Ex Parte Setty et al

Patent Trial and Appeal Board

Feb 16, 2017

12931746 (P.T.A.B. Feb. 16, 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.
12/931,746 02/09/2011 Harsha Setty CEMP0173PUSP 9770
22045 7590 02/21/2017
RROOKS KTTSHMAN P C EXAMINER
1000 TOWN CENTER BOLER, RYNAE E
TWENTY-SECOND FLOOR
SOUTHFIELD, MI 48075 ART UNIT PAPER NUMBER
3779
NOTIFICATION DATE DELIVERY MODE
02/21/2017 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):
docketing @brookskushman.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HARSHA SETTY, RICHARD SCHWARTZ, and
JOHN SCHWARTS
Appeal 2014-009375
Application 12/931,746
Technology Center 3700
Before MICHELLE R. OSINSKI, BEVERLY M. BUNTING, and
GORDON D. KINDER, Administrative Patent Judges.
OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Harsha Setty et al. (Appellants)1 appeal under 35U.S.C. § 134 from
the Examiner’s final decision rejecting claims 1—6 and 10—39, which are all
of the pending claims. An oral hearing was held on January 17, 2017.2 We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify AI Medical Devices, Inc. as the real party in interest.
Appeal Br. 3.
2 The record includes a transcript of the oral hearing (“Tr.”).
Appeal 2014-009375
Application 12/931,746
THE CLAIMED SUBJECT MATTER
Claims 1 and 3 8 are the independent claims on appeal. Claim 1 is
reproduced below and is illustrative of the claimed subject matter on appeal.
1, An endotracheal intubation device comprising:
(a) a channel element having a proximal end and a distal
end, the channel element comprising
(i) a rigid channel portion at the proximal end of the
channel element and
(ii) a curveable channel portion at the distal end of
the channel element, the curveable channel portion being
operatively connected to the rigid channel portion,
wherein the rigid channel portion and the curveable
channel portion together define a first channel that (A)
extends from the proximal end to the distal end and (B)
defines a centerline direction between the proximal end
and the distal end;
(b) a control wire or push rod extending through the first
channel between the proximal end and the distal end, the control
wire or push rod being operatively connected to the curveable
channel portion to cause the intubation device to move between
a relaxed position and a curved position; and
(c) a removable flexible sheath encasing the channel
element and having integrally formed retaining surfaces that
define a second channel adjacent the first channel and extending
in the centerline direction along at least a segment of the rigid
channel portion and at least a segment of the curveable channel
portion;
wherein:
(i) the curveable channel portion and the second channel
are together continuously and reversibly moveable between the
relaxed position and the curved position upon actuation of the
control wire or push rod; and
(ii) the second channel (A) exerts a retaining force on an
endotracheal tube when present in the second channel and the
second channel is in the curved position and (B) relaxes the
retaining force to release the endotracheal tube as the second
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Application 12/931,746
channel moves from the curved position toward the relaxed
position,
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Sosnowski US 4,911,148 Mar. 27, 1990
Opie US RE 34,110 Oct. 27, 1992
Ishikawa US 6,071,233 June 6, 2000
Matsuura US 6,450,948 B1 Sept. 17, 2002
Yokota US 2007/0106121 A1 May 10, 2007
Schwartz US 2008/0200761 A1 Aug. 21,2008
Totz US 2009/0125002 A1 May 14, 2009
Padget US 7,553,275 B2 June 30, 2009
Matsumoto US 7,766,819 B2 Aug. 3, 2010
REJECTIONS3
I. Claims 1, 17—21, 23—26, 31, and 33 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Sosnowski and Totz. Final Act. 5—9.
II. Claims 2—5, 10, and 11 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Sosnowski, Totz, and Matsumoto. Id. at 9-11.
III. Claim 6 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
Sosnowski, Totz, Matsumoto, and Padget. Id. at 11—12.
IV. Claims 12—16 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Sosnowski, Totz, Matsumoto, and Opie. Id. at 12—15.
3 The rejection of claims 1—42 under 35 U.S.C. § 112(b) or 35 U.S.C. § 112
(pre-AIA), second paragraph, as being indefinite (Final Act. 2—3) has been
withdrawn and is not before us on appeal. See Adv. Act. 2 (Apr. 23, 2014).
The rejection of claims 40-42 under pre-AIA 35 U.S.C. § 102(b) as being
anticipated by Sosnowski (Final Act. 3 4) is not before us on appeal due to
the cancellation of claims 40-42 by Appellants. See Amendment and
Response to Final Act. 10 (Feb. 18, 2014).
