Ex Parte Chebator

Patent Trial and Appeal Board

May 4, 2016

13549938 (P.T.A.B. May. 4, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/549,938 07/16/2012
127558 7590 05/06/2016
Covidien LP/Shumaker & Sieffert P,A,
Attn: IP Legal Department
15 Hampshire Street
Mansfield, MA 02048
FIRST NAMED INVENTOR
Casey CHEBATOR
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.
H-KN-01612 5990
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
05/06/2016 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):
iplegalus@covidien.com
pairdocketing@ssiplaw.com
medtronic_mitg-pmr_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CASEY CHEBATOR
Appeal2014-003963
Application 13/549,938
Technology Center 3700
Before MICHAEL L. HOELTER, LYNNE H. BROWNE, and
PAUL J. KORNICZKY, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 1-20. Final Act. 1 (Office Action Summary). We have
jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "relates to indwelling catheters. More
particularly, the present disclosure relates to a tunneler device for preparing
a subcutaneous tunnel for catheter placement." Spec. ,-r 1. Claims 1, 8, and
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Application 13/549,938
15 are independent. Claim 1 is illustrative of the claims on appeal and is
reproduced below:
1. A tunneler device comprising:
a handle;
a shaft extending distally from the handle;
a connecting segment positioned on a distal end of the
shaft, the connecting segment being configured to engage one
end of a catheter; and
a flush assembly including a fluid channel and a one-way
flush valve, the flush valve being supported on the handle and
being disposed in fluid communication with the fluid channel,
the flush valve and the fluid channel being configured to
facilitate a supply of a flush solution from the handle to the
connecting segment and into the catheter.
REFERENCES RELIED ON BY THE EXAMINER
Mayer US 5,470,319 Nov. 28, 1995
Hiejima US 2004/0158208 Al Aug. 12, 2004
Wilson US 2005/0187535 Al Aug. 25, 2005
Secrest US 2005/0267417 Al Dec. 1; 2005
Martin US 2012/0083794 Al Apr. 5, 2012
THE REJECTIONS ON APPEAL
Claims 1-5 and 8-12 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Martin and Hiejima.
Claims 6, 7, 13, and 14 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Martin, Hiejima, and Wilson.
Claims 1, 8, and 15-20 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Martin and Secrest.
Claims 1, 8, 15, 17, and 20 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Martin and Mayer.
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Application 13/549,938
ANALYSIS
The rejection of claims 1-5 and 8-12
as unpatentable over Martin and Hiejima
Appellant argues independent claims 1 and 8, and their respective
dependent claims 2-5 and 9-12, together as a group. 1 App. Br. 3---6. We
select claim 1 for review with claims 2-5 and 8-12 standing or falling with
claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
Independent claim 1 includes the limitation of "a handle" and a flush
valve "supported on the handle." The Examiner relies on Martin for
disclosing "a handle" but acknowledges that Martin does not disclose "the
flush valve being supported on the handle." Final Act. 2. For this
limitation, the Examiner relies on Hiejima for disclosing "flush valve 3
being supported on the handle 2." Final Act. 2. Appellant contends that one
skilled in the art "would not have considered Hiejima's female connector 2
to be a handle" (and hence, there is no disclosure of a flush valve supported
on a handle). App. Br. 5; Reply Br. 3.
Appellant's Specification provides guidance as to the meaning of the
term "handle." For example, paragraph 18 thereof discusses handle 110
"that is dimensioned to receive a clinician's fingers." This same paragraph
also states, "[h]andle 110 may include ridges, bumps, knurls, and/or any
other suitable non-slip features configured to improve gripping engagement
of handle 110 by a clinician." Consistent with the Specification, the
1 Appellant contends that with respect to claim 8 "[f]or at least the reasons
discussed above with respect to claim 1," the Examiner has not "formed a
prima facie case of obviousness with respect to claim 8, and claims 9-12
which depend from claim 8." App. Br. 6.
