Ex Parte Wang

Patent Trial and Appeal Board

Dec 29, 2017

13538736 (P.T.A.B. Dec. 29, 2017)

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.
13/538,736 06/29/2012 MAI WANG 7712
Mai Wang
311 Ohua Ave
Apt# 1003 C
7590 01/02/2018 EXAMINER
BRUSCA, JOHN S
Honolulu, HI 96815 ART UNIT PAPER NUMBER
1631
MAIL DATE DELIVERY MODE
01/02/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MAI WANG1
Appeal 2017-005768
Application 13/538,736
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and TAWEN CHANG,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state that the real party-in-interest is the inventor, Mai Wang.
App. Br. 1.
Appeal 2017-005768
Application 13/538,736
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1-16 as unpatentable under 35 U.S.C.
§112, first paragraph, for lack of enablement.
Claims 1-16 also stand rejected as unpatentable under 35 U.S.C.
§ 101 as being directed to nonstatutory subject matter.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellant’s invention is directed to a method for organizing and
analyzing the distribution and/or ratio of thymine, cytosine, adenine, and
guanine of a DNA sequence from a target organism. The result is then used
to determine the possible impacts the target organism may have in a host
such as a human body. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A DNA analysis method, comprising:
accessing a DNA sequence input, the DNA sequence input
comprising a plurality of triplets of nucleo[tide] base
representation;
converting the DNA sequence input into a reassembled
sequence, wherein the reassembled sequence includes
three layers: a first layer comprising a first element of each
triplet in the DNA sequence input, a second layer
comprising a second element of each triplet in the DNA
sequence input, and a third layer comprising a third
element of each triplet in the DNA sequence input; and
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outputting an output result based on the reassembled
sequence.
App. Br. 11.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner’s findings of fact and
conclusions that the appealed claims are not enabled and are directed to
nonstatutory subject matter. We address the arguments raised by Appellant
below.
A. Rejection of the claims under 35 U.S.C. $ 101
Issue 1
Appellant argues the Examiner erred because the claims are directed
to statutory matter and are patent-eligible. App. Br. 7.
Analysis
The Examiner finds that Appellant’s claims 1-16 are directed to an
abstract idea, viz., of reassembling a DNA sequence to generate nucleotide
base sums as exemplified in the Specification. Final Act. 9-10. The
Examiner further finds that claims 7-10 are further directed to a law of
nature, viz., relating a reassembled DNA sequence to a physiological effect
of a target organism on a host. Id. at 10. The Examiner finds claim 11 is
also directed to a law of nature relating a reassembled sequence to a
treatment of a host. Id. The Examiner finds claim 12 is also directed to a
law of nature relating a reassembled DNA sequence to a prevention strategy
of a host. Id.
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Appellant argues that claims 1-13 recite a novel DNA analysis
method (i.e., a process) comprising six steps. App. Br. 7 (citing Spec., Fig.
7). Appellant contends claims 7-10 recite step 6 of the DNA analysis
process of claim 1, further comprising: determining a physiological effect of
a target organism on a host organism, the target organism embodying the
input DNA sequence, to produce a determination result based on the output
from the DNA analysis process, and the Imbalance Factors as illustrated in
FIG. 12A, 12B, and 12C, or one or more of the theories listed in claim 8. Id.
(citing Spec. 50-51, 24, 26, 28-31, Figs. 7, 12A-12C). Appellant asserts
claim 11 claims step 6 of the DNA analysis process of claim 1, further
comprising producing a treatment strategy based on the output from the
DNA analysis process, as illustrated in 710 of Figure 7, and a Reverse
Imbalance Method illustrated in Figure 13A-B. Id. (citing 36, 52).
Appellant argues further that claim 12 claims step 6 of the DNA analysis
process of claim 1, further comprising producing a prevention strategy based
on the output from the DNA analysis process and a prevention method
described. Id. at 8 (citing Spec. 37, 52).
Appellant asserts that all results disclosed in Appellant’s Specification
are based on the output of the DNA analysis process of claim 1 and
represent solid data. App. Br. 8. Appellant therefore asserts that claims 1-
16 are not directed to an abstract idea and that claims 7-12 are similarly not
directed to a law of nature. Id.