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Application 12/931,746
V. Claim 22 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Sosnowski, Totz, and Ishikawa. Id. at 15—16.
VI. Claim 27 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Sosnowski, Totz, and Matsuura. Id. at 16.
VII. Claims 28—32, 34, and 35 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Sosnowski, Totz, and Yokota. Id. at 17—18.
VIII. Claims 36—39 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Sosnowski, Totz, and Schwartz. Id. at 18—20.
OPINION
Rejection I
Appellants argue claims 1, 17—21, 23—26, 31, and 33 as a group.
Appeal Br. 7. We select claim 1 as the representative claim, and claims
17—21, 23—26, 31, and 33 stand or fall therewith. 37 C.F.R.
§ 41.37(c)(l)(iv)(2014).
The Examiner finds that Sosnowski teaches an endotracheal
intubation device 1, 3 meeting all of the structural and functional limitations
of claim 1, except for those relating to the removable flexible sheath. Final
Act. 5 (citing Sosnowski, 3:40-68, 4:1—68, Figs. 1—5). The Examiner turns
to Totz to remedy this deficiency, finding that Totz teaches:
removable flexible sheath 906 ... encasing an analogous channel
element 912 and having integrally formed retaining surfaces
906a, 906e that define a second channel 906h adjacent an
analogous first channel 905 via 912 and capable of extending in
a centerline direction along at least a segment of an analogous
rigid channel portion and at least a segment of an analogous
curvable channel portion.
Id. at 7 (citing Totz, Figs. 9A, 23 A, 23B). The Examiner concludes that it
would have been obvious to a person of ordinary skill in the art to:
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Application 12/931,746
provide[] the distal end of the rigid portion 34 and the curvable
channel portion 24 of Sosnowski with the removable flexible
sheath 906 as taught by Totz ... to permit removable attachment
of the channel element [of Sosnowski] and an endotracheal tube
to one another such that the channel element could easily and
efficiently be attached ... to endotracheal tubes.
Id. at 8. Additionally, the Examiner suggests that the removable flexible
sheath of Totz could be provided on Sosnowski’s device for easy and
efficient attachment of Sosnowski’s device to “other instruments of various
sizes.” Id.
As to curveable channel portion 24 at distal end 5 of Sosnowski’s
device and second channel 906h defined by retaining surfaces of Totz’s
device being “together continuously and reversibly moveable between the
relaxed position and the curved positi on upon actuation of the control wire
or push rod,” as claimed (Appeal Br. 12 (Claims App,)), the Examiner
reasons that Totz’s device “moves together with [Sosnowski’s] curvable
channel portion [24 at distal end] 5” “since [Totz’s] sheath [906] is attached
to the curvable channel portion” and “sheath 906 has resilience and
flexibility due to its material.” Final Act. 9.
As to the second channel “exert jingi a retaining force on an
endotracheal tube when present in the second channel and the second
channel Is in the curved position,” as claimed (Appeal Br. 12 (Claims
App.)), the Examiner points to the resilience and flexibil ity of the material of
sheath 906 and reasons that second channel 906h of Totz’s sheath 906 will
“exert[] retaining forces onto the endotracheal tube 101 as the curvable
portion [24 at distal end 5 of Sosnowski’s device] is bent and curved as
shown in [F]ig. IE, because . . . endotracheal tube 101 will bend therewith
and the inner surfaces of. . . second channel 906h will exert forces on the
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outer circumferential surface of. . . tube 101.” Final Act. 9. As to the
second channel “relaxing] the retaining force to release the endotracheal
tube as the second channel [9Q6h of Totz’s sheath 906] moves from the
curved position toward the relaxed position,” as claimed (Appeal Br. 12
(Clai ms App.)), the Exami ner points to the resilience and flexibility of the
material of sheath 906 and reasons that the exerted forces will be released
“when . . . curvable portion [24 at distal end 5 of Sosnowski’s device] along
with . . . second channel 906h [of Totz’s sheath 906] are straightened in the
relaxed position.” Final Act. 9.
Appellants argue that Sosnowski fails to disclose an endotracheal
intubation device in that Sosnowski discloses endoscopes “designed and
intended for use in viewing body organs through interior body cavities, tubes
or conduits, and not: for intubation,” Appeal Br. 8. We review' this argument
in light of the established rule that claims directed to an apparatus must be
distinguished from the prior art in terms of structure rather than function,
provided the structure is capable of performing the function. See In re
Schreiber, 128 F.3d 1473, 1477—78 (Fed. Cir. 1997) (holding that a funnel
disclosed for oil dispensing anticipated a claim to a funnel-like structure
employed for dispensing popcorn and that applicant had the burden to
provide that the prior art funnel was not capable of dispensing popcorn once
the Examiner established a similarity in structure) and Hewlett-Packard Co.
v. Bausch &Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (“[Apparatus
claims cover what a device is, not what a device does.”).
