Ex Parte Park et al

Patent Trial and Appeal Board

Feb 21, 2017

13508319 (P.T.A.B. Feb. 21, 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.
13/508,319 07/17/2012 Christopher Y. Park STAN-696 1703
77974 7590 02/23/2017
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
LONG, SCOTT
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
02/23/2017 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.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER Y. PARK, WENDY W. PANG, and
IRVING L. WEISSMAN1
Appeal 2015-007714
Application 13/508,319
Technology Center 1600
Before TAWEN CHANG, TIMOTHY G. MAJORS, and DAVID COTTA,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of phenotyping a myelodysplastic condition,2 which have been
rejected as lacking in patentable subject matter. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as the Board of Trustees of
the Leland Stanford Junior University. (Br. 1.)
2 A myelodysplastic condition is a type of hematologic (i.e., blood) disorder.
(Spec. 11.)
Appeal 2015-007714
Application 13/508,319
STATEMENT OF THE CASE
Myelodysplastic syndromes (MDS) represent a related group of clonal
hematologic disorders characterized by reduced number of peripheral blood
cells due to ineffective blood cell production. (Spec. 11.) The Specification
states that “diagnosis [of MDS] remains a clinical challenge due to the
absence of a single objective criterion for diagnosis, except in the cases
where conventional cytogenetics may reveal a clonal abnormality.” {Id. at
14.) According to the Specification,
[i]n the methods of the invention, hematologic samples ... are
differentially analyzed for the distribution of hematopoietic
stem and progenitor cells among specific phenotypes
[including] hematopoietic stem cells (HSC); myeloid
progenitors; common lymphoid progenitors (CLP);
megakaryocyte progenitors; etc. Specifically, it is shown that
myelodysplastic syndromes . . . show reproducible alterations in
hematopoietic stem cell and myeloid progenitor cell frequency,
with decreased . . . granulocyte/macrophage progenitors (GMP)
and increased . . . hematopoietic stem cells.
{Id. at 16.) Further according to the Specification, “[a]n analysis based on
the presence of cell surface markers that provide an assignment of cells into
a class of interest, are generally used for determining the distribution of
phenotypes in a patient sample.” {Id. at 17.)
Claims 1, 6, and 7 are on appeal. Claim 1 is illustrative and
reproduced below:
1. A method of phenotyping a myelodysplastic
condition, the method comprising:
combining a hematologic sample from a patient
suspected of said myelodysplastic condition with antibodies
specific for CD34, CD38 and CD45RA;
determining the distribution of progenitor cells between
hematopoietic stem and progenitor subsets as follows:
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Application 13/508,319
CD34+CD38' hematopoietic stem cells (HSC),
CD34+CD38+CD45RA' common myeloid progenitor (CMP),
CD34+CD38+CD45RA' megakaryocyte erythroid progenitors
(MEP) and CD34+CD38+CD45RA+ granulocyte/macrophage
progenitors (GMP)
wherein an increase in the traction of HSC and a
decrease in the fraction of myeloid progenitor cells that are
granulocyte macrophage progenitor cells relative to a normal
control of at least 1.5 fold is indicative of an initial diagnosis of
myelodysplastic syndrome (MDS).
(Br. 9 (Claims App’x).)
The Examiner rejects claims 1, 6, and 7 under 35 U.S.C. § 101 as
being lacking in patentable subject matter. (Ans. 2.)
DISCUSSION
Issue
The Examiner finds that claims 1, 6, and 7 are directed to a law of
nature, i.e., “[t]he relationship between hematopoietic cell types in a patient
with myelodysplastic syndrome (MDS).” (Ans. 3.)
The Examiner further finds that other steps in the claims, including
“[ujsing antibodies to detect the marker profile of the cell types” and
“[determining the presence of a specific level of change in relation to a
control value,” do not amount to “significantly more than the law of nature.”
(Id. at 4)
Citing to the March 2014 Guidance,3 Appellants contend that the
claims recite something significantly different than a law of nature.
3 U.S. Patent & Trademark Office, Guidance for Determining Subject Matter
Eligibility of Claims Reciting or Involving Laws of Nature, Natural
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Application 13/508,319
Appellants do not separately argue claims 6 and 7. We therefore limit
our analysis to claim 1. The issue with respect to this rejection is whether
the evidence of record support the Examiner’s conclusion that the claims are
directed towards non-statutory subject matter.
