Ex Parte UCHIDA et al

Patent Trials and Appeals Board

Jun 13, 2019

14263645 - (D) (P.T.A.B. Jun. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/263,645 04/28/2014
127226 7590 06/17/2019
BIRCH, STEW ART, KOLASCH & BIRCH, LLP
8110 Gatehouse Road
Suite 100 East
Falls Church, VA 22042-1248
Kazuhiko UCHIDA
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.
4877-0110PUS2 9190
EXAMINER
CHERNYSHEV, OLGAN
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
06/17/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mailroom@bskb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KAZUHIKO UCHIDA, T AKASHI ISHI, KOHJI MENO, and
HIDEAKI SUZUKI 1
Appeal 2019-000733
Application 14/263,645
Technology Center 1600
Before RY ANH. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods for detecting biomarkers for a psychiatric disease or cognitive
impairment. The Examiner rejected the claims as being directed to patent-
ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the Real Party in Interest as MCBI INC. Br. 1. Herein
we reference the Final Office Action dated July 31, 2017 ("Final Act."); the
Appeal Brief filed Jan. 2, 2018 ("Br."); the Examiner's Answer dated Sept.
4, 2018 ("Ans."); and the Substitute Specification filed Sept. 10, 2014
("Spec.").
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Application 14/263,645
STATEMENT OF THE CASE
According to the Specification, "methods for screening and diagnosis
of dementia including AD [Alzheimer's disease] that are available at present
[are] dependent on tests lacking objectivity and [] on expensive instruments,
and so it is very difficult to use these tests for screening of early stage-
cognitive impairment." Spec. ,r 10. Thus, per the Specification, the
invention "provides novel biomarkers and a novel and potent diagnostic
method for cognitive impairment by using such biomarkers." Id.
Claims 1, 2, 12, and 13 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A method for detecting a biomarker for a psychiatric
disease in a human subject, comprising:
(a) obtaining a serum sample from the human subject;
and
(b 1) detecting at least one biomarker for the psychiatric
disease in the serum sample by contacting the serum sample
with an antibody that specifically binds to the at least one
biomarker for the psychiatric disease,
wherein the at least one biomarker of step (b 1) is at
least one protein selected from the group consisting of
Neurexin-2-beta precursor consisting of amino acid
sequence expressed by SEQ ID NO: 1, Prothrombin
precursor consisting of amino acid sequence expressed
by SEQ ID NO: 3, Pendrin consisting of amino acid
sequence expressed by SEQ ID NO: 6, Coatomer subunit
zeta-I consisting of amino acid sequence expressed by
SEQ ID NO: 8, Retinoic acid receptor responder protein
2 precursor consisting of amino acid sequence expressed
by SEQ ID NO: 10, Gelsolin precursor consisting of
amino acid sequence expressed by SEQ ID NO: 13,
Clusterin precursor consisting of amino acid sequence
expressed by SEQ ID NO: 15, Eukaryotic translation
initiation factor 3 subunit J consisting of amino acid
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Application 14/263,645
sequence expressed by SEQ ID NO: 18, and Leucine-rich
repeat-containing protein 27 consisting of amino acid
sequence expressed by SEQ ID NO: 20; or
(b2) detecting at least one biomarker for the psychiatric
disease in the serum sample by contacting the serum sample
with an antibody that specifically binds to the at least one
biomarker for the psychiatric disease,
wherein the at least one biomarker of step (b2) is at
least one peptide selected from the group consisting of
Neurexin-2-beta precursor-derived peptide NRX2B
consisting of amino acid sequence expressed by SEQ ID
NO: 2, Prothrombin precursor-derived peptide
THRB(R-) consisting of amino acid sequence expressed
by SEQ ID NO: 4, Prothrombin precursor-derived
peptide THRB(R +) consisting of amino acid sequence
expressed by SEQ ID NO: 5, Pendrin-derived peptide
S26A4 consisting of amino acid sequence expressed by
SEQ ID NO: 7, Coatomer subunit zeta- I-derived peptide
COPZl consisting of amino acid sequence expressed by
SEQ ID NO: 9, Retinoic acid receptor responder protein
2 precursor-derived peptide RARR2(S-) consisting of
amino acid sequence expressed by SEQ ID NO: 11,
Retinoic acid receptor responder protein 2 precursor-
derived peptide RARR2(S+) consisting of amino acid
sequence expressed by SEQ ID NO: 12, Gelsolin
precursor-derived peptide GELS consisting of amino acid
sequence expressed by SEQ ID NO: 14, Clusterin
precursor-derived peptide CLUS(Nterm SDVP)
consisting of amino acid sequence expressed by SEQ ID
NO: 16, Clusterin precursor-derived peptide CLUS(N-
term RFFT) consisting of amino acid sequence expressed
by SEQ ID NO: 17, Eukaryotic translation initiation
factor 3 subunit I-derived peptide EIF3J consisting of
amino acid sequence expressed by SEQ ID NO: 19, and
Leucine-rich repeat-containing protein 27-derived
peptide LRC27 consisting of amino acid sequence
expressed by SEQ ID NO: 21,
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Application 14/263,645
wherein detecting is performed by a fluorescence-labeled
antibody method or a radioisotope-labeled antibody method,
and
wherein the biomarker of steps (b 1) and (b2) is optionally
fluorescently labeled.
