Ilan Sadeh

Patent Trials and Appeals Board

Apr 27, 2020

14246100 - (D) (P.T.A.B. Apr. 27, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/246,100 04/06/2014 Ilan SADEH 564/5 3184
44696 7590 04/27/2020
Dr. Mark M. Friedman
Moshe Aviv Tower, 54th floor
7 Jabotinsky St.
Ramat Gan, 5252007
ISRAEL
EXAMINER
WOITACH, JOSEPH T
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
04/27/2020 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):
friedpat.uspto@gmail.com
patents@friedpat.com
rivka_f@friedpat.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ILAN SADEH
____________

Appeal 2019-001414
Application 14/246,100
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1, 3–7, 9–11, 13–17, 19, 20, 22–26, 28, and 30 (see
Appeal Br. 5). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Ilan Sadeh,
an individual and sole inventor of the instant patent application”
(Appellant’s June 7, 2018 Appeal Brief (Appeal Br.) 3).
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to bioinformatics and, more
particularly, but not exclusively, to a method and system for predicting a
disease by computational analysis of a DNA sequence” (Spec.2 1:13–15).
Appellant’s claims 1, 4, and 5 are reproduced below:
1. A method of estimating a likelihood of developing a gene-
related disease, the method comprising:
[a] accessing a database stored on non-transitory
computer readable medium to obtain a set of gene sequences
corresponding to the gene-related disease, wherein at least one
gene sequence of said set includes at least one of an oncogene
and a tumor suppressor gene, and, each of said gene sequences
of the set including an average reoccurrence distance between
adjacent occurrences of each of said gene sequences;
[b] extracting a DNA sequence from isolated cells of a
subject by using laboratory equipment to perform a cell lysis
procedure followed by a purification procedure;
[c] converting the extracted DNA sequence into digital
data for analysis by a data processor;
[d] performing operations on a data processor for
estimating the likelihood of said subject to develop the gene-
related disease, wherein said operations comprise:
[e] selecting at least one gene sequence from said
set of gene sequences corresponding to the gene-related
disease;
[f] searching over said extracted DNA sequence
for reoccurrences of said selected at least one gene
sequence, and calculating an average reoccurrence
distance between adjacent reoccurrences of said selected
at least one gene sequence in said extracted DNA
sequence; and,

2 Appellant’s April 6, 2014 Specification.
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[g] estimating the likelihood of said subject to
develop the gene-related disease of said set of gene
sequences, is estimated based on an analysis of said
average reoccurrence distances of: 1) said adjacent
occurrences of said selected at least one gene sequence
from said set of gene sequences corresponding to said
gene-related disease, and 2) adjacent reoccurrences of
said selected at least one gene sequence in said extracted
DNA sequence.
(Appeal Br. 24.)
4. The method of claim 1, further comprising randomly
selecting a starting position over said DNA sequence, wherein
said searching is initiated at said selected starting position.
(Id. at 25.)
5. The method of claim 1, further comprising randomly
selecting a plurality of starting positions over said DNA
sequence, wherein said searching is initiated a respective
plurality of times, each time at a different selected starting
position.
(Id.)
Claims 1, 3–7, 9–11, 13–17, 19, 20, 22–26, 28, and 30 stand rejected
under 35 U.S.C. § 101.
ISSUE
Does the preponderance of evidence of record support Examiner’s
finding that Appellant’s claimed invention is directed to patent-ineligible
subject matter?
PRINCIPLES OF LAW
A. Section 101
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 U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to
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include implicit exceptions: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573
U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part 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. Kappos, 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 thus 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 (Gottschalk v. Benson, 409 U.S. 63, 67 (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 waterproof cloth, vulcanizing India
rubber, smelting ores” (id. at 182 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
Court held that “a claim drawn to subject matter otherwise statutory does not
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become nonstatutory simply because it uses a mathematical formula.”
Diehr, 450 U.S. at 187; 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 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. (citation omitted)
(citing Benson and Flook); see, e.g., id. at 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 turn 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. (alterations in original) (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.
B. USPTO Section 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
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(“Guidance”).3 “All USPTO personnel are, as a matter of internal agency
management, expected to follow the guidance.” Id. at 51; see also October
2019 Update at 1.
Under the Guidance and the October 2019 Update, 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) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th
ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).4
Guidance, 84 Fed. Reg. at 52–55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, 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

