Ex Parte Harttig

Patent Trials and Appeals Board

Jun 18, 2019

13669952 - (D) (P.T.A.B. Jun. 18, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/669,952 11/06/2012
23690 7590 06/20/2019
ROCHE DIAGNOSTICS OPERATIONS INC.
9115 Hague Road
Indianapolis, IN 46250-0457
FIRST NAMED INVENTOR
Herbert Harttig
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.
26659US-dc 6369
EXAMINER
HOEKSTRA, JEFFREY GERBEN
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
06/20/2019 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):
j ackie.pike@roche.com
pair_roche@firsttofile.com
meg.ward@roche.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HERBERT HARTTIG 1
Appeal 2017-011205
Application 13/669,952
Technology Center 3700
Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant identifies Roche Diabetes Care, Inc. as the real party-in-interest.
App. Br. 2.
Appeal 2017-011205
Application 13/669,952
SUMMARY
Appellant files this Appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1-12 and 17. Specifically, claims 1-2,
4--7, and 9-12 stand rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Boecker et al. (US 2003/0199893 Al,
October 23, 2003) ("Boecker"), Raney et al. (US 2004/0116829 Al, June
17, 2004) ("Raney"), and Davis et al. (US 2007 /0031283 Al, February 8,
2007) ("Davis").
Claim 3 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Boecker, Raney, Davis, and Ditter et
al. (US 5,846,422, December 8, 1998) ("Ditter").
Claim 8 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Boecker, Raney, Davis, and Gofman
et al. (US 2009/0149725 Al, June 11, 2009) ("Gofman").
Claim 17 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Raney and Harman et al. (US
2007/0232956 Al, October 4, 2011) ("Harman").
Claim 17 also stands rejected as unpatentable under 35 U.S.C. §
I03(a) as being obvious over the combination of Raney and Calasso et al.
(US 2007/0016103 Al, January 18, 2007) ("Calasso").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
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Application 13/669,952
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to a lancet magazine which includes
a housing and a plurality of lancets each of which is enclosed in a sterile
chamber of the housing. Abstr.
REPRESENTATIVE CLAIM
Claim 1 is illustrative of the claims on appeal and recites:
1. A lancet magazine, comprising a housing and a plurality
of lancets each of which is enclosed in a sterile chamber of the
housing, wherein the chambers each have a puncturing opening
which is closed with a foil, wherein the lancets comprise a
sample receiving device for receiving body fluid and the
chambers each comprise a further opening which is closed with
a membrane that is permeable to gas and fluid and comprises a
lower side that faces the lancet and serves to receive body fluid
from the sample receiving device and an upper side that serves
to transfer body fluid to a test field arranged on the membrane.
App. Br. 19.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings,
reasoning, and conclusion that Appellant's claims are primafacie obvious
over the combined cited prior art. We address the arguments raised by
Appellant below.
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Application 13/669,952
A. Claims 1-12 i
Issue 1
Appellant argues that the Examiner erred in finding that Boecker
teaches both a "puncturing opening" and a "further opening which is closed
with a membrane that is permeable to gas and fluid," as required by claim 1
App. Br. 7-8.
Analysis
The Examiner finds that Boecker teaches a lancet magazine,
comprising a housing and a plurality of lancets each of which is enclosed in
a sterile chamber of the housing. Final Act. 3 ( citing Boecker ,r,r 84--85,
Figs. 1, 11 ). The Examiner finds that Boecker teaches that chambers each
have a puncturing opening which is closed with a foil, and that the lancets
within each comprise a sample receiving device for receiving body fluid. Id.
(citing Boecker ,r,r 85, 114). The Examiner also finds that the chambers
each comprise a further opening closed by a membrane (barrier 438) and
comprises a lower side that faces the lancet and serves to receive body fluid
from the sample receiving device, in which the sensing elements may be
formed on the top of the penetrating member cartridge, including
electrochemical or optical detection. Id. at 3--4 ( citing Boecker claims 10,
11, ,r,r 109, 169).
Appellant argues that the Examiner relies on barrier 254 or barrier 438
of Boecker as teaching the limitation of claim 1 reciting a: "further opening
2 Appellant argues dependent claims 3 and 8 together with claims 1-2, 4--7,
and 9-12. See App. Br. 7.
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Application 13/669,952
which is closed with a membrane that is permeable to gas and fluid." App.
