Ex Parte Walls et al

Patent Trial and Appeal Board

Jun 20, 2018

12161409 (P.T.A.B. Jun. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/161,409 09/09/2008
23117 7590 06/22/2018
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Andrew Finlay Walls
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.
GRT/3772-56 1117
EXAMINER
FOSTER, CHRISTINE E
ART UNIT PAPER NUMBER
1677
NOTIFICATION DATE DELIVERY MODE
06/22/2018 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):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREW FINLAY WALLS
and XIAOYING ZHOU1
Appeal2017-007759
Application 12/161,409
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and DAVID COTTA,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of diagnosing and treating anaphylaxis, which have been rejected as
containing new matter and as being directed to patent-ineligible subject
matter. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as the University of
Southampton. Br. 3.
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Application 12/161,409
STATEMENT OF THE CASE
"[M]ast cell activation as a result of allergen exposure may be
triggered on occasions in multiple organ systems ( anaphylaxis) and such
allergic reactions can be life-threatening." Spec. 1:14--16. "In recent years,
immunoassays for mast cell tryptase in serum samples have been helpful in
diagnosing ... anaphylaxis." Id. at 1 :24--25. "However, it has become
increasingly clear that elevation of serum tryptase concentration is not
detectable in all cases of anaphylaxis." Id. at 1 :28-29. The Specification
discloses that "a raised level of mast cell carboxypeptidase may be detected
in serum samples from individuals as a result of anaphylaxis even though
they test negative for serum tryptase." Id. at 2:15-17.
Claims 1, 7, 10, and 14--19 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A method of using an immunoassay to detect an elevated
level of mast cell carboxypeptidase following suspected
anaphylaxis in order to diagnose anaphylaxis, and treating said
anaphylaxis; which comprises:
(a) detecting an elevated level of mast cell carboxypeptidase
in a serum or plasma sample by immunoassay; wherein said
sample is liable to contain mast cell carboxypeptidase released
from mast cells as a result of anaphylaxis, said sample is
derived from blood taken from an individual between 8 and 24
hours of the onset of suspected anaphylaxis, and anaphylaxis is
diagnosed for the individual when the level of mast cell
carboxypeptidase is detected above a baseline level of an
unaffected individual; and
(b) treating the individual diagnosed with anaphylaxis.
Claims 1, 7, 10, and 14--19 stand rejected under 35 U.S.C. § 112, first
paragraph, for lack of adequate written description (Ans. 2) and under
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35 U.S.C. § 101 on the basis that the claimed method is not eligible for
patenting (Ans. 3).
I
The Examiner has rejected all of the claims on appeal for lack of
adequate written description (new matter). The Examiner finds that
[ c ]laims 1 and 19 were amended in the 3/18/16 reply to recite a
step of treating the individual diagnosed with anaphylaxis (see
preamble and step (b) of the claims).
Support could not be found by the examiner in the
specification or claims as originally filed. The specification
does not describe treating anaphylaxis following diagnosis.
Ans. 3.
We agree with the Examiner that the Specification fails to provide an
adequate written description of the treating step of claim 1.
Adequate written description means that, in the specification,
the applicant must "convey with reasonable clarity to those
skilled in the art that, as of the filing date sought, he or she was
in possession of the [claimed] invention." When no such
description can be found in the specification, the only thing the
PTO can reasonably be expected to do is to point out its
nonexistence.
Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007) (citation omitted,
alteration in original).
The Specification consistently describes the invention as a method of
diagnosis only, and does not mention treatment. See, e.g., Spec. 1 :4--6 ("The
present invention relates to use of mast cell carboxypeptidase as a marker for
mast cell activation, more particularly, for example, as a blood sample
marker for mast cell activation resulting in anaphylaxis."), id. at 2:14--18
("[A] raised level of mast cell carboxypeptidase may be detected in serum
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samples from individuals as a result of anaphylaxis even though they test
negative for serum tryptase. This has pointed the way to new diagnostic use
of mast cell carboxypeptidase .... "), and id. at 3: 18-21 ("[T]he present
invention thus provides use of an immunoassay for detection of mast cell
carboxypeptidase ... , wherein said use is for diagnosis of anaphylaxis.").
Appellants argue that "[i]t is important to recognize that the rejected
subject matter is original to this application." Br. 8. Appellants do not,
however, identify where the original Specification describes treating
anaphylaxis, and our review of the Specification does not reveal any such
description.
Id.
Appellants also argue that
[a] skilled person would recognize that diagnosis of allergic
disease is not useful unless the anaphylactic reaction is treated.
Certainly, as an alternative to diagnosis by immunoassay of
mast cell tryptase as practiced in the prior art, the same
treatments can be administered. There was no need to describe
such treatment explicitly because the specification does not
need to teach, and preferably it omits, what is well known in the
art.
As the Examiner pointed out, however, "[a]lthough it may have been
obvious to perform a step of treatment following diagnosis of an individual
according to the disclosed methods, obviousness is not the standard for
addition of new limitations to the claims." Ans. 3. See Ariad Pharms., Inc.
v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) ("[W]hile the
description requirement does not demand any particular form of disclosure,
or that the specification recite the claimed invention in haec verba, a
description that merely renders the invention obvious does not satisfy the
requirement.") ( citations omitted).