The Examiner responds that claims 7-12 are directed to a law of
nature that correlates a DNA sequence of a target organism to the effect of
the target organism on a host, or with the efficacy of a treatment or
prevention. Ans. 11. The Examiner finds, contrary to Appellant’s
argument, that it is insufficient that the claims are within one of the four
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categories of invention of 35 U.S.C. § 101 because the Supreme Court has
created judicial exceptions to the statute, i.e., of laws of nature, abstract
ideas, and natural phenomenon exceptions to patent eligibility.
We are not persuaded by Appellant’s arguments. In Mayo
Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289
(2012), the Supreme Court established a two-step framework for
distinguishing patents that claim laws of nature, natural phenomena, and
abstract ideas from those that claim patent-eligible applications of those
concepts. The first step of the analysis is to determine whether the claims at
issue are directed to one of those patent-ineligible concepts. Mayo, 132
S.Ct. at 1296-1297. If we determine that the claims are directed to a patent-
ineligible exception to Section 101, the second step of the analysis seeks to
determine whether there are additional limitations of the claim that add
significantly more than the exception itself. Id. at 1297.
Claims 1-16 are all directed to a method of accessing, reorganizing
and outputting DNA sequences, viz.,
converting the DNA sequence input into a reassembled
sequence, wherein the reassembled sequence includes three
layers: a first layer comprising a first element of each triplet in
the DNA sequence input, a second layer comprising a second
element of each triplet in the DNA sequence input, and a third
layer comprising a third element of each triplet in the DNA
sequence input.
App. Br. 11 (claim 1). As such, the essential limitations of the claimed
method constitutes a reorganization of the nucleotide base sequences into a
new order, in some instances reflecting one or more guiding principles. See,
e.g., claims 8-10.
Appellant’s claims are thus directed to a process, which is a category
of patent-eligible subject matter under 35 U.S.C. § 101. However, it is well-
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established in our laws that Section 101 contains important implicit
exceptions: laws of nature, natural phenomena, and abstract ideas are not
patentable. Association for Molecular Pathology v. Myriad Genetics, Inc.,
133 S.Ct. 2107, 2116 (2013). Recognition of such exceptions have been part
of this country’s patent law jurisprudence for more than 150 years. See, e.g.,
O’Reilly v. Morse, 15 How. 62, 112-120 (1854); Le Roy v. Tatham, 14 How.
156, 174-175 (1853).
The Supreme Court has held that:
The “abstract ideas” category embodies “the longstanding
rule that ‘[a]n idea of itself is not patentable.’” [Gottschalk v.
Benson, 409 U.S. 63, 93 (1972)] (quoting Rubber Tip Pencil Co.
v. Howard, 20 Wall. 498, 507, (1874)); see also Le Roy, supra,
at 175 (“A principle, in the abstract, is a fundamental truth; an
original cause; a motive; these cannot be patented, as no one can
claim in either of them an exclusive right”). In Benson, for
example, this Court rejected as ineligible patent claims involving
an algorithm for converting binary-coded decimal numerals into
pure binary form, holding that the claimed patent was “in
practical effect ... a patent on the algorithm itself.” 409 U.S., at
71-72. And in Parker v. Flook, 437 U.S. 584, 594-595 (1978),
we held that a mathematical formula for computing “alarm
limits” in a catalytic conversion process was also a patent-
ineligible abstract idea.
Alice Corp. Pty. Ltd. v. CLSBankInt’l, 134 S.Ct. 2347, 2355 (2014).
Appellant’s claim 1 requires accessing a DNA sequence, applying an
algorithm to it to rearrange the data based upon certain principles and
subsequently outputting the data. We find that, as such, Appellant’s claims
are directed to a rules-based reorganization of data, i.e., an abstract idea, and
we therefore conclude that they are directed to a patent-ineligible exception
to Section 101. Alice, 134 S.Ct. 2356-57; Benson, 409 U.S. at 93; Parker,
437 U.S. at 594-95.
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Having concluded that the claims are directed to a judicially-created
exception to Section 101, we then undertake the second step of the Mayo
analysis to determine whether it contains an “inventive concept” sufficient to
“transform” the claimed abstract idea into a patent-eligible application. 132
S.Ct. at 1294, 1298. 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. at 1297. Transformation
from an abstract idea into a patent-eligible application requires “more than
simply stat[ing] the [abstract idea] while adding the words ‘apply it.’” Id. at
1294.
