Ex Parte Mark et al

Patent Trial and Appeal Board

Jun 11, 2018

13474433 (P.T.A.B. Jun. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/474,433 05/17/2012
22045 7590 06/13/2018
BROOKS KUSHMAN P.C.
1000 TOWN CENTER
TWENTY-SECOND FLOOR
SOUTHFIELD, MI 48075
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Joseph L. Mark
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.
NIC00111PUSA5 5441
EXAMINER
LUONG, PETER
ART UNIT PAPER NUMBER
3737
NOTIFICATION DATE DELIVERY MODE
06/13/2018 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
kdilucia@brookskushman.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH L. MARK and AMIN KASSAM 1
Appeal2017-005858
Application 13/474,433
Technology Center 3700
Before DONALD E. ADAMS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Nico Corporation as the real party-in-interest. App Br.
4.
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Application 13/474,433
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1-20. Specifically, claims 1, 3, 4, 8, 9,
and 11-13 stand rejected as unpatentable under 35 U.S.C. § I03(a) as being
obvious over the combination ofRabiner et al. (US 2003/0212333 Al,
November 13, 2003) ("Rabiner"), Hermann et al. (US 5,599,305, February
4, 1997) ("Hermann"), and Hinchliffe et al. (US 2003/0045811 Al, March 6,
2003) ("Hinchliffe").
Claims 2, 5, and 10 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination ofRabiner, Hermann,
Hinchliffe, and Wang et al. (US 5,951,494, September 14, 1999) ("Wang").
Claim 6 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Rabiner, Hermann, Hinchliffe, Wang,
and Johnson (US 5,669,383, September 23, 1997) ("Johnson").
Claim 7 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Rabiner, Hermann, Hinchliffe, Wang,
and Tsonton et al. (US 2005/0277829 Al, December 15, 2005) ("Tsonton").
Claims 2-5, 7, and 10 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of Rabiner, Hermann,
Hinchliffe, and Tsonton.
Claim 6 also stands rejected as unpatentable under 35 U.S.C. § I03(a)
as being obvious over the combination of Rabiner, Hermann, Hinchliffe,
Tsonton, and Johnson.
Claims 12-19 stand rejected as unpatentable under 35 U.S.C. § I03(a)
as being obvious over the combination of Rabiner, Hermann, Hinchliffe, and
Lubock et al. (US 2008/0125766 Al, May 29, 2008) ("Lubock").
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Claim 19 also stands rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination ofRabiner, Hermann,
Hinchliffe, Lubock, and Lakin et al. (US 2008/0306490 Al, December 11,
2008) ("Lakin").
Claim 20 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Rabiner, Hermann, Hinchliffe,
Lubock, and Greenan et al. (US 2008/0171934 Al, July 17, 2008)
("Greenan"). 2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to a surgical access assembly and
method of use comprising an outer sheath and an obturator configured to be
delivered to an area of interest within the brain. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method of using a surgical access assembly,
compnsmg:
identifying an area of interest within the brain;
2 The Examiner also rejected claims 1-11 and 19-20 as unpatentable under
35 U.S.C. § 112, second paragraph, as being indefinite. Final Act. 2. The
Examiner has withdrawn this rejection. Ans. 8.
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assembling an outer sheath over an obturator in an
insertion configuration so as to expose a tapered, atraumatic
distal tip of the obturator to define an assembly distal end;
advancing the assembled outer sheath and obturator
through brain tissue so as to atraumatically move the brain
tissue and vessels within the brain while delivering the
assembled outer sheath and obturator to the area of interest until
the assembly distal end is positioned at or adjacent the area of
interest;
after advancing the assembled outer sheath and obturator
to the area of interest, decanting the outer sheath with respect to
the obturator such that a distal end of the outer sheath is moved
distally toward a distal end of the obturator and toward the area
of interest while the obturator remains stationary, such that the
outer sheath moves to align with a distal end of the obturator;
after decanting the outer sheath, removing the obturator
from the outer sheath and leaving the outer sheath in place to
provide access to the area of interest; and
interrogating the area of interest to acquire information
about the area of interest.
App. Br. 28.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are obvious over the combined cited prior art. We
address the arguments raised by Appellants below.
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A. Claim 1
Issue 1
Appellants argue that the Examiner erred in finding that the
combination of Rabiner, Hermann, and Hinchliffe teaches or suggests the
limitation of claim 1 reciting:
decanting the outer sheath with respect to the obturator such
that a distal end of the outer sheath is moved distally toward a
distal end of the obturator and toward the area of interest while
the obturator remains stationary, such that the outer sheath
moves to align with a distal end of the obturator.
