Olga Ornatsky

Patent Trials and Appeals Board

Jul 29, 2019

14823980 - (D) (P.T.A.B. Jul. 29, 2019)

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.
14/823,980 08/11/2015 Olga Ornatsky 085665-
D00120US-0954009
4081
103479 7590 07/29/2019
Kilpatrick Townsend & Stockton LLP
Fluidigm Corporation
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
EXAMINER
SISSON, BRADLEY L
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
07/29/2019 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):
KTSDocketing2@kilpatrick.foundationip.com
ipefiling@kilpatricktownsend.com
pair_fluidigm@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte OLGA ORNATSKY
__________

Appeal 2018-001623
Application 14/823,9801
Technology Center 1600
__________

Before FRANCISCO C. PRATS, JOHN G. NEW, 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 protein and gene expression analysis of a cellular sample using an
inductively coupled plasma mass spectrometer system. The Examiner
rejected the claims as being indefinite, as failing to comply with the
enablement requirement, as failing to comply with the written description
requirement, as lacking utility, and as being directed to a judicial exception
to patentability. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellant is the applicant Fluidigm, which identifies itself as the real party
in interest. (Appeal Br. 4.)
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STATEMENT OF THE CASE
Appellant’s Specification states that “[t]he Human Genome project
has opened access to a wealth of genetic sequence information that will help
diagnose and treat many types of human diseases.” (Spec. ¶ 29.) “Genomic
screening methods for monitoring thousands of genes simultaneously
include such technologies as DNA microarrays, differential display, and
serial analysis of gene expression (SAGE).” (Id.) “Sample preparation and
universal reference standards are critical since genomic information obtained
from a heterogeneous population of cells will interfere with the gene profile
of a particular cancer cell.” (Id.) “Several methods for multiplexed
detection of nucleic acids in single cells exist, but they do not currently
combine quantification with massive multiplexing.” (Id. ¶ 31.) According
to Appellant’s Specification “the development of a highly sensitive,
quantitative and multiplex system for gene and protein expression analysis
in single cells remains an elusive goal for molecular research and diagnosis.”
(Spec. ¶32.)
Claims 1–5, 7–12, 14–19, and 21–25 are on appeal. Claims 1 and 10
are representative and read as follows:
1. A method of analysis using an inductively coupled
plasma mass spectrometer system, the method comprising:
introducing a cellular sample comprising one or more
cells or cellular particles into the inductively coupled plasma
mass spectrometer system, the cellular sample comprising:
(a) a first oligonucleotide probe coupled with a first metal
tag, the first oligonucleotide probe complementary to and
hybridized with a first target mRNA molecule of the cellular
sample; and
(b) an affinity reagent coupled with a second metal tag
having an elemental or isotopic composition different than the
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first metal tag, the affinity reagent bound to a cell surface
protein or an intracellular protein;
assessing a protein expression of the cellular sample and
assessing a gene expression of the cellular sample by detecting,
with the inductively coupled plasma mass spectrometer system,
the first metal tag and the second metal tag based on the
elemental or isotopic compositions of the first and second metal
tags.

10. A method of using an inductively coupled plasma
mass spectrometer system for analysis of a cellular sample
having one or more cells or cellular particles, the method
comprising:
rendering a target nucleic acid available for hybridization
to complementary oligonucleotide probes by at least one of
fixing and permeabilizing the one or more cells or cellular
particles of the cellular sample, wherein the complementary
oligonucleotide probes comprise a nucleic acid sequence that is
complementary to the target nucleic acid;
incubating the cellular sample in a hybridization solution
comprising the complementary oligonucleotide probes under
conditions to enable the complementary oligonucleotide probes
to hybridize to the target nucleic acid through complementary
base pairing between the complementary oligonucleotide
probes and the target nucleic acid;
separating unhybridized complementary oligonucleotide
probes from complementary oligonucleotide probes hybridized
to the target nucleic acid;
labeling the complementary oligonucleotide probes with
a unique metal tag such that the complementary oligonucleotide
probes are distinguishable by the inductively coupled plasma
mass spectrometer from any other oligonucleotide probe
labeled with a metal tag having
an elemental or isotopic composition different than the
unique metal tag; and
detecting the unique metal tag associated with the
complementary oligonucleotide probes hybridized to the target
nucleic acid with the inductively coupled plasma mass
spectrometer system by detecting, with the inductively coupled
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plasma mass spectrometer system, the unique metal tag labeling
the complementary oligonucleotide probes.