We conclude that there are no such additional features sufficient to
establish more than just the abstract idea itself. Claim 1 simply adds
accessing the DNA sequence and outputting the results of the reorganized
sequences. Claims 2-6, 9, and 13 further limit the parameters or rules of the
manner by which the data is reorganized (claims 2-6), limit the organisms
from which the DNA sequence is to be obtained (i.e., human, animal, or
plant) (claim 9), or require that the output “includes one of a graph, chart,
table, figure, photo, and outline” (claim 13).
Claims 14-16 add “input modules” or “output modules” for accessing
the initial DNA sequence and outputting the results of the data
reorganization and a processor for performing the data reorganization.
Appellant’s Specification discloses that such modules and processor can be
part of an ordinary or generic computer using software well known in the
art. See, e.g., Spec. 57-58. These, too, are insufficient to raise the claims
above the judicial-exception barrier. Wholly generic computer
implementation is not generally the sort of “additional featur[e]” that
provides any “practical assurance that the process is more than a drafting
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effort designed to monopolize the [abstract idea] itself.” Alice, 134 S.Ct. at
2350-51 (quoting Mayo, 132 S.Ct. at 1297). Similarly, Appellant’s claim
16, which recites: “A tangible non-transitory computer-readable storage
medium that stores computer instructions which, when executed by a
computer, cause the computer to perform operations comprising the DNA
analysis method of Claim 1,” is directed to a generic computer storage
medium that performs the abstract algorithm function of claim 1 and fails to
add a significant inventive concept to the claim to allow it to rise above the
judicial exception.
Finally, Appellant points to claims 7-12, which recite various
treatment strategies based upon the output of the recited algorithm and
certain principles of traditional Chines medicine. We agree with the
Examiner that applying the recited principles of treatment to an already
existing phenomenon of nature also falls within the judicial exceptions to
Section 101. In this respect, the facts of the appeal are similar to those of
Mayo, in which physicians were required to determine a course of treatment
based upon administering a thiopurine drug, determining the results of a
previously known assay, and determining a course of treatment. See Mayo,
132 S.Ct. at 1295. In this instance, Appellant’s claims require determining
the relationship between the derived DNA sequences of a certain organism
and the nature of the disease or condition caused by the organism (a
phenomenon of nature, existing prior to Appellant’s discovery) and applying
a known principle of treatment to that disease condition. As such, and by
the same reasoning set forth by the Supreme Court in Mayo, we conclude
that these claims also fall within the judicially-created exception to Section
101 barring claims that recite a phenomenon of nature without also adding a
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significant inventive concept. We consequently affirm the Examiner’s
rejection of the claims on this ground.
B. Rejection of the claims under 35 U.S.C. $ 112, first paragraph
Issue
Appellant argues the Examiner erred in finding that the claims are not
enabled by the disclosures of Appellant’s Specification.
Analysis
The Examiner finds that Appellant’s claims recite subject matter that
was not described in Appellant’s Specification in such a way as to enable a
person of ordinary skill in the appropriate art to make and/or use the
invention. Final Act. 4. In reaching this conclusion, the Examiner applies
the analysis set forth by our reviewing court in In re Wands, 858 F.2d 731,
737 (Fed. Cir. 1998) to Appellant’s claims. Id. at 5.
Applying the Wands factors, the Examiner finds, specifically, that: (a)
there would be an unpredictable amount of experimentation required to use
the claimed subject matter, because: (b) Appellant’s Specification does not
disclose how a starting point for a given polynucleotide sequence is
determined, nor does it provide guidance for how to choose a nucleotide
sequence from the entire genome of a target organism, which for bacterial
target organisms is on the order of 1-5 million nucleotides in length; (c) the
DNA sequences analyzed in Figure 8C shows a dengue fever virus
sequence, but without suggesting how the initial nucleotide sequence is
determined, as explained in (b); (d) the nature of the invention, i.e.,
determining the effect of a sequence of an organism on a host, is complex;
(e) the prior art does not disclose the claimed subject matter and teaches that
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there is no rational basis for the contention in the specification that
reassembled sequences can be used to discern effects of polynucleotides in
different layers of an organism; (f) The skill of those in the art of medicine is
high; (g) because the prior art does not show the claimed subject matter and
provides no rational basis for using the claimed subject matter, the prior art
suggests that the predictability of success in practicing the claimed subject
matter is low; and (h) the claims are broad because using the claimed subject
matter requires correctly identifying the effect of a target organism on a host
by analysis of a reassembled sequence that has no rational relationship to the
action of the polynucleotide sequence from which the reassembled sequence
was derived. Final Act. 5-9.
