Ex Parte Goode et al

Patent Trial and Appeal Board

Mar 17, 2017

11404666 (P.T.A.B. Mar. 17, 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.
10923/049 (PA-5720-RFB) 1697
EXAMINER
HOLLM, JONATHAN A
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
11/404,666 04/14/2006
48003 7590 0:
BGL/Cook - Chicago
PO BOX 10395
CHICAGO, IL 60610
Louis B. Goode
03/20/2017 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 PATENT TRIAL AND APPEAL BOARD
Ex parte LOUIS B. GOODE, CHUN KEE LUI, BENJAMIN T. EWING,
JOSEPH J. SCHILLINGER, and ROBERT BOOKER
Appeal 2014-004001
Application 11/404,666
Technology Center 3700
Before ANNETTE R. REIMERS, JILL D. HILL, and
PAUL J. KORNICZKY, Administrative Patent Judges.
REIMERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Louis B. Goode et al. (Appellants) appeal under 35 U.S.C. § 134(a)
from the Examiner’s decision to reject claims 1—6, 9, 10, 30, 31, 34, and
36—38. Claims 39-42 have been withdrawn from consideration. Claims 7,
8, 11—29, 32, 33, and 35 have been canceled.1 We have jurisdiction under
35 U.S.C. § 6(b).
1 Appellants submitted an Amendment After Final Action canceling claim 32.
See Response After Final Act. (filed July 25, 2013). In the Advisory Action,
the Examiner states that “the proposed amendment(s)” “will be entered.”
Advisory Act. Summary Sheet (mailed Aug. 12, 2013); see also Br. 16 n.3.
Appeal 2014-004001
Application 11/404,666
We AFFIRM.
CLAIMED SUBJECT MATTER
The claimed subject matter “relates to devices for separating an
implanted elongated structure, such as an implanted electrical pacemaker or
defibrillator lead, from encapsulating biological tissue.” Spec. 12, Figs. 1,
18. Claims 1 and 30 are independent.
Claim 1 is illustrative of the claimed subject matter and recites:
1. A device for removing an implanted structure from a body
vessel, the device comprising:
an elongated sheath having a proximal end, a distal end,
and a passageway extending therethrough, said sheath having a
length such that at least a distal portion of said sheath is
receivable in said body vessel, said passageway sized such
that said implanted structure is receivable therein;
a tip engaged with said sheath distal end for disassociating
at least a portion of said implanted structure from said body
vessel, said tip comprising a proximal end portion and a distal
end portion, said proximal end portion configured for
engagement with said sheath distal end, said tip comprising a
disruptor mechanism disposed along an outer surface of said
distal end portion, said disruptor mechanism comprising a
plurality of helices, each of said helices spanning a length of said
distal end portion outer surface to an outer surface of said
proximal end portion; and
a handle configured and arranged to receive said sheath
proximal end, said handle including an actuator and a drive
mechanism responsive to said actuator, said drive mechanism
operable for selectively translating linear motion of said actuator
into rotational motion of said sheath.
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REJECTIONS
I. Claims 1, 2, and 9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Goode (US 5,013,310, iss. May 7, 1991),
Hooven (US 5,814,044, iss. Sept. 29, 1998), McCorkle (US
4,576,162, iss. Mar. 18, 1986), and Clark (US 4,030,503, iss. June
21, 1977).
II. Claims 3 and 4 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Goode, Hooven, McCorkle, Clark, Mella (US
3,756,090, iss. Sept. 4, 1973), and Dekel (US 5,591,187, iss. Jan.7,
1997).
III. Claim 5 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Goode, Hooven, McCorkle, Clark, Mella, Dekel, and Ritchart
(US 5,913,857, iss. June 22, 1999).
IV. Claims 6 and 38 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Goode, Hooven, McCorkle, Clark, and Ritchart.
V. Claim 10 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Goode, Hooven, McCorkle, Clark, and Domingo (US
2002/0143358 Al, pub. Oct. 3, 2002).
