Ex Parte Gleave et al

Patent Trial and Appeal Board

Apr 15, 2016

12423359 (P.T.A.B. Apr. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/423,359 04/14/2009
57381 7590
Larson & Anderson, LLC
P.O. BOX 4928
DILLON, CO 80435
04/18/2016
FIRST NAMED INVENTOR
Martin Gleave
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.
UBC.P-048 8395
EXAMINER
ANGELL, JONE
ART UNIT PAPER NUMBER
1674
MAILDATE DELIVERY MODE
04/18/2016 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 MARTIN GLEAVE, CHRISTOPHER ONG, and
NORIHIRO HAYASHI
Appeal2013-009646
Application 12/423,359
Technology Center 1600
Before ERIC B. GRIMES, ROBERT A. POLLOCK, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1, 2, 5-7, 10-12, and 18-20, mailed October 12, 2012. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The Specification discloses that "Hsp27 is a cell survival protein
found in elevated levels in many human cancers," whereas the
chemotherapeutic compound paclitaxel is a known inhibitor ofhsp27
expression, as are hsp27-specific antisense oligonucleotides such as OGX-
427. Spec. 1-2. Appellants' invention relates to the observation that the
status of PTEN (a tumor suppressor protein referred to as phosphatase and
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Application 12/423,359
tensin homologue deleted from chromosome 10) in target cancer cells
predicts the efficacy of therapeutic compounds that reduce hsp27 levels, in
particular, "in PTEN deficient/negative cancer cell lines, hsp27 inhibition is
observed, while no statistical benefit is observed from hsp27 inhibition when
functional PTEN protein is present in the target cells. Accordingly, the
present invention provides a method for the treatment of cancer using hsp27
inhibition that includes a preliminary test to ascertain the status of the PTEN
in the target cells." Id. at 2. The disclosed methods include administering a
chemotherapeutic active agent that inhibits the expression or activity of
hsp27 (e.g., paclitaxel or OGX-427) "where the expression level of
functional PTEN is below a threshold level." Id.
Independent claims 1 and 6 are illustrative:
1. A method for evaluation of a cancer, comprising the steps
of:
(a) evaluating a sample of cancerous tissue to determine
an expression level of phosphatase and tensin homologue
deleted from chromosome 10 (PTEN); and
(b) in the case where the expression level of functional
PTEN is below a threshold level, identifying the cancer as
susceptible to an active agent that inhibits the expression
of heat shock protein 27 (hsp27).
6. A method for treating cancer in a patient diagnosed as
suffering from cancer comprising the steps of:
(a) obtaining a sample of cancerous tissue from the
patient;
(b) evaluating the sample of cancerous tissue to determine
an expression level of functional phosphatase and tensin
homologue deleted from chromosome 10 (PTEN); and
( c) in the case where the expression level of functional
PTEN is below a threshold level, administering to the
patient a therapeutic composition comprising as an active
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agent a composition effective to inhibit the expression of
heat shock protein 27 (hsp27).
Claims 1, 2, 5-7, 10-12, and 18-20 stand rejected under 35 U.S.C.
§ 112, second paragraph, as indefinite; 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement; 35 U.S.C. § 112,
first paragraph, as failing to comply with the enablement requirement; and
35 U.S.C. § 101, as drawn to unpatentable subject matter.
ANALYSIS
Definiteness and Written Description
The Examiner rejects claims 1, 2, 5-7, 10-12, and 18-20 under 35
U.S.C. § 112, second paragraph, as indefinite with respect to the term
"threshold level." Fin. Rej. 2-3. The Examiner reasons that the claim
language requires a PTEN level "below a threshold level" to identify a
cancer as susceptible to an agent that inhibits the expression ofhsp27. Ans.
5. But because the claims viev,red in light of the Specification do not provide
a numerical value, or otherwise define the term "threshold level," the claims
are indefinite "as it is not clear what level would indicate that the cancer is
susceptible to an active agent and what level would indicate that the cancer
is not susceptible to the active agent." Id.
