Ex Parte Ward et al

Patent Trial and Appeal Board

Dec 15, 2016

12765643 (P.T.A.B. Dec. 15, 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.
12/765,643 04/22/2010 Kenneth Ward JBL-0013 9848
76737 7590 12/19/2016
SrTirarnrn-Tiineaii-APT EXAMINER
Juneau Biosciences, LLC
2749 East Parleys Way
HANEY, AMANDA MARIE
Suite 300 ART UNIT PAPER NUMBER
Salt Lake City, U1 64 IUv 1634
NOTIFICATION DATE DELIVERY MODE
12/19/2016 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):
mschramm @juneaubiosciences.com
mikeschramm @ besstek. net
mschramm @ axialbiotech.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KENNETH WARD and HANS ALBERTSEN
Appeal 2015-004927
Application 12/765,643
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
Appellants have requested rehearing of the decision entered October
24, 2016 (“Decision”) regarding the claims being directed to non-statutory
subject matter as to claims 36-40, 43, and 44. The Decision affirmed, inter
alia, the Examiner’s rejection of claims 1—25 and 32—50 under 35 U.S.C.
§ 101 as being directed to non-statutory subject matter.
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. § 41.52(a)(1). We have considered
Appellants’ Request for Rehearing as to claims on the merits but are not
persuaded that it shows that we misapprehended or overlooked any relevant
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Application 12/765,643
issues of fact or law in reaching the conclusions set out in the Decision. The
request for rehearing is denied.
DISCUSSION
In the Request for Rehearing, Appellants argue that our Decision
erroneously:
1) “misconstrued a patent ineligible law of nature with a patent
eligible physical concrete step performed by the hand of man,”
2) “conflated ‘detecting’ (an eligible step) with ‘correlating’ (an
ineligible step),
3) “contradicted itself by acknowledging that appellant’s rejected
claims recite the use of knowledge (affirmed by SCOTUS as being
patent eligible) and yet still rejecting the claims as not reciting the
use of knowledge,”
4) “deemed the step of ‘detecting’ (a patent eligible physical concrete
step performed by the hand of man) as ineligible,”
5) “decided that that claims comprising exclusively eligible steps
need rescuing by other novel and nonobvious claim steps”
6) “misconstrued and misapplied Mayo and Ariosa,” and
7) determined patent ineligibility “in direct contradiction of a
previous PTAB decision.”
(Req. Reh’g 2.) These arguments are unpersuasive.
With respect to 1 above, the Request for Rehearing summarizes the
argument as follows: “the Board’s error is in finding that the claims are
directed to a patent ineligible concept.” {Id. at 2.) The ensuing several
pages {id. at 3—6) do not point out what point of law or fact Appellants
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believe we have misapprehended or overlooked. Rather, Appellants simply
disagree with our conclusion that method claims 36, 39, and 43 “are focused
‘on the use of a natural principle, namely a correlation between the minor
alleles of the SNPs listed in Table 1 and endometriosis,’” regardless of
whether they specifically recite a correlating step because
the Specification indicates the analysis of genetic association
between SNPs and phenotypic traits for endometriosis
diagnosis, predisposition screening, prognosis and treatment
"and other uses described herein" relies on determination of a
genetic association which involves genotyping and
endometriosis status classification (Spec. Tflf 127-137) and then
setting up a classification/prediction system to predict whether
an individual is within or not within the classification which
can then "be exploited" to justify various activities including
treatment or monitoring (Spec, 138-140, 148-149).
(Decision 7—8.) In particular, Appellants note as to claim 36 that a “method
of treatment” is per se patent eligible (id. at 3), and even if not, the recited
method simply requires administering a therapeutic, which cannot be patent
ineligible activity (id. at 3 4). As to claim 39, Appellants note that
“developing [an appropriate therapeutic] is not a natural principle” (id. at 4),
and “the steps of detecting a marker or developing a therapeutic” are not
patent ineligible activity (id. at 5). As to claim 43, Appellants question what
is ineligible about a “method of screening human subjects” (id. at 5—6); and
assert that the “steps of obtaining a sample, inspecting a sample, detecting a
marker, or responding to the detection of a marker” are not patent ineligible
activity (id. at 6).