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We affirm the rejection of claim 1 under 35 U.S.C. § 112, first
paragraph. Claims 7, 10, and 14--19 were not argued separately and
therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
II
The Examiner has rejected all of the claims on appeal on the basis that
they are "directed to a law of nature/natural phenomenon" and therefore are
not eligible for patenting. Ans. 3. The Examiner finds that "the claims are
directed to a judicial exception ... as they recite the naturally occurring
correlation between levels of mast cell carboxypeptidase and anaphylaxis.
. . . Such concepts as diagnosing an abnormal condition and comparing data
to determine diagnosis represent judicial exceptions." Ans. 4.
The Examiner also finds that "although the claims recite that mast cell
carboxypeptidase is determined by immunoassay, immunoassays were well-
understood, routine and conventional activity at the time of the invention. In
fact, others had previously detected mast cell carboxypeptidase by
immunoassay." Id. at 5, citing Castells. 2 Finally, the Examiner finds that,
[a]lthough the claims now recite a step of treating, no specific
treatment is set forth. Generically invoking treatment, recited at
a high level of generically [ sic, generality], is insufficient to
ensure that the claims amount to significantly more because the
generic treatment step would preempt all possible treatments
and further does not go beyond routine/conventional activity
since treatment of anaphylaxis was known in the prior art.
2 Castells et al., "The presence of membrane-bound stem cell factor on
highly immature nonmetachromatic mast cells in the peripheral blood of a
patient with aggressive systemic mastocytosis," 98 J. Allergy Clin.
Immunol. 831-840 (1996).
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Id. at 4--5. The Examiner concludes that, "[fJor all of these reasons, the
claims fail to include additional elements that are sufficient to amount to
significantly more than the judicial exception." Id. at 7.
We agree with the Examiner that, under the two-step test of Alice
Corp. Pty. Ltd. v. CLS Bank Int'!, 134 S. Ct. 2347 (2014), claim 1 is not
directed to patent-eligible subject matter. The Alice Court stated that "[i]n
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S.-,
132 S.Ct. 1289, 182 L.Ed.2d 321 (2012), we 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." Alice Corp., 134 S. Ct. at 2355.
The Alice Court described the Mayo test as follows:
First, we determine whether the claims at issue are directed to
one of those patent-ineligible concepts. If so, we then ask,
"[ w ]hat else is there in the claims before us?" To answer that
question, 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. We have described
step two 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. (alterations in original, citations omitted).
The Mayo Court applied its test to claims that are similar to those of
the instant application. In Mayo, the claimed invention was a "method of
optimizing therapeutic efficacy for treatment of an immune-mediated
gastrointestinal disorder" comprising administering a certain class of drug
and then determining the level of 6-thioguanine ( 6-TG) in a patient, where a
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level of 6-TG below or above certain amounts indicated a need to increase or
decrease, respectively, the drug dosage. Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 566 U.S. 66, 74--75 (2012).
Claim 1 of the instant application is similar, in that it is directed to a
method of detecting whether the level of mast cell carboxypeptidase in a
patient's serum or plasma sample is above a baseline level, and then treating
the patient for anaphylaxis. Similar to the method at issue in Mayo,
therefore, the method of instant claim 1 is directed to a method of providing
therapy based on the level of biomarker ( mast cell carboxypeptidase) in
patient samples.
The Mayo Court concluded that the claims at issue in that case "set
forth laws of nature-namely, relationships between concentrations of
certain metabolites in the blood and the likelihood that a dosage of a
thiopurine drug will prove ineffective or cause harm." Id. at 77.
Similarly here, claim 1 on appeal sets forth a law of nature-namely,
a relationship between the level of a certain biomarker ( mast cell
carboxypeptidase) and the likelihood that ( an unspecified) treatment for
anaphylaxis is likely to be effective. Under the first step of the Alice/Mayo
test, claim 1 on appeal is directed to a law of nature or natural phenomenon.
The Mayo Court next turned to the question "[ w ]hat else is there in
the claims before us?" Id. at 78. The claims in Mayo included an
"administering" step, a "determining" step, and a "wherein" clause. Id. The
Court concluded that "[t]he 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. at 79. In other words,
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the claims inform a relevant audience about certain laws of
nature; any additional steps consist of well-understood, routine,
conventional activity already engaged in by the scientific
community; and those steps, when viewed as a whole, add
nothing significant beyond the sum of their parts taken
separately.
Id. at 79--80. The Court concluded that "the steps are not sufficient to
transform unpatentable natural correlations into patentable applications of
those regularities." Id. at 80.
Like the steps of the claims in Mayo, the manipulative steps of claim 1
on appeal also "consist of well-understood, routine, conventional activity
already engaged in by the scientific community." Id. at 79--80. "Whether
something is well-understood, routine, and conventional to a skilled artisan at
the time of the patent is a factual determination." Berkheimer v. HP Inc., 881
F.3d 1360, 1369 (Fed. Cir. 2018). The Castells reference cited by the
Examiner shows that using an immunoassay to detect mast cell
carboxypeptidase was routine in the art. See Castells 833, left col. ("For
immunochemistry, slides were incubated ... with one of the following
antibodies: ... mouse monoclonal anti-CPA (1 :800; Sigma Chemical Co.,
St. Louis, Mo.), mouse monoclonal anti-CPA (gift of Dr. S. Goldstein).")