Br. 8 ( citing Final Act. 3). Appellant contends that each of these
foil/membranes (i.e., items 28, 254, and 438) taught by Boecker are the same
barrier structure pictured in different embodiments of the penetrating
membrane cartridge. Id. Specifically, Appellant argues that barriers 28,
254, and 438 are each essentially the same element of different embodiments
in which each covers the top surface of the penetrating member 18, 262, and
436 respectively. Id. Therefore, Appellant contends, Boecker does not
"teach two separate openings that are each closed with a foil and[,]
separately[,] a membrane as was alleged in the Office Action and as claimed
in claim 1." Id. at 9.
We are not persuaded by Appellant's argument. Figure 18 of Boecker
is reproduced below:
Figure 18 of Boecker depicts an embodiment of a lancing
device having features of the invention
With respect to Figure 18, Boecker teaches:
The penetrating member cartridge 244 has a plurality of
penetrating member slots 252 disposed in a radial configuration
in a top surface 254 a base plate 256 of the penetrating member
cartridge 244. The distal ends 253 of the penetrating member
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slots 252 are disposed at an outer surface 260 of the base plate
256. A fracturable sterility barrier 258, shown partially cut away,
is disposed on the top surface 254 of base plate 256 over the
plurality of penetrating member slots 252. The sterility barrier
258 is also disposed over the outer surface 260 of the base plate
256 in order to seal the penetrating member slots from
contamination prior to a lancing cycle. A distal portion of a
penetrating member 262 is shown extending radially from the
penetrating member cartridge 244 in the direction of a patient's
finger 264.
Boecker ,r 109. Thus each penetrating member slot 252 is sealed from
contamination prior to a lancing cycle by a portion of the sterility barrier
258. Boecker thus expressly teaches a "puncturing opening" 252 covered
with a foil through which a penetrating member passes as it emerges from
the cartridge. The puncturing openings are separated from one another and
each opening is covered with a segment of the sterility barrier 258 which
only is punctured when a lancet in the respective opening is moved forward
past the barrier, thus meeting the claim requirement that "the chambers each
have a puncturing opening which is closed with a foil."
With respect to the "further opening which is closed with a membrane
that is permeable to gas and fluid," the Examiner relies on the combination
of Boecker and Davis. Boecker teaches:
In another embodiment of the present invention, a
manufacturing method provides a cartridge that has a plurality of
cavities at least partially holding a plurality of penetrating
members. The cartridge is sterilized while each of the cavities is
in a sealed condition. Sensors are added to the cavities by
opening cavities in a sterile environment, coupling a sensor layer
to the cartridge that provides the sensors, and resealing the
cavities to maintain a sterile environment.
Boecker ,r 20. More specifically, Boecker teaches:
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Application 13/669,952
In another embodiment as seen in FIG. 72, sensing elements 760
may be directly printed or formed on the top of bottom of the
penetrating member cartridge 700, depending on orientation. The
bare penetrating member 720 is then actuated through a hole 762
in the plastic facing, withdrawn into the radial cavity followed
by the blood sample. Electrochemical or optical detection for
analyte sensing may then be carried out (FIG. 72). Again the
cavity 766 may have a clear portion to allow light to pass for
optical sensing. In one embodiment, a multiplicity of
miniaturized sensor fields may be placed on the floor of the radial
cavity as shown in FIG. 72 or on the microfluidic module shown
in FIG. 71 to allow many tests on a single analyte form a single
drop of blood to improve accuracy and precision of
measurement. Although not limited in this manner, additional
sensor fields or regions may also be included for calibration or
other purposes.
Id. at ,r 169. Figure 72 of Boecker is reproduced below:
!
!/
'
----, I\..___ ____ _
I
,,.,,
------------------------- /L _1 __ ,
V
Figure 72 of Boecker depicts a sample module with still further
embodiments of a cartridge according to the present invention.
Boecker further teaches:
If the cartridge 800 uses a sensor arrangement where the sensors
are on a substrate attached to the bottom of the cartridge, there
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Application 13/669,952
may be through holes (as shown in FIG. 76), wicking elements,
capillary tube or other devices on the cartridge 800 to allow body
fluid to flow from the cartridge to the sensors 808 for analysis.
In other configurations, the sensors 808 may be printed, formed,
or otherwise located directly in the cavities housing the
penetrating members 802 or areas on the cartridge surface that
receive blood after lancing.
Id. at ,I 175.
Boecker thus expressly teaches: "a further opening ... comprising a
lower side that faces the lancet and serves to receive body fluid from the
sample receiving device and an upper side that serves to transfer body fluid
to a test field," as recited in claim 1. However, Boecker does not expressly
teach that the opening is: "closed with a membrane that is permeable to gas
and fluid and comprises a lower side that faces the lancet and serves to
receive body fluid from the sample receiving device and an upper side that
serves to transfer body fluid to a test field arranged on the membrane," as
recited in claim 1.
