Ex Parte Andersen et al

Patent Trial and Appeal Board

Jun 13, 2016

13352435 (P.T.A.B. Jun. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/352,435 01/18/2012
93599 7590
Eric P. Mirabel, JD, LLM
3783 Darcus Street
Houston, TX 77005
06/15/2016
FIRST NAMED INVENTOR
Lars Dyrskjpt Andersen
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.
SRG-321-MBNL2-II 9431
EXAMINER
HIBBERT, CATHERINE S
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
06/15/2016 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):
emirabel@comcast.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LARS DYRSKJ0T ANDERSEN and
TORBEN FALCK ORNTOF 1
Appeal2013-008591
Application 13/352,435
Technology Center 1600
Before ERIC B. GRIMES, ROBERT A. POLLOCK, and JACQUELINE T.
HARLOW, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a business
method based on determining the likelihood of bladder cancer progression,
which have been rejected based on patent-ineligibility, indefiniteness, lack
of written description, nonenablement, and anticipation. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as Catalyst Assets LLC and
Aros Applied Biotechnology A/S. (Appeal Br. 3.)
Appeal2013-008591
Application 13/352,435
STATEMENT OF THE CASE
The Specification states that bladder cancer can take the form of either
recurring superficial tumors (stages Ta and T 1 ), or it can progress to a
muscle invasive form (stages T2 and up). (Spec. 1.) "The ability to predict
which tumors are likely to recur or progress would have great impact on the
clinical management of patients with superficial disease, as it would be
possible to treat high-risk patients more aggressively." (Id. at 2.)
"The invention relates to determining expression levels of certain
markers associated with progression or death from bladder cancer. More
particularly, expression levels of markers MBNL2, F ABP4, UBE2C, and
BIRC5 have been associated with progression or death from bladder
cancer." (Id. at 3.)
Claims 1, 13, and 14 are on appeal. Claim 1 is illustrative and reads
as follows:
1. A business method of generating revenue for conducting assays where the
assays are predictive of progression of a stage Ta or Tl bladder cancer,
compnsmg:
a. determining the likelihood of progression of an individual's bladder
cancer, by, using an assay in which assay reagents hybridize with
nucleic acids in a bladder tumor sample from the individual, or an
assay in which assay reagents bind to proteins in the sample, for
determining:
the level of gene expression from the markers FABP4 and MBNL2
and if the expression level determined for both F ABP4 and MBNL2 is
increased as compared to their expression levels in a control or
different bladder cancer sample, it indicates a decreased risk of
progression relative to said control or different bladder cancer sample;
and if the expression level for F ABP4 and MBNL2 is decreased as
compared to their expression levels in a control or different bladder
cancer sample, it indicates an increased risk of progression relative to
said control or different bladder cancer sample; and
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b. reporting to a customer whether the risk of progression is increased
or decreased and charging the customer in connection with the report.
The claims stand rejected as follows:
Claims 1, 13, and 14 under 35 U.S.C. § 101 as being directed to non-
statutory subject matter (Ans. 2);
Claims 1, 13, and 14 under 35 U.S.C. § 112, second paragraph, as
indefinite (Ans. 6);
Claims 1, 13, and 14 under 35 U.S.C. § 112, first paragraph, as
containing new matter (Ans. 7);
Claims 1, 13, and 14 under 35 U.S.C. § 112, first paragraph, as
nonenabled (Ans. 8); and
Claims 1, 13, and 14 under 35 U.S.C. § 102(e) as anticipated by
Mack2 (Ans. 14).
I
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 101 as being directed to patent-ineligible subject matter. The Examiner
applied the test set out in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 132 S. Ct. 1289 (2012), as directed in a 2012 guidance
memo. (Ans. 3---6.) The Examiner concluded that the claims were directed
to "a law of nature or natural correlation, with additional steps that involve
well-understood, routine, conventional activity previously engaged in by
researchers in the field," and therefore not eligible for a patent. (Id. at 6.)
2 US 2004/0076955 Al, published April 22, 2004.
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Appellants argue that the claims require using reagents that hybridize
with nucleic acids in a sample or reagents that bind to a protein in a sample,
"which are steps well beyond any 'natural law' in the claims." (Appeal Br.