App. Br. 8.
Analysis
The Examiner finds Rabiner teaches a method of using a surgical
access assembly comprising identifying an area of interest within a body,
assembling an outer sheath over an obturator in an insertion configuration
defining an assembly distal end, and advancing the assembled outer sheath
and obturator to the area of interest until the assembly distal end is
positioned at or adjacent the area of interest. Final Act. 3 ( citing Rabiner
,r,r 19, 21). The Examiner finds Rabiner also teaches decanting the outer
sheath, such that a distal end of the outer sheath is moved distally with
respect to the obturator, removing the obturator from the outer sheath and
leaving the outer sheath in place to provide access to the area of interest, and
interrogating the area of interest to acquire information about the area of
interest. Id. at 3--4 ( citing Rabiner ,r,r 17, 19, 21, 41 ).
The Examiner finds that Rabiner does not teach a tapered distal tip or
decanting the outer sheath such that a distal end of the outer sheath is moved
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distally toward the area of interest so as to move toward a distal end of the
obturator. Final Act. 4. The Examiner finds Hermann teaches these
limitations of claim 1. Id. (citing Hermann, col. 3, 11. 30-39; col. 5, 11. 35-
44; col. 8, 11. 44--51). The Examiner concludes that it would have been
obvious to one of ordinary skill in the art at the time the invention was made
to have combined the teachings of Rabiner with the method of Hermann,
because it was well known in the art to move the sheath over the obturator
towards the area of interest. Id.
The Examiner also finds that Rabiner does not expressly teach using
the apparatus in the brain. Final Act. 4. However, the Examiner finds,
Hinchliffe teaches using a sheath and obturator in the brain. Id. (citing
Hinchliffe ,r 7 5). The Examiner therefore concludes that it would have been
obvious to one of ordinary skill in art to combine the teachings of Rabiner
and Hermann with those of Hinchliffe, as the use of a sheath and obturator in
the brain was well known in the art. Id.
Appellants initially point to the limitation of claim 1 requiring the step
of decanting the outer sheath after the assembled outer sheath and obturator
is advanced to the area of interest. App. Br. 8. According to Appellants, the
claim term "decanting," as used in Appellants' Specification, requires that a
distal end of the outer sheath is moved distally toward the area of interest so
as to move the outer sheath toward a distal end of the obturator. Id. ( citing,
e.g., Spec. ,r 129). Furthermore, Appellants argue, claim 1 further requires
that the decanting step is performed such that the distal end of the outer
sheath is moved distally toward a distal end of the obturator and toward the
area of interest while the obturator remains stationary, such that the outer
sheath moves to align with a distal end of the obturator. Id. Appellants
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assert that the Examiner has failed to address this language in the last two
Office Actions rejecting claim 1. Id. at 9.
Specifically, Appellants argue that Rabiner teaches a trocar sheath and
an obturator. The trocar sheath surrounds the obturator and is inserted
within an organ or body, the obturator is then removed and an instrument
that is to be inserted into the body is slid within the trocar sheath and passed
forward. App. Br. 9 ( citing Rabiner ,r 21 ). In contrast, argue Appellants,
claim 1 explicitly recites decanting the outer sheath such that the outer
sheath is moved toward a distal end of the obturator before removing the
obturator from the outer sheath. Id.
Appellants argue that Hinchliffe teaches a biopsy apparatus 10 with an
elongated body 12 composed of a hollow outer sleeve 13 and an inner tube
20 fixedly mounted therein. App. Br. 9 (citing Hinchliffe ,r 53). According
to Appellants, Hinchliffe teaches that an obturator 50 is positioned within
the lumen 25 of the inner tube 20, and is "spring biased proximally." Id.
( citing Hinchliffe ,r 58). Appellants assert Hinchliffe teaches that, once the
apparatus 10 is advanced through the tissue and into position within the
body, the surgeon releases a thumb button, causing the tip 52 to
automatically retract to a shielded position. Id. ( citing Hinchliffe ,r 61 ).
However, Appellants contend, Hinchliffe neither teaches nor suggests
"decanting the outer sheath," as required by claim 1. Id.
Appellants note that the Examiner relies upon Hermann as teaching
the "decanting" limitation. App. Br. 9. Appellants assert that Hermann
teaches an introducer sheath that is directed into a blood vessel. Id.
