Ex Parte Donovan et al

Patent Trial and Appeal Board

Mar 1, 2019

12821664 (P.T.A.B. Mar. 1, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
12/821,664
76808 7590
Leason Ellis LLP
One Barker A venue
Fifth Floor
FILING DATE
06/23/2010
03/05/2019
White Plains, NY 10601-1526
FIRST NAMED INVENTOR
Michael Donovan
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.
10043/002881-USO 4357
EXAMINER
GODDARD, LAURA B
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
03/05/2019 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):
uspto@leasonellis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL DONOVAN, DOUG POWELL, and FAISAL KHAN
Appeal2017-005993
Application 12/821,664
Technology Center 1600
Before RICHARD M. LEBOVITZ, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134 involving
claims to methods of administering a course of treatment to a subject with a
cancer type. The Examiner rejected the claims as anticipated and for lack of
eligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the Real Party in Interest as the Funda9ao D. Anna
Sommer Champalimaud E Dr. Carlos Montez Champalimaud. App. Br. 3.
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Application 12/821,664
STATEMENT OF THE CASE
According to the Specification, "[i]n the U.S. - 211,000 women [are]
diagnosed with Breast cancer each year of which 42,000 over-express
HER2." Spec. 2:26-27. Moreover, "less than 35% of these HER2 over-
expressors respond to trastuzumab (Herceptin) therapy and of the initial
responders, 25% of metastatic breast cancer patients develop resistance to
trastuzumab." Id. at 2:27-29. The Specification, thus, states that "a need
exists to better predict the response to therapy." Id. at 2:29-30.
Appellants' "invention relates to the identification of biomarkers
associated with breast cancer," and more specifically, "the invention
provides a multiplex immunofluorescent quantitative assay for Her-2 in
formalin fixed paraffin embedded breast tumor samples." Id. at 5: 16-17.
As the Specification explains, the "invention further provides systems and
apparatuses that use clinical information, molecular information and
computer-generated morphometric information in a predictive model for
predicting the occurrence, response to treatment, or survivability of a subject
with breast cancer." Id. at 5:20-23. Further, the "systems methodology
represents an integrative platform which relies on principles of machine
learning to combine clinical data, with quantitative biomarker
characteristics." Id. at 5:24--26; see id. at 5:29-31 ("Mathematical models
are incorporated to threshold and then normalize individual and multiple
(bio) markers in a given tissue section which allows for an accurate
assessment of any given marker across multiple patient samples.").
Claims 39, 40, 42--44, 46--49, 51-54, 57-59, 65 and 66 are on appeal.
Independent claim 65 is illustrative and is reproduced below:
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65. A method for administering a course of treatment to a
subject with a cancer type comprising the steps of:
A. measuring, using an immunofluorescence imaging
device having a connection to a computing device configured to
execute code in a processor, at least a plurality of protein
expression levels of the subject by contacting a formalin fixed
paraffin embedded tissue sample of the subject to antibodies of
Her2, Her2-ECD, cytokeratin and p95HER2;
B. capturing an image of the tissue sample with the
immunofluorescence imaging device and analyzing the image
with an image analysis device to determine plurality of protein
expression levels present in the sample;
C. automatically storing the plurality of protein expression
levels measured by the image analysis device in a subject dataset
in a memory of the computing device wherein the subject dataset
includes clinical and biographic data relating to the subject;
D. calculating, using the computing device, a protein
expression level of p95HER2 for the subject according to a
function (1 );
i. where function (1) = p95HER2= (Her2 + pHer2)
- Her2-ECD·
' E. providing a machine learning application with a
population dataset from a data storage device, wherein the
machine learning application is configured to generate an
effective treatment model using a linear discriminant analysis on
the population dataset, wherein the population dataset includes
data relating to each member of the population obtained at least
two different points in time, wherein each member is diagnosed
with the same cancer type and similar clinical features as the
subject and the data obtained at the at least two different points
in time relating to each member includes:
i. at least one data value corresponding to treatment
resistance status, []
ii. at least one data value corresponding to treatment
status;
iii. at least one data value corresponding to the
health outcome,
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iv. and the protein express10n levels for each
individual as obtained by:
1. contacting a formalin fixed paraffin-
embedded tissue sample of each
member of the population with
antibodies to Her2, Her2-ECD,
cytokeratin, p95HER2 and p95HER2
for each member of the population
dataset, and
2. deriving the protein expression level of
p95HER2 of each member of the
population dataset according to
function (1 );
F. evaluating the subject dataset with the effective
treatment model, wherein the evaluation yields a value related to
a probability that the subject will have a resistance to at least one
treatment for the cancer type;
G. generating, using a treatment module configured as
instructions for the computer, a output data object that includes
at least information indicating a course of treatment for the
subject that does not include any treatment where the probability
that the subject will have resistance is above a given threshold.
