Ex Parte Gammie et al

Patent Trial and Appeal Board

Nov 14, 2018

14478325 (P.T.A.B. Nov. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/478,325 09/05/2014
30452 7590 11/14/2018
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE, CA 92614
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
James Gammie
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.
HVTHP-93 l 4US04 9905
EXAMINER
TEMPLETON, CHRISTOPHER L
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
11/14/2018 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 JAMES GAMMIE,
RAHUL PATEL, and MEHRDAD GHOREISHI
Appeal2017-010538
Application 14/478,325
Technology Center 3700
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
method for performing cardiac valve repairs. The Examiner rejected the
claims as indefinite, lacking written description, anticipated, and obvious.
We have jurisdiction under 35 U.S.C. § 6(b ). We affirm-in-part.
1 Appellants identify the Real Parties in Interest as the University of
Maryland, Baltimore and Harpoon Medical, Inc. (see App. Br. 3).
2 We have considered and herein refer to the Specification of Sept. 5, 2014
("Spec."); Final Office Action of Aug. 17, 2016 ("Final Act."); Appeal Brief
of Mar. 21, 2017 ("App. Br."); Examiner's Answer of June 15, 2017
("Ans."); and Reply Brief of Aug. 8, 2017 ("Reply Br.").
Appeal 2017-010538
Application 14/478,325
Statement of the Case
Background
The human heart includes two atrioventricular valves that separate
the atria from the ventricles (Spec. ,r 4). Valve regurgitation may occur
when one or more valve leaflets prolapse "above the plane of coaptation"
(Spec. ,r 10). "This is the most common cause of mitral regurgitation, and is
often caused by the stretching or rupturing of chordae tendinae normally
connected to the leaflet" (id.). Leaflet sparing procedures "involve the
implantation of sutures ... so as to form artificial chordae in the valve" (id.
,r 15). "[C]onventional methods currently being practiced for the
implantation of the artificial chordae are particularly problematic. Because
the conventional approach requires the heart to be stopped ... it is difficult
to accurately ... secure the appropriate chordal length" (id. ,r 17). The
Specification teaches chordal replacement procedures, which do not require
cardiac arrest and "ensure the appropriate chordal length and spacing so as
to produce a competent valve" (id. ,r 18).
The Claims
Claims 1-5, 7-9, 11, 12, and 16-32 are on appeal. Independent claim
1 is representative and reads as follows:
1. A method of repairing a prolapsed leaflet of a valve of a
heart comprising:
introducing into a ventricle of the heart a distal portion of
a delivery system having a distal tip and carrying an artificial
chordae having a distal portion and a proximal portion;
disposing the distal tip of the delivery system in contact
with a ventricular side of the leaflet;
2
Appeal 2017-010538
Application 14/478,325
while maintaining the entire distal portion of the delivery
system on the ventricular side of the leaflet, extending from the
distal tip of the delivery system a needle having a distal portion
carrying the distal portion of the artificial chordae to pierce a
prolapsed segment of the leaflet from the ventricular side of the
leaflet to an atrial side of the leaflet to form an opening in the
leaflet;
passing through the opening from the ventricular side to
the atrial side the distal portion of the artificial chordae
disposed in a first configuration, and with the proximal portion
of the artificial chordae remaining on the ventricular side of the
leaflet;
causing the distal portion of the artificial chordae to
change from the first configuration to a second configuration,
the second configuration being larger than the opening in the
leaflet; and
securing the artificial chordae to an apex region of the
heart to reduce prolapse of the leaflet.
The Issues
A. The Examiner rejected claims 26-32 under 35 U.S.C. § 112(pre-AIA),
second paragraph as indefinite (Final Act. 3--4).
B. The Examiner rejected claims 18-23, 25, 3 28, and 30 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement (Final Act. 2-3).
C. The Examiner rejected claims 1, 2, 7, 9, 11, 12, 25, and 29 under
35 U.S.C. § I02(b) as being anticipated by Alkhatib4 (Final Act. 4--7).
3 While the Examiner inadvertently omitted claim 25 from the statement of
rejection, claim 25 was included in the body of the rejection, so we consider
the rejection to include this claim (see Final Act. 2-3).
4 Alkhatib, US 2008/0228223 Al, published Sept. 18, 2008.
3
Appeal 2017-010538
Application 14/478,325
D. The Examiner rejected claims 1, 2, 9, 11, and 12 under 35 U.S.C.
§ 102(b) as being anticipated by Kudlik5 (Final Act. 8-9).