Appellants contend that the introducer sheath and obturator of Hermann are
configured to be laterally deflected to "facilitate intravascular" placement of
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the sheath and the obturator is guided through the vascular system. Id.
Appellants argue Herman teaches placing the sheath on the obturator and
guiding the sheath and obturator through the vascular system. Id. However,
Appellants argue, Herman does not teach decanting the outer sheath over the
obturator to align with the distal end of the obturator at the area of interest.
Id. Appellants note that Herman also teaches an alternative method, by
which the obturator is threaded through the vascular system beyond the
sheath, to reach the target location, and the sheath is then advanced over the
obturator. Id. Even by this method, argue Appellants, Hermann does not
teach advancing the assembled outer sheath and obturator to the area of
interest, nor does Herman teach decanting the outer sheath toward the area
of interest while the obturator remains stationary or moving the distal end of
the outer sheath, such that the outer sheath moves to align with the distal end
of the obturator. Id. at 9-10.
We are not persuaded by Appellants' arguments. With respect to the
disputed limitation, Appellants' Specification discloses:
[O]uter sheath 102 is decanted with respect to obturator
104 such that distal end 108 of outer sheath 102 is moved toward
distal end 106 of obturator 104 .... when grip ring 120 is aligned
with indicator 194A, distal end 108 of outer sheath 102 is aligned
[with] tip member 17 4 of obturator 104. Moreover, outer sheath
102 is positioned within area of interest 500.
In step 424, once outer sheath 102 is appropriately
positioned, obturator 104 is then removed from outer sheath 102,
as shown in FIG. 17B. More specifically, outer sheath 102 is
maintained to be relatively stationary at area of interest 500, and
obturator 104 is moved in a proximal direction until fully
removed from outer sheath 102. This action results in outer
sheath 102 forming a pathway to area of interest 500 ....
Spec. ,r,r 129-130. Hermann teaches:
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Usually, the obturator will be within the sheath with its
deflectable distal end axially aligned with a distal portion of the
sheath having enhanced flexibility. Alternatively, the obturator
could be advanced distally beyond the sheath, using the steering
mechanism to reach the desired target location, with the sheath
then being advanced over the obturator.
Hermann col. 3, 11. 28-38 (emphasis added). Hermann also teaches:
Alternatively, the obturator could be advanced distally beyond
the sheath, with the sheath being subsequently advanced over the
obturator. In either case, the obturator is removed after the
sheath reaches the target location, providing an open access
lumen for subsequent introduction of interventional or other
catheters and devices.
Id. at col. 5, 11. 42--47 (emphasis added). Finally, Hermann teaches that:
In some cases, it may be desirable to provide obturator having
lengths substantially greater than that of the associated flexible
sheath which is part of the catheter introducing system. In those
cases, it will be possible to advance the obturator beyond the
distal end of the sheath and subsequently advanced the sheath
over the obturator, after the obturator has reached desired target
location.
Id. at col. 8, 11. 44--51 (emphasis added).
We consequently agree with the Examiner that the plain language of
Hermann expressly teaches the limitation of claim 1 reciting:
after advancing the assembled outer sheath and obturator to the
area of interest, decanting the outer sheath with respect to the
obturator such that a distal end of the outer sheath is moved
distally toward a distal end of the obturator and toward the area
of interest while the obturator remains stationary, such that the
outer sheath moves to align with a distal end of the obturator.
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We find that a person of ordinary skill in the art, reading the passages
of Hermann quoted supra, would understand that Hermann expressly
teaches that the sheath can be moved distally towards the distal end of the
obturator so that the distal end of the sheath is aligned with the distal end
and at the place of interest.
In their Reply Brief, Appellants argue that, contrary to the Examiner's
findings, Hermann teaches away from the claimed recitation in that the
embodiment relied upon by the Examiner, as Hermann requires the obturator
to be advanced first, and then the outer sheath delivered over the obturator,
after the obturator reaches the desired location, in contrast to claim 1, which
requires that the obturator and outer sheath be delivered together, in the
advancing configuration. Reply Brief 2. Appellants also reply that
Hermann fails to teach that the obturator is held stationary at the position of
interest as the sheath is decanted to align with the distal tip of the obturator.
Id. at 3.
We do not find these arguments persuasive. A reference may be said
to teach away when "a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant." In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Appellants
point to no such teaching in the cited prior art that would so discourage or
divert a skilled artisan.