Our reviewing court, based on the Supreme Court’s 101
jurisprudence, has held a prenatal diagnostic method patent ineligible despite
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the fact that the claims recite concrete steps, Ariosa Diagnostics, Inc. v.
Sequenom, Inc., 788 F.3d 1371, 1374, 1376—78, (Fed. Cir. 2015) (noting that
patent ineligible claim 25 directed to “A method for performing a prenatal
diagnosis” including obtaining a certain fraction from a blood sample,
amplifying certain nucleic acid from the fraction and performing analysis on
it to detect paternally inherited fetal nucleic acid was generally “directed to
detecting the presence of a naturally occurring thing or a natural
phenomenon.”) The Supreme Court has held a treatment method
(optimizing therapeutic efficacy) ineligible, which method includes such
concrete steps as administering a particular drug, noting that limiting the
treatment method to a particular environment cannot be used to circumvent
“the ‘prohibition against patenting abstract ideas [or natural phenomena].”
Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1297
(2012). The Court further noted that telling doctors to “engage in well-
understood, routine, conventional activity previously engaged in by
scientists who work in the field” is also “normally not sufficient to transform
an unpatentable law of nature into a patent-eligible application of such a
law.” Id. at 1298. The Court explained:
The upshot is that the three steps simply tell doctors to gather
data from which they may draw an inference in light of the
correlations.
Id. Claims 36, 39, and 43 are no different, i.e., they essentially tell the
relevant audience to engage in well-understood, routine, conventional
activity in an unsuccessful effort to transform an unpatentable law of nature
into a patent-eligible application of such a law. Thus, as we noted in our
Decision, the method of treating (claim 36), which merely requires
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administration of a therapeutic to at least partially compensate for
endometriosis, does not include a step that transforms the claim that is
essentially a general recitation of applying the natural phenomenon (the
noted correlation) into the realm of patent eligibility. (Decision at 6, 10—11).
Likewise, the method of developing an appropriate therapeutic (claim 39),
which simply recites determining the correlation (by detecting an increased
risk of endometriosis associated allele . . .) and developing an appropriate
therapeutic that at least partially compensates for endometriosis, does not
include a step that transforms the claim that is essentially a general recitation
of applying the natural phenomenon (the noted correlation) into the realm of
patent eligibility. (Id.) The method of screening (Claim 43), while also
reciting concrete steps, is also essentially a general recitation of applying the
natural phenomenon (the noted correlation). Appellants do not even argue
that the concrete steps are not those normally engaged in by those in the
field, and just as the concrete steps in the diagnostic method of Ariosa and
the optimizing therapeutic efficacy method of Mayo were insufficient, so too
are those steps here. While Appellants disagree with the ultimate conclusion
reached in the Decision regarding claims 36-40, 43, and 44, Appellants have
not sustained their burden of showing that the Board misapprehended or
overlooked relevant points of fact or law.
With respect to 2 above, Appellants argue that none of the claims at
issue in the request “claim correlating ‘genetic information to having a risk
of or predisposition to endometriosis’,” and that our Decision “erroneously
combines and conflates a patent eligible step of detecting with a patent
ineligible step of correlating.” (Id. at 7.) First, Appellants’ assumption that
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detecting steps are per se “patent eligible” is not accurate as discussed
above. See, e.g.,Ariosa, 788 at 1374, 1376—78. Moreover, we did not
misapprehend the fact that not all claims explicitly recited a correlation step.
As noted above, the Decision indicates that whether the claims specifically
recite a step of correlating is not dispositive of the issue of the patent
ineligibility question because Appellants’ Specification teaches that each of
the methods depends upon status classification (“involves genotyping and
endometriosis status classification (Spec. Tflf 127—137) and then setting up a
classification/prediction system to predict whether an individual is within or
not within the classification”), which is determined by the correlation, prior
to exploiting the classification “to justify various activities including
treatment or monitoring.” (Decision 7—8.) Furthermore, the Decision
indicated how each of independent claims 36, 39, and 43 depend on the
correlation; namely, the “method of treating” of claim 36 requires the human
subject to which the therapeutic is administered be identified as a “subject
that has a genetic marker that is indicative of an increased risk of
endometriosis” (Decision at 8, 10), the “method of developing an
appropriate therapeutic” of claim 39 is for a human subject in which
detection of a marker that is “associated with an increased risk of
endometriosis” has taken place before the appropriate therapeutic is
developed (Decision at 9-10), and claim 43’s screening method, similarly,
requires detection of a marker that is “associated with an increased risk of
endometriosis” has taken place before “responding to the detection”
(Decision at 9).
