Ex Parte Hoffman et al

Patent Trial and Appeal Board

Jul 15, 2016

10826595 (P.T.A.B. Jul. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/826,595 04/16/2004
46169 7590 07119/2016
SHOOK, HARDY & BACON LLP,
(Cerner Corporation)
Intellectual Property Department
2555 GRAND BOULEVARD
KANSAS CITY, MO 64108-2613
FIRST NAMED INVENTOR
Mark A. Hoffman
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
CRNI.114070 1203
EXAMINER
SIMS, JASON M
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
07/19/2016 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):
IPDOCKET@SHB.COM
IPRCDKT@SHB.COM
BPARKERSON@SHB.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK A. HOFFMAN and DAVID P. MCCALLIE, JR. 1
Appeal2014-005776
Application 10/826,595
Technology Center 1600
Before FRANCISCO C. PRATS, MELANIE L. MCCOLLUM, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
computer system for providing information about the risk of an atypical
clinical event, which have been rejected as lacking statutory subject matter,
as indefinite and as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
The invention relates to a method for determining the risk of an
atypical clinical event occurring by determining if a patient has a gene
associated with an atypical event, specifically a drug interaction. Spec. i-f 11.
1 Appellants identify the Real Party in Interest as Cemer Innovation, Inc.
Br. 3.
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The method involves receiving clinical agent information, and then
determining if there is a gene associated with the clinical agent information.
Id. Clinical agents include drugs, pharmaceuticals, nutraceuticals, foods,
salves, dietary supplements and the like. Spec. i-f 31. Next, a determination
is made whether the patient has had a genetic test to determine the presence
of a gene associated with the clinical agent. Spec. i-f 37. If not, a
determination is made as to the likelihood that the patient has a gene or a
variant of the gene indicative of an atypical clinical event. Spec. i-f 11.
When it is determined that the gene or gene variant may be present a
determination is made whether to order a test to confirm the presence of the
gene or variant. Spec. i-f 38.
Claims 1, 3, 5, 6, 11-14, 16, 18, 20-23, 27-31, 33, and 52---63 are on
appeal. Claim 1 is illustrative and reads as follows:
1. A computer-implemented method for displaying a
\'l/arning that a clinical agent received from a clinician should
not be administered to a person, comprising the steps of:
receiving from a clinician clinical agent information, the
clinical agent information including an identifier of a specific
clinical agent and a dosage of the specific clinical agent,
wherein receiving comprises:
(a) receiving a selection of an entry in a listing of clinical
agents on a graphical user interface (GUI); and
(b) receiving a selection of the dosage from a range of
dosages recommended for the clinical agent associated with the
selected entry on the GUI;
identifying the genes associated with the clinical agent by
comparing the identifier of the clinical agent received from the
clinician to a first data set including agent-gene associations,
wherein the associated genes are likely to interact with the
clinical agent to result in an atypical clinical event;
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when a gene is associated with the clinical agent,
automatically obtaining a genetic test result value for the
associated gene of a person, wherein automatically obtaining
comprises:
(a) receiving identification of the person to whom the
clinical agent is to be administered and receiving proper
authorization to access an electronic medical record (EMR) of
the person; and
(b) utilizing the identification and the proper
authorization from the clinician to access patient information
within the EMR of the person stored within a comprehensive
healthcare system;
when the patient information comprises the genetic test
result value for the associated gene of a person, comparing the
genetic test result value to the second data set containing one or
more polymorphism values associated with one or more
atypical clinical events for the clinical agent;
otherwise, performing the following procedure:
(a) determining whether to seek a clinician's
authorization to order a test of the person or whether to order
the test without the clinician's input based on both a likelihood
of one or more genetic variations of the associated gene
occurring and a severity of interaction of the one or more
occurring genetic variations with the clinical agent;
(b) when the severity and the likelihood of the associated
gene's one or more genetic variations indicate ordering the test
without the clinician's input, automatically ordering the test to
determine the genetic test result value for the associated gene of
the person when the test is available;
( c) when the severity and the likelihood of the associated
gene's one or more genetic variations indicate seeking the
clinician's authorization to order the test, seeking a clinician's
authorization for the test by presenting a genetic test ordering
window; and
( d) automatically ordering the test to determine the
genetic test result value for the associated gene of the person
when the test is available and the authorization is granted by a
clinician at the genetic test ordering window;
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determining whether the genetic test result value
correlates to one or more of the one or more polymorphism
values contained in the second data set; and
when the genetic test result value correlates to one or
more of the one or more polymorphism values, displaying a
warning to the clinician that the clinical agent received from the
clinician should not be administered, and recording an
indication of the warning in the EMR of the person.
