Ex Parte Bown et al

Patent Trials and Appeals Board

Feb 26, 2019

14098147 - (D) (P.T.A.B. Feb. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/098,147 12/05/2013 Matthew W. Bown
158673 7590 02/28/2019
ED/Rutan & Tucker, LLP
611 ANTON BL VD
SUITE 1400
COST A MESA, CA 92626
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.
101672.0069P2 6074
EXAMINER
TOWA,RENET
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
02/28/2019 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):
patents@rutan.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte MATTHEW W. BOWN and DAVID M. BUTTS 1
Appeal2018-000783
Application 14/098, 14 7
Technology Center 3700
Before JAMES P. CALVE, MICHELLE R. OSINSKI, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1-20, which are all of the pending claims. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM and enter a NEW GROUND OF REJECTION of
claim 1 pursuant to our authority under 37 C.F.R. § 41.50(b).
1 C.R. Bard, Inc. ("Appellant") is the Applicant as provided in 37 C.F.R.
§ 1.46 and is identified as the real party in interest. Appeal Br. 4.
Appeal2018-000783
Application 14/098,147
THE CLAIMED SUBJECT MATTER
Claims 1 and 16 are the independent claims and are reproduced
below.
1. A method of treating a patient, comprising:
providing a guidewire having an elongate body defining a
proximal end and a distal end, the elongate body including a
shapeable portion disposed proximate the proximal end, the
shapeable portion being malleable so as to be shaped into a shape
and remain in the shape until reshaped;
advancing the distal end of the elongate body into a
vasculature of the patient; and
shaping the shapeable portion of the elongate body into a
first shape that prevents advancement of the guidewire further
into the vasculature of the patient.
16. A method of treating a patient, comprising:
providing a guidewire having an elongate body defining a
proximal end and a distal end, the elongate body including a
shaped portion disposed proximate the proximal end, the shaped
portion comprising a shape memory material and being deflected
from a longitudinal axis defined by an undeflected portion of the
body, wherein the shaped portion is substantially deformable
when a load is applied thereon, and wherein the shaped portion
returns to its undeformed shape when the load is removed;
advancing the distal end of the elongate body into a
vasculature of the patient;
causing the guidewire to cease further advancement into
the vasculature of the patient by bringing the shaped portion into
contact with an apparatus or tissue of the patient at an incision
site.
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Sakamoto
Sahatjian
us 4,925,445
us 5,238,004
2
May 15, 1990
Aug. 24, 1993
Appeal2018-000783
Application 14/098,147
Ressemann
Douk
Ryan
Vaillancourt
us 5,281,203
us 5,827,241
US 2005/0054953 Al
US 2006/0264834 Al
THE REJECTIONS
Jan.25, 1994
Oct. 27, 1998
Mar. 10, 2005
Nov. 23, 2006
I. Claim 1 stands rejected under 35 U.S.C. § I02(b) as anticipated by
Ressemann. Final Act. 2-3.
II. Claims 2--4, 7, 8, 13, and 15-18 stand rejected under 35 U.S.C.
§ I03(a) as unpatentable over Ressemann and Douk. Id. at 3-8.
III. Claims 5, 6, and 19 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Ressemann, Douk, and Vaillancourt. Id. at 8-
10.
IV. Claim 9 stands rejected under 35 U.S.C. § I03(a) as unpatentable
over Ressemann, Douk, and Sakamoto. Id. at 10-11.
V. Claims 10, 11, and 20 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Ressemann, Douk, and Ryan. Id. at 11-13.
VI. Claims 12 and 14 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Ressemann, Douk, and Sahatjian. Id. at 13-14.
OPINION
Rejection I
The Examiner finds that Ressemann discloses a method of treating a
patient, including, among other things, "providing a guidewire 20 ...