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Application 13/549,938
dictionary definition of "handle" is "a part that is designed esp. to be grasped
by the hand. "2
Hiejima describes item 2 as a "female connector (a catheter connector,
an external needle hub)." Hiejima i-f 58. The Examiner acknowledges that
"Hiejima does not explicitly state that the female connector 2 [is] a handle"
but states "one skilled in the art would recognize that the user [would] have
to hold the handle/connector 2 to insert the indwelling catheter under the
skin." Ans. 10. Appellant disagrees with this interpretation of "a handle"
because "the ability to grasp the female connector 2 does not make it
suitable for use as a handle." App. Br. 5. Appellant further contends that
the Examiner "ignores the plain meaning of the term 'handle' and the
contextual guidance provided in the specification to a person of ordinary
skill in the art." Reply Br. 3. In short, Appellant contends that "the Office's
interpretation of 'handle' as covering a connector piece of a catheter is
overly broad to the point of reading the term 'handle' out of Applicant's
claims." App. Br. 6.
Appellant appears to acknowledge the need for a handle when
tunneling through tissue, but contends that Hiej ima' s item 2 is not such a
device, and does not explain how a clinician could insert needle 1 other than
via gripping and leveraging item 2. 3 However, Hiejima depicts item 2 as
secured to tube or needle 1 and Hiejima discloses that needle 1 is "stuck into
2 WEBSTER'S NEW COLLEGIATE DICTIONARY 515 (1979). See also
Dictionary.com, http://www.dictionary.com/browse/handle?s=t (last visited
April 28, 2016) ("a part of a thing made specifically to be grasped or held by
the hand').
3 Appellant states "Hiejima's female connector 2 would not have provided
the gripping surface and leverage required to control a tunneling device as it
is pushed through tissue to create a tunnel within tissue." App. Br. 5-6.
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Application 13/549,938
the blood vessel or the like of the patient." Hiejima if 71. Appellant does
not explain how Hiejima's needle insertion into a patient would have been
accomplished other than as stated by the Examiner, i.e., "one skilled in the
art would recognize that the user [would] have to hold the handle/connector
2 to insert the indwelling catheter under [the] skin." Ans. 10. In view of
Hiejima's disclosure of sticking needle 1 (secured to "external needle hub"
2) into a patient's tissue (see supra), we are not persuaded by Appellant's
arguments that the Examiner erred in correlating Hiejima's item 2 to the
claimed "handle."
Appellant also acknowledges that Martin discloses "a tunneler device
for subcutaneously tunneling a catheter under a patient's skin" and that
Hiejima discloses "an external needle type indwelling catheter." App. Br. 5.
However, Appellant contends that "[t]he only suggestion or motivation" for
combining the two "is in the Applicant's own disclosure." App. Br. 5; see
also Reply Br. 2.
We disagree. Appellant acknowledges that "in the field of catheter
placement, flushing is used to ensure that there is no air inside the catheter."
App. Br. 8. The Examiner also relies on "flushing" when expressing the
reason to combine the teachings of Martin and Hiejima.4 Final Act. 3.
Appellant does not explain how the Examiner's stated suggestion or
motivation for combining Martin and Hiejima is not based on this known
need for catheter flushing, but instead is gleaned only from Appellant's own
disclosure.
4 The stated reason to combine Martin and Hiej ima is "to provide the fluid
channel for flushing from the handle to the connecting segment and into the
catheter." Final Act. 3; see also Ans. 10.
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Appellant also addresses the Examiner's reliance on Martin's "lumen
of shaft 120 and tube 52" as disclosing a fluid channel. Reply Br. 3; Final
Act. 2. Appellant contends that "Martin's shaft 120, however, has not been
shown to have included a lumen" and that Martin's "tube 52 is part of a
catheter 50." Reply Br. 3. However, Appellant does not indicate how the
cross-sectional view of these components in figure 1 OB of Martin fails to
disclose that they are hollow. Hence, Appellant's contention is not
persuasive that the Examiner erred in finding that Martins' shaft 120 and
tube 52 disclose a fluid channel. Final Act. 2.
