Ex Parte Beaudenon et al

Patent Trial and Appeal Board

Feb 13, 2019

14051354 (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/051,354 10/10/2013
32425 7590 02/15/2019
NORTON ROSE FULBRIGHT US LLP
98 SAN JACINTO BOULEVARD
SUITE 1100
AUSTIN, TX 78701-4255
FIRST NAMED INVENTOR
Sylvie Beaudenon
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.
ASUR.P0016US.Cl/ll316107 3318
EXAMINER
STRZELECKA, TERESA E
ART UNIT PAPER NUMBER
1637
NOTIFICATION DATE DELIVERY MODE
02/15/2019 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):
aoipdocket@nortonrosefulbright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SYLVIE BEAUDENON, LAURA ELIZONDO,
MARTINA DOLESHAL, DAVID BROWN, and
EMMANUEL LABOURIER
Appeal2017-008538
Application 14/051,3 54 1
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, 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
for detecting in a patient the presence of cancer cells in a lymph node
sample, which have been rejected as failing to comply with the enablement
requirement and as being directed to patent-ineligible subject matter. We
have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the real party in interest as Asuragen, Inc. (Br. 2.)
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Application 14/051,354
STATEMENT OF THE CASE
"For many cancers, lymph node involvement, or metastasis to lymph
nodes, has become recognized as a strong predictor of disease recurrence
and patient survival." (Spec. ,r 6.) "In general, current methods for
assessing lymph node involvement, especially those for evaluating the
presence of MMD[, micrometastatic disease], have significant limitations."
(Id. ,r 7.) "Only a very small fraction of a lymph node (approximately 0.1-
0.2%), is evaluated microscopically for metastatic cancer cells by a
pathologist." (Id.) "It is believed that a major contributing factor to missed
metastases is the presence in the lymph node of occult metastasis (i.e., not
readily apparent or hidden) and/or MMD that is not detected by the present
state of the art examination." (Id.) The invention is directed at overcoming
the current limitations for assessing lymph node involvement in the use of
novel molecular markers, microRNAs ("miRNAs"). (Id.)
Claims 1, 3, 4, 6, 7, 10, 11, 94, 95, 102, and 103 2 are on appeal.
Claims 1 and 102 are representative and read as follows:
1. A method for detecting in a patient the presence of cancer
cells in a lymph node sample associated with cancer or
suspected of cancer comprising measuring an elevated level of
expression of one or more of the following miRNAs: miR-141,
miR-200a, miR-200b, miR-200c, miR-203, or miR-429
compared to the expression level in cells of a non metastatic
lymph node and identifying the sample as containing cancer
cells.
(Br. 7.)
2 Claims 96-101 have been withdrawn from consideration. (Final Action
2.)
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102. A method for detecting in a patient the presence of
cervical or breast cancer cells in a lymph node sample
associated with cancer or suspected of cancer comprising
a) measuring an elevated level of expression of at least a
first miRNA that is miR-141, miR-200a, miR-200b, miR-
200c, miR-203, or miR-429 compared to the expression
level in cells of a non metastatic lymph node;
b) measuring an elevated level of expression of at least a
second miRN A that is miR-182 or miR-183,
c) identifying the sample as containing cervical or breast
cancer cells.
(Br. 8-9.) In response to a species restriction made by the Examiner on
November 18, 2014, Appellants elected to pursue examination of the claims
with respect to miR-200b and miR-141. (Response dated May 18, 2015.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 3, 4, 6, 7, 10, 11, 94, 95, 102, and 103 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the enablement requirement.
Claims 1, 3, 4, 6, 7, 10, 11, 94, 95, 102, and 103 under 35 U.S.C.
§ 101 as being directed to patent-ineligible subject matter.
DISCUSSION
Lack of Enablement
The Examiner finds that the broad invention recited by the claims is in
a highly unpredictable art. (Final Action 16.) As to the breadth of the claim,
the Examiner explains that "the claims are drawn to detecting expression
level of any one of these miRNAs[, the elected ones in addition to the other
named miRNAs,] or their combinations, in addition to any other miRNAs
due to the 'comprising' language." (Ans. 14.) In addition, the Examiner
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notes that the "lymph node sample" "can have a few cancer cells, a large
percentage of cancer cells or no cancer cells." (Id.) Moreover, explains the
Examiner, "[t]he claims do not require that the non-metastatic lymph node
[to which the expression level of miRNAs is to be compared] be obtained
from a patient, therefore it could be obtained from a different individual."