The Examiner finds that “there is no structural distinction between the
recited claim limitations of claim 1 and the cited prior art reference of
Sosnowski.” Ans. 21. The Examiner finds that Sosnowski’s device 1
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“having channel element 4,[]5 is fully capable of being inserted in a mouth
of a patient for applications in the trachea and the lungs for the purpose of
intubating a patient.” Id. at 20. In particular the Examiner points to
Sosnowski’s disclosure that “[ejndoscopes are used in various medical and
industrial applications for viewing unaccessible interior features of cavities,
tubes or conduits, such as body organs.” Id. at 21 (citing Sosnowski,
1:10-12).4
The Examiner had a sufficient basis for finding Sosnowski’s
endoscope to be capable of applications in the trachea for the purpose of
intubating a patient, and thus, capable of being an endotracheal intubation
device, based on the identified structural similarity of Sosnowski’s
4 The Examiner also points to Sosnowski’s disclosure that its endoscope has
working channel port 7 that “is configured for allowing connection of
syringes and other tubing adapters thereto” so as to make it “fully capable of
receiving a tubing for the purpose of endotracheal intubation” and “fully
capable of passing air and/or gas therethrough, which makes it ideal for
applications in the trachea and the lungs.” Ans. 21 (citing Sosnowski 3:64—
68, 4:1—3). To the extent Appellants may disagree and assert that
Sosnowski’s device alone is not capable of receiving and housing an
intubation tube (see, e.g., Tr. 5:16—21, 10:12—17; Reply Br. 4), we do not
find it necessary for the Examiner to make such a finding in order to
establish that Sosnowski is capable of functioning as an endotracheal
intubation device. Rather, we find it sufficient for the Examiner to find that
Sosnowski’s device is capable of applications in the trachea for the purpose
of intubating a patient (see Ans. 20) by virtue of it being a device capable of
assisting in controlling the curve of an endotracheal tube in an intubation
procedure. This is because an endotracheal intubation device is separate
from an endotracheal tube itself, but is merely able to control the curve of an
endotracheal tube (see Spec. 12 (“The disclosure relates to endotracheal
intubation devices, particularly to endotracheal intubation devices having an
improved means for curving the distal end and guiding of an endotracheal
tube inserted into a patient”) and Tr. 7:22—8:4 (explaining that the
endotracheal intubation device is separate from the endotracheal tube)).
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Application 12/931,746
endoscope to the claimed apparatus. In particular, the Examiner pointed to
Sosnowski having rigid channel portion 34, curveable channel portion 24,
and control wire or push rod 33 extending through a channel defined by rigid
channel portion 34 and curveable channel portion 24. Final Act. 3
(correlating elements of Sosnowski to the claim language).
Appellants have not provided sufficient reasoning or evidence to
overcome the Examiner’s finding that Sosnowski’s endoscope is capable of
performing the claimed functional limitation of serving as an endotracheal
intubation device (that is, capable of curving its distal end and guiding a
corresponding separate endotracheal tube, such as with the use of sheath to
receive both Sosnowski’s device and an endotracheal tube). See Schreiber,
128 F.3d at 1478 (where Patent Office has a reason to believe that a
functional feature is an inherent characteristic of the prior art, the burden can
be shifted to an applicant to show that the prior art structure is not capable of
performing the claimed function.”).
Appellants contend that providing an instrument having an extremely
small diameter like 0.15 inches or less “is incompatible with endotracheal
intubation,” where the diameters of intubation tubes range from about 0.4 to
about 0.5 inches for adults. Reply Br. 2.5 Such a conclusory statement
without accompanying evidence is unpersuasive. See In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974) (An “[ajttomey’s arguments in a brief cannot
take the place of evidence). Appellants’ contention is attorney’s argument,
not persuasive evidence that Sosnowski’s endoscope is incompatible with
endotracheal intubation. Indeed, Appellants have not identified any
5 We note that Appellants indicate that the smallest endotracheal tube is
about 0.13 inches for a 0.7 kg to 1.0 kg infant. Reply Br. 5.
