Ex Parte Rizk et al

Patent Trial and Appeal Board

Nov 23, 2018

13648144 (P.T.A.B. Nov. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/648,144 10/09/2012
25096 7590 11/27/2018
PERKINS COIE LLP - SEA General
PATENT-SEA
P.O. BOX 1247
SEATTLE, WA 98111-1247
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Isa Rizk
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.
07771 l-8001.US02 6289
EXAMINER
ALEMAN, SARAH WEBB
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
11/27/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patentprocurement@perkinscoie.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ISA RIZK and JOHN FULKERSON
Appeal2017-010675
Application 13/648, 144
Technology Center 3700
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2017-010675
Application 13/648,144
Appellants 1 seek our review, under 35 U.S.C. § 134(a), of the
Examiner's decision to reject claims 11-16 and 26-32. (Appeal Brief filed
March 6, 2017 ("App. Br.") 3.) We have jurisdiction under 35 U.S.C.
§ 6(b ). We affirm.
Appellants' Specification provides devices and methods for
addressing an occlusion within a blood vessel of a patient. (See
Specification ("Spec.") Abstract.) The method applies a crossing device for
mechanical penetration of an occlusion. (Id. ,r 31.)
We reproduce Figure 4 of Appellants' Specification below.
16 17 15
Fig. 4
Figure 4 depicts a cross-sectional view of a crossing device. (See Spec.
,r 22.) Element 12 in Figure 4 is the handle of the crossing device, element
13 is the body, element 14 is the plunger rod, element 16 is the blade, and
element 17 is the spring. (Id. ,r 33.)
1 The real party in interest is identified as ReFlow Medical Inc. (App. Br. 1 ).
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Application 13/648,144
Appellants' claim 11 recites:
A method for addressing blockage within a blood vessel
of a human patient, the method comprising:
intravascularly delivering a crossing device over a
guidewire to a desired treatment site within the blood vessel,
wherein the crossing device comprises -
a flexible elongate shaft having a lumen extending
therethrough;
a flexible blade within the lumen, wherein the blade is
sized and shaped to receive and slidably pass over the
guidewire during intravascular delivery to the treatment site,
and, wherein the blade has a generally consistent diameter; and
a handle assembly comprising a body, a handle, and a
plunger rod therebetween, wherein the body comprises a
proximal recess into which a portion of the plunger rod is
slidably disposed, and further wherein the handle is affixed to a
proximal end of the blade;
penetrating the occlusion to form a channel therethrough
by advancing a cutting surface of the blade from (a) a first
natural position within the lumen of the shaft to (b) a second
extended position beyond a distal end of the flexible shaft via
axial manipulation of the handle in a distal direction; and
retracting the blade from the second position to the first
natural position within the lumen via axial manipulation of the
handle in a proximal direction.
(App. Br. 16, Claims App'x (emphasis added).)
Independent claim 30 is similar to claim 11, but includes additional
features, such as "a spring carried by the handle assembly" where "the
spring is configured to compress to axially advance a cutting surface of the
blade from the natural position to the extended cutting position" and the
spring is "configured to expand to axially retract the blade from the extended
cutting position toward the natural position." (App. Br. 18, Claims App'x.)
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Application 13/648,144
The Examiner rejects claims 11-15 and 26-32 as being obvious under
35 U.S.C. § I03(a)(pre-AIA) over Jenson,2 Fischell, 3 and Secrest. 4 (See
Final Office Action, mailed May 18, 2016 ("Final Act.") 2-6.) The
Examiner also rejects claim 16 as being obvious under 35 U.S.C. § I03(a)
over Jenson, Fischell, Secrest, and Heuser. 5 (See Final Act. 6.)
The Examiner finds that Jenson teaches a method for penetrating an
occlusion with a crossing device that includes a flexible elongate shaft, a
flexible blade slidably disposed within the shaft, a body, a handle, and a
spring for biasing the blade to a retracted position within the sheath. (See
Final Act. 2--4, citing Jenson ,r,r 34, 36, 52, 103; Figures 1, 15, 23A, 23B.)
The Examiner finds that, although Jenson teaches a lumen for a guidewire,
Jenson does not teach delivering the crossing device over a guidewire.
(Final Act. 3.)
