Ex Parte Shea et al

Board of Patent Appeals and Interferences

Mar 30, 2009

10177376 (B.P.A.I. Mar. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte LAURENCE R. SHEA, DOUGLAS G. SUMMERS,
And RICHARD O. HILSON
____________

Appeal 2009-0378
Application 10/177,376
Technology Center 1700
____________

Decided:1 March 30, 2009
____________

Before CATHERINE Q. TIMM, LINDA M. GAUDETTE, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

ROBERTSON, Administrative Patent Judge.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1-5, 7, 9-16, 34-40, and 47-54.2 (App. Br. 7). We have
jurisdiction pursuant to 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
THE INVENTION
Appellants describe an array assay device having a rigid bottom
surface and a cover, which are sealed to each other by a frangible seal.
(Spec. ¶ [0008]). Appellants state that the device is easy to use, includes
minimal components, prevents drying out of the array, and is capable of
testing multiple arrays without cross-contamination. (Spec. ¶ [0007]).
Claims 1, 4, 13, 15, 36, 47, 51, and 54, reproduced below, are
representative of the subject matter on appeal.
1. A device comprising:

a substrate comprising at least one array;

a rigid bottom surface; and

a cover;

wherein said rigid bottom surface and said cover are
sealed to each other by a frangible seal such that said at least
one array is sealed between said rigid bottom surface and said
cover in a substantially fluid and vapor tight array assay area by

2 Claims 6, 8, 17, 19, 20, 29-33, and 44-46 have been canceled. Claims 18,
21-28, and 41-43 have been withdrawn from consideration. (Appeal Brief
filed November 13, 2007, hereinafter “App. Br.,” 3).
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said frangible seal, wherein said frangible seal separates before
material adjacent to said seal is broken.

4. The device according to claim 1, wherein said at least one
substantially vapor and fluid tight assay area provides an assay
volume ranging from about 10 µl to about 1000 µl.

13. The device according to claim 1, further comprising a
substrate receiving frame.

15. The device according to claim 1, further comprising an
array holder.

36. A method for performing an array assay, said method
comprising:

(a) receiving a device of claim 1 comprising said
substrate having at least one array pre-packaged therein from a
remote site;

(b) performing an array assay using said received device;

(c) removing said pre-packaged substrate from said
device; and

(d) reading said at least one array to obtain a result.

47. The device in claim 1, wherein said frangible seal is easily
broken by applying a force ranging from about 5 newtons/100
mm to about 500 newtons/100 mm.

51. The device according to claim 50, wherein said frangible
seal has a width of about 0.1 mm to about 50 mm.

54. The device according to claim 1, wherein said at least one
array is an addressable array of a plurality of molecular probes.

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THE REJECTIONS
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Constantz 6,149,655 Nov. 21, 2000
Pezzuto US 2002/0187560 A1 Dec. 12, 2002 (May 16, 2002)

There are four grounds of rejection before us on appeal: (1) the
Examiner rejected claims 1-5, 7, 9, 11-16, 34-39, 50, and 54 under 35 U.S.C.
§ 102(e) as being anticipated by Pezzuto; (2) the Examiner rejected claims
10 and 40 under 35 U.S.C. § 103(a) as being unpatentable over Pezzuto
alone or in view of Constantz; (3) the Examiner rejected claims 47-49 under
35 U.S.C. §103(a) as being unpatentable over Pezzuto; and (4) the Examiner
rejected claims 51-53 under 35 U.S.C. §103(a) as being unpatentable over
Pezzuto.3
The Examiner found that Pezzuto discloses a device, where Pezzuto’s
surface 159 corresponds to the recited rigid bottom surface, Pezzuto’s first
layer 155 corresponds to the recited cover, Pezzuto’s second and fourth
layers 156 and 158 correspond to the recited array(s). (Ans. 3). The
Examiner found that Pezzuto’s rupture regions 165A-B in third layer 157
and the adhesives used to hold together Pezzuto’s layers correspond to the
recited frangible seal. (Ans. 3 and 6). The Examiner found that Pezzuto

