Ex Parte Lee

Patent Trial and Appeal Board

Dec 14, 2016

13074948 (P.T.A.B. Dec. 14, 2016)

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.
13/074,948 03/29/2011 Nathan T. Lee P0038968.01 1744
12/16/201627581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
HOUSTON, ELIZABETH
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
12/16/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NATHAN T. LEE
Appeal 2014-009930
Application 13/074,9481
Technology Center 3700
Before JOSEPH A. FISCHETTI, MICHAEL C. ASTORINO, and
KENNETH G. SCHOPFER, Administrative Patent Judges.
SCHOPFER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims
1—5, 8—12, and 14—29. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
BACKGROUND
According to Appellant, the application “relates to fixation techniques
for implantable medical devices.” Spec. 1.
1 According to Appellant, the real party in interest is Medtronic, Inc. Appeal
Br. 2.
Appeal 2014-009930
Application 13/074,948
CLAIMS
Claims 1—5, 8—12, and 14—29 are on appeal. Claim 1 is illustrative of
the appealed claims and recites:
1. A kit for implanting an implantable medical device within
a patient, the kit comprising:
a delivery catheter including an inner member and an outer
member;
the implantable medical device, wherein the implantable
medical device is adjacent the inner member and constrained by
the outer member;
a force sensor in mechanical communication with the
implantable medical device via the inner member, wherein the
force sensor collects force feedback data representing force
applied by the inner member on the implantable medical device;
and
a user communication module configured to deliver force
feedback information corresponding to the force feedback data
collected by the force sensor to a user.
Appeal Br. 28.
REJECTIONS
1. The Examiner provisionally rejects claims 1, 3, 14, and 16 on the
ground of non-statutory obviousness-type double patenting over
claims 11, 19, 20, 22, and 23 of U.S. Patent Application No.
13/096,881 and claims 12, 16, 19, 21, and 22 of U.S. Patent
Application No. 13/284,761.
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Application 13/074,948
2. The Examiner rejects claims 1—3, 5, and 8—12 under 35 U.S.C.
§ 103(a) as unpatentable over Hastings2 in view of Blumenkranz3
and Cioanta.4
3. The Examiner rejects claim 4 under 35 U.S.C. § 103(a) as
unpatentable over Hastings in view of Blumenkranz, Cioanta, and
Verma.5
4. The Examiner rejects claims 14—16 and 18—296 under 35 U.S.C.
§ 103(a) as unpatentable over Hastings in view of Blumenkranz.
5. The Examiner rejects claim 17 under 35 U.S.C. § 103(a) as
unpatentable over Hastings in view of Blumenkranz and Verma.
DISCUSSION
Rejection 1
Appellant does not appeal the double patenting rejection of claims 1,
3, 14, and 16. Accordingly, we summarily sustain this rejection.
Rejection 2
Claim 1
With respect to claim 1, the Examiner finds that Hastings discloses a
device for implanting a medical device including a delivery catheter with
inner and outer members and an implantable medical device. Final Act. 4
(citing Hastings Figs. 7—9, H 81, 84, 89). The Examiner finds that
Blumenkranz teaches a force sensor that would be in mechanical
2 Hastings et al., US 2006/0085041 Al, pub. Apr. 20, 2006.
3 Blumenkranz et al., US 2009/0157092 Al, pub. June 18, 2009.
4 Cioanta et al., US 2002/0082610 Al, pub. June 27, 2002.
5 Verma, US 2009/0234367 Al, pub. Sept. 17, 2009.
6 Although the Examiner lists claim 17 in the heading for this rejection, the
body of the rejection does not include claim 17. See Final Act. 8—12.
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communication with the implant of Hastings in the proposed combination7
and that measures data representing force applied by the inner member; and
the Examiner also finds that Blumenkranz teaches a user communication
module. Id. at 5 (citing Blumenkranz Figs. 1C, 4B, H 36, 40).