Br. 25-27 (Claims Appendix).
The claims stand rejected as follows:
Claims 1, 3, 5, 6, 11-14, 16, 18, 20-23, 27-31, 33, and 52---63 have
been rejected under 35 U.S.C § 101 as being drawn to non-statutory subject
matter.
Claims 1, 3, 5, 6, 11-14, 16, 18, 20-23, 27-31, 33, and 52---63 have
been rejected under 35 U.S.C. § 112 second paragraph as being indefinite for
failing to particularly point out an distinctly claims the subject matter the
inventor regards as his invention.
Claims 1, 3, 5, 6, 11-14, 16, 18, 20-23, 27-31, 33, and 54--58 have
been rejected under 35 U.S.C. § 103(a) as unpatentable over Hogan US
2002/0110823 Al (published Aug. 15, 2002) ("Hogan"), in view of Classen,
U.S. 6,219,674 Bl (issued Apr. 17, 2001) ("Classen"), Portwood, et al. US
5,950,630 (issued Sep. 14,1999) ("Portwood") and Markin, US 5,985,670
(issued Nov. 16, 1999) ("Markin") and in further view of Fey, et al., US
2002/0052761 Al (published May 2, 2002) ("Fey").
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REJECTION UNDER 35 U.S.C. § 101
Appellants have presented no arguments with regard to the
Examiner's rejection based on 35 U.S.C. § 101. We therefore summarily
affirm the rejection. MPEP § 1205.02.
REJECTION UNDER 35 U.S.C. § 112
Issue
In rejecting the pending claims as indefinite the Examiner finds that
the claims are directed to a computer implemented method or a computer
system but the claims are not clear as to how a computer is used to perform
the specific steps. Final Act. 3. The Examiner finds that there is no actual
algorithm or description as to how the individual steps are performed. Id.
The Examiner finds that while the claimed method calls for using a
computer, the individual steps recite only mental steps without calling for
the use of even a general purpose computer. Ans. 4.
Appellants contend that the claims are not indefinite in that they are
clear as written. Br. 11. Appellants contend that no algorithm is needed. Id.
Appellants further contend that the Specification provides a clear description
as to how each step is to be performed. Id.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that the pending claims are
indefinite as defined by 35 U.S.C. § 112, second paragraph.
Principles of Law
"[A] patent is invalid for indefiniteness if its claims, read in light of
the specification delineating the patent, and the prosecution history, fail to
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inform, with reasonable certainty, those skilled in the art about the scope of
the invention." Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120,
2124 (2014).
"[W]hen the USPTO has initially issued a well-grounded rejection
that identifies ways in which language in a claim is ambiguous, vague,
incoherent, opaque, or otherwise unclear in describing and defining the
claimed invention, and thereafter the applicant fails to provide a satisfactory
response, the USPTO can properly reject the claim as failing to meet the
statutory requirements of§ 112(b)." In re Packard, 751F.3d1307, 1311
(Fed. Cir. 2014).