VI. Claims 30, 31, and 36 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Goode, Hooven, McCorkle, and Clark.
VII. Claim 34 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Goode, Hooven, McCorkle, Clark, and Domingo.
VIII. Claim 37 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Goode, Hooven, McCorkle, Clark, and Ritchart.
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Application 11/404,666
ANALYSIS
Rejection I— Obviousness over Goode, Hooven,
McCorkle, and Clark
Claims 1, 2, and 9
Appellants do not provide arguments for dependent claims 2
and 9 separate from those provided for claim 1. Br. 13. We select
claim 1 as the representative claim, and claims 2 and 9 stand or fall
with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner finds that Goode discloses a majority of the limitations
of claim 1. Final Act. 2—3. The Examiner relies on Hooven for disclosing a
handle. Id. at 3. The Examiner concludes it would have been obvious to
modify the device of Goode “to include a handle, as taught by Hooven, in
order to provide a user with easy, one-handed operation to rotate the sheath
to disrupt and separate tissue from an implanted lead.” Id. at 4. The
Examiner finds that the tip of the modified Goode device includes “an edge
having a number of teeth to separate tissue from an implanted lead . . .
instead of a plurality of helices disposed along the tip distal end outer
surface spanning a length of the tip distal end outer surface to the tip
proximal end outer surface,” as claimed. Id. (citing Goode, 8:64—67). The
Examiner relies on McCorkle for disclosing a “disruptor mechanism
including a plurality of disruptor/cutting elements (40A) disposed along the
tip distal end outer surface, each of the disruptor/cutting elements spanning a
length of the tip distal end outer surface to the tip proximal end outer surface
. . . to separate tissue from an implanted lead.” Final Act. 4 (citing
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McCorkle, 102:55 — 11:12, Figs. 9, 10, 13A). The Examiner determines that
the device tips of Goode and McCorkle are “equivalents recognized in the
art to achieve separation of tissue from an implanted lead.” Final Act. 4.
The Examiner concludes that
because these two tissue separation tips were art recognized
equivalents at the time the invention was made, one of ordinary
skill in the art would have found it obvious, as a matter of simple
substitution, to substitute the tip of McCorkle for the tip in the
modified device of [Goode] in view of Hooven in order to
achieve the predictable result of tissue separation from the lead
upon rotation of the sheath and tip.
Id. at 4—5.
The Examiner further finds that the modified Goode device “discloses
the invention substantially as claimed, except that each of the
disruptor/cutting elements [is] ‘linear . . . instead of being helical.’” Id. at 5
(citing McCorkle, 10:55—11:62, Figs. 9—13A). The Examiner relies on Clark
for disclosing “a disruptor/cutting element (12’) with a helical shape on an
outer, distal surface of a device tip to facilitate cutting into tissue.” Id.
(citing Clark, 1:57—64). The Examiner concludes it would have been
obvious “to modify each of the disruptor/cutting elements” of the modified
Goode device “[to] be helical, in view of Clark, in order to enhance tissue­
cutting action of the device tip to facilitate separation of tissue from the
implanted lead.” Final Act. 5.
2 The Examiner cites column 12 instead of column 10. We consider this a
typographical error.
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Appellants contend that Goode fails to disclose a handle including an
actuator and a drive mechanism or disrupting mechanism including a
plurality of helices as claimed. See Br. 5. Appellants further contend that
“[a]s with the Goode reference, Hooven does not disclose a tip engaged with
the sheath having a disruptor mechanism. Nor does Hooven teach or suggest
a disruptor mechanism comprising a plurality of helices, or any analogous
disrupting structure.” Id.
Appellants’ contentions are not persuasive because nonobviousness
cannot be established by attacking the applied references individually when
the rejection is predicated upon a combination of prior art disclosures. See
In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). In this case, the
Examiner relies on McCorkle and Clark for these limitations. See Final Act.
2-5.
Appellants contend that the Examiner’s “characterization of [the] two
very different tips [of Goode and McCorkle] as ‘art-recognized
equivalents,”’is “overly-broad.” Br. 8. In particular, Appellants contend
McCorkle teaches . . . that it is necessary to use the entire device
. . . including the sequentially-arranged tips and the grasping
mechanism, in order to achieve the benefits of the device. No
suggestion is made that a single tip having the radially directed
serrations would provide sufficient cutting action in the absence
of the remainder of this complex device. ... Goode, on the other
hand, does not teach or suggest any necessity of providing
disrupting structure along the outer surface of the tip, and teaches
that a single tip having axially directed teeth is sufficient.
Id. at 8—9.
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Additionally, Appellants “dispute any alleged art-recognized
equivalence of a tip having axially-directed cutting teeth at the leading (i.e.,
distal) end of the tip of Goode, and the structure of McCorkle that requires
multiple tips each having radially-directed linear serrations spaced from a
smooth distal edge.” Br. 8. Appellants conclude “that the explanation
provided by the Examiner does not provide sufficient support to infer
that somehow a skilled artisan would infer that tips having axially leading
cutting features are equivalent to tips having radially directed features along
the outer surface of the tip.” Id. at 9.
