Ex Parte Castillo et al

Board of Patent Appeals and Interferences

Jul 31, 2012

10860829 (B.P.A.I. Jul. 31, 2012)

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.
10/860,829 06/04/2004 Carlos Castillo 04/108 1317
7590 08/01/2012
LEON D. ROSEN
FREILICH, HORNBAKER & ROSEN
Suite 1220
10960 Wilshire Blvd.
Los Angeles, CA 90024
EXAMINER
MARMOR II, CHARLES ALAN
ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
08/01/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CARLOS CASTILLO, MAX HARRY WEIL,
JOE BISERA, and CLAYTON YOUNG
__________

Appeal 2011-006574
Application 10/860,829
Technology Center 3700
__________

Before MELANIE L. McCOLLUM, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
mucosal tissue sensing apparatus, an apparatus for sensing carbon dioxide,
and a method for assessing the condition of a patient by using a carbon
dioxide sensor. The Patent Examiner rejected the claims as failing to
comply with the written description requirement (new matter) and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

Appeal 2011-006574
Application 10/860,829

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STATEMENT OF THE CASE
Claims 1-3, 5, and 16-21 are on appeal.
1
Independent claims 1, 16,
and 17 read as follows:
1. A mucosal tissue sensing apparatus which includes a sensor
arrangement and a holder for holding the sensor arrangement at a mucosal
surface of mucosal tissue in the mouth region of a patient, wherein:
said sensor arrangement includes a sensor with a sensor end, a seal
that has a seal axis, said seal extending 360° around said axis and forming a
hollow microenvironment within said seal, said sensor lying in said
microenvironment, said seal being constructed of a material chosen from the
group of materials that consists of elastomeric and rigid materials;
said seal having a sealing surface that faces generally in a first
direction along said seal axis to seal to the mucosal surface of the patient;
said holder is constructed to apply a spring force that continually
presses said seal and presses said sensor end, firmly toward the mucosal
surface;
said sensor end being positioned to lie against the mucosal surface
within said 360° when said holder presses said seal against the mucosal
surface, to thereby hold the sensor end against a location on the mucosal
surface while sealing the area immediately around the location.

16. Apparatus for sensing CO2 at a mucosal surface of a patient's
mouth, comprising:
a sensor arrangement comprising a CO2 sensor with an end, and a seal
of material chosen from the group that consists of elastomeric and rigid
materials, and said seal extends 360° around said sensor end;
a clasp with first and second end portions that are biased toward each
other, said sensor arrangement mounted on said clasp first end portion;
said clasp first end portion lying in the patient's mouth with said
sensor end pressing against a mucosal surface location on mucosal tissue at
the inside of the patient's mouth, with said seal pressing against an area of

1
Appellants state that they do “not appeal the rejection of claims 20-21.”
(App. Br. 2.) The Examiner states that these claims have not been cancelled
and are, therefore, included in the appeal. (Ans. 7.) Appellants address
these claims in the Reply Brief. (Reply Br. 2.) Therefore, we treat claims
20-21 as part of the appeal.
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the mucosal surface that extends 360° around said mucosal surface location,
and with the clasp second end portion pressing against the outside of the
patient at a location approximately opposite said mucosal surface location.

17. A method for assessing the condition of a patient, by using a CO2
sensor to measure CO2 at a mucosal surface of the mouth region of the
patient, comprising:
mounting the sensor on a first end of a clasp and establishing a seal on
said first end of said clasp with the seal extending 360° around an end
portion of the sensor, and placing said first end of said clasp in the patient's
mouth with the seal lying against and extending 360° around a location on
said mucosal surface where the sensor end lies, said seal being of a material
chosen from the group that consists of elastomeric materials and rigid
materials;
placing an opposite second end of the clasp on the patient at an
outside location opposite said sensor end portion, and biasing said seal and
sensor end portion against the mucosal surface by biasing the clasp second
end against said outside location while the clasp ends remain continually
biased toward each other.

