Ex Parte Goronzy et al

Patent Trial and Appeal Board

Dec 8, 2016

13231282 (P.T.A.B. Dec. 8, 2016)

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.
13/231,282 09/13/2011 Jorg J. Goronzy STAN-780 1072
77974 7590 12/12/2016
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
1900 University Avenue
Suite 200
East Palo Alto, CA 94303
EXAMINER
HOWARD, ZACHARY C
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
12/12/2016 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JORG J. GORONZY and CORNELIA M. WEYAND1
Appeal 2015-000312
Application 13/231,282
Technology Center 1600
Before JOHN G. NEW, TAWEN CHANG, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Non-Final Rejection of claims 1 and 4—8 as unpatentable 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.
appellants state the real party-in-interest is Board of Trustees of the Leland
Stanford Junior University. App. Br. 2.
Appeal 2015-000312
Application 13/231,282
NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to compositions and methods for the
diagnosis and treatment of rheumatoid arthritis. Abstract.
REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal and
recites:
1. A method for determining the predisposition of a
patient that has shown symptoms of rheumatoid arthritis for
increased risk of development overt rheumatoid arthritis, the
method comprising:
(i) determining the expression of one or both of B-Raf
and K-ras in a cell population comprising T cells obtained from
said patient to provide a determination of expression levels;
(ii) comparing the determination of expression levels
obtained in step (i) with a determination of expression levels of
one or both of B-Raf and K-ras of a normal control cell
population; and
(iii) providing a determination of a predisposition of the
patient to increased risk of development of overt rheumatoid
arthritis when the comparing of step (ii) shows increased
expression of one or both of B-Raf and K-ras relative to the
normal control cell population.
App. Br. 15.
We agree with, and adopt, the Examiner’s findings and conclusion
that the appealed claims are unpatentable as being directed to non-statutory
subject matter. We address below the arguments raised by Appellants.
ISSUE
Appellants argue that the Examiner erred in concluding that the claims
are directed to non-statutory subject matter because the steps recited in the
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claims are not sufficient to ensure the claim amounts to significantly more
than a law of nature and the general instruction simply to “apply it.” App.
Br. 3.
ANALYSIS
Appellants argue that their claimed invention is distinguishable from
that which the Supreme Court held unpatentable in Mayo Collaborative
Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012). App. Br.
3—5. According to Appellants, in Mayo the Court held that the claims in
question involved well-understood, routine, conventional activity previously
engaged in by researchers in the field, and that the claims disproportionately
tied up the use of the underlying natural laws.2 * * * * *Id. at 4. In contrast to the
2 The representative claim in Mayo recites:
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; and
(b) determining the level of 6—thioguanine in said subject having
said immune-mediated gastrointestinal disorder,
wherein the level of 6—thioguanine less than about 230 pmol per
8x108 red blood cells indicates a need to increase the amount of
said drug subsequently administered to said subject and
wherein the level of 6—thioguanine greater than about 400 pmol
per 8x108 red blood cells indicates a need to decrease the amount
of said drug subsequently administered to said subject.
Mayo, 132 S.Ct. at 1295.
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comparing and providing steps of Appellants’ claims on appeal, Appellants
assert, the final clauses of the Mayo claim (the “wherein” clauses) were not
integrated into the claim and therefore did not apply, rely on, or use any
natural principle. Id.
Specifically, Appellants argue, the “wherein” clauses of the Mayo
claim contained the phrase “indicates a need to,” which allegedly does not
actually require anything of the one performing the method and instead
simply stated the law of nature itself. App. Br. 5. Appellants contend that
this lack of integration was critical because the “wherein” clauses therefore
provided no actual limitations to the claims and the only steps that were
limiting (steps (a) and (b )) were routinely carried out in the art, in the same
order, in the same patient population, and for the same purpose. Id.
In contrast to the Court’s findings in Mayo, Appellants argue, the
claims of the instant appeal integrate all the steps of the claimed method.
App. Br. 6. Appellants assert the “providing a determination” step specifies
that when performing the method, one determines the predisposition of a
patient by determining the expression of B-Raf and/or K-ras in a cell
population from the patient, comparing that expression to expression from
normal control cells, and determining that there is a predisposition to
increased risk of development of overt rheumatoid arthritis when the
comparing step shows increased expression in the cells from the patient
relative to control cells. Id. Appellants argue the claims on appeal are
distinguishable from the claims in Mayo because the comparing and
providing steps are explicitly integrated into the claim as a whole, thus
providing limitations that one would perform when practicing the method.
Id.
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Appellants further contend that the pending claims are a clear and
useful patent eligible application of any asserted natural principle. App. Br.
6. Appellants assert that a method that includes a step of providing a patient
with a determination of whether they have a predisposition to increased risk
of development of overt rheumatoid arthritis is an a useful, real-world
application that has major implications for how that person will
subsequently live. Id.
Appellants next point to the twelve factors used to determine the
eligibility of subject matter under 35 U.S.C. §101, as set forth by the Office
in its Guidance For Determining Subject Matter Eligibility Of Claims
Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural
Products, March 4, 2014. App. Br. 6. We have reviewed Appellants’
analysis of these factors, but we find them neither persuasive nor properly
reflective of current law or the USPTO’s analysis protocols on subject
