Ex Parte Patterson et al

Patent Trials and Appeals Board

Jul 8, 2019

14675335 - (D) (P.T.A.B. Jul. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/675,335 03/31/2015
27076 7590 07/10/2019
DORSEY & WHITNEY LLP - Seattle
INTELLECTUAL PROPERTY DEPARTMENT
Columbia Center
701 Fifth Avenue, Suite 6100
Seattle, WA 98104-7043
FIRST NAMED INVENTOR
Robert D. Patterson
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.
P246890.US.02 2668
EXAMINER
WISE, OLIVIA M.
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
07/10/2019 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-se@dorsey.com
seattle.ip@dorsey.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT D. PATTERSON, NICOLAS A. MOYER, and
JESSICA OESTERHELD
Appeal2019-000361
Application 14/675,335
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and JAMIE T. WISZ,
Administrative Patent Judges.
WISZ, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants 1 seek review of claims 1-
31.2 The Examiner rejected the claims as directed to patent-ineligible
subject matter. We have jurisdiction under 35 U.S.C. § 6(b ).
For the reasons set forth below, we AFFIRM.
1 Appellants identify the Real Party in Interest as Youscript Inc. App. Br. 3.
2 Claim 32 has been canceled.
Appeal2019-000361
Application 14/675,335
STATEMENT OF THE CASE
The Specification describes "methods and systems for improving
accuracy of prediction of substance-factor interactions in patients." Spec.
27. These systems may improve drug interaction prediction for a patient by
comparing computationally predicted changes in AUC for
interaction pairs involving the same metabolic pathways as the
drug with change in AUC information from clinical data ( e.g.
clinical studies). A correction factor for use in the
computational prediction may be identified which improves the
accuracy of the computational predictions relative to the clinical
data.
Id. The computational prediction "may be used to set and/or change the
amount or identity of the drug administered to a patient." Id.
Claims 1, 19, and 24 are independent claims; claim 1 is illustrative
and is set forth below:
1. A method for improving drug interaction prediction, the
method comprising:
selecting a substance-factor group, wherein the
substance-factor group includes at least one substance and at
least one factor, the substance including a drug and the factor
including at least one of an interactor drug, a gene, or a food;
computationally predicting, using a processor of a
computing system, a percent area under the curve (AUC)
change for the drug caused at least in part by an interaction of
the drug with one or more enzymes, selectable by a user,
involved in a metabolic pathway for the drug and the at least
one factor, wherein said computationally predicting includes
utilizing parameters for drug metabolism;
comparing, using the processor of the computing system,
the computationally predicted percent AUC change with a
stored percent AUC change associated with the drug, wherein
the stored percent AUC change is based on clinical data on the
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interaction of the drug and the at least one factor with the one or
more enzymes;
providing, using the processor of the computing system,
a correction factor for the one or more enzymes using the
comparison;
computationally predicting, using the processor of the
computing system, a modified percent AUC change for the
drug based at least in part on the interaction of the drug with the
one or more enzymes, wherein said computationally predicting
the modified percent AUC change includes utilizing parameters
for drug metabolism modified based in part on the correction
factor;
modifying, using the processor of the computing system,
a recommended dose of the drug based on the modified percent
AUC change; and
recommending, using the processor of the computing
system, the modified dose of the drug.
App. Br. 10 (Claims Appendix). Independent claims 19 and 24 recite
similar steps; however, claim 19 recites a "non-transitory computer-
readable medium" with instructions for performing these steps and
claim 24 recites a system programmed to perform these steps. Id. at
13-14.
TheExaminerrejectedclaims 1-31 under35U.S.C. § 101 as
directed to an abstract idea. Final Act. 2---6.
PRINCIPLES OF LAW
An invention is patent-eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
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ideas" are not patentable. See, e.g., Alice Corp. v. CLS Bank Int'!, 573 U.S.
208,216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Mayo
and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework,
we first determine what concept the claim is "directed to." See Alice, 573
U.S. at 219 ("On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk."); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4
in petitioners' application explain the basic concept of hedging, or protecting
against risk.").
Concepts determined to be abstract ideas, and therefore patent
ineligible, include certain methods of organizing human activity, such as
fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S.
at 611); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95
(1978)); and mental processes (Gottschalkv. Benson, 409 U.S. 63, 69
(1972) ). Concepts determined to be patent eligible include physical and
chemical processes, such as "molding rubber products" (Diamond v. Diehr,
450 U.S. 175, 191 (1981)); "tanning, dyeing, making water-proof cloth,
vulcanizing India rubber, smelting ores" (id. at 184 n.7 (quoting Corning v.