The Examiner rejected the claims as follows:
• claims 17, 18, and 21 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (new matter).
• claims 1-3, 16, 17 and 19-21 under 35 U.S.C. § 103(a) as
unpatentable over Anderson
2
and Meathrel;
3

• claim 5 under 35 U.S.C. § 103(a) as unpatentable over Anderson,
Meathrel, and Isaacson;
4

2
Patent Application Publication No. US 2003/0225324 A1 by Edward J.
Anderson et al., published Dec. 4, 2003.
3
US Patent No. 5,665,477 issued to William G. Meathrel et al., Sep. 9,
1997.
4
US Patent No. 5,800,349 issued to Philip O. Isaacson et al., Sep. 1, 1998.
Appeal 2011-006574
Application 10/860,829

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• claim 18 under 35 U.S.C. § 103(a) as unpatentable over Anderson,
Meathrel, and Weil.
5

NEW MATTER
The Examiner’s position is that the recitation of “rigid materials” in
claims 17, 18, and 21 constitutes new matter because the Specification only
recites that the seal is made of an elastomeric material or a soft resilient
foam. (Ans. 4.) According to the Examiner, this “disclosure is not sufficient
to establish that applicant was in possession of the entire genus of rigid
materials at the time of filing.” (Id.) However, as Appellants have correctly
asserted, the Specification states, “It is possible to use a seal of rigid
material.” (Reply Br. 1)(citing Spec. 6, ll. 6-7.)
Accordingly, we reverse the rejection.

OBVIOUSNESS
I. The Rejection over Anderson and Meathrel
The Examiner’s position is that Anderson disclosed a device including
CO2 sensor with a sensor end and a holder for holding the sensor at the
mucosal surface. (Ans. 4.) The Examiner found that the device further
includes a seal formed either by contact surfaces of the holder or by a
compressible material, i.e., compliant material, e.g., elastomeric material,
surrounding the opening. (Id.) The Examiner also found that the seal seals
the sensor in the mucosal environment of the mouth. (Id.) Additionally, the
Examiner found that Anderson’s holder is “constructed to apply a spring
force that continually presses the seal and presses the sensor end firmly