including a shapeable portion 72 ... being malleable so as to be shaped into
a shape and remain in the shape until reshaped." Final Act. 2-3. The
Examiner takes the position that retaining means 72 of guidewire 20 in
Ressemann must be shapeable and malleable as it was "given a shape [ of a]
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bend or crimp 72." Ans. 5; see also id. at 6 ("With respect to ... whether
the retaining means 72 is malleable and/or shapeable, the Office submits that
retaining means 72 of Ressemann clearly constitutes a shapeable portion that
is, in fact, a bend or a crimp of the elongated body of the guide wire 20 as
explained supra."). The Examiner also finds that Ressemann discloses the
claimed steps of "advancing the distal end of the elongate body into a
vasculature" and "shaping the shapeable portion of the elongate body into a
first shape that prevents advancement of the guidewire 20 further into the
vasculature of the patient." Final Act. 3 ( citing Ressemann, Abstract, Fig. 2,
3:66-67, 4:1-11, 6:29-36). The Examiner's position is that the "claimed
invention does not require a specific order for the claimed steps to carry out
the method; therefore, it is conceivable that the 'shaping' step immediately
precedes the 'advancing' step." Ans. 3.
Appellant argues that "a logical order [ of the claimed method steps] is
at least implied by the claims as submitted" because the claim recites
"advancing the distal end of the elongate body [ of a guidewire] into a
vasculature of a patient" and "shaping the shapeable portion of the elongate
body [ at the proximal end] into a first shape that prevents advancement of
the guidewire further into the vasculature of the patient." Reply Br. 5;
Appeal Br. 29 (Claims App.). We are not persuaded that grammar or logic
requires performance of the claimed steps in the order written in that the use
of the term "further" in the last limitation of claim 1 may merely mean
preventing advancement of the guidewire beyond the first shape, which is
disposed proximate the proximal end.
Appellant also argues that Ressemann does not teach shaping the
shapeable portion. Appeal Br. 12. Rather, Appellant argues, Ressemann
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teaches restraining means 72 is "pre-manifested in a 'first shape."' Id. at 13.
Appellant argues that "Ressemann does not disclose any method of shaping
the restraining means 72." Id. at 16 ( emphasis omitted). The Examiner
responds that "Ressemann clearly teaches an active step of shaping the
shapeable portion of the elongate body into a first shape" and "claim 1 only
requires shaping the shapeable portion to a first shape, e.g., the claim does
not require additional shapes." Ans. 8. The Examiner also responds that
"claim 1 does not make a distinction between a pre-formed shapeable
portion and a shapeable portion that is shaped during use of the guide wire"
and "whether or not said shapeable portion is shaped during manufacturing
or during use is completely moot." Id. at 8-9. We agree with the Examiner
that Ressemann teaches shaping a shapeable portion into a first shape as
evidenced by the shaped portion illustrated in Figure 2.
Appellant also argues that "merely providing a bend or crimp does not
support a conclusion that the bend or crimp is shapeable and malleable,
especially when Ressemann is silent with respect to materials and
corresponding characteristics." Reply Br. 4; see also Appeal Br. 12 (stating
that Ressemann fails to discuss how restraining means 72 is shaped, the
properties of restraining means 72, and/or the material of which restraining
means 72 is comprised and the shape of restraining means 72 is pre-formed).
The Examiner responds that "the claim language merely requires a
'shapeable portion' that is 'a portion capable of being given a particular
form or shape,' regardless of how the shapeable portion is shaped." Ans. 6
( emphasis omitted). The Examiner also responds that "the claim requires
'the shapeable portion being malleable so as to be shaped into a shape and
remain in the shape until reshaped."' Id. at 4. The Examiner has adequately
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Application 14/098,147
explained how restraining means 72 of Ressemann is shapeable, i .. e.,
capable of being given a particular form or shape, in that it has indeed been
shaped. The Examiner has also adequately explained how restraining means
72 of Ressemann is malleable as that term is defined in the claim, i.e., can be
shaped into a shape and remain in the shape until reshaped, in that there is
no indication in Ressemann that the shape of restraining member 72 is
temporary and will not remain in its shape until reshaped.
For the foregoing reasons, Appellant has not apprised ofus of error in
the Examiner finding that the subject matter of claim 1 is anticipated by
Ressemann. We sustain the rejection ofclaim 1 under 35 U.S.C. § 102(b) as
anticipated by Ressemann.