(Appeal Br. 48–50.)

The following grounds of rejection by the Examiner are before us on
review:
Claims 1–5, 7–12, and 25 under 35 U.S.C. § 112, second paragraph,
as being indefinite.2
Claims 1–5, 7–12, 14–19, and 21–25 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement.
Claims 1–5, 7–12, 14–19, and 21–25 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Claims 1–5, 7–12, 14–19, and 21–25 under 35 U.S.C. § 101 because
the claimed invention is not supported by a specific, substantial, and credible
utility.
Claims 7, 8, 11, and 25 under 35 U.S.C. § 101 because the claimed
invention is directed to a judicial exception without significantly more.3

2 The Examiner withdrew rejection of claims 1–19 and 21–24 as being
indefinite regarding the use of the term “oligonucleotide.” (Ans. 35.) The
Examiner also withdrew the rejection of claims 1–5, 7–12, and 14–19 as
being indefinite regarding the use of the term “bead.” (Id.) Thus, the only
claims that remain rejected under 35 U.S.C. § 112, second paragraph, are 1–
5, 7–12, and 25.
3 The Examiner withdrew the rejection as applied to claims 1–5, 9, 10, 12,
15–19, and 21–24 in the Examiner’s Answer. (Ans. 36.)
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DISCUSSION
I. 112, second paragraph
A. The Examiner finds that claim 25 is indefinite as to what
structures the means-plus-function term, “means for elemental analysis,” is
to comprise after examining the Specification to determine what is described
to achieve the claimed function. (Final Action 4, 6.) The Examiner
contends that “elemental analyzer” defined at paragraph 24, merely
identifies that the device is an “instrument” which “is not deemed to provide
adequate structure of the claimed devices,” and that the “listing of a plethora
of different types of analysis that can be conducted” in paragraph 23 for
“elemental analysis” also does not provide any structure.
The Appellant argues that one of ordinary skill in the art would have
understood what structures were encompassed because one of skill in the art
would understand the instruments that are capable of performing the
elemental analyses set forth in paragraph 23 of the Specification, namely (1)
an optical atomic spectrometer would be an instrument that could be used to
measure “optical atomic spectroscopy, such as flame atomic absorption,
graphite furnace atomic absorption, and inductively coupled plasma atomic
emission, which probe the outer electronic structure of atoms,” (2) a mass
spectrometer could be used to measure “mass spectrometric atomic
spectroscopy, such as inductively coupled mass spectrometry, which probes
the mass of atoms,” (3) an X-ray fluorescence detector, an x-ray
photoelectron spectrometer or an auger electron spectrometer, that could be
used to measure “particle induced x-ray emission, x-ray photoelectron
spectroscopy, and Auger electron an x-ray photoelectron spectroscopy which
probes the inner electronic structure of atoms.” (Appeal Br. 17 (citing
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paragraph 23).) The Appellant further notes that the Specification provides
numerous specific structures that would be capable of use as a means for
elemental analysis including “a mass spectrometer-based flow cytometer,”
for particle elemental analysis (¶ 25), and an “inductively coupled plasma
mass spectrometer” for simultaneous assessment of protein expression level
and gene expression level of the cellular sample (¶ 40), and a “mass
spectrometer” to measure an element such as an isotope or ion (¶ 53). (Id.)
The Examiner does not dispute the foregoing. (See Ans. 36 (arguing
that asserting the instruments “can be” those that perform the functions
“does not require that they are used”).) We agree with the Appellant that the
means-plus-function term is not indefinite based on the undisputed fact that
one of ordinary skill in the art would have known at least one specific
structure that would perform the identified elemental analyses set forth in the
Specification.

