Ex Parte Struck et al

Patent Trial and Appeal Board

Jul 10, 2017

13583350 (P.T.A.B. Jul. 10, 2017)

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.
13/583,350 11/09/2012 Joachim Struck BOEHMERP-0160 1038
23599 7590 07/12/2017
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON, VA 22201
EXAMINER
SKOWRONEK, KARLHEINZ R
ART UNIT PAPER NUMBER
1676
NOTIFICATION DATE DELIVERY MODE
07/12/2017 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOACHIM STRUCK, CHRISTIAN NICKEL,
ROLAND BINGISSER, SVEN GIERSDORF, and
OLIVER HARTMANN1
Appeal 2017-000269
Application 12/583,350
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state the real party-in-interest is B.R.A.H.M.S. GmbH. App. Br.
1.
Appeal 2017-000269
Application 13/583,350
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 14—17 and 20—32 as unpatentable
under 35 U.S.C. § 103(a) as being obvious over Struck et al. (WO
2009/019230 A2, February 12, 2009) (“Struck”).
We have jurisdiction under 35 U.S.C. § 6(b)
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to assays and in vitro methods for
the in vitro diagnosis, prognosis and risk stratification of a patient having a
primary, non-infectious disease, in which the level of procalcitonin (“PCT”)
in a sample of a body fluid of the patient is indicative for the risk of the
patient to contract a further disease or medical condition. Abstract.
REPRESENTATIVE CLAIM
Claim 14 is representative of the claims on appeal and recites:
14. A method for diagnosing a bacterial infection in a patient
who does not have a primary disease, and who presented to the
emergency department with one or more non-specific
complaints, by detection and quantification of a marker of
bacterial infection, wherein
said complaints are selected from the group consisting of
“not feeling well,” “feeling weak,” “feeling exhausted,”
“being tired or sleepy,” “feeling dizzy,” having a lack of
appetite, being unable to cope with usual daily activities,
and the patient being unable to recall why they were sent
to the emergency department, with the proviso that the
patient did not present to the emergency department with
any complaints specific to infection,
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comprising the steps of:
(i) detecting and quantifying the level of a Procalcitonin
(PCT), or a fragment thereof having at least 12 amino
acids (collectively, PCT analyte) in a bodily fluid
sample from said patient, wherein the detection and
quantitation comprises a PCT detection assay with a
functional assay sensitivity of below 0.06 ng/mL,
comprising contacting said PCT analyte with a capture
molecule that specifically binds to the PCT analyte to
form a detectable PCT analyte:capture molecule
complex, and detecting the complex;
(ii) comparing the thus-detected level of PCT analyte in
said sample to a predetermined threshold level of
between 0.02 ng/mL and 0.25 ng/mL; and
(iii) diagnosing whether said patient has a bacterial
infection or not by comparing said determined PCT
level with said predetermined threshold level;
wherein the patient is diagnosed with a bacterial infection if the
PCT analyte level is higher than the predetermined threshold
level, and whereby the diagnosis is used to determine whether to
prescribe antibiotic treatment for the patient diagnosed with a
bacterial infection.
App. Br. 8.
ISSUES AND ANALYSIS
We herein agree with, and adopt, the Examiner’s findings and
conclusion that the appealed claims are obvious over the cited prior art
references. We address the arguments raised by Appellants on appeal
below.
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Application 13/583,350
Issue 1
Appellants argue the Examiner erred in finding that Struck teaches or
suggests the limitation of claim 14 reciting: “A method for diagnosing a
bacterial infection in a patient who does not have a primary disease, and who
presented to the emergency department with one or more non-specific
complaints.” App. Br. 3.
Analysis
The Examiner finds the procalcitonin (“PCT”) testing method of
Struck is the same as claimed, but that Appellants’ claims have additional
limitations concerning the patient cohort subjected to testing. Final Act. 4.
Specifically, the Examiner finds Appellants’ claim 14 defines this cohort as
patients who do not have a primary disease and are presenting to the
emergency department with one or more nonspecific complaints listed in the
claims. Id. However, the Examiner finds that the patient cohort defined by
Struck are patients with a primary, noninfectious disease with an
asymptomatic second disease. Id.
The Examiner therefore finds that, because the diagnosis of the
infection is wholly disconnected from the symptoms of the primary disease,
as shown by Struck; it is evident that the presence of a primary disease is not
required for practicing the claimed invention. Final Act. 4. Furthermore,
the Examiner finds, Struck points to evidence, in the prior art, that PCT can
be used to diagnose non-septic infections, such as pneumonia, bacterial
meningitis and malaria. Id. (citing Struck 1—2). The Examiner therefore
concludes that it would have been obvious to one of ordinary skill in the art
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that the method of Struck would apply no differently to a patient without a
primary non-infectious disease. Id.
