Ex Parte Streeter et al

Patent Trials and Appeals Board

Mar 21, 2019

11115087 - (D) (P.T.A.B. Mar. 21, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
11/115,087
7590
Jeffrey J. Hohenshell
Medtronic, Inc.
FILING DATE
04/26/2005
03/21/2019
7601 Northland Drive
Minneapolis, MN 55428
FIRST NAMED INVENTOR
Richard B. Streeter
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.
VIA-10.01
(MTI0903/US/2)
EXAMINER
SHAY,DAVIDM
9294
ART UNIT PAPER NUMBER
3792
MAIL DATE DELIVERY MODE
03/21/2019 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 RICHARD B. STREETER, JOHN R. LIDDICOAT, and
TODD F. DA VENPORT 1
Appeal2018-002800
Application 11/115,087
Technology Center 3700
Before DANIELS. SONG, NATHAN A. ENGELS, and
ALYS SA A. FINAMORE, Administrative Patent Judges.
SONG, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
Final Office Action ("Final Act.") rejecting claims 28, 34--36, and 38-50 in
the present application. App. Br. 1. 2 We have jurisdiction under 35 U.S.C.
§§ 6(b) and 134(a).
1 Collectively referred to as "Appellant" herein. The Appellant identifies the
real party in interest as Medtronic, Inc. Appeal Brief ("App. Br.") 3.
2 The Appellant seeks "reversal of the Examiner's rejection of pending
claims 1-11, 20-24 and 28-50," (App. Br. 1), and Appellant asserts that
these claims "remain for consideration." Reply Brief ("Reply Br.") 1.
However, as the Examiner indicates, only claims 28, 34--36, and 38-50 are
subject to examination, with the remaining claims having been withdrawn.
Appeal2018-002800
Application 11/115,087
We AFFIRM-IN-PART.
Independent claim 28 illustrative of the claimed subject matter reads
as follows:
28. A method for providing access to a functioning vascular
system of a patient, said method comprising:
positioning an apparatus for providing access to a
functioning vascular system of a patient at least partially against
tissue of a functioning vascular system, said apparatus
compnsmg:
a main body having sidewalls defining an interior region
and an exterior region, and a bottom end and a top end;
a base being formed at said bottom end of said main body,
securing means being configured on said base so as to allow
attachment and formation of a seal between said base and the
functioning vascular system of the patient, and said base being
configurable to provide a passageway from said interior region
of said main body to the functioning vascular system of the
patient; and
a removable cover provided at said top end of said main
body, said cover including an instrument port, wherein said
cover, when closed, provides a barrier between said interior
region and said exterior region at said top end of said main body;
inserting an implant into the interior region of said main
body, including the steps of:
selectively removing said cover to provide an access
opening to the interior region of said main body, positioning said
implant within the interior region of said main body by way of
the access opening, and
subsequently closing said cover to provide a barrier
between said interior region and said exterior region at said top
end of said main body;
Final Act., Office Action Summary; Amendment filed January 25, 2017, p.
3-9 (indicating various claims as withdrawn).
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Application 11/115,087
attaching said securing means of said base to a selected
portion of the functioning vascular system of the patient;
wherein after the steps of inserting an implant and
attaching said securing means, the method further comprising
the steps of:
introducing a cutting instrument into the interior region of
the main body by way of the instrument port of the removable
cover;
forming an incision with the cutting instrument in said
selected portion of the vascular system of the patient within an
interior boundary of said base in attachment thereto;
passing an instrument through said incision formed in said
selected portion of the vascular system of the patient;
closing said incision in said selected portion of the
vascular system of the patient within said interior boundary of
said base in attachment thereto; and
removing at least a portion of said apparatus from the
functioning vascular system of a patient and leaving the implant
within the patient.
App. Br. 14--16 (Claims App., emphasis added).
Independent claim 40 recites a method for providing access to a
functioning vascular system of a patient including the step of "changing the
configuration of said base so as to selectively change the incision to be more
open as formed in said selected portion of the vascular system of the
patient." App. Br. 17-18 (Claims App., emphasis added).
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Application 11/115,087
REJECTIONS 3
The Examiner rejects various claims on appeal under 35 U.S.C.
