Ex Parte Feigl

Patent Trial and Appeal Board

Jul 18, 2017

12177694 (P.T.A.B. Jul. 18, 2017)

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.
12/177,694 07/22/2008 Alexander J. Feigl AFEI:002USD1 4892
32425 7590 07/20/2017
NORTON ROSE FULBRIGHT US LLP
98 SAN JACINTO BOULEVARD
SUITE 1100
AUSTIN, TX 78701-4255
EXAMINER
ORKIN, ALEXANDER J
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
07/20/2017 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):
aoipdocket @ nortonrosefulbright .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALEXANDER J. FEIGL1
Appeal 2016-004814
Application 12/177,694
Technology Center 3700
Before ERIC B. GRIMES, RYAN H. FLAX, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to needle
placement methods. The Examiner rejected the claims for lack of written
description, as anticipated, and for obviousness. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellant explains that “[traditional needle advancement and
positioning instruments almost exclusively use a hemostat-like tool that
allows a needle to be gripped by the tool and then advanced into the tissue
being sutured.” (Spec. 2:11—13.) Appellant’s invention “relates to an
1 Appellant identifies the Real Party in Interest as A&P Feigl Family
Limited Partnership. (Br. 1.)
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Application 12/177,694
instrument that may be used to position one or more needles in locations that
are difficult to suture using conventional methods.” {Id. at 2:6—7.)
The Specification’s drawings better illustrate Appellant’s invention.
Figures 1 and 6 are reproduced below and show a device usable for
practicing the claimed methods.
Figure 1 is a cross-sectional view of a suture-placement device including,
inter alia, body (10), and lumen (15) with respective first (16) and second
(17) lumen openings. {Id. at 11:26—28.) Figure 1 also shows an arcuate­
shaped needle guide channel (12) formed in the body, which is configured to
receive an arcuate-shaped needle (not depicted in Fig. 1) within the channel.
{Id. at 10:24—30.) The device may further include a handle (19) connected
via shaft (20) to the body (10). {Id. at 12:18—19.)
FIG. 1
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FIG, 6
Figure 6 is a cross-sectional view of the suture-placement device, and shows
a needle (60) attached at one end to suture (62) and being advanced out of
the needle guide channel (61) by pulling suture (62) outward from opening
(63) of the lumen in the direction of arrow (64). {Id. at 14:1—4.) As the
Specification explains, “the needle has at least one directional component,
represented by arrow 65a, that is opposite in direction to one of the
directional components, represented by arrow 64, of the second end of the
suture.” {Id. at 14:5—7; see also id. at 13:3—20.)
Claims 53—57, 59—61, and 64—76 are on appeal. The independent
claims (claims 53, 64, and 71) are reproduced below.
53. A needle placement method comprising:
using a medical device to position a first needle to which
a first length of suture is attached, the first needle being
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Application 12/177,694
positioned at least partially within a first needle guide channel of
the medical device; and
advancing the first needle completely out of the first needle
guide channel and the medical device by pulling the first length
of suture, wherein the pulling includes moving the first length of
suture in a first direction having a positive longitudinal
component, and the advancing includes the first needle moving
in a second direction having a negative longitudinal component.
64. A needle placement method comprising:
using a medical device to position a first needle to which
a first length of suture is attached, the first needle being
positioned at least partially within a first needle guide channel of
the medical device, the first needle having a length and being
curved along at least a portion of the length when the first needle
is in an unconstrained position', and
advancing the first needle by pulling the first length of
suture, wherein the pulling includes moving the first length of
suture in a first direction having a positive longitudinal
component, and the advancing includes the first needle moving
in a second direction having a negative longitudinal component.
71. A needle placement method comprising:
using a medical device to position a first needle to which
a first length of suture is attached, the first needle being
positioned at least partially within a first needle guide channel of
the medical device, the first length of suture not being attached
to another needle', and
advancing the first needle by pulling the first length of
suture, wherein the pulling includes moving the first length of
suture in a first direction having a positive longitudinal
component, and the advancing includes the first needle moving
in a second direction having a negative longitudinal component.