Rejection II
Claims 2-4, 7, and 8
The Examiner finds that Ressemann teaches restraining member 72
"interacting in contact with the apparatus 40 to prevent advancement of the
guidewire 20 further into the vasculature of the patient." Final Act. 3 ( citing
Ressemann, Abstract, Fig. 2, 3:66-67, 4:1-11, 6:29-36). The Examiner
acknowledges that Ressemann "fails to explicitly teach ... advancing an
apparatus over the guidewire to an incision site ... before shaping the
shapeable portion of the elongate body into the first shape." Final Act. 3.
The Examiner turns to Douk, finding that "it is known to ...
advanc[e] an apparatus 10 over the guidewire 12 to an incision site ...
before shaping the shapeable portion 3 8 of the elongated body into the first
shape." Id. at 4 (citing Douk, Abstract, Figs. 2-5, 1:18-24). The Examiner
concludes that it would have been obvious to advance apparatus 40 over
guidewire 20 before shaping shapeable portion 72 into the first shape "in
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order to selectively reduce the possibility that the proximal end of the guide
wire might slide distally of the proximal opening of the apparatus." Id.
Appellant argues that Douk fails to teach advancing an apparatus over
the guidewire, let alone doing so before shaping the shapeable portion.
Appeal Br. 17. We disagree with Appellant's argument because Douk
teaches advancing guidewire 12 and then advancing catheter 10 over
guidewire 12 to place balloon 22 within a stenosis (Douk, 10:18-36), and
then "deforming the proximal region of the guidewire 12" (id. at 10:41)
( emphasis omitted). Douk specifically identifies this deformation as an
alternative to "begin[ ning] the procedure with a guidewire having a pre-
formed non-linear segment" (id. at 10:43--45). Thus, Douk teaches the
advancement of apparatus 10 over guidewire 12 prior to shaping guidewire
12 and provides motivation for one of ordinary skill in the art to have been
led to modify Ressemann so as to place apparatus 40 over guidewire 20 prior
to shaping shapeable portion 72.
Appellant also argues that "Douk discloses a proximal end of the
guidewire that is inelastically or permanently deformed and does not teach
that the curved segment 3 8 is shapeable as required." Appeal Br. 1 7
( emphasis omitted). However, when considering Douk, it describes "a non-
linear segment formed permanently (i.e., inelastically) in the proximal
region of the guidewire" (Douk, 8:57-60) and contrasts this with a "bend
which is not permanent (i.e., which is elastically deformed)" (id. at 9:21-
22). Moreover, Douk describes that permanent deformation "is permanent in
the sense that the deformed portion of the guidewire will remain in the non-
linear shape in the absence of external stress" (id. at 9:27-31 ). Given this
description of its permanent or inelastic deformation, we understand Douk to
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Application 14/098,147
teach curved segment 3 8 of its guidewire 12 to be shapeable in that it is able
to be reshaped with the application of external stress.
Appellant also argues that Douk' s "segment 3 8 is not disposed
proximate the proximal end" because Douk discloses that "'[t]he non-linear
segment 3 8 should be formed far enough from the free proximal extremity
of the guidewire to leave a proximal tail 39 sufficiently long so that the
proximal extremity of the guidewire will be exposed proximally of the
guidewire leg 26."' Appeal Br. 17 (emphasis omitted) (quoting Douk, 8:38-
42). The Examiner responds that "Appellant does not appear to dispute the
teachings ... in the primary reference of Ressemann of a shapeable portion
72 that is disposed proximate the proximal end of the guide wire 20 (see at
least [F]ig. 2)." Ans. 13. We agree with the Examiner that modification to
Ressemann with the teachings of Douk extends to advancing apparatus 40
over guidewire 20 before shaping shapeable portion 72 into the first shape,
not to modifying the location of shapeable portion 72 relative to the
proximal end of the guidewire 20.
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the combination of Ressemann and Douk renders
obvious the subject matter of claim 2. We sustain the rejection of claim 2
under 35 U.S.C. § 103(a) as unpatentable over Ressemann and Douk. We
also sustain the rejection of claims 3, 4, 7, and 8, for which Appellant relies
on the same arguments and reasoning we found unpersuasive in connection
with dependent claim 2. See Appeal Br. 17-19.
