Ex Parte Atwood

Patent Trial and Appeal Board

Aug 16, 2016

13691048 (P.T.A.B. Aug. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/691,048 11130/2012
81391 7590 08/16/2016
Andrns Intellectual Property Law, LLP
100 East Wisconsin A venue
Suite 1100
Milwaukee, WI 53202-4178
FIRST NAMED INVENTOR
Craig S. Atwood
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.
1256-01823 5579
EXAMINER
POHNERT, STEVEN C
ART UNIT PAPER NUMBER
1634
MAILDATE DELIVERY MODE
08/16/2016 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 CRAIG S. ATWOOD
Appeal2015-001611
Application 13/691,048
Technology Center 1600
Before DONALD E. ADAMS, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 26-28, 30-32,
42, 44, 45, and 47--49 (App. Br. 22; see Final Rej. 2).2 Examiner entered
rejections under 35 U.S.C. § 101, 35 U.S.C. § 102(b), and 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies the Real Party in Interest as the "Wisconsin Alumni
Research Foundation" (App. Br. 1 ).
2 "Claim[s] 41, 43, 50-53, and 55 [stand] withdrawn from examination"
(App. Br. 22). Examiner failed to present a rejection of Claim 54, therefore,
we do not include Claim 54 in our deliberations.
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STATEMENT OF THE CASE
Appellant's independent claims 26 and 42 are representative and
reproduced below with the non-elected species of the claimed invention
ellipted3:
26. A method comprising administering treatment to a patient at risk
for developing Alzheimer's disease (AD) or a patient diagnosed with AD,
wherein the patient is homozygous or heterozygous for an Apolipoprotein
E4 (APOE4) allele, and the patient has a single nucleotide polymorphism
(SNP) ... rs4073366, wherein the patient is homozygous for the cytosine
allele ( C-allele) or the patient is homozygous for the guanine allele ( G-
alle le) at the polymorphic position of rs4073366 ....
42. A method for administering treatment to a patient at risk for
developing Alzheimer's disease (AD) or a patient diagnosed with AD,
wherein the patient is homozygous or heterozygous for an Apolipoprotein
E4 (APOE4) allele, the method comprising:
(a) treating a sample from the patient with reagents that detect a single
nucleotide polymorphism (SNP) ... consisting of ... rs4073366 ... ;
and
(b) administering AD treatment to the patient if ... the patient is
determined to be homozygous for the cytosine allele ( C-allele) or the
patient is determined to be homozygous for the guanine allele ( G-
allele) at the polymorphic position of rs4073366 ....
3 Due to a restriction requirement and species election, we limit the scope of
our review to Appellant's elected invention (see Examiner's February 5,
2013 Restriction Requirement and Appellant's June 3, 2013 Response to
Restriction Requirement; see also App. Br. 7: n. 1 ). See Ex parte Ohs aka, 2
USPQ2d 1460, 1461(BPAI1987).
2
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Application 13/691,048
Claims 26-28, 30-32, 42, 44, 45, and 47-49 stand rejected under
35 U.S.C. § 101.4
Claims 26-28 and 30 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Sano5 as evidenced by Wragg6 and dbSNP rs4073366. 7
Claims 26-28 and 30 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Sano, Wragg, and dbSNP rs4073366.
Claims 31 and 32 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Sano, Wragg, dbSNP rs4073366, and
Mattson. 8
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Sano teaches Appellant's claimed invention, as
evidenced by Wragg and dbSNP rs4073366?
4 Examiner's statement of the rejection includes canceled claims 29 and 46
(see generally App. Br. 22 and 24; Final Rej. 2). In addition, Examiner's
statement of the rejection includes claim 41, which stands withdrawn from
consideration (see App. Br. 22; Final Rej. 2). Claims 29, 41, and 46 were
not included in our deliberations.
5 Sano et al., A controlled trial of selegiline, alpha tocopherol, or both as
treatment for Alzheimer's disease, 336 The New England Journal of
Medicine 1216-1222 (1997).
6 Wragg et al., Genetic association between intronic polymorphism in
presenilin-1 gene and late-onset Alzheimer's disease, 34 7 Lancet 509-512
(1996).
7 NCBI dbSNP Short Genetic Variations Cluster Report: rs4073366,
http://www.ncbi.nlm.nih.gov/projects/SNP/snp _ref.cgi?rs=4073366,
accessed Jan. 6, 2014.