At the outset, the Examiner correctly points out that “it is not the case
that the entire system of McCorkle is substituted for the system of Goode.
The combination of the references sets forth a substitution of cutting tips
[i.e., substituting the cutting tip of McCorkle for the cutting tip of Goode],
not of entire lead removal systems.” Ans. 3; see also Advisory Act. 2—3;
Final Act. 4—5. The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the structure of a
primary reference. In re Keller, 642 F.2d 413, 425 (CCPA 1981). “Rather,
the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art.” Id.', see also Ans. 3; Advisory
Act. 2.
Further, in response to Appellants’ contention that use of the entire
device of McCorkle is necessary to “provide sufficient cutting action” (see
Br. 8—9), the Examiner states “[although the system of McCorkle utilizes
multiple cutting tips to retrieve an implanted cardiac lead, McCorkle teaches
that each individual cutting tip is configured for independent rotation to
independently cut tissue from the implanted lead.” Ans. 2 (citing McCorkle,
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11:43—62); see also Advisory Act. 2. The Examiner reasons that “[e]ach
individual tip taught by McCorkle has an individual utility to cut/disrupt
encapsulating tissue that aids in the function of the system as a whole, and
such utility is recognized and provided independently of the function of
other components of the system.” Ans. 2; see also Advisory Act. 2. The
Examiner concludes that a skilled artisan “would recognize that each
individual cutting tip taught by McCorkle is configured to cut tissue from
the lead and would further recognize that the use of multiple tips, although
sufficient to separate tissue from an implanted lead, is not required for
cutting tissue from the lead.” Ans. 2—3; see also Advisory Act. 2. The
Examiner’s findings and conclusions are supported by the record and based
on rational underpinnings. Appellants do not apprise us of error in the
Examiner’s findings or conclusions.
In response to Appellants’ contention that “art-recognized
equivalency between the tips taught by Goode and McCorkle was not
sufficiently shown or supported” (see Ans. 4; see also Br. 9), the Examiner
finds:
The [Goode] and McCorkle references show the different tips
operating in similar environments and by similar modes of
operation to achieve the predictable result of tissue separation
from a lead, thus reasonably supporting a finding of art-
recognized equivalency. The cutting tip taught by Goode
includes cutting elements (teeth; column 9, lines 64-67) and is
advanced within a blood vessel over an implanted cardiac lead
and rotated by a sheath connected thereto to cut tissue from the
implanted cardiac lead (column 9, lines 5-25). Similarly, the
cutting tip taught by McCorkle includes cutting elements
(serrations; column 10, lines 63 — column 11, line 12) and is
advanced within a blood vessel over an implanted cardiac lead
and rotated by a sheath connected thereto to cut tissue from the
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implanted cardiac lead (column 11, lines 43-57). As cited and
described in the combination, the prior art showed that the
respective cutting tips taught by Goode and McCorkle operate in
a similar manner (i.e., rotating to provide a cutting action) under
similar conditions (i.e., within a blood vessel cutting tissue
encapsulating an implanted lead) to achieve the same predictable
result (cutting of tissue from an implanted lead).
Ans. 3^4; see also Advisory Act. 3. The Examiner concludes that a skilled
artisan “would have recognized that the cutting tips taught by Goode and
McCorkle were equivalent structures recognized in the art for cutting tissue
from an implanted cardiac lead, and thus were art-recognized equivalents at
the time the invention was made.” Ans. 4; see also Advisory Act 3^4. The
Examiner’s findings and conclusions are supported by the record and based
on rational underpinnings.
Even if, as argued by Appellants, the tips of Goode and McCorkle
“carry out their cutting, or disrupting, functions in very different manners”
(see Br. 8, 11), that does not undercut the Examiner’s findings and reason to
combine the teachings of Goode and McCorkle in rendering obvious the
claimed subject matter. Appellants neither point to any lack of rational
underpinnings supporting the Examiner’s combination, nor provide any
evidence that the claimed invention achieves unexpected or surprising
results over that which was known in the art.
To the extent that Appellants’ argument regarding the cutting features
of Goode and McCorkle is to the effect that persons of ordinary skill in the
art would not substitute radially directed cutting features for axially directed
cutting features when considering the Goode and McCorkle disclosures (see
Br. 8—9), that is not persuasive of nonobviousness. KSR Int'l Co. v. Teleflex
Inc., 550 U.S. 398, 419 (2007) (“[Njeither the particular motivation nor the
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avowed purpose of [Appellants] controls” in an obviousness analysis.). The
rejection is grounded in the principle that a person of ordinary skill in the art
would recognize that the tips taught by Goode and McCorkle are
“equivalents recognized in the art [as alternative structures] to achieve
separation of tissue from an implanted lead,”3 and that the proposed
modification would have been within the level of ordinary skill in the art.