Analysis
Claim 1 is representative of the pending claims and is directed to a
system for determining the likelihood of an atypical clinical event based on a
patient's genetic profile. We agree with the Examiner that the pending
claims fail to particularly point out and distinctly claim the subject matter of
the invention. Ans. 22-25. Claim 1 is directed to a computer implemented
method and includes, in particular, an alternative series of steps that are
"otherwise" performed, the alternative series of steps including a step of
determining whether to seek a clinician's authorization to order a test or to
order the test without the clinician's input based on both a likelihood of one
or more occurring genetic variations and a severity of interaction of the one
or more occurring genetic variations with the clinical agent. Br. 26 (Claim
Appendix). We agree with the Examiner that the claim does not point out
how this step is performed, does not define objective criteria for making the
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determination, nor is the claim clear as to how a computer is used to perform
the step, thus rendering the claim indefinite. Ans. 23.
Appellants argue that the steps are clear, especially when read in light
of the Specification. Br. 10-12 (citing Spec. i-fi-138--41). We are not
persuaded. Appellants do not explain with any particularity how the
identified portions of the Specification disclose how the individual steps are
implemented by a computer, particularly the determining step noted above.
Appellants do not, therefore, persuade us that the Examiner erred in finding
that the Specification fails to provide guidance as to how to use a computer
to determine when the severity of likelihood associated with the associated
gene's one or more genetic variations indicates ordering a test. Ans. 23-24.
Conclusion of Law
We find that the Examiner has established by a preponderance of the
evidence that claim 1 is indefinite as defined by 35 U.S.C § 112, second
paragraph.
Claims 3, 5, 6, 11-14, 16, 18, 20-23, 27-31, 33, and 52---63 have not
been argued separately and therefore fall with claim 1. 3 7 C.F .R.
§ 41.37(c)(l)(iv).
REJECTION UNDER 35 U.S.C. § 103(a)
Issue
In rejecting claims 1, 3, 5, 6, 11-14, 16, 18, 20-23, 27-31, 33, and
52-58 as obvious under 35 U.S.C. § 103(a), the Examiner finds that Hogan
describes a method for tailoring a patient's surgical treatment, including
anesthesia, using genetic information. Final Act. 10. The Examiner finds
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that Hogan teaches that the genetic information is used to determine if there
is a possible adverse reaction with the anesthetic. Final Act. 11. The
Examiner also finds that Hogan teaches that if the genetic marker is present,
the dose of the anesthetic is adjusted or a different agent is used. Id. The
Examiner finds that Hogan teaches that the method can be accomplished
through the use of a computer. Final Act. 12.
The Examiner finds that Portwood teaches a computer system wherein
data prescribed is compared to pharmaceutical data to verify that the dosage
is within acceptable limits. Final Act. 14. The Examiner finds that Markin
discloses a system for automated testing of lab specimens in a hospital
setting. Final Act. 15. The Examiner finds that Markin teaches a system
that enables a doctor to provide authorization for a test using a user interface
and that the test is automatically ordered based on the authorization. Final
Act. 15-16. Next, the Examiner finds that Fey teaches the use of a graphical
user interface to order genetic tests. Id. at 16.
The Examiner concludes that
[i]t would have been obvious to one of ordinary skill in
the art at the time of the instant invention to have used the
database and methods for assessing risk based on general
population data and construct a message to communicate said
information as taught by Classen with the method taught by
Hogan, Portwood et al., Markin, and Fey et al. This is because
Hogan teaches an invention directed to determining risk based
on an obtained genomic profile. Hogan teaches calculating risk
based on a genomic profile wherein the information is
communicated to the clinician or other third party users. It
would be implicit that if a genomic test result value is not
available, the relevant risk assessment as taught by Classen
would be grounds for prompting the performance of such a
genomic test. Using this data as warrant to bypass clinician
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authority, is suggested by Hogan at paragraph [0035] which
teaches the use of the disclosed invention in an emergency
situation, where risk overwhelms the need for clinician
approval, and the test is automatically ordered.
Final Act. 18.
