Ex Parte Brown et al

Patent Trial and Appeal Board

Jan 5, 2017

11954881 (P.T.A.B. Jan. 5, 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.
HAY-1058 4676
EXAMINER
HINES, JANA A
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
11/954,881 12/12/2007
22827 7590 01/05/2017
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
Tameka Brown
01/05/2017 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
TAMEKA BROWN, AKOSUA ATTA-MENSAH, DANIEL BAIRD,
RICHARD HANTKE, TOD HOOVER SHULTZ, ERICA M. PHILLIPS,
SHAWN R. FEASTER, MIKE RAINONE,
THOMAS EDWARD PLOWMAN, and TALBOT PRESLEY1
Appeal 2015-007018
Application 11/954,881
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a method and device for detecting and quantifying an infection by a
pathogen. The Examiner rejects the claims as obvious and on the ground of
nonstatutory obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is Avent Inc. (App.
Br. 1.)
Appeal 2015-007018
Application 11/954,881
STATEMENT OF THE CASE
Claims 1, 8—12, 14—16, and 22—24 are on appeal2, and can be found in
the Claims Appendix of the Appeal Brief. Claims 1 and 10 are
representative of the claims on appeal, and read as follows:
1. A method for detecting the presence or amount of a pathogen
that is a source of a hospital acquired infection comprising:
locating a terminal portion of an implantable device within
a wound or surgical site, the terminal portion of the implantable
device comprising the end of a fiber optic cable held in
conjunction with the implantable device, the implantable device
comprising a catheter;
maintaining the terminal portion of the implantable device
within the wound or surgical site for continuous monitoring of
the wound or surgical site;
transmitting one or more excitation signals to the wound
or surgical site, the one or more excitation signals being
predetermined to induce the pathogen to autofluoresce in
response to the excitation signal and directly emit an optically
detectable signal,
wherein the optically detectable signal is transmittable
through the fiber optic cable to a detector;
transporting a fluid through the catheter from the wound
or surgical site to a reservoir, wherein the fluid includes the
pathogen; and
determining the presence or amount of the pathogen in the
wound or surgical site.
10. A device for detecting the presence or amount of a
pathogen that is a source of a hospital acquired infection
comprising:
2 Claim 7 is pending but currently not subject to any rejection (see App. Br.
14). We note that claim 7 is listed as rejected on form PTOL-303 of the
Advisory Action, mailed Nov. 11, 2014, as well as on form PTOL-326 of the
Final Office Action, mailed Sept. 11, 2014, but is not listed in a statement of
rejection or discussed in the body of the rejection. Therefore, claim 7 is not
currently before us for review.
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Application 11/954,881
an implantable device, the implantable device comprising
a first terminal portion locatable within a wound or surgical site
for continuous monitoring of the wound or surgical site and a
second terminal portion that is locatable exterior to the wound or
surgical site when the first terminal portion is within the wound
or surgical site, the implantable device comprising a drainage
tube catheter in fluid communication with a reservoir,
a fiber optic cable affixed to the implantable device, the
fiber optic cable comprising a first end for location in the wound
or surgical site, the first end of the fiber optic cable consisting
essentially of the terminal portion of one or more optical fibers,
the optical fibers consisting of core material and clad material,
the fiber optic cable being configured to deliver an excitation
signal to the wound or surgical site and detect an autofluorescent
response that is directly emitted by the pathogen in response to
the excitation signal, the fiber optic cable comprising a second
end in optical communication with an optical detector and an
excitation signal source;
a portable enclosure containing a power source, the optical
detector, a signal processor, the excitation signal source for
providing the excitation signal to the wound or surgical site, and
a signaling device for emitting a signal upon detection of the
presence or amount of the pathogen in the wound or surgical site;
and
a connecting device for attaching the enclosure to the
clothing or body of a wearer.
Appellants seek review of the Examiner’s rejection of claims 1, 8—12,
14—16, and 22—24 under 35 U.S.C. § 103(a) as unpatentable over Vo-Dinh3
in view of Lemelson4 and further in view of Jacoby,5 and claims 1, 10, 11,
12, 15, and 16 on the ground of nonstatutory-type double patenting over
claims 1, 6, 9—11, 13, 15, 19, and 21 ofU.S. Patent No. 8,280,471.