E. The Examiner rejected claims 3, 8, 26, and 27 under 35 U.S.C.
§ I03(a) as obvious over Alkhatib or Kudlik, and DiMatteo 6 (Final Act. 9-
13).
F. The Examiner rejected claims 18-20, 22, and 23 under 35 U.S.C.
§ I03(a) as obvious over Alkhatib and Allen7 (Final Act. 15-17).
G. The Examiner rejected claim 24 under 35 U.S.C. § I03(a) as obvious
over Alkhatib and Zlotnick8 (Final Act. 14--15).
H. The Examiner rejected claims 4 and 5 under 35 U.S.C. § I03(a) as
obvious over Alkhatib, DiMatteo, and Hart9, or Kudlik, DiMatteo and Hart
(Final Act. 13-14 ).
I. The Examiner rejected claim 16 under 35 U.S.C. § I03(a) as obvious
over Alkhatib, Allen, and DiMatteo (Final Act. 17-18).
J. The Examiner rejected claim 17 under 35 U.S.C. § I03(a) as obvious
over Alkhatib, Allen, DiMatteo, and Hart (Final Act. 18-20).
K. The Examiner rejected claim 21 under 35 U.S.C. § 103(a) as being
obvious over Alkhatib, Allen, and Zlotnick (Final Act. 20).
L. The Examiner rejected claims 28 and 30 under 35 U.S.C. § I03(a) as
being obvious over Alkhatib, DiMatteo, and Allen, or Kudlik, DiMatteo, and
Allen (Final Act. 20-22).
5 Kudlik et al., US 2014/0031926 Al, published Jan. 30, 2014 (As the
Examiner did, we also rely on provisional applications US 61/741,497 and
us 61/473,873).
6 DiMatteo et al., US 2011/0022083 Al, published Jan. 27, 2011.
7 Allen et al., US 6,626,930 Bl, issued Sept. 30, 2003.
8 Zlotnick et al., US 2011/0029071 Al, published Feb. 3, 2011.
9 Hart, US 5,626,614, issued May 6, 1997.
4
Appeal 2017-010538
Application 14/478,325
M. The Examiner rejected claims 31 and 32 under 35 U.S.C. § I03(a) as
obvious over Alkhatib, DiMatteo, Allen, and Lattouf10 (Final Act. 22).
A. 35 US.C. § 112, second paragraph
The Examiner finds claims 26, 30, and 31 indefinite for lacking
antecedent basis (Final Act. 3--4). The Examiner finds claim 29 unclear for
a second recitation of "a first perimeter" (id.). The Examiner finds "[ n Jo
arguments were presented for the 35 U.S.C. [§] 112, second paragraph
rejections" (Ans. 2).
Appellants failed to contest the indefiniteness rejections on appeal.
"When the appellant fails to contest a ground of rejection to the Board ...
the Board may treat any argument with respect to that ground of rejection as
waived. In the event of such a waiver, the PTO may affirm the rejection of
the group of claims that the examiner rejected on that ground without
considering the merits of those rejections." Hyatt v. Dudas, 551 F.3d 1307,
1314 (Fed. Cir. 2008).
In the absence of Appellants' argument on indefiniteness, we consider
the argument waived and summarily affirm the Examiner's rejection. See 37
C.F.R. § 4I.37(c)(l)(iv) ("[A]ny arguments or authorities not included in the
appeal brief will be refused consideration by the Board for purposes of the
present appeal.").
B. 35 US.C. § 112,first paragraph
The Examiner finds:
10 Lattouf et al., US 2008/0004597 Al, published Jan. 3, 2008.
5
Appeal 2017-010538
Application 14/478,325
[A]ppellant's figs. 5-7 and 10-20 ... do not show "while
contacting the prolapsed leaflet only on the ventricular side of
the prolapsed leaflet," "extending ... the needle while
contacting the prolapsed leaflet only on the ventricular side of
the prolapsed leaflet," or "extending ... the needle while
applying a forward force against the ventricular side of the
prolapsed leaflet.
(Ans. 2-3; emphasis in original).
Appellants respond that support for "only with the ventricular side"
and "only on the ventricular side" "can [be] found throughout various
embodiments in the Specification" in particular citing "at least paragraphs
[0063]-[0068] 11 and [0072] of the Specification in conjunction with FIGS.
5-7 and 12A-12C" (Reply Br. 2-3).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that the claims fail to comply with
the written description requirement?