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Application 12/931,746
difference in structure between the elements of the claimed endotracheal
intubation device that the Examiner found were disclosed in Sosnowski
(e.g., a rigid channel portion, a curveable channel portion, and a control wire
or push rod) and Sosnowski’s endoscope, apart from a possible difference in
size. To the extent Appellants are arguing that Sosnowski’s channel 22 is
too small to accommodate an intubation tube (Reply Br. 4—5), we note that
the Examiner’s rejection is based on Totz’s channel 906h, not Sosnowski’s
channel 22, being capable of receiving an endotracheal or intubation tube.
Ans. 23-24.
To the extent Appellants are arguing that the second channel would
not be capable of the functional limitations of exerting a retaining force on
an endotracheal tube when the second channel is curved and would not be
capable of relaxing the retaining force to release the endotracheal tube as the
second channel is relaxed, Appellants limit this argument in the briefs to the
fact that “[s]uch requirements cannot be met if the endotracheal tube is
located in the completely enclosed channel 22 of Sosnowski.” Reply Br. 5.
As explained above, the Examiner’s rejection is based on Totz’s channel
906h of Totz’s sheath 906 being capable of receiving an endotracheal tube,
not Sosnowski’s channel 22 being capable of doing so. See Ans. 23—24.
Appellants have not persuasively explained in the briefs why second channel
906h of Totz’s sheath 906 would not be capable of exerting a retaining force
on an endotracheal tube when second channel 906h is curved and,
conversely, relaxing the retaining force to release the endotracheal tube
when second channel 906h is relaxed.
Appellants’ representative at the oral hearing advanced a new
argument that had not been presented to the Examiner in the Appeal Brief or
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Reply Brief. In particular, Appellants’ representative argued that Totz’s
sheath 906 would not be capable of such functions because it is “just a static
clip . . . put on one discrete element at the end . . . [and] [i]t doesn’t go any
length” (Tr. 14:12—14) and it doesn’t “encase enough to allow for that
frictional force to move between those elements [of the endotracheal tube
and the sheath]” (Tr. 15:18—20). See also Tr. 16:19-17:1. As the argument
was not properly before the Examiner, such that we might have had the
benefit of the Examiner’s views on the argument in reaching our decision in
this appeal, we have considered only those arguments presented by
Appellants in the briefs. See 37 C.F.R. § 41.47(e)(1): “At the oral hearing,
appellant may only rely on Evidence that has been previously entered and
considered by the primary examiner and present argument that has been
relied upon in the brief or reply brief except as permitted by paragraph (e)(2)
of this section.” Paragraph (e)(2) of the relevant section provides: “Upon a
showing of good cause, appellant and/or the primary examiner may rely on a
new argument based upon a recent relevant decision of either the Board or a
Federal Court.” Appellants have not alleged that circumstance of good
cause is present here.
Appellants also argue that “[t]here is no mention or suggestion in the
prior art that the device of Sosnowski is suitable or can be suitably modified
for endotracheal intubation.” Reply Br. 2, 3. We are not persuaded by this
argument in that the prior art reference need not envision the device actually
being used to perform the claimed function. Schreiber, 128 F.3d at 1477
(“Although Schreiber is correct that [the prior art reference] does not address
the use of the disclosed structure to dispense popcorn, the absence of a
disclosure relating to function does not defeat the Board’s finding of
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anticipation.”). It is enough for the disclosed structure to be capable of the
claimed function.
Appellants also argue that the Examiner’s finding that “Totz teaches a
removable flexible sheath 906 . . . encasing an analogous channel element”
is in error. Appeal Br. 7 (quoting Final Act. 7). More particularly,
Appellants assert that Totz’s device is not “configured or intended to be used
for encasing an articulable channel element,” but rather is “configured to
facilitate, insertion of an enteral tube 280 .. . [and] a lumen 101 of an
endotracheal tube 100.” Id. at 8 (citing Totz, || 180, 181).
The Examiner responds that Totz’s flexible sheath 906 “is structurally
very similar to that of the removable flexible sheath 300 of the instant
invention.” Ans. 22. The Examiner further responds that “sheath 906 is
capable of encasing the channel element 4, 5 of Sosnowski” considering that
“[ejlement 912 of Totz is slidably received within the bore 906q of element
906d.” Id. at 23. The Examiner had a sufficient basis for finding Totz’s
flexible sheath 906 to be capable of encasing the channel element 4, 5 of
Sosnowski based on the identified structural similarity of Totz’s sheath 906
to the claimed sheath.