Appellant also contends, "the combination of Martin and Hiej ima
would not have resulted in the tunneler device as claimed" (Reply Br. 4), but
does not elaborate further as to how or why this might be the case.
Appellant's conclusory statement is not persuasive of Examiner error.
Accordingly, and based on the record presented, we affirm the
Examiner's rejection of claims 1-5 and 8-12 as being unpatentable over
Martin and Hiejima.
The rejection of claims 6, 7, 13, and 14
as unpatentable over Martin, Hiejima, and Wilson
Claims 6, 7, 13, and 14 depend indirectly from either independent
claim 1 or independent claim 8. The Examiner relies on the additional
reference to Wilson for disclosing a connecting segment having first and
second extensions as recited therein. Final Act. 4; Ans. 12. Appellant does
not dispute the Examiner's reliance on Wilson, but instead contends,
"Wilson has not been shown to have cured the deficiencies of Martin and
Hiejima discussed above with regard to claims 1 and 8." App. Br. 6.
Appellant's contention is not persuasive of Examiner error. Accordingly,
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we affirm the Examiner's rejection of claims 6, 7, 13, and 14 as being
obvious over Martin, Hiejima, and Wilson for the reasons stated.
The rejection of claims 1, 8, and 15-20
as unpatentable over Martin and Secrest
Appellant argues claims 1, 8, and 15-20 together. We select claim 1
for review, with claims 8 and 15-20 standing or falling with claim 1.
Here, the Examiner relies on Secrest for disclosing "handle 12" and
"wherein the flush valve [is] supported on an outer surface of the handle, see
Figs. 1-11." Final Act. 4--5. Appellant does not challenge this finding by
the Examiner but instead contends that the modification of "Martin's
tunneler device in view of Secrest' s irrigating biopsy inlet valve has not
been shown to be based on a solution found in the relevant art." App. Br. 7;
Reply Br. 4 (emphasis added). We understand this contention to be a
combination of a lack of a reason to combine (or hindsight reasoning), and
that Martin and Secrest are non-analogous art. 5
Regarding the lack of a reason to combine, the Examiner states that it
would have been obvious to combine Martin with Secrest's flush assembly
"for the benefit of providing a flush channel to flush inside the device
system." Final Act. 5; see also Ans. 14. Although the Examiner does not
elaborate further on what this benefit might be, Appellant acknowledges that
"in the field of catheter placement, flushing is used to ensure that there is no
5 This contention might further indicate that the solution was not found in
either Martin or Secrest. However, we have been instructed that "[t]he
obviousness analysis cannot be confined by a formalistic conception of the
words teaching, suggestion, and motivation, or by overemphasis on the
importance of published articles and the explicit content of issued patents."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007) (emphasis added).
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air inside the catheter." App. Br. 8. Furthermore, Secrest specifically
teaches that "[d]uring use of these instruments [i.e., endoscopes], a need
typically arises to irrigate the internal work site and sometimes, also the
instrument channel itself." Secrest i-f 5; see also Ans. 14. Accordingly, and
based on the well-known need for flushing medical devices (i.e., catheters
and endoscopes), we are not persuaded the Examiner's statement "for the
benefit of providing a flush channel to flush inside the device" lacks
articulated reasoning with a rational underpinning. Appellant's contention
that the Examiner lacked a reason to combine (i.e., relied on hindsight
reasoning) is not persuasive.
Regarding the contention that Martin and Secrest are non-analogous
art, Appellant states "Martin's tunneler device in view of Secrest' s irrigating
biopsy valve are related to problems associated with the use of an
endoscope, not in catheter placement." Reply Br. 4, emphasis added. Even
assuming arguendo that the problems solved are different, the Examiner
relies on the alternate "field of endeavor" prong of the analogous art test, not
the "problem" prong. 6 The Examiner states that Seacrest is "in [the] medical
area" (as is Martin) and as such, "the flushing assembly of Secrest can be
applied in other procedure[ s] for inserting into the patient" and that this is
"within the level of ordinary skill in the medical art." Ans. 14. Appellant
does not inform us of error in this analysis.
