Ex Parte Pandey

Patent Trials and Appeals Board

Jun 21, 2019

11332455 - (D) (P.T.A.B. Jun. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/332,455 01/13/2006 Rajesh Pandey
89554 7590 06/25/2019
Christopher & Weisberg, P.A.
1232 N. University Drive
Plantation, FL 33322
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.
21819H-1068U-HW-0601-US 2413
EXAMINER
SIMPSON, SARAH A
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
06/25/2019 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):
ptomail@cwiplaw.com
rs.patents.five@medtronic.com
cwdocketing@cardinal-ip. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAJESH PANDEY
Appeal 2018-006309
Application 11/332,455
Technology Center 3700
Before JAMES P. CALVE, BRETT C. MARTIN, and
MICHELLE R. OSINSKI, Administrative Patent Judges.
OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Rajesh Pandey ("Appellant") 1 appeals under 35 U.S.C. § 134(a) from
the Examiner's decision rejecting claims 1-10, 14, 15, 24, 26, and 27.2 We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies the real party in interest as HeartWare, Inc. Appeal
Br. 1.
2 Claims 11-13, 18, 20, 21, and 25 are cancelled, and claims 16, 17, 19, 22,
and 23 are withdrawn. Appeal Br. 14-17 (Claims App.).
Appeal 2018-006309
Application 11/332,455
THE CLAIMED SUBJECT MATTER
Claim 24, the sole independent claim, is reproduced below.
24. A surgical kit comprising:
a connector configured to connect a ventricular assist
device to a patient's body; and
a surgical tool for making a cut in a patient's body, the
surgical tool including:
a housing including a proximal end, a distal end,
and having an axis;
a shaft movably positioned along the axis;
a plurality of crossing blades attached to the shaft;
an interface extending from the distal end of the
housing, the interface configured to directly couple the
housing of the surgical tool to the connector, the connector
configured to be separate from the surgical tool and
attached to a patient's body prior to use of the surgical tool,
the interface extending beyond a top plane of the
connector and configured a to be at least partially disposed
within a boundary defined by the connector when the
interface couples the housing with the connector, the
crossing blades being movable with movement of the shaft
to form a crux cut incision in the patient within the
boundary of the connector when the connector is attached
to the patient's body; and
a resilient member positioned between the housing
and the shaft, the resilient member operative to bias the
shaft away from the interface.
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Alexander
Buckman
Pokorney
Prasad
US 6,187,022 Bl
US 2002/0099402 A 1
US 2005/0149093 A 1
US 2007 /0066943 Al
2
Feb. 13,2001
July 25, 2002
July 7, 2005
Mar. 22, 2007
Appeal 2018-006309
Application 11/332,455
THE REJECTIONS
I. Claims 1-3, 10, 14, 15, 24, 26, and 27 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Prasad, Alexander, and
Buckman. Final Act. 2-6.
II. Claims 4-9 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Prasad, Alexander, Buckman, and Pokorney. Id.
at 6-8.
OPINION
Rejection I
Appellant argues claims 1-3, 10, 14, 15, 24, 26, and 27 as a group.
Appeal Br. 3-11. We select independent claim 24 as the representative
claim, and claims 1-3, 10, 14, 15, 2 6, and 2 7 stand or fall therewith.
37 C.F.R. § 41.37(c)(l)(iv).
The Examiner finds, among other things, that Prasad teaches "an
interface (250) extending from the distal end of the housing ( extends from
body 244; [F]ig. 20), wherein the interface is shaped and dimensioned to
form an interconnection with a connector (202) ... , said interface extending
beyond the top plane of the connector when said interface is interconnected
with the connector prior to and during movement of the shaft ([F]igs. 20,
21)." Final Act. 3. The Examiner acknowledges that Prasad, even as
modified by Alexander, 3 "fails to disclose a resilient member positioned
3 The Examiner finds that Prasad "fails to specifically disclose" some of the
features of the claimed blades. Final Act. 4. The Examiner finds that
Alexander teaches such claimed features (id. ( citing Alexander 4:20-24,
Fig. 3)) and concludes that it would have been obvious to modify Prasad in
accordance with these teachings (id.). Appellant does not challenge these
particular findings or conclusions.