Claim 13
Dependent claim 13 recites "providing the shapeable portion with a
length of about 10 cm." Appeal Br. 30 (Claims App.). The Examiner finds
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that Douk teaches a "shapeable portion 3 8 with a length of about 8 cm,
which may be varied." Final Act. 5 (citing Douk 8:57---66). The Examiner
concludes that it would have been obvious to vary the length of the
shapeable portion as taught by Douk. Id.
In addition to relying on the same arguments and reasoning we found
unpersuasive in connection with claim 2 (Appeal Br. 19), Appellant also
argues that "Douk fails to teach an embodiment having a length of about 10
cm" and "[ a ]lthough variance with regard to the length L is considered by
Douk, the scope of such variance is not taught" (id. at 20).
We view the length of the shapeable portion as a design choice within
the ordinary skill of the art in the absence of any evidence to support the
criticality of a length of 10 cm. In re Gardner v. TEC Syst., Inc., 725 F.2d
1338, 1349 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (holding that, where
the only difference between the prior art and claims was recitation of relative
dimensions of the claimed device and a device having the claimed
dimensions would not perform differently than the prior art device, the
claimed device was not patentably distinct from prior art device); see also In
re Kuhle, 526 F.2d 553, 555 (CCPA 1974) (use of claimed feature solves no
stated problem and presents no unexpected result and "would be an obvious
matter of design choice within the skill of the art" ( citations omitted)).
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the combination of Ressemann and Douk renders
obvious the subject matter of claim 13. We sustain the rejection of claim 13
under 35 U.S.C. § 103(a) as unpatentable over Ressemann and Douk.
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Application 14/098,147
Claim 15
Claim 15 recites "reshaping the shapeable portion of the elongate
body from the first body shape into a second shape different from the first
shape." Appeal Br. 31 (Claims App.). The Examiner concludes that:
since Ressemann teaches that the proximal portion of the
guidewire may be bent or crimped so as to selectively reduce the
possibility that the proximal end of the guide wire might slide
distally of the proximal opening of the apparatus (see at least fig.
2; col. 6, lines 29-36), it would have been obvious to one of
ordinary skill in the art at the time Applicant's invention was
made to provide the method of Ressemann as modified by Douk
et al. further comprising reshaping the shapeable portion of the
elongate body from the first shape into a second shape different
from the first shape in order to bend or crimp the proximal
portion of the guidewire until a shape that reduces the possibility
that the proximal end of the guide wire might slide distally of the
proximal opening of the apparatus is reached.
Final Act. 5---6.
Appellant argues that "the Examiner concludes without rationale that
Ressemann as modified by Douk would teach ... reshaping the shapeable
portion of the elongate body." Appeal Br. 21. Appellant further argues that
"Douk does not even teach a shapeable portion, let alone reshaping that
portion into a second portion that is different from a first shape." Id.
Appellant, however, does not address the Examiner's articulated reasoning
or explain why this particular reasoning lacks rational underpinnings-i.e.,
that one of skill in the art would be led to reshape the shapeable portion into
more than one configuration, as needed, until a satisfactory shape that
reduces distal sliding of the guidewire is achieved. See Ans. 6.
Moreover, the Examiner's rationale identifies "selectively reduc[ing]
the possibility that the proximal end of the guide wire might slide distally"
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(id. at 5---6 ( emphasis added)), which suggests that in some instances it may
be desirable to not reduce the possibility of preventing distal sliding of the
guidewire, such that one of ordinary skill in the art might be led to reshape
the reshapable portion back into a straight portion in order to allow selective
sliding of the guidewire distally.
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the combination of Ressemann and Douk renders
obvious the subject matter of claim 15. We sustain the rejection of claim 15
under 35 U.S.C. § 103(a) as unpatentable over Ressemann and Douk.
