Ex Parte Sellappan et al

Patent Trial and Appeal Board

Jul 28, 2017

13537267 (P.T.A.B. Jul. 28, 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.
13/537,267 06/29/2012 SUBRAMANI SELLAPPAN 218695-30004 4522
69139 7590
LOEB & LOEB, LLP
321 NORTH CLARK
SUITE 2300
CHICAGO, IL 60654-4746
EXAMINER
BERKE-SCHLESSEL, DAVID W
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
08/01/2017 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):
CHPATENT @LOEB .COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SUBRAMANI SELLAPPAN, ANDREW HEARN, and
SALVATORE SEMINARA
Appeal 2015-003670
Application 13/537,2671
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
DAVID COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of detecting microorgainsms in a sample. The Examiner rejected the claims
on appeal as obvious under 35 U.S.C. § 103(a).
We reverse.
STATEMENT OF THE CASE
The Specification discloses that manufacturers of chemical, cosmetic,
personal care, pharmaceutical, and consumable products “must test the
1 According to Appellants, the real party in interest is Celsis International
Limited. App. Br. 4.
Appeal 2015-003670
Application 13/537,267
products for any contamination with incoming raw materials during the
manufacturing process and prior to shipping the finished products to
wholesale and/or retail and pharmacy outlets for sale.” Spec. 13. “The time
required to hold the products while testing for contaminants is known as
‘micro-hold time,’ and can cause companies to accrue significant costs.” Id.
Accordingly, “[a]ny method that simplifies, accelerates the means of
contamination detection, or increases its sensitivity would interest
manufacturers.” Id.
The Specification teaches that “most ‘rapid detection’ methods for
determining the presence or absence of microorganisms in chemical,
cosmetic, personal care, pharmaceutical, and consumable products can take
up to 24 hours, or even longer.” Id. 17. Therefore, “[a] need exists for
more rapid methods of detecting microorganisms that can be completed in
less than 8 hours, e.g., about 6 hours to about 8 hours, and decrease the so-
called micro-hold time are needed.” Id. There is also a need for “rapid
methods that greatly reduce any factors that might inhibit the detection of
microorganisms, yet increase overall detection sensitivity.” Id.
The Specification asserts: “the present devices, systems, and methods fulfill
the need for rapid, easy-to-perform methods of separating, amplifying, and
detecting microorganisms in a shorter time period than previously
achievable using conventional methods.” Id. 114.
Claims 1,2, 19, and 21—24 are on appeal. Claim 1 is illustrative of
the rejected subject matter and reads as follows (emphasis added to highlight
the disputed limitation):
1. A method of detecting microorganisms in a sample
containing microorganisms, comprising:
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a) filtering the sample through a pre-filter for allowing
microorganisms to flow through;
b) filtering the pre-filter filtrate through a capture filter in
a filtration device;
c) culturing the microorganisms retained on the capture
filter in the filtration device;
d) lysing the cultured microorganisms with extractant in
combination with adenosine diphosphate;
e) filtering the lysed microorganisms through the capture
filter;
f) adding luciferin and luciferase to react with the lysed
microorganism filtrate to produce a light; and
g) detecting the light from the reaction using a
luminometer, which indicates the presence of microorganisms
in the sample.
App. Br. 37.
The Examiner rejected claims 1,2, 19, and 21—24 under 35 U.S.C.
§ 103(a) as obvious over the combination of Squirrell,2 Roscoe,3 and
Banada.4
ANALYSIS
Appellants argue claims 1,2, 19, and 21—24 together. We designate
claim 1 as representative.
In rejecting claim 1 as obvious, the Examiner found that Squirrell
disclosed “a method for detecting the presence and/or [ajmount of
microorganisms by adding ADP to a sample suspected of containing
microorganisms and/or their intracellular material, and determining the
amount of adenosine triphosphate (ATP) generated by adenylate kinase
2 Squirrell, US Patent No. 5,648,232, issued July 15, 1997 (“Squirrell”).
3 Roscoe et al., US Patent Publication No. 2011/0143334 Al, published June
16, 2011 (“Roscoe”).