Findings of Fact
1. Figure 7 of the Specification is reproduced below:
11 Appellants' citations use the paragraph numbers of the published
application corresponding to paragraphs 61-66 and 70 of the original
Specification.
6
Appeal 2017-010538
Application 14/478,325
Figure 7 shows instrument 75 with elongate member 78, distal portion 81,
and tip 84, where "characteristics of the end surface of the tip 84 include
ease of location on the leaflet, tendency to remain in one location, does not
harm the leaflet by penetration, and can serve as a platform to deploy one or
more needle" (Spec. ,r 66).
7
Appeal 2017-010538
Application 14/478,325
2. Figure 5 of the Specification is reproduced below:
10
75
FIG. 5
Figure 5 illustrates instrument 7 5 that is introduced through the heart apex
72 into ventricle 14 "and advanced in such a manner so as to contact ... a
leaflet" (Spec. ,r 61 ).
3. The Specification teaches "[a] suitable instrument 7 5 ... will
typically include an elongate member 78 with a functional distal portion 81
having a tip 84 configured for repairing a cardiac valve tissue, for instance, a
mitral valve leaflet 52, 54" (Spec. ,r 62).
4. The Specification teaches "[ w ]hile a smaller seating surface
enables the tip 84 to be more easily localized, it may be more likely to
8
Appeal 2017-010538
Application 14/478,325
perforate the leaflet. ... [T]he delivery system may have a blunt end, to
avoid pushing the entire device through the leaflet" (Spec. ,r 64).
5. Figures 12a-12c of the Specification are reproduced below:
52
171 165
168
~ ,)
173 ~ 'i
.... 168
179 ~~-
__ j'
FIG. 12a
Figure 12a shows "needle 165 [with] a suture 168 tightly wrapped around
one end .... [I]n Figure 12b, the wrapped needle 165 is inserted into the
heart toward the mitral valve leaflet 52 ... [and] advanced across the mitral
valve leaflet 52 ... in Figure 12c." (Spec. ,r 70).
Principles of Law
"[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement." Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1352 (Fed. Cir. 2010)
9
Appeal 2017-010538
Application 14/478,325
Analysis
Claims 18-23, 28, and 30
We agree with the Examiner that the claims contain subject matter
that was not described in the Specification in such a way as to convey
possession of the claimed invention. Final Act. 2. None of the Figures cited
by the Appellants, or the accompanying descriptive text, disclose an
"embodiment of contacting only the ventricle side" (Ans. 3). Figures 5-7
and 12A-12C do not show the distal tip of the delivery device contacting a
leaflet (see FF 1, 2, and 5). As admitted by Appellants, "FIG. 12 omits the
distal tip of the delivery system for ease of explanation of the needle 165 and
anchor deployment" (Reply Br. 4). Likewise, the Specification describes
contacting the leaflet from the ventricular side, but does not support the
newly added "only" claim limitations. Although Appellants argue that "the
concept ... (1) is central to the solution to problems associated with
conventional approaches and (2) fulfils the 'need for new procedures and
devices for performing cardiac valve repairs"' (Reply Br. 3), Appellants
provide no evidence based on the Specification supporting these statements.
At best, use of the term "only" is an obvious alternative that is not described
by the original Specification, and therefore does not satisfy the written
description requirement.
Claim 25
Appellants did not contest the rejection of claim 25 on appeal. In the
absence of Appellants' argument on claim 25, we consider the argument
waived and affirm the Examiner's written description rejection of claim 25.
10
Appeal 2017-010538
Application 14/478,325
Conclusions of Law
The evidence of record supports the Examiner's conclusion that
claims 18-23, 25, 28, and 30 represent new matter.
C. 35 US.C. § 102(b) over Alkhatib
The Examiner finds:
Alkhatib discloses a method of repairing a prolapsed leaflet of a
valve of a heart ( abstract; paragraph 95) comprised of
introducing into a ventricle of the heart (Fig. 1; paragraph 48) a
distal portion (Fig. 25A []) of a delivery system 30a having a
distal tip (Figs. 1, 25A- see distal end of 30a), and carrying an
artificial chordae 130, 132, 138 (Figs. 23, 24, 25A-29) having a
distal and proximal portion (Figs. 23, 24, 25A-29); disposing
the distal tip of the delivery system 30a in contact with a
ventricular side of the leaflet (Fig. 25A); while maintaining the
entire distal portion (Figs. 25A, B) of the delivery system on
the ventricular side of the leaflet (paragraph 7 4) extending from
the distal tip a needle 140 having a distal portion carrying the
distal portion of the artificial chordae to pierce a prolapsed
segment of the leaflet from a ventricular side to an atrial side
(Figs. 25A-25C) to form an opening in the leaflet.