Appellants argue Struck teaches that their “invention is based on the
surprising finding that in samples of patients with a primary, non-infectious
disease, slightly elevated PCT concentrations have been detected at a large
frequency and are of diagnostic relevance.” App. Br. 3 (quoting Struck 3).
According to Appellants, Struck also teaches that the “presence of slightly
elevated PCT levels may be indicative for the risk of a patient having a non-
infectious primary disease to acquire a yet clinically unmanifested and/or yet
asymptomatic further disease or medical condition” and that “patients with a
primary disease not being an infection should be assayed for their PCT level
to allow for the prognosis of the risk to acquire a further disease or medical
condition and ultimately to allow for the adaption of therapy.” Id.
Appellants therefore argue that the method taught by Struck involves a
completely different patient class than that of Appellants’ claimed method;
viz., that taught by Struck is defined as patients who have a primary disease,
whereas the patient class in Appellants’ claimed method constitutes patients
who do not have a primary disease and who present with one or more non­
specific complaints selected from a specified group. Id. at 3^4.
Appellants also point out that Struck discusses a prior study involving
treating patients with lower respiratory tract infections in which only
patients with PCT concentrations greater than 0.25 ng/ml or 0.5 ng/ml were
treated with antibiotics. App. Br. 4. Appellants note that, based on this
study, Struck teaches:
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[I]t is unclear so far, whether the presence of a primary disease
in addition to an infection should influence the interpretation of
PCT concentrations below 0.25 ng/mL. A relevant primary
disease might put an additional burden on the immune system,
and biomarkers of infection, such as PCT, in such situation might
be indicative of an infection in a different, i.e. lower,
concentration range than in the absence of a relevant primary
disease.
Id. (quoting Struck 2).
Therefore, Appellants argue, Struck teaches that a determination that
the presence of primary disease can have an effect, such that a concentration
range of PCT lower than the concentration range used for indicating an
infection in the “absence of a relevant primary disease,” can be itself
indicative of an infection. App. Br. 4.
Appellants dispute the Examiner’s finding that Struck teaches that
“the diagnosis of the infection is wholly disconnected from the symptoms of
the primary disease.” App. Br. 4 (quoting Final Act. 40). Appellants assert
that Struck does not make such a disclosure or suggestion, but rather
suggests that the presence of the primary disease affects the level of PCT
and thereby permits the use of a lower concentration of PCT to be indicative
of an infection, i.e., a lower, concentration range than is used when a
primary disease is absent. Id. Appellants argue Struck suggests only using
lower concentrations when a primary disease is present, and not when a
primary disease is absent. Id. Therefore, Appellants contend, the teachings
of Struck would not have led one of ordinary skill in the art to Appellants’
claimed invention. Id.
Appellants further argue the surprising finding of the present
invention is that patients with no symptoms of an infection, but who have
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non-specific complaints severe enough to cause them to present themselves
to an emergency room, may, nevertheless, have an infection and may be
diagnosed by measuring their PCT level and comparing it to a threshold
value that is outside the range used in the prior art for making the decision to
treat for an infection. App. Br. 5. According to Appellants, patients with
bacterial infections normally have classical clinical symptoms and/or
manifestations of an infection. Id. However, argue Appellants, they have
discovered that the threshold levels that are indicative of an asymptomatic
infection in this patient class are relatively low: PCT levels of less than 0.25
ng/mL are considered normal; however, according to the present invention,
patients who do not have symptoms of an infection and have what have been
considered relatively normal PCT values, may nevertheless be diagnosed as
having a bacterial infection by determining their PCT levels and comparing
to the threshold values discovered by Appellants. Id.
Appellants contend that a person of ordinary skill in the art would
understand from the teachings of Struck that the described patient class (i.e.,
patients having a primary, non-infectious disease) were not being diagnosed,
but were rather having their risk of acquiring a yet clinically unmanifested
and/or yet asymptomatic further disease or medical condition assessed.
App. Br. 15. Appellants assert that the teachings of Struck would therefore
not suggest to, or motivate, a skilled worker to consider PCT as a diagnostic
marker in a different patient class. Id.
The Examiner responds that, comparing the patient cohort taught by
Struck to that of Appellants’ claims, the claims define a patient cohort
broader in scope than that of Struck. Ans. 3. The Examiner finds the
nonspecific complaints recited in claim 14 as defining the patient population,
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i.e., “not feeling well,” “feeling weak,” “feeling exhausted,” “being tired or
sleepy,” “feeling dizzy,” etc., are necessarily nonspecific by definition and,
as such, may well be associated with the primary disease of the patient
cohort defined by Struck. Id. at 3^4. The Examiner finds that, because the
diagnosis of the patient cohort of the instant claims is inherently unknown,
as they are presenting to the emergency room with non-specific complaints,
the cohort recited in claim 14 must inevitably include patients who have an
undiagnosed primary non-infectious disease who fall within the cohort
defined by Struck. Id. at 4.