The Examiner similarly rejects claims 1, 2, 5-7, 10-12, and 18-20
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement. Id. at 3. In particular, the Examiner finds that
the claims encompass evaluating any type of cancer such that
if the level of PTEN is below "a threshold" level in said
cancer, it is indicative that the cancer is susceptible to an
inhibitor of hsp27 expression. As such the claims encompass
a genus of "threshold levels" that includes the "threshold
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Application 12/423,359
level" for every type of cancer, wherein the "threshold level"
could be different for every type of cancer. The specification
does not provide a "threshold level" value for even a single
member of the enormous genus encompassed by the claims.
Therefore, at best, the specification has provided the mere
notion that a "threshold level" could be determined for any
cancer. Therefore, the disclosure does not demonstrate
possession of any specific threshold value.
Id. at 6.
Having considered Appellants' arguments (see App. Br. 8-12; Reply
Br. 5) we find that the Examiner has the better position (see Ans 5-7). At
best, Appellants point to page 6, lines 14--22 of the Specification for a
definition of "threshold value," which recites:
The test result of the performed assay are compared to
a relevant threshold level. The relevant threshold level is
determined for the tissue type tested and for the assay
performed and reflects an average or lower value of PTEN
expression. It will be appreciated that this threshold value is
a balance between the likelihood of missing the opportunity
to give appropriate therapy to a patient with a higher, but still
reduced level of PTEN against the risk of treating a patient
with a therapeutic that will not be effective resulting in a
delay in administering alternative therapy. Thus, the specific
threshold selected for any given cancer will depend on the
variability of PTEN expression levels in non-cancerous
"normal" tissues, the precision and accuracy of the assay
employed, and the availability of viable alternative treatment
modalities.
Appellants do not persuade us that the above paragraph, nor any other
portion of the Specification, adequately defines a "threshold value" for
purposes of showing definiteness and written description under 35 U.S.C.
§ 112, first and second paragraphs. Accordingly, we affirm the rejections
based on definiteness and written description.
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Application 12/423,359
Enablement
The Examiner rejects claims 1, 2, 5-7, 10-12, and 18-20 under 35
U.S.C. § 112, first paragraph, as failing to comply with the enablement
requirement because undue experimentation would be required to determine
a "threshold level." Fin. Rej. 3; Ans. 7-8. Again citing page 6, lines 14--22
of the Specification, Appellants contend that one of ordinary skill in the art
is capable of determining a "threshold level" with only routine
experimentation "based upon their given fact pattern (e.g. type of cancer,
type of tissue, type assay, and their own preferences)." App. Br. 13.
"[T]he question of undue experimentation is a matter of degree. The
fact that some experimentation is necessary does not preclude enablement:
what is required is that the amount of experimentation 'must not be unduly
extensive."' PPG Indus. Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564
(Fed. Cir. 1996) (quoting Atlas Powder Co. v. E.I. DuPont De Nemours &
Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984)). In the present case, Appellants
have established an inverse relationship between PTEN levels and
susceptibility to chemotherapeutic agents that inhibit the expression of
hsp27. The Examiner has presented insufficient evidence demonstrating that
it would require undue experimentation to determine at what "threshold
level" it would be beneficial to administer a composition effective to inhibit
the expression of heat shock protein 27 (hsp27) as required by the instant
claims. Accordingly, we reverse the enablement rejection.
35 U.S.C. § 101
The Examiner rejects claims 1, 2, 5-7, 10-12, and 18-20 under 35
U.S.C. §101 as drawn to non-statutory subject matter. Fin. Rej. 3; Ans. 2--4
(citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289
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(2012)). In Alice, the Supreme Court referred to the two-step analysis set
forth in Mayo Collaboration Services v. Prometheus Laboratories, Inc., 132
S. Ct. 1289 (2012), as providing "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." Alice Corp. Pty. Ltd.
v. CLS Bank Int 'l, 134 S. Ct. 2347, 2355 (citing Mayo, 132 S. Ct. at 1289).
Under Mayo, "[ w ]e must first determine whether the claims at issue are
directed to a patent-ineligible concept." Id. If the answer is yes, "we
consider the elements of each claim both individually and 'as an ordered
combination' to determine whether the additional elements 'transform the
nature of the claim' into a patent-eligible application." Id. (citing Mayo, 132
S. Ct. at 1297-98). This second step involves 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. Nevertheless,
"simply appending conventional steps, specified at a high level of generality,
to laws of nature, natural phenomena, and abstract ideas cannot make those
laws, phenomena, and ideas patentable." Id. at 1292; see Alice Corp. Pty.
