Ex Parte Ma

Patent Trial and Appeal Board

Jun 9, 2017

12454746 (P.T.A.B. Jun. 9, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/454,746 05/21/2009 Yunqing Ma 70-005410US (4247.1) 2180
34791 7590 06/12/2017
Quine Intellectual Property Law Group P.C.
P.O. Box 458
Alameda, CA 94501
EXAMINER
SISSON, BRADLEY L
ART UNIT PAPER NUMBER
1634
MAIL DATE DELIVERY MODE
06/12/2017 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YUNQING MA
Appeal 2017-0004811
Application 12/454,746
Technology Center 1600
Before, DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JOHN
SCHNEIDER Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to methods of determining copy
number of a repeated sequence element that is present in multiple, tandem
copies on a nucleic acid target molecule.
The Examiner rejected the claims under 35U.S.C. §§ 101, 112, and
102(e)/103(a). We have jurisdiction under 35 U.S.C. § 6(b). The rejections
are affirmed.
STATEMENT OF THE CASE
Appellant appeals from the Examiner’s rejection of claims 1, 9—11,
19, and 44—63. The claims stand rejected as follows:
1 The Appeal Brief (“Appeal Br.”) at 1 lists Affymetrix, Incorporated, as the
real-party-in-interest.
Appeal 2017-000481
Application 12/454,746
Claims 1, 9-11, 19, and 44—63 under pre-AIA 35U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement. Ans. 2.
Claims 1, 9-11, 19, and 44—63 under pre-AIA 35U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Ans. 19.
Claims 1, 9-11, 19, and 44—63 under pre-AIA 35 U.S.C. § 101 as
having claims directed to a judicial exception to patent eligibility. Ans. 30.
Claims 1, 9—11, 19, and 44—63 under pre-AIA 35 U.S.C. § U.S.C.
§ 102(e) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Master et al. (US 2008/0050746 Al, publ. Feb. 28,
2008) (“McMaster”). Ans. 42.
Claim 1, the only independent clam on appeal, and reads as follows
(bracketed numbers have been added to refer to the steps of the method):
1. A method of determining copy number of a repeated sequence
element that is present in multiple, tandem copies on a first
nucleic acid target molecule, the method comprising:
[1] providing a test sample comprising the first nucleic
acid target molecule;
[2] providing multiple copies of a label extender, which
label extender is a first polynucleotide that is capable of
hybridizing to one or more tandem copies of the repeated
sequence element;
either
i) providing multiple copies of a label probe, which
label probe is a second polynucleotide that
comprises a label;
or
ii) providing multiple copies of a label probe, which
label probe is a second polynucleotide that is
configured to bind to a label, and binding the label
to the second polynucleotide;
wherein the label provides a detectable signal;
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[3] hybridizing the label extender copies to the copies of
the repeated sequence element;
[4] binding the label probe copies to the label extender
copies;
wherein the hybridizing and binding steps bind the label
probe copies and the label to the first nucleic acid target molecule
in an amount that is proportional to the number of copies of the
repeated sequence element on the first nucleic acid target
molecule;
[5] after the hybridizing and binding steps, measuring
intensity of a signal from the label bound to the first nucleic acid
target molecule; and
[6] correlating the intensity of the signal with the number
of copies of the repeated sequence element on the first nucleic
acid target molecule.
§ 102(e)/103(a) REJECTION
The Examiner rejected the claims as anticipated, or alternatively, as
obvious in view of McMaster. Ans. 42. Specifically, the Examiner found
that the steps of the claimed method correspond to the branched-chain DNA
(“bDNA”) described in McMaster. Ans. 42 46 (citing, e.g., paragraphs
121—24 of McMaster).