The Examiner acknowledges that Boecker does not teach: "a further
opening which is closed with a membrane that is permeable to gas and
fluid," as recited in claim 1. Ans. 7. However, the Examiner relies, inter
alia, upon Davis as teaching this limitation, additionally finding that: "Davis
explicitly teaches using filter material with pores sized of 0.2 micrometers to
exclude viruses and later particles, i.e.[,] bacterial." Id. at 9 ( citing Davis
i-fi-fl30, 136, 17, 247-251).
We agree. Davis teaches:
Cartridge 202 can also be operative to detect and/or record events
or environmental conditions relating to sample collection,
including but not limited to the presence of a sample within
cartridge 202, the environment temperature, humidity, exposure
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of the sample to oxygen, and the number of test cartridge-
interfaces.
As illustrated in FIG. 2, cartridge 202 can comprise one or more
interfaces 204 that can align with instrument 100 so that an
analysis of the sample can be performed. Interface 204 can be
provided in various manners consistent with the principles
known in the art. For example, depending on the technique used
by the apparatus, interface 204 can comprise a gas permeable,
liquid permeable membrane, solid membrane, or a mesh area.
Interface 204 can be located at any location on cartridge 202
allowing the apparatus the access to the sample necessary to
perform a test on the sample.
Davis ,r,r 129--130. Davis thus expressly teaches a: "a further opening which
is closed with a membrane that is permeable to gas and fluid," as recited in
claim 1, and that the combination of the cited prior art teaches or suggests
the limitations disputed by Appellant.
Issue 2
teach:
Appellant argues that the Examiner erred because Raney does not
the chambers each comprise a further opening which is closed
with a membrane that is permeable to gas and fluid and
comprises a lower side that faces the lancet and serves to receive
body fluid from the sample receiving device and an upper side
that serves to transfer body fluid to a test field arranged on the
membrane,
as claimed in claim 1. App. Br. 8.
Analysis
We do not find Appellant's argument persuasive because, as we have
explained supra, the Examiner also relies upon Davis as teaching this
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Application 13/669,952
limitation, and we agree with the Examiner's findings, reasoning and
conclusion with respect to the latter. See Final Act. 5; Ans. 9.
Issue 3
Appellant argues that Davis fails to teach the limitation of claim 1
reciting: "the chambers each comprise a further opening which is closed
with a membrane that is permeable to gas and fluid and comprises a lower
side that faces the lancet and serves to receive body fluid from the sample."
App. Br. 10-11.
Analysis
Appellant argues that the Examiner finds that "Davis teaches a
sampling cartridge [202] having a top surface having a sensor interface 204
which can comprises a gas, liquid permeable membrane." App. Br. 11
( quoting Final Act. 5). According to Appellant, in the embodiment taught in
Davis, the interface 204 is designed to interact with an instrument 100 for
sample analysis, and the interface 204 of cartridge 202 is formed such that
the apparatus can interact with a sample without physically contacting it:
"The material forming interface 204 of cartridge 202, which allows the
apparatus to interact with the sample without physically contacting it, can
vary depending on the assay technique employed by instrument 100." Id.
( quoting Davis ,r 23 8). Appellant contends that such a membrane would not
be suitable to transfer body fluid to a test field arranged on the membrane, as
claimed in claim 1. Id.
We are not persuaded. Appellant does not address the teaching of
Davis quoted supra, which expressly teaches that:
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Application 13/669,952
For example, depending on the technique used by the apparatus,
interface 204 can comprise a gas permeable, liquid permeable
membrane, solid membrane, or a mesh area. Interface 204 can be
located at any location on cartridge 202 allowing the apparatus
the access to the sample necessary to perform a test on the
sample.
Davis ,r 130. In this embodiment, Davis expressly teaches the use of a gas
and liquid permeable membrane, as recited in claim 1, at the interface
between the sample and the sensor. "[A]ll disclosures of the prior art,
including unpreferred embodiments, must be considered." In re Lamberti,
545 F.2d 747, 750 (C.C.P.A. 1976).
Issue 4
Appellant contends that a person of ordinary skill in the art would not
have combined the teachings of the cited prior art to arrive at Appellant's
claimed invention. App. Br. 11.