App. Br. 22-23 (Claims App'x).
The claims stand rejected as follows:
I. Claims 39, 40, 42--44, 46--49, 51-54, 57-59, 65 and 66 under
35 U.S.C. § 101 for lack of patent eligible subject matter.
II. Claims 39, 40, 42--44, 46--49, 51-54, 57-59, 65 and 66 under
35 U.S.C. § 102(e) as anticipated by Singh. 2
2 Singh et al., US 8,163,499 B2, issued Apr. 24, 2012.
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I. SUBJECT MATTER ELIGIBILITY
1. Supreme Court Eligibility Framework
An invention is patent-eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.
Nevertheless, the Supreme Court has interpreted § 101 to include certain
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
ideas" are not patentable. Alice Corp. v. CLS Bank Int 'l, 573 U.S. 208, 216
(2014). 3
The Supreme Court has further established a two-step framework,
described in Mayo and Alice for assessing whether a claim falls within one
of those excepted, patent-ineligible, categories. Id. at 217-218 (citing Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)).
Under that framework, the Supreme Court explains, first "we determine
whether the claims at issue are directed to one of those patent-ineligible
concepts." Id. "If so, we then ask, '[w]hat else is there in the claims before
us?"' Id. (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566
U.S. 66, 78 (2012)). In answering this second question, the Court explains,
we consider the elements of each claim both individually and as
an ordered combination to determine whether the additional
elements transform the nature of the claim into a patent-eligible
application. . . . We have described step two of this analysis as a
3 For instance, concepts determined to be abstract ideas, and thus patent
ineligible, include certain methods of organizing human activity, such as
fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski v.
Kappas, 561 U.S. 593, 611 (2010)); mathematical formulas (Parker v.
Flook, 437 U.S. 584, 594--95 (1978)); and mental processes (Gottschalk v.
Benson, 409 U.S. 63, 69 (1972)).
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search for an inventive concept-i.e., an element or combination
of elements that is sufficient to ensure that the patent in practice
amounts to significantly more than a patent upon the [ineligible
concept] itself.
Id. (internal citations and quotation marks omitted).
2. Subject Matter Eligibility Guidance
The Patent Office recently published revised guidance on the
application of§ 101 in proceedings taking place before the Office. 2019
Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 51 (Jan. 7,
2019) (hereafter "Revised Guidance"). Under that guidance, we first look to
whether the claim recites:
(1) Step 2A - Prong One: 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); and
(2) Step 2A-Prong Two: additional elements that integrate the
judicial exception into a practical application (see MPEP4
§ 2106.05(a}-(c), (e}-(h)). 5
4 All Manual of Patent Examining Procedure (MPEP) citations herein are to
MPEP Rev. 08.2017, January 2018.
5 We acknowledge that some of the considerations at Step 2A, Prong Two,
properly may be evaluated under Step 2 of Alice (Step 2B of the Office
guidance). For purposes of maintaining consistent treatment within the
Office, we evaluate them under Step 1 of Alice (Step 2A of the Office
guidance). See 2019 Revised Patent Subject Matter Eligibility Guidance, 84
Fed. Reg. at 55 n. 25, 27-32. "As before, Step 1 of the USPTO's eligibility
analysis entails considering whether the claimed subject matter falls within
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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:
(3) adds a specific limitation beyond the judicial exception that is not
"well-understood, routine, 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.
See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg.
at 56 ("Step 2B: If the Claim Is Directed to a Judicial Exception, Evaluate
Whether the Claim Provides an Inventive Concept").