With respect to determining the copy number of repeated sequence
elements, the Examiner cited paragraph 24 of McMaster disclosing
“repetitive DNA can be quantitated (e.g., in a dilution series) for
determination of a standard function, e.g., by any suitable technique, such as
bDNA analysis.” Id. 124. The Examiner also cited disclosure in McMaster
describing the existence of repeated sequences in the genome, such as
ribosomal DNA. Id. 42, 60.
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Anticipation
Appellant contends that McMaster does not describe “determining
copy number of a repeated sequence element that is present in multiple,
tandem copies on a first nucleic acid target molecule” and no [6]
“correlating the intensity of the signal with the number of copies of the
repeated sequence element on the first nucleic acid target molecule.”
We agree with Appellant that there is no disclosure in McMaster of
determining the “copy number” of repeated sequence elements. While
McMaster mentions the existence of repeated elements in the genome
(McMaster |73) and quantitates them (id. || 23, 24), McMaster does not
describe determining the number of copies of the element. Rather,
McMaster describes inputting the total amount of repetitive DNA into a
standard function to determine the ratio of cells to repetitive DNA (e.g.,
ribosomal DNA) in order to normalize the sample, for example, by
determining the cell number. Id. at || 24, 69, 75, 100, 110. For this reason,
we are compelled to reverse the anticipation rejection of claim 1 and
dependent claims 9—11, 19, and 44—63.
Obviousness
As evidence of obviousness, the Examiner cited Kozlowski (US
5,834,193, iss. Nov. 10, 1998) and Lansdorp (US 6,514,693 Bl, iss. Feb. 4,
2003) for their teachings of telomere repeats. Ans. 48 49. It appears that
the Examiner only considered these publications pertinent to claims 54—56
and 58 which recite repeats of a certain size and telomeres. Ans. 49.
Because these publications are not part of the statement of the
rejection, and because these Examiner did not address the obviousness of
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claim 1, we shall reverse the rejection as to the obviousness over McMaster,
as well, and set forth a new ground of rejection as discussed below.
NEW GROUND OF REJECTION
Claims 1, 9-11, 19, and 44—63 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious in view of McMaster, Hahn (US 2005/0191636 Al,
publ. Sept. 1, 2005), Marcel E. Gil & Theresa L. Coetzer, Real-Time
Quantitative PCR of Telomere Length, 27 MOLECULAR
BIOTECHNOLOGY 169-72 (2004) (“Gil”), and Lansdorp (US 6,514,693
Bl, iss. Feb. 4, 2003). This is a new ground of rejection pursuant to 37
C.F.R. § 41.50(b)
Findings of Fact (“FF”)
McMaster
FF 1. McMaster describes a bDNA assay comprising providing and
hybridizing a label extender (compare steps [2], [3] of rejected claim 1)
(McMaster || 121, 122, 123), providing and binding a label probe to the
label extender (compare steps [2], [4] of rejected claim 1) {id. Tflf 121, 122,
124, 125), and measuring signal intensity (compare step [5] of rejected claim
1 {id. 1124 (“The amount of chemiluminescence is proportional to the level
of target nucleic acid originally present in the sample (a relationship
describable with a standard function)”)).
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FF2. McMaster describes utilizing its assay to determine copy
number of a nucleic acid.
Ribosomal DNA references and/or degraded in vitro RNAs are
used to normalize standard curves and to establish nucleic acid
copy numbers per cell.
Id. 12.
FF3. McMaster teaches:
Methods of the invention include combinations of inventive
techniques working together to enhance the sensitivity and
accuracy of a nucleic acid determination. For example, mRNA
copy numbers can be estimated accurately by determining the
number of cells in a test sample (e.g., by comparing a test sample
rDNA value to a standard function of rDNA versus cell number)
Id. 113.
FF4. McMaster teaches:
The repetitive DNA can be quantitated (e.g., in a dilution series)
for determination of a standard function, e.g., by any suitable technique,
such as bDNA analysis, Southern blot analysis, polymerase chain
reaction, agarose gel electrophoresis, and the like.
Id. 124.