8 Mattson, Pathways towards and away from Alzheimer's disease, 430
Nature 631-639 (2004).
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FACTUAL FINDINGS (FF)
FF 1. Appellant discloses that "[t]he APOE4 allele (E4) ... [is] a risk
factor for late-onset AD," but, "the risk for AD imparted by one or two E4
alleles is only partially penetrant: ~50% of AD patients do not carry an E4
allele" (Spec. ii 3).
FF 2. Appellant discloses methods "to determine that a patient has an
increased risk for developing AD (e.g., a risk greater than about 99%)
where: (i) the patient has at least one APOE4 allele; (ii) the patient is female;
and (iii) the patient is homozygous for the C-allele or the G-allele for
rs4073366" or "(e.g., a[] risk greater than about 85%) where: (i) the patient
has at least one APOE4 allele; (ii) the patient is homozygous for the C-allele
or the G-allele for rs4073366" (Spec. ii 16; see generally Ans. 9-10).
FF 3. Sano discloses the treatment "of patients with Alzheimer's disease[]
with selegiline or alpha-tocopherol or both was beneficial in delaying the
primary outcome of disease progression" (Sano 1220; see Ans. 8; see also
Sano 1218: Table 1 (identifying the number of male and females in the
population)).
FF 4. Examiner relies on dbSNP rs4073366 to establish that the
homozygous G allele at the polymorphic position of SNP rs4073366 occurs
in "over 75% of people assayed in populations greater than 44," therefore,
Examiner finds that the population of AD patients treated according to
Sano's methodology, "would inherently encompass th[ e] [rs4073366]
genotype" required by Appellant's claimed invention (Ans. 9).
FF 5. Wragg discloses that "[a]s much as 40-50% of the risk for late-onset
[Alzheimer's] disease is attributable to alleles at the ApoE locus," wherein
"ApoE4 is thought to increase risk of Alzheimer's disease in a dose-
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dependent manner" (Wragg 509; Ans. 9; see also Wragg 509 (discussing
"DNA sequence analysis" and sample populations that include male and
female patients "blood samples from 208 [] cases of dementia of the
Alzheimer type and from 185 age-matched controls( ... ; 58% female in
each series))).
ANALYSIS
Examiner finds that Sano's method of treating Alzheimer's subjects
"inherently anticipates claim 26 as one subject would have the required
genotype" (Ans. 10). We are not persuaded.
As Appellant explains,
the Office appears to be arguing that because 40-50% of the
risk for late-onset disease is attributable to alleles at the ApoE
locus, and because over 75% of people assayed in populations
greater than 44 are homozygous for the G-allele of dbSNP
rs4073366, it is highly probable that Sano's method of treating
[] Alzheimer's subjects would have included treating a patient
that is positive for the ApoE-allele and the G-allele of dbSNP
rs4073366.
(App. Br. 8-9; cf Ans. 8-10; FF 3-5.) Similarly, with respect to
Examiner's discussion of Appellant's Specification, Appellant contends that
the Office appears to be arguing that because patients having
AD have been treated in the prior art, and because the genetic
markers that the present inventor has identified are indicative of
a high risk for AD, then statistically patients having the
inventor's identified genetic markers must have been
administered treatment for AD in the prior art.
(App. Br. 9; cf Ans. 9-10; FF 1-5.) "Inherency, however, may not be
established by probabilities or possibilities. The mere fact that a certain
thing may result from a given set of circumstances is not sufficient." In re
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Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal
quotation marks omitted).
As Appellant explains, "the mere fact that at least one of Sano' s
Alzheimer subjects may have had the genotype recited in the present claims
based on statistics is not sufficient to establish inherent anticipation" (App.
Br. 10). We agree. We recognize, but are not persuaded by, Examiner's
assertion that Appellant's "claims require a single active step of
administering a treatment to a patient with AD or risk of AD" and
Appellant's "response has provided no arguments that the prior art does not
anticipate the single positive active step of the claims" (Ans. 16 and 17).9
As Appellant explains, Examiner's interpretation of Appellant's claimed
invention fails to account for all the limitations of Appellant's claimed
invention. Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628,
631 (Fed. Cir. 1987) ("A claim is anticipated only if each and every element
as set forth in the claim is found, either expressly or inherently described, in
a single prior art reference.").