§ I03(a) as follows:
1. Claims 28, 34, 35, and 38--42 as obvious over Taylor (US
7,335,158 B2, iss. Feb. 26, 2008), in view of Harper et al. (US
6,042,539, iss. Mar. 28, 2000 ("Harper")), Beane et al. (US 5,906,577,
iss. May 25, 1999 ("Beane")), and Downing (US 6,840,246 B2, iss.
Jan. 11, 2005). Final Act. 4.
2. Claims 40 and 43--46 as unpatentable over Taylor in view of
Harper, Beane, and Valentini et al. (US 6,837,851 Bl, iss. Jan. 4,
2005 ("Valentini")). Final Act. 6.
3. Claim 36 as unpatentable over Taylor, Harper, Beane,
Downing, and Kaplan et al. (US 6,488,689 Bl, iss. Dec. 3, 2002
("Kaplan")). Final Act. 8.
4. Claims 47-50 as unpatentable over Taylor, Harper, Beane,
Valentini, and Downing. Final Act 8.
ANALYSIS
Only those arguments actually made by the Appellant have been
considered in this decision. In that regard, the Appellant only submits
arguments directed to independent claims 28 and 40. Arguments that the
Appellant could have made but chose not to make have not been considered
and are deemed to be waived. See 37 C.F.R. § 4I.37(c)(l)(iv); In re Jung,
3 Rejections of various claims under 35 U.S.C. § 112 have been withdrawn.
Ans. 9.
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Application 11/115,087
637 F.3d 1356, 1365---66 (Fed. Cir. 2011); Ex parte Frye, 94 USPQ2d 1072,
1075-76 (BPAI 2010) (precedential).
Claim 28
The Examiner rejects independent claim 28 finding that
Taylor teaches a method of cardiac surgery wherein a device is
attached to the heart and an incision is made (see Figure 4;
column 2, line 63 to column 3, line 12; column 4, lines 44-57;
and column 5, lines 22-36), as well as the use of sutures to close
the incision ( column 6, lines 21-28), the device has a base
(element 7, see column 5, lines 7-14), sides (that portion of the
device between the base and the openings) and a top ( the upper
portion of the dome, including ports, 9), also provided are covers
(see Figure 2, element 23).
Final Act. 4.
The Examiner finds that Harper teaches the desirability of providing
sealable closures, and that Beane teaches equivalence of unitary and modular
barrier/access port combinations, as well as a removable cover having a port.
Final Act. 4 (citing Beane, col. 9, 11. 7-25, Figs. 4, 5, 8, 9). The Examiner
also finds that Downing discloses a device that is attached to a heart wall
and is used to insert an annuloplasty ring. Final Act. 4--5 ( citing Downing,
col. 15, 1. 47---col. 16, 1. 41, Figs. 7, 22).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to have implemented a removable cover and
method of Beane in the device and method of Taylor
since this would allow the cover to be removed for insertion of
devices which are larger than the port could accommodate or to
provide a better view of the surgical field, as it would not be
distorted by looking through the cover, and would also allow the
cover to be dispensed ... in situations where it is not needed, as
well as to employ the multiple the sealable membrane and
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Application 11/115,087
method of Harper ... in the device and method of Taylor, since
this would allow inert fluids ( e.g. CO2, saline) to be maintained
in the interior of the device, which would prevent embolism.
Final Act. 5.
The Appellant does not dispute the above-noted Examiner's factual
findings as to the disclosures of the prior art or the above-noted conclusion
that it would have been obvious to a person of ordinary skill in the art to
have used a removable cover.
The Examiner also concludes that it would have been obvious to a
person of ordinary skill in the art to have placed the implant within the
device before inserting the cutting instrument, before securing the device to
the heart, and creating the incision, as this would have provided "a
predictable result" of reducing time of the surgery during which blood can
escape the circulatory system and would have been within the skill of those
in the art. Final Act. 6. In that regard, the Examiner finds, and the
Appellant does not dispute, that a person of ordinary skill "would be a
cardiac surgeon with experience in performing e.g. open heart surgery,
therefore, the level of ordinary skill in the art is high." Ans. 11. The
Examiner further concludes that "the cardiac surgeon's common sense
would allow him or her to realize that of the two possibilities of inserting the
implant before the cutting device and inserting the cutting device before the
implant, both are equally achievable," and likewise, "that of the two
possibilities of inserting the implant before attaching the device to the heart
and attaching the device to the heart before inserting the implant, both are
equally achievable." Ans. 11-12.