With respect to claim 1, the Examiner finds that Hogan teaches that
genomic testing only needs to be performed where there is sufficient
information about the correlation between the gene and the agents. Final
Act. 19. The Examiner also finds that Hogan teaches that genetic markers
may be subtracted from the screening process where the markers do not
affect the patient. Id. The Examiner finds that "it is implied from the
teaching of Hogan, that if an agent is not associated with a gene from a
known data set, that the administration of the agent would be approved." Id.
The Examiner concludes that "it would have been obvious to one of ordinary
skill in the art at the time of the instant invention to have approved the
administration of a clinical agent if the agent is not associated with a gene
from a data set known to be associated with the agent." Id..
With respect to claim 58, the Examiner finds that Hogan teaches the
use of a risk assessment method to account for post-treatment patient care.
Final Act. 22. The Examiner finds that it would have been obvious to apply
this methodology to after the fact exposure. Id.
Appellants contend that Hogan does not teach or suggest a likelihood
of a genetic variation or severity of interaction of the genetic variations that
are both used to determine whether to seek a clinicians' authorization. Br.
15. Appellants maintain that the secondary references do not cure this
deficiency. Br. 15-17. With respect to claim 18, Appellants contend that
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Hogan fails to teach determining whether the risk of damage from not
administering the clinical agent is greater than the risk of damage by
lowering the dosage of the clinical agent. Br. 18-19. Appellants contend
that the secondary references do not make up for the deficiency of Hogan.
Br. 19-20. Finally, with respect to claim 58, Appellants argue that Hogan
does not teach determining whether to request authorization for a clinician
based on three criteria, the cost of the genetic test, whether the test is
available and the likelihood of a genetic variation based on the demographic
information of the patient. Br. 21. Appellants again contend that the
secondary references do not address the deficiencies of Hogan. Id.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that the rejected claims
would have been obvious over Hogan in combination with Classen,
Portwood, Markin and Fey as defined by 35 U.S.C. § 103(a).
Findings of Fact
We adopt as our own the Examiner's findings and analysis. The
following findings are included for emphasis and reference convenience.
FF 1. Hogan discloses a computer based method for tailoring a
surgical treatment to reflect genetic information. Hogan, Abstract.
FF2. Hogan teaches that surgical treatment includes the
administration of anesthesia and/or other drugs. Hogan i-fi-14--10.
FF3. The method of Hogan includes determining if the patient is a
candidate for genomic profiling. Hogan i-f 187.
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FF4. Determination of whether a profile should be developed
includes reference to the patient's medical history or medical exam. Hogan
ii 123.
FF5. Hogan teaches that if the patient is a candidate for preparation of
a genomic profile, a sample is taken and a profile is developed. Id.
FF6. Hogan discloses that the method used to generate the genomic
profile is selected based on the method's ability to provide useful
information, its practicality, including costs, and the validity of the assay for
clinical utility. Id.
FF7. Hogan teaches that the data from the genomic assay can be
generated, processed, and/ or managed using electronic communication
systems. Id.
FF8. Hogan teaches that the genetic markers can be selected using
medical histories, physical exams and non-genomic testing. Hogan ii 123.
FF9. Hogan teaches a computer based analysis can be used to
translate the raw data generated by the genomic profile into data of
predictive value. Hogan ii 188.
FFlO. Hogan teaches that the "[r]esults of the genomic profile are
used to make appropriate decisions about patient care, including choice of
analgesics and anesthetics, post-surgical monitoring, and additional
medications or treatments." Hogan ii 203.
FF 11. Hogan teaches that the genetic information is used to establish
the patient's prognosis or odds of survival. Hogan ii 36.
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FF12. Hogan goes on to teach that in some embodiments, the
information is used to select the safest and most efficacious surgical
procedure. Id.
FF 13. Hogan teaches that the genetic markers can be selected for
which the alternative treatment has little or no effect on the cost or
inconvenience of the patient. Hogan i-f 124.