(Id.) In addition, the Examiner points out that, "[ e ]xcept for claim 10, the
claims do not require any specific method of measuring expression levels of
the claimed miRNAs." (Id.) And as to claim 10, which requires using RT-
PCR or hybridization or both, the claim does not provide for "specific
miRNA or their combination to be used for gene expression normalization,"
which one of ordinary skill in the art usually used "[i]n order to obtain
meaningful expression data." (Id. at 14--15.) The Examiner further explains
that "the claims are drawn to any cancer (claims 1, 3, 4, 6, 7, 10), breast,
colon or cervical cancer ( claim 11) or cervical or breast cancer ( claim[ s] 94,
95, 102 and 103)." (Id. at 15.)
Regarding the state of the art, based on a review of several published
papers, the Examiner finds that "there is a large variability in the miRNA
expression profiles, which can be the result of genuine differences in the
levels of miRNA expression between primary tumors and metastatic cells,
sample heterogeneity, differences in the number of samples used for
analysis, differences in technical platform and analysis methods." (Final
Action 13.) This conclusion is based on the following findings by the
Examiner.
The Examiner finds that in one paper concerning the study of cancer
tissue discrimination from normal tissue using levels of miRNA expression,
and in which the goal was to determine whether there were universal
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miRNAs that were overexpressed in more than one tumor type, a number of
miRNAs were found to be overexpressed in more than one tumor type
compared to normal tissue samples but the authors noted "a significant
discrepancy between their findings and the results obtained" by another
author. (Id. at 11.) The other author, carrying out a similar study, found all
of the miRNAs differentially expressed between cancer and normal tissues
were underexpressed relative to normal tissue. (Id.) The Examiner notes
that the authors suggest that the "differences in results could be caused by
differences in sample number ... and/or the detection technique and
different analytical approach." (Id.)
Additionally, the Examiner explains that in another paper, published
after the filing date of the present invention where microarray hybridization
was carried out,
Mir-200b and mir-141 were found to be downregulated in the
lymph node samples as compared to the tumors. However,
when the tissue specificity was considered, there was no
overlap between the miRN As differentially expressed in all
tumors vs. all lymph nodes as compared to specific pairs of
tumors and lymph nodes (Table 2). Further, the specific
differentially expressed miRNAs were both overexpressed and
underexpressed in the metastatic lymph nodes as compared to
solid tumors.
(Id. at 12 (emphasis added).)
In yet another study examining the possibility of classifying the origin
of metastatic tissues based on miRNA expression, it was noted by the
authors that
"For most cancers, such as breast or colon cancer
(Supplementary Fig. 4a,b online ), we found no significant
differences between primary and metastatic tumors (Fig. 2a,b)."
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(Id. (quoting Rosenfeld3).) But in stomach, prostate, or head and neck
primary tumors there was some differentiation from solid tumor and
metastases to lymph node for three miRNAs. (Id.) However, those miRNA
were not miR200b or 141 and overexpression for two was found in primary
tumors from the stomach not in lymph cells. (Id.) Thus, even differentiating
primary tumors from metastases, the authors note "that primary tumors can
be used in training a classifier for metastases, but must be used with care and
with attention to specific markers and to context." (Id. at 13.)
Turning to the Specification guidance, the Examiner finds that while
the Specification includes working examples where differential expression
of sets of miRNAs was detected between normal tissues and cancer-negative
lymph nodes or between cancer and/or cancer-positive lymph nodes and
cancer-negative lymph nodes, these examples do not determine whether
cells of unknown status at the time of testing are cancer-positive. (Id. at 8-
9.) Moreover, the Examiner finds that differential expression data indicates
that the "fold-change of mir-200b and mir-141 expression is of the same
magnitude in normal breast cancer and cancer-positive lymph nodes as
compared to cancer-negative lymph nodes." (Id. at 9.) The Examiner finds
also that while there is data concerning differential expression of mir-200b
and mir-141 in normal tissue type as compared with normal lymph nodes,
(see Specification Table 37), the disclosure "does not provide any data
which shows that the same miRNAs are overexpressed in all of the 15, 12
and 10 metastatic cells found in the lymph nodes." (Id. at 10.)
3 Rosenfeld et al., MicroRNAs accurately identify cancer tissue origin, 26
Nature Biotech. 462--469, 463 (2008).