(Final Act. 5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Alkhatib anticipates claims 1
and 29?
Findings of Fact
6. Alkhatib teaches a heart valve leaflet tether attaching apparatus
with a shaft that is inserted "through the apex of the patient's heart to extend
up through the left or right ventricle to the patient's heart valve to be
repaired" (i-f 48).
11
Appeal 2017-010538
Application 14/478,325
7. Figure 25A of Alkhatib is reproduced below:
3.0b
FIG. 25A
Alkhatib teaches:
In FIG. 25(a) leaflet 16 is captured between the jaws 40 near
the distal end of shaft 30. Tether structure 130/132 is pushed
distally along a needle lumen 112 using needle 140 until anchor
132 has passed through leaflet tissue (FIG. 25(b )). After
passing through tissue 16, anchor 132 can enter a space in the
distal shaft portion 30c.
(Alkhatib if 74).
Principles of Law
The Examiner bears the initial burden of establishing a prima facie
case of anticipation. In re King, 801 F.2d 1324, 1326-27 (Fed. Cir. 1986).
Anticipation under 35 U.S.C. § 102 requires that "each and every element as
set forth in the claim is found, either expressly or inherently described, in a
single prior art reference." In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
1999).
12
Appeal 2017-010538
Application 14/478,325
Analysis
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared to the prior art. Here, the dispute
centers over the term "entire distal portion" in claims 1 and 29.
Appellants contend "it is improper to read 'while maintaining the
entire distal portion of the delivery system on the ventricular side of the
leaflet' onto a less-than-entire portion of a prior art device" (App. Br. 12).
Appellants contend "during delivery of the tether structure, Alkhatib 's entire
delivery system, which must include the distal shaft portion 30c, is not
maintained on the ventricular side of the leaflet" (App. Br. 11 ).
The Examiner responds that "30c was not used in the rejection" and
instead cites "30a as the delivery system, which is maintained on the
ventricular side" (Ans. 5). The Examiner further argues that the transitional
phrase "comprising" "does not exclude additional, unrecited element[ s] or
method steps, was used in the claim. Thus, the claims do not exclude
additional, unrecited elements," such as 30c of Alkhatib (Ans. 4).
We agree with Appellants that the plain language of claims 1 and 29
"maintaining the entire distal portion of the delivery system on the
ventricular side of the leaflet" is a limitation on the method that precludes
the distal portion of the delivery device from extending to an atrial side of
the leaflet (see Claim 1 ). The Specification reinforces this interpretation by
disclosing at least one embodiment of a tip that does not perforate the
ventricular side of the leaflet, and prevents the distal portion from being
pushed through the leaflet (FF 3--4).
While we agree with the Examiner that "comprising" may allow
additional elements (see Ans. 4), that presumption may be overcome when
13
Appeal 2017-010538
Application 14/478,325
"there is evidence of a clear intent to limit the claims." Scanner
Technologies Corp. v. !COS Vision Systems Corp. N. V., 365 F.3d 1299,
1305---6 (Fed. Cir. 2004). In this case, we disagree with the Examiner's
interpretation based on "comprising" because of the express exclusion in
claim 1 that the disposing step must occur "while maintaining the entire
distal portion ... on the ventricular side of the leaflet." We note that "every
limitation positively recited in a claim must be given effect in order to
determine what subject matter that claim defines." In re Wilder, 429 F.2d
447,450 (CCPA 1970).
The method of Alkhatib, which disposes "distal shaft portion 30c" on
the atrial side of the leaflet (see Alkhatib ,r,r 51 and FF 7), does not teach
"maintaining the entire distal portion on the ventricular side." As such,
Alkhatib does not teach all the limitations of the claimed methods.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that Alkhatib anticipates claims 1, 2, 7, 9, 11, 12, 25, and 29.
D. 35 USC§ 102(b) over Kudlik
The Examiner finds:
Kudlik discloses a method of repairing a prolapsed leaflet of a
valve of a heart (see page 2 of provisional application nos.