Further, with respect to Hastings and Blumenkranz, the Examiner
concludes:
Therefore it would have been obvious to one of ordinary
skill in the art to have a force sensor, as taught by Blumenkranz,
to be in mechanical communication with the implantable medical
device of Hastings for purposes of providing feedback to the
surgeon as to how much force is being applied on the instrument
or the implantable medical device as it is being deployed into the
body; as such the surgeon, with that information, can accordingly
adjust the force being applied in order to prevent tissue damage
inside the body cavity.
Blumenkranz is analogous art and one of ordinary skill in
the art would be motivated to combine the teachings of said
reference with primary reference because it is directed towards
solving the same problem — implanting medical device in a body
such that it provides force sensor communication to the operating
physician to regulate the force he is exerting on the device in
order to prevent injury or inaccurate deployment of the device
inside the body cavity.
Final Act. 5—6. Finally, the Examiner concludes that it would have been
obvious to include the combination of Hastings and Blumenkranz in a kit as
claimed, based on the teachings of Cioanta. Id. at 6 (citing Cioanta Fig. 11,
180).
7 Although the Examiner states that Blumenkranz teaches a force sensor in
mechanical communication with an implantable medical device, we
understand the Examiner to mean that the sensor in the proposed
combination would be in mechanical communication with Hastings’
implantable medical device. See Final Act. 5.
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Application 13/074,948
Appellant argues that the art does not teach or suggest a force sensor
that measures the force applied by the inner member on the medical device
and that the Examiner has not adequately explained why it would have been
obvious to do so. Appeal Br. 10-16.
We begin our analysis by construing the relevant claim language. We
note that the claimed structure relevant to the arguments presented is only a
force sensor in mechanical communication with the implantable medical
device via the inner member. The remaining portion of this limitation, i.e.
the “wherein” clause, is functional language, which may be interpreted to
only require that the claimed force sensor is capable of collecting data
representing the force applied by the inner member on the implantable
device. Further, contrary to Appellant’s assertions, the claim only requires
that the force sensor collects data representing the force applied by the inner
member on the implantable medical device, which may include force exerted
by tissue on the device, noting Newton’s third law. See Ans. 12—13.
Moreover, the claim does not require the capability of directly measuring the
force on the implantable device. Thus, Appellant’s argument that the claim
requires that “the force measured is the force applied by the inner member to
the device” {id. at 12), is not commensurate with the scope of the claim.
In light of the claim construction above, we are persuaded by the
Examiner’s findings that the art of record renders the claimed structure
obvious. Hastings discloses a delivery catheter with inner members and
outer members for delivering an implantable medical device adjacent to the
inner member as claimed. See Hastings Fig. 7,1 81; see also Final Act. 4.
Hastings does not disclose a force sensor in mechanical communication with
the implant via the inner member or a user communication module.
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However, Blumenkranz discloses a catheter including a force sensor in
mechanical communication with a surgical tool via an inner member. See
Blumenkranz Figs. 3B, 4B; see also Final Act. 5. Blumenkranz also
discloses a user module, surgeon’s console 90, that transmits position, force,
and tactile sensations from the surgical instrument back to the surgeon, i.e. it
is configured to transmit force data collected from the force sensors on the
inner member back to the user. See Blumenkranz 136; see also Final Act. 5.
Further, Blumenkranz discloses that the device is intended to provide a
means for sensing forces applied to tissue and “to provide accurate feedback
of forces and torques to the surgeon to improve user awareness and control
of. . . instruments.” Blumenkranz H 6, 34.
Based on these disclosures and the reasoning provided by the
Examiner, we agree with the Examiner’s findings that because both devices
are in the same field of endeavor and use relatively the same movement
mechanisms, i.e. for pushing and pulling a catheter in order to perform a
desired surgical procedure, one of ordinary skill would have found it
desirable to include force sensors in Hastings device. See Ans. at 5—6, 8—9.