Claim 16
Independent claim 16 recites "the shaped portion comprising a shape
memory material and being deflected from a longitudinal axis defined by an
undeflected portion of the body, wherein the shaped portion is substantially
deformable when a load is applied thereon, and wherein the shaped portion
returns to its undeformed shape when the load is removed." Appeal Br. 31
(Claims App.). The Examiner finds that Douk teaches that the foregoing is
known and concludes that it would be obvious to modify the method of
Ressemann "in order to selectively reduce the possibility that the proximal
end of the guide wire might slide distally of the proximal opening of the
apparatus." Final Act. 7.
In addition to the same arguments and reasoning we found
unpersuasive in connection with other claims (Appeal Br. 21-22), Appellant
also argues that Douk teaches "the segment 3 8 is inelastically deformed or
pre-formed-the exact opposite of what is required." Id. at 22. The
Examiner responds that Douk also teaches elastic deformation. Ans. 12-13
(citing Douk, 8:15-20, 49-56). More specifically, the Examiner finds that
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"Douk specifically teaches that an elastic material such as shape memory
alloys may alternatively be used in lieu of an inelastic material such as
stainless steel to achieve a shapeable portion in order to selectively reduce
the possibility that the proximal end of the guide wire might slide distally of
the proximal opening of the apparatus." Id. at 17-18 ( citing Douk 8: 15-20,
26-32, 38-56, 15:1--47). Appellant does not respond with sufficient
particularity to the Examiner's specific findings regarding Douk's disclosure
of elastic or non-permanent deformation so as to persuade us of error in the
Examiner's findings. See Reply Br. 9.
Appellant also argues that "the Examiner does not explain how [ the
articulated reasoning] is any different from what Ressemann already
allegedly does or how the incorporation of a shape memory material makes
this any[] more possible." Appeal Br. 22. The Examiner reasons that
modifying Ressemann so as to have restraining means 72 comprised of a
shape memory material would allow non-permanent, elastic deformation that
returns restraining means 72 to an undeformed state in order to selectively
reduce the possibility of the proximal end of guide wire 20 from sliding
distally of proximal opening 52 of guidewire sheath 40. Final Act. 7.
Appellant has not adequately explained why this articulated reasoning lacks
rational underpinnings.
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the combination of Ressemann and Douk renders
obvious the subject matter of claim 16. We sustain the rejection of claim 16
under 35 U.S.C. § 103(a) as unpatentable over Ressemann and Douk.
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Claims 17 and 18
Dependent claim 1 7 recites "advancing the apparatus over the
guidewire to the incision site ... and then causing the guidewire to cease
further advancement into the vasculature of the patient by bringing the
shaped portion into contact with the apparatus." Appeal Br. 31 (Claims
App.). Dependent claim 18 recites that "the shaped portion interacts with a
proximal end of the apparatus to prevent further advancement of the
guidewire further into the vasculature of the patient." Id. Appellant argues
that Douk fails to teach these limitations. Appeal Br. 22-23. The Examiner
responds that the rejection "clearly relies on Ressemann to teach the claimed
features." Ans. 18. We agree with the Examiner that the modification to
Ressemann with the teachings of Douk extends to having the shaped portion
comprise a shape memory material resulting in elastic or non-permanent
deformation, not to modifying Ressemann' s interaction of restraining
member 72 with apparatus 40.
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the combination of Ressemann and Douk renders
obvious the subject matter of claims 17 and 18. We sustain the rejection of
claims 17 and 18 under 35 U.S.C. § 103(a) as unpatentable over Ressemann
and Douk.
Re} ection III
Claims 5, 6, and 19 specify that the apparatus advanced over the
guidewire to the incision site before shaping the shapeable portion of the
guidewire is a needle assembly. Appeal Br. 29-30, 32 (Claims App.). The
Examiner turns to Vaillancourt as teaching "that it is known to provide a
method wherein the apparatus is a needle assembly." Final Act. 8 (citing
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Vaillancourt, Figs. 1, 3, 10, 11, ,r,r 2, 28-30, 41, 42). The Examiner
concludes that it would have been obvious for the apparatus to be a needle
assembly as taught by Vaillancourt "in order to allow [one] to first gain
access to a vein or an artery of a patient and then slide the guidewire through
the needle into place in the vein or artery." Id.