Br. (Claims Appendix).
The claims stand rejected under 35 U.S.C. § 101 as directed to patent-
ineligible subject matter (a law of nature). Final Act. 2.
ANALYSIS
"[T]he examiner bears the initial burden ... of presenting a prima
facie case ofunpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant." In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992). We have considered those arguments
made by Appellants in the Appeal Brief; arguments not so presented in
Appellants' brief are deemed waived. See 37 C.F.R. § 4I.37(c)(l)(iv)
(2015); see also Ex Parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) ("Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.").
An invention is patent-eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
ideas" are not patentable. See, e.g., Alice Corp. v. CLS Bankint'l, 573 U.S.
208,216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Mayo
and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus
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Application 14/263,645
Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework,
we first determine what concept the claim is "directed to." See Alice, 573
U.S. at 219 ("On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.").
If the claim is "directed to" an abstract idea, we tum to the second
step of the Alice and Mayo framework, where "we must examine the
elements of the claim to determine whether it contains an 'inventive
concept' sufficient to 'transform' the claimed abstract idea into a patent-
eligible application." Alice, 573 U.S. at 221 (quotation marks omitted). A
claim that recites a law of nature must include "additional features that
provide practical assurance that the process is more than a drafting effort
designed to monopolize the law of nature itself." Mayo, 566 U.S. at 77. "A
patent, for example, [cannot] simply recite a law of nature and then add the
instruction 'apply the law."' Id. at 77-78.
The U.S. Patent and Trademark Office ("USPTO") recently published
revised guidance on the application of§ 101. USPTO's 2019 Revised Patent
Subject Matter Eligibility Guidance ("Revised Guidance"). 2 Under the
Revised Guidance and consistent with case law, in determining what concept
the claim is "directed to," we first look to whether the claim recites:
2 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50--
57 (January 7, 2019).
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Application 14/263,645
(1) any judicial exceptions, i.e., an abstract idea, a law of
nature, or a natural phenomenon; 3 and
(2) additional elements that integrate the judicial
exception into a practical application (see MPEP § 2106.05(a}-
(c), (e}-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim
contains an "'inventive concept' sufficient to 'transform"' the claimed
judicial exception into a patent-eligible application of the judicial exception.
Alice, 573 U.S. at 221 ( quoting Mayo, 566 U.S. at 82). In so doing, we thus
consider whether the claim:
(3) adds a specific limitation beyond the judicial
exception that is not "well-understood, routine, conventional"
in the field (see MPEP § 2106.05(d)); or
( 4) simply appends well-understood, routine,
conventional activities previously known to the industry,
specified at a high level of generality, to the judicial exception.
See Revised Guidance, 84 Fed. Reg. at 54--56.
We adopt the Examiner's findings and rationale underpinning the
§ 101 rejection (Final Act. 2--4; Ans. 3-8), and agree that Appellants'
claimed methods are patent-ineligible.
STEP], PRONG 14
Pursuant to the first step of the inquiry under the Revised Guidance,
we begin by determining whether the claims recite any judicial exception(s)
3 Per the Revised Guidance, for laws of nature and natural phenomena,
Prong One does not represent a change in analysis. Revised Guidance, 84
Fed. Reg. at 54.
4 The Revised Guidance refers to Step 1, Prong 1, and with Step 1, Prong 2,
as "Step 2A."
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to patent eligibility. The Examiner found that the claims recite a law of
nature, stating: "the preamble of the claims recites that it is a method for
detecting a biomarker for psychiatric disease, thus making a clear correlation
between naturally occurring factors and naturally occurring pathology."
Final Act. 3; see also Ans. 3. We agree.