3. Examiner's §101 Rejection-Alice/Mayo Steps 1 and 2
a. Guidance Step 2A - Prong One
Although the Examiner does not, in the rejection on appeal, delineate
between the different steps in the eligibility analysis ( either under the
Alice/Mayo framework or the then-existing Office guidance), 6 the Examiner
concludes that all of the pending claims "are drawn to detecting the judicial
exception of naturally occurring levels ofHER2, HER2-ECD, cytokeratin,
phosphorylated HER2 (pHER2), and p95HER2 in cancer and a prognosis."
Final Act. 2. Accordingly, we understand the Examiner to have rejected the
the four statutory categories [e.g., process, machine, etc.]" and the Revised
Guidance "does not change Step 1 ... analysis." Id. at 53-54.
6 The 2019 Revised Patent Subject Matter Eligibility Guidance, discussed
above, was not published and available to the Examiner at the time the
particular § 101 rejection on appeal was made final (Dec. 10, 2015).
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Application 12/821,664
claims, at least partly, for being directed to a natural phenomenon or law of
nature. Considering the Examiner's conclusion in view of the Office's
recent guidance (Step 2A, Prong 1 ), we note claim 65 's recitation of "protein
expression levels of ... Her2, Her2-ECD, cytokeratin and p95HER2" in a
subject's tissue sample. See claim 65 (portion of step (A), and portion of
step (E)(iv )( 1) regarding protein expression levels in samples from
population members). 7
The Examiner further asserts that the "steps of storing numerical
values in a computer dataset, mathematical manipulation and evaluation of
data, and generating treatment modules are considered a law of nature in the
form of a mathematical algorithm or an abstract idea." Id. at 3--4; see also
id. at 5---6 ("mathematical manipulation of protein expression data to develop
a treatment module for patients, however the manipulation of data to
produce theoretical treatment modules is an abstract idea"). Hence, viewing
the Examiner's assertions through the lens of the Office's recent guidance,
the Examiner appears to further find that some of the claimed steps include
abstract ideas for reciting mathematical concepts or relationships related to
expression levels of certain protein biomarkers.
7 Claim 65 may include a drafting error insofar as it appears to indicate that
the expression levels of p95HER2 is measured ( e.g., through fluorescent
imaging), yet other elements of claim 65 indicate that the expression level of
p95HER2 is separately calculated or derived with a computing application
performing function (1 ). See claim 65, steps (D) and (E)(iv)(2); see Reply
Br. 3--4 ( arguing that p95HER2 is derived from other measured protein
values, thus eliminating the need to directly measure p95HER2 expression
levels).
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We find that some elements of the claims recite at least some
judicially excepted subject matter. As noted above, the claims do recite
measuring "expression levels" of naturally occurring proteins ( e.g., "Her2,
Her2-ECD, cytokeratin," etc.), which may be overexpressed in subjects with
cancer. See, e.g., claim 65; Spec. 1:13-14 ("HER2 is a member of the
epidermal growth factor receptor family and is amplified/ over-expressed in
approximately 15-20% of breast cancers."). Thus, such step is simply
identifying the naturally occurring relationship between expression levels
and a disease or non-diseased state.
Moreover, as the Examiner suggests, some of the claim limitations
recite or rely upon mathematical relationships. For example, claim 65
recites calculating a subject's protein expression level of p95HER2
according to the function: p95HER2 = (Her2 + pHer2)-Her2-ECD. See
claim 65 (step (D)(i)); see also claim 65 (step (E) (reciting, inter alia,
generating a model "using linear discriminant analysis").
b. Guidance Step 2A - Prong Two
Under Prong 2, the Patent Office "evaluate[ s] whether the claim as a
whole integrates the recited judicial exception into a practical application of
the exception." See Revised Guidance 54. As the Revised Guidance further
explains, "[a] claim that integrates a judicial exception into a practical
application will apply, rely on, or use the judicial exception in a manner that
imposes a meaningful limit on the judicial exception." Id. Such practical
application may be evidenced, for example, by "an additional element [that]
implements a judicial exception with, or uses a judicial exception in
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conjunction with, a particular machine or manufacture that is integral to the
claim." Id. at 5 5.
Beyond the limitations that the Examiner indicates include patent
ineligible natural laws and abstract ideas, the Examiner determines that some
of the other claimed steps recite only "routine laboratory procedures," such
as antibody assays. Final Act 3. Such "[r]outine data gathering," the
Examiner asserts, does not add any "meaningful limitation" to the claims.
