Ex Parte Wenchell et al

Patent Trial and Appeal Board

Sep 26, 2016

12409149 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/409,149 0312312009
50855 7590 09/28/2016
Covidien LP
555 Long Wharf Drive
Mail Stop SN-I, Legal Department
New Haven, CT 06511
FIRST NAMED INVENTOR
Thomas W enchell
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.
H-US-00295CON
(203-3568CO
CONFIRMATION NO.
1807
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
09/28/2016 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):
mail@cdfslaw.com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS WENCHELL and RICHARD D. GRESHAM
Appeal2014-009599
Application 12/409,149
Technology Center 3700
Before JENNIFER D. BAHR, LINDA E. HORNER, and
BRANDON J. WARNER, Administrative Patent Judges.
WARNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Thomas Wenchell and Richard D. Gresham ("Appellants") 1 appeal
under 35 U.S.C. § 134(a) from the Examiner's decision rejecting claims 1---6,
10-13, 17-19, 21-23, 25, and 26, which are all the pending claims. See
Appeal Br. 2. We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM.
According to Appellants, the real party in interest is Covidien LP.
Appeal Br. 1.
Appeal2014-009599
Application 12/409,149
CLAIMED SUBJECT MATTER
Appellants' disclosed invention relates to "apparatus and methods for
accessing the interior of the body for performing surgery, diagnostics[,] or
other medical procedures." Spec. 1. Claims 1, 13, and 25 are independent.
Claim 1, reproduced below, is illustrative of the subject matter on appeal.
1. A trocar access assembly comprising:
a sheath tube extending along a longitudinal axis, the
sheath tube having a proximal end positioned closest to a user
during proper use of the trocar access assembly, and a distal end
positioned furthest from a user during proper use of the trocar
access assembly, the sheath tube including an elastic portion,
and a tip portion secured to a distal end of the elastic portion;
an anchor sleeve having proximal and distal ends
positioned about the sheath tube, the distal end of the anchor
sleeve being fixedly secured to a distal end of the tip portion;
and
an obturator insertable through the sheath tube such that a
distal end of the obturator extends distally beyond the tip
portion, whereby the obturator is engag[e]able with a patient's
tissue to facilitate advancement of the trocar access assembly
through the tissue;
wherein a portion of the obturator is configured and
dimensioned to contact the tip portion of the sheath tube such
that distal advancement of the obturator causes at least a portion
of the anchor sleeve to be axially elongated and a radial cross-
section of the portion of the anchor sleeve to become smaller,
and wherein when the obturator is retracted from the anchor
sleeve, the obturator causes the portion of the anchor sleeve to
be axially shortened and the radial cross-section of the portion
of the anchor sleeve to become larger such that the portion of
the anchor sleeve having the enlarged radial cross-section
engages an inner surface of an incision.
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Application 12/409,149
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Quinn
Taylor
us 5,865,816
us 5,935,107
REJECTION
Feb.2, 1999
Aug. 10, 1999
The following rejection is before us for review: Claims 1---6, 10-13,
17-19, 21-23, 25, and 26 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Quinn and Taylor.
ANALYSIS
Appellants present arguments against the rejection of independent
claims 1, 13, and 25 together as a group (see Appeal Br. 6-17; Reply
Br. 2-5), and present additional argument against the rejection of dependent
claims 10 and 18 (see Appeal Br. 17-19). We select independent claim 1 as
representative of the issues that Appellants present in the appeal of this
rejection, with claims 2-6, 12, 13, 17, 21-23, 25, and 26 standing or falling
therewith. See 37 C.F.R. § 41.37(c)(l)(iv). We address the additional
arguments directed to dependent claims 10, 11, 18, and 19 infra. 2
Claims 1-6, 12, 13, 17, 21-23, 25, and 26
The Examiner found that Quinn discloses a trocar access assembly,
substantially as claimed, including ... "a sheath tube 41," "an anchor sleeve
2 Claims 11 and 19 depend from claims 10 and 18, respectively. See
Appeal Br. 22, 24, Claims App.