5
US Patent No. 6,055,447 issued to Max Harry Weil et al., Apr. 25, 2000.
Appeal 2011-006574
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toward the mucosal surface.” (Id. at 5.) However, the Examiner found that
Anderson did not teach a 360° seal. (Id.)
The Examiner found that Meathrel taught a sensor for the same
purpose as Anderson, where the seal/sensor is of a circular design, with the
seal extending 360° around the sensor, creating a hollow microenvironment
and sealing the outside air in order to prevent any inaccuracies in the CO2
and O2 measurement. (Id.) According to the Examiner, it would have been
obvious to a person of ordinary skill in the art at the time the invention was
made to have modified Anderson to change the shape of the sensor/seal, as it
would have been merely the substitution of one known seal for another.
(Id.) The Examiner also found that Anderson taught an embodiment with
the compressible seal wherein the sensor will lie against the mucosal
surface. (Id.)
Further, regarding claim 3, the Examiner found that the seal of the
combined references is doughnut shaped. (Id.) Regarding claim 16, the
Examiner found that Anderson’s device has the recited clasp, e.g., elements
14 and 50 of Figure 8. (Id.) Regarding claim 17, the Examiner found that
the combined references taught the recited method. (Id.) Regarding claim
19, the Examiner found that Anderson disclosed in Figure 6C a plurality of
sensor tips that all lie within the seal and press into the mucosal surface.
(Id.) Regarding claim 20, the Examiner found that the seal of the combined
references retains its shape. Regarding claim 21, the Examiner found that
the seal is elastomeric. (Id.)
Appellants contend that Anderson’s Figure 1A shows that its
“rightward surface… is a downstep that would hold his sensor … away from
the patient’s tissue in most cases.” (App. Br. 4.) Appellants also assert that
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Anderson’s “other figures do not show seal portions at opposite sides of his
sensor.” (Id.) Therefore, according to Appellants, Anderson’s surface “does
not form a 360° seal against a mucosal surface.” (Id. at 4-5.)
We are not persuaded of nonobviousness by Appellants’ assertion that
Anderson’s holder “would hold his sensor [] away from the patient’s tissue
in most cases” (App. Br. 4) as this is attorney argument and not evidence.
Moreover, Anderson’s holder need only be capable of pressing the sensor
firmly toward the mucosal surface in some instance, even if not in “most
cases,” to read on the disputed claim limitation. Nor are we persuaded of
nonobviousness by Appellants’ assertion that Anderson’s surface “does not
form a 360° seal against a mucosal surface” (id. at 4-5) as the Examiner
found that Meathrel provided this teaching. (Ans. 5.)
Regarding Meathrel, Appellants assert that while Meathrel’s adhesive
hydrogel could hold the sensor close to the patient’s surface, “there is no
indication that his adhesive would act like a spring to continually press his
sensor end firmly toward the mucosal surface….” (App. Br. 5.)
This argument is not persuasive, as the Examiner found that
Anderson’s holder, i.e., clip, was constructed to apply a spring force that
continually pressed the seal and sensor end firmly toward the mucosal
surface. (Ans. 5.) Accordingly, we affirm the rejection of claim 1.
Regarding claim 2, Appellants assert that Anderson does not describe
a seal being of elastomeric material and Meathrel’s “hydrogel deforms a lot
from Fig. 1 to Fig. 2, and this appears to be a plastic deformation (that will
not fully recover) rather than an elastic deformation.” (App. Br. 5.)
While we agree with Appellants that Anderson did not use the term
“elastomeric material” when describing its seal, we conclude that the
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Examiner provided sound reasoning supported by the evidence that a skilled
artisan would have found it obvious to use elastomeric material for the seal.
Specifically, the Examiner correctly found that Anderson disclosed using
compressible material to form its seal. (Ans. 4.) The Examiner also
correctly found that Anderson did not disclose (or limit) the type of
compressible material that may be used. (Id.) Additionally, the Examiner
found that elastomeric materials were known compressible materials, and
Appellants have not disputed this finding. Therefore, we agree with the
Examiner that Anderson taught the use of any compressible material, and
that a skilled artisan would have found it obvious to use any known
compressible material, such as elastomeric material. Accordingly, we affirm
the rejection of claim 2.
Regarding claim 3, Appellants assert that Anderson’s surfaces that
engage the tissue do not form a donut and Meathrel’s surface that engages
tissue is “distinctly concave, not donut shaped.” (App. Br. 6.) According to
the Examiner, the combined apparatus of Anderson and Meathrel provide a
seal that has a donut shape because Anderson has a central opening for the
sensor and Meathrel provides a 360° shape. (Ans. 8.) The Specification has
not defined or otherwise limited the definition of the term “donut shaped.”
The seal 20 in Figure 1 of the Specification, described as being donut
shaped, is depicted as having a 360° circular shape with a central opening in
which the sensor is located. (Spec. 5 and Fig. 1.) Similarly, the Examiner’s