To the contrary, Hermann teaches that: "The sheath and obturator are
usually introduced together through a percutaneous access site to a desired
target location within a body lumen or cavity, with the steerable obturator
being used to guide the sheath through a tortuous path." Hermann col. 5, 11.
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35--40 (emphases added). We find that Hermann thus expressly teaches
introducing and moving obturator and sheath together, contrary to
Appellants' argument.
We similarly find that Hermann teaches that: "it will be possible to
advance the obturator beyond the distal end of the sheath and subsequently
advanced the sheath over the obturator, after the obturator has reached
desired target location." Hermann col. 8, 11. 47-51 (emphasis added). We
agree with the Examiner that a person of ordinary skill would understand
that, since the explicit object of both Hermann and Appellants' claimed
method is to advance the sheath to the point of interest (i.e., the target
location), once the tip of the obturator had reached that point of interest, it
would have been obvious to hold the obturator stationary at that position so
that the sheath may be advanced to that position over the tip of the obturator.
Issue 2
Appellants argue that the Examiner erred because Rabiner, Hermann,
and Hinchliffe fail to teach or suggest the limitation of claim 1 reciting:
"[ A ]dvancing the assembled outer sheath and obturator through brain tissue
so as to atraumatically move brain tissue and vessels within the brain while
delivering the assembled outer sheath and obturator to the area of interest
until the assembly distal end is positioned at or adjacent the area of interest."
App. Br. 10.
Analysis
Appellants argue that the Examiner relied upon paragraph [0019] of
Rabiner as teaching "assembling an outer sheath over an obturator in an
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insertion configuration defining an assembly end" and "advancing the
assembled outer sheath and obturator to the area of interest until the
assembly distal end is positioned at or adjacent the area of interest." App.
Br. 10. However, Appellants assert, Rabiner does not teach exposing a
tapered atraumatic distal tip of the obturator, or atraumatically moving brain
tissue and vessels within the brain while delivering the assembled outer
sheath and obturator to the area of interest. Id.
Rather, argue Appellants, Rabiner teaches that the obturator "contains
a point or sharpened profile that is able to penetrate the human anatomy."
App. Br. 10. Appellants point to their Specification, which discloses that the
distal tip of the obturator is non-sharpened, so as to atraumatically move
tissue "without cutting tissue or other structures." Id. (citing Spec ,r 74).
Nor, Appellants contend, does Herman cure the alleged deficiencies of
Rabiner, rather, Appellants assert, Hermann teaches an introducer sheath
that is actually directed into a blood vessel and thus there is no need to
atraumatically move tissue and vessels. Id. at 9-10.
Finally, Appellants argue, Hinchliffe neither teaches nor suggests the
disputed limitation. App. Br. 10. Appellants contend that, because there is
no suggestion that the inventions of Rabiner and Herman may be used in the
brain, the Examiner's reliance upon Hinchliffe as teaching a device that may
be used in the brain in the manner recited in the claim is insufficient to
establish a prima facie case of obviousness. Id. at 10-11. Furthermore,
argue Appellants, Hinchliffe teaches that the obturator 50 has a penetrating
tip that is spring biased to a retracted position such that the tip is normally
shielded within the obturator cannula. Id. ( citing Hinchliffe ,r 61 ).
Appellants assert Hinchliffe, like Rabiner and Herman, fails to teach or
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suggest atraumatically moving tissue and vessels within the body while
delivering the assembled outer sheath and obturator to the area of interest.
Id.
The Examiner responds that Appellants' Specification provides no
express definition of the claim term "atraumatically" and the Examiner
therefore adopts the broadest reasonable definition of the term consistent
with Appellants' Specification. Ans. 8-9. The Examiner points to the
Merriam-Webster dictionary, which defines the term "atraumatically" as
meaning: "designed to minimize tissue damage; not causing injury or
trauma." Id. at 9. The Examiner similarly finds that Dictionary.com defines
minimally invasive as meaning "requiring only a small incision or the
insertion of an instrument into a body cavity; involving minimal damage of
body tissue." Id.
The Examiner finds Hinchliffe teaches a minimally invasive device
comprising of a sheath and obturator for use in the brain. Ans. 9 ( citing
Hinchliffe ,r,r 11, 7 5). The Examiner therefore concludes that it would have
been obvious to a person of ordinary skill in the art to use the combined
teachings of Rabiner and Hermann of a sheath and obturator which can be
applied to other areas within the body, with Hinchliffe, which teaches that an
obturator and sheath can be used in the brain as a minimally invasive device.