FF14. Hogan also teaches the use of demographic information to
select markers. Hogan i-f 123.
FF15. Hogan teaches that the genetic markers are selected based on
analytical validity, clinical validity and commercial value. Hogan i-f 122.
FF 16. Portwood teaches a computer system for improving medical
regimes wherein data prescribed is compared to pharmaceutical data to
verify acceptable limits, durations and to check for contraindications and/or
abnormalities. Portwood, Abstract.
FF 17. Markin teaches a computerized system which enables a doctor
to enter a request for a specific test to be performed to include authorization
and the test is then automatically ordered. Markin col. 3, 11. 1-9.
FF18. Classen teaches storing adverse event data for drugs in a
database. Classen col. 3, 11. 13-21.
FF 19. Classen teaches that the data can be used to analyze the risk for
an individual wherein the data is compared to patients with similar
characteristics before receiving the medication. Classen col. 6, 11. 9-30.
Principles of Law
"The factual predicates underlying an obviousness determination
include the scope and content of the prior art, the differences between the
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prior art and the claimed invention, and the level of ordinary skill in the art."
In re Rouffet, 149 F.3d 1350, 1355, 47 USPQ2d 1453, 1455 (Fed. Cir.
1998).
"[W]hile an analysis of obviousness always depends on evidence that
supports the required Graham factual findings, it also may include recourse
to logic, judgment, and common sense available to the person of ordinary
skill that do not necessarily require explication in any reference or expert
opinion." Perfect Web Techs., Inc. v. Info USA, Inc., 587 F.3d 1324, 1329
(Fed. Cir. 2009).
Analysis
Claim 1
We agree with the Examiner that claim 1 would have been obvious to
one skilled in the art. Hogan discloses a computer based method for
tailoring patient's surgical treatment using data from a genetic profile. FF 1.
The genetic profile can be ordered if indicated by the patient's medical
history or medical exam. FF3. The genetic profile can be used to alter the
surgical procedure to include changing the amount of type or anesthetic used
or the amount or type of drugs administered. FF 10. The genetic test is
selected using a cost benefit analysis. FF 12 and 13. Portwood teaches a
computer system wherein data relating to prescribed medication is compared
with pharmaceutical data to verify acceptable limits, duration and to check
for contraindications or abnormalities. FF 16. Markin teaches a computer
based system to automatically order a lab test when authorized by a
physician. FF 1 7. Classen teaches the use of a database of adverse clinical
information that comprises "subgroup analysis" to determine specific high
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risk groups. FF 18. The groups of Classen can include patients with similar
genetic characteristics. FF 18. We agree with the Examiner that one skilled
in the art at the time the invention was made would have combined the
method of Hogan with the teachings of Portwood, Clausen, Markin and Fey
to develop the claimed invention. Ans. 18. For example, the system and
pharmaceutical data described by Portwood would enable a person using the
method of Hogan to have more efficient access to the pharmaceutical data to
tailor a patient's medical regime. Ans. 15. Markin's automated ordering
system would improve the processing of tests needed to practice the method
of Hogan. Ans. 16. Using the risk analysis of Clausen would serves as
grounds for ordering the genomic test and bypassing a clinician's authority if
the risk indicates. Ans. 17-18.
Appellants argue that the references do not teach the limitation of
determining whether to seek a clinician's authorization to order the test or
whether to order the test without the clinician's input. Br. 14. We are
unpersuaded. First, as the Examiner pointed out, the limitation at issue is
preceded by the words "otherwise, perform the following procedure:" Ans.
26. This makes the recited steps optional. Id. The prior art teaches all the
steps up to the optional step. Moreover, we agree with the Examiner that
it would have been obvious to one of ordinary skill in the
art at the time of the instant invention to have used the
database and methods for assessing risk based on general
population data and construct a message to communicate
said information as taught by Classen with the method
taught by Hogan, Portwood et al., Markin, and Fey et al.