Analysis
Appellant contends that a person of ordinary skill in the art would not
have been compelled to modify Boecker to make
a further opening which is closed with a membrane that is
permeable to gas and fluid and comprises a lower side that faces
the lancet and serves to receive body fluid from the sample
receiving device and an upper side that serves to transfer body
fluid to a test field arranged on the membrane,
as recited in claim 1. App. Br. 12. Appellant contends that Boecker teaches
a lancet magazine comprising chambers that are sealed by a single
sterilization barrier and contain lancets. Id. According to Appellant, one
embodiment of Boecker teaches a sensing element 7 60 can be directly
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Application 13/669,952
printed or formed on the top or bottom of the cartridge 700. Id. (citing
Boecker, ,r 169, Fig. 72). Appellant asserts that the inclusion of sensing
element 7 60 onto the top of the cartridge would require the sensing element
to be in contact with the cavity (i.e., a clear portion for optical sensing, or a
test element for exposure to the substance to be tested. Id.
Appellant argues that Raney could not have been readily combined
with Boecker by a person skilled in the art because the incorporation would
have changed their respective functions. App. Br. 11 ( citing MPEP
§ 2143). According to Appellant, the device in Raney is a "capillary suction
device" for testing blood, in which the test reagent 24 is found within the
device, instead of outside the magazine as claimed, and the purpose of the
absorbent material 23 is simply to wick the test liquid. Id. Appellant
contends that inclusion of such an absorbent material would also serve to
defeat the sterility of the sterile chamber in the housing as also is required in
claim 1. Id. at 11-12. Appellant argues that, although the Examiner finds
that the device of Boecker does not need to be sterile, such a limitation for a
sterile chamber is claimed in claim 1. Id. at 12 (citing (Final Act. 16).
Appellant argues that Davis discloses an assay cartridges 202
comprising a chamber that is closed by a permeable membrane 204. App.
Br. 13. According to Appellant, testing of the sample within the chamber
may be accomplished with a test field within the chamber, or though
connection to an apparatus 100. Id. Appellant contends that, although the
Examiner has stated that the reason to combine Davis is to facilitate the
analysis of collected samples, such an inclusion would at the best not
facilitate, and would most likely hinder, analysis by getting between the
clear window or the test element of Boecker. Id.
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We are not persuaded by Appellant's arguments. We have explained
supra why we conclude that the combination of at least Boecker and Davis
teach or suggest all of the limitations of claim 1. The Examiner finds that
the principle of operation and function of the devices taught by each of the
references is to collect and analyze an analyte in blood. Ans. 12. The
Examiner finds that the proposed combinations are capable of performing
the intended function of collecting and sampling an analyte. Id.
We agree. Appellant's argument against combining the teachings of
Boecker and Davis is that the inclusion of the latter's gas and liquid
membrane between the substrate and chamber of Boecker would at best not
facilitate, and would most likely hinder, analysis by getting between the
clear window or the test element of Boecker. App. Br. 13.
Appellant offers no evidence in support of this argument. Indeed,
Davis neither teaches nor suggests that the inclusion of such a membrane
hinders or otherwise interferes with analysis of a sample between the sensor
and the chamber into which it is drawn. See Davis ,r,r 129-130. Attorney
arguments and conclusory statements that are unsupported by factual
evidence are entitled to little probative value. In re Geisler, 116 F .3d 1465,
1470 (Fed. Cir. 1997). We consequently affirm the Examiner's rejection of
claims 1-12.
B.
Issue
Claim 1 7 over Raney and Harman
Independent claim 1 7 recites:
17. A method comprising:
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Application 13/669,952
transporting a body fluid sample from a lancet on one
side of a membrane to a test field on the other side of the
membrane, the step of transporting comprises:
contacting the lancet having the body fluid sample with
the inner side of the membrane, and
delivering the body fluid sample through the membrane
to the test field by capillary forces;
wherein the membrane is permeable to gas and fluid and
is configured to close an opening of a chamber of a lancet
magazme.
App. Br. 20. Appellant argues that the device of Harman cannot be
combined with the membrane and test field of Raney because it would alter
the intended function of Harman. 3 App. Br. 14.
Analysis
The Examiner finds that Harman teaches, inter alia, a method
comprising: transporting a body fluid sample from a lancet on one side of a
sensor to a test field on the other side of the membrane, the step of
transporting comprises: contacting the lancet having the body fluid sample
with the inner side of the sensing member, and the sensor positioned in an
3 Appellant also asserts that: "all of the teachings of claim 1 7 are not present
in the cited references." App. Br. 14. However, Appellant makes no
argument and adduces no evidence in support of this assertion. We
consequently do not find Appellant's conclusory statement persuasive. See
In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) ("[W]e hold that the
Board reasonably interpreted Rule 41.3 7 to require more substantive
arguments in an appeal brief than a mere recitation of the claim elements
and a naked assertion that the corresponding elements were not found in
the prior art").