B. The Examiner finds that claims 1–5 and 7–12 are indefinite with
respect to what the metes and bounds of the term “affinity reagent” are.
(Final Action 7.) The Appellant explains that one of ordinary skill in the art
would understand what is meant in light of the Specification, which
particularly defines the term at paragraph 17, and the Specification as a
whole, which makes clear that affinity reagent means a biological molecule
that can form specific non-covalent bonds with a target and which provides
examples of such biological molecules that are known to form such bonds
with specific target molecules. (Appeal Br. 20.) We agree with the
Appellant that one of ordinary skill in the art would have understood with
reasonable certainty what is within the scope of the term. Breadth is not
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equated with indefiniteness. In re Miller, 441 F.2d 689, 693 (CCPA 1971).
Thus, we do not agree with the Examiner that the claims reciting the term
“affinity reagent” are indefinite.
We therefore reverse the Examiner’s rejection of claims 1–5, 7–12,
and 25 as being indefinite
.
II. 112, first paragraph
A. Enablement
The Examiner indicates that the claims are “construed as
encompassing the analysis of any and all nucleic acids that are to be found in
any life form.” (Final Action 13.) The Examiner notes that “[i]n order to
select the appropriate probe/primers, which are deemed to be essential, one
must have knowledge of the nucleotide sequence of the template.” (Id. at
14.) The Examiner states that “[a]bsent knowledge of the nucleotide
sequence of the template, selection of the correct primer is highly
unpredictable.” (Id.) According to the Examiner “[w]ithout knowledge of
what the target sequence(s) is/are, one would not be able to select for the
correct/useful probe(s) and primers as operative embodiments for the master
mix of such probe system as broadly claimed in the presently pending
claims.” (Id.) The Examiner further finds, by way of example, that, because
the nucleotide sequence for the genome of any given species of bacteria is
highly unpredictable, for a person of ordinary skill to practice the full scope
of the invention, one would have to first determine the nucleotide sequence
for each and every organism before one would be able to select appropriate
probe and/or primer sequences that are essential to the claimed invention.
(Id. at 15.)
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We disagree with the Examiner’s conclusion. Appellant’s claim is
directed at using inductively coupled plasma mass spectrometry to analyze a
cell sample for at least a target nucleic acid. We agree with the Appellant
that “[t]he rejection and Answer fail to identify why identification of the
various target molecules and complementary probes is necessary to enable
the novel aspect of the claimed invention.” (Reply Br. 9.) Having identified
a target nucleic acid sequence of interest, a person of ordinary skill in the art
would have been able to apply the claimed method to identify the presence
of that target nucleic acid sequence without undue experimentation. “[A]t
the time the claim[ed] invention would be practiced, the particular target
mRNA molecule to use and the particular oligonucleotide probe to use
would be known to the individual practicing the claimed invention.” (Id. at
10.) Appellant’s Specification describes how to carry out the claimed
invention and “provides various working examples where model human
leukemia cell lines, A431 human epidermoid carcinoma cells, and K562
model cell lines were analyzed using the claimed methods.” (Appeal Br. 27;
Spec. ¶¶ 88–94.)
The Examiner does not advance specific persuasive evidence
demonstrating sufficiently that a person of ordinary skill in the art, who has
a high skill level (Appeal Br. 29–30), would have needed to experiment
unduly to determine suitable probe and target sequences for practicing the
claimed invention. The existence of numerous as yet undiscovered and un-
sequenced potential target sequences does not persuade us that such a highly
skilled artisan would have been able to practice the methods as claimed and
described only with undue experimenting.
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As the Appellant explains, and the Examiner does not dispute, “the
state of the art of molecular biology and the detection of nucleic acids is
quite developed” and “identifying a target mRNA and a complementary
oligonucleotide probe is not very difficult nor time consuming, and is
routine in the art.” (Appeal Br. 29.) The Appellant explains that “[d]esign
of probes capable of hybridizing to target nucleic acids is based on well-
known base pairing hybridization rules (e.g., A to T or U, C to G) that do not
depend on the origin of sample or species from which a target nucleic acid is
obtained. Such probes can be made, for example, using standard
oligonucleotide synthesis techniques known in the art.” (Id. at 30.) We
agree with the Appellant that “[t]he design of probes that bind to a target
mRNA/nucleic acid is not unpredictable.” (Reply Br. 8.) As the Appellant
notes “it is well known in the art that a sequence complementary to a known
target mRNA sequence will bind that target.” (Id. at 8–9.)
Regarding the breadth of the claims, we agree with the Appellant that
“regardless of the range of samples and target nucleic acids that may be
practiced with the claimed methods, the ability of nucleic acids to hybridize
with one another is not at issue.” (Id.) The Appellant explains that “one of
skill in the art would recognize that the various aspects of the claimed
methods do not differ according to the origin of the target nucleic acids.”
(Id.) We agree.
We, therefore, reverse the Examiner’s rejection that the claimed
invention is not enabled.
B. Written Description
The Examiner’s written description rejection is founded on the same
perceived deficiency noted for lack of enablement, namely that “the as-filed
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disclosure has not been found to teach the nucleotide sequence for neither
target that occurs in any life form nor the nucleotide sequence for any
corresponding probe.” (Final Action 28.)
We agree with the Appellant. As we have explained in the preceding
section of this Decision, the Appellant asserts that the method is universally
applicable to any known nucleic acid sequence and the Examiner has not
provided evidence to doubt that assertion. Thus the claimed method does
not require the recitation of any genus or genera of oligonucleotides. In
other words, the particular nucleic acid sequence of an oligonucleotide is
entirely immaterial to the practice of the Appellant’s claimed method, apart
from a knowledge of the target nucleotide sequence itself. The Appellant is
not claiming that any particular genus of nucleic acid molecules are new, but
rather the application of the method to target nucleic acids.
The instant facts are similar to those in Falko-Gunter, which teaches
that “where, as in this case, accessible literature sources clearly provided, as
of the relevant date, genes and their nucleotide sequences (here ‘essential
genes'), satisfaction of the written description requirement does not require
either the recitation or incorporation by reference (where permitted) of such
genes and sequences.” Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1368
(Fed. Cir. 2006) (footnote omitted). As already noted, the Specification
describes several model cell lines that were analyzed using the claimed
methods. (See Appeal Br. 33.) There can be no reasonable dispute that the
method of detecting a target nucleic acid in a cell sample using inductively
coupled plasma mass spectrometer would not function with any target
sequence hybridized with a complementary oligonucleotide probe labeled
with a unique metal tag. The Examiner does not advance persuasive
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evidence showing that a skilled artisan, viewing the claims and written
disclosure in the light of the knowledge in the prior art, would have failed to
recognize that the Appellant adequately described, and thereby possessed,
the claimed invention.
We therefore conclude that the evidence of record does not support
the Examiner’s conclusion that the Specification fails to provide descriptive
support for the claims. Accordingly, we reverse the Examiner’s rejection on
that ground.