61/741,497 and 61/473,873) comprised of introducing into a
ventricle of the heart (see Figs. 4a-4c of provisional
applications) a distal portion (the part of '25' that contacts the
leaflet) of a delivery system 23 having a distal tip 25 (Fig. 3 of
the provisional applications) and carrying an artificial chordae
2, 12, 14 (see Figs. 1, 2 of provisional applications) having a
distal and proximal portion; disposing the distal tip 25 of the
delivery system in contact with a ventricular side of the leaflet
(Figs. 4a-4c of provisional applications); while maintaining the
14
Appeal 2017-010538
Application 14/478,325
entire distal portion (the part of '25' that contacts the leaflet) of
the delivery system on the ventricular side, extending from the
distal tip a needle 22 (Figs. 4b, 3 of the provisional
applications) having a distal portion carrying the distal portion
of the artificial chordae to pierce a prolapsed segment of the
leaflet from a ventricular side to an atrial side (see Figs. 3-4c of
provisional applications) to form an opening in the leaflet
(Final Act. 8).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Kudlik anticipates claim 1?
Findings of Fact
8. Kudlik teaches:
[A] method for deploying the device 2 for treatment of a
prolapsed mitral valve .... The tip 25 of the catheter 23 is
inserted through the myocardium 38 until the catheter 25 is
juxtaposed to the underside of the leaflet 32 . ... With the heart
still beating ... the catheter 27 is rotated so as to screw the
spiral wire 27 into the underside of the valve leaflet 32. Then
as shown in Fig. 4b, the sharp tip 24 of the needle 22 is made to
pierce through the leaflet 32.
(Kudlik US 61/471,497 4:11-22).
Analysis
Appellants contend "[d]uring deployment of Kudlik's device 50,
Kudlik's entire delivery system, which necessarily includes the spiral wire
27, is in fact not maintained on the ventricular side of the leaflet" (App. Br.
11; emphasis is original). Instead, "[t]he spiral wire 27 is configured to
screw into the underside of the valve leaflet being treated ... and must be
unscrewed before the delivery system can be removed" (id.).
15
Appeal 2017-010538
Application 14/478,325
As discussed above, we agree with Appellants that "maintaining the
entire distal portion of the delivery system on the ventricular side of the
leaflet" is a limitation on the method precluding the distal portion from
piercing through to the atrial side. However, we agree with the Examiner
that this limitation is taught by Kudlik.
As noted by the Examiner, Kudlik teaches juxtaposing tip 25 of the
delivery system 23 with a ventricular side of the leaflet during the method of
treating the prolapsed leaflet (FF 8). Even if spiral wire 27 is part of the
"distal portion of the delivery system," it is screwed into and maintained in
the underside, or ventricular side, of the valve leaflet (FF 8). Kudlik does
not teach that the spiral wire 27 pierces through the leaflet, i.e., to the atrial
side.
Appellants also contend that the spiral wire of Kudlik "must be
unscrewed before the delivery system can be removed" (App. Br. 11 ). 12
Claim 1 does not preclude an unscrewing step, particularly where the
transitional phrase "'comprising' would not exclude additional method
steps" ( cf App. Br. 11 ). "[W]hile it is true that claims are to be interpreted
in light of the specification ... , it does not follow that limitations from the
specification may be read into the claims. . . . [T]he claims define the
invention." Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988).
Because both the tip 25 and the spiral wire 27 are maintained on the
ventricular side of the leaflet, a reasonable reading of Kudlik and a
12 Appellants also argue improper reconstruction citing In re Ratti, 270 F.2d
813 (CCPA 1959). Reconstruction, as discussed in Ratti, deals with
obviousness, not anticipation, and therefore does not apply.
16
Appeal 2017-010538
Application 14/478,325
reasonable interpretation of claim 1 support the Examiner's anticipation
position.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Kudlik anticipates claims 1.
E. 35 US.C. § 103(a) over Alkhatib or Kudlik, and DiMatteo
The Examiner finds:
Alkhatib or Kudlik do not expressly disclose drawing the
proximal and distal portion of the artificial chordae towards
each other to form a loop, the distal portion of the chordae
being formed as a coil having a plurality of turns; the coil being
straight in the first configuration and the coil being the loop in
the second configuration.
(Final Act. 12).
The Examiner finds:
DiMatteo, in the analogous art of anchoring sutures to
tissue, teaches a suture having a first configuration (Fig. 2c) and
a second configuration (Fig. 2d), the second configuration
being larger than an opening in the tissue, the distal portion of
the suture being formed as a coil having a plurality of turns
(Fig. 2b ), the coil being a loop in the second configuration (Fig.