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Application 12/409,149
51," and "[a]n obturator 97." Final Act. 2-3 (citing Quinn, Figs. 1, 5,
12-14; col. 8, 11. 6-9). Next, the Examiner acknowledged that Quinn "does
not disclose the distal end of the obturator extending through the device such
that it is engageable with a patient's tissue and also contacting the tip portion
(as opposed to contacting the bolus)." Id. at 3. However, the Examiner
noted that "Quinn does disclose an alternative embodiment without the
bolus 16." Id. (citing Quinn, Fig. 27; col. 12, 11. 6-13).
The Examiner also found that "Taylor discloses a trocar assembly
with an expandable member on tube 40" and "an obturator 25 which has a
shoulder 78 ... to engage a shoulder 48 ... on the tube (figure 7) to move
the tube into a low-profile insertion position." Id. at 4 (citing Taylor, col. 5,
11. 3-13, 27--40). The Examiner explained that Taylor's "obturator has a
distal end with either a sharpened tip or an electrode ... to penetrate the
body," after which "the obturator is removed to allow the expandable
member to assume a second position where it engages the cavity it is
inserted into." Id. (citing Taylor, col. 5, 11. 47-58). The Examiner
concluded that, given the teachings of the prior art:
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to modify the distal end of the
sheath tube and distal end of the obturator of Quinn by adding a
shoulder to both and a cutting device to the distal end of the
obturator as taught by Taylor to allow the obturator of Quinn to
penetrate tissue while inserting the device.
Id. The Examiner also concluded that it would have been obvious to one
having ordinary skill in the art "to remove the bolus of Quinn[,] ... as it is
both an identified alternative proposed by the primary reference itself[,] and
the combination ... [with] Taylor changes the way in which the obturator
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Application 12/409,149
engages the catheter to extend it, removing the necessity of the bolus." Id. at
4--5 (citing Quinn, col. 12, 11. 6-13).
Appellants argue that "the interpretation of Quinn set forth in the
Final Office Action constitutes an impermissible hindsight reconstruction of
the disclosed subject matter in view of that which is recited in the pending
claims." Appeal Br. 14. In particular, Appellants assert that the Examiner's
rejection "essentially combines two separate embodiments of ... Quinn" (id.
(citing Final Act. 3, 7)), and that "one skilled in the art would not only find
no motivation to combine the two embodiments ... , but that the
embodiments actually teach away from combination with each other" (id. at
15). According to Appellants, "the [first] embodiment described in
connection with FIGS. 1-3, 5, 12-14 cannot be combined with the [second]
embodiment seen in FIGS. 26-29 in the manner proffered in the Final Office
Action." Id. at 16. Appellants also argue, with respect to Quinn's second
embodiment, that "a person of ordinary skill in the art would not have been
motivated to modify the PEG tube assembly 410 of Quinn" because
"[r]eplacing the PEG tube insertion unit 411 ... with the obturator of Taylor
would render the PEG tube assembly 410 of Quinn unsatisfactory for its
intended purpose, i.e., conventional PEG." Reply Br. 4.
We are not persuaded by Appellants' arguments because they are not
responsive to the rejection presented by the Examiner. The rejection does
not propose combining the two embodiments of Quinn, nor does the
rejection propose modifying the PEG tube assembly 410 of Quinn's second
embodiment. Rather, the rejection proposes the modification of Quinn's
tube assembly shown in Figures 5 and 12-14 (i.e., the first embodiment)
according to the teachings of Taylor. See Final Act. 2-5; see also Ans. 6-7.
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Application 12/409,149
The Examiner clarifies that Quinn's second embodiment (shown in
Figures 26-29) is cited simply as support for the proposed combination with
the teachings of Taylor. See Ans. 6. Namely, Quinn's second embodiment
shows that the tube assembly could operate with an open end having no
bolus. See id. at 7. Moreover, we are not persuaded by Appellants'
contention that the Examiner relied on impermissible hindsight
reconstruction because Appellants do not identify any knowledge relied
upon by 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, 1395 (CCPA 1971).