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Application 13/669,952
opening of a chamber of a lancet magazine (chamber 24). Final Act. 9
(citing Harman ,r 113, Fig. 2). The Examiner finds Harman also teaches the
use of an optical sensing means. Id. (citing Harman ,r 147).
The Examiner finds that Raney teaches an analyte sensor for a lancet
mechanism comprising a membrane, in which fluid is delivered from one
side of a membrane to a test field on the other side of the membrane
comprising delivering the body fluid sample through the membrane to the
test field by capillary forces. Final Act. 9. The Examiner finds that Raney
teaches that the membrane is permeable to gas and fluid and is configured to
close an opening of a chamber of a lancet magazine (i.e., the absorbent
material transfers fluid to a reagent 24 on a top side of the absorbent
material). Id. (citing Raney ,r 44). The Examiner finds that Raney teaches
that the fluid moves to the test area 18 by, e.g., wicking into an absorbent
material 23, and there contacts the test reagent 24 positioned on top of the
wicking material para 79, the wicking material closing an opening in the
magazine 18. Id. (citing Raney ,r,r 79--84, Figs. 1--4).
The Examiner also points to Roe (2010/0145228 Al, June 10, 2010)
("Roe")4 as teaching the combination of the sensor closing an opening of a
chamber of a lancet magazine. Final Act. 10 ( citing Roe ,r 30, Fig. 7).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to modify the device taught by Harman to include
an optical sensor, as taught by Raney, on the top surface of the cartridge to
4 The instant application was filed on November 6, 2012, and claims,
ultimately, the priority benefit of European Patent Application, EPO
10004776.0, filed May 6, 2010. See Spec. ,r 1. Roe was filed June 10,
2010, and thus does not qualify as prior art to the instant application.
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provide a suitable conventional means for determining a blood analyte
parameter by substituting one suitable sensing means for another. Final Act.
10 (citing Raney ,r,r 13, 80).
We are not persuaded that the Examiner has established a prima facie
case of obvious over the cited prior art with respect to claim 17. Raney
teaches a device in which fluid from a wound caused by a lancet is drawn
into a channel by capillary action and then enters a test chamber, by wicking
into an absorbent material, and then comes in contact with the sensor. See
Raney Figs. 1--4, ,r,r 43--45. Raney does not teach or suggest a: "membrane
[that] is permeable to gas and fluid and is configured to close an opening of
a chamber of a lancet magazine," and we decline to include in that limitation
the "absorbent material" of Raney, because such an absorbent material does
not necessarily have the selectivity (i.e., "permeable to gas and fluid" but
not, presumably, to cells or macromolecules) recited in the limitation.
Furthermore, Harman does not teach or suggest a membrane between
the sensor and the fluid withdrawn from the wound. Because the Examiner
has not shown that the cited prior art teaches or suggests all of the
limitations recited in claim 17, we conclude that the Examiner has not
established a prima facie case of obviousness, and we reverse the rejection.
C. Claim 1 7 over Raney and Calasso
Analysis
We similarly conclude that the Examiner has failed to establish a
prima facie case of obviousness over Raney and Calasso. We have
discussed the relevant teachings of Raney supra. Calasso teaches a:
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[b Jody fluid sampling device comprising a skin-piercing element
having a collection zone for receiving body fluid, and the device
further comprising a fluid receiving means remote spaced apart
from the collection zone so that body fluid in the collection zone
will not contact the fluid receiving means initially .... The fluid
receiving means may have a test zone for performing an
analytical reaction. Fluid sample from the collection zone is
automatically or manually transported to the fluid receiving
means to contact the fluid with the test zone.
Calasso Abstr. However, Calasso contains no teaching or suggestion of a
membrane permeable to gas and liquid separating the sampled fluid from the
sensor surface.
Because the Examiner has not shown that the cited prior art teaches or
suggests all of the limitations recited in claim 17, we conclude that the
Examiner has not established a prima facie case of obviousness, and we
reverse the rejection.
DECISION
The Examiner's rejection of claims 1-12 and 17 under 35 U.S.C.
§ 103(a) is affirmed.
The Examiner's rejection of claim 17 under 35 U.S.C. § 103(a) is
reversed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
17