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The Examiner further finds that in the examples "different miRNAs
were used for calibration of results in the different samples. Which miRNA
was used depended on its expression level between samples, i.e., the miRNA
used for result calibration was determined after the data was collected." (Id.
at 9.) The Examiner further finds that the data in the Specification
demonstrates that "the number of lymph nodes examined influences the
results due to the heterogeneity of miRNA expression in cancer-positive
lymph nodes." (Id. at 11.) In summary the Examiner explains
[Appellants] data presented in Examples 3-8, 11, 12, 17, 18, 40
and 42--47 for samples of lymph nodes from patients with
melanoma, colon, breast and cervical cancers clearly indicates
that issues such as the method of detection of the miRNA
expression level, normalization factor, amount of cancer cells in
the lymph node and sample heterogeneity have a significant
effect on the determined levels of miRNAs in the different
types of cancerous lymph nodes, indicating unpredictability in
the outcome of the measurements.
(Ans. 15.)
The Examiner concludes:
While the data presented shows that some miRNA expression
levels can differentiate between different tissue types or
between cancerous and non-cancerous lymph nodes, there is no
evidence that expression levels of any single miRNA or any
miRNAs combinations can be used to determine a status of an
unknown lymph node. Further, even if such status could be
determined, i.e., indicating that the lymph node is cancer-
positive, it would further require investigation as to which type
of tumor cells is present in the lymph node. . . . [A] lot of
further research is required before the instant data can be used
to assess any disease or condition, including cancer.
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(Final Action 10-11.) The Examiner further finds that "years of inventive
effort" would be required to determine the usefulness of the elected miRNAs
for cancer diagnosis. (Id. at 15-16.) In particular, the Examiner notes
The quantity of experimentation in this area is extremely large
since there is significant number of parameters which would
have to be studied to apply this technology to detection of
cancer cells in lymph nodes, including, among others,
determination of unique, cancer specific miRNA markers which
are specific for metastatic cells, development of techniques for
miRNA expression determination which produce consistent
results among different technical platforms, large-scale clinical
trials of the markers to determine their usefulness ....
(Id. at 15.)
We agree with the Examiner's factual findings and conclusion that the
claims are not enabled. Appellants argue that the enablement requirement is
met because (a) "[t]he specification shows which miRNAs have differential
expression-including miRNAs recited in the claims, and it provides
guidance to one skilled in the art how this would be done on a lymph node
of unknown cancer status," (Br. 3--4), and (b) "the Action admits that the
data in the specification-that is data generated as of the time of filing-
provides evidence of differential miRNA expression" (id. at 4). We are not
persuaded for the reasons explained by the Examiner, which we note above.
In particular, we agree with the Examiner that while the Specification
includes working examples where differential expression of sets of miRNAs
was detected between normal tissues and cancer-negative lymph nodes or
between cancer and/or cancer-positive lymph nodes and cancer-negative
lymph nodes, these examples do not determine whether cells of unknown
status at the time of testing are cancer-positive and the level of expression of
a given miRNA depends on the type of cancer examined. Furthermore, we
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agree with the Examiner that Appellants' own data indicates that "[ t ]he level
of overexpression ( or a lack thereof) of a given miRNA strongly depends on
the assay used to determine the level of expression: the levels of expression
obtained by microarray hybridization differ from levels obtained using
quantitative real-time PCR, and even different microarray-based methods
produce different results." (Ans. 24.) As the Examiner explained, despite
the differential expression data in the Specification of sets of miRNAs
detected between normal tissues and cancer-negative lymph nodes or
between cancer and/or cancer-positive lymph nodes and cancer-negative
lymph nodes:
one of ordinary skill in the art at the time of the invention
would have to examine cancer-positive lymph nodes for all
possible types of cancers to determine which miRNAs provide
consistent expression levels for different analysis platforms and
analysis parameters. Further, one of ordinary skill in the art at
the time of the invention would have to determine what the
expression threshold is for each of these miRNAs or their
combinations in order to be able to determine whether a given
miRNA is overexpressed in the lymph nodes harbouring cancer
cells.
Considering the conflicting results presented by Appellant[ s]
and unpredictability in the art of determining miRNA
expression in metastatic cells and lymph nodes, as described in
the cited references, this would constitute undue
experimentation ....
(Ans. 25.) Appellants do not refute the foregoing or that there is
unpredictability using miRNA overexpression for cancer tissue
discrimination evidenced in the prior art.
Thus, for the foregoing reasons, Appellants do not persuade us that
the Examiner erred in rejecting claim 1 for lack of enablement.