Claim 1 recites "[a] method for detecting a biomarker for a psychiatric
disease in a human subject," and "detecting at least one biomarker for the
psychiatric disease." While not affirmatively stated, the detecting step
necessarily links the detection of the biomarker with an indication of
psychiatric disease. Similarly, claims 2, 12, and 13 recite "[a] method for
detecting a biomarker for a cognitive impairment in a human subject," and
"detecting at least one biomarker for the cognitive impairment." Claim 12
affirmatively recites what is implicit in claim 1, with the recitation "wherein
detecting the presence of the biomarker in a higher quantity than a control
sample is indicative that the human subject is suffering from the cognitive
impairment." Similarly, claim 13 additionally recites "wherein detecting the
presence of the biomarker in lower quantity than a control sample is
indicative that the human subject is suffering from the cognitive
impairment." Br. (Claims Appendix).
We find that these limitations recite a natural law, i.e., the correlation
between psychiatric disease or cognitive impairment and the presence or
absence of the claimed naturally-occurring biomarkers in the serum sample
obtained from a human subject. This correlation exists in nature apart from
any human action. Thus, the claims are directed to patent-ineligible laws of
nature. See, e.g., Mayo, 566 U.S. at 1296-97 (claims that recognized a
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Application 14/263,645
relationship between concentrations of metabolites in the blood and the
likelihood that a dosage of drug will be ineffective or cause harm, without
more, were patent-ineligible as directed to a law of nature); Athena
Diagnostics, Inc. v. Mayo Collaborative Servs. LLC, 915 F.3d 743, 750,
753-54 (Fed. Cir. 2019) (claim directed to natural correlation between the
presence ofMuSK autoantibodies in body fluid and MuSK-related
neurological diseases, without more, was patent ineligible).
Appellants argue that previous claim amendments obviated the
Examiner's concern that the claims are directed to a naturally-occurring
correlation. Br. 8. Specifically, Appellants previously amended claims 1
and 2 to remove limitations that stated "wherein detecting the presence of
the biomarker in the serum sample is indicative that the human subject is
suffering from" psychiatric disease and cognitive impairment, respectively.
Id. Appellants further argue that the appealed claims are analogous to claim
1 of Example 29 in the USPTO's May 2016 Interim Guidance on Patent
Subject Matter Eligibility ("Interim Guidance"), because their claims and
claim 1 from the Interim Guidance include the same steps, i.e., "obtaining"
and "detecting" steps. Id. at 8-9.
We are not persuaded by Appellants' arguments. Despite the
amendments to claims 1 and 2, Appellants' claims still specifically describe
a correlation or relationship between the presence of a biomarker in a serum
sample and the presence of psychiatric disease in the subject. See, e.g.,
claim 1 ("biomarker for a psychiatric disease"); claims 2, 12, 13 ("biomarker
for a cognitive impairment"); claim 12 ("wherein detecting the presence of
the biomarker in higher quantity than a control sample is indicative that the
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Application 14/263,645
human subject is suffering from the cognitive impairment"); claim 13
("wherein detecting the presence of the biomarker in lower quantity than a
control sample is indicative that the human subject is suffering from the
cognitive impairment"). Accordingly, we agree with the Examiner that the
claims expressly recite a judicial exception, "because this type of correlation
is a consequence of natural process[ es], similar to the naturally occurring
correlation found to be a law of nature by the Supreme Court in Mayo."
Ans. 8 ( citation omitted).
We are also not persuaded by Appellants' argument likening their
claims to claim 1 of Example 29 in the Interim Guidance. Claim 1 of
Example 29 from the Interim Guidance is reproduced below:
1. A method of detecting JUL- I in a patient, said
method comprising:
a. obtaining a plasma sample from a human
patient; and
b. detecting whether JUL- I is present in the
plasma sample by contacting the plasma sample
with an anti-JUL-I antibody and detecting binding
between JUL- I and the antibody.
Interim Guidance, Subject Matter Eligibility Examples: Life Sciences, at 10.
Appellants' claims differ from this claim in that Appellants' claims
specifically describe a correlation or relationship between the presence of a
biomarker in a serum sample and the presence of psychiatric disease in the
subject, as noted above. Ans. 8.
In this regard, Appellants' claims are more similar to those found
patent-ineligible by the Federal Circuit as directed to natural laws. For
example, in Cleveland Clinic Foundation v. True Health Diagnostics LLC,
859 F.3d 1352 (Fed. Cir. 2017), the Federal Circuit found that claims
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Application 14/263,645
directed to "'seeing' MPO already present in a bodily sample and correlating
that to cardiovascular disease" were ineligible. 859 F.3d at 1361. Similarly,
in Athena Diagnostics, Inc., the Federal Circuit found claims directed to
detecting MuSK autoantibodies naturally present in a patient sample and
correlating the presence of such autoantibodies with MuSK-related
neurological disorder were ineligible. 915 F.3d at 751. Following this
precedent, we conclude that Appellants' claims are directed to a patent-
ineligible law of nature.