4 Banada et al., Highly Sensitive Detection of Staphylococcus Aureus
Directly from Patient Blood, 7(2) 1—7 PLoS ONE (2012) (“Banada”).
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present by using a bioluminescent assay involving luciferase and luciferin.”
Ans. 4. The Examiner also found that Squirrell disclosed lysing the cell
structure using a detergent or other mechanical or enzymatic means, adding
luciferase and luciferin agents to the lysed sample, and measuring the
amount of light emitted by the lysed sample. Id. at 5. This disclosure
generally meets the limitations d) through g) of claim 1. The Examiner
acknowledged, however, that Squirrell “does not explicitly teach to use a
filter to capture the microorganisms and a pre-filter to reduce the risk of
filter clogging. Neither does Squirrell teach to culture the captured
microorganisms on the filter.” Id. Thus, the Examiner found that Squirell
does not disclose the limitations a) through c) of the claim.
The Examiner found that Roscoe disclosed a method for detecting the
presence of a microorganism comprising the steps of “passing [a] liquid
sample through a surface filter, placing the surface filter into contact with a
culture device, incubating the culture device for a period of time and
detecting the presence of a target microorganism.” Id. The Examiner noted
that Roscoe also taught that “[a]fter collecting the sample on the membrane
filter, the filter can be transferred to a culture device.” Id. at 6. Thus, the
Examiner found that the steps of claim 1 not described in Squirrell were
disclosed by Roscoe.
Based on the combined teachings of Squirrell and Roscoe, the
Examiner concluded:
It would have been obvious to modify the luminescent
microorganism detection method of Squirrell with the
microorganism filter-collection and cultivation method of
Roscoe because it has been suggested by Roscoe et al, that
when a small number of microorganisms are collected and
multiplied the detection limit for microorganisms is increased.
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Therefore, it would have been obvious to one of the ordinary
skill in the art at the time the invention was made, to combine
the teaching of Squirrell with that by Roscoe et al to capture
and culture microorganisms on a filter and then detect the
microorganisms with a luminescent assay for ATP produced.
Id. at 7.
With respect to the claimed pre-filter step b), the Examiner found that
Banada disclosed “the isolation of bacteria from blood samples by capture of
the bacteria on a secondary capture filter, followed by lysis and filtration of
the bacteria to produce a bacterial lysate filtrate from the microorganisms to
be detected.” Id. at 9. The Examiner concluded:
It would have been obvious for one practiced in the art to
produce a bacterial lysate filtrate according to the teachings of
Banada et al. and combine those with the disclosures of
Squirrell to utilize the indigenous bacterial adenylate kinase by
adding ADP and detecting and measuring the generated ATP
using luciferin-luciferase and luminescence detection.
Id. at 9.
Appellants argue, inter alia, that none of the references disclose
culturing in a filtration device and that the only reference that teaches
culturing at all — Roscoe — discloses culturing only after transferring the
filter to a culture device. App. Br. 24.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
“[T]he examiner bears the initial burden ... of presenting a prima facie case
of unpatentability.” Appellants have persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
Paragraph 32 of Roscoe states:
The target microorganisms can be collected on a membrane
filter by transferring a liquid or solid sample onto the surface of
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the filter or by filtering a liquid sample through the membrane
filter. After collecting the sample on the membrane filter, the
filter can be transferred to a culture device.
Roscoe 132. As an initial matter, we note that Roscoe’s “membrane filter”
is not a “filtration device” as that term is used in the claims. Accordingly,
Roscoe’s disclosure of culturing microorganisms on the “membrane filter”
after the filter has been transferred to a “culturing device” does not
constitute “culturing the microorganisms ... in the filtration device” as
required by the present claims. This is because the claims, as interpreted
through the lens of the Specification, make clear that the “filtration device”
is a structure that contains filters, not the filters themselves.