(Br. 8—9, 11 (Claims App.) (emphases added).)
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The claims stand rejected as follows:
I. Claims 71—76 under 35 U.S.C. § 112, first paragraph (pre-
AIA), for failure to satisfy the written description requirement.
II. Claims 53 and 54 under 35 U.S.C. § 102(b) by Kontos ’539.2
III. Claims 55, 57, 71—73, and 75 under 35 U.S.C. § 103(a) over
Kontos ’539.
IV. Claims 56 and 74 under 35 U.S.C. § 103(a) over Kontos ’539
and Kontos ’849.3
V. Claims 59, 61, and 76 under 35 U.S.C. § 103(a) over Kontos
’539 and Pilling.4
VI. Claim 60 under 35 U.S.C. § 103(a) over Kontos ’539, Kontos
’849, and Pilling.
VII. Claims 64—69 under 35 U.S.C. § 103(a) over Kontos ’539,
Kontos ’849, and Stalker.5
VIII. Claim 70 under 35 U.S.C. § 103(a) over Kontos ’539, Kontos
’849, Stalker, and Pilling.
I - WRITTEN DESCRIPTION
The Examiner rejected claim 71, and dependent claims 72—76, for
failing to comply with the written description requirement. According to the
Examiner, the limitation of claim 71 that “the first length of suture not being
2 Kontos, US 5,980,539, issued Nov. 9, 1999.
3 Kontos, US 5,810,849, issued Sept. 22, 1998.
4 Pilling et al., US 1,815,725, issued July 21, 1931.
5 Stalker et al., US 5,972,005, issued Oct. 26, 1999.
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Application 12/177,694
attached to another needle” is a negative limitation that lacks support in
Appellant’s disclosure. (Final Act. 2—3.)
“[T]he test for sufficiency [of the written description] is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date.” AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en banc). Thus, the issue before us is whether Appellant’s
disclosure reasonably conveys to the skilled artisan possession of a method
using a one-to-one arrangement between the suture and the needle.
We are unpersuaded the Examiner met the burden to show that claim
71 lacks adequate descriptive support. As Appellant points out, in haec
verba support is not required.6 (Br. 2.) Hence, contrary to the Examiner’s
suggestion, the Specification need not literally recite that the suture is not
attached to more than one needle. (Ans. 4 (“the specification needs to
disclose that not only the suture may be attached to a needle, BUT it is not
attached to more than one needle.”).) In any event, Appellant’s disclosure
does adequately describe “the first length of suture not being attached to
another needle.” As Appellant contends, all the relevant figures show a one-
to-one relationship between the suture and the needle. (Br. 3.) And the
Specification elsewhere describes a single needle attached to a single suture.
For example, the Specification describes “a first needle, and a length of
suture attachable to the first needle” (Spec. 4:24—25), “[e]ach additional
6 “[T]he disclosure as originally filed does not have to provide in haec verba
support for the claimed subject matter at issue.” Purdue Pharma L.P. v.
Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000).
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needle may have its own additional length of suture” and “[e]ach additional
length of suture may be attached to its own additional needle.” {Id. at 5:15—
17.) From this, we disagree the skilled person would read Appellant’s
disclosure and conclude the inventor did not have possession of a method
where the suture is connected to one needle — and one needle alone — as
required in claim 71.
The Examiner further responds that Appellant’s description “would
not rule out the possibility of the suture attached to another needle.” (Ans.
4.) We assume for the moment that is true. Indeed, in describing that any
additional needle “may” have its own length of suture (Spec. 5:15—17), the
Specification reasonably discloses that additional needles may be connected
to the first suture to which a first needle is attached. That does not, however,
change our conclusion because it would mean Appellant described
alternative embodiments (e.g., additional needles may or may not be
connected to a common suture), and opted to claim one of them in claim 71.
Cf. Inphi Corp. v. Netlist, Inc., 805 F.3d 1350, 1357 (Fed. Cir. 2015)
(holding that “[prior precedent] did not create a heightened written
description standard for negative claim limitations and that properly
described, alternative features are sufficient to satisfy the written description
standard of § 112, paragraph 1 for negative claim limitations.”)