9 We recognize, as does Appellant, that in response to Appellant's arguments
concerning the prior art rejections, Examiner refers to "Haasl (BMC Medical
Genetics (2008) volume 9, page 37)" to support Examiner's assertion that "it
is unclear if APOE4 positive and CC genotype as claimed is correlated with
AD as asserted" (see Ans. 14-15; cf Reply Br. 2). Examiner, however,
failed to rely upon Haasl in any statement of rejection before this panel,
therefore, we decline to consider Haasl. In re Hoch, 428 F.2d 1341, 1342
n.3 (CCPA 1970).
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CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner's finding that Sano teaches Appellant's claimed invention, as
evidenced by Wragg and dbSNP rs4073366.
The rejection of claims 26-28 and 30 under 35 U.S.C. § 102(b) as
anticipated by Sano as evidenced by Wragg and dbSNP rs4073366 is
reversed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 6. Examiner relies on Sano, dbSNP rs4073366, Wragg, and Appellant's
Specification as discussed above (see FF 1-5; Ans. 11-13).
FF 7. Examiner finds that the combination of Sano, dbSNP rs4073 3 66, and
Wragg fails to suggest "treating subjects with diet or lifestyle" and relies on
Mattson to disclose "that behavior, diet, and environmental factors affect the
risk of AD," wherein Mattson "suggests increasing exercise and changing
diet as potential methods of reducing Alzheimer disease and slowing
progression" (Ans. 13-14; see Mattson 631 ("interventions for the
prevention and treatment of AD [] range from changes in diet and lifestyle,
to vaccines and drugs")).
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ANALYSIS
The rejection over the combination of Sano, Wragg, and dbSNP rs4073366:
Based on the combination of Sano, Wragg, and dbSNP rs4073366,
Examiner concludes that, at the time Appellant's invention was made, it
would have been prima facie obvious to treat Alzheimer subjects as
disclosed by Sano, wherein "at least one Alzheimer patient ha[ s] the
required genotype being treated" (Ans. 13). In this regard, Examiner finds
that Sano "is merely treating a population that must statistical[ly] have one
subject with the required genotype" (id.). We are not persuaded.
For the reasons discussed above, the evidence of record fails to
support Examiner's conclusion (see App. Br. 8-10). "[R ]ejections on
obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness." In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006). In this regard, Examiner's conclusion
that Sano might possibly treat at least one individual with AD fails to
provide a sufficient evidentiary basis to support Examiner's conclusion that
the combination of Sano, Wragg, and dbSNP rs4073366 makes obvious
Appellant's claimed invention.
The rejection over the combination of Sano, Wragg, dbSNP rs4073366, and
Mattson:
Based on the combination of Sano, Wragg, dbSNP rs4073366, and
Mattson, Examiner concludes that, at the time Appellant's invention was
made, it would have been prima facie obvious "to treat subjects in the
method [suggested by the combination] of Sano, Wragg, and dbSNP
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[rs4073366] by chang[ing] [the subjects'] diet and/or lifestyle" (Ans. 14).
We are not persuaded. Examiner failed to establish that Mattson makes up
for the deficiency in the combination of Sano, Wragg, and dbSNP rs4073366
discussed above.
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 26-28 and 30 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Sano, Wragg, and dbSNP rs4073366 is
reversed.
The rejection of claims 31 and 32 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Sano, Wragg, dbSNP rs4073366, and
Mattson is reversed.
Patent-eligible Subject Matter:
ISSUE
Does the evidence of record support Examiner's finding that
Appellant's claimed invention is not directed to patent-eligible subject
matter?
ANALYSIS
Examiner finds that Appellant's claimed invention is directed to a
"method" that involves "a naturally recurring correlation of APOE[ 4 ],
rs407336 ... and risk or diagnosis of AD" (Ans. 3--4). See Mayo
Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289,
1296-97 (2012). Examiner finds that Appellant's "claims do not provide
additional elements" that would establish that Appellant's claims would do
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"more than [apply] the natural principle" (Ans. 5). Mayo, 132 S. Ct. at
1297. In sum, Examiner finds that Appellant's claimed invention "merely
requires the detection of [a] naturally occurring sequence that is correlated
with AD risk or diagnosis and administration of therapy claimed with a high
degree of generality," which "are not patent eligible" (Ans. 5). We agree.