Specifically, the claims distinguish between a “capture filter” and the
“filtration device.” Per the claim language, the “capture filter” is something
that is “in a filtration device,” and thus the capture filter is not, itself, the
“filtration device.”5 This is consistent with how the “filter device” is
described in the Specification, which states:
The filters of the subject methods, devices, and systems can be
arranged in a filtration device. A preferred filtration device
includes: a) a vessel for receiving a sample potentially
containing microorganisms; b) a pre-filter for allowing the
passage of microorganisms; c) a capture filter for retaining
microorganisms; d) an outlet; and e) a fluid retention element.
The vessel is operably connected to the pre-filter, which is
operably connected to the capture filter, which is operably
connected to an outlet through which filtrate flows.
5 The Specification defines the “capture filter” as a filter that retains
microorganisms. See, Spec. 19 (“the filter retains the microorganisms, also
known as a capture filter”); id. 177 (“[t]he filter that retains
microorganisms, or 'capture filter'”).
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Spec. 1 59; see also, id. 1 60 (“The filtration device may be in the form of a
syringe utilized in the upright position, where the barrel forms the vessel for
receiving a sample potentially containing contaminating microorganisms.
Accordingly, the vessel is operably connected to a pre-filter, which is
operably connected to a capture filter that retains microorganisms, which is
operably connected to an outlet from which liquids (e.g., sample, media,
buffers, reagents) may pass.”); id. 113 (“The components of the filtration
device in the kit may be provided in an operably connected configuration,
where the vessel is connected to the pre-filter, and which is connected to the
filter or as separate components for the user to set up prior to use.”); and id.
122 (“In one embodiment the method of separating microorganisms from a
sample utilizes a filtration device comprising a series of filters with
decreasing pore sizes.”). Accordingly, we do not consider a filter, by itself,
and without supporting and/or containing structure to be a “filtration
device.”
We turn now to the Examiner’s basis for finding that the cited art
suggests culturing microorganisms “in the filtration device” as required by
the claims. The Examiner cites Roscoe’s definition of a “culturing device”
as a “device that is used to propagate microorganisms under conditions that
will permit at least one cell division to occur” and asserts, “[pjurely based
upon this definition, one of ordinary skill in the art could envision the
‘filtering device’ and the ‘culturing device’ to be the same ‘device.’” Ans.
8. The Examiner similarly cites Roscoe’s teaching that the “culturing
device” can include “a porous support, like glass fiber filters and paper
filters” and asserts “it would be reasonable to suggest that the syringe filters
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taught by Roscoe, having a glass fiber filter, could simultaneously be used as
the ‘filtering device’ and the ‘culturing device.’” Id. at 9.
While we do not disagree with the Examiner that Roscoe’s culturing
device could be used as a filtering device, Roscoe does not use them as such.
Rather, Roscoe describes the filtration step as occurring in a separate and
distinct location. See, e.g., Roscoe 135 (“After the liquid sample has passed
through the membrane filter, the membrane filter can be removed from the
filtration unit and transferred to a culture device”). After filtering, Roscoe
describes removing the filter alone and transferring to a culture device where
bacterial culture is accomplished. Id. Thus, the bacteria are not cultured “on
the capture filter in the filtration device” as required by claim 1. As Roscoe
does not disclose using the culture device as a filter (or vice versa), the
Examiner must articulate some reason for doing so. Here, the Examiner
simply asserts that culturing in the filtering device is “nothing more than an
obvious variant of the culturing method explicitly described by Roscoe.”
Ans. 11. This is not sufficient. See, In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006) (explaining that “rejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness”). Because the Examiner has not carried the
initial burden of presenting a prima facie case of unpatentability, we reverse
the Examiner’s rejection of claims 1, 2, 19, and 21—24 as obvious.
SUMMARY
For these reasons and those set forth in the Examiner's Answer, the
Examiner’s decision to reject claims 1, 2, 19, and 21—24 as under 35 U.S.C.
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§ 103(a) as obvious over the combination of Squirrell, Roscoe, and Banada
over 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).
REVERSED
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