Hahn
Hahn teaches:
FF5.
Eukaryotic DNA has tandem repeats of very short simple
sequences termed short tandem repeat polymorphisms (STRPs).
Repeat polymorphisms include dinucleotide, trinucleotide and
tetranucleotide repeats. Trinucleotide and tetranucleotide repeats
are repeats of three and four nucleotides. A growing number of
diseases are known to be associated with the expansion of
trinucleotide STRs (Trottier, Y, et al., Current Biology 3:783-
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786 (1993); Bates, G. et al., Bioassays 16:277-284 (1994);
Kawaguchi, Y. et al., Nature Genetics 8:221-227 (1994)). In
these diseases, the size of the repeat block generally correlates
with and thereby indicates the severity and age of the onset of the
disease.
Hahn 12.
FF6.
A method using highly sensitive colorimetric detection has now
been developed that is able to accurately estimate the copy
number of STRs present in genomic DNA, e.g. CGG repeats in
the 5'-untranslated region of the FRAXA [fragile X syndrome]
gene.
Id. 112.
FF7.
The copy number of the CGG repeats of such an unknown
sample is then accurately estimated by determining the ratio of
the signal intensity at the CGG repeat region probe to that at the
internal control probe and comparing such ratio with values that
were earlier generated from known control samples.
Id.
Gil
FF8. Gil describes a method which “measures the factor by which the
ratio of telomere repeat copy number to single-gene copy number differs
between a sample and that of a reference DNA sample [citing Cawthon].”
Gil 170.
Lansdorp
FF9. Lansdorp teaches a method “for quantitating multiple copies of
a repeat sequence in a nucleic acid molecule, preferably a telomere or
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centromere repeat sequence.” Lansdorp, Abstract. See also id. at col. 4,11.
2AA7.
FF10. Lansdorp teaches “quantitating the length of the multiple copies
of the repeat sequences in the nucleic acid molecule based on the direct
relationship between the intensity of the signal produced directly or
indirectly by the detectable substance and the length of the multiple copies
of the repeat sequence.” Id. at col. 3,11. 41—47.
Specification
FF11. The Specification teaches that it was known that telomere
length is associated with risk of cancer. Spec. 1 6.
Analysis
McMaster describes steps [1] to [5] of the claimed method. FF1.
McMaster describes determining copy number of a nucleic acid (FF2), but
not the copy number of a repetitive DNA as required by the preamble and
step [6] of claim 1. Rather, McMaster describes determining the quantity of
the repetitive DNA, e.g., ribosomal DNA, to normalize standard curves and
determine the number of cells in a sample. FF2—FF4.
However, Hahn, Gil, and Lansdorp each describe methods of
measuring the copy number of repeat sequences in the genome. FF5—FF7
(short tandem repeats), FF8 (telomere repeats), FF9 (telomere and
centromere repeat sequences). Hahn teaches the relationship between
diseases and expansion of STRs (FF5) (i.e., increase in copy number). The
Specification also teaches that telomere length (i.e., increase in copy
number) is associated with a risk of cancer (FF11). Consequently, the
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reason to measure copy number of repeats was well-established in the prior
art and had been accomplished by each of Hahn, Gil, and Lansdorp.
Correlating signal intensity with the copy number of repeats as recited in
step [6] of claim 1 is described by Hahn (FF7) and Lansdorp (FF10).
McMaster also uses signal intensity to measure copy number in its bDNA
assays (e.g., McMaster 1124; FF1). Thus, it would have been obvious to
one of ordinary skill in the art to have used signal intensity to measure copy
number of repeated sequences for its established function in quantitating
copy number. KSRInt'l Co. v. Teleflex Inc., 550 U.S. 398, 413 (2007).
With respect to dependent claims 9—11, 19, and 44—63, we rely on the
same findings and conclusions made by the Examiner. Final Act. 54—59,
60—62; Ans. 42—50. In addition, the reason to measure telomeric repeats as
in claims 11, 19, and 58 is provided by Gil and Lansdorp.