Appellant argues that Douk' s catheter 10 provides a barrier preventing
direct contact between apparatus 40 and guidewire 12 and that the needle
assembly of Vaillancourt could not be combined with Douk. Appeal Br. 24,
25. Appellant also argues that combining Vaillancourt with Ressemann and
Douk "would add needless complication to the device without providing the
missing features for elements of the base claim," such that "there would be
no motivation to modify Ressemann and Douk in view of Vaillancourt
absent impermissible hindsight." Id. at 24.
Appellant's arguments are not persuasive in that they do not consider
the Examiner's articulated rejection, which modifies Ressemann with the
teachings of Douk only to the extent of advancing apparatus 40 over
guidewire 20 before shaping shapeable portion 72 into the first shape ( claims
5 and 6) or making shaped portion 72 comprise a shape memory material
that is deformable when a load is applied and returns to its undeformed state
when the load is removed (claim 19). See Ans. 19 ("Appellant's argument
... fails to consider the combination of references as proposed by the
Office."). In other words, there is no direct modification of Douk.
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the combination of Ressemann, Douk, and
Vaillancourt renders obvious the subject matter of claims 5, 6, and 19. We
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sustain the rejection of claims 5, 6, and 19 under 35 U.S.C. § 103(a) as
unpatentable over Ressemann, Douk, and Vaillancourt.
Re} ections IV and VI
Appellant relies on the same arguments and reasoning we found
unpersuasive in connection with independent claim 1 as the basis for
contesting the rejection of dependent claims 9, 12, and 14. Appeal Br. 25-
27. Accordingly, for the same reasons discussed above, we also sustain the
rejections, under 35 U.S.C. § 103(a), of: claim 9 as unpatentable over
Ressemann, Douk, and Sakamoto and claims 12 and 14 as unpatentable over
Ressemann, Douk, and Sahatjian.
Rejection V
Dependent claim 10 recites "shaping the shapeable portion into a hook
shape." Appeal Br. 30 (Claims App.). Dependent claims 11 and 20 recite
shaping the shapeable portion so that the proximal end "points in a direction
toward the distal end of the elongate body." Id. at 30, 32. The Examiner
turns to Ryan as teaching that "it is known to provide a method wherein
shaping the shapeable portion 25 of the elongate body into the first shape
includes shaping the shapeable portion 25 into a hook shape." Final Act. 11
( citing Ryan, Fig. 2, ,r 28). The Examiner concludes that it would have been
obvious to utilize the teachings of Ryan because "such a modification would
provide a bend at the proximal end [ of the guidewire] so as to selectively
reduce the possibility that the proximal end of the guide wire might slide
distally of the proximal opening of the apparatus." Id.
In addition to relying on the same arguments and reasoning we found
unpersuasive in connection with the independent claims (Appeal Br. 26-27),
Appellant also argues that "none of the cited art teaches reorienting the
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proximal body as claimed." Id. at 26. Appellant does not identify with
sufficient particularity any deficiency in the findings of the Examiner with
respect to Ryan. See Final Act. 11 (citing Ryan, Fig. 2, ,r 28).
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the combination of Ressemann, Douk, and Ryan
renders obvious the subject matter of claims 10, 11, and 20. We sustain the
rejection of claims 10, 11, and 20 under 35 U.S.C. § 103(a) as unpatentable
over Ressemann, Douk, and Ryan.
NEW GROUND OF REJECTION
We enter a new ground of rejection of claim 1 under 35 U.S.C.
§ 103 (a) as unpatentable over Ressemann and Douk. We rely on the
Examiner's findings that Ressemann teaches providing a guidewire 20
having an elongate body defining a proximal end and a distal end, the
elongate body including a shapeable portion 72 disposed proximate the
proximal end. Final Act. 2-3.