Final Act. 3. Other claim elements, the Examiner asserts are known. Id.
( citing "known and conventional treatments for breast cancer including
trastuzumab"); see also, e.g., claim 47 (reciting administration of
immunotherapy, including trastuzumab or bevacizumab ). 8
Appellants argue that the claims are not merely directed to naturally-
occurring expression levels ofHer2, Her2-ECD, pHER2, and cytokeratin.
App. Br. 6. To the contrary, Appellants contend, "[t]he claims include
specific hardware and structural limitations," such as "an imaging device
and an immunofluorescence biomarker assay," which "render the subject
matter as directed to more than just a natural correlation." Id. at 7.
According to Appellants, the claims require "a collection of analytic tools
8 The Examiner, in the Final Rejection on appeal as well as in the Answer,
does not provide separate § 101 analysis for the dependent claims ( or any
separate response to Appellants' arguments identifying certain limitations in
the dependent claims that Appellants contend confer eligibility to those
claims). See, e.g., App. Br. 7, 9 (regarding "morphometric data acquisition
tools" and "use of morphometric imaging devices," as allegedly required for
dependent claim 43).
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specifically arranged and ordered to make practical use of measured
biomarker data." Id.
Moreover, Appellants argue, the claims require, inter alia, a "machine
learning application" that "evaluate[ s] the effects that the presence of
multiple biomarkers within a population have on that population's resistance
to specific cancer treatments, using linear discriminant analysis on the
population data to generate statistical models." Id. at 9; 9 see claim 65 ("the
machine learning application is configured to generate an effective treatment
model using linear discriminant analysis ... "). Then, Appellants contend, a
machine learning application "evaluates the subject data [ with the effective
treatment model] and makes a determination that a subject with a cancer
type, compared to previous subjects with the same cancer type, will derive a
clinical benefit from a selected treatment." Id. ("treatment is determined that
has a high probability of effectiveness [i.e., excludes treatments where
probability of resistance is above a given threshold]"); see claim 65.
Although such steps may involve computer functionalities, Appellants
contend, that does not doom the claims to abstraction ( citing Enfzsh, LLC v.
Microsoft Corp., 822 F.3d 1327, 1338 (Fed. Cir. 2016) ("[W]e are not
persuaded that the invention's ability to run on a general-purpose computer
dooms the claims.").
9 Although Appellants make some of these arguments in the context of
whether the claims recite "significantly more" than the ineligible subject
matter (i.e., Alice, Step 2; Revised Guidance Step 2B), Appellants'
arguments are also germane to Alice Step 1 and the Revised Guidance's
"integrated into a practical application" inquiry.
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The Examiner responds that the claimed method fails to recite a
practical application of a law of nature or natural phenomenon. Ans. 8-9.
The Examiner asserts that the mathematically manipulated expression data
that is processed is never applied to perform a physical step. Id. Moreover,
the Examiner asserts, the complexity of the computer algorithm (i.e.,
analysis of multiplexed protein expression values) "does not render the
manipulation of data on a computer any less abstract." Id. at 9-10 ("the
instant claims do not confine an abstract idea to a useful application because
the claims do not recite administration of any specific cancer treatment
based on any specific threshold biomarker value").
Having considered the Examiner's rejection and Appellants'
arguments in response, we conclude the claims are patent eligible because
they include additional elements sufficient to integrate the judicial exception
into a practical application.
As Appellants point out, claim 65 requires hardware and computing
features that interoperate in specific ways to carry out the claimed method.
Claim 65 requires "an immunofluorescence imaging device," and further
specifies that this imaging device is connected to a "computing device."
Claim 65 further requires an "image analysis device" that determines
expression levels in the captured sample images. Even accepting arguendo
that certain limitations such as "immunofluorescence" or antibody assays are
routine or conventional ( an inquiry generally addressed under Step 2B of the
Revised Guidance), or merely "data gathering" as the Examiner asserts,
claim 65 requires more than that.