3 The Examiner fails to list claims 50-54 in the Grounds of Rejection section
of the Answer. However, we view this as harmless error as the Final
Rejection addressed the grounds of rejection of claims 50-54 and both the
Examiner and Appellants clearly addressed the rejections of these claims.
(See Final Rejection, June 15, 2007, 3-4; Examiner’s Answer entered
January 30, 2008, hereinafter “Ans.,” 9; App. Br. 7, 22-27; Reply Brief filed
March 27, 2008, hereinafter “Rep. Br.,” 10-11).
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describes chamber volumes of from 1-100 microliters and specifically
discloses a total chamber volume of 16 microliters. (Ans. 3 and 4).
Regarding claims 13 and 15, the Examiner found that the recited “substrate
receiving frame” and “array holder” were sufficiently broad to read on the
multilayer elements disclosed in Pezzuto. (Ans. 4). For claims 47-49, the
Examiner determined that the amount of force required to rupture the
frangible seal is a result effective variable that would have been within the
ordinary skill in the art. (Ans. 5 and 6).
Appellants contend that Pezzuto does not disclose at least one array
sealed between a rigid bottom surface and a cover, because rather than
teaching an array area bounded circumferentially by a frangible seal,
Pezzuto teaches a first chamber bounded on top by a layer and
circumferentially by another layer. (App. Br. 8, 13-16). Appellants argue
that Pezzuto does not disclose the assay volume recited in claim 4, the
substrate receiving frame of claim 13, or the array holder of claim 15. (App.
Br. 16 and 17). Appellants additionally contend that Pezzuto fails to
disclose the method recited in claim 36, and that the array is an addressable
array of a plurality of molecular probes as recited in claim 54. (App. Br. 19,
20, and 22). For claims 47-49, Appellants contend that Pezzuto does not
teach or suggest the amount of force required in the claims. (App. Br. 29-
31). Appellants argue claims 51-53 would not have been obvious over
Pezzuto. (App. Br. 22-25). Appellants contend that Pezzuto teaches away
from using a frangible seal to seal a rigid bottom surface and a cover
because Pezzuto discloses an intermediate third layer and that rupture
elements are confined to rupture regions of intermediate layers, such that the
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sealing of the top and bottom surfaces are not to be weakened. (App. Br. 26
and 27).

ISSUES
After considering the Appellants’ and the Examiner’s contentions, we
frame the issues on appeal as:
Have Appellants shown that the Examiner reversibly erred in
determining that Pezzuto discloses a substrate comprising at least one array
frangibly sealed between a rigid bottom surface and a cover as recited in
claims 1-3, 5, 7, 9-12, 34, 35, 40, and 50?
Have Appellants shown that the Examiner reversibly erred in finding
that Pezzuto discloses assay volumes within the recited range of claim 4?
Have Appellants shown that the Examiner reversibly erred in finding
that Pezzuto discloses a substrate receiving frame and an array holder as
recited in claims 13-16, 37, and 38?
Have Appellants shown that the Examiner reversibly erred in finding
that Pezzuto discloses removing a pre-packaged substrate from the device as
recited in claim 36?
Have Appellants shown that the Examiner reversibly erred in
determining that the forces recited in claims 47-49 would have been obvious
to one of ordinary skill in the art in view of Pezzuto?
Have Appellants shown that the Examiner reversibly erred in
determining that the frangible seal widths recited in claims 51-53 would
have been obvious to one of ordinary skill in the art in view of Pezzuto?
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Have Appellants shown that the Examiner reversibly erred in finding
that Pezzuto discloses the recited addressable array of a plurality of
molecular probes in claim 54?