Principles of Law
In Mayo Collaborative Services v. Prometheus Laboratories,
Inc., 566 U.S. [66] . . . (2012), the Supreme Court set forth a
framework for distinguishing patents that claim laws of nature,
natural phenomena, and abstract ideas from those that claim
patent-eligible applications of those concepts. First, we
determine whether the claims at issue are directed to a patent-
ineligible concept. Id. at 1297. If the answer is yes, then we
next consider the elements of each claim both individually and
“as an ordered combination” to determine whether additional
elements “transform the nature of the claim” into a patent-
eligible application. Id. at 1298. The Supreme Court has
described the second step 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. at 1294.
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1375 (Fed. Cir.
2015).
Analysis
We analyze this case under the framework set forth by the Supreme
Court in Mayo and applied by our reviewing court in Ariosa. With respect
to the first step, whether claim 1 is directed to a patent-ineligible concept, we
agree with the Examiner that claim 1 recites a patent-ineligible law of
Phenomena, & Natural Products (March 4, 2014), available at
https://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf.
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Application 13/508,319
nature, specifically, the relationship between hematopoietic stem and
progenitor cell phenotype distribution and a diagnosis of MDS. (Ans. 3.) In
Mayo, for instance, the Supreme Court found that a claim was directed to a
natural law, where the claim required administering a drug and determining
the levels of a metabolite following administration, wherein the level of
metabolite was indicative of a need to increase or decrease the dosage of the
drug. See Mayo Collaborative SetMces v. Prometheus Labs., Inc., 566 U.S.
66, 74 (2012). Here, similarly, claim 1 states that “an increase in the
fraction of HSC and a decrease in the fraction of myeloid progenitor cells
that are granulocyte macrophage progenitor cells relative to a normal control
of at least 1.5 fold is indicative of an initial diagnosis of myelodysplastic
syndrome (MDS).”
Next, we consider whether claim 1 recites “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.’” Ariosa, 788 F.3d at 1375 (citation omitted). We agree with the
Examiner that it does not. (Ans. 4.) In particular, the Examiner found, and
Appellants have not persuasively disputed, that “all of the antibodies used by
the applicant for measuring hematopoietic stem or progenitor subsets in a
hematological sample from the patient suspected of said myelodysplastic
condition were known prior to the instant application” and that “these
antibodies were used for measuring hematopoietic stem or progenitor
subsets in hematological samples.” (Id. at 10; see also Spec. 1 53 (stating
that “[t]he details of the preparation of antibodies and their suitability for use
as specific binding members are well-known to those skilled in the art”),
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| 56 (stating that “[a] number of. . . methods are known in the art” for
quantitating labeled cells as to the expression of cell surface markers).)
Accordingly, we find that instant claim 1 is analogous to the claim found
unpatentable in Mayo.
Appellants argue that the claims recite something significantly
different than a law of nature based on the twelve factors enumerated in the
March 2014 Guidance. As an initial matter, we note that the March 2014
Guidance is not law and also does not reflect the USPTO’s current analysis
protocols on subject matter eligibility. See, e.g., 2014 Interim Guidance on
Patent Subject Matter Eligibility, 79 Fed. Reg. 74618 (Dec. 16, 2014)
(“2014 Interim Guidance); July 2015 Update on Subject Matter Eligibility,
80 Fed. Reg. 45429 (July 30, 2015) (“2015 Update”); May 2016 Subject
Matter Eligibility Update, 81 Fed. Reg. 27381 (May 6, 2016) (“2016
Update”) (collectively “Interim Guidance”).
Neither are we persuaded by Appellants’ arguments. Appellants first
contend that the claims recite something significantly different than a law of
nature because the claims do not preclude others from applying the natural
principle, i.e., the correlation between progenitor cell distribution and MDS,
in other methods. (Br. 3,5.) However, “[wjhile preemption may signal
patent ineligible subject matter, the absence of complete preemption does
not demonstrate patent eligibility.” Ariosa, 788 F,3d at 1379. Instead, as
our reviewing court has explained, “[wjhere a 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. Here, as
in Ariosa, Appellants’ “attempt to limit the breadth of the claims by showing
alternative uses of [the natural phenomenon] outside of the scope of the
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Application 13/508,319
claims does not change the conclusion that the claims are directed to patent
ineligible subject matter.” Id, Accordingly, even though the claims are
limited to the use of antibodies to determine the distribution of progenitor
cells and do not fully preempt the natural correlation, the claims remain
ineligible because they are drawn to patent ineligible subject matter. Id.; see
also Ariosa, 788 F.3d at 1377 (holding dependent claim invalid as lacking
subject matter even though claim is limited to using a specific technique
(polymerase chain reaction, or PCR) to amplify a particular type of DNA).
Appellants next argue that the claims are distinguishable from those in
Mayo because the instant claims recite additional elements that relate to the
natural principle in a significant way, e.g., diagnosing MDS using
hematopoietic cell type distribution and providing the assessment to an
individual, and further argue that
the claimed elements do more than describe the natural
principle with general instructions to apply it [because] the
claim . . . recites an application . . . that is limited to
measurement of expression levels of specific cell surface
markers with specific antibodies, requires determining the
presence of a specific level of change in relation to a control
value, and providing a diagnosis.