STEP], PRONG2
Moving to the next inquiry under the Guidance, we find that the
claims do not integrate this law of nature into a practical application.
Revised Guidance, 84 Fed. Reg. at 54--55. The claimed methods merely
result in detection of the biomarker. They do not require that any action to
be taken based on the information ascertained in the detection of the natural
correlation. Like the claims found patent-ineligible in Mayo, Appellants'
claims involve acquiring information to observe the natural law, but do not
require any particular use of the acquired information to, e.g., alter a
patient's condition. Mayo, 566 U.S. at 79--80 (claims ineligible where they
merely "tell doctors to gather data from which they may draw an inference
in light of the correlations"); cf Vanda Pharm. Inc. v. West-Ward Pharm.
Int'! Ltd., 887 F.3d 1117, 1134--35 (Fed. Cir. 2018) (claims eligible where
they recited administration of a specific dose of a drug in response to genetic
testing results); Natural Alternatives Int'! v. Creative Compounds LLC, 918
F.3d 1338, 1345 (Fed. Cir. 2019) (claims eligible where they rely on natural
relationship but also require that "specific steps be taken in order to bring
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Application 14/263,645
about a change in a subject, altering the subject's natural state").
Accordingly, we conclude that the appealed claims do not integrate the law
of nature or natural phenomenon into a practical application.
STEP 25
Because the claims (1) recite a judicial exception and (2) do not
integrate that exception into a practical application, we next determine
whether the claims add specific limitation(s) beyond the judicial exception
that are not "well-understood, routine and conventional in the field" (see
MPEP § 2106.05(d)), or whether they simply append well-understood,
routine, conventional activities previously known to the industry, specified
at a high level of generality, to the judicial exception. See Revised
Guidance, 84 Fed. Reg. at 56.
In addition to the "detecting" steps discussed above, claims 1, 2, 12,
and 13 recite "obtaining a serum sample" and that the biomarker "is
optionally fluorescently labeled." Br. (Claims Appendix). Claims 1 and 2
additionally recite "contacting the serum sample with an antibody that
specifically binds" to the biomarker, and that the "detecting is performed by
a fluorescence-labeled antibody method or a radioisotope-labeled antibody
method." The Examiner found that these limitations are not sufficient to
transform the claim into something significantly more than the judicial
exception. Final Act. 3; Ans. 3, 6. The Examiner found that obtaining a
serum sample and contacting the sample with labeled antibodies "is routine
in the art, recited at a high level of generality (any antibody can be used) and
5 The Revised Guidance refers to this step as "Step 2B."
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is a necessary step required in order to make the correlation." Final Act. 3.
The Examiner further found that the claims "recite detection steps at a high
level of generality and encompass well-understood and purely conventional
routine techniques of fluorescent immunostaining of proteins in biological
samples (see also the specification at [0031] and [0032])." Ans. 6.
We adopt these findings, and note that Appellants have not disputed
that these claim limitations, alone and in combination, represent well-
understood, conventional, and routine activities, considered individually and
as an ordered combination, which are insufficient to transform the claim into
patent-eligible subject matter. See, e.g., Mayo, 566 U.S. at 79 ("Purely
'conventional or obvious' '[pre]-solution activity' is normally not sufficient
to transform an unpatentable law of nature into a patent-eligible application
of such a law.") (second brackets in original) ( citing Parker v. Flook, 437
U.S. 584, 590 (1978)); Athena, 915 F.3d at 752 ("Because the specification
defines the individual immunoprecipitation and iodination steps and the
overall radioimmunoassay as conventional techniques, the claims fail to
provide an inventive concept.").
Thus, like the claims in cases such as Mayo, Cleveland Clinic, and
Athena, the claimed methods start and end with naturally-occurring
phenomena-the correlation between certain biomarkers in a serum sample
and psychiatric disease or cognitive impairment-with no meaningful non-
routine steps in between. The claims are therefore directed to a natural law
without significantly more. For these reasons, we affirm the rejection of
claims 1, 2, 12, and 13 under 35 U.S.C. § 101.
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SUMMARY
We affirm the rejection of claims 1, 2, 12, and 13 under 35
U.S.C. § 101 as directed to patent-ineligible subject matter.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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