Finally, we also find that because the inner member, force sensor(s),
and implant are working in unison, the device would be capable of collecting
force feedback data representing the force applied by the inner member on
the implant. For example, we agree with the Examiner that where the
combined device contacts or abuts patient tissue, and specifically in the
situation where the combined device is perpendicular to and contacts patient
tissue, the force sensors would provide force feedback that is representative
of the force applied by the inner member on the implant. See Ans. 12—13.
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Thus, we find that the Examiner’s findings and conclusions regarding
the proposed combination of Hastings and Blumenkranz are supported by a
preponderance of the evidence before us. For these reasons, we sustain the
rejection of claim 1. Appellant does not provide separate arguments with
respect to dependent claims 2, 5, and 8—12, and thus, we sustain the rejection
of those claims for the same reasons.
Claim 3
With respect to claim 3, the Examiner relies on the combination of
Hastings, Blumenkranz, and Cioanta as discussed above, and the Examiner
also finds that the force feedback data provided by Blumenkranz would also
allow the user to determine whether an implant is adequately fixated within
a patient as claimed. Final Act. 5—6 (citing Blumenkranz 136). Further
with respect to this claim, the Examiner also finds that “it would be
advantageous and necessary to add a force feedback sensor on Hastings as
force is applied to [the implantable] medical device such that [the] surgeon
does not apply too much or unnecessary force resulting in tissue damage.”
Id. at 5.
In addition to the arguments raised with respect to claim 1, Appellant
raises additional arguments with respect to this claim. First, Appellant
argues that Hastings inner tube is used to push the implant into tissue and the
force required to push the implant into tissue is not the force required to pull
it out and thus does not provide a measure of the adequacy of the device’s
securement as claimed. Appeal Br. 17. Second, Appellant argues:
there is no reason to believe it would actually work even to
perform the argued desired function of avoiding “tissue
damage”. The express purpose of the device in Hastings is to
cause tissue damage. Tissue damage is necessary in order for the
device to work. If tissue damage were avoided, the device could
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not be forcibly implanted into the tissue as is required for it to
function at all.
Id. at 18. Third, Appellant also argues that the Examiner’s rejection of this
claim refers to other embodiments of Hastings and the Examiner has not
provided enough detail to indicate which elements of these other
embodiments are relied upon in the rejection. Id. at 18—19.
For the reasons discussed below, we are not persuaded of error.
As an initial matter, we note that this claim includes an additional
wherein clause, which we again interpret as functional language that requires
only that the claimed force sensor be capable of providing data to the user to
allow the user to evaluate whether an implantable medical device is
adequately fixated within the patient.
Regarding Appellant’s first argument, we agree with the Examiner
that both Hastings and Blumenkranz teach devices that involve pulling and
pushing mechanisms used to perform a desired surgical procedure. See
Ans. 8. Thus, contrary to Appellant’s assertion, one of ordinary skill in the
art would understand that Hastings is not only concerned with providing a
pushing force for implanting a device, but Hastings is also concerned with
directing the catheter to the desired cite and removing said catheter using
various pushing and pulling forces. Further, as indicated above with respect
to claim 1, we agree that it would have been obvious to include force sensors
on Hastings’ device in order to provide haptic feedback to the surgeon.
Thus, we are not persuaded, as Appellant indicates, that including force
sensors in Hastings’ device would only measure the pushing force required
to insert the medical implant into tissue. Further, based on this analysis, we
find that the proposed combination of art would be capable of providing
information to the user to evaluate whether the device is adequately fixated
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Application 13/074,948
within the patient by providing a measurement of the force applied to the
force sensors when the catheter is being pulled before the implant is
permanently released.
Regarding Appellant’s second argument, we agree with the
Examiner’s conclusion that preventing tissue damage would have motivated
one of ordinary skill in the art to include force sensors in Hastings’ device as
claimed. Appellant’s argument is focused on the necessary tissue damage
required by implanting the medical device in tissue. However, the Examiner
explains that one of ordinary skill in the art would recognize that it would be
advantageous to include force feedback sensors such that the “surgeon does
not apply too much or unnecessary force.” We agree with the Examiner that
avoiding unnecessary tissue damage would have motivated one of ordinary
skill in the art to add feedback sensors to Hastings’ device.