FINDINGS OF FACT
The record supports the following findings of fact (FF) by a
preponderance of the evidence.
1. Figure 4 of Appellants’ Specification is reproduced below:

Figure 4 is an exploded view of an array assembly device having: a rigid
bottom surface 1; a cover 3; substrate 110 having an array side 111b;
array positioning area 5; border 20, which forms a frangible seal; array
112; fluid access port 4; and border 22. (¶¶ [0083]-[0085], [0088]).
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2. Appellants’ Specification states:
By frangible seal it is meant a seal that is readily or easily
broken apart or fracturable. In such a frangible seal, the seal
will separate before the material adjacent to the seal is actually
torn, fractured, broken or separated. The frangible seal of the
present invention may be formed by a variety of mechanisms,
including but not limited to applying at least one of thermal
energy, ultrasonic energy, RF energy, and adhesive such as
9425 UPVC double coated film carrier reclosable adhesive and
665 reclosable adhesive, both of which are available from 3M
Corporation.
(Spec. 21, ¶ [0093]).

3. Appellants’ Specification states:
To remove the substrate from the array assay device, the
frangible seal is broken. In certain embodiments, the frangible
seal is broken by the application of manual force provided by
the user. In many embodiments, the user peels back the flexible
cover of the device to break the frangible seal. In other
embodiments, the user may simply grip the rigid bottom surface
or array substrate and the cover and turn them in opposite
directions, such as the rigid bottom surface 1 clockwise and the
cover counter-clockwise. In some embodiments, a mechanical
device such as a knife or the like may be employed to break the
frangible seal.
(Spec. 29, ¶ [00115]).

4. Pezzuto’s Figure 1C is reproduced below;

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Figure 1C is a cross-sectional view of a portion of a microfluidic device
having: first layer 141 along the top of the device; second layer 145;
chamber 146; third layer 150; fourth layer 148; chamber 149; and fifth
layer 152 defining the lower boundary of the second chamber. (¶
[0054]).
5. Pezzuto states:
The first and second chambers 146, 149 are separated by the
third layer 150, in which a rupture region or slit 151 is defined
along the boundary between the two chambers 146, 149. A
fifth layer 152 defines the lower boundary of the second
chamber 149. In a preferred embodiment, the first and fifth
layers 141, 152 are made of a polymeric film, the second layer
145 is made of a double-sided tape, the third layer 150 is made
of single-sided tape with the adhesive facing down, and the
fourth layer 148 is made of single- or double-sided tape.
(¶ [0054]).

6. Pezzuto’s Figure 2A is reproduced below:
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Figure 2A is an exploded perspective view of a five-layer microfluidic
device 160 having: first layer 155; second layer 156; third layer 157;
fourth layer 158; outer layer 159; channels 161A, 161B, 162A, 162B;
inlet ports 163A; outlet ports 163B; chambers 164A-164D and 166A-
166D; and rupture regions 165A, 165B. (¶ [0056]).
7. Pezzuto states:
Various means may be used to seal or bond layers of a device
together, preferably to construct a substantially sealed structure.
For example, adhesives may be used. In one embodiment, one
or more layers of a device may be fabricated from single- or
double-sided adhesive tape, although other methods of adhering
stencil layers may be used.
(¶ [0044]).

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8. Pezzuto states ”[t]he term ‘self-adhesive tape’ as used herein refers
to a material layer or film having an integral adhesive coating on
one or both sides.” (¶ [0037]).
9. Pezzuto discloses substantially rigid substrates. (¶ [0043]).
10. Pezzuto discloses arrays composed of two groups of four chambers
with fluid volumes less than about 2 microliters. (¶ [0055],
[0056]).
11. Pezzuto discloses that microfluidic volumes range from 1-100
microliters. (¶ [0006]).
12. Pezzuto discloses that the sample chambers are prepared from
optically transmissive materials to permit observation or analysis
of the contents. (¶ [0077]).
13. Pezzuto states:
The term “synthesis” as used herein refers to molecular
rearrangement, addition, or subtraction of molecular species,
generally including either chemical or biological
transformation. Biological transformations include
bioanalytical methods for the detection and quantification of
molecular species of interest, also referred to herein as
bioassays or assays.
(¶ [0039]).