The Examiner recognizes that Appellants also argue that Struck does
not teach how to use the PCT level diagnostically to detect the presence of
an infection. Ans. 4 (citing App. Br. 5—6). The Examiner finds Struck
introduces the method they define with the following statement:
[The sjubject of the invention is the in vitro diagnosis,
prognosis and risk stratification of a patient having a primary,
noninfectious disease, whereby the level of Procalcitonin (PCT)
in a sample of a body fluid of the patient is indicative for the risk
of the patient to contract a further disease or medical condition.
Ans. 4 (quoting Struck 1). The Examiner finds the teachings of Stmck
expand significantly on the diagnostic aspect of the method, teaching:
“An in vitro method for diagnosis of the presence of a bacterial infection in a
patient, the method comprising: determining the level of procalcitonin....”
Id. (quoting Struck claim 26; see also Struck 10, 13). The Examiner finds
therefore finds that Struck teaches its method specifically as a method for
diagnosing an infection. Id.
We are not persuaded by Appellants’ arguments. The language of
claim 14 reciting: “A method for diagnosing a bacterial infection in a
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patient who does not have a primary disease. Is part of the preamble of
the claim, and we therefore must consider whether the language is limiting
upon the claim.
Generally, a preamble limits the invention if it recites essential
structure or steps, or if it is “necessary to give life, meaning, and vitality” to
the claim. See Catalina MarketingInt7, Inc. v. Coolsavings.com, Inc., 289
F.3d 801, 808 (Fed. Cir. 2002) (citing Pitney Bowes, Inc. v. Hewlett-
Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). Moreover, a preamble
may limit an invention when it is employed to distinguish a new use of a
prior art apparatus or process. Bristol-Myers Squibb Co. v. Ben Venue Labs.,
Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001). Conversely, a preamble is not
limiting “where a patentee defines a structurally complete invention in the
claim body and uses the preamble only to state a purpose or intended use for
the invention.” Catalina, 289 F.3d at 808 (quoting Rowe v. Dror, 112 F.3d
473, 478 (Fed. Cir. 1997)).
In the appeal before us, the question presented is whether the
preambular language reciting “A method for diagnosing a bacterial infection
in a patient who does not have a primary disease” is so essential to the
practice of Appellants’ claims that it limits the claims. We conclude that it
does not. Appellants’ claim further recites:
“[W]ho presented to the emergency department with one or more
non-specific complaints, by detection and quantification of a
marker of bacterial infection, wherein
said complaints are selected from the group consisting of “not
feeling well,” “feeling weak,” “feeling exhausted,” “being tired
or sleepy,” “feeling dizzy,” having a lack of appetite, being
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unable to cope with usual daily activities, and the patient being
unable to recall why they were sent to the emergency department,
with the proviso that the patient did not present to the emergency
department with any complaints specific to infection
We agree with the Examiner that the claim thus requires patients
explicitly presenting at an emergency department with only non-specific
complaints and that this class of required patients could include both patients
with a primary disease (e.g., arteriosclerosis, heart failure, acute coronary
syndrome, coronary disease, myocardial infarction, cancer, diabetes, chronic
gastrointestinal diseases, chronic renal diseases, hypertension, orthopaedic
diseases including osteoporosis, and neurodegenerative diseases including
Alzheimer's disease (See Spec. 8) as well as those without. We therefore
conclude that the preambular language reciting “in a patient who does not
have a primary disease” is not necessary to the invention, because the
limitation expressly requiring patients presenting at an emergency
department with one or more non-specific complaints is sufficient to practice
the invention without necessarily relying on the language of the preamble.
As for Appellants’ alleged “surprising finding” that that patients with
no symptoms of an infection, but who have non-specific complaints severe
enough to cause them to present themselves to an emergency room, may,
nevertheless, have an infection and may be diagnosed by measuring their
PCT level and comparing it to a threshold value, Appellants point to no
evidence of record that such a finding is indeed “surprising.” See App. Br.
5. Appellants point to no evidence of record in the prior art that suggests
that it would be otherwise surprising that patients with nonspecific
symptoms sufficient to warrant a trip to the emergency room might have a
bacterial infection. See In re Baxter Travenol Labs., 952 F.2d 388, 392
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(Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art”). As such, Appellants provide only attorney argument,
to which we accord little probative value. See In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997) (Attorney arguments and conclusory statements that
are unsupported by factual evidence are entitled to little probative value).
Appellants do not argue that their claimed method is otherwise
different from that taught by Struck. We therefore conclude that Appellants’
argument that their claimed invention is not obvious over the teachings of
Struck because the preamble to claim 14 recites “in a patient who does not
have a primary disease” is not persuasive. We consequently affirm the
Examiner’s rejection of the claims.
DECISION
The Examiner’s rejection of claims 14—17 and 20—32 as unpatentable
under 35 U.S.C. § 103(a) 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).
AFFIRMED
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