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Therefore, in interpreting the claims, we gave weight to the ordinary
meaning of the preamble phrases because the “claims’ recitation of a patient
or a human ‘in need’ gives life and meaning to the preambles’ statement of
purpose.” Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir.
2003). “The preamble is therefore not merely a statement of effect that may
or may not be desired or appreciated. Rather, it is a statement of the
intentional purpose for which the method must be performed.” Id. Reading
claims such as claim 36 to exclude the preamble would result in a claim
solely drawn to administering a therapeutic for endometriosis treatment,
where the Specification does not teach any novel endometriosis therapies,
resulting in an interpretation at odds with the Specification.
Appellants’ argument 3 does not indicate what point of law or fact
Appellants believe we have misapprehended, but rather contends the
Decision is internally inconsistent. (Req. Reh’g at 7—8.) We disagree. The
Decision makes clear that the claims, which Appellants contend are patent
eligible because they recite “use of knowledge” and “concrete steps”
(Decision 6—7), are, rather, “focused on the use of a natural principle” (the
correlation between the minor alleles of the SNPs listed in Table 1 and
endometriosis and responding to it to screen human subjects (claim 43), or to
develop an appropriate therapeutic (claim 39), or to administer a therapeutic
to at least partially compensate for endometriosis (claim 36)) (Decision 7—9),
and do not recite steps that transform the use into a patent eligible
application (Decision 10—11 (noting that claims recite routine, conventional
steps at a high level of generality that were “previously engaged in by those
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in the field, similar to what the Supreme Court found in Mayo and the
Federal Circuit found in Arioso)).
Appellants’ arguments 4 and 5 (Req. Reh’g 8—9) also do not point out
what point of law or fact Appellants believe we have misapprehended or
overlooked. Rather, Appellants simply disagree with our analysis that the
claims are directed to patent ineligible subject matter (the correlation
discussed above) and the “physical act[s] performed by the hand of man,”
including “detecting,” recited in these claims are routine, conventional steps
specified at a high level of generality that are insufficient to supply an
inventive concept. The decision follows the law as laid out by the Supreme
Court in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct.
1289 (2012), and subsequently followed by our reviewing court in Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) as
discussed above. Disagreement with the Decision does not constitute an
issue misapprehended or overlooked by the Board.
Appellants’ argument 6 urges that we have misapplied the Supreme
Court’s decision in Mayo and the Federal Circuit’s decision in Ariosa
because the patent claims here, unlike those at issue in Mayo and Ariosa,
“include no patent ineligible steps.” (Req. Reh’g at 10—11.) For the reasons
already discussed above, we disagree with Appellants premise that claims
36, 39, and 43 do not rely on patent ineligible steps simply because they do
not explicitly recite the correlation the Specification teaches is necessary to
carry out the methods.
As to Appellants’ argument 7, we note that Appellants have not
directed us to where this specific new argument was made in the Appeal or
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Reply briefs such that our Decision may have overlooked or
misapprehended it. Nor have Appellants explained why this argument falls
within the exceptions in 37 C.F.R. § 41.52(a)(2) through (a)(4), which
permit submission of new argument in rehearing requests. We are,
therefore, not persuaded that Appellants have adequately explained why it
would be appropriate to consider this new argument at this time. Even so,
we note that in Appeal 2016-001939, there was no rejection under 35 U.S.C.
§101 raised for the PTAB to review in that appeal. The PTAB is directed to
“review adverse decisions of examiners” (35 U.S.C. § 6(b)); in so doing,
they are not required to raise new issues sua sponte, although they may
choose to do so. The PTAB did not choose to raise a new issue concerning
§ 101 in Appeal 2016-001939.
For the foregoing reasons, while Appellants disagree with the ultimate
conclusion regarding claims 36-40, 43, and 44 that we reached in our
Decision, Appellants have not sustained their burden of showing that we
misapprehended or overlooked relevant points of fact or law in arriving at
that Decision.
DECISION
We have granted Appellants’ request to the extent that we have
reconsidered our decision entered October 24, 2016.
We deny Appellants’ request for relief from that Decision.
DENIED
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