Ex Parte Chamberlain et al

Patent Trial and Appeal Board

Jan 18, 2017

12293763 (P.T.A.B. Jan. 18, 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.
12/293,763 09/19/2008 John Chamberlain 6947-95217-01 3853
24197 7590 01/20/2017
KLARQUIST SPARKMAN, LLP
121 SW SALMON STREET
SUITE 1600
PORTLAND, OR 97204
EXAMINER
SITTON, JEHANNE SOUAYA
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
01/20/2017 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):
tanya.harding@klarquist.com
docketing @klarquist.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN CHAMBERLAIN,
HALINA FITZ-CLARENCE, and MARK THOMAS1
Appeal 2014-009849
Application 12/293,763
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN and
JOHN E. SCHNEIDER, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to methods of
treating individuals with bone disorders, such as osteoporosis. The
Examiner rejected the claims under 35 U.S.C. § 101 as being directed to
non-statutory subject matter.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses that bone disorders, “such as osteoporosis,
result in a decrease in bone mass and bone density and/or an increased risk
and/or incidence of fracture. Oral bisphosphonates are the commonest first-
1 Appellants identify the real party in interest as UCL Business PLC. Br. 2.
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Application 12/293,763
choice treatment where a reduction in osteoclasis would be beneficial, for
example, for post-menopausal osteoporosis . . . Spec. 1. Nonetheless,
“around 40% of individuals treated with bisphosphonates do not fully
respond to the drug.” Id.
To address that issue, the “present inventors have shown that
polymorphism in and around the coding region of the famesyl diphosphate
synthase (FDPS) gene is predictive of the densitometric response of patients
subsequent to commencing treatment with amino-bisphosphonates.” Id. at
1—2. In particular, Appellants discovered that the “presence of a T residue at
SNP rs2297480 in both copies of the FDPS gene (i.e. a TT genotype at
rs2297480) is indicative that the individual has a bone disorder which is
responsive to treatment with bisphosphonate.” Id. at 4.
Claims 1, 25, 43, and 44, the independent claims under rejection,
illustrate the appealed subject matter and read as follows (Br. 10—12):
1. A method of treating a human individual having a bone
disorder, the method comprising:
determining in a nucleic acid sample obtained from the
individual, the presence of a TT genotype at a single nucleotide
polymorphism rs2297480 (SNP rs2297480) in the famesyl
diphosphate synthase (FDPS) gene,
the presence of the TT genotype at SNP rs2297480 being
indicative that the individual as is responsive to bisphosphonates; and
administering a bisphosphonate to the individual if the TT
genotype is present.
25. A method of treating a bone disorder in a human individual, the
method comprising:
identifying the individual as having a TT genotype at single
nucleotide polymorphism rs2297480 (SNP rs2297480) in the famesyl
diphosphate synthase (FDPS) gene, the presence of the TT genotype
at SNP rs2297480 being indicative that the individual is responsive to
bisphosphonates; and,
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Application 12/293,763
administering a bisphosphonate to the individual.
43. A method of treating a bone disorder in a human individual, the
method comprising:
administering to the individual a bisphosphonate selected from
the group consisting of alendronate, clodronate, ibandronate,
pamidronate, risedronate and zoledronate,
wherein the individual has been identified as having a TT
genotype at single nucleotide polymorphism rs2297480 (SNP
rs2297480) in the famesyl diphosphate synthase (FDPS) gene.
44. A method of treating osteoporosis in a human individual having
a BMD T score of -1 or less, the method comprising:
determining in a nucleic acid sample obtained from the
individual, the presence of a TT genotype at single nucleotide
polymorphism rs2297480 (SNP rs2297480) in the famesyl
diphosphate synthase (FDPS) gene,
wherein the presence of the TT genotype is determined by
hybridizing the nucleic acid sample to a nucleic acid probe which
comprises SEQ ID NO: 1 or the complement thereof; wherein the
probe or the nucleic acid sample is immobilized in a nucleic acid
array, and;
administering intravenous palmadronate [sic, pamidronate2] to
the individual if the TT genotype is present in the sample.