Appellants argue that "the bolus 16 and the stylet 96 described in
Quinn are in fact required in the first embodiment (FIGS. 1-3, 5, 12-14) in
that advancement of the assembly through the tissue in the disclosed manner
could not take place in the absence of these structures." Appeal Br. 15. This
argument regarding Quinn is not persuasive because it attacks the reference
individually, where the rejection is predicated upon a combination of prior
art disclosures. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986) (citing In re Keller, 642 F.2d 413, 425 (CCPA 1981)). Here, the
Examiner found that Quinn discloses a first embodiment of a trocar access
assembly in which obturator 96 engages bolus 16 to elongate sheath tube 41
and anchor sleeve 51 for advancement into tissue, except that Quinn does
not disclose that obturator 96 extends through sheath tube 41 to engage
tissue or that obturator 96 contacts the tip of the sheath tube for extending
the assembly. Final Act. 2-3. The Examiner relied on Taylor for teaching
obturator 25 having a sharpened tip to extend through a trocar assembly and
penetrate tissue, and for teaching obturator 25 having shoulder 78 to engage
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Application 12/409,149
shoulder 48 of expandable tube 40 for extending the assembly into a low-
profile insertion position. Id. at 4. According to the Examiner, "Taylor
provides the missing step on how to extend the tube without engagement of
the obturator and bolus." Id. Thus, the rejection is based on the combined
teachings of Quinn and Taylor. Appellants' allegation of differences or
shortcomings of Quinn alone is not responsive to the rejection as articulated
by the Examiner and therefore does not apprise us of error.
Appellants argue that "the Quinn disclosure does not suggest an
embodiment which fails to include the disclosed bolus 16, yet utilizes
extension via engagement with the stylet 96." Appeal Br. 16. This
argument is unpersuasive for two reasons. First, to the extent that the
argument appears to urge us to apply a strict teaching, suggestion, or
motivation ("TSM") test for obviousness, rigid application of the TSM test
was explicitly disavowed by the Supreme Court in KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 415, 419 (2007). Second, Appellants' argument does not
address the Examiner's articulated reasoning for the conclusion of
obviousness. Namely, the Examiner reasoned that, given the teachings of
Quinn and Taylor, the proposed modification of Quinn's tube assembly to
remove the bolus, add shoulders to the distal ends of the obturator and tube
assembly, and add a cutting tip to the distal end of the obturator, would
"allow the obturator of Quinn to penetrate tissue while inserting the
device, ... [and] change[] the way in which the obturator engages the
catheter to extend it, removing the necessity of the bolus." Final Act. 4--5.
According to the Examiner, such a modification of Quinn's assembly would
be "useful for Quinn so that a separate, penetrating device and step is not
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Application 12/409,149
required." Ans. 7. Appellants' arguments in this regard do not persuasively
refute the Examiner's reasoned position.
Appellants argue that "it would not have been obvious to use the
obturator of the apparatus for accessing a body cavity of Taylor with the
tube assembly of Quinn." Reply Br. 2. In particular, Appellants assert that
Quinn's tube assembly 10 is a replacement tube assembly, and "a person of
ordinary skill in the art would have appreciated that an obturator for
penetrating tissue/creating a stoma was not necessary as the replacement
tube assembly 10 is received through a preexisting stoma." Id. (citing
Quinn, col. 1, 1. 64 - col. 2, 1. 2; col. 7, 1. 8). This argument is not
convincing because it rests on a presumption that the tube assembly
according to the Examiner's proposed combination of Quinn and Taylor
could only be used to replace a tube in a preexisting stoma. Moreover, even
if a tissue-penetrating obturator was not "necessary" to insert Quinn's tube
into a preexisting stoma, the lack of such a necessity does not apprise us of
error in the Examiner's reasoning that modifying the tube assembly of Quinn
according to the teachings of Taylor would advantageously result in a tube
assembly that can penetrate tissue and insert a tube without requiring a
separate penetrating device and step. See Final Act. 4; Ans. 7.
Appellants also argue that "modifying the tube assembly of Quinn ...
to include an obturator for creating a stoma as taught by Taylor would
change the principle of operation of the tube assembly of Quinn." Reply
Br. 2-3. We are not persuaded by this argument. Although modifying the
tube assembly of Quinn-as proposed by the Examiner-may change the
manner in which the sleeve anchor extends and the tube assembly is inserted
(i.e., by providing tissue penetration and tube insertion without a preexisting
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Application 12/409,149
stoma) and would involve some alteration to Quinn's original device,
Appellants do not provide any factual evidence or persuasive technical
reasoning to explain why such a modification of Quinn' tube assembly
would change the principle of operation of the device such that it would no
longer function as a corporeal access tube assembly (i.e., a medical catheter).