§ 101 REJECTION
The Examiner rejected claims 1, 9-11, 19, and 44—63 as ineligible for
a patent under 35 U.S.C. § 101 as being directed to a law of nature, a natural
phenomenon, or an abstract idea, judicially recognized exceptions to the
statute. Ans. 30. The Examiner specifically identified the correlating step of
claim 1 as an abstract idea. Id. at 31. The Examiner also found that the
recited steps of the claimed method are well-known, routine, and
conventional in the art. Id. at 32.
Appellant contends that the claims do not preempt the idea of
“correlating” because the claim “solves the very specific problem of
determining a copy number of repeat sequence elements.” Appeal Br. 9.
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Appellant also contends that the claim includes substantial inventive
concepts as evidence by the Examiner’s failure to establish obviousness. Id.
Discussion
A two-step analysis has been promulgated by the U.S. Supreme Court
to determine whether a claim is eligible for a patent under 35 U.S.C. § 101.
The test is set forth in Alice Corp. Pty. Ltd. v. CLS Banklnt'l, 134 S. Ct.
2347, 2355 (2014):
First, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts[, e.g., a law of nature,
natural phenomenon, or abstract idea]. If so, we then ask, what
else is there in the claims before us? . . . We have described step
two of this analysis as a search for an inventive concept—i.e., an
element or combination of elements that is sufficient to ensure
that the patent in practice amounts to significantly more than a
patent upon the ineligible concept itself.
Id. (alterations, citations, and quotation marks omitted).
We, thus, must first decide whether the claim is directed to patent-
ineligible subject matter. We begin with the purpose and steps of claim 1.
The purpose of claim 1 is to determine “copy number of a repeated
sequence element that is present in multiple, tandem copies on a first nucleic
acid target molecule.” While the claim does not require the target molecule
to be from a particular source, the exemplary repeats disclosed in the
Specification are of naturally-occurring repeats, such as telomeric and
minisatellite repeats found on chromosomal DNA. Spec. 116.
Consequently, claim 1 reads on determining repeats in natural-occurring
DNA molecules.
The determination of copy number in claim 1 is made by a five step
process [1] to [5] of manipulating nucleic acid target molecule in a test
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sample to produce a detectable signal from a label probe bound to the
repeated sequence elements in the molecule. In step [6], the intensity of the
detectable signal is correlated with the number of copies of the repeated
sequence elements. Although the patent Specification does not expressly
define how the correlating step [6] of the claim is carried out, we find that it
is an “abstract idea” because it is not associated in the claim with a concrete
object, but rather is a mathematical concept of detecting signals from a label
probe and using that data to determine copy number. Claim 1 is therefore
simply a process of determining a natural phenomenon — the number of
repeated sequences in a nucleic acid molecule — using an abstract
correlating step. Accordingly, we conclude that claim 1 is directed to
ineligible subject matter for a patent under § 101, namely, a natural
phenomenon or a law of nature. As held in Mayo Collaborative Serv. v.
Prometheus Labs., Inc., 132 S .Ct. 1289, 1297 (2012), a patent which simply
describes a relation that “exists in principle apart from any human action,”
namely, the number of repeated sequences present in a naturally occurring
nucleic acid molecule, is a natural law and patent ineligible subject matter.
Because claim 1 is directed to patent ineligible subject matter, we
proceed to step two of the Alice test to decide whether the claims contains an
“in ventive concept” sufficient to transform the claimed law of nature into
patent-eligible subject matter. Alice, 134 S. Ct. at 2355,
“The question ... is whether the claims do significantly more than
simply describe [a] natural relation[ ].”, Mayo 132 S.Ct. at 1297.