Id.
We agree with the Examiner. Appellants' Specification provides no
express definition of the claim term "atraumatically," but discloses:
"Tapered portion 130 and radiused distal tip 132 cooperates with obturator
104 to atraumatically move tissue, as well as various structures within the
brain, including white matter, away from outer sheath 102 without cutting
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tissue or such structures." Spec. ,r 74. Figure 2 of Appellants' Specification,
reproduced below, depicts an exemplary embodiment of the claimed
obturator:
Figure 2 of Appellants' Specification illustrates a perspective
cross-sectional view of an exemplary arrangement of a surgical
access assembly. See Spec. iI 22
With respect to Figure 2, Appellants' Specification further discloses:
Distal end 106 is configured with a generally conical shaped
distal tip portion 172 that tapers to a tip member 17 4 to provide
atraumatic dilation of tissue. In one exemplary arrangement, tip
portion 172 tapers toward a closed tip member 17 4 so as to
prevent coring of tissue as obturator 104 is inserted into the
brain.
Spec. ,r 81. We consequently interpret the claim terms "a tapered,
atraumatic distal tip" and "atraumatically" to mean "a tapered, conical tip
located at the distal portion of the obturator, capable of penetrating and
dilating the tissues of the brain with minimal tissue damage."
Hinchliffe teaches an obturator which: "is positioned within the
lumen 25 of inner tube 20 and has a sharp penetrating tip such as a trocar tip
52 shown in FIG. 6. Alternatively, the obturator can have a blunt tip as in
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obturator 60 of FIG. 6A." Hinchliffe ,r 58. Figure 6 of Hinchliffe depicts
the "trocar tip 52" of the obturator as having a conical or pyramidal distal
tip, similar in appearance to Appellants' distal tip 106. Hinchliffe further
teaches:
With the tip 52 in the exposed position, the sheath 40 and
apparatus 10 therein can be advanced through the tissue as shown
in FIGS. 6 and 6A. Once the sheath is in position, the surgeon
releases the thumb button, causing the tip 52 to automatically
retract to a shielded position, and the obturator is withdrawn.
Id. ati-f 61.
Both Hermann and Rabiner also teach obturators. Hermann, for
instance teaches an obturator: "with a tapered distal tip 26 extending from
the distal end 28 of the sheath 16." Hermann col. 9, 11. 50---51. Hermann
teaches that the: "Flexible body 20 [of obturator 14] is tubular, typically
having a closed distal tip which is preferably tapered to provide atraumatic
introduction to the desired target body location." Id. at col. 10, 11. 55-57
( emphasis added). Hinchliffe thus teaches a distal obturator tip that is
tapered to atraumatically deliver the assembled outer sheath and obturator to
the area of interest.
Rabiner similarly teaches an: "a trocar sheath and an obturator. The
trocar sheath is an outer thin walled tube that surrounds the obturator. The
obturator contains a point or sharpened profile that is able to penetrate the
human anatomy." Rabiner ,r 19.
We find that, based upon the teachings of the combined cited
references, a person of ordinary skill in the art would have realized that
obturators with tapering points capable of delivering the combined obturator
and sheath assembly atraumatically to the point of interest were well known
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in the prior art and would have concluded that the disputed limitation was
obvious over the combined teachings of Rabiner, Hermann, and Hinchliffe.
We consequently affirm the Examiner's rejection of claim 1.
B. Claim 12
Appellants argue that the combined cited prior art neither teaches nor
suggests the limitation of claim 1 reciting: "decanting the outer sheath such
that a distal end of the outer sheath is moved distally toward a distal end of
the obturator and toward the area of interest while the obturator remains
stationary such that the outer sheath moves to align with the distal end of the
obturator." App. Br. 11. Appellants argue that: "As shown above in
connection with claim 1, this recitation is not taught or shown in the
Rabiner/Herman/Hinchliffe combination." Id.
We are not persuaded by Appellants' argument, which relies upon the
arguments presented with respect to claim 1, for the reasons we have
explained supra. We therefore affirm the Examiner's rejection of claim 12.
C. Claims 2-11 and 13-20
Appellants argue these claims severally and separately. App. Br. 11-
13. Appellants rely upon the same arguments presented supra with respect
to claim 1. Id. We consequently affirm the Examiner's rejection of the
claims for the reasons we have explained with respect to claim 1.
DECISION
The Examiner's rejection of claims 1-20 as unpatentable under
35 U.S.C. § 103(a) is affirmed.
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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)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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