2d), and the coil being straight in the first configuration (Fig. 2c
), and causing the suture to change from the first to the second
configuration by proximal pulling of a proximal portion
(paragraph 48), for the purpose of maximizing the retention
strength of the anchor in tissue, minimizing the risk of anchor
breakage or pullout from the tissue when the suture is
tensioned, and for a less traumatic surgical incision, shallower
penetration into or through the tissue, less vertical access
needed to deploy the anchor, and for reducing surgical trauma
(paragraphs 4, 6, 38).
17
Appeal 2017-010538
Application 14/478,325
(Id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Alkhatib and DiMatteo or
Kudlik and DiMatteo render the claims obvious?
Findings of Fact
9. Figures 2b-2d of DiMatteo are reproduced below:
FIG. 2b
214~
206
208
FIG. 2c
,o t c • r IQ.F ± s0
FIG. 2d
c.212
Figures 2b-2d illustrate a twisted braid suture anchoring device, where
Figure 2b illustrates a configured suture head 214 with "[a] loop 204 . ..
repetitively twisted to provide a plurality of openings" (DiMatteo ,r 46).
Figure 2c "illustrates the suture head 214 in a compressed cross section form
218, as for disposition in a delivery needle" (DiMatteo ,r 47). Figure 2d
illustrates suture head 214 "collapsed [into] anchoring knot 220" (id.).
18
Appeal 2017-010538
Application 14/478,325
10. DiMatteo teaches:
(pulling) the first suture tail 212 away from the suture head 214,
so that the portion of the first suture tail 212 that is woven
through the plurality of openings 216 is pulled further through
the plurality of openings 216 and through the first head end
206, thereby gathering or bunching the twisted suture along
[with] the head length 210 into the anchoring knot 220.
(DiMatteo ,r 48).
Analysis
Alkhatib and DiMatteo
Claims 3 and 8
Claims 3 and 8 depend from claim 1. Having reversed the rejection of
claim 1 over Alkhatib, we also necessarily reverse the obviousness rejection
of claims 3 and 8 because the Examiner does not identify where DiMatteo
suggests "maintaining the entire distal portion of the delivery system on the
ventricular side of the leaflet."
Claim 26
Appellants contend "nowhere does DiMatteo disclose or suggest
deflecting a distal end of the distal portion of the artificial chordae laterally;
rather DiMatteo discloses merely collapsing longitudinally ... its suture
head to an anchoring knot by tensioning the suture tail with respect to the
head" (App. Br. 14). Appellants further cite to their previous arguments
regarding the distal portions of the delivery systems of Alkhatib 30a and 30c
and Kudlik (id.).
The Examiner responds that "[t]he distal end of the suture ...
bends/gathers/bunches (see Fig. 2b) when collapsed, and thus it deflects
laterally when collapsed" (Ans. 8).
19
Appeal 2017-010538
Application 14/478,325
First, we address the Appellants' earlier arguments regarding the
"entire distal portion" as recited by claims 1 and 29. Unlike claims 1 and 29,
claim 26 does not require "maintaining the entire distal portion ... on the
ventricular side of the leaflet." We, therefore, interpret claim 26 to allow for
the distal portion of the delivery device to extend beyond the ventricular side
of the leaflet. "There is presumed to be a difference in meaning and scope
when different words or phrases are used in separate claims. To the extent
that the absence of such difference in meaning and scope would make a
claim superfluous, the doctrine of claim differentiation states the
presumption that the difference between claims is significant." US. v.
Telectronics, Inc., 857 F .2d 778, 783-84 (Fed. Cir. 1988) ( citation omitted).
Thus, the method of Alkhatib is not excluded from claim 26, and we find
that Alkhatib teaches the steps of disposing the distal tip of the delivery
device in contact with the ventricular side of the leaflet as indicated by the
Examiner.
Appellants are correct in that Figures 2a-2d of DiMatteo illustrate
longitudinal collapse (FF 13). However, we find this argument unpersuasive
because we agree with the Examiner that the distal end of the suture also
deflects laterally during the longitudinal collapse. As claim 26 does not
exclude longitudinal collapse in addition to lateral deflection, a reasonable
reading of DiMatteo and a reasonable interpretation of claim 26 support the
Examiner's obviousness position.
Kudlik and DiMatteo
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 12, FF 9 and 10) and agree that
claims 3, 8, 26, and 27 are rendered obvious by Kudlik and DiMatteo,
20
Appeal 2017-010538
Application 14/478,325
incorporating the discussion of DiMatteo above. Appellants provide no
other arguments specific to this combination.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
claims 3, 8, 26, and 27 would have been obvious.