The sole rejection before us for review is the Examiner’s rejection of
claims 1, 13—17, 25, 30, 31, and 37^44 under 35 U.S.C. § 101 as being
directed to non-statutory subject matter (Final Action 2-4).3
2 Appellants’ Specification exemplifies the “use of regular intravenous
Pamidronate” (Spec. 21), not palmadronate.
3 Final Action entered June 3, 2013.
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DISCUSSION
The Examiner’s Position
The Examiner determines that the rejected claims “set forth laws of
nature and focus on the relationship between a specific genotype TT for
rs2297480 in the FDPS gene and responsiveness to bisphosphonates. The
instant claims essentially provide steps for a practitioner to gather data from
which they may draw an inference (phenotype).” Final Action 3.
Therefore, the Examiner reasons, the claimed process “is taken to
recite a law of nature because the claim simply describes that relationship.
Mental activities such as forming a judgment, observation, evaluation or
opinion are examples of general concepts.” Id.
As to the actual process steps required by the rejected claims, the
Examiner finds as follows:
The claim features of amplification, sequencing and
hybridization are typically taken by those in the field to
determine a genotype and do not add anything substantial to the
process of claim 1, while the treatment claims essentially set
forth the law of nature with the generalized instructions to
apply it and covers every substantial practical application of the
correlation.
Id. at 4.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
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.
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Appellants do not persuade us that a preponderance of the evidence
fails to support the Examiner’s conclusion that the rejected claims recite
subject matter ineligible for patenting under 35 U.S.C. § 101.
35 U.S.C. § 101 states that “[wjhoever invents or discovers any new
and useful process, machine, manufacture, or composition of matter, or any
new and useful improvement thereof, may obtain a patent therefor, subject to
the conditions and requirements of this title.”
The Supreme Court has “long held that this provision contains an
important implicit exception: Laws of nature, natural phenomena, and
abstract ideas are not patentable.” Alice Corp. Pty. Ltd. v. CLS Bank Intern.,
134 S.Ct. 2347, 2354 (2014).
Our reviewing court has summarized the Supreme Court’s two-part
test for distinguishing between claims to patent-ineligible exceptions, and
claims to patent-eligible applications of those exceptions, as follows:
Step one asks whether the claim is “directed to one of
[the] patent-ineligible concepts.” [Alice, 134 S.Ct. at 2354], If
the answer is no, the inquiry is over: the claim falls within the
ambit of § 101. If the answer is yes, the inquiry moves to step
two, which asks whether, considered both individually and as
an ordered combination, “the additional elements ‘transform the
nature of the claim’ into a patent-eligible application.” Id.
(quoting Mayo [Collaborative Services v. Prometheus Labs,
Inc., 132 S.Ct. 1289, 1297 (2012)]).
Step two is described “as a search for an ‘inventive
concept.’” Id. (quoting Mayo, 132 S.Ct. at 1294). At step two,
more is required than “well-understood, routine, conventional
activity already engaged in by the scientific community,” which
fails to transform the claim into “significantly more than a
patent upon the” ineligible concept itself. Mayo, 132 S.Ct. at
1298, 1294.
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Rapid Litigation Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1047 (Fed.
Cir. 2016) (paragraphing added).
In the present case, claim 1 recites the step of “determining in a
nucleic acid sample obtained from the individual, the presence of a TT
genotype at a single nucleotide polymorphism rs2297480 (SNP rs2297480)
in the famesyl diphosphate synthase (FDPS) gene, the presence of the TT
genotype at SNP rs2297480 being indicative that the individual as is
responsive to bisphosphonates.” Br. 10 (claim 1).
We, therefore, agree with the Examiner that, as to part one of the
Supreme Court’s test, Appellants’ claim 1 is expressly directed to the law of
nature discovered by Appellants—that the presence of the TT genotype at
SNP rs2297480 is indicative that an individual having a bone disorder will
respond to treatment with bisphosphonates.