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Claims 3, 4, 6, 7, 10, 11, 94, 95, 102, and 103 have not been argued
separately and therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
II
Patent-Ineligible Subject Matter
The Examiner finds that claim 1 is directed to a method of detecting
cancer cells in lymph nodes by measuring elevated levels of expression of at
least two miRNA's compared to expression levels in cells of non-metastatic
lymph nodes. (Final Action 17.) The Examiner finds that the method is,
thus, directed to a naturally existing correlation, i.e., the level of expression
of particular miRNAs and the presence of cancer cells in a lymph node
sample. (Id.; see also id. at 6.) The Examiner explains that "this type of
correlation is a consequence of a natural process[], similar to the naturally
occurring correlation found to be a law of nature by the Supreme Court in
Mayo[ Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66
(2012)]." (Ans. 26.) The Examiner notes that "[t]he only step required by
the claims is measuring expression level" in order to determine whether the
lymph node contains cancer cells. (Id.) The Examiner finds that this step
"is recited at a high level of generality such that it amounts to insignificant
presolution activity, e.g., a mere data gathering step necessary to use the
correlation." (Id. at 26-27.)
Appellants argue that the claim is "not attempting to patent a 'law of
nature"' because there is "is no evidence that laws of nature involve
measuring the levels of expression of certain miRNAs in order to detect the
present of cancerous cells among non-cancerous cells. There is nothing
natural about measuring these levels of miRNA expression in these cells."
(Br. 5) ( emphasis omitted.) Appellants further argue that unlike in Mayo,
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the claimed method "set[ s] forth a limitation as a result of the previous
[measuring] step[], such as the identification of a sample as containing
cancer cells" and unlike in Mayo, there is no prior art that indicates the thing
that is measured is indicative of the result observed. (Id.)
We agree with the Examiner that Appellants claimed methods are
patent-ineligible. We analyze this case under the two-step framework
described by the Supreme Court in Mayo 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 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 our analysis, we must still determine whether Appellants claims are
directed to a law of nature. We analyze claim 1 as representative. We agree
with the Examiner that claim 1 is directed to a law of nature. Claim 1 recites
a method in which a law of nature is observed, the presence of an elevated
level of expression of specific miRNA that is correlated to whether a lymph
node sample contains a cancer cell. The method does not purport to alter the
expression levels in any way, it just "sees" the levels. "The correlation
exists in nature apart from any human action." Athena Diagnostics v. Mayo
Collaborative Servs., appeal no. 2017-2508, slip op. at 10 (Fed. Cir. Feb. 6,
2019). This is similar to the facts of Cleveland Clinic Foundation v. True
Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017) in which our
reviewing Court found the following claim directed to a law of nature:
11. A method of assessing a test subject's risk of having
atherosclerotic cardiovascular disease, comprising
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comparing levels of myeloperoxidase in a bodily sample from
the test subject with levels of myeloperoxidase in comparable
bodily samples from control subjects diagnosed as not having
the disease, said bodily sample being blood, serum, plasma,
blood leukocytes selected from the group consisting of
neutrophils, monocytes, subpopulations of neutrophils, and sub-
populations of monocytes, or any combination thereo [ fJ;
wherein the levels of myeloperoxidase in the bodily from the
test subject relative to the levels of [ m ]yeloperoxidase in the
comparable bodily samples from control subjects is indicative
of the extent of the test subject's risk of having atherosclerotic
cardiovascular disease.
859 F.3d 1352, 1356, 1360-61. Similarly in Mayo, the Supreme Court
found that a claim was directed to a natural law, where the claim required
administering a drug and determining the levels of a metabolite following
administration, where the level of metabolite was indicative of a need to
increase or decrease the dosage of the drug. Mayo, 566 U.S. at 74.4; see also
Athena, slip op. at 9-10 (noting that detecting the presence of a label in a
method for diagnosing neurotransmission or developmental disorders related
4 The claim in Mayo recited:
A method of optimizing therapeutic efficacy for treatment of an
immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having
said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having
said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per
8x 108 red blood cells indicates a need to increase the amount of said
drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per
8xl08 red blood cells indicates a need to decrease the amount of said
drug subsequently administered to said subject.
Id. at 74--75 (quotations omitted).
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to MuSK comprising contacting labeled MuSK with a bodily fluid,
immunoprecipitating any antibody/MuSK labeled complex, monitoring for
the label, and noting the presence of the label is indicative neurotransmission
or developmental disorder related to MuSK, involves "the correlation
between the presence of naturally-occurring MuSK autoantibodies in bodily
fluid and MuSK related neurological diseases" that "exists in nature apart
from any human action.").
Under the Revised Guidance, we further determine "whether the claim
recites additional elements that integrate the exception into a practical
application of that exception." 84 Fed. Reg. at 54. Limitations that are
indicative of integration into a practical application include applying the
natural law to effect a particular treatment or prophylaxis for a disease or
medical condition. See, e.g., Vanda Pharms. Inc. v. West-Ward Pharms.
