus the system can
be used to contemplate alternative treatments, as well as to help
minimize toxicity once the treatment has begun, for example,
over the several cycles of chemotherapy that usually constitute a
course of chemotherapy (for example, 6 or more cycles).
Id. at 39: 10-18.
Reason to combine
One of ordinary skill in the art would have had reason to utilize
Pendergast’s system of “monitoring parameters received from the patient” to
identify “a significant immediate risk to the patient” by using a historic
reference database (FF14) to determine the presence of toxicity associated
with cancer treatment because Dranitsaris teaches that assessing risk factors
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can be used to minimize toxicity associated with cancer treatment (FF20,
FF21).
Furthermore, the skilled worker would have had reason to receive
biomarkers related to toxicity as described in Dranitsaris (FF18) in order to
identify toxic events as taught by Dranitsaris (FF19, FF20) because
Pendergast teaches its system is useful to monitor “worsening of the
patient’s condition” (FF14), meeting all the limitations of step 1) of claim
18. Likewise, the skilled worker would have had reason to access a database
for the reference toxicity markers in the manner described by Pendergast
(FI 1) but for the purpose of assessing toxicity of a cancer treatment to
minimize risks of on-going cancer treatment as in step 2) of clam 18.
Pendergast, as discussed, determines similarities and differences
between biomarkers to determine risks to a patient (FF10, FF14), i.e., if
similarities are identified, then records which are not similar (differences)
must also be identified.
Pendergast also describes step 3) of the claim. FF12. Even if
Pendergast does not describe step 3) of determining “statistical difference
exists between the biomarkers of the patient [having acceptable toxicity
levels] and the reference biomarkers,” Dranitsaris teaches using its system
“during the course of treatment, for ex ample, cycle by cycle to decide
whether any other interventions need to be made to minimize toxicity, such
as dose reduction, institution of supportive care, medication, and the like.”
FF21, Such determination would involve observing a toxic response either
by similarity to a historic patient database or by noticing deviations from
blood markers in a previous patient who did not experience toxicity. The
latter is conventionally done when a clinician compares a. patient’s blood
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markers to normal reference markers to determine w! the markers are
in the normal range.
Dranitsaris teaches making assessments about risks of toxic events
using statistics (FF20), making it obvious to apply such analysis to the
comparisons performed by Pendergast as a conventional way of assessing
data, meeting the limitation of step 3) of making a risk determination based
on statistical analysis.
In the final step, the claim requires issuing an alarm when differences
exist. As already discussed, while Pendergast does not expressly teach an
alert when there are differences between the biomarkers of the patient and
the reference biomarkers, such step is encompassed by Pendergast’s
disclosure or obvious therefrom. FF16. As discussed above, it is not new to
determine differences between normal and acceptable biomarker values and
a patient’s to determine the patient’s health status. Thus, the skilled worker
would have reason to send an alert when markers deviate from a normal and
acceptable pattern (i.e., where the reference markers are indicative of “prior
patients that have been characterized as having had acceptable toxicity
levels” as recited in step 2) of claim 18.
In sum, we conclude that claim 18 is obvious in view of Pendergast
and Dranitsaris. Claims 13 and 25 comprise the same limitations and
therefore are rejected as obvious for the same reason. We leave it to the
Examiner to determine whether the dependent claims are obvious based on
the combination of Pendergast, Dranitsaris, and other pertinent prior art.
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TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” 37 C.F.R. § 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
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: 37 C.F.R, $ 41.50(b)
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