9.) Appellants also argue that claim 14 requires an RT-PCR (a.k.a. QPCR)
assay, "which is a further step beyond a natural law or its application." (Id.
at 9-10.)
Appellants also argue that the claims do not preempt the natural
principle, because "[n]o one is foreclosed from simply correlating gene
expression with bladder cancer progression and reporting it." (Id. at 11.)
Finally, Appellants argue that "[i]t was not known to compare FABP4 and
MBNL2 gene expression levels to determine the likelihood of bladder
cancer progression ... and then report it and charge a customer, as in all the
claims." (Id. at 12.)
We agree with the Examiner that, under the two-step test of Mayo, the
claims are not directed to patent-eligible subject matter. The Mayo court
applied its test to claims that are similar to those of the instant application.
In Mayo, the claimed invention was a "method of optimizing therapeutic
efficacy for treatment of an immune-mediated gastrointestinal disorder"
comprising administering a certain class of drug and then determining the
level of 6-thioguanine ( 6-TG) in a patient, where a level of 6-TG below or
above certain amounts indicated a need to increase or decrease, respectively,
the drug dosage. Mayo, 122 S. Ct. at 1295.
Claim 1 of the instant application is similar, in that it is directed to a
method of predicting whether a given patient's bladder cancer is or is not
likely to progress from an early, superficial stage to a muscle-invasive stage,
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by measuring the expression of the F ABP4 and MBNL2 genes and
comparing the results to a control, then reporting the result and charging the
customer for the service.
The Mayo Court concluded that the claims at issue in that case "set
forth laws of nature-namely, relationships between concentrations of
certain metabolites in the blood and the likelihood that a dosage of a
thiopurine drug will prove ineffective or cause harm." Id. at 1296.
Similarly here, claim 1 on appeal sets forth a law of nature-namely,
a relationship between the levels of expression of F ABP4 and MBNL2, and
the likelihood that a bladder cancer will progress to a more invasive form.
Under the first step of the Mayo test claim 1 on appeal is directed to a law of
nature or natural phenomenon.
The Mayo Court next turned to the question "[ w ]hat else is there in
the claims before us?" Id. at 1297. The claims in Mayo included an
"administering" step, a "determining" step, and a "wherein" clause. Id. The
Court concluded that "[t]he upshot is that the three steps simply tell doctors
to gather data from which they may draw an inference in light of the
correlations." Id. at 1298. In other words,
the claims inform a 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.
Id. The Court concluded that "the steps are not sufficient to transform
unpatentable natural correlations into patentable applications of those
regularities." Id.
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Like the steps of the claims in Mayo, the manipulative steps of claim 1
on appeal also "consist of well-understood, routine, conventional activity
already engaged in by the scientific community." Id. Using assay reagents
that hybridize to nucleic acids (including using quantitative PCR (QPCR,
a.k.a. RT-PCR)) or reagents that bind to proteins in order to measure the
expression level of a given gene is conventional, as shown by Mack:
"Often, amplification-based assays are performed to measure the expression
level of bladder cancer-associated sequences .... Methods of quantitative
amplification are well known to those of skill in the art." (Mack i-f 153.) See
also id. at i-f 60 (examples of "a reagent that specifically detects expression
levels" include "antibodies capable of specifically binding to proteins
expressed by the gene of interest").
The step of comparing gene expression levels is also routine, as also
shown by Mack, which states that its "invention provides nucleic acid and
protein sequences that are differentially expressed in bladder disease or
cancer relative to normal tissues." (Id. at i-f 104.) The final step of claim 14,
reporting the result and charging the customer, simply informs a customer of
the correlation in exchange for payment.
Thus, when claim 1 is considered as an ordered combination, it
informs a relevant audience of certain laws of nature: specifically, that the
expression levels of F ABP4 and MBNL2 can be used to distinguish between
bladder cancer patients whose cancer is more likely or less likely to
progress. All of the additional steps of claim 1 consist of well-understood,
routine, conventional activity already engaged in by the scientific
community such as Mack. The same is true of claim 14 because, as
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discussed above, using QPCR to measure gene expression levels is routine
and conventional, as shown by Mack.