F. 35 US.C. § 103(a) over Alkhatib and Allen
The Examiner finds:
Alkhatib does not expressly disclose while contacting the
prolapsed leaflet only on the ventricular side of the prolapsed
leaflet.
Allen ... teaches contacting only a ventricular side of a
prolapsed leaflet (see column 3, lines 4-18[]) . .. to repair the
mitral valve .... Using a vacuum and contacting only one side
of a leaflet is an art recognized equivalent of clamping both
sides of the leaflet (see Figs. lb, 4a---c; column 3, lines 4-18) ...
. Therefore, because vacuum and clamping delivery systems
were art recognized equivalents at the time the invention was
made, one of ordinary skill in the art would have found it
obvious to substitute the clamp delivery system with a vacuum
delivery system since both are capable of stabilizing
leaflets/tissue.
(Final Act. 16-17; emphasis in original).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Alkhatib and Allen render
claim 18 obvious?
Findings of Fact
11. Allen teaches a mitral valve repair procedure in Figure 1 b using
a probe that "has a size suitable for minimally invasive surgery" with the
21
Appeal 2017-010538
Application 14/478,325
"ability to perform valve repair surgery on a beating heart" (Allen 6:41-
7: 13).
12. Figure 1 b of Allen is reproduced below:
'
' ,V ...-·- 20 I: "!'---,, j>'
,, I
1
' 11
d 'i 30
·, ... _ !
--->------·-·---~,,.....L,..: --- ~~------~---...
::-~ '\ 11i -~~~ ''2 __ ) \\\
.. 22 7' \' .r: · . })
\ 1' '. \ ..,; /
FIG. 1 ~II
Figure 1 b shows a tissue stabilizer 20 with a cylindrical probe 24 contacting
heart valve leaflets 22 with vacuum indicated by arrows pointing to the
probe through the leaflets (Allen 6:41-7:13).
13. Allen teaches the device can be delivered "transapically ... [or]
through ... the left ventricle" (Allen 3:4--18).
14. Figure 4a is reproduced below:
..._,..,.~_./-86 ~---·-·· 82
~88 ------·___.,,-·-
f ~ J)
'84 (
FIG. 4a
Figure 4a "shows a mechanical tissue stabilizer 80 with a four-part, linearly
displaceable tissue clamp 82" (Allen 7:66--8:8).
22
Appeal 2017-010538
Application 14/478,325
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Moreover, an "[ e ]xpress suggestion to substitute one equivalent for
another need not be present to render such substitution obvious." In re Fout,
675 F.2d 297,301 (CCPA 1982). As noted by the Court in KSR, "[a] person
of ordinary skill is also a person of ordinary creativity, not an automaton."
550 U.S. at 421.
Analysis
Appellants contend that "Allen explicitly teaches away from applying
vacuum stabilization to a leaflet from the ventricle side of the leaflet (i.e.[,]
transapically)" (App. Br. 13). Appellants contend Figure lb, cited by the
Examiner, is directed to an "approach from the left atrium 30" due to lower
pressure in the atrium, and that "every disclosed embodiment is transatrial"
(App. Br. 13).
While Appellants are correct that the teaching of Figure 1 b is
transatrial due to lower pressure in the atrium, this does not amount to a
teaching away. "The prior art's mere disclosure of more than one alternative
does not constitute a teaching away from any of these alternatives because
such disclosure does not criticize, discredit, or otherwise discourage the
solution claimed .... " In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
We find the Appellants' argument unpersuasive. The Examiner has
shown that vacuum and clamping delivery systems were art recognized
equivalents used in valve repair procedures with a ventricular approach (see
FF 12-14). Allen merely expresses a general preference for applying
23
Appeal 2017-010538
Application 14/478,325
vacuum stabilization to a leaflet from a transatrial approach, but does not
discourage a ventricle side approach. Allen's specific teaching is not a
teaching away when it does not criticize, discredit, or discourage the other
approach. Fulton, 391 F.3d at 1201. As argued by Appellants, Alkhatib
teaches a clamping delivery system for repairing cardiac valves using a
ventricular approach (see App. Br. 10). The combination of the art teaches
repairing a valve by disposing the distal tip of the delivery system in contact
with only a ventricular side of the prolapsed leaflet.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Alkhatib and Allen suggest a method of repairing a prolapsed heart valve as
required by claim 18.