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Claim 65 requires the computing device and a machine learning
application that are also configured to carry out specific operations in
furtherance of generating an effective course of treatment for the subject
with cancer. Those operations include, inter alia, calculating p95HER2
expression levels with the computer according to a particular function. The
machine learning application, on the other hand, is configured to generate an
effective treatment model using population data according to a specific
statistical functionality (linear discriminant analysis) and relying on
particular inputs ( e.g., data for each member of the population taken at two
different times, data values corresponding to treatment resistance and health
outcomes, and both measured and derived protein expression levels for a
plurality of biomarkers ). Hence, as with the incorporation of particular
"rules" in the claims of McRO, we find that the specific operations and
inputs employed by the recited machine learning application in generating
an effective treatment model impose meaningful limits to the claims beyond
any judicial exception. McRo, Inc. v. Bandai Namco Games America Inc.,
837 F.3d 1299, 1315 (Fed. Cir. 2016). 1° Further, upon evaluation of the
10 In McRO, the court further observed that "[t]here has been no showing
that any rules-based lip synchronization process must use rules with the
specifically claimed characteristics." McRo, 837 F.3d at 1315. As
discussed, infra, concerning the rejection under§ 102, the Examiner did not
show on this record that generating treatment models with a machine
learning application was known or conventional, nor that such a method
would require the particular operations and inputs as claimed by Appellants
here. To the extent certain inputs and operations may be characterized as
broad, the Federal Circuit has noted that § 101 does not render claims
reciting a "genus" of rules unpatentable. Id. at 1313 (indicating that breadth
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measured and calculated subject dataset in relation to the effective treatment
model generated by the machine learning application, the computing device
includes programming (i.e., instructions) in the form of a treatment module
to generate a course of treatment for the cancer subject----excluding
ineffective treatments where resistance is probable. 11 The Examiner
provides no support or authority for the notion that a "physical step," outside
the aforementioned hardware and specific computer operations/steps must
be made in order to demonstrate a sufficient practical application of the
invention claimed.
To be sure, some of the features recited in the claims invoke
mathematics or require computer operations that might be characterized as
abstract. That a claim may rely on or recite such patent-ineligible features
is, however, unsurprising. Indeed, the Supreme Court has long recognized
that all inventions, at some level, embody or apply laws of nature, natural
phenomena, and abstract ideas and, thus, we must "tread carefully in
of claim scope under such circumstances is principally addressed under
§ 112).
11 Insofar as the Examiner suggests that the claims could be made more
specific by identifying particular treatments and threshold values, the
Examiner is correct. Ans. 9. For example, claim 65 might (as in some of
the dependent claims) recite that the cancer type is breast cancer and that the
therapy is administration of immunotherapy including trastuzumab and
bevacizumab. See, e.g., dependent claims 46, 4 7, and 54. Reciting, in the
claims, more specific disease conditions and administration of specific
agents may be a further indication of a practical application. See, e.g.,
Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117,
1134 (Fed. Cir. 2018) ( claims reciting administration of the drug iloperidine
to the schizophrenic patient based on analysis of the patient's genotype).
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construing this exclusionary principle lest it swallow all of patent law."
Alice, 134 S. Ct. at 2354. To that end, as part of the analysis, we must
neither overgeneralize the claim nor overemphasize limitations that might
recite a natural law or an abstract idea dissected from the whole. Id.; Thales
Visionix Inc. v. US., 850 F.3d 1343, 1347 (Fed. Cir. 2017) ("[We] ensure at
step one that we articulate what the claims are directed to with enough
specificity to ensure the step one inquiry is meaningful"). We consider the
claim elements individually and as a whole. And, when we consider claim
65 as a whole, including the series of orchestrated steps requiring specific
interoperation of hardware and specially configured computing modules that
generate effective treatment models and courses of treatment for cancer, we
find, contrary to the Examiner's conclusion, that the alleged ineligible
subject matter is integrated into a practical application.
Having reached the decision above, we need not analyze claim 65
under Step 2B of the Revised Guidance or Step 2 of Alice. See Revised
Guidance 51; Thales, 850 F.3d at 1349 ("Because we find the claims are not
directed to an abstract idea, we need not proceed to step two").
For the above reasons, we conclude that claim 65 (and dependent
claims 39, 40, 42--44, 46--49, and 51-54) are not patent-ineligible under 35
U.S.C. § 101. We reach the same conclusion for claim 66 (and dependent
claims 57-59), for similar reasons. Although claim 66 does not recite
certain elements in claim 65 ( e.g., "an immunofluorescence imaging
device"), claim 66 includes other limitations that are more specific
implementations than in claim 65 ( e.g., Step (E) evaluating the subject
dataset with the effective treatment model by identifying a hyperplane that
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separates first and second classes of disease resistance). Moreover, as noted
above, the Examiner provided no separate analysis under § 101 for any of
the pending claims. See supra n.9.