After careful consideration of all the evidence, Appellants' arguments
do not apprise us of error in the Examiner's findings or reasoning for the
conclusion of obviousness with respect to claim 1. Accordingly, we sustain
the rejection of claim 1, and of claims 2---6, 12, 13, 17, 21-23, 25, and 26
falling therewith, under 35 U.S.C. § 103(a) as being unpatentable over
Quinn and Taylor.
Claims 10, 11, 18, and 19
The Examiner found that "the device of Quinn provides an anchor
flange 21 secured to the proximal end of the anchor sleeve, via sheath tube
41." Final Act. 5 (emphasis added). Appellants argue that Quinn fails to
disclose "an anchor flange secured to the proximal end of the anchor
sleeve," as recited in claims 10 and 18. Appeal Br. 19. In particular,
Appellants assert that Quinn's "tube segment 15 ... merely passes through
the bolster 21, [which] is separate from, and movable in relation to, the tube
segment 15." Id. at 18 (citing Quinn, col. 7, 11. 40-44; col. 11, 11. 6-9).
Appellants also assert that Quinn's "bolster 21 is spaced distally from the
casing 51 of the balloon 20, which ... was characterized as the claimed
'anchor sleeve' in the Final Office Action." Id. (citing Final Act. 2).
We are not persuaded by Appellants' arguments. Initially, we note
that there is nothing in the claims that would exclude relative movement
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Application 12/409,149
between the anchor flange and the sheath tube. See Appeal Br. 22, 24,
Claims App. Instead, the claims only require, in relevant part, that the
anchor flange is "secured to the proximal end of the anchor sleeve," without
reciting additional specifics. Id. As stated by our reviewing court in In re
Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998), "the name of the game is
the claim." It is well established that limitations not appearing in the claim
cannot be relied upon for patentability. See In re Self, 671 F.2d 1344, 1348
(CCPA 1982). Further, Appellants' Specification does not require that there
be no movement between the anchor flange and the sheath tube. Rather, the
Specification describes that "anchor flange 22 is fitted around anchor sleeve
20 in a manner which will allow the proximal end of anchor sleeve 20 to
slide distally along sheath tube 14." Spec. 9 (emphasis added). As such, we
agree with the Examiner that Quinn's "anchor flange 21 is secured about
intermediate structure 15/41 (figs 2 and 6) ... as it is not easily separable
from the rest of the device." Ans. 8.
Moreover, we are not persuaded by Appellants' contention that
Quinn's bolster 21 being spaced distally from casing 51 renders it something
other than an anchor flange that is "secured to" the proximal end of an
anchor sleeve, as recited in the claims. As the Examiner found, Quinn's
"anchor flange 21 [is] secured to the proximal end of the anchor sleeve, via
sheath tube 41." Final Act. 5 (emphasis added). The Examiner's position
appears to be that, because Quinn's bolster 21 is secured to the balloon
casing 51 by way of tube 41, Quinn discloses "an anchor flange secured to
the proximal end of the anchor sleeve," as recited in the claims. In this
regard, Appellants do not identify, nor do we discern, anything in the
Specification that would compel a narrower reading of the claim language,
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Application 12/409,149
and, as such, Appellants' arguments do not apprise us of error in the
Examiner's broad-but reasonable---construction of the claim.
Appellants also argue that Taylor fails to cure the asserted deficiency
in the disclosure of Quinn. Appeal Br. 19. As we do not find any deficiency
of Quinn, this argument does not apprise us of error in the Examiner's
rejection.
For the foregoing reasons, we sustain the rejection of claims 10 and
18, and of claims 11 and 19 falling therewith, under 35 U.S.C. § 103(a) as
being unpatentable over Quinn and Taylor.
DECISION
We AFFIRM the Examiner's decision rejecting claims 1---6, 10-13,
17-19, 21-23, 25, and 26 under 35 U.S.C. § 103(a) as being unpatentable
over Quinn and Taylor.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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