PRINCIPLES OF LAW
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).
“A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from following the
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path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant. The degree of teaching away will
of course depend on the particular facts; in general, a reference will teach
away if it suggests that the line of development flowing from the reference’s
disclosure is unlikely to be productive of the result sought by the applicant.”
In re Gurley, 27 F.3d 551, 552-53 (Fed. Cir. 1994). In determining whether
prior art references teach away from the claimed combination, the nature of
the teachings is highly relevant. Id. at 553.

ANALYSIS
Appellants have separated the claims on appeal into fifteen groups.
However, Appellants rely on the same arguments for many of the groups of
claims. Accordingly, regarding the first ground of rejection under 35 U.S.C.
102(e), we will address Groups I (claims 1, 3, 5, 7, 9, 11, and 12)4, II (claim
2), VI (claim 34), VII (claim 35), and XIII (claim 50) together, and confine
our discussion to appealed claim 1, which contains claim limitations
representative of the arguments made by Appellants pursuant to 37 C.F.R. §
41.37(c)(1)(vii) We will also address Groups IV (claims 13 and 14), V
(claims 15 and 16), IX (claim 37), X (claim 38), and XI (claim 39) together.
We will address Groups III (claim 4), VIII (claim 36), and XV (claim 54)
separately as argued by Appellants. Regarding the second, third, and fourth
grounds of rejection under 35 U.S.C. 103(a), we will address claims 10 and

4 Although Appellants group claims 10 and 40 with Group 1, because claims
10 and 40 are rejected under 35 U.S.C. § 103(a), we will address these
claims separately.
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40, and Groups XII (claims 47-49) and XIV (claims 51-53) separately as
argued by Appellants.5

REJECTION OF CLAIMS 1-5, 7, 9, 11-16 34-39, 50, AND 54 UNDER 35
U.S.C § 102(e)
Rejection of Groups I, II, VI, VII, and XIII
Appellants have failed to present sufficient evidence that Pezzuto’s
second and fourth layers 145 and 148 circumferentially bounding chambers
146 and 149 are distinguishable from the recited frangible seal. (See FF 4
and 5). Specifically, Appellants’ Specification states that the frangible seals
may be formed using adhesives. (FF 2). Similarly, Pezzuto discloses that
second and fourth layers 145 and 148, located circumferentially to chambers
146 and 149, are formed from adhesives in the form of a double-sided
adhesive tape, while third layer 150 is made of adhesives in the form of a
single-sided tape. (FF 5). In addition, Appellants describe that a frangible
seal is readily or easily broken, and that a mechanical device such as a knife
may be used to break the frangible seal. (FF 3). Although we agree with
Appellants that the rupture regions in third layer 150 do not correspond to
the recited frangible seal, we agree with the Examiner that the presence of an
additional frangible seal in rupture regions of third layer 150 is not excluded
by the claim language. (See Ans. 7). The Examiner also found that the
adhesives used to bond the layers, such as those present in layers 145 and
148 correspond to the recited frangible seal. Appellants have failed to

5 Only those arguments actually made by Appellants have been considered in
this decision. Arguments which Appellants could have made but chose not
to make have not been considered and are deemed to be waived. See 37
C.F.R. § 41.37 (c)(1)(vii) (2007).
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present any persuasive evidence that second and fourth layers 145 and 148
would not provide a frangible seal as recited in the present claims and
defined in the Specification. Therefore, Appellants have failed to
demonstrate that the recited frangible seal is patentably distinct from the
second, third, and fourth layers of Pezzuto.