3 Vo-Dinh, US 5,938,617, issued Aug. 17, 1999.
4 Lemelson, US 4,803,992, issued Feb. 14, 1989.
5 Jacoby, US 5,328,365, issued July 12, 1994.
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Obviousness-type Double Patenting
Appellants do not contest the provisional obviousness-type double
patenting rejection (see App. Br. 14 (“Applicants agree to submit a terminal
disclaimer to the extent necessary upon allowance of the claims”); see
Ans. 26—27). Therefore, we summarily affirm, and will not further discuss,
this rejection. See Manual of Patent Examining Procedure § 1205.02 (“If a
ground of rejection stated by the examiner is not addressed in the appellant’s
brief, that ground of rejection will be summarily sustained by the Board.”).
Obviousness over Vo-Dinh, Lemelson, and Jacoby
The Examiner finds that Vo-Dinh teaches most of the claimed
limitations (see Final Act. 8—11) but acknowledges that “Vo-Dinh does not
specifically recite the implantable device being within the wound or surgical
site; or the implantable device comprising a drainage tube catheter in fluid
communication with a reservoir” (id. at 11). The Examiner relies on the
teachings of Lemelson and Jacoby for these limitations and concludes that
the combination would have been obvious at the time the invention was
made (see id. at 11—16).
Appellants contend that the references do not disclose continuous
monitoring of a wound site (App. Br. 6), application following a hospital
procedure (id. at 9), “long-term monitoring” (id. at 10), and that the rejection
relies on hindsight reconstruction (id. at 13).
The issue is: Does the preponderance of evidence of record support
the Examiner’s conclusion that the combination of references renders
obvious a method and device for monitoring an infection?
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Findings of Fact
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art as set out in the Answer and Final Office
Action mailed Sept. 11, 2014, and Advisory action mailed Nov. 14, 2014.
For emphasis only, we highlight the following:
FF1. Vo-Dinh teaches “a method and apparatus which utilizes synchronous
luminescence to identify biological pathogens” (Vo-Dinh, col. 2,11.
38-40)
FF2. Figure 2 of Vo-Dinh is reproduced below.
Fig. 2, reproduced above, is a schematic view of an instrument
capable of making chemical and biochemical identifications. The
figure shows “[t]he optical fiber 30 transmits the output beam to a
probe 32 juxtaposed [to] a sample 34. The probe 32 can be inserted
into the working channels of an endoscope for in vivo measurements”
(Vo-Dinh, col. 5,11. 27-30).
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FF3. In addition to an output beam Vo-Dinh teaches “[a]n optical fiber (or
fibers) 36 transmits the fluorescence of the sample 34 to detector
means 38. The detector means 38 includes a monochromator (MON)
40 and a photomultiplier (PM) 42” (id. at col. 5,11. 31-34).
FF4. Vo-Dinh teaches “[a] portable computer 50, or other suitable data
collection, analysis and/or display devices, can be used to generate the
synchronous luminescence spectra” (id. at col. 5,11. 39-43).
FF5. Vo-Dinh teaches “the steps of exposing the sample to an excitation
radiation and thereby generating an emission radiation and
synchronously scanning the wave length of the excitation radiation
and the wavelength of the emission radiation to produce a multi-
spectral image (id. at col. 2,1. 64—col. 3,1. 2).
FF6. Vo-Dinh teaches that many types of samples can be assayed with their
device:
For example, tissue samples, either in vitro or in vivo,
may be tested to detect and identify infectious agents.
Food samples may be tested to detect and identity
biological pathogens, such as, for example, E. Coli and
other organisms. The present invention is useful to
perform environmental monitoring, such as bacterial
identification in water supplies and bioremediation.
Likewise, the present invention is useful in the field of
biotechnology, to detect and identify bacteria in
bioprocesses. Also, the present invention is useful in the
detection of biological warfare agents in solid, liquid and
air samples. Moreover, the present invention is useful in
the detection of infectious agents, for example, infectious
pathogens.