The inventive concept necessary at step two of the Mayo/Alice
analysis cannot be furnished by the unpatentable law of nature
(or natural phenomenon or abstract idea) itself. That is, under
the Mayo/Alice framework, a claim directed to a newly
discovered law of nature (or natural phenomenon or abstract
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idea) cannot rely on the novelty of that discovery for the
inventive concept necessary for patent eligibility; instead, the
application must provide something inventive, beyond mere
“well-understood, routine, conventional activity.” Mayo, 132
S.Ct. at 1294; see also Myriad, 133 S.Ct. at 2117; Ariosa, 788
F.3d at 1379. “[Sjimply appending conventional steps, specified
at a high level of generality, to laws of nature, natural
phenomena, and abstract ideas cannot make those laws,
phenomena, and ideas patentable.” Mayo, 132 S.Ct. at 1300.
Claims directed to laws of nature are ineligible for patent
protection when, “(apart from the natural laws themselves) [they]
involve well-understood, routine, conventional activity
previously engaged in by researchers in the field.” Mayo, 132
S.Ct. at 1294.
Genetic Tech. Ltd. v. Merial L.L.C., 818 F.3d 1369, 1376 (Fed. Cir. 2016).
In this case, as indicated by the analysis under the § 103(a) rejection,
the steps of the claimed method “involve well-understood, routine,
conventional activity previously engaged in by researchers in the field.”
Mayo, 132 S. Ct. at 1294. Specifically, steps [1] to [5] involving the
manipulation of a nucleic acid molecule are the same steps performed in a
bDNA assay as described in McMaster. McMaster || 121—25. As noted by
the Examiner, Figure 17 of McMaster showing a bDNA assay is
substantially the same as Figure 1 of the Specification which shows a bDNA
assay to detect repeated sequences. Spec. ^fl[ 68, 75. Thus, the Examiner’s
findings that the manipulative steps are routine and conventional activity is
supported by a preponderance of the evidence.
Appellant argues that the correlating step of the claim does not
preempt “the concept of ‘correlating’.” Appeal Br. 8. “Here, the deemed
exception of ‘correlating’ in the claim is focused on such a narrow field of
correlations that not only does the claim not tie up use of the abstract idea of
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correlating, but it only takes less than a billionth of the possible uses of
correlations.” Id. at 9.
As discussed in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d
1371, 1379 (Fed. Cir. 2015), “[wjhile preemption may signal patent
ineligible subject matter, the absence of complete preemption does not
demonstrate patent eligibility.” Moreover, Ariosa held: “Where a patent’s
claims are deemed only to disclose patent ineligible subject matter under the
Mayo framework, as they are in this case, preemption concerns are fully
addressed and made moot.” Id. Consequently, since the claimed subject
matter is ineligible under Mayo, we need not address the preemption
concern.
For the foregoing reasons, the rejection of claims 1, 9—11, 19, and 44—
63 under pre-AIA 35 U.S.C. § 101 as having claims directed to a judicial
exception to patent eligibility is affirmed.
§ 112, FIRST PARAGRAPH, WRITTEN DESCRIPTION REJECTION
The Examiner rejected the claims as lacking a written description as
required by35U.S.C§ 112, first paragraph. Ans. 19. The Examiner made
repeated statements about the breadth of the claims (“determining the copy
number of any and all manner of repeated sequences”; “diagnosing any
disease that can occur in any life form- known or yet to be discovered”). Id.
at 22—23. The Examiner also construed “repeated sequence” as
encompassing any nucleic acid of interest. Id. at 25. The Examiner found
that the claimed “genus” was not described because only five sequences ae
disclosed. Id. at 26—27.
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To satisfy the written description requirement of 35 U.S.C. § 112, the
inventor must “convey with reasonable clarity to those skilled in the art that,
as of the filing date sought, he or she was in possession of the invention.”