Burden, 56 U.S. 252, 267---68 (1854))); and manufacturing flour (Benson,
409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that "[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
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mathematical formula." Diehr, 450 U.S. at 176; see also id. at 191 ("We
view respondents' claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula."). Having
said that, the Supreme Court also indicated that a claim "seeking patent
protection for that formula in the abstract ... is not accorded the protection
of our patent laws,[] and this principle cannot be circumvented by
attempting to limit the use of the formula to a particular technological
environment." Id. ( citing Benson and Flook), 187 ("It is now commonplace
that an application of a law of nature or mathematical formula to a known
structure or process may well be deserving of patent protection.").
If the claim is "directed to" an abstract idea, we tum to the second
step of the Alice and Mayo framework, where "we must examine the
elements of the claim to determine whether it contains an 'inventive
concept' sufficient to 'transform' the claimed abstract idea into a patent-
eligible application." Alice, 573 U.S. at 221 (quotation marks omitted). "A
claim that recites an abstract idea must include 'additional features' to
ensure 'that the [claim] is more than a drafting effort designed to
monopolize the [abstract idea]."' Id. ( quoting Mayo, 566 U.S. at 77).
"[M]erely requir[ing] generic computer implementation[] fail[ s] to transform
that abstract idea into a patent-eligible invention." Id.
The United States Patent and Trademark Office published revised
guidance on the application of 35 U.S.C. § 101. USPTO's 2019 Revised
Patent Subject Matter Eligibility Guidance ("Guidance"). 3 Under the
3 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg.
50-57 (January 7, 2019).
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Guidance, in determining what concept the claim is "directed to," we first
look to whether the claim recites:
(1) any judicial exceptions, including certain groupings
of abstract ideas (i.e., mathematical concepts, certain methods
of organizing human activity such as a fundamental economic
practice, or mental processes) (Guidance Step 2A, Prong 1);
and
(2) additional elements that integrate the judicial
exception into a practical application (see MPEP § 2106.05(a}-
(c), (e}-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look to
whether the claim contains an "'inventive concept' sufficient to 'transform"'
the claimed judicial exception into a patent-eligible application of the
judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82).
In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial
exception that are not "well-understood, routine and
conventional in the field" (see MPEP § 2106.05(d)); or
( 4) simply appends well-understood, routine,
conventional activities previously known to the industry,
specified at a high level of generality, to the judicial exception.
(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54--56.
ANALYSIS
Applying the Revised Guidance to the facts on this record, we find
that Appellants' claims 1-31 are directed to patent-ineligible subject matter.
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A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any
judicial exception to patent eligibility is recited in the claim. The Revised
Guidance identifies three judicially-excepted groupings identified by the
courts as abstract ideas: ( 1) mathematical concepts, (2) certain methods of
organizing human behavior such as fundamental economic practices, and (3)
mental processes.
The Examiner finds that the claims recite "the judicial exception that
is the abstract idea of an algorithm for predicting a dose of drug for a
patient" and are, therefore, "directed to at least one judicial exception."
Final Act. 4.
We agree with the Examiner that claim 1 recites patent-ineligible
subject matter. More specifically, claim 1, reproduced above, recites the
following steps: (1) "selecting a substance-factor group," (2)
"computationally predicting, using a processor of a computing system, a
percent area under the curve (AUC) change for the drug caused at least in
part by an interaction of the drug with one or more enzymes ... ," (3)
"comparing, using the processor of the computing system, the
computationally predicted percent AUC change with a stored percent AUC
change associated with the drug ... , " ( 4) "providing, using the processor of
the computing system, a correction factor for the one or more enzymes using
the comparison," (5) "computationally predicting, using the processor of the
computing system, a modified percent AUC change for the drug .... ," (6)
"modifying, using the processor of the computing system, a recommended
dose of the drug based on the modified percent AUC change," and (7)
"recommending, using the processor of the computing system, the modified
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dose of the drug." App. Br. 10. Under the broadest reasonable
interpretation, limitations (1) and (7) recite mental steps of selecting and
recommending, which are judgments and opinions that can be performed in
the mind. Likewise, under the broadest reasonable interpretation, limitations
(2) through (7) recite mathematical concepts.
The claimed invention is described in the Specification as a solution
to the problem of physicians having to "retain in memory knowledge
relating to potential adverse drug reactions, pharmacology, and
pharmacogenetics, or to have access to such information from published
(generally hard-copy) report- information that is not accessible from a
single source and which is increasingly complex." Spec. ,r 3.