Rejection of Group III (Claim 4)
Appellants’ argument that Pezzuto fails to teach the recited assay
volume due to the difficulty in consistently creating droplets having a low
volumetric standard deviation at the low end of Pezzuo’s disclosed 1-100
microliter range is without merit. (App. Br. 16). Claim 4 recites a range of
from about 10 microliters to 1000 microliters. Thus, even if Pezzuto is
interpreted to disclose that the lower end of the 1-100 microliter range
should not be used, the remaining range still falls within Appellants’ recited
range. In addition, the Examiner found that Pezzuto teaches devices having
eight chambers each having a volume of less than about two microliters, or
less than about 16 microliters, which reads on Appellants’ recited range.
(Ans. 3 and 4; FF 10).

Rejection of Groups IV (claims 13 and 14), V (claims 15 and 16), IX
(claim 37), X (claim 38), and XI (claim 39)
The Examiner found that the recited “substrate receiving frame” and
“array holder” were sufficiently broad to read on the multilayer elements
disclosed in Pezzuto, base layer 159 and layers 156, 157, 158. (Ans. 4 and
7; FF 6). However, we agree with Appellants that the “substrate receiving
frame” and “array holder” are recited in the claims and described in the
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Specification as separate additional elements. (Rep. Br. 7). The Examiner
has not identified with any particularity what elements in Pezzuto’s device
correspond to the recited substrate receiving layer and array holder.
Additionally, the ordinary artisan would understand from the Specification
that the “substrate receiving frame” and “array holder” refer to distinct parts
of the device and would not be interpreted as reading on the multilayer
elements as disclosed in Pezzuto. Therefore, we reverse the Examiner’s
decision rejecting claims 13-16 and 37-39.

Rejection of Group VIII (Claim 36)
We agree with Appellants that Pezzuto does not disclose all of the
elements of the recited method. Specifically, Pezzuto does not disclose
“removing said pre-packaged substrate from said device.” As pointed out by
Appellants, Pezzuto discloses that the samples are detected through optically
transmissive windows in the device layers. (Rep. Br. 8; FF 12). The
Examiner fails to identify where Pezzuto discloses the recited step of the
method. Therefore, we reverse the Examiner’s decision rejecting claim 36
as being anticipated by Pezzuto.

Rejection of Group XV (Claim 54)
The Examiner finds that the recited “plurality of molecular probes”
does not provide any further structural limitations to the claims and that
Pezzuto discloses use of the microfluidic device in synthesis methods
requiring molecular probes. (Ans. 9). However, we agree with Appellants
that the portions of Pezzuto relied on by the Examiner do not expressly or
inherently teach an array of a plurality of molecular probes. (Rep. Br. 10;
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FF 13). Therefore, Appellants have demonstrated that the Examiner erred in
finding that Pezzuto anticipates claim 54.

REJECTION OF CLAIMS 10, 40, 47-49, AND 51-53 UNDER 35 U.S.C §
103(a)
Rejection of Group XII (Claims 47-49)
Appellants’ contention that Pezzuto does not teach or suggest the
forces required to rupture the frangible seal recited in the claims is not
persuasive. The Examiner determined that the amount of force has well-
known and expected results of breaking the seal. (Ans. 5-6). Appellants
have failed to provide any persuasive evidence that the amount of force
would not have been a matter of routine experimentation. See In re Kulling,
897 F.2d 1147, 1149-50 (Fed. Cir. 1990). In addition, Appellants have not
provided any persuasive evidence that Pezzuto’s seals would not be broken
through the application of force within Appellants’ recited range. Nor have
Appellants shown that there is any structural difference between the seals
based upon the force limitation.