For the reasons set forth herein, we are not persuaded by Appellant's
contention that Appellant's "claims do recite statutory subject matter
because the claims are narrowly drawn to [a] specific SNP[J and include a
practical step of administering treatment to a patient that has the specific
SNP[]" (App. Br. 11; see Reply Br. 4-6).
We recognize, but are not persuaded by, Appellant's contention that
if the Office were to define the "natural principle" encompassed
by [Appellant's] claims more broadly and commensurate with
the inventor's finding that a plurality of genes that encode gene
products that function in the steroidogenic pathway are
associated with the risk of AD, then the claims would not be
viev"1ed as reciting steps \"1ith a "high degree of generality."
(App. Br. 12.) The method of Appellant's claim 26 comprises administering
any treatment to a patient at risk for developing, or diagnosed with, AD (see
Appellant's claim 26). Similarly, the method for administering treatment to
a patient at risk for developing, or diagnosed with, AD, set forth in
Appellant's claim 42, requires the administration of any AD treatment to the
patient (see Appellant's claim 42). Methods comprising the administration
of treatment to a patient at risk for developing, or diagnosed with, AD were
known in the art at the time of Appellant's claimed invention (see FF 3 and
7; see Ans. 19 (Appellant's "claims encompass the use of any treatment.
[Appellant's] dependent claims require the administration of lifestyle or diet
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changes, [which were known in the art,] but do[] not limit diet or life style
changes in any fashion")).
Appellant's claimed invention requires a patient that is homozygous
or heterozygous for an APOE4 allele, which was, at the time of Appellant's
claimed invention, "thought to increase risk of Alzheimer's disease in a
dose-dependent manner" (see Appellant's claims 26 and 42; cf FF 5; see
Ans. 19 ("The APOE4 genotype and presence of APOE4 allele are naturally
occurring as is there correlation with AD or risk of AD")). The rs4073366
SNP was also known in the art at the time of Appellant's claimed invention
(see FF 4).
Moreover, Appellant's claimed method is not transformed into patent-
eligible subject matter because it further requires identifying a protein or a
mutation. To the contrary, the claims merely apply well-understood, routine
methods to identify a subpopulation of patients with, or at risk of
developing, AD that are homozygous or heterozygous for the APOE4 allele
and homozygous for the C-allele or G-allele at a polymorphic position of the
rs4073366 SNP (see, e.g., Appellant's independent claims 26 and 42). Cf In
re BRCAJ- and BRCA2-Based Hereditary Cancer Test Patent Litig., 774
F.3d 755, 759 (Fed. Cir. 2014) ("The two method claims now on appeal
involve comparisons between the wild-type BRCA sequences with the
patient's BRCA sequences"). Comparing two sequences to detect
alterations is a patent-ineligible "abstract mental process." Id. at 763.
Therefore, the question before this panel distills down to the same
question presented in Mayo: Do Appellant's "claims add enough to
[Appellant's] statements of the correlations to allow the process [Appellant]
describe[ s] to qualify as [a] patent-eligible process[] that appl[ies] natural
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laws?" Mayo, 132 S. Ct. at 1297. On this record, as in Mayo, we find "that
the answer to this question is no." See id.
We recognize, but are not persuaded by, Appellant's contention that
"[t]he present claims do recite statutory subject matter because the claims
are narrowly drawn to [a] specific SNP[] and include a practical step of
administering [any] treatment to a patient that has the specific SNP[]" (App.
Br. 11; see id. at 12; see Reply Br. 4-6). Notwithstanding Appellant's
contention to the contrary, it is not sufficient for a claim to "simply recite a
law of nature and then add the instruction 'apply the law."' See Mayo, 132
S. Ct. at 1297. As discussed above, the administration step of Appellant's
claimed invention was known in the art prior to the date of Appellant's
claimed invention (see FF 3 and 7). Cf Mayo, 132 S. Ct. at 1297.
Nevertheless, "the 'prohibition against patenting abstract ideas 'cannot be
circumvented by attempting to limit the use of the formula[, abstract mental
process, or natural law,] to a particular technological environment."' Id.
(citing Bilski v. Kappas, 130 S. Ct. 3218, 3230 (2010)).