We conclude that, under the Mayo test, claims 1 and 14 are directed to
patent-ineligible subject matter. The rejection of claims 1 and 14 under 35
U.S.C. § 101 is affirmed. Claim 13 was not argued separately and therefore
falls with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
II
The Examiner has rejected claims 1, 13, and 14 as indefinite. The
Examiner reasons that "[c]laim 1 provides for the 'using' of 'an assay' and
claim 14 recites 'use in a RT-PCR assay' but ... it is unclear what
method/process applicant is intending to encompass. A claim is indefinite
where it merely recites a use without any active, positive steps delimiting
how this use is actually practiced." (Ans. 6.)
Appellants argue that "[c]laim 1 actually provides for using 'an assay
... for determining"' the level of gene expression ofFABP4 and MBNL2
compared to a control or different bladder cancer sample. (Appeal Br. 13)
"Accordingly, the claim recites positive steps, in a conventional format for
method claims." (Id.)
We will reverse this rejection. Assays using reagents that hybridize to
nucleic acids or reagents that bind to proteins in order to determine
expression levels are conventional in the art, as discussed above in the
context of the§ 101 rejection. The Examiner has acknowledged as much.
(See Ans. 4--5: "these additional steps consist of well-understood, routine,
conventional activity." See also Mack i-fi-160 and 153, which discuss assays
using such reagents.) Thus, the evidence supports Appellants' position that
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those skilled in the art would know the scope of a step of "using" the recited
assays to determine the expression level of a particular gene. The rejection
under 35 U.S.C. § 112, second paragraph, is reversed.
III
The Examiner has rejected claims 1, 13, and 14 as containing new
matter. The Examiner finds that "[t]he specification as originally filed does
not provide support for a business method of generating revenue as now
claimed. None of the terms 'business', 'customer' or 'revenue' are present
in the application as filed." (Answer 7.) The Examiner therefore finds that
"[ s ]uch limitations recited in the present claims, which did not appear in the
specification as filed, introduce new concepts and violate the description
requirement of the first paragraph of 35 U.S.C. 112." (Id.)
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prim a facie case of unpatentability." In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). "In the context of the
written description requirement, an adequate prima facie case must ...
sufficiently explain to the applicant what, in the examiner's view, is missing
from the written description." Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed.
Cir. 2007). "When no such description can be found in the specification, the
only thing the PTO can reasonably be expected to do is to point out its
nonexistence." Id. The Examiner's finding that the Specification does not
include three of the key terms in claim 1 is sufficient basis for a prima facie
case that the Specification lacks adequate written description of the claimed
method.
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Appellants argue that, before the filing dates of their priority
applications, it was well known in the art that Affymetrix was commercially
producing oligonucleotide arrays, and Incyte Pharmaceuticals was
developing a business based on selling genomic information. (Appeal Br.
14--15.) Appellants also contend that the Specification "demonstrates how
well known it was by those in the art to generate revenues by reporting assay
results." (Id., citing Spec. i-f 136.)
Appellants also argue that the Specification's disclosure under the
heading "Assays" demonstrates "to one skilled in the art that performing the
assays and the data gathering, analysis and reporting are conducted by a
laboratory as fee for service, as such persons know that only a commercial
lab would be able to retain and maintain the personnel, facilities, equipment
and reagents needed" to carry out such assays on multiple samples. (Id. at
15-16.)
We do not find Appellants' argument persuasive. First, Appellants
have not pointed to evidence in the record supporting their position that,
based on the businesses of Affymetrix and Incyte Pharmaceuticals, a person
of ordinary skill in the art would have recognized the Specification as
showing possession of the method now claimed. "Attorney's argument in a
brief cannot take the place of evidence." In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974).
In addition, Appellants have not shown that Affymetrix's business of
synthesizing oligonucleotide arrays, or Incyte Pharmaceuticals' business of
selling information from a gene sequence database, would have led a skilled
artisan to recognize in the Specification a description of a business that
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involves carrying out gene expression assays to predict the progress of a
patient's bladder cancer, which is a completely different business from
described for Affymetrix or Incyte Pharmaceuticals.