3
Appeal 2018-006309
Application 11/332,455
between the housing and the shaft, the resilient member operative to bias the
shaft away from the interface." Id. at 4. The Examiner finds that Buckman
teaches a "surgical tool including crossing blades ([F]ig. 3) and a resilient
member (spring) operative to bias the shaft away from the interface." Id. at
5 ( citing Buckman ,i 46). The Examiner concludes that it would have been
obvious "to modify the actuation device of the surgical tool of modified
[Prasad] to include a spring between the housing and the shaft, which biases
the shaft away from the interface," with "the predictable result of actuating
or driving the blade member of modified [Prasad]." Id.
Appellant argues that Prasad's "shroud 250 is disposed between two
opposing ends of the sewing cuff 202 and does not extend beyond a 'top
plane' of the sewing cuff 202." Appeal Br. 4 (boldface omitted). The
Examiner responds that "the claim does not necessitate the direction in
which the interface extends beyond the top plane." Ans. 4. More
particularly, the Examiner explains:
When viewing Figure 20 of Prasad, it is clear that the shroud 250
i.e. interface extends below the top plane of the sewing cuff 202
when the sty let assembly 204 is attached to the sewing cuff 202,
as the shroud 250 extends within the graft section 212 of the
sewing cuff 202, which is below the top edge of the sewing cuff
202. Because the shroud 250 extends below the top plane of the
sewing cuff 202, the shroud 250 extends past the top plane; thus,
beyond the top plane.
Id. Appellant replies that such an interpretation is unreasonable, when
considering "Appellant's disclosure which necessitates that the interface
extends 'from the distal end of the housing' and 'beyond a top plane of the
connector' to pilot into the connector to establish the connection." Reply
Br. 5.
4
Appeal 2018-006309
Application 11/332,455
We do not find Appellant's argument persuasive, and instead agree
with the position taken by the Examiner and explained on page 4 of the
Answer. By referring to the interface extending from the distal end of the
housing, it is not unreasonable to view the direction in which the interface
extends beyond a top plane of the connector to be in a direction from the
distal end of the housing. Using this direction also adequately correlates
with how the interface pilots into the connector.
Appellant also argues that Prasad' s shroud 250 is not an "interface
configured to directly couple the housing of the surgical tool to the
connector," as recited in claim 24. Appeal Br. 5. More particularly,
Appellant argues "the definition of 'couple' is 'something that joins or links
two things together."' Id. at 6 ( quoting https://www.merriam-webster.com/
dictionary/couple). Appellant further argues that "[t]wo items are not
directly coupled to each other, i.e., joined or linked, simply by touching one
another," such that "[t]he shroud 250 [i.e., the interface] simply touching the
graft section 212 of the sewing cuff 202 [i.e., the connector] does not,
inherently or obviously, equate to the shroud 250 itself being configured to
directly couple the stylet assembly 204 [i.e., the housing] to the sewing cuff
202 [i.e., the connector]." Id. (boldface omitted).
The Examiner responds that "the shroud 250 of Prasad communicates
with the graft section 212 of the sewing cuff 202 in the same manner as the
cylindrical lip of the interface 50 of [ A Jppellant' s invention communicates
with the sewing ring 2, such that the ... [housing] is directly coupled to the
sewing cuff 202 by at least an interference fit[,] i.e.[,] touching/contacting."
Ans. 5; see also id. ( citing Spec. ,-J,-J 35, 37). The Examiner further explains
that, as shown in Figure 20, Prasad' s shroud 250 has a height extending
5
Appeal 2018-006309
Application 11/332,455
below a bottom edge of male connector 239; an outer diameter less than an
outer diameter of the bottom edge of male connector 239; and an outer
diameter less than an inner diameter of sewing cuff 202, such that "shroud
250 fits within an inner diameter of the sewing cuff 202 and the male
connector 239 is in direct contact with the connector 214 of the sewing cuff
202." Id. at 5-6. The Examiner then finds that "no structural difference is
found between the claimed limitation and Prasad, and the shroud 250 is
found to directly couple the housing of the sty let assembly 204 [i.e., the
housing] to the sewing cuff 202 [i.e., the connector]." Id.