The Appellant argues that it is
presumptive and speculative that the implant and the cutting
instruments of the proposed combination of cited references can
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be inserted into the device in either order and that the insertion
of the implant and the placement of the device on the heart can
occur in either order and that the untaught modifications would
result in any of the alleged benefits based on the teachings of the
cited references. For example, it is unclear to Applicant how the
annuloplasty device/"implant" 64 of Downing, would be inserted
into the modified device having the housing of Taylor (as
modified by Harper and Beane) and then the sutures S
subsequently attached prior to implantation.
App. Br. 8-9; see also Reply Br. 2. The Appellant also argues that "[t]he
combination of cited references do[ es] not specify that they are appropriately
configured to create an incision with an implant positioned within an interior
region," and that "it is conceivable that the method would take longer as
now care must be taken to traverse and prevent damage to the implant."
Reply Br. 2-3. Thus, according to the Appellant, there is no motivation to
modify the references in the manner suggested. Reply Br. 3.
We find the Appellant's arguments unpersuasive. To any extent that
the Appellant is requiring explicit disclosure of insertion of an implant
before introduction of a cutting instrument, such explicit disclosure is not
required. KSR Int'! v. Teleflex, Inc., 550 U.S. 398, 418-419 (2007)
( explaining "the analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim" and "obviousness analysis
cannot be confined ... by overemphasis on the importance of published
articles and the explicit content of issued patents"). Moreover, Taylor
discloses instrument port 9 allows instrument 10, which may be a cutting
device, to be received into the interior of the dome. Taylor, col. 5, 11. 22-33,
Fig. 2. Downing specifically discloses that cardiac port 50 is sized to
receive "conventional flexible annuloplasty device 64." Downing, col. 16,
11. 12-17, Figs. 21, 22 ("FIGS. 21 and 22 illustrate the placement of a
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conventional flexible annuloplasty device 64, for example, an annuloplasty
ring, through a cardiac port 50 of the present invention. The annuloplasty
ring 64 is flexible and can be inserted through the cardiac port 50 in a
sideways orientation."). It would have been obvious to one of ordinary skill
in the art to implement a covered opening in Taylor to receive objects to be
used during the surgical procedure such as a conventional flexible
annuloplasty device (as well as a cutting instrument). See Final Act. 4--5;
see also id. at 6.
The Appellant argues that providing such components in the device
makes the surgical procedure less predictable and possibly longer in that
"the annuloplasty ring/staples provide an obstacle(s) within the interior
region" of the device. Reply Br. 2. However, as explained by the Examiner,
there are only two possibilities (before or after) as to the timing for placing
the implant within the device relative to a cutting instrument. Ans. 11.
Similarly, there are only two possibilities (before or after) as to the timing
for placing the implant within the device relative to a securing the device to
the heart. Ans. 12. We agree with the Examiner's essential position that
because the possible timing of the placement of the implant within the
device is very limited, any of these limited timing possibilities would have
been obvious and common sense to a cardiac surgeon. KSR, 550 U.S. at 421
("When there is a design need or market pressure to solve a problem and
there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the product
not of innovation but of ordinary skill and common sense."). A cardiac
surgeon would consider when the implant should be positioned within the
device relative to a cutting instrument and attachment of the device, based
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on the particular surgical circumstance confronting the surgeon, and would
have found the recited sequence an obvious option.
As to the Appellant's assertion that such configuration would not
allow for suturing, we fail to see how the Examiner's proposed modification
to Taylor's disclosure based on Downing would have prevented suturing in
view of Downing' s disclosure of suturing through its cardiac port (see
Downing Figs. 13). Moreover, as noted by the Examiner, Downing also
teaches using staples as an easier alternative to suturing in a beating heart.
Ans. 14; Downing, col. 16, 11. 2-9.
Therefore, we affirm the Examiner's rejection of independent
claim 28 under Rejection 1. The Appellant does not submit any separate
arguments relative to claims that depend from claim 28. Accordingly, we
affirm the Examiner's rejection of claims 34--36, 38, 39, 41, 42, and 47-50
as well under Rejections 1, 3, and 4.