Appellants also have not pointed to evidence supporting their position
that the Specification's description of assays would be recognized as
describing a laboratory that carries out the disclosed assays as a fee-for-
service business. The paragraphs from the Specification that Appellants cite
refer to hybridization and antibody reagents; gathering data from
oligonucleotide or microcapillary arrays; and reporting those data to a "data
analysis operation" such as a programmed digital computer. Appellants
have not explained why this description of assays would have been read to
show possession of a fee-for-service business of carrying out the described
assays, and Appellants' conclusory statement to that effect is not supported
by evidence.
"After evidence or argument is submitted by the applicant in response
[to the prima facie case], patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration to
persuasiveness of argument." In re Oetiker, 977 at 1445.
We conclude that the rejection of claim 1 for lack of adequate written
description is supported by a preponderance of the evidence and Appellants'
arguments are unpersuasive. The rejection of claim 1 under 35 U.S.C.
§ 112, first paragraph (written description), is affirmed. Claims 13 and 14
have not been argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
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IV
The Examiner has rejected claims 1, 13, and 14 as nonenabled. The
Examiner finds that the claims are broad, in that they only require assaying
two marker genes. (Ans. 9.) The Examiner cites several references as
evidence that "the MBNL2 gene marker is considered to be a gene that
would be predictive of likelihood of progression or poor prognosis." (Id.
(citing Mack3, Clarke,4 and Bignotti5).) The Examiner also cites Sanchez-
Carbayo6 as evidence of unpredictability (id. at 11), and notes that the
Specification does not include a working example of the claimed method (id.
at 12). The Examiner concludes that "the skilled artisan could not make and
use the claimed invention from the disclosures in the application coupled
with information known in the art without undue experimentation." (Id. at
14.)
Appellants argue that they have provided evidence showing that the
correlation between MBNL2 and F ABP4 expression levels and either
progression or non-progression of bladder cancer is statistically significant.
(Appeal Br. 16-17.) Appellants also argue that the references cited by the
Examiner as evidence that MBNL2 expression is associated with increased
likelihood of progression are either unreliable or not on point. (Id. at 17-
3 US 2004/0076955 Al published April 22, 2004.
4 US 2006/0019256 Al published January 26, 2006.
5 Bignotti et al., Gene expression profile of ovarian serous papillary
carcinomas: identification of metastasis-associated genes, 196 American
Journal of Obstetrics & Gynecology 245.el-245.el l (2007).
6 Sanchez-Carbayo, Use of High-Throughput DNA Microarrays to IdentifY
Biomarkers for Bladder Cancer, 49 Clinical Chemistry 23-31 (2003).
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18.) Finally, Appellants argue that the evidence does not show the claimed
method to be unpredictable. (Id. at 18.)
We agree with Appellants that the Examiner has not shown, by a
preponderance of the evidence, that undue experimentation would be
required to practice the claimed method.
[T]he PTO bears an initial burden of setting forth a reasonable
explanation as to why it believes that the scope of protection
provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the
application; this includes, of course, providing sufficient reasons
for doubting any assertions in the specification as to the scope of
enablement.
In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir. 1993). "After evidence or
argument is submitted by the applicant in response, patentability is
determined on the totality of the record, by a preponderance of evidence
with due consideration to persuasiveness of argument." In re Oetiker, 977 at
1445.
In this case, the Examiner has cited several references as evidence that
practicing the claimed method would require undue experimentation because
(a) MBNL2 expression has been associated by others with an increased,
rather than decreased, likelihood of cancer progression, and (b) using gene
expression data for cancer prognosis was unpredictable at the time of the
invention. (Ans. 9-12.)
In response, Appellants cite evidence that they submitted in
application 13/316,765, which was published as US 2012/0082994. (Appeal
Br. 16.) The evidence describes the methodology used to determine whether
increased expression of certain genes was correlated with increased or
decreased likelihood of bladder cancer progression, and shows that the
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results indicated that both MBNL2 and F ABP4 were found to be "protective
markers" that correlated with non-progression. (Appeal Br. 22-25,
Evidence App'x.)
