Ex Parte McCulloch et al

Patent Trial and Appeal Board

Oct 31, 2018

13252069 (P.T.A.B. Oct. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/252,069 10/03/2011
6147 7590 11/02/2018
GENERAL ELECTRIC COMPANY
GPO/GLOBAL RESEARCH
901 Main Avenue
3rd Floor
Norwalk, CT 06851
FIRST NAMED INVENTOR
Colin Craig McCulloch
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.
250530-5/120718-00505 7441
EXAMINER
QIAN, CELINE X
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
11/02/2018 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):
haeckl@ge.com
gpo.mail@ge.com
Lori.e.rooney@ge.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte COLIN CRAIG McCULLOCH, CHRISTOPHER J. SEVINSKY,
and FIONA GINTY
Appeal2017-008682
Application 13/252,069 1
Technology Center 1600
Before DONALD E. ADAMS, MICHAEL J. FITZPATRICK, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of analyzing tissue features, which have been rejected as being directed to
patent ineligible subject matter, as anticipated, and for obviousness-type
double patenting. 2 We have jurisdiction under 35 U.S.C. § 6(b).
1 Appellants identify the real party in interest as the General Electric
Company. (Appeal Br. 2.)
2 We note that the subject matter of this application is similar to that of
Application 13/252,078, which is the subject of Appeal No. 2017-002258
and which Appellants note is a related appeal (Appeal Br. 2). In a decision
issued simultaneously herewith, we affirm the rejections of the claims on
appeal in Appeal No. 2017-004722, as being both directed to patent
ineligible subject matter and as being obvious. Appellants also note that
Application 13/252,072 is related. (Id.) That application was the subject of
Appeal2017-008682
Application 13/252,069
We affirm.
STATEMENT OF THE CASE
Studying tissue specimens using labelled antibodies or antibody
surrogates as biomarkers is well known, including testing "for the
"expression of numerous biomarkers." (Spec. ,r,r 3, 5.) "The techniques of
tissue treatment and examination have been refined so that the level of
expression of a given biomarker in a particular cell or even a compartment
of the given cell such as the nucleus, cytoplasm or membrane can be
quantitatively determined." (Id. ,r 4.) "Commonly the treated tissue is
examined with digital imaging and the level of different signals emanating
from different biomarkers can consequently be readily quantified." (Id.)
Appellants' Specification explains that
[ t ]he invention relates generally to analyzing and visualizing the
expression of biomarkers in individual cells, wherein the cells
are examined in situ in their tissue of origin, to identify and
understand patterns of expression that have an association with
a diagnosis, a prognosis, or a response to treatment of a
condition or a disease.
(Spec. ,r 2.)
Claims 1, 5-13, and 30 are on appeal. 3 Claim 1 is representative and
reads as follows:
1. A method of analyzing tissue features based on
multiplexed biometric image data comprising:
obtaining a tissue sample from a patient;
Appeal No. 2016-001180, in which the Board affirmed the Examiner's
rejection of the claims as being both directed to patent ineligible subject
matter and as obvious.
3 Claims 14--29 have been withdrawn from consideration. (Appeal Br. 2.)
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applying a multiplexing staining and destaining
technique to the tissue sample and generating two or more
images of the tissue sample during the multiplexing staining
and destaining, wherein the two or more images comprise
image data representative of biomarker concentration levels and
location in the tissue of a plurality of biomarkers;
registering the two or more images to generate one or
more overlay images;
quantifying the biomarker concentration levels and
location to create a cell profile;
storing the cell profile;
establishing an association of relative biomarker
concentration levels and location with at least one field of view
in which individual cells are delineated, based on subcellular
markers, and segmented into cell compartments generating cell
profile data;
calculating, from the cell profile data, at least one cell
feature based on the concentration levels of each of the plurality
of biomarkers for a respective cell, wherein the at least one cell
feature comprises a ratio based on a respective concentration
level of each biomarker between cell compartments;
calculating a first moment for each respective at least one
cell feature for each respective at least one field of view; and
examining the calculated first moments for an association
with a second data set, wherein the second data set comprises
cell profile data generated from a plurality of tissue samples
drawn from a cohort of patients having a commonality.