This is because Hogan teaches an invention directed to
determining risk based on an obtained genomic profile.
Hogan teaches calculating risk based on a genomic
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Ans. 28
profile wherein the information is communicated to the
clinician or other third party users. It would be implicit
that if a genomic test result value is not available, the
relevant risk assessment as taught by Classen would be
grounds for prompting the performance of such a
genomic test. Using this data as warrant to bypass
clinician authority, is suggested by Hogan at paragraph
[0035] which teaches the use of the disclosed invention
in an emergency situation, where risk overwhelms the
need for clinician approval, and the test is automatically
ordered.
Claims 3, 5, 6, 11-14, and 16.
While these claims have been separately listed in Appellants' brief,
the only argument presented is that the arguments for claim 1 are applicable
to these dependent claims. Br. 1 7. Therefore these claims fall with claim 1.
Claim 18
With respect to claim 18, Appellants argue that none of the references
teach using the genetic data to "determine whether a risk of damage from not
administering the clinical agent is greater than the risk of damage by
lowering the dosage of the clinical agent." Br. 19. We agree with the
Examiner that
[ w ]hile Hogan does not explicitly recite the steps of
determining whether a risk of damage from not administering
the clinical agent is greater than the risk of damage by lowering
the dosage of the clinical agent, it is inherent in the description
of Hogan that the operating physician would go through the
same decision tree when determining the optimal agent
corresponding to the surgical procedure at hand, specifically in
view of knowing if a patient had a predisposition.
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Ans. 30. Hogan teaches that the genetic information is used to establish the
patient's prognosis or odds of survival. FF 11. Hogan goes on to teach that
in some embodiments, the information is used to select the safest and most
efficacious surgical procedure. FF12. Common sense dictates that the
physician would inherently need to determine whether the risk of not
administering a clinical agent is greater than using a lower dosage of the
agent.
Claims 20--23, 27-31, 33, and 54-57
Claims 20-23, 27-31, 33, and 54--57 depend, either directly or
indirectly, from claim 18. Appellants have offered no separate arguments to
support patentability for these claims other than the arguments relating to
claim 18 discussed above. Br. 20. Therefore, these claims fall with claim
18.
Claim 58
Appellants contend that none of the references of record teach the
limitation that the determination of whether to request authorization for a
test is based on three criteria, whether the genomic profiles are cost and time
effective, whether the test is available and the likelihood of a genetic
variation based on demographic data of the patient. Br. 21-23. We are
unpersuaded. Hogan teaches that the genetic markers can be selected for
which the alternative treatment has little or no effect on the cost or
inconvenience of the patient. FF 13. Hogan also teaches that the genetic
markers are selected based on several criteria including analytical validity,
clinical validity, and commercial value. FF15. Hogan also teaches the use
of demographic information to select markers. FF 14. We therefore agree
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with the Examiner that "Hogan contemplates the three categories of
information when implementing the invention." Ans. 31-32.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 1, 3, 5, 6, 11-14, 16, 18, 20-23, 27-31, 33, and 54--
58 are obvious over Hogan in combination with Portwood, Classen, Markin
and Fey as defined by 35 U.S.C. § 103(a).
SUMMARY
We affirm the rejection of claims 1, 3, 5, 6, 11-14, 16, 18, 20-23, 27-
31, 33, and 52---63 under 35 U.S.C § 101 as being drawn to non-statutory
subject matter.
We affirm the rejection of claims 1, 3, 5, 6, 11-14, 16, 18, 20-23, 27-
31, 33, and 52---63 under 35 U.S.C. § 112 second paragraph as being
indefinite for failing to particularly point out and distinctly claims the
subject matter the inventor regards as his invention.
We affirm the rejection of claims 1, 3, 5, 6, 18, 20-23, 27-31, 33, and
54--58 under 35 U.S.C. § 103(a) as unpatentable over Hogan, in view of
Classen, Portwood, and Markin, and in further view of Fey
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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