The Examiner's position, on the other hand, is that Sanchez-Carbayo
provides evidence of the unpredictability of using gene expression data in
prognosis of bladder cancer. (Ans. 11-12.) Sanchez-Carbayo, however,
states that "[ n ]umerous markers have been described to correlate to some
extent with tumor stage and prognosis of patients with bladder cancer."
(Sanchez-Carbayo 23, Background.) The Examiner has not explained how
Sanchez-Carbayo indicates unpredictability in using known biomarkers,
such as MBNL2 and F ABP4, in the claimed method.
The Examiner also cites Mack, Clarke, and Bignotti as evidence that
others have found increased MBNL2 expression to be associated with an
increased, not decreased, likelihood of cancer progression. (Ans. 9-11.) We
conclude that, while the Examiner's evidence shows some unpredictability,
it is insufficient to outweigh the evidence submitted by Appellants. Clarke
addresses "gene expression profiles associated with solid tumor stem cells."
(Clarke, i-f 8.) Clarke also discloses "providing a prognosis to [a] subject"
based on "at least one stem cell cancer marker ... from Table 8" (id. at
i-f 11), but Table 8 does not include MBNL2 (or MBLL39, which the
Examiner states is synonymous (Ans. 10)).
Bignotti lists MBNL2 as among the genes that are up-regulated at
least two-fold in metastatic, as compared to primary, OSPC. (Bignotti
245.e5.) However, "OSPC" is short for "ovarian serous papillary
carcinoma." (Id. at 245.el.) The Examiner has not provided evidence that a
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gene that is overexpressed in metastatic ovarian carcinoma would be
expected to predictive of cancer progression for bladder cancer.
Finally, the Examiner cites Mack as evidence that MBNL2 expression
shows a higher, not lower, likelihood of bladder cancer progression. (Ans.
9-10.) The Examiner points out that Mack includes MBNL27 in its list of
"Genes predictive of bladder cancer progression," although it includes
F ABP4 in its list of "Genes predictive of no bladder cancer progression."
(Id.)
Mack, unlike Bignotti and Clark, directly addresses the prognostic
value of MBNL2 in bladder cancer progression. Mack also discloses that
increased expression of MBNL2 leads to the opposite prognosis than is
recited in the claims on appeal. However, the Examiner has not persuasively
explained why Mack's conclusion should be considered more likely to be
accurate than Appellants'.
As Appellants point out (Appeal Br. 17), Mack provides little detail in
how the genes that are up-regulated in tumors that later progressed were
identified. Mack states that "[ m ]olecular profiles of various normal and
cancerous tissues were determined and analyzed using gene chips. RNA
was isolated and gene chip analysis was performed as described" in prior art
references. (Mack i-f 347.) As Appellants point out, "[t]here is no analysis
showing whether up-regulation of MBNL2 ... is correlated in any
7 There is no dispute that MBNL2 is the same as the gene referred to by
Mack as PR02032. (Ans. 5, Appeal Br. 19 (acknowledging that Mack's
Table 8A includes MBNL2).)
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statistically meaningful way with bladder cancer progression." (Appeal Br.
17.)
By contrast, Appellants' evidence (or the published application from
which it came), states that RNA ('994 publ., i-f 94) from 205 patients with
stage Ta or Tl bladder cancer (id. at i-f 91) was converted to cDNA (id. at
i-f 94) and analyzed by QPCR (id. at i-f 95). The '994 published application
also states that "[a ]nalysis of these results led to selection of markers of
interest, which appeared to have high or low expression levels that
correlated well with the clinical determinations of either progression
(including death from bladder cancer) or non-progression." (Id. at i-f 97 .)
Appellants' evidence states that sets of markers of interest were then
identified, and statistical analysis was carried out for each marker: "the
Pearson correlation coefficient ... was calculated" (id. at i-f 101) and "a
t-test, Wilcoxon signed rank test P<0.01, Kolmogorov-Smimov (KS) test,
P<0.01, and Chi-squared test, P<0.01, were run" (id. at i-f 102). Appellants'
evidence states that "the markers that performed the best in all or most of the
above criteria" were separated into groups based on whether higher
expression correlated with progression or non-progression. (Id. at i-f 104.)