For these reasons, we conclude the preponderance of the evidence
does not support the Examiner’s rejection for lack of written description.
II-ANTICIPATION
The Examiner rejected method claims 53 and 54 as anticipated by
Kontos ’539. (Final Act. 3—5.) As to the key disputed step of claim 53, the
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Examiner finds Kontos ’539 teaches “advancing the first needle completely
out of the first needle guide channel and the medical device by pulling the
first length of suture (col. 6,11. 55-59).” (Id. at 3.)
Appellant argues Kontos ’539 does not disclose the method of claim
53 because, in Kontos ’539, the needle is only partially advanced out of the
alleged needle guide channel by pulling the suture. (Br. 3 4.) Appellant
contends “Kontos [’539] state[s] that it is the doctor grasping needle 14 itself
and pulling on it that gets it completely out of lumen 10.” (Id. at 4 (quoting
Kontos ’539 6:55-7:7).)
Appellant’s argument is persuasive. “Anticipation requires that all of
the claim elements and their limitations are shown in a single prior art
reference.” In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). As
Appellant points out (Br. 4), Kontos ’539 discloses:
The first needle 14 is drawn proximally by means of the first
suture portion 20' until the pointed end 14' of the first needle
protrudes from the skin. The first needle 14 is then grasped by
the doctor and withdrawn from the needle retention lumen 10,
thereby drawing the first suture portion 20' out through the skin.
(Kontos ’539 6:62—66; see also id. Fig. 10.) The method described in
Kontos ’539 thus requires the doctor to physically grasp and pull the needle
to advance the needle completely out of the lumen. This differs from the
method of claim 53, where the needle is advanced completely out of the
needle guide channel and device by pulling the suture.
The Examiner responds that “one can read that the pulling step of the
suture helps or aids or starts the step of advancing the first needle completely
out of the first needle guide channel” and that even if the doctor “pulls the
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needle out as well, there is still ‘a pull’ being applied to the suture.” (Ans.
5.) We are unpersuaded the Examiner is applying a reasonable
interpretation of claim 53. The pulling of the suture (with the directionality
claimed) is responsible for advancing the needle completely out of the
needle guide channel and device. (See, e.g., Spec. 13:28—29 (“it is the suture
itself that advances the needle out of the needle guide channel”).)
In sum, the preponderance of the evidence does not support the
Examiner’s finding that claims 53 and 54 are anticipated.
Ill & VII - OBVIOUSNESS
The Examiner rejected claims 55, 57, 71—73, and 75 over Kontos ’539
(Rejection III), and claims 64—69 over Kontos ’539, Kontos ’849, and
Stalker (Rejection VII).
Rejection III
Claims 55 and 57 depend from claim 53. The Examiner reprises the
findings about Kontos ’539 and claim 53 (Final Act. 6) that we concluded
were unpersuasive as discussed above concerning Rejection II.
For claim 71, from which claims 72, 73, and 75 depend, the Examiner
finds “modification to include an additional needle guide channel will have
the first length of suture not attached to another needle as shown in Fig. 15
of Kontos.” (Id. at 7.)
We disagree. Kontos ’539’s related description and drawings make
clear that Figure 15 does not disclose a length of suture that is attached to
only one needle. (See Kontos ’539 7:40-60 (describing how each needle
withdrawal lumen includes two needles coupled to a suture); see also id.
Figs. 15 and 17—21 (showing the operation of the device shown in Fig. 15).)
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As correctly noted by Appellant, “each disclosed length of suture (20 and
85) [as depicted in Figure 15] are attached to two needles.” (Br. 5.) Kontos
’539 does not, therefore, teach or suggest all the limitations of claim 71.
For these reasons, the preponderance of the evidence does not support
the Examiner’s conclusion that claims 55, 57, 71—73, and 75 would have
been obvious over Kontos ’539.
Rejection VII
The Examiner rejected claim 64, and dependent claims 65—69, based
on the combination of Kontos ’539, Kontos ’849, and Stalker. (Final Act. 9—
10.) The key limitation of claim 64 is “the first needle having a length and
being curved along at least a portion of the length when the needle is in an
unconstrained position.” In other words, the needle is at least partially
curved in its natural (unconstrained) state.