As to part two of the Supreme Court’s test, the only other step in
Appellants’ claim 1, administering bisphosphonate to the individual having
the bone disorder, is a well understood and routine treatment step for such
patients, as explained in Appellants’ Specification. See Spec. 1 (“Oral
bisphosphonates are the commonest first-choice treatment where a reduction
in osteoclasis would be beneficial, for example, for post-menopausal
osteoporosis . . . .”).
We, therefore, agree with the Examiner that, under the Supreme
Court’s two-part test, claim 1 recites subject matter ineligible for patenting
under § 101.
Appellants’ arguments do not persuade us to the contrary.
As to Appellants’ contentions that claim 1 is distinguishable from the
claims of Mayo on the basis of the recited treatment step, and recites
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additional elements that amount to a practical application of their discovered
law of nature (see Br. 5—8), we first note that, contrary to Appellants’
assertion, the claims in Mayo recited a treatment step. See Mayo, 132 S.Ct.
at 1295 (“[CJlaim 1 of the ’623 Patent, which describes one of the claimed
processes[, recites] as follows: 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 (internal quotations
omitted).
As noted above, moreover, it is undisputed that the step of
administering a bisphosphonate recited in Appellants’ claim 1 was a well-
known and routine treatment for individuals suffering from bone disorders.
Claim 1 ’s treatment step, therefore, does not transform the claim into
something significantly more than the discovered law of nature itself. To the
contrary, on this record, claim 1 ’s treatment step administers a drug, a
bisphosphonate, to a patient population, bone disorder sufferers, that was
undisputedly already known to receive the drug routinely.
We are not persuaded, moreover, that claim 1 ’s step of determining
the presence of the critical TT genotype at SNP rs2297480 of the FDPS gene
is sufficient to render claim 1 eligible for patenting under § 101. Like the
determining step in the patent-ineligible process at issue in Mayo, 132 S.Ct.
at 1297—98, the genotype determining step in claim l’s process is performed
using conventional techniques. See Spec. 5:
The presence of a variant allele at the one or more sites
of polymorphism may be determined by any convenient
technique, including amplification of all or part of the genomic
region of the FDPS gene, including the FDPS gene itself,
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sequencing all or part of the genomic region of the FDPS gene,
including the FDPS gene itself, and/or hybridisation of a probe
which is specific for a variant allele.
See also Spec. 6 (“PCR is well-known in the art. . . .”); id. at 7 (“Binding of
a probe to target nucleic acid (e.g. DNA) may be measured using any of a
variety of techniques at the disposal of those skilled in the art.”); id. at 10
(“Sequencing may be performed using any one of a range of standard
techniques.”).
Appellants contend that claim 1 ’s step of determining the presence of
the critical TT genotype at SNP rs2297480 does not preempt others from
detecting and using variant alleles other than rs2297480, or detecting
genotypes other than the claimed TT genotype. Br. 6, 8.
That alleles other than the claimed allele might also be linked to
responsiveness to bisphosphonates does not persuade us that Appellants’
claim 1 fails to effectively preempt the application of the specific law of
nature recited in claim 1 —that the presence of the TT genotype at SNP
rs2297480 is indicative that an individual having a bone disorder will
respond to treatment with bisphosphonates.
Indeed, our reviewing court has expressly rejected similar contentions
regarding preemption, stating that a patentee’s “attempt to limit the breadth
of the claims by showing alternative uses . . . outside of the scope of the
claims does not change the conclusion that the claims are directed to patent
ineligible subject matter.” Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788
F.3d 1371, 1379 (Fed. Cir. 2015). The court explained that, “[wjhile
preemption may signal patent ineligible subject matter, the absence of
complete preemption does not demonstrate patent eligibility. . . . Where a
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patent’s claims are deemed only to disclose patent ineligible subject matter
under the Mayo framework . . . preemption concerns are fully addressed and
made moot.” Id.
In the present case, as discussed above, Appellants’ claim 1 is limited
to patented ineligible subject matter under the Mayo framework. Thus, that
alternatives outside the claims are not preempted does not demonstrate
patent eligibility.