3 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at
https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.p
df).
4 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
practical application. See 2019 Revised Guidance — Section III(A)(2), 84
Fed. Reg. 54–55.
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(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, 84 Fed. Reg. at 52–56.
ANALYSIS
Appellant’s claims 1, 4, and 5 are representative.
(Step 1)
We first consider whether the claimed subject matter falls within the
four statutory categories set forth in § 101, namely “[p]rocess, machine,
manufacture, or composition of matter.” Guidance, 84 Fed. Reg. at 53–54;
see 35 U.S.C. § 101. Appellant’s claims 1, 3–7, 9, 20, 22–26, 28, and 30 are
directed to a process; claim 10 is directed to a system, i.e., a machine; and
claims 11, 13–17, and 19 are directed to a product. Thus, Appellant’s claims
squarely fall within the statutory categories set forth in § 101. Therefore, we
proceed to the next steps of the analysis.
(Step 2A, Prong 1)
In the first prong of Step 2A, the Guidance instructs us to determine
whether any judicial exception to patent eligibility is recited in the claim. 84
Fed. Reg. at 54. In this regard, the Guidance identifies three judicially-
excepted groupings identified by the courts as abstract ideas: (1)
mathematical concepts, (2) certain methods of organizing human behavior,
and (3) mental processes. Guidance, 84 Fed. Reg. at 52–54.
On this record, Examiner finds that Appellant’s claims are “directed
towards a computer implemented method [of] estimating the likelihood of
developing a disease by comparing the distance between the reoccurrence of
a gene sequence” (Final Act. 8). Specifically, method steps d–g of
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Appellant’s claim 1, although performed on a data processor,5 recite a
mental process involving the selection and analysis of data to determine an
estimated likelihood of a subject developing a gene-related disease that,
depending on the size of the sequences, may be performed in the human
mind, or by a human using a pen and paper. See CyberSource Corp. v.
Retail Decisions, Inc., 654 F.3d 1366, 1372–73 (Fed. Cir. 2011)
(determining that a claim whose “steps can be performed in the human mind,
or by a human using a pen and paper” is directed to an unpatentable mental
process); see generally Final Act. 4–5 and 9; Ans. 5.
(Step 2A, Prong 2)
Having determined that Appellant’s claim recites a judicial exception,
the Guidance requires an evaluation as to whether the claim as a whole
integrates the recited judicial exception into a practical application of the
exception. See 84 Fed. Reg. at 54.
On this record, Examiner finds that to the extent the method of
Appellant’s claims 1, 4, and 5 are performed on a computer, “the computer
is used only to implement the judicial exception,” i.e. mental process, rather
than “improve the functioning of the computer itself . . . [or] any other
technology or technical field” (Final Act. 7 and 9; see Ans. 7–8). See
Finjan, Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 1303 (Fed. Cir.