(Appeal Br. 10.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 5-13, and 30 under 35 U.S.C. § 101 as being directed to
non-statutory subject matter. (Ans. 5-7.)
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Claims 1, 5-13, and 30 under pre-AIA 35 U.S.C. § I02(e) as being
anticipated by Sarachan et al. 4 (Final Action 2-5.)
Claims 1, 5-13, and 30 provisionally on the ground of non-statutory
double patenting as being unpatentable over claims 1-20, 41, and 42 of
copending Application No. 13/252,078. (Final Action 6-7.)
DISCUSSION
I
Patent Ineligible Subject Matter
The Examiner finds that the following steps of claim 1 are directed to
the following abstract ideas:
creating and storing a cell profile; calculating from the cell
profile data for a cell feature and moments based on such cell
feature; examining the calculated moments from cell imaging
data for an association with a second dataset, which comprises
all profile data generated from a plurality of tissue samples
drawn from a cohort of patients having a commonality.
(Ans. 5.) The Examiner explains that these steps are deemed abstract
because they are directed to "data storage, data processing based on
mathematical calculation, and comparing information regarding a sample to
a control." (Id. at 6).
The Examiner then determines that the following claim limitations are
not abstract: obtaining a tissue sample; applying a multiplexing staining and
destaining technique to the tissue sample and generating two or more images
of the tissue sample during the multiplexing staining and destaining. (Id.)
The Examiner explains, however, that "[ t ]hese steps are performed for the
4 Sarachan et al., US 2011/0091081 Al, published Apr. 21, 2011.
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purpose of gathering image data so that it may be processed to determine
whether there is an association between said data and a known set of cell
profile data." (Id.) With respect to those steps, the Examiner notes that they
"consist of well understood, routine and conventional activity already
engaged [in] by the scientific community." (Id.) The Examiner further
explains that these additional steps when considered, as a whole, "add
nothing significant beyond the sum of their parts taken separately." (Id.)
The Examiner concludes that, in light of the foregoing, the claim is not
significantly different than the abstract idea and, thus, is patent ineligible
under 35 U.S.C. § 101. (Id.)
Appellants contend that claim 1 is not abstract because it improves an
existing technological process just as was the case with the claims in McRO
Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299 (Fed. Cir. 2016).
(Reply Br. 4--5.) In particular, Appellants assert that the prior art is
improved "by replacing the subjective judgment of a human with the
objective judgment of algorithm going through a different process than the
human would." (Id. at 5.) Appellants explain that in the prior art:
the user did not have a rigorous approach for selecting the
appropriate number of groups. See [Spec. ,r 15.] Users may
inadvertently group cells with important distinctive
characteristics being grouped together. See id. As a result, the
process was less accurate and "difficult for a medical
practitioner to understand." See id, [,I 16].
(Id.) Appellants then explain that by calculating first moments "for an
association with a second data set . . . [that] comprises cell profile data
generated from a plurality of tissue samples drawn from a cohort of patients
having a commonality," "improve[s the] predictive properties for patient
survival." (Id.)
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We do not find Appellants' argument persuasive and agree with the
Examiner's findings and conclusions that claim 1 is patent ineligible under
35 U.S.C. § 101.
Section 101 provides that "[ w ]hoever invents or discovers any new
and useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent therefor." 35
U.S.C. § 101. In Alice, the Supreme Court articulated a two-step test for
examining patent eligibility under § 101. Alice Corp. Pty. Ltd. v. CLS Bank
Intern 'l, 134 S. Ct. 2347 (2014). Step one involves determining whether the
claims at issue are directed to a patent ineligible concept, and step two,
reached only if the determination in step one is yes, considers the elements
of each claim both individually and "as an ordered combination" to
determine whether additional elements "transform the nature of the claim"
into a patent eligible application. Id. at 2355 (internal quotation marks and
citation omitted).
Regarding Appellants' reliance on McRO, we note that the claims in
that case "were directed to the creation of something physical-namely, the
display of 'lip synchronization and facial expressions' of animated
characters on screens for viewing by human eyes. [McRO, 837 F.3d] at
1313. The claimed improvement was to how the physical display operated
(to produce better quality images)." SAP Am., Inc. v. Investpic, LLC, 898
F.3d 1161, 1167 (Fed. Cir. 2018); see also Affinity Labs of Tex., LLC v.