(Vo-Dinh col. 12,11. 9-22)
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FF7. The Examiner finds that “A. coli, [is] a pathogen capable of being the
source of a hospital acquired infection” (Ans. 19).
FF8. Lemelson teaches devices such as “endoscopes as well as other
medical instruments, have employed means, insertable into a body
duct through a natural opening or incision made by a tool” (Lemelson,
col. 1,11. 19-22).
FF9. Lemelson teaches “electrooptically analyzing light passed through
body fluid in the cavity 16 to determine such variables as
identification of specific microorganisms” (id. at col. 8,11. 58—60).
The photosensors “may each be operable to detect a different
physiological phenomenon, such as a different microbiological
element, enzyme or other chemical when such sensors operate” (id. at
col. 11,11. 63-65).
FF10. Lemelson teaches light beam sensing means that include a “catheter
which is adapted to ingest a small quantity of body fluid by means of
a valve controlled to open and admit such fluid to a chamber . . .
utilizing suction or capillary action to admit such sample of body
fluid” (id. at col. 9,11. 40-44).
FF11. Jacoby teaches an endoscopic instrument “incorporate[s] one or more
fluid infusion passageways [and] may be formed in any instrument or
probe of the present invention to permit infusion of fluid” (Jacoby,
col. 7,11. 43 46). Jacoby teaches that “one or more aspiration lumens
may be formed in any instrument or probe of the present invention to
permit aspiration of fluid and debris from the periodontal pocket or
crevice” (id. at col. 7,11. 53—55). The aspiration lumen is attached to a
suction source “to effect suction or aspiration of fluid and/or debris
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from the periodontal pocket during operation of the device” {id. at col.
12,11. 53-55).
FF12. The Examiner finds that “Jacoby teaches a fluid outlet aperture. Thus,
Jacoby teach an implantable device comprising a drainage tube
catheter in fluid communication with a reservoir” (Final Act. 13;
Ans. 8).
Principle of Law
“If the claim extends to what is obvious, it is invalid under § 103.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). ft is obvious to
adapt a known product “using modem electronic components in order to
gain the commonly understood benefits of such adaptation, such as
decreased size, increased reliability, simplified operation, and reduced cost.”
Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161 (Fed.
Cir. 2007).
Analysis
Vo-Dinh teaches methods for detecting biological pathogens, such as
E. coli, using excitation and emission radiation (FF1—FF6). The Examiner
finds that E. coli is a pathogen that is capable of being acquired in a hospital
setting (FF7). Vo-Dinh also teaches that the apparatus contains optical
fibers and suggests that it can be part of a working endoscope (FF2).
Lemelson teaches an endoscope for insertion into the body (FF8) and using
light to detect microorganisms in the body fluid (FF9). Lemelson also
teaches a “catheter which is adapted to ingest a small quantity of body fluid
by means of a valve controlled to open and admit such fluid to a chamber”
so that the fluid may be analyzed with light (FF10). Jacoby also teaches an
endoscope that contains a passage way to infuse fluid into a surgical site as
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well as a passage way for aspirating fluid from a surgical site using suction
(FF11).
We have reviewed Appellants’ contention that the Examiner erred in
rejecting the claims as obvious. We are not persuaded and adopt the
Examiner’s findings of fact and reasoning regarding the scope and content of
the prior art as set out in the Answer, Final Office Action, and Advisory
Action, and agree that the claims are rendered obvious by the combination of
Vo-Dinh, Lemelson, and Jacoby. We address Appellants’ arguments below:
Appellants contend that “[a]n endoscope is used to visualize an
internal area during a medical procedure. It is not, however, implanted and
maintained at a site for continuous monitoring of the site as is the case for
the implantable device of the claimed method” (App. Br. 6; see generally id.
at 6—8).