CPA is an abbreviation for carboxypeptidase A. Id. at 832, left col. See also
id. at 839, left col. ("That the mast cells ... were of the normal phenotype ...
was revealed by the expression of tryptase, chymase, and CPA.").
Claim 1 also recites a step of "treating the individual diagnosed with
anaphylaxis," but the Examiner found that "treatment of anaphylaxis was
known in the prior art," and concluded that "[g]enerically invoking treatment
... is insufficient to ensure that the claims amount to significantly more
because the generic treatment step would preempt all possible treatments"
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(Ans. 4--5). We agree. See Mayo, 566 U.S. at 82 ("[S]imply 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."). Claim 1 does not require any specific treatment for
anaphylaxis, and thus "the step[] add[ s] nothing of significance to the natural
laws themselves. Unlike, say, a typical patent on a new drug or a new way of
using an existing drug, the patent claims do not confine their reach to
particular applications of those laws." Id. at 87.
In conclusion, when claim 1 is considered as an ordered combination,
it informs a relevant audience of a certain law of nature: specifically, that the
level of mast cell carboxypeptidase in a patient's plasma or serum indicates
that the patient has anaphylaxis, and that treatment for anaphylaxis is
appropriate. All of the additional steps of claim 1 consist of well-understood,
routine, conventional activity already engaged in by the scientific
community, as shown by the evidence cited by the Examiner. We conclude
that, under the Alice/Mayo test, claim 1 is directed to patent-ineligible subject
matter.
Appellants argue that "the claimed method requires performing an
immunoassay with antibody specific for mast cell carboxypeptidase. The
antibody was not present naturally in treated patients. See page 10 lines 14-
24 of the specification. This is a significant step that is markedly different
from anything existing in nature." Br. 9.
The rejection, however, is based on the claimed method being directed
to a law of nature-a naturally occurring correlation-not on its using a
naturally occurring product. See Mayo, 566 U.S. at 77 ("Prometheus'
patents set forth laws of nature-namely, relationships between
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concentrations of certain metabolites in the blood and the likelihood that a
dosage of a thiopurine drug will prove ineffective or cause harm."), and
Ass 'nfor Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591
(2013) ("Myriad found the location of the BRCAl and BRCA2 genes, but
that discovery, by itself, does not render the BRCA genes 'new ...
composition[ s] of matter,' § 101, that are patent eligible." ( alteration in
original)). Both categories of invention are ineligible for patenting, but for
different reasons. Appellants' arguments on this point are, therefore,
unpersuasive.
Appellants also argue that "the sample required by the claims is not a
natural product. ... Neither plasma nor serum exists naturally in the body.
The former has an anticoagulant ( e.g., EDTA, citrate, or heparin) added; the
latter has the clot removed." Br. 10. Appellants, however, cite no evidence
to support this position, and "[ a ]ttomeys' argument is no substitute for
evidence." Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
In any event, as discussed above, the rejection is not based on whether the
claimed method uses naturally occurring products, but on whether it
amounts to significantly more than the natural correlation between the level
of mast cell carboxypeptidase in a patient's serum or plasma and the
occurrence of anaphylaxis in the patient.
Finally, Appellants argue that
[ t ]he claimed method provides ... for treatment of patients who
would not otherwise have been treated when previously-known
methods of diagnosis of anaphylaxis were used. Thus,
diagnosis and treatment of individuals by Appellants' invention
is neither conventional nor routine. The diagnosis step is
practically applied by treating the individual. It was also not
conventional or routine to measure the amount of mast cell
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carboxypeptidase in blood taken from an individual between 8
and 24 hours of the onset of suspected anaphylaxis. Therefore,
based on analyzing the invention as a whole, Appellants'
claimed invention amounts to significantly more than a judicial
exception.
Br. 9--10.
This argument is also unpersuasive. As discussed above, detecting
mast cell carboxypeptidase using an immunoassay was routine in the art.
See Castells 833, left col. Appellants do not dispute that treating an
individual with anaphylaxis was known, and in fact the Specification
discloses nothing regarding treatment. Appellants argue that "[ t ]here was no
need to describe such treatment explicitly because the specification does not
need to teach, and preferably it omits, what is well known in the art." Br. 8.
Thus, there is no dispute that the treating step of claim 1 was also
conventional.
In summary, we conclude that claim 1 does not "contain other
elements or a combination of elements, sometimes referred to as an
'inventive concept,' sufficient to ensure that the patent in practice amounts
to significantly more than a patent upon the natural law itself." Mayo, 566
U.S. at 72-73.
We affirm the rejection of claim 1 under 35 U.S.C. § 101. Claims 7,
10, and 14--19 have not been argued separately and therefore fall with claim
1. 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm both of the rejections on appeal.
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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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