The Examiner finds Fischell teaches intravascularly delivering a
crossing device over a guidewire to a desired treatment site. (Final Act. 3,
citing Fischell 7:9-14.) The Examiner determines that it would have been
obvious for those of ordinary skill in the art to deliver the crossing device of
Jenson over a guidewire as taught by Fischell in order to ensure proper
placement of the device. (Id.)
The Examiner finds that the combination of Jenson and Fischell fails
"to disclose a plunger between the body and handle." (Final Act. 4.) The
Examiner finds, that "[a]lthough Jenson explains that the blade (32, 94, or
2 Jenson et al., US 2006/0293612 Al; published December 28, 2006
3 Fischell, US 5,423,846; issued June 13, 1995
4 Secrest et al., US 6,666,847 B2; issued December 23, 2003
5 Heuser, US 2009/0093791 Al; published April 9, 2009
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Application 13/648,144
248) can be moved axially and rotationally by mechanical means [0078-
0079], Jenson is silent with regard[] to the particular construction of the
handle assembly." (Answer mailed June 13, 2017 ("Ans.") 3.)
The Examiner finds Secrest teaches a handle assembly with a handle,
a body, and a plunger therebetween. (Final Act. 4, citing Secrest 4:33--42;
56-62; and Fig. 4; Ans. 2.) The Examiner determines it would have been
obvious for those of ordinary skill in the art to have modified the apparatus
taught in Jenson with the handle assembly of Secrest, in order to aid in the
actuation of the blade given the finite number of ways to slide a blade
relative to a shaft using a handle. (Ans. 4.)
Appellants do not dispute the Examiner's findings regarding Jenson
and Fischell, but disagree that Secrest teaches the claimed handle assembly
arrangement, i.e., a handle assembly comprising a body, a handle, and a
plunger rod "therebetween." (App. Br. 8-9.) Appellants argue that the
plunger of Secrest is not arranged between a body and a handle and instead
"extends the entire length of Secrest's shaft." (Id.) Here, Appellants dispute
two points: 1) the Examiner's interpretation of the term "there between," and
2) the Examiner's finding that Secrest teaches a plunger between the body
and handle.
We first interpret "therebetween" applying the broadest reasonable
interpretation of the claims. See In re ICON Health & Fitness, Inc., 496
F.3d 1374, 1379 (Fed. Cir. 2007) ("[T]he PTO must give claims their
broadest reasonable construction consistent with the specification ....
Therefore, we look to the specification to see if it provides a definition for
claim terms, but otherwise apply a broad interpretation.").
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Application 13/648,144
We are not persuaded by Appellants' argument that the Examiner
improperly interprets the claims in view of a person of ordinary skill in the
art. According to the Examiner's interpretation, "the term 'therebetween'
does not necessarily require the entire structure to be located within the
boundaries of the handle and body." (Ans. 2.) In contrast, Appellants
interpret the claims as "the claimed plunger rod is between components of
the handle assembly itself" (App. Br. 9, emphasis in original.) To support
their interpretation that the plunger rod is entirely between the components,
Appellants cite to the language of claim 11 and Figures 2A and 2B. (See
Reply Br. 3.) Appellants do not direct us to, and we do not find, a specific
definition of the term "between" in the Specification. The Specification
provides only minimal discussion of the plunger rod and does not list any
express limitations of the plunger rod in relation to the handle or body.
In the absence of a definition or express limitation, we interpret the
term as broadly as reasonable and consistent with the Specification. We are
mindful, though, not to import limitations from a specification
unnecessarily. See E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369
(Fed. Cir. 2003). Appellants do not explain how either the other language of
claim 11 or Figures 2A and 2B indicate that the entire plunger rod must exist
only between the handle and body.
The Examiner interprets "therebetween" as an arrangement "wherein
at least a portion of a component is physically located between or is arranged
to couple the function of two other components." (See Ans. 2.) Because we
find this definition to be reasonable and consistent with the Specification, we
adopt this interpretation under as the broadest reasonable interpretation and
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conclude that the claims does not require locating the entire plunger within
the boundaries of the handle and body.
Having agreed with the Examiner's interpretation of "therebetween,"
we tum to whether Secrest teaches a plunger that meets this limitation.