Id. at 417; see also Final Act. 4, 18—19; see also Ans. 4.4
In this case, the Examiner provides “citation and support within the
references and knowledge [within] the level of ordinary skill... to establish
the finding of equivalency, thus the [proposed combination of Goode and
McCorkle meets] the burden of forming a prima facie case of obviousness.”
Ans. 4; see also Br. 11—12.
Appellants contend that “Clark does not show a plurality of helices
spanning a surface from a distal end to a proximal end. Rather, a single
helix 12’ is machined into a rigid screw form, wherein the screw root is
attached to wire 8.” Br. 10 (citing Clark, 1:56—59).
We are not persuaded by Appellants’ contention because it
misapprehends the Examiner’s rejection and is not responsive to the key
aspects of the Examiner’s proposed rejection. At the outset, the Examiner
correctly points out that “the Clark reference is not relied up on for a
teaching of a plurality of cutting elements, such a teaching being provided
3 The Examiner finds “the prior art recognizes each tip taught by McCorkle
and [Goode] as alternative structures to address the same problem of
separating encapsulating tissue from an implanted lead that are utilized in
similar manners (i.e., rotation to disrupt tissue).” Final Act. 18-19.
4 Appellants acknowledge that the cutting tips taught by Goode and McCorkle
“address similar problems.” Br. 9.
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by McCorkle in the plurality of serrations (see at least figures 9-10).” Ans.
6—7; see also Advisory Act. 5; Final Act. 4 ( McCorkle discloses a
“disruptor mechanism including a plurality of disruptor/cutting elements
(40A) disposed along the tip distal end outer surface, each of the
disruptor/cutting elements spanning a length of the tip distal end outer
surface to the tip proximal end outer surface.”), id. at 19. The Examiner
further finds that “[i]n the combination, the shape of each of the plurality of
serrations of [Goode with McCorkle is] modified to be helical, in view of the
teachings of Clark, in order to enhance tissue-cutting action of the device tip
to facilitate separation of tissue from the implanted lead.” Ans. 7; see also
id. at 5; Advisory Act. 4; Final Act. 5, 19-20. Appellants’ argument does
not account for these findings by the Examiner.
Appellants contend that
the skilled artisan seeking to remove a lead from a vessel would
not be inclined to follow the teachings of Clark, and indeed,
would likely disregard such teachings, as the teachings
emphasize the suitability of the disclosed structure for aggressive
cutting action of a type that is to be avoided when removing an
implanted structure, such as a cardiac lead, from a vessel.
Br. 10—11; see also id. at 12—13.
At the outset, Appellants’ argument is not persuasive because it
amounts to unsupported attorney argument, and, thus, is entitled to little, if
any, weight. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)
(arguments and conclusions unsupported by factual evidence carry no
evidentiary weight); see also Ans. 5—6; Advisory Act. 4—5. In response to
Appellants’ argument, the Examiner finds that
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[t]he Goode and McCorkle references both provide evidence that
cutting elements on cutting tips that are rotated within a blood
vessel are acceptable and effective means to cut tissue in lead-
removal applications. Further, one of ordinary skill in the art
would not recognize the cutting action taught by Clark to be
“aggressive”, as alleged by Appellant, since the Clark reference
teaches the helical cutting element being configured to inhibit
unintentional forward cutting (column 1, lines 60-64). This
consideration aligns with the teachings of McCorkle concerning
avoidance of forward cutting the lead (column 11, lines 1-12).
Ans. 6; see also Advisory Act. 5; Final Act. 20—21. The Examiner
concludes that a skilled artisan “would have readily recognized the
applicability of the teachings of Clark to the cutting tip of [Goode as
modified by] McCorkle and would been motivated to modify the cutting tip
of [Goode as modified by] McCorkle in view of the teachings of Clark.”
Ans. 6; see also Advisory Act. 5. The Examiner’s findings and conclusions
are supported by the record and based on rational underpinnings. Appellants
do not apprise us of error in the Examiner’s findings or conclusions.
Appellants further contend that the Examiner engages in impermissible
hindsight in combining the references. Br. 12—13.5 We are not persuaded.