We do not find error in this position taken by the Examiner. Contrary
to Appellant's argument, it is not mere touching between Prasad's shroud
250 and graft section 212 of sewing cuff 202 that is being relied on by the
Examiner in support of a direct coupling, but rather the particular fit between
these elements based on both relative size and shape as illustrated in Figure
20. In the Reply Brief, Appellant argues that its "interface is specifically
sized and shaped to engage the connector to establish the connection
between the connector and the surgical tool" and "[t]he shroud 250 does not
provide the same benefit." Reply Br. 3. We do not find such arguments
persuasive of error in that the Examiner is relying on the similarity in both
size and shape of Prasad' s shroud 250 and graft section 212 of sewing cuff
202 in support of a finding of a direct coupling. Appellant has not addressed
the Examiner's findings with sufficient particularity to apprise us of error in
the Examiner's finding.
Appellant also argues that "the sole purpose of the shroud 250
[ disclosed in Prasad] is to align and protect the graft section 212 from the
blades." Appeal Br. 6. Appellant points out that, on the other hand, Prasad
6
Appeal 2018-006309
Application 11/332,455
specifically discloses "connector 239, and not the shroud 250 [i.e., the
interface], [ as being] configured to directly couple the sty let assembly 204
[i.e., the housing] to the sewing cuff 202 [i.e., the connector]." Id. (citing
Prasad, 10:53-66; 11: 1-5)4• Thus, Appellant argues "it is clearly the
connectors 214,239, and not the shroud 250, which directly couple the
sewing cuff 202 to the stylet assembly 204." Id. at 7 (boldface omitted).
The Examiner responds that although "Prasad discloses that the male
connector 239 is directly coupled to the sewing cuff 202 through the use of
knob 230 and grooves 228 ... , the shroud 250 is also found to directly
couple the housing of the sty let assembly 204 to the sewing cuff 202."
Ans. 7 (citing Prasad, Fig. 19; ,i 70). Again, we do not find error in the
position taken by the Examiner. That Prasad discloses features specifically
described as coupling male connector 239 (i.e., the housing) and sewing cuff
202 (i.e. the connector) does not take away from and/or negate the
interference fit provided by shroud 250 (i.e., the interface) extending from
male connector 239 (i.e., the housing) and sewing cuff 202 (i.e., the
connector) as relied on by the Examiner. See id. at 6 ("While the shroud 250
may also function to align and protect the graft section 212 from the blades,
one cannot ignore that the structure of the shroud 250 is found equivalent to
the interface 50 of [ A Jppellant' s invention, as discussed above; therefore, the
shroud 250 is also configured to directly couple the male connector 239 of
the stylet assembly 204 to the sewing cuff 202.").
4 Appellant refers to the column and line numbers of issued patent US
9,283,314 B2 (iss. Mar. 15, 2016), which corresponds to the published
application US 2007 /006943 Al (pub. Mar. 22, 2007) as relied on by the
Examiner. The portion of the issued patent cited by Appellants corresponds
to paragraph 70 of the patent application publication.
7
Appeal 2018-006309
Application 11/332,455
Finally, Appellant argues that
the Examiner's proposed modification of Prasad in light of the
disclosure of Buckman would render Prasad unsatisfactory for
its intended purpose of providing a surgeon with the ability to
control the lowering and retraction of the blades as the blades
penetrate and are released from heart tissue to reduce the
likelihood of significant blood loss during implantation of a
cannulae.
Appeal Br. 8 (citing Prasad, 6:1-5; 12:24-67).5 More specifically,
Appellant argues that:
[t]o modify Prasad to include a resilient member, such as the
spring 26 which automatically retracts, as suggested by the
Examiner, would render Prasad inoperable for its intended
purpose because the resilient member would cause the plunger
assembly 238 and the blades 266 to automatically move forward
and retract instead of providing the surgeon with the ability to
tum the knob 230 to control and monitor the insertion and
retraction of the blades 266. Resultantly, significant blood loss
would occur because the surgeon would not be able to
appropriately control and monitor the blade retraction to time
when to apply a clamp to the graft section 212 of the sewing cuff
202 to prevent blood from leaking out of the penetrated heart
tissue.