DirectTV, LLC, 838 F.3d 1253, 1262 (Fed. Cir. 2016) (noting that the claims
in McRO were held patent-eligible because they made "a specific asserted
improvement in computer animation"). Here, on the other hand, as
Appellants explain, the improvement is not to something physical or an
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improvement in computer technology, but to the "predictive properties for
patient survival" that is achieved by a mathematical technique. (Reply Br.
5.) We find that the claims here are much more similar to those in SAP than
those in McRO, which were found to be patent ineligible.
One of the claims at issue in SAP was as follows:
11. A method for providing statistical analysis of investment
data over an information network, comprising the steps of:
(a) storing investment data pertaining to at least one investment;
(b) receiving a statistical analysis request corresponding to a
selected investment;
( c) receiving a bias parameter, wherein the bias parameter
determines a degree of randomness in a resampling process; and,
( d) based upon investment data pertaining to the selected
investment, performing a resampled statistical analysis to
generate a resampled distribution.
898 F.3d at 1165. The SAP court explained that "[t]he focus of the claims, .
. . [including claim 11 recited above,] ... is on selecting certain information,
analyzing it using mathematical techniques, and reporting or displaying the
results of the analysis." Id. at 1167. The Court explained that under the
principles set forth in prior cases, claims such as these are directed at
unpatentable abstract ideas. In particular, the Court stated:
We have explained that claims focused on "collecting
information, analyzing it, and displaying certain results of the
collection and analysis" are directed to an abstract idea.
Electric Power[Group, LLC v. Alstom S.A.], 830 F .3d ...
[1350,] 1353 [(Fed. Cir. 2016)]. "Information as such is an
intangible," hence abstract, and "collecting information,
including when limited to particular content ( which does not
change its character as information), [i]s within the realm of
abstract ideas." Id. ( citing cases). So, too, is "analyzing
information ... by mathematical algorithms, without more."
Id. at 1354 (citing cases, including Parker v. Flook, 437 U.S.
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584 ... (1978), and Gottschalkv. Benson, 409 U.S. 63 ...
(1972)). And "merely presenting the results of abstract
processes of collecting and analyzing information, without
more (such as identifying a particular tool for presentation), is
abstract as an ancillary part of such collection and analysis." Id.
( citing cases).
SAP, 898 F.3d at 1167. The SAP court explained that "[t]he claims in McRO
thus were not abstract in the sense that is dispositive here." Id. "Here, in
contrast [to McRO], the focus of the claims is not a physical-realm
improvement but an improvement in wholly abstract ideas-the selection
and mathematical analysis of information, followed by reporting or display
of the results." Id. at 1168. Here, as in SAP, the focus of claim 1 is not a
physical-realm improvement, but an improvement in wholly abstract ideas-
the selection and mathematical analysis of information. Thus, as in SAP,
under Alice step-one, we conclude that present claim 1 is directed at an
abstract idea.
Turning to Alice step-two, Appellants argue that "the claims
specifically recite steps that are different from, further limit, and improve
upon, well-understood, routin[ e ], and conventional activities," and, thus, the
claims recite "'significantly more' than an abstract idea." (Reply Br. 7 .)
Appellants appear to rely on the arguments it makes as to why Sarachan
does not anticipate claim 1. (Id.) However, we do not find that lack of
anticipation establishes that claim 1 is directed to something significantly
more than an abstract idea. See, e.g., SAP, 898 F.3d at 1162 (citing
Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir.
2016) ("[A] claim for a new abstract idea is still an abstract idea. The search
for a § 101 inventive concept is thus distinct from demonstrating § 102
novelty."). "The 'novelty' of any element or steps in a process, or even of
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the process itself, is of no relevance in determining whether the subject
matter of a claim falls within the § 101 categories of possibly patentable
subject matter." Diamond v. Diehr, 450 U.S. 175, 188-89 (1981) (emphasis
added). There can be no dispute that claim 1 uses a generic computer to
perform generic computer functions: calculating and comparing data.