G. 35 USC§ 103(a) over Alkhatib and Zlotnick
The Examiner rejects claim 24 as obvious over Alkhatib in view of
Zlotnick. Having reversed the rejection of claim 1 over Alkhatib, we also
necessarily reverse this obviousness rejection because Zlotnick does not
teach or suggest the limitation of "while maintaining the entire distal portion
of the delivery system on the ventricular side of the leaflet."
H 35 US. C. § 103 (a) over Alkhatib, DiMatteo, and Hart or Kudlik,
DiMatteo, and Hart
Claims 4 and 5 depend from claim 1. Having reversed the rejection of
claim 1 over Alkhatib, we also necessarily reverse the obviousness rejection
of claims 4 and 5 because the Examiner does not identify where DiMatteo or
24
Appeal 2017-010538
Application 14/478,325
Hart suggest "maintaining the entire distal portion of the delivery system on
the ventricular side of the leaflet."
Appellants do not separately argue the obviousness rejections of
claims 4 and 5, instead relying on their arguments to overcome Kudlik. The
Examiner provides sound fact-based reasoning combining Kudlik, DiMatteo,
and Hart (see Final Act. 13-14). Having affirmed the rejection of claim 1,
from which these claims depend for the reasons given above, we also
conclude the claims would have been obvious for the reasons given by the
Examiner.
1.-M. 35 US.C. § 103(a)
Appellants do not separately argue the obviousness rejections of
claims 16, 17, 19-23, and 27-32, instead relying on their arguments to
overcome Alkhatib, Kudlik, Allen, and DiMatteo. The Examiner provides
sound fact-based reasoning combining each of Hart, Zlotnick, and Lattouf
(see Final Act. 13-22). Having affirmed the rejections of claims 18 and 26
from which these claims depend for the reasons given above, we also
conclude the claims would have been obvious for the reasons given by the
Examiner.
SUMMARY
In summary, we affirm the rejection of claims 26-32 under 35 U.S.C.
§ 112, second paragraph as indefinite.
We affirm the rejection of claims 18-23, 25, 28, and 30 under
35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement.
We reverse the rejection of claims 1, 2, 7, 9, 11, 12, 25, and 29 under
35 U.S.C. § 102(b) as anticipated by Alkhatib.
25
Appeal 2017-010538
Application 14/478,325
We affirm the rejection of claim 1 under 35 U.S.C. § 102(b) as
anticipated by Kudlik. Claims 2, 9, 11, and 12 fall with claim 1.
We reverse the rejection of claims 3 and 8 under 35 U.S.C. § 103(a)
as obvious over Alkhatib and DiMatteo.
We affirm the rejection of claims 3 and 8 under 35 U.S.C. § 103(a) as
obvious over Kudlik and DiMatteo.
We affirm the rejection of claims 26 and 27 under 35 U.S.C. § 103(a)
as obvious over Alkhatib and DiMatteo, or Kudlik and DiMatteo.
We reverse the rejection of claim 24 under 35 U.S.C. § 103(a) as
obvious over Alkhatib and Zlotnick.
We reverse the rejection of claims 4 and 5 under 35 U.S.C. § 103(a)
as obvious over Alkhatib, DiMatteo, and Hart.
We affirm the rejection of claims 4 and 5 under 35 U.S.C. § 103(a) as
obvious over Kudlik, DiMatteo, and Hart.
We affirm the rejection of claim 18 under 35 U.S.C. § 103(a) as
obvious over Alkhatib and Allen. Claims 19, 20, 22, and 23 fall with claim
18.
We affirm the rejection of claims 16 under 35 U.S.C. § 103(a) as
obvious over Alkhatib, Allen, and DiMatteo.
We affirm the rejection of claims 17 under 35 U.S.C. § 103(a) as
obvious over Alkhatib, Allen, DiMatteo, and Hart.
We affirm the rejection of claim 21 under 35 U.S.C. § 103(a) as being
obvious over Alkhatib, Allen, and Zlotnick.
We affirm the rejection of claims 28 and 30 under 35 U.S.C. § 103(a)
as being obvious over Alkhatib, DiMatteo, and Allen, or Kudlik, DiMatteo,
and Allen.
26
Appeal 2017-010538
Application 14/478,325
We affirm the rejection of claims 31 and 32 under 35 U.S.C. § 103(a)
as obvious over Alkhatib, DiMatteo, Allen, and Lattouf.
We therefore note that claims 7 and 24 are not subject to an affirmed
rejection.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
27