Claim 40
Independent claim 40 recites a method for providing access to a
functioning vascular system of a patient including the step of "changing the
configuration of said base so as to selectively change the incision to be more
open as formed in said selected portion of the vascular system of the
patient." App. Br. 17-18 (Claims App.). The Examiner rejects independent
claim 40 as unpatentable, relying on findings with respect to Taylor, Harper,
and Beane, as discussed above. Final Act. 6-7. The Examiner also relies on
Figure 5 of Taylor and Valentini for teaching that "displacing the elements
attached at either side of an incision improves the exposure of the tissue to
be replaced." Final Act. 7 (citing Taylor, Fig. 5, col. 6, 1. 55---co. 7, 1. 9;
Valentini, col. 23, 1. 59---col. 24, 1. 10); Ans. 15-16. Accordingly, the
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Examiner concludes that it would have been obvious to a person of ordinary
skill to configure the base of the device of Taylor "such that the sides thereof
can be pulled apart," because
pulling the edges of the inc1s10n apart by means of the
attachments surrounding incision is well within the scope of one
having ordinary skill in the art, merely provides a predictable
result, and will improve the exposure of the area accessed by the
incision, as taught by Valentini.
Final Act. 7-8.
The Appellant argues that Taylor teaches away from modifying its
housing "in a way that is no longer fixed" because its objective is to
maintain a fixed position such that the position of the tissue and various
instruments are fixed so as to prevent injury. App. Br. 10 ( citing Taylor,
Abs., col. 5, 11. 45-65). The Appellant also argues that Figure 5 of Taylor
and Valentini merely disclose retractors such that a person of ordinary skill
would not glean any teachings pertinent to modifying the base of the
housing shown in Figure 2 of Taylor. App. Br. 9-10; Reply Br. 3--4 (citing
Taylor, col. 4, 11. 34--40, col. 7, 11. 2-9). The Appellant further argues that
"it is not clear in view of the disclosure of Taylor how would one modify the
shape of the base 7 of the dome housing of FIG. 2." Reply Br. 4. We
generally agree with the Appellant for the reasons argued.
The Examiner responds that the Taylor discloses both devices, and as
such, does not teach away from their combination, and that the Appellant
"has neglected to address the combination applied to the claims" in that
Beane discloses that "combining retractors ... with surgical port devices
was extremely well known." Ans. 16-1 7. The Examiner points out that
Beane discloses the lower portion of the port functioning as a retractor (Ans.
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14 (citing Beane, col. 6, 11. 25-28, 30-43, col. 7, 11. 7--46, Figs. 2A-E)), and
explains that a person of ordinary skill in the art would have been aware of
the use of pulling forces to part the edges of an incision . . .
regardless of whether or not the pulling forces are applied by
retractor elements that engage the edges of the wound, as those
of Beane ... and Valentini ... , or those that are entirely outside
of the incision, as those of Taylor.
Ans. 18.
However, it is unclear in what manner the retractor of Taylor's
Figure 5, or the retractor of Valentini, suggests modifying the base of the
housing shown in Figure 2 of Taylor. In that regard, we observe that claim
40 requires the step of "changing the configuration of said base so as to
selectively change the incision to be more open." App. Br. 17-18 (Claims
App., emphasis added). The Examiner's rejection, while establishing the
art's recognition of changing the incision to be more open by engaging the
edges or the outside of the incision, fails to address the fact that the claim
recites a method in which such change in the incision is attained by
"changing the configuration of said base." The rejection, as articulated, does
not make clear how or why a person of ordinary skill in the art would have
modified the base of Taylor's housing so that "changing the configuration of
said base ... selectively change[s] the incision to be more open." In that
regard, we note that such modification should be consistent with Taylor's
desire to maintain the relative position of the tissue and various instruments
via its housing. App. Br. 10; Taylor, Abs., col. 5, 11. 45---65. These aspects
are not addressed by the Examiner's rejection or response.
Therefore, we find that the Examiner's rejection of claim 40 is
inadequate to establish obviousness, and reverse the same under Rejections 1
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and 2. We accordingly also reverse Rejection 2 of claims 43--46 that
ultimately depend from claim 40.
CONCLUSIONS
1. Rejection 1 is:
a. AFFIRMED as to claims 28, 34, 35, 38, 39, 41, and 42; and
b. REVERSED as to claim 40.
2. Rejection 2 of claims 40 and 43--46 is REVERSED.
3. Rejection 3 of claim 36 is AFFIRMED.
4. Rejection 4 of claims 47-50 is AFFIRMED.
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-IN-PART
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