The Examiner reasons it would have been obvious to modify Kontos
’539 with the flexible distal section of Kontos ’849 (which provides the
arcuate-shaped needle guide channel), in order to “prevent the device from
penetrating or damaging the lining of the blood vessel.” {Id. at 9.) The
Examiner, finding that the device modified according to Kontos ’539 and
’849 fails to disclose the curved needle of claim 64, turns to Stalker. {Id.)
According to the Examiner, Stalker teaches a needle that “resiliently
maintain[s] a linear configuration when positioned in the delivery device and
elastically assume[s] a curved configuration to conform to the guide channel
after it pierces tissue.” {Id.) The Examiner then reasons it would have been
obvious to use the curved unconstrained needle of Stalker in the modified
device of Kontos ’539 and ’849. {Id. at 9-10.)
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Appellant’s only argument is that the Examiner’s reasoning for
combining Kontos ’539 and ’849 “makes no sense” because the Examiner
references Fig. 6B of Kontos ’849, but then relies on a rationale that
concerns Fig. 20 of Kontos ’849. (Br. 6.)
Although Appellant’s argument is generally unconvincing,7 neither
are we persuaded the Examiner made a threshold showing that claim 64
would have been prima facie obvious and Appellant’s point that the rejection
“makes no sense” is correct for other reasons.
We do not understand — and the Examiner does not adequately
explain — how the curved needle disclosed in Stalker would work in the
modified Kontos device. The needle (14) of Kontos ’539 is naturally
straight, and the needle (37) of Kontos ’849 appears to take on a slightly
curved configuration only when it is disposed in needle retention bore (32)
(i.e., when constrained) at the flexible distal end (24). (See Kontos ’539 Fig.
10; Kontos ’849 Figs. 6B and 7.) If, as the Examiner proposes, a needle that
assumed a curved position when unconstrained were used in the modified
Kontos device, we are unpersuaded the device would work as intended. For
example, as shown in Fig. 6B of Kontos ’849 and the related description,
“proximal end of the needle 37 is drawn through the wall of the blood
vessel, enters opening 10 and extends into the needle withdrawal lumen 26.”
(Kontos ’849 6:18—20.) Using a needle that is naturally biased to curve, like
7 The Examiner’s reference to Figs. 6B and 20 of Kontos ’849 together teach
that the distal portion of the suturing device should be made flexible (and
capable of partially curving) in order to avoid damage to the blood vessel
into which the distal portion is inserted. (See Kontos ’849 Figs. 6B and 20.)
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Stalker’s needle (see Stalker 3:16—27 and 6:33 46) in a device with the
distal end of Kontos ’849 would appear to prevent the needle from exiting
needle retention bore (32), piercing the blood vessel (BV), traversing the
gap/void caused by the bend at central arcuate portion (22), and then
entering needle withdrawal lumen (26) across the void. (See Kontos ’849
Fig. 6B.) Put succinctly, once the needle exited needle retention bore (32) it
would curve and miss opening (10) of needle retention lumen (26). (Id.)
The fact that the needles described in Kontos are naturally straight (see, e.g.,
Kontos ’849 Fig. 7) would seem to allow the needles to exit and enter the
relevant bores and lumens, and pierce the tissues as intended. And the
Examiner provides no reason with rational underpinning sufficient to explain
why the straight needles of Kontos would be modified to Stalker’s needles
having a natural curve.
For the above reasons, we reverse the rejection of claim 64 and
dependent claims 65—69 as obvious.
IV, V, VI & VIII
These rejections relate to various claims, all of which depend directly
or indirectly from one of independent claims 53, 64, or 71. The Examiner
has not shown the prior art combinations for these rejections make up for the
deficiencies with respect to the cited art and the independent claims. (Final
Act. 7—8, 10.) We thus reverse these rejections as well for the reasons
explained above. (See discussion regarding Rejections II, III, and VII.)
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SUMMARY
We reverse the rejections of the claims on appeal for lack of written
description, anticipation, and obviousness.
REVERSED
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