We begin with claim interpretation because it is at the heart of patent
examination as a claim cannot be compared to the prior art before its scope
is properly ascertained. Cf. In re Abbott Diabetes Care Inc., 696 F.3d 1142,
1146 (Fed. Cir. 2012)). “[Djuring examination proceedings, claims are
given their broadest reasonable interpretation consistent with the
specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). We first
turn to the Specification to interpret the term “continuous monitoring.”
The Specification provides:
The present disclosure is generally directed to methods for
detection of HAI [(hospital acquired infection)]. In one
particular embodiment, disclosed methods may be utilized for
continuous monitoring of a potential infection site and may be
utilized to alert patients and/or health care providers to the
presence of pathogens at an early stage of infection, thereby
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Application 11/954,881
providing for earlier intervention and improved recovery rates
from infection.
(Spec. 4:8—13). We agree with the Examiner that neither the Specification
nor the claims provide any time span that is required to meet the limitation
of “continuous monitoring.” Therefore, we agree with the Examiner that
“continuous monitoring” reasonably “embraces continuous monitoring
throughout the time during a procedure to achieve the instantly claimed
results. Based on the instant claims and even the instant specification, it
appears the continuous uninterrupted monitoring is only long enough to
transmit excitation signals, receive a detectable signal transmitted through
the optic fiber to the detector, to ultimately determine the presence/amount
of pathogen” (Ans. 16—17). We agree with the Examiner’s interpretation
that broadest reasonable interpretation of “continuous monitoring”
encompasses monitoring for the time it takes to complete a procedure (see
id. at 17).
The Examiner finds that Lemelson and Jacoby both teach placing the
terminal portion of their endoscope into the surgical sites “so that [the]
device remains undisturbed within the site” thereby meeting the limitation of
continuous monitoring as claimed (Ans. 17, 18; see FF8—FF11). We agree
with the Examiner’s position that both Lemelson and Jacoby teach placing
the endoscope into a surgical site for the time it takes to perform the
particular surgical procedure and thereby would meet the limitation of
“continuous monitoring” as claimed.
Appellants contend that “[n]one of the cited references, however, are
concerned with the development of infection following a surgical procedure
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or hospital stay” (App. Br. 9) or “with long-term monitoring and early
detection of infection following a medical procedure” {id. at 10).
We are not persuaded. As stated by our reviewing court in In re
Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998), “the name of the game is
the claim.” It is well established that limitations not appearing in the claims
cannot be relied upon for patentability. In re Self, 671 F.2d 1344, 1348
(CCPA 1982). As recognized by the Examiner, the claims do not require
“‘long term’ implantation. The only limitation regarding implantation is that
a terminal portion of an implantable device be located within a wound or
surgical site” (Ans. 17; see also id. at 20 (“that the features upon which
applicant relies (i.e., early development of an infection following a surgical
procedure or hospital stay) are not recited in the rejected claims”)). We
agree with the Examiner that Appellants are arguing limitations that are not
in the claims and, therefore, find these arguments unavailing.
Appellants contend that the “various devices are merely components
of the entire instrument 20 [of Vo-Dinh], however, and there is no
suggestion that these devices are contained within a single portable
enclosure” (Reply Br. 4; App. Br. 11 (“none of the cited references disclose
or suggest a portable enclosure that contains all of a power source, an optical
detector, a signal processor, an excitation signal source, and a signaling
device”)).
We are not persuaded. Appellants are arguing the size of the
components, alleging that “there is no rationale for incorporating such a
portable enclosure with a device utilized for a medical procedure” (App. Br.
12). The term “portable” is reasonably interpreted to mean that the device
can be moved as opposed to being stationary. Vo-Dinh teaches such a
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device. “Portable computer 50, or other suitable data collection, analysis
and/or display devices, can be used to generate the synchronous
luminescence spectra” (Vo-Dinh, col. 5,11. 39-43, Ans. 23, see also Ans. 4;
see FF2).
The limitation that “the enclosure that houses the portable device can
be attached to the patient/wearer,” again is a limitation that is directed to
size. The Examiner finds that Vo-Dinh’s “portable enclosure can be carried
by the user, since the pathogen detecting catheter is already attached” (Ans.