The Examiner cites specific teachings in the references themselves, not
Appellants’ disclosure, in support of the Examiner’s articulated reasoning
5 Appellants contend that combining “structure from a second, third,
and fourth reference (Goode, Hooven, [McCorkle,] Clark) is classic
hindsight reconstruction.” See Br. 12. We note, however, that reliance
on an allegedly large number of references in a rejection does not,
without more, weigh against the obviousness of the claimed invention.
In re Gorman, 933 F.2d 982, 986, 987 (Fed. Cir. 1991).
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for combining the references as proposed in the rejection. See Final Act. 2—
5; see also Ans. 7; Advisory Act. 6.
Accordingly, for the foregoing reasons, we sustain the Examiner’s
rejection of independent claim 1 as unpatentable over Goode, Hooven,
McCorkle, and Clark. We further sustain the rejection of claims 2 and 9,
which fall with claim 1.
Rejections II— V— Obviousness over Goode, Hooven,
McCorkle, Clark, and any of Mella, Dekel,
Ritchart, and Domingo
Claims 3—6, 10, and 38
Appellants contend that each of claims 3—6, 10, and 38 includes the
limitations of claim 1 “including the limitations with respect to the
configuration of the tip,” and that none of Mella, Dekel, Ritchart, or
Domingo address the “shortcomings” of the combination of Goode, Hooven,
McCorkle, and Clark. See Br. 13—16
For the reasons discussed above, we find no deficiencies in the
Examiner’s rejection of independent claim 1 as unpatentable over Goode,
Hooven, McCorkle, and Clark. As Appellants do not present any arguments
for claims 3—6, 10, and 38 separate from those presented for claim 1, we
likewise sustain the Examiner’s rejections of these claims.
Rejection VI— Obviousness over Goode, Hooven,
McCorkle, and Clark
Claims 30, 31, and 36
Appellants do not provide arguments for dependent claims 31
and 36 separate from those provided for claim 30. Br. 16—17. We
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select claim 30 as the representative claim, and claims 31 and 36 stand
or fall with claim 30. 37 C.F.R. § 41.37(c)(l)(iv).
Appellants present similar arguments for claim 30 as those
presented for claim 1. Br. 16. As discussed above for claim 1,
Appellants’ arguments are not persuasive. Appellants further contend
that the combined teachings of Goode, Hooven, McCorkle, and Clark
“fail to teach or suggest a plurality of helices for disrupting tissue that
span the axial length of a large diameter distal tip portion as claimed.”
Id.
In this case, the Examiner finds that “McCorkle teaches [] each of the
plurality of disruptor/cutting elements spanning the axial length of the larger
diameter distal end tip [portion] (see figures 9-10 and 13 A)” and “Clark
teaches forming a cutting element to be helical (column 1, lines 57-64).”
See Final Act. 21; see also id. at 13—14, Ans. 9; Advisory Act. 7.
The Examiner concludes that
each of the disruptor/cutting elements is helical (in view of
Clark) and spans the axial length of the tip larger diameter distal
end portion outer surface to the smaller diameter tip proximal
end portion outer surface (in view of McCorkle) in the modified
device of Goode in view of Hooven, McCorkle, and Clark.
Final Act. 21; see also Ans. 10. The Examiner’s findings and conclusions
are supported by the record and based on rational underpinnings. Appellants
do not apprise us of error in the Examiner’s findings or conclusions.
Accordingly, for the foregoing reasons, we sustain the Examiner’s
rejection of independent claim 30 as unpatentable over Goode, Hooven,
McCorkle, and Clark. We further sustain the rejection of claims 31 and 36,
which fall with claim 30.
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Rejections VII & VIII— Obviousness over Goode, Hooven,
McCorkle, Clark, and either Ritchart or Domingo
Claims 34 and 37
Appellants contend that each of claims 34 and 37 includes the
limitations of claim 30 “including the limitations with respect to the
configuration of the tip” and that neither Ritchart or Domingo address the
“shortcomings” of the combination of Goode, Hooven, McCorkle, and
Clark. See Br. 17.
For the reasons discussed above, we find no deficiencies in the
Examiner’s rejection of independent claim 30 as unpatentable over Goode,
Hooven, McCorkle, and Clark. As Appellants do not present any arguments
for claims 34 and 37 separate from those presented for claim 30, we likewise
sustain the Examiner’s rejections of these claims.
DECISION
We AFFIRM the decision of the Examiner to reject claims 1—6, 9, 10,
30, 31, 34, and 36—38.
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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