Ex Parte Gleave et al

Patent Trial and Appeal Board

Aug 30, 2016

12423359 (P.T.A.B. Aug. 30, 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
08/30/2016
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
08/30/2016 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 REQUEST FOR REHEARING
Pursuant to 37 C.F.R. § 41.52, Appellants filed a Request for Rehearing
("Request") of the decision entered April 18, 2016 ("Decision"). We have jurisdiction
under 35 U.S.C. § 6(b).
A request for rehearing "must state with particularity the points [of
law or fact] believed to have been misapprehended or overlooked by the
Board," and must comply with 37 C.F.R. § 4 l.52(a)(l ).
We have considered Appellants' Request for Rehearing on the merits;
because the Request fails to establish that the Board misapprehended or
overlooked a point of fact or law, we deny the relief requested.
Appeal2013-009646
Application 12/423,359
DISCUSSION
Appellants' Request focuses on our affirmance of the Examiner's
rejection under 35 U.S.C. § 101 of independent claim 6 and claims 7, 10-12,
and 18-20, depending therefrom. In particular, Appellants contend that our
Decision with respect to this issue "is inconsistent with case law and the
USPTO's own guidance regarding subject matter eligibility. Specifically,
the Board's decision is contrary to the USPTO's Subject Matter Eligibility
Examples: Life Sciences Example 29 - Diagnosing and Treating Julitis,
claim 6 (Examples issued May 2016)." Request, 1. Contrary to this thesis,
however, Appellants present absolutely no analysis of Life Sciences
Example 29. Accordingly, Appellants fail to demonstrate that claim 6 of
Example 29 is sufficiently similar to the claims at issue here such that we
should find the Office's patentability guidance persuasive.
With respect to Appellants' contention that our Decision "is
inconsistent with case law" we, likewise, note that the Request lacks any
discussion of the claim at issue in Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 132 S. Ct. 1289 (2012), which stands at the heart of our analysis.
See Decision, 7-8.
Independent claim 6 on appeal recites:
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
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Appeal2013-009646
Application 12/423,359
patient a therapeutic composition comprising as an active
agent a composition effective to inhibit the expression of
heat shock protein 27 (hsp27).
Appellants acknowledge that "it was known to administer chemotherapeutic
agents that inhibit the expression or activity of hsp27 to treat cancer."
Request, 3. Accordingly, claim 6 encompasses a method of identifying a
subset of cancer patients for which these known chemotherapeutic agents
were likely to be effective (i.e., those having expression levels of functional
PTEN below a threshold level), and subsequently administering those
chemotherapeutic agents to the identified patient subset.
Similarly, the claim at issue in Mayo included a step of determining
the level of a 6-thioguanine metabolite in a patient, and "wherein" clauses
indicating a need to increase (or decrease) the amount of parent drug
subsequently administered when the patient's 6-thioguanine levels were less
than (or greaterthan) specified limits. Mayo, 132 S. Ct. at 1295 (e.g., a
ll'... .. r'" / , .. • • .. ,.. "1 , l""llo,....A "1 l'"'\ -1 nQ .. -t "1 -t "1"1 --1eve1 or o-tmoguanme iess man aoout LjU pmo1 per ~x1uu rea 01000 ceus
indicates a need to increase the amount of said drug subsequently
administered to said subject"). The "wherein" clauses thus, describe
metabolite concentrations above which there is a likelihood of harmful side-
effects and below which it is likely that the drug dosage is ineffective, and
inform doctors that metabolite concentrations above or below these
thresholds "indicate a need" to decrease or increase (respectively) the drug
dosage. See id. at 1295. The Court explained that these limitations
simply tell a doctor about the relevant natural laws, at most
adding a suggestion that he should take those laws into
account when treating his patient. That is to say, these
clauses tell the relevant audience about the laws while
trusting them to use those laws appropriately where they are
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Appeal2013-009646
Application 12/423,359
relevant to their decisionmaking (rather like Einstein telling
linear accelerator operators about his basic law and then
trusting them to use it where relevant).
Id. at 1297.
Accordingly, once the relationship between safe and effective dosing
of the parent drug and threshold levels of the 6-thioguanine metabolite was
known, the Mayo claim implicitly directed a health care provider to increase
(or decrease) the amount of drug administered when metabolite levels are
below (or above) certain thresholds. Here, once the relationship between
PTEN levels and hsp27 inhibitor responsiveness is known, claim 6 and its
dependent claims expressly direct a health care provider to administer hsp27
inhibitors when the PTEN levels are below a certain threshold. That claim 6
of the instant application expressly directs a health care provider to
administer a therapeutic composition fails to distinguish Mayo.
As in Mayo, "the steps in the claimed processes (apart from the
natural laws themselves) involve well-understood; routine; conventional
activity previously engaged in by researchers in the field." Mayo, 132 S. Ct.
at 1299. Because it was known to administer chemotherapeutic active
agents that inhibit the expression or activity of hsp27 to cancer patients, the
administration of the same compounds to a subset of those patients amounts
to purely conventional post-solution activity that fails to transform an
unpatentable natural phenomenon (here, the relationship between PTEN
levels and hsp27 inhibitor responsiveness) into a patentable method. See id.
at 1299 ("' [P]ost-solution activity' that is purely 'conventional or obvious,'
... can[ not] transform an unpatentable principle into a patentable process.")
(quoting Parker v. Flook, 437 U.S. 584, 590 (1978)).
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Appeal2013-009646
Application 12/423,359
For the above reasons, Appellants have not sustained their burden of
showing that the Board misapprehended or overlooked relevant points of
fact or law.
DECISION
We have granted Appellants' request to the extent that we have
reconsidered our Decision entered April 18, 2016.
We deny Appellants' request for relief from that Decision.
DENIED
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