5 Examiner “acknowledge[s] that the claims recite and require the use of a
processor, however in view of the guidance . . . [in Appellant’s]
[S]pecification and evidence of record, for the purposes of the 101 analysis
this is considered a general purpose computer” (Final Act. 6–7; see also
Ans. 8–9; see generally Spec. 5:30–6:14; 17:31–18:14). See Alice, 573 U.S.
at 221 (“[M]erely requir[ing] generic computer implementation[] fail[s] to
transform that abstract idea into a patent-eligible invention.”).
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2018) (quoting Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335–36
(Fed. Cir. 2016) (“In cases involving software innovations, th[e] inquiry
often turns on whether the claims focus on ‘the specific asserted
improvement in computer capabilities . . . or, instead, on a process that
qualifies as an abstract idea for which computers are invoked merely as a
tool.”’) (Internal quotation marks omitted)); see Koninklijke KPN N.V. v.
Gemalto M2M GmbH, 942 F.3d 1143, 1150 (Fed. Cir. 2019) (“software
inventions [were found] to be patent-eligible where they have made non-
abstract improvements to existing technological processes and computer
technology”).
As Examiner explains, “it appears that the technical improvement
would be associated with the correlation of the genetic data as it is related to
disease caused from . . . [a gene-related disease]” (Final Act. 7). In this
regard, we note that the method of Appellant’s claims 1, 4, and 5 result in an
estimate, i.e. determination, of the likelihood that a subject will develop a
gene-related disease. Here, unlike the claim in Vanda that required the
administration of a treatment in response to a diagnostic determination, the
method of Appellant’s claim 1 does not require that anything be done with
the estimated likelihood a subject will develop a gene-related disease. See
Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117, 1133–
36 (Fed. Cir. 2018). Thus, the method of Appellant’s claims 1, 4, and 5 are
more similar to the claims held ineligible in Mayo, than the claims in Vanda,
because it analyses data and draws an inference, i.e. estimate, from the
analysis, wherein, as discussed below, any additional steps consist of well-
understood, routine, conventional activity already engaged in by the
scientific community. See Mayo, 566 U.S. at 79–80 (“[T]he claims inform a
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relevant audience about certain laws of nature; any additional steps consist
of well-understood, routine, conventional activity already engaged in by the
scientific community; and those steps, when viewed as a whole, add nothing
significant beyond the sum of their parts taken separately.”).
The remaining limitations of Appellant’s claimed method, i.e. steps a–
c of Appellant’s claims 1, 4, and 5 are directed to “obtain[ing] a set of gene
sequences corresponding to . . . gene-related disease” as well as obtaining
and digitizing a DNA sequence extracted from isolated cells of a subject are
pre-solution, data collection, steps that do not amount to significantly more
than the abstract idea because they are insignificant pre-solution activities
(see Appeal Br. 24). See Mayo, 566 U.S. at 79 (quoting Flook, 437 U.S. at
590) (“Purely ‘conventional or obvious’ ‘[pre]-solution activity’ is normally
not sufficient to transform an unpatentable law of nature into a patent-
eligible application of such a law”); see also Guidance, 55, n.31. The same
is true of the limitations in Appellant’s claims 4 and 5 of “randomly
selecting a starting position over said DNA sequence, wherein said searching
is initiated at said selected starting position” and “randomly selecting a
plurality of starting positions over said DNA sequence, wherein said
searching is initiated a respective plurality of times, each time at a different
selected starting position,” respectively (see Appeal Br. 25).
The method of Appellant’s claim 1 reads on the comparison of: (a) a
single first sequence, selected from a database of sequences corresponding to
a gene-related disease, to (b) a single second sequence isolated from the cells
of a subject (see Appeal Br. 24). Appellant failed to establish an evidentiary
basis on this record to establish that the comparison of one sequence to
another cannot be done, depending on the size of the sequences, in the
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human mind or by a human using a pen and paper. Therefore, we are not
persuaded by Appellant’s contention that “all operations[, required by the
method of Appellant’s claim 1, are] performed on ‘big data’, which can only
be performed by a computer (e.g., data processor), with specialized and
complex data processing capabilities” (Appeal Br. 16; see id. at 17
(Appellant contends that “processing ‘Big Data’ is clearly something that
cannot be done by the human mind, nor done by pencil and paper”)).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Buckley’s disclosure relating to the size of a “typical human
genome,” genome mapping, “sequencing multiple genomes and tracking
gene interactions” supports a finding that a comparison of one first sequence
to one second sequence represents “Big Data,” wherein the “data sets . . . are
so voluminous and complex that traditional data processing application
software are inadequate to deal with them” (see Appeal Br. 16 and 18 (citing
Buckley6 and Wikipedia7)).
According to Appellant, the random selection of
a starting position of the DNA sequence and counting a number
of reoccurrences, result[s] in only a portion of the DNA
sequence being analyzed by computers, as opposed to the entire
sequence, from the start of the sequence. Accordingly, the
claimed invention saves computer processing resources, when
compared to the current state of the art. . . . [Thus,] the claims
are not “abstract ideas”, since [the] claims [are] directed to an