combination of Meathrel’s 360° circular seal provides a central opening in
which the sensor is located. . Therefore, we agree with the Examiner, that
the combined prior art yields a donut shaped seal. Accordingly, we affirm
the rejection of claim 3.
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Regarding claim 16, Appellants assert that Anderson did not provide a
360° seal around its sensor and Meathrel provided a hydrogel seal which has
disadvantages. (App. Br. 6.) We are not persuaded by this argument, as the
Examiner’s combination modified Anderson’s sensor to include Meathrel’s
360° seal around it. Accordingly, we affirm claim 16.
Regarding claim 17, Appellants assert that Anderson did not provide a
true 360° seal while Meathrel did not use a seal of solid (non liquid and non
gel) material. (Id. at 7.) We are not persuaded by this argument, as the
Examiner’s combination modified Anderson’s sensor to include Meathrel’s
360° seal, formed of compressible material, as taught by Anderson, wherein
such material was known in the art to include elastomeric material.
Accordingly, we affirm the rejection of claim 17.
Regarding claim 19, Appellants assert that Anderson did not disclose
a plurality of sensor tips pressed against tissue, or a seal that seals 360°
around such plurality of tips. (Id.) Additionally, Appellants assert that
Meathrel’s figures only show a single sensor and the reference used the
adhesively-held hydrogel to keep his sensor close to a surface rather than
pressing against the patient. (Id.)
This argument is not persuasive. The Examiner correctly found that
Anderson disclosed in Figure 6C a plurality of sensor tips that all lie within
the seal, as modified by Meathrel, and would be pressed into the mucosal
surface. (Ans. 5; Anderson Fig 6c and [0035].) Accordingly, we affirm the
rejection of claim 19.
Regarding claims 20 and 21, Appellants assert only that they stand or
fall with claim 1. (Reply Br. 2.) Accordingly, we affirm the rejection of
claims 20 and 21.
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II. The Rejection over Anderson, Meathrel, and Isaacson
The Examiner relied on Anderson and Meathrel as applied to claim 1,
but found that the combination did not teach that the bar is bent in about a
primarily circular 360° loop, as recited in claim 5. (Ans. 6.) However, the
Examiner found that Isaacson disclosed a pulse oximeter sensor, capable of
detecting CO2 and O2 levels in the blood, which can be used on the tongue
tissue or ear of an animal. (Id.) The Examiner also found that Isaacson
taught that its device includes a gripper that is in the form of a bar that is
bent in about a 360° loop and used to keep the measuring device in place.
(Id.) According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to have used
Isaacson’s gripper to hold the sensor in place to keep the sensor in the
desired location while monitoring or measuring biological parameters. (Id.)
Appellants contend that Isaacson’s gripper is formed from a bar that is
bent 180° and not 360°, wherein the first and second end portions of the bar
do not face each other, but instead extend parallel to the patient’s surfaces.
(App. Br. 6; Reply Br. 2.)
We agree with Appellants that Isaacson did not disclose that its bar “is
bent in about a primarily circular 360° loop to form first and second end
portions that face each other,” as required by claim 5. (See Ans. 6, 8;
Isaacson Fig. 9.) Accordingly, we reverse the rejection of claim 5.
III. The Rejection over Anderson, Meathrel, and Weil
The Examiner relied on Anderson and Meathrel as applied to claim
17, but found that the combination did not explicitly teach that the seal and
sensor were placed against a location that lies under the tongue of the
patient, as required by claim 18. (Ans. 6.) However, the Examiner found
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that Weil taught a similar system that takes measurements under the tongue.
(Id.) According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to have modified
the combination for use under the tongue, as it is merely a substitution of
one desired measurement location for another. (Id.)
Appellants contend that Weil’s Figure 12 disclosed a sensor in a
patient’s mouth and a block of rubber 202 to press up the sensor against the
bottom of the tongue, which “is different from a clasp with ends biased
toward each other and which press downward under the tongue (toward the
floor of the mouth).” (App. Br. 7.) However, as the Examiner explained,
Weil is cited in the combination only to show an alternate measurement
location for Anderson. (Ans. 8.) Accordingly, we affirm the rejection of
claim 18.

SUMMARY
We reverse the rejection of claims 17, 18, and 21 under 35 U.S.C. §
112, first paragraph, as failing to comply with the written description
requirement (new matter);
we affirm the rejection of claims 1-3, 16, 17 and 19-21 under 35
U.S.C. § 103(a) as unpatentable over Anderson and Meathrel;
we reverse the rejection of claim 5 under 35 U.S.C. § 103(a) as
unpatentable over Anderson, Meathrel, and Isaacson;
we affirm the rejection of claim 18 under 35 U.S.C. § 103(a) as
unpatentable over Anderson, Meathrel, and Weil.

Appeal 2011-006574
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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-IN-PART

cdc