Ltd. v. CLS Bank Int'!, 134 S. Ct. 2347, 2357 (2014). As interpreted by the
Federal Circuit,
appending routine, conventional steps to a natural
phenomenon, specified at a high level of generality, is not
enough to supply an inventive concept. Where claims of a
method patent are directed to an application that starts and
ends with a naturally occurring phenomenon, the patent fails
to disclose patent eligible subject matter if the methods
themselves are conventional, routine and well understood
applications in the art.
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Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (2015),
petition/or cert.filed, (U.S. March 21, 2016) (No. 15-1182).
In the present case, the claims are directed to the patent-ineligible
natural phenomenon or law of nature that PTEN levels are inversely related
to the chemotherapeutic efficacy of agents that inhibit the expression of
hsp27. Applying the second step of the Mayo framework to claim 1, we do
not find that the steps of "evaluating" a sample of cancer tissue to determine
the expression level of PTEN and "identifying" the cancer as susceptible to
agents that inhibit the expression of hsp 27 identify significantly more than
the underlying patent-ineligible concept itself.
Appellants essentially concede the rejection of claim 1 on the present
record and in view of Mayo and ask us to focus on claim 6, which includes
the express step of "administering to the patient a therapeutic composition
comprising as an active agent a composition effective to inhibit the
expression of heat shock protein 27 (hsp27)." See App. Br. 7-8; Reply Br.
1-5; Tr. 4:11-18. In particular, Appellants argue that in contrast to the
claim at issue in Mayo, the addition of this express "administering" step
transforms claim 6 into an application of the idea, rather than a mere
recitation of the idea itself. See App. Br. 5 ("[C]ontrary to [Mayo], the
claims have limitations directed to concrete applications of the discovery.").
We do not agree. The claim at issue in Mayo included "wherein"
clauses indicating, for example, that a "level of 6-thioguanine less than about
230 pmol per 8xl 08 red blood cells indicates a need to increase the amount
of said drug subsequently administered to said subject" (Mayo, 132 S. Ct. at
1295), and thus implicitly directed a health care provider to increase the
amount of drug administered. That claim 6 of the instant application
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expressly directs a health care provider to administer a therapeutic
composition fails to distinguish Mayo. To the contrary, the "obtaining,"
"evaluating," and "administering" steps of claim 6 and its dependent claims
amount to nothing more than routine, conventional steps appended to a
natural phenomenon. See Ariosa, 788 F.3d at 1379; see also Genetic
Technologies Ltd. v. Merial L.L.C., Nos. 2015-1202, -1203, slip op. at 13-15
(Fed. Cir. Apr. 8, 2016) (finding claim invalid under§ 101 where the
physical implementation steps of DNA amplification and analysis of the
amplified DNA were "well known, routine, and conventional" as of the
filing date).
Because it was known to administer chemotherapeutic active agents
that inhibit the expression or activity of hsp27, the administration of such
compounds in the treatment of cancer amounts to purely conventional post-
solution activity that fails to transform an unpatentable natural phenomenon
into a patentable method. See Mayo, 132 S. Ct. at 1299 ("'[P]ost-solution
activity' that is purely 'conventional or obvious,' ... can[ not] transform an
unpatentable principle into a patentable process.") (quoting Diamond v.
Diehr, 450 U.S. 175, 191 (1980)).
SUMMARY
I. We affirm the rejection of claims 1, 2, 5-7, 10-12, and 18-20 under
35 U.S.C. § 112, second paragraph, as indefinite.
II. We affirm the rejection of claims 1, 2, 5-7, 10-12, and 18-20 under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
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III. We reverse the rejection of claims 1, 2, 5-7, 10-12, and 18-20 under
35 U.S.C. § 112, first paragraph, as failing to comply with the
enablement requirement.
IV. We affirm the rejection of claims 1, 2, 5-7, 10-12, and 18-20 under
35 U.S.C. § 101, as drawn to unpatentable 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).
AFFIRMED
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