6 Buckley, Big Data Analytics Alters How We Study the Human Genome,
Dataversity (Sept. 16, 2015), available at http://www.dataversity.net, last
accessed Feb. 7, 2018.
7 Wikipedia, “Big data” entry, available at
https://en.wikipedia.org/wiki/Big_data.
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improvement in computing or other technology are not
“abstract ideas”
(Appeal Br. 19; see also id. at 25 (Appellant’s claims 4–5).) We are not
persuaded. Initially we note that Appellant’s claim 1 does not expressly or
implicitly require the random selection of a starting position of the DNA
sequence, but instead reads on starting a comparison at the beginning of each
sequence (cf. Appeal Br. 19 (Appellant contends that “the searching over
said extracted DNA sequence for reoccurrences of said selected at least one
gene sequence, implicitly involves randomly selecting a starting position of
the DNA sequence”)). Further, although Appellant’s claims 4 and 5
comprise randomly selecting a starting position over the DNA sequence,
Appellant failed to establish an evidentiary basis on this record to support a
finding that the selection of one sequence from a group of sequences, i.e.
selecting a sequence from a database of sequences, and randomly selecting
the starting point along a sequence to start a comparison of two sequences
prevents the comparison from being performed in the human mind or by a
human using a pen and paper (cf. Appeal Br. 17–18 and 21–23 (directing
attention to Spec. 19:29–32 and 23:28–24:17); Reply Br. 4–6).
Thus, although we agree with Appellant’s contention that in Finjan
our reviewing court found that “[t]he asserted claims are . . . directed to a
non-abstract improvement in computer functionality, rather than the abstract
idea of computer security writ large,” for the reasons set forth above,
however, the same is not true of Appellant’s claimed invention. See Finjan,
879 F.3d at 1305; see generally Appeal Br. 20. On this record, Appellant’s
contention emphasizes the use of a computer as a tool to implement the
abstract idea, rather than a “specific asserted improvement in computer
capabilities.” See Finjan, 879 F.3d at 1303; see also OIP Technologies, Inc.
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v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015) (“[R]elying on a
computer to perform routine tasks more quickly or more accurately is
insufficient to render a claim patent eligible.”).
For the reasons set forth above, we find no practical integration of the
mental process, i.e. abstract idea, recited in the method of Appellant’s claims
1, 4, and 5.
(Step 2B)
Having determined that Appellant’s claims 1, 4, and 5: (1) recite a
judicial exception and (2) do not integrate that exception into a practical
application, the Guidance requires that we evaluate whether Appellant’s
claim 1: (a) adds a specific limitation beyond the judicial exception that is
not “well-understood, routine, conventional” in the field or (b) simply
appends well-understood, routine, conventional activities previously known
to the industry, specified at a high level of generality, to the judicial
exception. 84 Fed. Reg. at 52–56.
On this record, Examiner finds that method step b of Appellant’s
claims 1, 4, and 5, which requires the extraction of a DNA sequence from
isolated cells of a subject using laboratory equipment to perform a cell lysis
procedure followed by a purification procedure was well-understood,
routine, conventional activity already engaged in by the scientific
community (see Final Act. 4; see Ans. 4; cf. Spec. 27:18–20 (Appellant
discloses that “the DNA sequence . . . [is] extracted by laboratory techniques
as known in the art”)).
Examiner further finds that method step c of Appellant’s claims 1, 4,
and 5, which requires
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“converting the extracted DNA sequence into digital data for
analysis” is considered a physical step encompassed by the
general methodology for obtaining a DNA sequence,
and . . . appears in view of the specification and the evidence of
record, to be a step that is considered a conventional step
necessary to obtain DNA sequence data for analysis.
(Final Act. 4.)
Thus, the foregoing limitations set forth in Appellant’s claims 1, 4,
and 5 simply append well-understood, routine, conventional activities
previously known to the industry, specified at a high level of generality, to
the judicial exception. 84 Fed. Reg. at 52–56.
CONCLUSION
The preponderance of evidence of record supports Examiner’s finding
that Appellant’s claimed invention is directed to patent ineligible subject
matter. The rejection of claims 1, 4, and 5 under 35 U.S.C. § 101 is
affirmed. Appellant’s claims 3, 9–11, 13, 19, 20, 22, 28, and 30 are not
separately argued and fall with Appellant’s claim 1. Appellant’s claims 14
and 23 are not separately argued and fall with Appellant’s claim 4.
Appellant’s claims 6, 7, 15–17, and 24–26 are not separately argued and fall
with Appellant’s claim 5.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–7, 9–11,
13–17, 19, 20,
22–26, 28, 30
101 Eligibility 1, 3–7, 9–
11, 13–
17, 19,
20, 22–
26, 28, 30

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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