Appellants' evidence is specific to the expression of MBNL2 and
FABP4 in bladder cancer cells and their correlation with progression or non-
progression of the cancer. And Appellants provided a detailed explanation
of how the data were derived and the statistical methods that were used to
correlate changes in expression with progression or non-progression of the
cancer. We conclude that Appellants' evidence is entitled to greater weight
than the evidence cited by the Examiner.
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The Examiner responded that Appellants' evidence "is not a study of
the MBNL2 and F ABP4 markers (i.e., called a two-gene signature) but is a
study of a twelve-gene signature, specifically the twelve marker genes listed
in Table 4 of the accompanying Evidence Appendix." (Ans. 23.)
Appellants' evidence, however, states that calculation of the Pearson
correlation coefficient and statistical analyses were performed "for each
marker." (Appeal Br. 22.) We therefore agree with Appellants (Reply Br.
5) that the Examiner's position is not consistent with the evidence presented.
v
The Examiner has rejected the claims on appeal as anticipated by
Mack. The Examiner finds that Mack discloses assessing the likelihood of
bladder cancer progression based on gene expression levels. (Ans. 14.) The
Examiner finds that Mack includes F ABP4 in a table of genes predictive of
no bladder cancer progression and MBNL2 (which Mack calls PR02032) in
a table of genes predictive of bladder cancer progression. (Id. at 14--15.)
The Examiner concludes that "the method steps of reporting to a customer
and charging a customer do not materially change the method steps and are
not afforded patentable weight regarding prior art." (Id. at 15.)
Appellants contend that "the listing of MBNL2 in [Mack's] Table 8A
was based on such preliminary data that its mere listing there does not
indicate if it is or is not associated with bladder cancer progression."
(Appeal Br. 16.) Appellants also contend that "Mack et al. is not
anticipatory because if Mack et al. imply anything about MBNL2, it is that
MBNL2 is a harmful marker, and the claims are to the 'protective bladder
cancer progression marker MBNL2. "' (Id. at 17.)
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We agree with the Examiner that the broadest reasonable
interpretation of claim 1 reads on Mack's disclosure. Mack discloses "genes
that are up- and down-regulated in bladder cancer cells." (Mack i-f 8.) Mack
states that "[t]he identification of sequences that are differentially expressed
in bladder cancer versus non-bladder cancer tissue allows the use of this
information in a number of ways." (Id. at i-f 103.) Mack states that its
invention relates to "the use of such expression profiles and compositions in
the diagnosis, prognosis, and therapy of bladder cancer." (Id. at i-f 2.) Mack
discloses that differential expression can be determined using quantitative
reverse transcriptase PCR. (Id. at i-f 208.)
Mack states that its "Table 8A shows about 1440 genes up regulated
in Ta or Ti [sic] bladder tumors from patients who later presented with
muscle-invasive bladder tumors (stage T2-T4)." (Id. at i-f 355.) Table 8A is
headed "Genes predictive of bladder cancer progression." (Id. at i-f 382)
Table 8A includes MBNL2. 8 (Id. at page 133, seventh entry.)
Mack states that its "Table 9A shows about 1200 genes up regulated
in Ta or TI [sic] bladder tumors from patients who later presented with either
more Ta tumors or no tumors at all." (Id. at i-f 356.) Table 9A is headed
"Genes predictive of no bladder cancer progression." (Id. at i-f 382) Table
8A includes FABP4. 9 (Id. at page 145, thirty-third entry.)
8 Mack refers to MBNL2 as "PR02032" but Appellants acknowledge that
Table 8A includes MBNL2. (Appeal Br. 19; cf Spec. 25, gene number
295.)
9 Mack refers to F ABP4as "fatty acid binding protein 4, adipocyte" but
Appellants acknowledge that Table 9A includes FABP4. (Appeal Br. 20.)