Int'! Ltd., 887 F.3d 1117, 1134--35 (Fed. Cir. 2018) (holding that claims
including a limitation of genotyping to determine if a patient is a CYP2D6
poor metabolizer and then administering a drug in certain amounts
depending upon whether the patient is or is not a CYP2D6 poor metabolizer
where risk of QTc prolongation is correlated to the amount of drug
administered and status as CYP2D6 metabolizer is an application of the
relationship between the drug, CYP2D6 metabolism, and QTc prolongation).
On the other hand, diagnostic methods that simply measure the
concentration of a drug after administration and determine whether a
particular dosage of a drug will prove ineffective or cause harm is not a
practical application. Mayo, 566 U.S. at 77. That is because the method
itself does not recite a use of the relationship that is an entirely natural
process, it simply provides for an observation based on that relationship. Id.;
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see also Athena, slip op. at 12 (noting that while the claims include certain
concrete steps, those steps only apply conventional techniques to detect the
natural law, i.e., "observe its operation."), Cleveland Clinic, 859 F.3d at
1362. We find, as the Examiner did, that the only steps required by the
claims is measuring expression level and once that is done an observation is
made as to whether cancer cells are present. The measuring step is not an
additional element that integrates the exception into a practical application,
nor is the observation. Similar to the "determining" step in Mayo, here the
measuring step tells the person performing the method to determine the level
of miRNAs through whatever process that person wishes to use. See Mayo,
566 U.S. at 79. 5 The identification step simply notes that a particular
conclusion can be drawn in light of the correlation: "rather like Einstein
telling linear accelerator operators about his basic law and then trusting them
to use it where relevant." Id. at 78. Moreover, as indicated in Appellants'
Specification, the determination of the miRNAs in a sample can be done
using "techniques well known to one of ordinary skill in the art." (Spec. ,r,r
10-11, 49, 177-178, 180-185, 187, 190-191, 195.)
Furthermore, considering the steps of claim 1 together as an ordered
combination "adds nothing to the laws of nature that is not already present
when the steps are considered separately." Id. at 79. We conclude,
therefore, that the claims do not recite additional elements that integrate the
5 While claim 10 recites the use of a particular detection method, the named
methods are conventional techniques. Indeed, Appellants does not purport
to have invented these techniques. (See Br. 5.) As the Supreme Court stated
in Mayo: "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." Mayo, 566 U.S. 79.
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exception into a practical application of that exception. The process steps
here merely tell those "interested in the subject about the correlations that
the researchers discovered" id. at 78, just as our reviewing court found was
the case in Cleveland Clinic, where the diagnostic method claims had steps
paralleling the ones present here, see supra. Cleveland Clinic, 859 F.3d at
1363; see also Athena, slip op. at 13 and 16-17 ("The claims here are
directed to a natural law because they recite only the natural law together
with standard techniques for observing it. That the routine steps are set forth
with some specificity is not enough to change that conclusion.").
Appellants essentially argue that the prior art does not disclose that
overexpression of the recited miRNAs could be used to identify cancer cells
among non-cancerous lymph cells. (Br. 5.) But the correlation between
those miRNAs and the relationship to cancer is a law of nature, and cannot
impart patentability to the claims even if it was previously unknown.
Athena, slip op. at 17-18. The process itself, not merely the recognition of
the law of nature, must be new and useful. See Parker v. Flook, 437 U.S.
584, 591-95 (1978) ("[R]espondent's claim is, in effect, comparable to a
claim that the formula 2nr can be usefully applied in determining the
circumference of a wheel. As the Court of Customs and Patent Appeals has
explained, 'if a claim is directed essentially to a method of calculating, using
a mathematical formula, even if the solution is for a specific purpose, the
claimed method is nonstatutory.' In re Richman, 563 F.2d 1026, 1030
( 1977). "). That is "to supply an inventive concept the sequence of claimed
steps must do more than adapt a conventional assay to a newly discovered
natural law; it must represent an inventive application beyond the discovery
of the natural law itself." Athena, slip op. at 18.
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Thus, for the foregoing reasons, Appellants do not persuade us that
the Examiner erred in rejecting claim 1 as being directed to patent-ineligible
subject matter.
Claims 3, 4, 6, 7, 10, 11, 94, 95, 102, and 103 have not been argued
separately and therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1, 3, 4, 6, 7, 10, 11, 94, 95, 102, and
103 under 35 U.S.C. § 112, first paragraph as failing to comply with the
enablement requirement.
We affirm the rejection of claims 1, 3, 4, 6, 7, 10, 11, 94, 95, 102, and
103 under 35 U.S.C. § 101 as being directed to patent-ineligible subject
matter.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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