matter eligibility, as set forth by the Director in the 2014 Interim Guidance
on Patent Subject Matter Eligibility, December 10, 2014, and subsequently
updated in 2015 and 2016 (the “Interim Guidance”).
As an initial matter, we agree with the Examiner that the limitations of
the claims on appeal, as exemplified by claim 1, are analogous to the claims
at issue in Mayo and, consequently, dictate the same outcome. See Ans. 5.
Specifically, the instant claims are directed to determining the elevated
levels of expression of B-Raf and K-ras that indicate a predisposition to
increased risk of development of overt rheumatoid arthritis. Appellants do
not dispute that this is a phenomenon of nature, i.e., that it occurs naturally
in the body. As in Mayo, the claims on appeal require an assay to detect the
phenomenon and a treatment based upon the outcome of that assay, i.e.,
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“determining the expression of one or both of B-Raf and K-ras in a cell
population comprising T cells obtained from said patient.” Appellants do
not argue that the assay is separately novel and their Specification discloses
that such assays are well known in the art. See Spec. Tflf 53—62.
Consequently, we apply the two-part test set forth in the Interim
Guidance for claims involving phenomenon of nature. See Interim Guidance
9-25; 35—37. First, we look to whether the claims on appeal are directed to
a statutory category. In this instance, we conclude that they are: the claims
are explicitly directed to a method or process. Next, we determine whether
the claims are directed to a judicially-created exception, in this instance, a
natural law or phenomenon of nature. Although the claims require a non­
novel assay to determine the phenomenon, the phenomenon itself, elevated
levels of expression of B-Raf and K-ras by T-cells, occurs naturally in
patients with a disposition to increased risk of development of overt
rheumatoid arthritis. See Spec, 8—10; see also Ans. 12. Consequently we
find that the claims are directed to a phenomenon of nature and therefore
falls within one of the judicially-created exceptions.
Having determined that the claims are directed to a phenomenon of
nature, we look to the claim as a whole to determine whether any element, or
combination of elements, is sufficient to ensure that the claim amounts to
significantly more than the exception. See Interim Guidance 36. The
“assay” step refers to the activities of the relevant audience, viz., physicians
who treat patients with a predisposition to developing rheumatoid arthritis.
The claims direct these physicians to the recited proteins which, when
expressed at elevated levels in T-cells, are associated with a predisposition
to development of overt rheumatoid arthritis. See Spec. ]Hf 4—11. The
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audience is a pre-existing audience and is certainly well established;
moreover, the assays recited in the claims are well known in the art and can
be routinely performed. Id. The “identifying” step tells the doctor to
determine whether T-cell expression of B-Raf and K-ras is elevated
compared to a control group.
Therefore, as in Mayo, the claims inform a relevant audience about a
certain phenomenon of nature (specifically here, a correlation between
elevated T-cell expression of B-Raf and K-ras in patients with a disposition
to increased risk of development of overt rheumatoid arthritis), and the
additional steps of the claims consist merely of “well understood, routine,
conventional activity already engaged in by the scientific community.”
Mayo, 32 S.Ct. at 1298 ; see Spec. Tflf 4—11. These steps, when viewed as a
whole, add nothing significantly inventive beyond the sum of their parts
taken separately. The claims therefore do not amount to significantly more
than the natural law itself and we consequently affirm the Examiner’s
rejection.
Furthermore, our reviewing court has recently explained:
In recent cases, we found claims “directed to” a patent-ineligible
concept when they amounted to nothing more than observing or
identifying the ineligible concept itself. For example, in Genetic
Technologies, the claim recited methods for detecting a coding
region of DNA based on its relationship to non-coding regions.
Genetic Techs., Ltd. v. MenialL.L.C., 818 F.3d at 1369, 1373—74
(Fed. Cir. 2016). Because the relationship between coding and
non-coding sequences was a law of nature, the claim amounted
to nothing other than identifying “information about a patient's
natural genetic makeup.” Id. at 1375. Fikewise in Ariosa, the
claims recited methods for detecting paternally inherited cffDNA
in the blood or serum of a pregnant female. Ariosa Diagnostics,
Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373—74 (Fed. Cir. 2015),
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cert, denied, No. 15—1102,----- U.S.-------- , 136 S.Ct. 2511,-----
L.Ed.2d------- , 2016 WL 1117246 (June 27,2016). The existence
and location of cffDNA is a natural phenomenon; identifying its
presence was merely claiming the natural phenomena itself. Id.
at 1376. And in In re BRCA, the claims recited methods for
screening human germline for an altered BRCA1 gene by
comparing the target DNA sequence with wild-type sequence. In
re BRCA1— & BRCA2—Based Hereditary Cancer Test Patent
Litig., 774 F.3d 755, 761—62 (Fed. Cir. 2014). But comparing
two sequences to detect alterations is a patent-ineligible “abstract
mental process.” Id. at 763. Although the claims in each of these
cases employed method steps, the end result of the process, the
essence of the whole, was a patent-ineligible concept.
Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1048 (Fed. Cir.
2016).
In the appeal presently before us, the relationship between elevated
expression of B-Raf and K-ras and an increased disposition to develop overt
rheumatoid arthritis is a natural phenomenon and the claimed invention
consists of nothing more than observing or identifying the non-eligible
natural phenomenon. As such, although this relationship may perhaps be a
discovery, it is not a patentable invention. We consequently affirm the
Examiner’s rejection of the claims as being directed to non-statutory subject
matter.
DECISION
The Examiner’s rejection of claims 1 and 4—8 as unpatentable under
35U.S.C. § 101 is affirmed.
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.
§ 1.136(a)(l)(iv).
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AFFIRMED
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