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Thus, Mack discloses using QPCR (a.k.a. RT-PCR) to determine
F ABP4 and MBNL2 expression levels in bladder cancer cells and
comparing them with expression in non-bladder cancer cells to determine
genes that are up- or down-regulated. Mack discloses that F ABP4 and
MBNL2 are genes that are useful in determining a patient's prognosis
because they are predictive of either bladder cancer progression (MBNL2)
or no bladder cancer progression (FABP4).
Mack does not expressly disclose reporting a prognosis to a customer
and charging the customer for the report. However, as the Examiner pointed
out, an "informing" (or "reporting") step does not distinguish a claimed
method from an otherwise anticipating prior art method. See In re Kao, 639
F.3d 1057 (Fed. Cir. 2011). One of the claims in Kao recited "providing
information" that the bioavailability of oxymorphone was increased in
subjects with renal impairment. Id. at 1064. The court held that "[t]hough
the correlation between the renal impairment and bioavailability was not
known, informing someone of the correlation cannot confer patentability
absent a functional relationship between the informing and administering
steps." Id. at 1072. The same is true here: absent a functional relationship
between the prognosis recited in claim 1 and some active step, reporting a
particular prognosis does not confer patentability on the claimed method.
We also agree with the Examiner that a step of charging a customer
for a service does not patentably distinguish a method of providing that
service from prior art that discloses an otherwise identical method. A step of
charging for a service, after all, is simply a request for money in exchange
for the service. As noted above, an informing step (such as informing a
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customer of the cost for conducting an assay) does not patentably distinguish
a claimed process from the prior art unless there is some functional
relationship between the informing step and some active step.
This conclusion is also supported by In re Ngai, 367 F.3d 1336
(2004). The claimed invention in Ngai was a kit comprising one or more
known assay components, along with instructions describing a specific
method. Id. at 1337-38. The court held that the printed matter (instructions)
was not functionally related to the kit, or vice versa, because "[a]ll that the
printed matter does is teach a new use for an existing product." Id. at 1339.
The court noted that if it "were to adopt Ngai's position, anyone could
continue patenting a product indefinitely provided that they add a new
instruction sheet to the product." Id.
Claim 1 on appeal is comparable to Ngai's invention because all of
the active steps of the claim are in the prior art. If we were to hold that the
"charging" step of the claim distinguishes the claimed method from the prior
art, anyone could obtain a new patent on an old process by adding a step at
the end of charging money for carrying out the process. That outcome
would be contrary to the rationale of In re Ngai.
Mack does not disclose the specific interpretation given to MBNL2
expression levels that is recited in claim 1. That is, Mack discloses that
MBNL2 expression indicates increased likelihood of bladder cancer
progression, while claim 1 states that increased MBNL2 expression indicates
decreased likelihood of progression.
However, the interpretation of data is a purely mental step; whether a
user interprets data in a particular way does not change the actual steps of
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Application 13/352,435
generating those data. See, e.g., In re Kao, discussed above: If a step of
informing someone of a specific prognosis does not confer patentability,
then neither does a step of interpreting data to determine the prognosis. That
is, even if Mack does not disclose the meaning ascribed to MBNL2
expression levels recited in claim 1, interpreting the meaning of an increase
or decrease in MBNL2 expression does not confer patentability absent a
functional relationship between the interpretation of the data and some
active step carried out as a consequence of the interpretation.
Thus, Appellants' argument that "Mack et al. is not anticipatory
because if Mack et al. imply anything about MBNL2, it is that MBNL2 is a
harmful marker" (Appeal Br. 20) does not persuade us that the claimed
method differs in any of its active steps from the method disclosed by Mack.
Claims 13 and 14 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1, 13, and 14 under 35 U.S.C. § 101.
We reverse the rejection of claims 1, 13, and 14 under 35 U.S.C.
§ 112, second paragraph.
We affirm the rejection of claims 1, 13, and 14 under 35 U.S.C. § 112,
first paragraph (written description).
We reverse the rejection of claims 1, 13, and 14 under 35 U.S.C.
§ 112, first paragraph (enablement).
We affirm the rejection of claims 1, 13, and 14 under 35 U.S.C.
§ 102(e).
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Application 13/352,435
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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