The invention is a method of "computationally predicting a change
percent AUC for a drug based at least in part on an enzyme involved in a
metabolic pathway for the drug." Spec. ,r 7. This "computational
prediction," which is also described in the Specification as a "predictive
algorithm," may be calculated using known methods in the art. Id. at ,r,r 18,
38. In some examples, the following formulas may be used:
i\ UCt+inhibitor) 1
AlJC(controf) J;n.CYP +(l- "'.,~·,.-i)
] + [ /J / K; . .h,t 11 .
or
A lf ··" (''L rJ·J
l"\ "~" l .. i ;.,,,· -iul -. t . · ........................ = ....................... = I+ .......... .
Al T('" c·L- r:"' '~ -·· · .. .-- · ·. ··. ·. tnti fi. i
Id. at ,r,r 39, 42--43.
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The Specification also explains that a "correction factor" may be
applied to "a computationally predicted change in AUC" and that this
"correction factor may be calculated by comparing a computationally
predicted change in AUC for different substance-factor pairs or groups with
change in AUC information derived from clinical data ( e.g. clinical studies)
for the corresponding pairs or groups." Id. at ,r 16. The "correction factor
may be provided using a linear extrapolation or calculated using statistical
methods." Id. at ,r 45. The correction factor is then applied to the
computational prediction to calculate an improved percent AUC. Id. at 46.
The output of the computational prediction may be presented as a table or
graph. Id. at ,r,r 56-58. "The improved predicted AUC change may be used
to calculate the dose of and/or select an identity of a drug administered to a
patient." Id. at ,r 25.
The Federal Circuit has "recognize[d] that defining the precise
abstract idea of patent claims in many cases is far from a 'straightforward'
exercise." Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150
(Fed. Cir. 2016) (quoting DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d
1245, 1257 (Fed. Cir. 2014)). However, "we continue to 'treat[] analyzing
information by steps people [ could] go through in their minds, or by
mathematical algorithms, without more, as essentially mental processes
within the abstract-idea category."' Id. at 1146-47 (quoting Electric Power
Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016) (citations
omitted)). The Federal Circuit has recognized that "a claim for a new
abstract idea is still an abstract idea." Id. at 1151. It is well established that
mental processes are abstract ideas. CyberSource instructs that "a method
that can be performed by human thought alone is merely an abstract idea and
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is not patent-eligible under§ 101." CyberSource Corp. v. Retail Decisions,
Inc., 654 F.3d 1366, 1373, 1375 (Fed. Cir. 2011) ("That purely mental
processes can be unpatentable, even when performed by a computer, was
precisely the holding of the Supreme Court in Gottschalk v. Benson."). And,
"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).
Here, the claims recite steps for selecting and/or analyzing
information, which people could go through in their minds, or by
mathematical algorithms, which is a mental process within the abstract-idea
category. Moreover, the claims recite making computational predictions
using mathematical formulas. Accordingly, we conclude that the steps of
claim 1 recite the judicial exceptions of mathematical concepts and mental
processes.
B. Guidance Step 2A, Prong 2
Having determined that the claims are directed to a judicial exception,
the Revised Guidance directs us to next consider whether the claims
integrate the judicial exception into a practical application. Guidance Step
2A, Prong 2. "[I]ntegration into a practical application" requires that the
claim recite an additional element or a combination of elements, that when
considered individually or in combination, "apply, rely on, or use the
judicial exception in a manner that imposes a meaningful limit on the
judicial exception, such that the claim is more than a drafting effort designed
to monopolize the judicial exception." Guidance at 54.
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Here, there is no practical integration of the abstract idea. Other than
the limitations directed to the abstract idea, discussed above, the invention is
claimed at a very high level of generality and is only limited in the type of
data used in computationally predicting the AUC change or how the results
are displayed. Furthermore, the end result of the claimed method is advice,
amounting to data like the "indicates a need" language found insufficient in
Mayo, 566 U.S. at 74, 86.
Appellants argue that, like the claims in McRo, Inc. v. Bandai Namco
Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016), the present claims
"embody the automation of specific tasks that previously could only be
performed subjectively by humans." Appeal Br. 2. For example, Appellants
argue that the step of computationally predicting the AUC change
"embodies the automation of a previously subjective determination made by
doctors 'expected to retain in memory knowledge relating to potential
adverse drug reactions, pharmacology, and pharmacogenetics. '" Id. at 2
(citing Spec. ,r 3]). Appellants further argue that "the information used by
doctors to make the ultimately subjective determination according to
existing predictive approaches was 'not accessible from a single source' and
was 'increasingly complex."' Id. at 3 ( citing Spec. ,r 3).