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563—64 (Fed. Cir. 1991). “One
shows that one is ‘in possession’ of the invention by describing the
invention, with all its claimed limitations.” Lockwood v. Am. Airlines, Inc.,
107 F.3d 1565, 1572 (Fed. Cir. 1997) (internal citation omitted).
Thus, the first step is to determine what is the claimed invention. In
this case, as already discussed, the claims are directed to a method of
determining copy number of a repeated sequence element present in
multiple, tandem copies in a target nucleic acid. The method comprises the
use of label extenders and label probes to accomplish the determination of
copy number. The Specification expressly describes these components of
the method and their function. Spec. H 11, 12, 53—55, 59, 68 (describing
Fig. 1). All the limitations of claim 1 are described in the Specification. Id.,
e.g., 1111, 13,21.
The Specification discloses several different known types of repeated
sequence elements that can be used in the method:
Exemplary repeated sequence elements of particular interest in
the context of the present invention include, but are not limited
to, telomeric repeats, short tandem repeats, variable number of
tandem repeats, micro satellite repeats, minisatellite repeats, and
trinucleotide repeats, as well as other tandemly repeated
elements where multiple (at least two, e.g., 3, 4, or 5 or more)
repeats are immediately adjacent to each other.
Spec. 116.
The Specification further teaches that any desired repeated sequence
element can be analyzed by the disclosed method. Id. 117.
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Based on the plain language of the claims and the disclosure in the
Specification, it is apparent that the claimed invention is not directed to a
specific repeated sequence element, but instead is described in the
Specification more broadly as a general method which can be performed on
any known or desired repetitive element. The Examiner’s objection to the
Specification as not providing sufficient examples of repeated sequences is
improper because the invention is not of a specific repeated sequence, but
rather of general method determining their copy number in a nucleic acid
molecule. The Examiner’s additional objections to the claim regarding its
breadth ignores that the invention is a general method that can be performed
to determine copy number of a repeated sequence element for any desired
purpose. The Examiner made no findings that the Specification failed to
described the invention with all its claimed limitations. Rather, the
Examiner improperly focused on the breadth of the claim without explaining
why such breadth lacked written description. Accordingly, because the
Examiner did not establish that the claimed lacked written description, we
reverse the written description rejection.
§ 112, ENABLEMENT REJECTION
The Examiner rejected the claims as lacking enablement as required
by35U.S.C. § 112. The Examiner found that the claims are unlimited as to
the source and type of the repeated sequence element. Ans. 7—11. The
Examiner found that to carry out the claimed method, one of ordinary skill
in the art would needed nucleotide sequence information on the repeated
sequence elements. Id. at 11—13. Because the Specification lacks this
information, the Examiner found that the claimed method is not enabled. Id.
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The Examiner’s objection is misplaced. As already discussed, the
method is a general method of determining copy number of repeated
sequences. The inventor does not allege to have invented repeated sequence
elements. The Examiner did not provide an explanation as to why the
example in the Specification of using its assay to determine copy number of
telomeres (Spec. 150-53) is inadequate to enable the determination of the
copy number of any desired repeated sequence.
The Examiner also found that the claims did not require removing the
unbound label (Ans. 17), specific hybridization that would enable detection
of the desired repeated sequences {id. at 18), and different detectable labels
when multiplexing is used as recited in dependent claims {id. at 18—19). For
these reasons, the Examiner found that specific hybridization to repeated
sequences could not be detected. Id. In other words, the Examiner
determined that the claims are inoperable. Id. at 17.
We are not persuaded by the Examiner’s arguments. To begin, the
method is directed to determining copy number of repeated sequences in a
nucleic acid target molecule. Thus, the claim only includes embodiments
which are operable.
The Examiner found that the hybridizing step [3] lacked the
requirement that the hybridization be specific. However, the claim
specifically recites that the “label extender is a first polynucleotide that is
capable of hybridizing to one or more tandem copies of the repeated
sequence element.” It is not reasonable to interpret this language to read on
non-specific hybridization to any sequence because that would effectively
make the limitation superfluous if the label extender could hybridize not
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only to the tandem copies of repeated sequences, but non-specifically to any
sequence present in the nucleic acid.