Id. at 9 ( emphasis omitted). Appellant also suggests that one of
ordinary skill in the art would not have been led to modify Prasad
with a feature that "minimizes the need for specialized surgical skill"
when Prasad' s device is one that "requires highly specialized surgical
skill." Id. at 10 (citing Buckman ,-J 44).
The Examiner responds that although the modification "would cause
the plunger assembly and the blades thereon to automatically retract, the
5 This portion of the issued patent corresponds to paragraphs 46 and 78-80
of the published patent application.
8
Appeal 2018-006309
Application 11/332,455
modification would not cause the plunger assembly to automatically move
forward." Ans. 7. The Examiner explains that in Buckman, "the user
controls forward movement of the plunger assembly and blades ... with
tactical feedback as the handle is pushed, rather than by rotating a knob as
disclosed by Prasad" (id.) and "[b Jecause the user mechanically depresses
the handle 28 of Buckman to enact actuation of the plunger assembly and
blades, the depth and speed of penetration of the blades is ultimately
controlled by the user" (id. at 8). The Examiner takes the position that
modification of Prasad "to include the resilient spring of Buckman would
not inhibit the surgeon's ability to control and monitor the insertion of the
blades" and "the markings 259 of Prasad would still allow the user to
monitor insertion and retraction of the plunger assembly." Id. at 8.
Appellant replies that "[t]he markings would be meaningless if the
blades were to automatically retract such as through the use of Buckman's
spring." Reply Br. 5. Appellant also replies that "automatic retraction of the
blades would be dangerous when using Prasad's device as the surgeon
would not be able to properly monitor when to apply the clamp to prevent
blood loss." Id. Although we agree with Appellant that the markings would
appear to be of more limited value in connection with automatic retraction of
the plunger assembly (where the surgeon's ability to control the retraction
process is limited), they would still provide a marking function. Moreover,
the Examiner has adequately explained how the markings would retain their
value in connection with the insertion process. Ans. 7-8.
As to Appellant's argument that a user would not be able to determine
when to apply the clamp with automatic retraction of the blades, we are not
persuaded of error by the Examiner. Prasad describes application of the
9
Appeal 2018-006309
Application 11/332,455
clamp to the graft section of the sewing cuff below the blade assembly
housing "[o]nce the blades have been fully retracted." Id. ,i 80. Appellant
has not adequately explained how automatic retraction via a spring would
prevent application of the clamp by a user once the blades have been fully
retracted. In addition, although Appellant correctly points out that Prasad' s
device is designed for one with specialized surgical skills, we are not
persuaded that one of ordinary skill in the art would not have been led to
seek to ease implementation of the device via automatic retraction as
Appellant argues. In sum, we are not persuaded by Appellant's arguments
that the Examiner's articulated reasoning as to why it would have been
obvious to modify Prasad' s device to use a spring for automatic retraction of
the plunger assembly and blades (i.e., to "yield[] the predictable result of
actuating or driving the blade member of modified [Prasad]" (Final Act. 5))
lacks rational underpinnings.
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner's rejection of claim 24 as unpatentable over Prasad,
Alexander, and Buckman. We sustain the Examiner's rejection of claim 24,
and claims 1-3, 10, 14, 15, 26, and 27 falling therewith, under 35 U.S.C.
§ 103(a) as unpatentable over Prasad, Alexander, and Buckman.
Rejection II
Appellant presents no separate arguments contesting the rejection of
dependent claims 4-9, thus appearing to rely on the same arguments and
reasoning we found unpersuasive in connection with independent claim 24
as the basis for seeking reversal of the rejection of claims 4-9. Appeal
Br. 3-11. Accordingly, for the same reasons discussed above in connection
with the rejection of claim 24, we also sustain the rejection of claims 4-9
10
Appeal 2018-006309
Application 11/332,455
under 35 U.S.C. § 103(a) as unpatentable over Prasad, Alexander, Buckman,
and Pokorney.
DECISION
The Examiner's decision to reject claims 1-3, 10, 14, 15, 24, 26, and
27 under 35 U.S.C. § 103(a) as unpatentable over Prasad, Alexander, and
Buckman is affirmed.
The Examiner's decision to reject claims 4-9 under 35 U.S.C.
§ 103(a) as unpatentable over Prasad, Alexander, Buckman, and Pokorney is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
11