Appellants' arguments reinforce the finding that the claims are merely
directed to the abstract ideas of mathematical concepts and mental processes.
In McRO, the Federal Circuit held claims that "set out meaningful
requirements for [a] first set of rules" by which a computer could
synchronize animated lip movements to spoken sounds, as a whole, were
directed to "a process specifically designed to achieve an improved
technological result," that result being a computer-generated animation
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having automatically synchronized mouth movements, and were not directed
to an abstract idea. McRO, 837 F.3d at 1313, 1316. The present claims do
not recite the claimed specificity of technological improvement that the
Federal Circuit found present in the invention of McRO. Also, contrary to
McRO, where the ultimate product produced was a synchronized computer
animation, the result of the presently claimed method is a recommendation
of a modified dose of a drug, which is mere advice.
We agree with the Examiner's finding that "Appellant[s] ha[ve] not
provided any evidence of a technical solution to a technical problem that
results in an improvement to technology. Rather, Appellant[ s '] arguments
rely upon gathering data from different sources and using that data in the
determination of a recommended dose that is asserted to be improved." Ans.
6. We also agree, that "Appellant[ s] ha[ ve] not provided any evidence that
the claimed invention recites technical components that provide a technical
solution to a technical problem but rather requires the carrying out of an
abstract idea on a generic computer." Id.
We find the instant claims similar to those in SmartGene, where the
Federal Circuit held that claims directed to "comparing new and stored
information and using rules to identify medical options" did not
satisfy Alice step one. See SmartGene, Inc. v. Advanced Biological Labs.,
SA, 555 F. App'x 950, 951-52, 955-56 (Fed. Cir. 2014) (nonprecedential).
As in Smartgene, the instantly claimed steps do not rely on an inventive
device or technique for displaying information or new techniques for
analyzing information, but rather constitute a generic recitation of steps for
mathematically manipulating data. See SmartGene, 555 Fed. Appx. at 954
(holding claims were patent ineligible because they did "no more than call
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on a 'computing device,' with basic functionality for comparing stored and
input data and rules, to do what doctors do routinely.").
Therefore, on this record, we conclude that the ineligible subject
matter in Appellants' claim 1 is not integrated into a practical application.
C. Guidance Step 2B
Having determined that the judicial exception is not integrated into a
practical application, the Revised Guidance requires us to evaluate the
additional elements individually and in combination to determine whether
they provide an inventive concept, such as a specific limitation beyond the
judicial exception that is not well-understood, routine, conventional in the
field, or simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of generality, to
the judicial exception. See 84 Fed. Reg. 51.
Appellants argue that the claims "amount to significantly more than
an abstract idea by reciting a combination of elements that is not
well-understood, routine or conventional. This fact is evidenced by the
absence of similar technology in the medical field." Appeal Br. 6.
Appellants assert that the steps of the claims "embody methods uniquely
adapted to utilize a variety of information sources in a comprehensive
manner that ultimately improves the accuracy of drug interaction prediction
in an automated manner not previously conceived." Id. at 8. Appellants
conclude that "the claimed technology is configured to improve drug
interaction prediction precisely at least because it combines non-generic,
unfamiliar features that equip it to accurately process data from a wide range
of diverse sources." Id.
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We are not persuaded by Appellants' arguments. There is nothing in
the Specification indicating that any steps or components recited in the
claims are not generic or conventional. The methods recited in the claims
may be implemented by "computers, servers, desktops, laptops, PDAs,
tablets, or cellular telephones" and "the arrangement of computing
components is quite flexible." Spec. ,r 26. In addition, the computational
predictions may be generated using methods described in three prior art
patents cited in the Specification. Id. at ,r 18. Appellants point to no
additional steps that could not be performed mentally or without using a
generic computer. The use of a generic computer to perform generic
computer functions that are "well-understood, routine, conventional
activit[ies]" previously known in the industry is not enough to transform the
abstract idea into a patent-eligible invention. See Alice, 573 U.S. at 225-26.
We find that Appellants' claims do not require anything other than the
use of conventional and well-understood techniques and equipment to gather
and process data according to the recited judicial exception. Accordingly,
the preponderance of evidence of record supports the 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 is affirmed. Claims
2-31 are not separately argued and fall with claim 1. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
CONCLUSION
We affirm the Examiner's rejection of claims 1-31 under 35 U.S.C.
§ 101.
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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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