With respect to Appellant’s third argument (Appeal Br. 16), we
understand that the Examiner has only relied on the embodiment of Figure
1 IF of Hastings to show that Hastings teaches applying a force on a delivery
catheter to deliver an implant to a desired implantation cite (Final Act. 5).
We are not persuaded that the rejection is in error based on the Examiner’s
additional citation to this embodiment.
For these reasons, we sustain the rejection of claim 3.
Rejection 3
Claim 4 depends from claim 1 and further requires “wherein the force
feedback information includes an indication that a holding force of the
implantable medical device at least meets a predetermined threshold.” With
respect to this claim, the Examiner finds that Hastings, Blumenkranz, and
Cioanta are “silent on [a] clear teaching of including a holding force that
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meets a predetermined threshold level.” Final Act. 8. However, the
Examiner finds that Verma teaches a force assessment device providing an
indication that a holding force meets a predetermined level, and the
Examiner concludes “it would be obvious to have a holding force that meets
a predetermined threshold level for purposes of using such measures as
guidelines for limits of pressure that can be tolerated by a tissue or organ
where the implantable medical device is being placed.” Id. (citing Verma
Figs. 5-8,127).
With respect to this rejection, Appellant raises the following
arguments: 1) that the Examiner’s finding that the art relied upon with
respect to claim 1 is silent regarding measuring a holding force as claimed is
inconsistent with the Examiner’s findings regarding claim 3; 2) that Verma’s
force transducer would not measure holding force unless it were attached as
in Verma; 3) that there is no reason suggested in Hastings that Hastings’
device can “be removed by pulling force without exceeding the limits of the
tissue”; and 4) that the rejection is defective because it does not cite to
Cioanta, which was cited with respect to independent claim 1. Appeal Br.
21-22.
For the reasons discussed below, we are not persuaded of error by
Appellant’s argument.
With respect to Appellant’s first argument, Appellant has not
adequately explained any inconsistency in the Examiner’s findings at least
because the language of claim 4 regarding a predetermined threshold is
different than the language of claim 3 regarding an evaluation of whether the
device is adequately fixated. With respect to claim 3, the Examiner did not
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find that the art teaches or suggests comparing the holding force to a
predetermined threshold.
Regarding Appellant’s second argument, “[t]he test for obviousness is
not whether the features of a secondary reference may be bodily
incorporated into the structure of the primary reference .... Rather, the test
is what the combined teachings of those references would have suggested to
those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA
1981). The rejection does not rely on the physical incorporation of Verma’s
force transducer into Hastings’ device. Rather, we understand the rejection
to rely on Verma’s teaching of predetermined thresholds relating to limits of
pressure that can be tolerated by different tissues. Appellant does not point,
with particularity, to any error in the Examiner’s reliance on Verma for this
teaching.
Next, for reasons discussed previously, we are not persuaded by
Appellant’s third argument. Specifically, we find that the combination of art
shows that the capability required by claim 4 would have been obvious for
the reasons discussed with respect to claims 1 and 3 because one of ordinary
skill would have found it obvious to employ force sensors in Hastings’
device in order to prevent unnecessary tissue damage and one of ordinary
skill in the art would recognize that unnecessary tissue damage could be
prevented by ensuring that the pulling force measured when the adequacy of
fixation is tested falls below the threshold amounts taught by Verma.
With respect to Appellant’s final argument, we find that the rejection
of claim 4 does cite to Cioanta, contrary to Appellant’s assertion. See Final
Act. 8.
For these reasons, we sustain the rejection of claim 4.
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Rejections 4 and 5
With respect to the rejections of the remaining claims, Appellant
relies on substantially the same arguments as those discussed above. See
Appeal Br. 23—26. We find those arguments unpersuasive here for the same
reasons identified above. Accordingly, we sustain the rejections of claims
14—29.
CONCLUSION
For the reasons set forth above, we AFFIRM the rejections of claims
1-5, 8-12, and 14—29.
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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