In sum, for the reasons discussed, Appellants do not persuade us that a
preponderance of the evidence fails to support the Examiner’s conclusion
that Appellants’ claim 1 is patent-ineligible under § 101. Accordingly, we
affirm the Examiner’s rejection of claim 1 on that ground. Because they
were not argued separately, claims 13—17, 25, 30, and 31 fall with claim 1.
See 37 C.F.R. § 41.37(c)(l)(iv).
Turning to Appellants’ arguments separately directed to claims 37—44,
we first note that Appellants do not present their arguments under the
separate subheadings required by § 41.37(c)(l)(iv). In any event, we do not
find Appellants’ arguments persuasive.
Claim 37 recites “[a] method according to claim 1 wherein the
individual has a bone mineral density (BMD) T score of -1 or less” and
claim 38 recites “[a] method according to claim 37 wherein the bone
disorder is osteoporosis.” Br. 11.
As noted above, however, administering bisphosphonates to
osteoporosis sufferers was routine in the art (Spec. 1), and the Specification
discloses that a BMD T score of -1 or less was known to be the clinical
definition of osteoporosis (see id. at 10-11). Appellants do not persuade us,
therefore, that claims 37 and 38 add anything to the discovered law of nature
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beyond routine, conventional activity. We, therefore, affirm the Examiner’s
rejection of claims 37 and 38 as well.
Claims 39 and 40 both depend ultimately from claim 1, and require
the TT genotype to be determined by hybridization to a nucleic acid having
SEQ ID NO: 1. Br. 11—12. Claims 41 and 42 both depend from claim 40,
and recite the use of a nucleic acid array in the hybridization. Id. at 12.
As noted above, however, the use of hybridization as a technique for
determining the presence of a particular nucleic acid sequence was routine
and conventional in the art. See Spec. 7 (“Binding of a probe to target
nucleic acid (e.g. DNA) may be measured using any of a variety of
techniques at the disposal of those skilled in the art.”). The Specification
also discloses that nucleic acid arrays were conventionally used in
hybridization assays. Id. at 8. (“Nucleic acid arrays are well known in the
art and may be produced in a number of ways.”).
Appellants do not persuade us, therefore, that claims 39-42 add
anything to the discovered law of nature beyond routine, conventional
activity. We, therefore, affirm the Examiner’s rejection of claims 39-42 as
well.
Claim 43 is similar to claim 1, discussed above, except that claim 43
limits the bisphosphonate administered to the bone disease sufferer to
specific compounds. Br. 12.
The Specification discloses, however, that the claimed compounds
were conventionally used to treat bone disorders. See Spec. 11 (“Examples
of bisphosphonates currently in use as pharmaceuticals include alendronate,
clodronate, ibandronate, pamidronate, risedronate and zoledronate.”).
Appellants do not persuade us, therefore, that claim 43 adds anything to the
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discovered law of nature beyond routine, conventional activity. We,
therefore, affirm the Examiner’s rejection of claim 43 as well.
Claim 44 is similar to claim 1, discussed above, except that claim 44
requires the determination of the TT genotype to be made by hybridization,
and also requires the bisphosphonate specifically to be pamidronate, and
specifically requires the compound to be administered intravenously. Br. 12.
As discussed above, however, hybridization was a conventional
technique known to be used for detecting nucleic acids of interest, and
pamidronate was among conventionally used bisphosphonates. As to
intravenous administration of the drug, Appellants’ Specification discloses
that “[mjethods of determining the most effective means and dosage of
administration are well known to those of skill in the art. . . .” Spec. 18.
Appellants do not persuade us, therefore, that claim 44 adds anything to the
discovered law of nature beyond routine, conventional activity. We,
therefore, affirm the Examiner’s rejection of claim 44 as well.
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 1, 13—17, 25, 30, 31, and 37-44 under 35 U.S.C. § 101 as being
directed to non-statutory subject matter.
TIME PERIOD
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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