II - ANTICIPATION
The Examiner also rejected claims 39, 40, 42--44, 46--49, 51-54, 57-
59, 65 and 66 as anticipated by Singh. Final Act. 7-9; Ans. 5-6. According
to the Examiner, Singh teaches methods of screening breast cancer patient
samples for expression levels and activation states of tumor proteins in the
HER2 pathway. Ans. 4. Further, the Examiner finds, Singh teaches creating
expression profiles for selection of appropriate therapy, such as trastuzumab
therapy. Id. at 4--5. According to the Examiner, Singh teaches the measured
proteins may include HER2, phosphorylated HER2, p95HER2, and
cytokeratins, and that detection can occur using immunofluorescence. Id. at
5. Moreover, the Examiner finds, Singh teaches expression profiles that
correspond to treatment outcomes "can be stored in a computer database."
Id. at 4--5.
Regarding "steps C-G of claim 65 and steps B-F of claim 66," the
Examiner asserts that such steps "are a mathematical manipulation of data
and abstract idea where no physical steps occur, no material/structural
limitations are recited, [ and] therefore do not distinguish the instantly
claimed method from that taught by the prior art." Id. at 5---6.
On the record before us, we are unpersuaded that the Examiner has
met the burden to show, by a preponderance of the evidence, that the
appealed claims are anticipated by Singh. In re Oetiker, 977 F.2d 1443,
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1445 (Fed. Cir. 1992) (The Examiner "bears the initial burden ... of
presenting a primafacie case ofunpatentability.").
As an initial matter, we note that the Examiner, after discussing what
Singh allegedly describes, provides a single block cite identifying at least ten
figures, eight examples, over ten tables, more than fifteen columns of text
from Singh's specification, and all sixty-five of Singh's claims. From these
myriad disclosures (including descriptions of several distinct embodiments),
the Examiner does not clearly or sufficiently identify in Singh a cohesive
anticipatory disclosure that meets all the limitations for each of the claims.
To anticipate, "it is not enough that the prior art reference discloses part of
the claimed invention, which an ordinary artisan might supplement to make
the whole, or that it includes multiple, distinct teachings that the artisan
might somehow combine to achieve the claimed invention." Net MoneyIN,
Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Under these
circumstances, the Board declines the Examiner's invitation to piece
together an anticipation rejection from those many and varied disclosures.
In addition to the above, the Examiner's dismissal of several steps of
the claims as allegedly including "mathematical manipulation of data and
abstract idea[ s ]" is not warranted. Ans. 5---6. As Appellants point out, there
is no authority or basis for the Examiner, in effect, ignoring such steps of the
appealed method claims. App. Br. 14. Inasmuch as the Examiner contends
that "Examiner did consider and address" those steps in the rejection, we are
unpersuaded. Ans. 11-12. The Examiner responds that "[t]he computer
provided by Singh et al reasonably comprises a 'machine learning
application' and ability to perform or use mathematical analysis as claimed."
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Id. at 12. But the pending claims recite methods and require various
computer elements operate or be configured to operate in particular ways.
An ability for Singh's computer to be so configured (even assuming that's
true) is not enough to establish anticipation. Singh also appears to merely
disclose that results (i.e., suitability of certain drug treatments) may be
recorded or stored in a computer. See, e.g., Singh 24:1-12 ("the methods of
the present invention may further comprise recording or storing the results of
step ( d) [ determining whether the anticancer drug is suitable or unsuitable
for the treatment of the breast tumor] in a computer database or other
suitable machine or device for storing information, e.g., at a laboratory").
That does not describe all the computer functionalities and operations that
are claimed, and the Examiner provides no sufficient and persuasive
evidence otherwise.
For the above reasons, the anticipation rejection of claims 39, 40, 42-
44, 46-49, 51-54, 57-59, 65 and 66 is reversed.
SUMMARY
We reverse the rejections for ineligible subject matter and anticipation
on appeal.
REVERSED
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