According to Appellants, "Sarachan does not disclose using any
calculated moments [ of the determined ratios] to examine any associations
with another data set." (Appeal Br. 7.) However, that step is simply a
mathematical calculation, which is an abstract idea. An innovation that
consists of using particular ineligible subject matter is insufficient to
establish that the claims at issue are directed to a patent-eligible application
of an abstract idea. SAP, 898 F.3d at 1162 ("an advance ... [that] lies
entirely in the realm of abstract ideas, with no plausibly alleged innovation
in the non-abstract application realm ... is ineligible for patenting"); see
also Synopsys, 839 F.3d at 1152
(To the extent the Asserted Claims add anything to the abstract
idea (i.e., translating a functional description of a logic circuit
into a hardware component description of the logic circuit), it is
the use of assignment conditions as an intermediate step in the
translation process .... But, given that the claims are for a
mental process, assignment conditions, which merely aid in
mental translation as opposed to computer efficacy, are not an
inventive concept that takes the Asserted Claims beyond their
abstract idea.).
Appellants further argue that claim 1 prevents preemption because it
recites "specific characteristics of one of multiple possible approaches to
biological data analysis." (Reply Br. 6, 8.) This argument is not found
persuasive either because "the absence of complete preemption does not
demonstrate patent eligibility." Ariosa Diagnostics, Inc. v. Sequenom, Inc.,
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788 F.3d 1371, 1379 (Fed. Cir. 2015). Where a patent's claims are deemed
only to disclose patent ineligible subject matter under the two-step
framework, as they are in this case, preemption concerns are fully addressed
and made moot. Id.; see also Intellectual Ventures I LLC v. Symantec Corp.,
838 F.3d 1307, 1321 (Fed. Cir. 2016) ("A narrow claim directed to an
abstract idea, however, is not necessarily patent-eligible .... "); OIP Techs.,
Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362-63 (Fed. Cir. 2015) ("[T]hat
the claims do not preempt all ... [inventions in the field] or may be limited
to [ certain processes in the field] do[ es] not make them any less abstract.").
Finally, Appellants argue that because claim 1 "is tied to a particular
machine or apparatus" that "points to patent eligibility." (Reply Br. 8.) This
argument is not persuasive because the machine that stores data and
performs the analytical processing is a general purpose computer, and the
use of such a generic computer element does not transform an otherwise
abstract idea into patent-eligible subject matter. See, e.g., Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 US 66, 84--85 (2012)
("[S]imply implementing a mathematical principle on a physical machine,
namely a computer, ... [i]s not a patentable application of that principle.")
(describing Gottschalk, 409 U.S. at 64); DDR Holdings, LLC v. Hotels.com,
L.P., 773 F.3d 1245, 1256 (Fed. Cir. 2014) ("[A]fter Alice, there can remain
no doubt: recitation of generic computer limitations does not make an
otherwise ineligible claim patent-eligible .... The bare fact that a computer
exists in the physical rather than purely conceptual realm is beside the
point.") (Internal quotation marks and citation omitted.) Furthermore, as
the Specification indicates, machines for obtaining a tissue sample; applying
a multiplexing staining and destaining technique to the tissue sample and
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generating two or more images of the tissue sample during the multiplexing
staining and destaining were known at the time of filing. (See, e.g., Spec. ,r,r
3-14.) Appellants do not assert that the machines used to gather the images
for the data analysis are new or non-obvious. Thus, these limitations do not
imbue the claim with an inventive concept. Accord Berkheimer v. HP Inc.,
881 F.3d 1360, 1370 (Fed. Cir. 2018) (holding claims lacked an inventive
concept because they "amount to no more than performing the abstract idea
of parsing and comparing data with conventional computer components");
Affinity Labs, 838 F.3d at 1262 (holding a claim lacked an inventive concept
because it "simply recites the use of generic features ... as well as routine
functions ... to implement the underlying idea").
Consequently, for all of the reasons discussed above, we sustain the
Examiner's rejection of claim 1 under 35 U.S.C. § 101 as being directed to
non-statutory subject matter.
Claims 5-13, and 3 0 have not been argued separately and, therefore,
fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
II
Anticipation
The Examiner finds that Sarachan discloses a method
that involves capturing data on the expression of biomarkers
within the compartments of individual cells located within their
tissue of origin, preserving this data on a cell by cell basis,
analyzing this data to reveal pattern of expression, creating
subsets of cells based on these patterns, visualizing the
occurrence of these subsets on images of the tissues of origin
and analyzing the occurrence of certain biomarkers in the
subsets of cells for association to the diagnoses or prognoses of
a condition or disease or to the response of treatment.