Appellant points to paragraph [0044] of the Specification, which
discloses: “The starting point of the DNA sequence is predetermined before
entering the DNA analysis system.” App. Br. 5. Appellant therefore asserts
that defining the starting point of the sequence is not part of the invention
and the Examiner’s statements are therefore irrelevant to the invention. Id.
Appellant also contends that the invention is enabled because over
120 pathogen genome sequences provided by NCBI have been analyzed by
Appellant using the methods claimed, and the results are allegedly consistent
with high accuracy. App. Br. 5-6. Appellant argues that Figure 7 of the
Specification provides flow charts of the process, and Figure 5 depicts an
illustration of how the input digital genome data are converted to the output
(i.e., the “HUE Structure”). Id. at 6. According to Appellant, a skilled
person in the art, which Appellant defines as someone with basic computer
programming training, can make the same system following the steps
depicted in Figures 5, 7, 9, and 10. Id.
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Appellant asserts that, to apply the tool in the medical field,
researchers and doctors will read the HUE Charts (i.e., the output generated
from the process) and a list of preset rules, such as the information provided
in Figures 12A-C and 13A-B, to determine the physiologic impacts on the
target organism, and the corresponding treatment and prevention plans.
App. Br. 6.
The Examiner responds that the data presented with respect to the
NCBI sequences were not persuasive of enablement, because evidence was
not provided showing how the choice of preliminary sequence was enabled
at the time of filing.2 Ans. 10. The Examiner finds that, contrary to
Appellant’s arguments, the basis of the Examiner’s rejection is not that the
tables cannot be generated given a starting sequence, but rather that the
combination of the prior art and the specification does not enable the critical
choice of what initial sequence to analyze and further does not enable useful
results. Id. at 10-11.
We are not persuaded by Appellant’s arguments. Paragraph [0044]
recites, in relevant part:
Flowchart 700 of FIG. 7 illustrates a method, to be
performed by, for example, a DNA analysis system, configured
according to an embodiment of the invention. At 702, a DNA
sequence input is received at, for example, an input module. This
input may include a digital sequence with nucleobase
representations, such as a “ready-made” DNA sequence in
GENBANK or FAST A format. Alternatively, actual DNA may
be obtained by, for example, extraction from the target organism,
after which a DNA sequence is produced by a sequencer. The
2 The Examiner further observes that the NCBI sequences cited by
Appellant, and their analyses, are not of record in the prosecution of this
application. Ans. 10 (citing Appendix to Appl. Ser. No. 12/391,866).
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starting point of the DNA sequence is predetermined before
entering the DNA analysis system
(emphasis added). Although the Specification discloses that the “starting
point of the DNA sequence is predetermined,” Appellant’s Specification
does not specify how such a predetermination is made or by which rules or
procedures it may be determined, nor does it disclose examples of prior art
teaching how such a predetermination may be made.
Furthermore, the claims recite simply “a DNA sequence,” without
further limitation, and the Specification discloses no clear guidance as to
how such a sequence may be selected. Given the fact that a reading frame
difference of a single nucleotide in a given DNA sequence would provide
significantly different results when Appellant’s method is applied, the lack
of guidance as to how a person of ordinary skill would choose an initial
sequence of DNA at which to begin the method recited in Appellant’s claims
renders the claims non-enabled. The conclusory statement in the
Specification that the “starting point of the DNA sequence is predetermined
before entering the DNA analysis system” is, absent further clarification in
the Specification or in the prior art, in itself insufficient to show that a
person of ordinary skill in the art would understand how to use Appellant’s
invention. We consequently agree with the Examiner’s conclusion that the
claims are not enabled, and we affirm the rejection of the claims on this
ground.
DECISION
The Examiner’s rejection of claims 1-16 as unpatentable under 35
U.S.C. § 101 is affirmed.
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The Examiner’s rejection of claims 1-16 as unpatentable under 35
U.S.C. § 112, first paragraph, for lack of enablement is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
AFFIRMED
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