6 A reference is analogous art if it "is either in the field of the applicant's
endeavor or is reasonably pertinent to the [particular] problem with which
the inventor was concerned." In re Kahn, 441F.3d977, 987 (Fed. Cir.
2006).
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In Appellant's reply briet: Appellant repeats the contention that
"Martin's shaft 120 has not been shown to have included a lumen." Reply
Br. 5. However, Appellant does not indicate how Martin's figure 1 OB fails
to illustrate that the hollow shaft 120 incorporates a lumen. In other words,
there is no indication that shaft 120 is solid, and Appellant proffers no
evidence that it is.
Appellant also contends that the "Office has relied on impermissible
hindsight" (App. Br. 9), but Appellant does not identify which limitations
were gleaned only from Appellant's disclosure. See In re McLaughlin, 443
F.2d 1392, 1395 (CCPA 1971).
Accordingly, and based on the record presented, we are not of the
opinion the Examiner erred in combining Martin and Secrest for the reasons
stated. We sustain the Examiner's rejection of claims 1, 8, and 15-20 as
being obvious over Martin and Secrest.
The rejection of claims 1, 8, 15, 17, and 20
as unpatentable over Martin and Mayer
Appellant argues claims 1, 8, 15, 17, and 20 together. We select claim
1 for review, with claims 8, 15, 17, and 20 standing or falling with claim 1.
Similar to the arguments above, Appellant contends that "[ t ]he
modification of Martin's tunneler device in view of Mayer's needleless
injection site for intravenous infusions has not been shown to be based on a
solution found in the relevant art." App. Br. 9 (emphasis added); see also
App. Br. 10, 11. Similar to the earlier rejections, the Examiner provides the
same reason to combine Martin and Mayer, i.e., "for the benefit of providing
a flush channel to flush inside the device system." Final Act. 6; see also
Ans. 15. Because it is known to flush catheters and endoscopes (see App.
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Br. 8; Secrest if 5), we do not find fault with the Examiner's stated reason to
combine Martin and Mayer. Furthermore, regarding the non-analogous art
argument (see App. Br. 10, Reply Br. 5), Appellant does not dispute that
Mayer is directed to the field of endeavor of "medical arts, and more
particularly to a needleless injection site for use in relation to intravenous
infusions." Mayer 1: 5-7. Appellant's contention is not persuasive of
Examiner error.
Appellant also contends that the "Office has relied on impermissible
hindsight" (App. Br. 11; see also Reply Br. 5), but Appellant does not
identify which limitations were only gleaned from Appellant's disclosure.
See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
Appellant also repeats the argument that "Martin's shaft 120 has not
been shown to have included a lumen." Reply Br. 5. For the reasons
previously discussed, Appellant's contention is not persuasive.
Appellant further contends, "the Office has not shown Mayer to have
described a valve located at a proximal end of a handle." App. Br. 10.
Appellant makes this assertion but does not elaborate how or why the
Examiner erred in (a) correlating Mayer's Y-shaped housing 12 to the
claimed "handle" or (b) finding "wherein the flush valve 28 is being
supported on an outer surface of the handle 12."7 Final Act. 6. Instead,
rather than address the structure disclosed in Mayer, Appellant appears to be
focusing on Mayer's use involving a different procedure (i.e., "intravenous
7 Our reviewing court has stated that 37 C.F.R. § 41.37 requires more
substantive arguments in an appeal brief than a mere recitation of the claim
elements and a naked assertion that the corresponding elements were not
found in the prior art. See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir.
2011).
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infusions"). App. Br. 10. Appellant's focus on what Mayer is used for is
not dispositive that Mayer fails to disclose the recited structure.
Accordingly, and based on the record presented, Appellant's contention is
not persuasive of Examiner error. We sustain the Examiner's rejection of
claims 1, 8, 15, 17, and 20 as unpatentable over Martin and Mayer.
DECISION
The Examiner's rejections of claims 1-20 are 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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