The Examiner also found that the claim is inoperable because it does
not require the unbound label to be separated from the bound label; the
Examiner found that the presence of the unbound label would obscure the
bound label. However, the Examiner did not consider the language in the
claim that requires “measuring intensity of a signal from the label bound to
the first nucleic acid target molecule.” Because this language requires that
the intensity of the label be measured, the measuring step would require, by
its language, that any unbound label be removed, if needed, to measure
intensity.
However, as additionally noted by Appellant, washing is optional
because the intensity of the bound label could be detected in the presence of
the unbound label by its position on a solid support. Spec. 1113; Appeal Br.
7—8. The Specification also describes signal detection using FRET
technology, which also does not require removing the unbound label. Spec.
1134. Appeal Br. 7. Thus, the claim is not operable; it simply reads on
multiple embodiments, some which would require removal of the bound
label and some which do not.
The Examiner also objected to the claims because “the method does
not require the use of different labels on different probes.” Ans. 18. It
appears that the Examiner is referring to claims 49 and 50 which depend
from claim 1 and require detection of a repeated sequence element in a
second nucleic acid. The Examiner has not established, nor even argued that
the claims require detection of different repeated sequences and/or a second
and different label would be necessary to accomplish the claimed purpose of
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determining copy number of repeated sequences. While in some
circumstances a second label might be necessary to distinguish two different
types of repetitive sequences, the claim is broader and included
embodiments where a second label is not needed, e.g., when the same
repetitive sequence is detected on both sequences. Thus, the Examiner has
not demonstrated that a critical element is missing from the claims. See
Manual of Patent Examining Procedure (MPEP) § 2164.08(C) (9th Ed.,
Rev. 9, Nov. 2015). Again, the claim covers multiple embodiments; the
Examiner merely pointed this out without providing evidence that the
embodiments requiring more than one label lacked an enabling disclosure in
the Specification.
The Examiner also found that the claims cover multiple probes sets
for detecting repetitive sequences. The Examiner stated that “[t]he use of
multiple probe sets for the detection of STRs is deemed to be analogous to
that in Promega Corp. v. Life Techs. Corp., [773 F.3d 1338] (Fed. Cir.
2014)” which was found to lack enablement. Ans. 14. In Promega, claims
involves amplification; amplification is not a requirement of the rejected
claim at issue in this appeal. Promega, 773 F.3d at 1347. The court found
“no genuine dispute that identifying STR loci multiplexes that will
successfully co-amplify is a complex and unpredictable challenge, and as a
result, undue experimentation may be required to identify a successfully co­
amplifying multiplex that adds even a single new locus to an existing loci
combination.” Id.
In this case, the Examiner did not cite any evidence that utilized
additional multiple probes sets were an “unpredictable challenge.”
Furthermore, Promega had argued before the USPTO that multiplex
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amplification was unpredictable. Id. The Examiner did not point to those
arguments made in this case. Thus, the evidence of unpredictability in
Promega is absent from this record.
“‘[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” Genentech, Inc. v. Novo Nordisk, A/S,
108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557,
1561 (Fed. Cir. 1993)). Here, the Examiner has not provided adequate
evidence that the full scope of the claims lack enablement. Accordingly, the
rejection is reversed.
SUMMARY
The enablement and written description rejections are reversed. The
rejection under 35 U.S.C. § 101 is affirmed. The 102/103 rejection is
reversed. A new ground of rejection of claims 1, 9—11, 19, and 44—63 is set
forth over under 35 U.S.C. § 103(a) as obvious.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
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Appeal 2017-000481
Application 12/454,746
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under §41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the MPEP § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§§ 41.50(f), 41.52(b).
AFFIRMED; 37 C.F.R, § 41.50(b)
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