We also rely on the Examiner's finding that Douk teaches a shapeable
portion 38 in guidewire 12. Id. at 4. Douk teaches a guidewire 12 "initially
hav[ing] a linear proximal end (as in FIG. 2)" and then a "non-linear
configuration [as illustrated in FIG. 3] may be formed, by deforming the
guidewire and is permanent in the sense that the deformed portion of the
guidewire will remain in the non-linear shape in the absence of external
stress." Douk 9:23-31 ( emphasis omitted). Because Douk specifically
teaches the deformation of guidewire 12 and suggests that the application of
external stress will prevent the deformation from being permanent, we find
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that Douk teaches a guidewire that is shapeable and malleable so as to be
shaped into a shape and remain in the shape until reshaped.
We determine that one of ordinary skill in the art would have been led
to modify Ressemann to make Ressemann's restraining member 72 of
guidewire 20 shapeable and malleable like Douk's shapeable member 38 of
guidewire 12 for selective prevention of distal sliding of guidewire 20
relative to apparatus 40 in Ressemann. That is, one of ordinary skill in the
art would have been led to ensure that Ressemann's restraining means 72 is
shapeable and malleable based on the Examiner's articulated reasoning of
being able to "selectively" prevent guidewire 20 from sliding distally of
apparatus 40. Final Act. 4, 6 (citing Ressemann, Fig. 2, 6:29-36).
We also rely on the Examiner's finding that Douk teaches that "it is
known to provide a method further comprising advancing an apparatus 10
over the guidewire 12 to an incision site ... before shaping the shapeable
portion 3 8 of the elongated body into the first shape" and the Examiner's
conclusion that it would have been obvious to modify Ressemann in
accordance with these teachings of Douk "in order to selectively reduce the
possibility that the proximal end of the guide wire might slide distally of the
proximal opening of the apparatus." Final Act. 3--4 ( citing Douk, Abstract,
Figs. 2-5, 1:18-24). More particularly, Douk teaches advancing guidewire
12 and then advancing catheter 10 over guidewire 12 to place balloon 22
within a stenosis (Douk, 10: 18-36), and then "deforming the proximal
region of the guidewire 12" (id. at 10:41) (emphasis omitted). Douk's
teachings would have led one of ordinary skill in the art to modify
Ressemann so as to place apparatus 40 over guidewire 20 prior to shaping
shapeable portion 72.
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Appeal2018-000783
Application 14/098,147
Thus, Ressemann, as modified by the teachings of Douk as described
above, teaches "advancing the distal end of the elongate body into a
vasculature of the patient" (Final Act. 3) and "shaping the shapeable portion
of the elongate body into a first shape [ e.g., after advancement of guidewire
20 and apparatus 40] that prevents advancement of the guidewire further into
the vasculature of the patient" (Appeal Br. 29 (Claims App.); Final Act. 4).
Accordingly, we enter a new ground of rejection of claim 1 under
35 U.S.C. § 103(a) as unpatentable over Ressemann and Douk.
DECISION
The Examiner's decision to reject claim 1 under 35 U.S.C. § 102(b) as
anticipated by Ressemann is affirmed.
The Examiner's decision to reject claims 2--4, 7, 8, 13, and 15-18
under 35 U.S.C. § 103(a) as unpatentable over Ressemann and Douk is
affirmed.
The Examiner's decision to reject claims 5, 6, and 19 under 35 U.S.C.
§ 103(a) as unpatentable over Ressemann, Douk, and Vaillancourt is
affirmed.
The Examiner's decision to reject claim 9 under 35 U.S.C. § 103(a) as
unpatentable over Ressemann, Douk, and Sakamoto is affirmed.
The Examiner's decision to reject claims 10, 11, and 20 under
35 U.S.C. § 103(a) as unpatentable over Ressemann, Douk, and Ryan is
affirmed.
The Examiner's decision to reject claims 12 and 14 under 35 U.S.C.
§ 103(a) as unpatentable over Ressemann, Douk, and Sahatjian is affirmed.
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Appeal2018-000783
Application 14/098,147
We enter a NEW GROUND OF REJECTION of claim 1 under
35 U.S.C. § 103(a) as unpatentable over Ressemann and Douk.
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 4I.50(b ). Section 40.50(b) provides "[a] new ground of rejection pursuant
to this paragraph shall not be considered final for judicial review." Section
41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
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Appeal2018-000783
Application 14/098,147
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; 37 C.F.R. § 4I.50(b)
20