24). We agree with the position that it is obvious to adapt a known product
“using modem electronic components in order to gain the commonly
understood benefits of such adaptation, such as decreased size, increased
reliability, simplified operation, and reduced cost.” Leapfrog Enterprises,
Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161 (Fed. Cir. 2007). The
references already teach devices that are portable, even if they are not sized
to be attached to the body of the wearer. Making a device smaller would be
understood by the ordinarily skilled artisan to be obvious in order to derive
the benefit of making it easier to move the device between patients for
performing the associated procedures operable by such a device.
Accordingly, we find this argument unpersuasive as well.
Appellants contend that it is not proper to use the “disclosure as a
blueprint to reconstmct the claimed invention out of isolated teachings in the
prior art” (App. Br. 13).
We are not persuaded by this argument.
Any judgment on obviousness is in a sense necessarily a
reconstmction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
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does not include knowledge gleaned only from applicant’s
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395, (CCPA 1971). Here, the Examiner
has pointed to specific disclosure in the references that describes each of the
limitations and provides sound reasons for combining the references.
Therefore, we conclude that the Examiner has not relied on hindsight.
Appellants contend that “[njowhere does Jacoby mention a method
that includes transporting a fluid through a catheter from a wound or surgical
site to a reservoir as is found in claim 1” (Reply Br. 2).
While Appellants do present arguments directed to “a reservoir” at
page 2 in the Reply Brief, we note that no such argument was presented in
the principal brief. The Board is not required to address arguments in the
Reply Brief that could have been presented in the principal Brief. See Ex
parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (“informative”); see
also 37 C.F.R. § 41.41(b)(2) (“Any argument raised in the reply brief which
was not raised in the appeal brief, or is not responsive to an argument raised
in the examiner’s answer . . . will not be considered by the Board for
purposes of the present appeal, unless good cause is shown.”). However, in
the interest of compact prosecution, we will address Appellants’ argument
with respect to the “reservoir” limitation raised in the Reply Brief.
The Examiner finds that “Jacoby teaches a fluid outlet aperture. Thus,
Jacoby teach[es] an implantable device comprising a drainage tube catheter
in fluid communication with a reservoir” (FF12). Jacoby teaches an
aspiration lumen that is attached to a suction source “to effect suction or
aspiration of fluid and/or debris from the periodontal pocket during
operation of the device” (FF11). We agree with the Examiner’s position that
one of ordinary skill in the art would appreciate that a fluid trap, i.e. a
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reservoir, is part of the aspiration line disclosed in Jacoby in order to avoid
fluid entering the suction apparatus/vacuum device. Accordingly, we agree
with the Examiner’s position that Jacoby teaches a reservoir.
Furthermore, we note that Lemelson also teaches a reservoir:
Lemelson teaches a light beam sensing means that includes a “catheter
which is adapted to ingest a small quantity of body fluid by means of a valve
controlled to open and admit such fluid to a chamber . . . utilizing suction or
capillary action to admit such sample of body fluid” (FF10). Here, we find
the valve and suction source that allows fluid to enter the camber of
Femelson reasonably meets the claimed requirement that the “drainage tube
catheter is in fluid communication with a reservoir” as claimed.
Accordingly, we are not persuaded by Appellants’ contention that the
combination of references does not teach a “reservoir” as claimed.
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the combination of Vo-Dinh,
Femelson, and Jacoby renders obvious the method and device for detecting a
pathogen of claims 1 and 10. We thus affirm the rejection of claims 1 and
10 under 35 U.S.C. § 103(a) as being obvious. As claims 8, 9, 11, 12, 14-
lb, and 22—24 were not separately argued, they fall with claims 1 and 10.
37C.F.R. §41.37(c)(l)(iv).
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SUMMARY
We affirm the rejection claims 1, 8—12, 14—16, and 22—24 under 35
U.S.C. § 103(a) over Vo-Dinh, Lemelson, and Jacoby.
We summarily affirm the rejection of claims 1, 10, 11, 12, 15, and 16
on the ground of nonstatutory-type double patenting over claims 1, 6, 9-11,
13, 15, 19, and 21 ofU.S. Patent No. 8,280,471.
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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