There is no requirement in Appellant's claimed invention that the art
recognized "treatment" regimens already provided to patients with, or at risk
of developing, AD is changed in any way by detecting APOE4 and
rs4073366 SNP alleles, or otherwise subdividing the foregoing patient
population (see Ans. 20 (Appellant's "claims are not limited to any ...
specific treatment); Ans. 22; cf App. Br. 14 (Appellant's "claims do require
an active step of administering therapy based on an identified correlation");
see also id. at 14-15 (Appellant "has identified a novel and non-obvious
class of patients that will benefit from treatment for AD and the claims recite
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an active step of administering therapy to the identified class of patients"; id.
at 19; see Reply Br. 6-11).
The "wherein" clauses of Appellant's claimed invention, as in Mayo,
"simply tell a doctor about the relevant natural laws ... while trusting them
to use those laws appropriately where they are relevant to their
decisionmaking." Mayo, 132 S. Ct at 1297.
While Appellant's claims do not recite determining steps, in haec
verba, determining steps are implied by the requirement of Appellant's
claim 26 that the patient is homozygous or heterozygous for an APOE4
allele and homozygous for the C-allele or G-allele at the polymorphic
position of the rs4073366 SNP (see Appellant's claim 26; cf Ans. 20
(Appellant's "[c]laim 26 ... does not provide a positive active step in which
the genotype is determined"). A determining step is also implied by the
requirement of Appellant's claim 42 that requires that the patient is
homozygous or heterozygous for an APOE4 allele and the step of treating a
sample from the patient with reagents that detect a SNP rs4073366
polymorphism (see Appellant's claim 42; cf Ans. 20 (Appellant's "claims
are not limited to any specific method of detection[ or] any specific reagent
for detecting")). Here, however, as in Ariosa, the detection of APOE4 and
rs4073366 SNP alleles-"natural phenomen[a]- ... add[] no inventive
concept to the limitations of' Appellant's claimed invention. Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1378 (Fed. Cir. 2015);
see In re BRCAJ, 774 F.3d at 763 (Comparing two sequences to detect
alterations is a patent-ineligible "abstract mental process.").
As discussed above, Appellant's claimed method does no more than
identify a sub-population of patients with, or at risk of developing, AD and
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then administer exactly the same treatment to those patients as was done in
the prior art for the entire population of patients with, or at risk of
developing, AD. Therefore, we are not persuaded by Appellant's contention
that "[i]n contrast to the claims at issue in Mayo, [Appellant's] claims do
require an active step of administering therapy based on an identified
correlation" (App. Br. 14). Notwithstanding Appellant's contention to the
contrary, Appellant's therapy administration step is not based on any
identified correlation, because patients are administered exactly the same
treatment regimen suggested by the prior art for any AD patient. We are,
also, not persuaded by Appellant's unsupported contention that the medical
community would not appreciate that a treatment regimen that can be
applied to the entire genus of AD patients - can also be applied to a sub-
genus of those AD patients (see App. Br. 17 "the active step of
administering AD therapy to [a sub-]class of [ADJ patients is not a well
understood, routine, and conventional activity engaged by the medical
community").
Therefore, we find that, here, as in Mayo, Appellant's
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. For these reasons we believe that the steps are not
sufficient to transform unpatentable natural correlations into
patentable applications of those regularities.
Mayo, 132 S. Ct. 1298.
Appellant's dependent claims which limit the scope of Appellant's
independent claims 26 and 42 to a female or male (see Appellant's claims
27-28 and 44-45, respectively; cf FF 3 and 5) or to a treatment that
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comprises administering medication, changing the diet or lifestyle of the
patient (see Appellant's claims 30-32 and 47--49, respectively; cf FF 3 and
7) simply append routine, conventional steps to a natural phenomenon,
which, when the claims are read as a whole, are specified at a high level of
generality and do not supply an inventive concept to Appellant's claims (see
Ans. 20 (Appellant's "claims are set forth with a high degree of generality
and therefore do not recite elements/steps in addition to the judicial
exception that would narrow the scope of the claims . . . . The steps are
highly generalized")). Therefore, we are not persuaded by Appellant's
contention that "the rejection be ... withdrawn, at least in regard to
[Appellant's] claims 30-32 and 47-49" (App. Br. 18).
CONCLUSION OF LAW
The evidence of record supports Examiner's finding that Appellant's
claimed invention is not directed to patent-eligible subject matter.
The rejection of claims 26-28, 30-32, 42, 44, 45, and 47--49 under
35 U.S.C. § 101 is affirmed.
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. § l.136(a).
AFFIRMED
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