101: Utility
The Examiner contends that independent claims 1, 10, 21, and 25 do
not require that the nucleic acids or proteins that are within the cellular
sample analyzed need to be known at the time of filing, much less that they
be useful. (Final Action 36.) Accordingly, the Examiner concludes that the
claims lack a specific and/or substantial utility because the material to be
identified itself is not considered to have a substantial utility. The Examiner
also concludes that the invention does not have a utility specific to the
subject matter “in contrast with a general utility that would be applicable to
the broad class of the invention.” (Id.)
We disagree with the Examiner’s rejection.
The Examiner’s concern appears to be that the claims read on
situations where one has no idea what is in a sample and, therefore, cannot
even design appropriate probes for use in the method. However, we do not
agree with the Examiner that this potential issue is sufficient to support a
utility rejection. See e.g., Brooktree Corp. v. Advanced Micro Devices, Inc.,
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977 F.2d 1555, 1571 (Fed. Cir. 1992) (“To violate 101 the claimed device
must be totally incapable of achieving a useful result.”).
“[T]o satisfy the ‘substantial’ utility requirement, an asserted use must
show that that claimed invention has a significant and presently available
benefit to the public.” In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005). It
is not necessary that the Appellant demonstrates that all uses of the method
be directed to the identification of useful nucleic acids as such; rather, what
is required is that the claimed method possess a specific utility. We agree
with the Appellant that it does. As the Appellant explains, “the
[S]pecification shows how the claimed methods may provide an alternative
assay to prior methods of nucleic acid detection, such as fluorescent in situ
hybridization (FISH), Fourier spectroscopy-based spectral imaging (Sim),
and Quantitative fluorescence in situ hybridization (Q-FISH).” (See e.g.,
Reply Br. 4 (citing ¶¶ 31–32.) Furthermore, the Specification describes use
of the method “to detect disease-relevant genes in human leukemia cells.”
(Id. (citing Spec. ¶ 73).)
We therefore reverse the Examiner’s rejection that the claimed
invention lacks a specific, substantial, and credible utility.