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(Final Action 3.) The Examiner finds that Sarachan's method of analyzing
the data involves "quantifying the biomarker concentration levels and
location of said biomarkers to create a cell profile" and "calculating at least
one cell feature based on the cell's expression of each of the plurality of
biomarkers ([0037]-[0038]); calculating a first moment for each of the at
least one cell feature for each of the at least one field view; and examining
the calculated first moments for an association with second data set." (Id. at
3--4.) The Examiner contends that a second data set can be "of any sort,
possibly an expression level of a biomarker" and that in carrying out the
process described in Sarachan a person of "ordinary ... [ skill] in the art
would look at the data including the calculated moment and a second data
set ... and think about whether there is any type of association." (Ans. 8-
9.) The Examiner notes that "[ w ]hile grouping cells for having similar
profiles, one would examine the calculated data and decide, either in one's
mind or by running an algorithm, if there is an association between the data
such that the cells may be grouped." (Id. at 9.)
Appellants contend that while Sarachan discloses determining ratios,
it does not disclose "determining first moments of the ratios" and then using
the first moment to find an association with a second data set step required
by the claims. (Appeal Br. 6-7.) Instead, Appellants explain, Sarachan uses
the ratio to group cells, and after having been grouped "a mean value of the
attribute in the group may be determined." (Id.)
We agree with Appellants that Sarachan does not disclose examining
the calculated first moments of ratios for an association with a second data
set. Sarachan's general disclosure of creation of a database describes first
moments may be calculated for biomarker measures obtained, i.e., "[t ]he
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data for a given biomarker across all the cells examined may not follow a
distribution which readily lends itself to standard statistical treatment."
(Sarachan ,r 41.) Thus, the data set may be transformed using first moment
determination. (Id.) Sarachan explains that the transformed "database may
now be interrogated for groups of cells that have similar profiles of
biomarker expression." (Id.) Sarachan notes that the cells can be grouped
using the first moment data and a ratio between the expression level of two
biomarkers but does not describe obtaining a first moment of the ratio.
(Sarachan ,r 43.) Example 1 of Sarachan describes a specific embodiment of
data assessment in which intensity values were first standardized and then
groups were created by using ratios. (Sarachan ,r,r 59---63.) The ratios were
then analyzed for an association with cells from controls or treated samples.
(Sarachan ,r 64.) We do not find any express disclosure in Sarachan
examining the calculated first moments of ratios for an association with a
second data set. Nor do we find that Sarachan's disclosure necessarily and
inevitably discloses such an examination as required to establish an inherent
disclosure. In re Oelrich, 666 F.2d 578,581 (CCPA 1981) ("Inherency,
however, may not be established by probabilities or possibilities. The mere
fact that a certain thing may result from a given set of circumstances is not
sufficient.") (Internal citation omitted. )5
For the reasons discussed, we do not sustain the Examiner's rejection
of claim 1 as being anticipated by Sarachan. Because claims 5-13 and 30
5 We do not determine, here, whether such an analysis of the data would
have been obvious from the disclosure of Sarachan, because that is not the
rejection made by the Examiner.
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ultimately depend from claim 1, we also do not sustain the Examiner's
rejection of these claims as being anticipated by Sarachan.
III
Obviousness-Type Double Patenting
Appellants have not substantively argued the propriety of the non-
statutory double patenting rejection made by the Examiner. (See Appeal Br.
4.) Consequently, we summarily affirm the Examiner's non-statutory
double patenting rejection.
SUMMARY
We affirm the rejection of claims 1, 5-13, and 30 under
35 U.S.C. § 101 as being directed to non-statutory subject matter.
We reverse the rejection of claims 1, 5-13, and 30 under pre-AIA
35 U.S.C. § 102(e) as being anticipated by Sarachan et al.
We affirm the rejection of claims 1, 5-13, and 30 provisionally on the
ground of non-statutory double patenting as being unpatentable over claims
1-20, 41, and 42 of copending Application No. 13/252,078.
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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