Rejection of Group XIV (Claims 51-53)
Appellants’ argument that the recited widths of the adhesive layer
would not have been obvious to one of ordinary skill in the art is
unpersuasive. Appellants contend that the differences between Pezzuto’s
device and the claimed device are not merely a change between the claimed
invention and the cited art amounting to a mere scale-up in dimension,
change in spacing, or scale-up of a known process, and, therefore, the
Examiner’s reliance on In re Rose, 220 F.2d 459 (CCPA 1955) and Gardner
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v. TEC Systems, Inc., 725 F.2d 1338 (Fed. Cir. 1984) is inappropriate. (App.
Br. 23-25). Appellants also contend that Pezzuto teaches away from using a
frangible seal to seal a rigid bottom and a cover, because Pezzuto discloses
that discrete chambers are physically separated by a third layer containing a
rupture region. (App. Br. 26).
The Examiner contends that the selection of the widths of Pezzuto’s
adhesive layers to achieve the known and expected results of adhesion
would have been within the level of skill of the ordinary artisan. (Ans. 9).
As discussed above, Pezzuto discloses adhesives used to seal the layers that
are not distinguishable from the recited frangible seals. Thus, we agree with
the Examiner that selection of the width of the adhesive applied in Pezzuto
would have been within the skill level of the ordinary artisan. In addition,
Appellants have not provided any persuasive evidence that the adhesives
used in Pezzuto would have been applied in widths not encompassed by the
presently recited ranges. Further, Pezzuto’s recitation of a third layer or
silence regarding the frangible nature of the adhesives does not amount to a
teaching away, where the recited frangible seal is not patentably distinct
from the adhesives used in Pezzuto’s second, third, and fourth layers.

Rejection of Claims 10 and 40
Appellants contend that claims 10 and 40 would not have been
obvious due to the alleged deficiencies of Pezzuto as argued with respect to
claim 1 and because Pezzuto teaches away from the use of a frangible seal as
argued with respect to claims 51-53. (App. Br. 27-28). We do not find
Appellants’ arguments persuasive for the reasons discussed above.

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CONCLUSION
Appellants have failed to show that the Examiner reversibly erred in
determining that Pezzuto discloses a substrate comprising at least one array
frangibly sealed between a rigid bottom surface and a cover as recited in
claims 1-3, 5, 7, 9-12, 34, 35, 40, and 50.
Appellants have failed to show that the Examiner reversibly erred in
determining that the forces recited in claims 47-49 would have been obvious
to one of ordinary skill in the art in view of Pezzuto.
Appellants have failed to show that the Examiner reversibly erred in
determining that the frangible seal widths recited in claims 51-53 would
have been obvious to one of ordinary skill in the art in view of Pezzuto.
Appellants have failed to show that the Examiner reversibly erred in
finding that Pezzuto discloses assay volumes within the recited range of
claim 4.
Appellants have shown that the Examiner reversibly erred in finding
that Pezzuto discloses a substrate receiving frame and an array holder as
recited in claims 13-16 and 37-39.
Appellants have shown that the Examiner reversibly erred in finding
that Pezzuto discloses removing a pre-packaged substrate from the device as
recited in claim 36.
Appellants have shown that the Examiner reversibly erred in finding
that Pezzuto discloses the recited addressable array of a plurality of
molecular probes in claim 54.

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ORDER
We affirm the Examiner’s decision rejecting claims 1-5, 7, 9, 11, 12,
34, 35, and 50 under 35 U.S.C. § 102(e) as being anticipated by Pezzuto.
We affirm the Examiner’s decision rejecting claims 10 and 40 under
35 U.S.C. § 103(a) as being unpatentable over Pezzuto alone or in view of
Constantz.
We affirm the Examiner’s decision rejecting claims 47-49 under 35
U.S.C. § 103(a) as being unpatentable over Pezzuto.
We affirm the Examiner’s decision rejecting claims 51-53 under 35
U.S.C. §103(a) as being unpatentable over Pezzuto.
We reverse the Examiner’s decision rejecting claims 13-16, 36-39,
and 54 under 35 U.S.C. § 102(e) as being anticipated by Pezzuto.

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)(v).
AFFIRMED-IN-PART

PL initial:
sld

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GORDON STEWART
AGILENT TECHNOLOGIES, INC.
LEGAL DEPARTMENT, DL429
P.O. BOX 7599
LOVELAND, CO 80537-0599