101: Judicial Exception
The Examiner determines that the methods of analysis claims are
“directed to an abstract idea” because the target mRNA and target nucleic
acid recited in the independent claims “can be from any source, and relate to
any gene as found in any source” and the “‘means for elemental analysis’
encompasses that which will perform any and all forms of analysis listed in
the non-limiting list found in paragraph [0023].” (Final Action 42; see also
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Ans. 50.) In the Answer, the Examiner contends that the “limitations found
in dependent claims 7, 8, and 11 speak of a judicial exception.” (Ans. 52.)
The Examiner next determines that the claimed methods do not include
additional elements that amount to significantly more than the judicial
exception because “the aspect of using an inductively coupled mass
spectrometer so to detect metal tags associated with a nucleic acid was well
known, routine in the art.” (Final Action 42.)
We disagree with the Examiner’s findings and conclusion that the
claims are directed to patent-ineligible subject matter. In the first place, we
agree with the Appellant that claims 7, 8, and 11, which are dependent
claims, are not properly rejected as directed to patent-ineligible subject
matter where the independent claim from which they depend are no longer
considered by the Examiner to be directed to patent-ineligible subject matter.
(Reply Br. 11.) As the Appellant correctly observes, these claims must be
considered as a whole, including all limitations recited in the independent
claims from which they depend. The independent claims have been deemed
by the Examiner to be directed to patent-eligible subject matter, it is unclear
how the further recitations in the dependent claims which narrow the
independent claims somehow render the narrower claimed subject matter to
be directed to patent-ineligible subject matter.
Notwithstanding the foregoing, we analyze this case under the two-
step framework described by the Supreme Court in Mayo Collaborative
Services v. Prometheus Laboratories, Inc., 566 U.S. 60 (2012) and Alice
Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014) taking into consideration the
“2019 Revised Patent Subject Matter Eligibility Guidance” (“Revised
Guidance”), issued by the Director of the USPTO on January 7, 2019, and
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which provides further details regarding how the Patent Office is to analyze
patent-eligibility questions under 35 U.S.C. § 101. 84 Fed. Reg. 50–57 (Jan.
7, 2019).
In the first step of the analysis “we determine whether the claims at
issue are directed to” a patent-ineligible concept. Alice, 573 U.S. at 217.
Under the Guidelines, that first step is broken down into two prongs.
Revised Guidance at 54. The first prong requires determination of the
whether the claim recites a judicial exception. If not then our inquiry ends
and we determine the claims are not directed to patent-ineligible subject
matter. Only if the claim is determined to recite a judicial exception do we
get to the second prong, which requires evaluation of the claim to determine
whether the judicial exception is integrated into a practical application. We
determine that the claims do not recite a judicial exception, and even if they
did any exception is integrated into a practical application.
STEP 2A. Prong One:
Under the Revised Guidance, a claim is considered to recite an
abstract idea if it recites (a) a mathematical concept, (b) methods of
organizing human activity, and/or (c) mental processes. We find that none
of the claims recite one of the foregoing categories of abstract idea. Claim 1
requires protein expression to be assessed with the inductively coupled
plasma mass spectrometer. Claim 10 requires the unique metal tag
associated with the complementary oligonucleotide probes hybridized to the
target nucleic acid with the inductively coupled plasma mass spectrometer
system. Claim 21 requires detecting the presence or absence of the target
nucleic acid in the cellular sample by detecting, with the inductively coupled
plasma mass spectrometer. Claim 25 requires assessing gene expression
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with the means for elemental analysis. As discussed above with regard to
the Examiner’s rejection of claim 25 under 112, second paragraph, (which
we reverse), we determine that the Specification defines sufficiently for one
of ordinary skill in the art instruments to perform this function in paragraphs
23–25, 40, and 53.
We also do not find the independent claims are directed to any law of
nature or a natural phenomenon. These claims are not directed at the nucleic
acids, per se, but rather are directed to specific steps for carrying out a
method for their detection, which steps do not rely on a correlation that is a
consequence of natural processes such as in Mayo or a naturally occurring
relationship as in Genetic Technologies Ltd v. Merial LLC, 813 F.3d 1369
(Fed. Cir. 2016). In claim 1, while it is true that the sample being analyzed
is a cellular sample, the claims require the sample be modified from its
natural state by including a first oligonucleotide probe coupled with a first
metal tag and an affinity reagent coupled with a second metal tag. It is the
detection of this metal tag by the inductively coupled plasma mass
spectrometer system that provides for the ability to assess the protein
expressing and gene expression. Similarly in independent claims 10 and 21,
while the detection relies on natural hybridization, the detection requires
labeling the complementary probe of the target sequence with a unique metal
tag. Here, again, the detection of the metal tag by the inductively coupled
plasma mass spectrometer is used to determine the presence of the target
nucleic acid. Claim 25 also relies on the addition of a metal tag on a probe
for detection of the gene of interest.
The fact that claim 7 is directed at determining a disease-relevant
gene, that claim 8 is directed at identifying bacteria, that claim 11 adds the
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step of quantifying the gene expression level does not change the foregoing
analysis. Thus, we conclude that none of the claims on appeal are directed
to a judicial exception.
However, even if we were to assume for the sake of argument that the
claims are directed to a natural phenomenon because they involve analysis
of cell samples for naturally occurring nucleic acids, similar to the claims to
detecting paternally inherited nucleic acid of fetal origin from a pregnant
female as in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed.
Cir. 2015), we determine that under the second prong, the judicial exception
is integrated into a practical application.