Appellants additionally argue that Totz’s sheath 906 is not a sheath
“(i.e., an elongate covering) and would not encase (i.e., enclose) a channel
element.” Reply Br. 3. Appellants’ Specification describes that sheath 300
can encase only a portion of channel element 120 (Spec. 1 63), which we
determine is consistent with Totz’s disclosed structure of a tubular shaped
clip capable of enclosing a portion of Sosnowski’s device. Appellants have
not provided sufficient reasoning or evidence to overcome the Examiner’s
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finding that Totz’s sheath is capable of performing the claimed functional
limitation of encasing the channel element.
Appellants also argue that the Examiner’s articulated reasoning based
on providing an improved intubation device and improved flexible sheath
lacks rational underpinnings. Appeal Br. 9-10. Appellants argue that the
Examiner’s proposed combination relies on using Sosnowski’s endoscope
and Totz’s catheter “in a manner inconsistent with the teachings of these
references to address problems not recognized by either of these references.”
Id. at 9. For example, Appellants assert that Totz’s device “employs
conventional manipulation of an endotracheal tube without the assistance of
a channel element having an articulable distal end.” Id. at 8. Appellants
also assert that merely because Totz’s “clip 906 could be configured to be
attached to the endoscope of Sosnowski does not provide a rationale for
attaching . . . clip 906 to the Sosnowski endoscope.” Reply Br. 4.
We determine that the Examiner has adequately explained that a
person of ordinary skill in the art would be led to provide Sosnowski’s
device with a flexible sheath like the one disclosed in Totz in order to
facilitate easy and efficient attachment of Sosnowski’s device to
endotracheal tubes or other instruments of various sizes. Ans. 24. This
desire to attach Sosnowski’s device to other instruments has a rational
evidentiary underpinning in support of the Examiner’s conclusion of
obviousness of the claimed apparatus, even considering that Totz
conventionally manipulates an endotracheal tube and does not contemplate
assistance of a channel element having an articulable end (as argued by
Appellants).
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Appellants also argue that “[ajdding clip 906 of Totz to the distal end
of the Sosnowski endoscope would defeat the objective of Sosnowski to
provide an endoscope having a shaft of diameter less than 0.15 inches.”
Reply Br. 3. We are not persuaded by this argument because it merely
shows that the reference expresses a general preference for a certain size, but
does not ‘“criticize, discredit, or otherwise discourage’ investigation into the
invention claimed.” DePuy Spine, Inc. v. Medtronic Sofamor Danek,
Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (quoting In re Fulton, 391 F.3d
1195, 1201 (Fed. Cir. 2004)). Appellants have not identified where
Sosnowski actually criticizes or discourages investigation into the claimed
invention.
In addition, Appellants do not identify any knowledge relied upon the
Examiner that was gleaned only from Appellants’ disclosure and that was
not otherwise within the level of ordinary skill at the time of the invention.
See In re McLaughlin, 443 F.2d 1392 (CCPA 1971). As such, we disagree
with Appellants’ assertion that the Examiner relied on impermissible
hindsight (see Appeal Br. 9) in reaching the determination of obviousness of
the subject matter of claim 1.
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the combination of Sosnowski and Totz renders
obvious the subject matter of independent claim 1, and we sustain the
rejection of independent claim 1, and claims 17—21, 23—26, 31, and 33
which fall therewith, under 35 U.S.C. § 103(a) as unpatentable over
Sosnowski and Totz.
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Rejections II—VII
Appellants’ arguments in support of the patentability of claims 2—6,
10-16, 22, 27—32, and 34—39 relate to the perceived deficiencies in the
combined teachings of Sosnowski and Totz. Appeal Br. 10—11. Because we
have found no such deficiencies in the combination of Sosnowski and Totz,
we are not persuaded of error in the Examiner’s rejections of claims 2—6,
10-16, 22, 27—32, and 34—39. Accordingly, we sustain the rejections, under
35 U.S.C. § 103(a), of: claims 2—5, 10, and 11 as unpatentable over
Sosnowski, Totz, and Matsumoto; claim 6 as unpatentable over Sosnowski,
Totz, Matsumoto, and Padget; claims 12—16 as unpatentable over
Sosnowski, Totz, Matsumoto, and Opie; claim 22 as unpatentable over
Sosnowski, Totz, and Ishikawa; claim 27 as unpatentable over Sosnowski,
Totz, and Matsuura; claims 28—32, 34, and 35 as unpatentable over
Sosnowski, Totz, and Yokota. Id. at 17—18; and claims 36—39 as
unpatentable over Sosnowski, Totz, and Schwartz.
DECISION
The Examiner’s decision to reject claims 1—6 and 10—39 under
35 U.S.C. § 103(a) 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)(l)(iv).
AFFIRMED
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