(Br. 3—4, 5—6.) In particular, Appellants argue that “unlike the claims in
Mayo, the asserted natural principle is required to be used,” that “it is clear
how the correlation is applied and used in order to determine a diagnosis,”
and that “determining a diagnosis is clearly an important and practical
application of the alleged natural correlation.” (Id.)
We are not convinced because, as in Mayo, the wherein clause of
claim 1 “simply tell[s] a doctor about the relevant natural 1aw[], at most
adding a suggestion that he should take th[e] law[] into account when
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Application 13/508,319
treating his patient. That is to say, th[e] clause[] tell[s] the relevant audience
about the law[] while trusting them to use th[e] law[] appropriately.” Mayo,
566 U.S. at 78. Likewise, to the extent that claim 1 is an “important and
practical application of the . . . natural correlation” between progenitor cell
distribution and MDS diagnosis (Br. 4), the claim in Mayo wras a similarly
important and practical application of the natural con-elation between the
level of a particular metabolite in the blood and the appropriate dosage of a
drug, 6-thioguanine, to be given to a patient. Nevertheless, the Supreme
Court found that such application was insufficient for patentable utility
because the claim “steps are not sufficient to transform unpatentable natural
correlations into patentable applications of those regularities.” Id. at 80.
Finally, as we have already discussed, limiting the claim by requiring
conventional steps such as “measuring] expression levels of specific cell
surface markers with specific antibodies” and “determining the presence of a
specific level of change in relation to a control value” do not suffice to
render the claim patentable where such steps are merely conventional steps
employed in the art. Ariosa, 788 F.3d at 1377 (explaining that “‘[sjimply
appending conventional steps, specified at a high level of generality, ’ [is] not
enough to supply an inventive concept”) (citing Mayo, 566 U.S. at 82).
We also note but are not persuaded by Appellants’ argument that
assaying for subsets of hematopoietic cells as recited in the claims requires
“transformation” of a property of a biological molecule (i.e., concentration)
into a detectable signal. (Br. 4.) Again, such “transformation” does not
render a claim patentable where the method of detection is conventional:
Mayo similarly involved a step of determining the concentration of a
metabolite in the blood. Mayo, 566 U.S. at 74.
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Finally, Appellants contend that claim 1 “recites steps that are more
than well-understood, purely conventional or routine in the art,” because
“[i]t is not routine or conventional in the art to measure hematopoietic stem
or progenitor subset distributions in a hematologic sample from a patient
suspected of said myelodysplastic condition.” (Br, 4, 5.) Again, we are not
convinced. As the Examiner finds and the Specification acknowledges,
antibody preparation and quantification of cells based on cell surface
markers are known in the art. (A ns. 10; Spec, f8!! 53, 56.) That these
conventional processes were not previously used to diagnose a patient with
MDS does not distinguish the claims because “appending routine,
conventional steps to a natural phenomenon, specified at a high level of
generality, is not enough to supply an inventive concept.” Ariosci, 788 F.3d
at 1378, In Ariosa, for instance, claims relating to a method for detecting
paternally inherited nucleic acid of fetal origin performed on a maternal
serum or plasma sample were found to be directed to non-patentable subject
matter even though, prior to the patent at issue, “no one was using the
plasma or serum of pregnant mothers to amplify and detect paternally-
inherited cffDNA [(cell-free fetal DNA)].” Id. at 1379; see also id. at 1381
(Linn, J., concurring).4
4 We note that “a new combination of steps in a process may be patentable
even though all the constituents of the combination were well known and in
common use before the combination was made.” Mayo, 566 U.S. at 79
(quotation marks and citation omitted). In this case, however, considering
the additional steps of claim 1 as an ordered combination “adds nothing to
the laws of nature that is not already present when the steps are considered
separately,” because anyone who wants to make use of the correlation
between progenitor cell distribution and MDS diagnosis must first measure
hematopoietic stem or progenitor subset distributions in a hematologic
sample from a patient. Id. (“Anyone who wants to make use of [the
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Accordingly, we affirm the Examiner’s rejection of claim 1. Claims 6
and 7, which were not separately argued, fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
SUMMARY
For the reasons above, we affirm the Examiner’s rejection of claims 1,
6, and 7.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
relationship between metabolite concentration and thiopurine drug] must
first administer a thiopurine drug and measure the resulting metabolite
concentrations, and so the combination amounts to nothing significantly
more than an instruction to doctors to apply the applicable laws when
treating their patients.”).
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