STEP 2A, Prong Two:
“Integration into a practical application” requires that the claim recite
an additional element or a combination of elements, that when considered
individually or in combination, “apply, rely on, or use the judicial exception
in a manner that imposes a meaningful limit on the judicial exception, such
that the claim is more than a drafting effort designed to monopolize the
judicial exception.” Revised Guidance at 54. As discussed above, the
nucleic acids that are to be detected must be hybridized with a probe that is
labeled with a metal tag. That metal tag is what is used for the detection of
the target nucleic acid. Thus the claims recite a combination of elements in
the method of detection that rely on the judicial exception in a manner that
imposes a limitation on the manner of detecting the judicial exception.
The fact that the claims “do not require any specific reaction
conditions” (Final Action 43) or that inductively coupled plasma mass
spectrometers were known in the art to detect metal tags so as to detect
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nucleic acids (Final Action 42) does not negate that the claims recite
limitations that rely on, or use the judicial exception in a manner that
imposes a meaningful limit on the judicial exception.
In light of the foregoing, for this additional reason, we do not sustain
the Examiner’s rejection of claims 7, 8, 11, and 25 as being directed to
patent-ineligible subject matter.
SUMMARY
We reverse the rejection of claims 1–5, 7–12, and 25 under 35 U.S.C.
§ 112, second paragraph, as being indefinite.
We reverse the rejection of claims 1–5, 7–12, 14–19, and 21–25 under
35 U.S.C. § 112, first paragraph, as failing to comply with the enablement
requirement.
We reverse the rejection of claims 1–5, 7–12, 14–19, and 21–25 under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
We reverse the rejection of claims 1–5, 7–12, 14–19, and 21–25 under
35 U.S.C. § 101 because the claimed invention is not supported by a
specific, substantial, and credibly utility.
We reverse the rejection of claims 7, 8, 11, and 25 under 35 U.S.C.
§ 101 because the claimed invention is directed to a judicial exception
without significantly more.

REVERSED