Appellants argue that Secrest's plunger extends the entire length of the shaft
because Secrest teaches motion transmitting unit 25 having rigid first
member 70 fixed to flexible second member 72. (See App. Br. 9; see Reply
Br. 4.) In contrast, the Examiner cites plunger elements 25 and 70 that are
directly coupled to the proximal end of a slidable blade (72 and 31 ). (Final
Act. 4; Ans. 3.)
We are not persuaded by Appellants' argument that the Examiner
mischaracterizes Secrest. The motion transmitting element 25 of Secrest
includes two separate parts: 1) rigid member 70 "constructed from
conventional hypodermic needle stock [that] remains stiff under manually
applied axial force," which is fixed to 2) flexible second member 72 that
bends within an endoscope. (Secrest 4:32--42; Final Act. 4.) The Examiner
applies only first part, rigid member 70, located between handle 80 and body
20, to teach a handle assembly in combination with Jenson and Fischell.
The Examiner does not apply second part, flexible part 72. Accordingly, we
are not persuaded that Secrest fails to teach a handle assembly having a
body, a handle, and a plunger therebetween.
Appellants further argue that the Examiner mischaracterizes Secrest
for citing element 84 as a handle, instead citing to "handle 86." (App. Br. 9--
10, citing Secrest 7:8-20.) The Examiner cites Secrest as teaching a
"proximal handle 84" and a "handle 80." (Final Act. 4; Ans. 2) Secrest
teaches that a surgeon may axially move fitting 80 (including surface 84) or
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handle 86 to actuate the needle. (Secrest 4:56-62; 7:8-22.) We find that
both fitting 80 and handle 86 provide a handle in view of the broadest
reasonable interpretation of the term. Therefore, Appellants do not persuade
us that the Examiner erred in finding a handle in Secrest.
In addition to arguing against the teaching of the references,
Appellants argue that the Examiner does not provide a rationale for
combining the teachings of Jenson, Fischell, and Secrest. (App. Br. 10-11.)
Appellants further argue that combining Secrest with Jenson and Fischell
would "be impracticable" and provide a redundant feature that would
increase costs and complexity. (App. Br. 11.)
We do not find Appellants' arguments persuasive. Based on the
finding in Jenson that "stylet 32 can be made to move axially and
rotationally using any known technique or method, both manual and
mechanical means included" (Jenson ,r 36; see Ans. 3--4), the Examiner
reasonably concludes that it would have been obvious to modify Jenson with
Secrest's known arrangement of handle components "to aid in the actuation
of the blade." Appellants provide no persuasive evidence that the
combination would be either impracticable or redundant in view of the
invitation of Jenson to use known means, both manual and mechanical, to
move the sty let. As the Supreme Court explained, the Examiner's "analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ." KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007).
Finally, Appellants argue that the Examiner engages in hindsight
reconstruction. We disagree. As discussed above, the Examiner takes into
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account only knowledge that was within the level of ordinary skill in the art
at the time the invention was made and provided a rationale to combine, i.e.,
to aid in the actuation of the blade. Therefore, the Examiner properly
reconstructs the prior art. See In re McLaughlin, 443 F.2d 1392, 1395
(CCPA 1971).
Accordingly, we are not persuaded that the Examiner erred in
rejecting claim 11.
Appellants do not provide other arguments against the rejections of
independent claim 30 or dependent claims 12-16 and 26-29, 31 and 32.
(See App. Br. 13-14.) We note that Appellants raise an argument in the
Reply Brief for the first time before us against the rejection of claim 26.
Appellants have not shown good cause for the failure to present this
argument in the appeal brief. See 37 C.F.R. 4I.41(b)(2): "Any argument
raised in the reply brief which was not raised in the appeal brief, or is not
responsive to an argument raised in the examiner's answer . . . will not be
considered by the Board for purposes of the present appeal, unless good
cause is shown." We also lack the Examiner's input on this issue.
Accordingly, we are not persuaded that the Examiner erred in rejecting these
claims as being obvious over Jenson, Fischell, and Secrest.
Conclusion
Upon consideration of the record and for the reasons given, the
rejection of claims 11-16 and 26-32 is sustained.
Therefore, we affirm the decision of the Examiner.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
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