Ex Parte BLOM et al

Board of Patent Appeals and Interferences

Feb 13, 2004

09149359 (B.P.A.I. Feb. 13, 2004)

The opinion in support of the decision being entered today was
not written for publication and is not binding precedent of the
Board.
Paper No. 21
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte ERIC D. BLOM,
W. GREGORY CHERNOFF
and DANIEL W. KARAKLA
__________
Appeal No. 2002-2187
Application 09/149,359
___________
ON BRIEF
___________
Before STAAB, MCQUADE, and CRAWFORD, Administrative Patent
Judges.
MCQUADE, Administrative Patent Judge.
DECISION ON APPEAL
Eric D. Blom et al. originally took this appeal from the
final rejection (Paper No. 13) of claims 7 through 13 and 17
through 19, all of the claims pending in the application. As the
examiner has since withdrawn all rejections of claims 10 through
13, the appeal as to these claims is hereby dismissed, leaving
for review the standing rejections of claims 7 through 9 and 17
through 19. Claims 11 through 13 stand allowed and claim 10
stands objected to as depending from a rejected base claim.
Appeal No. 2002-2187
Application 09/149,359
2
THE INVENTION
The invention relates to a method for inserting a medical
device into an opening in a human body. Representative claims 7
and 17 read as follows:
7. A method for inserting into a first opening in a human
body a device including a device body having a longitudinal axis
and a flexible first flange provided on an outside surface of the
device body, the flange having a continuous radially-extending
surface which extends radially outward from the body to a radial
outer edge of the flange and having a deployed, use orientation
in which it projects generally outwardly from the outside surface
of the device body comprising resiliently deflecting the flange
toward the axis of the device body and placing over the
resiliently deflected flange a retainer of a material soluble in
a fluid, inserting the device into the first opening, and
permitted dissolution of the retainer.
17. A method for inserting into an opening in a human body a
device including a resiliently deflectable device body having a
substantially uniform insertion cross-section transverse to its
longitudinal extent which is insufficient to fill the opening and
a larger use cross section transverse to its longitudinal extent,
the method comprising resiliently deflecting the device body into
it substantially uniform insertion cross-section, placing over
the resiliently deflected device body a retainer for retaining
the device body in its substantially uniform insertion cross
section, inserting the device with the retainer in place into the
opening, and removing the retainer to permit deployment of the
device body to its use cross section.
THE PRIOR ART
The references relied on by the examiner to support the
final rejection are:
Bruce et al. (Bruce) 4,695,275 Sep. 22, 1987
Blom et al. (Blom) 4,911,716 Mar. 27, 1990
Appeal No. 2002-2187
Application 09/149,359
3
Bouton et al. (Bouton) 4,964,850 Oct. 23, 1990
Shikani 5,246,455 Sep. 21, 1993
THE REJECTIONS
Claims 17 through 19 stand rejected under 35 U.S.C. § 112,
first paragraph, as being based on a specification which fails to
comply with the written description requirement of this section
of the statute.
Claims 17 through 19 stand rejected under 35 U.S.C. § 112,
second paragraph, as failing to particularly point out and
distinctly claim the subject matter the appellants regard as the
invention.
Claims 17 and 18 stand rejected under 35 U.S.C. § 102(e) as
being anticipated by Shikani.
Claims 17 through 19 stand rejected under 35 U.S.C. § 102(b)
as being anticipated by Blom.
Claims 17 and 18 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by, and in the alternative under 35 U.S.C.
§ 103(a) as being unpatentable over, Bouton.
Claims 17 and 18 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by, and in the alternative under 35 U.S.C.
§ 103(a) as being unpatentable over, Bruce.
Appeal No. 2002-2187
Application 09/149,359
1 The final rejection also contained a provisional
obviousness-type double patenting rejection of claims 7 through
13 and 17 through 19, § 102(b) and § 103(a) rejections of claims
9 and 10 based on Bouton, and § 102(b) and § 103(a) rejections of
claim 9 based on Bruce. The examiner has since withdrawn all of
these rejections (see pages 2 through 4 in the answer).
4
Claims 7 through 9 stand rejected under 35 U.S.C. § 102(b)
as being anticipated by, and in the alternative under 35 U.S.C.
§ 103(a) as being unpatentable over, Blom.
Attention is directed to the main and reply briefs (Paper
Nos. 15 and 18) and to the answer (Paper No. 17) for the
respective positions of the appellants and the examiner regarding
the merits of these rejections.1
DISCUSSION
I. The 35 U.S.C. § 112, first and second paragraph, rejections of
claims 17 through 19
These rejections stem from the examiner’s concern (see page
5 in the answer) that the recitation in independent claim 17 of
the insertion cross-section of the resiliently deflectable device
body as being “substantially” uniform lacks written descriptive
support in the underlying specification and, as a consequence,
also renders the scope of the claimed subject matter indefinite.
Claim 17, and claims 18 and 19 which depend therefrom,
pertain to the nasal packing insertion method disclosed by the
appellants on pages 13 and 14 in the specification and in Figures
Appeal No. 2002-2187
Application 09/149,359
2 The appellants’ assertion on page 11 in the main brief
that these claims also relate to the voice prosthesis and septal
button insertion methods described and illustrated elsewhere in
the disclosure is not well taken. The limitations in these
claims, viewed in light of the underlying disclosure, simply do
not read on these other embodiments (in accord is the summary of
the invention set forth on pages 3 through 7 in the main brief).
5
17 and 18 of the drawings.2 Page 13 in the original
specification indicates that resiliently deflectable device
bodies of the sort set forth in claims 17 through 19, i.e. nasal
packings 224, “are compressed and inserted into thin-walled,
sleeve-like, flexible gelatin retainers 226,” and that “[t]he
packing 224 - retainer 226 combination is flexible and of small
enough cross sectional area, for example, to be inserted easily
through nostril 220 into nasal cavity 222 without causing
significant trauma.” Original Figure 18 depicts the insertion
step.
The written description requirement of 35 U.S.C. § 112,
first paragraph, requires the disclosure of the application as
originally filed to reasonably convey to the artisan that the
inventors had possession at that time of the later claimed
subject matter. In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ
1089, 1096 (Fed. Cir. 1983). The content of the drawings may be
considered in determining compliance with the written description
requirement. Id. The second paragraph of 35 U.S.C. § 112
Appeal No. 2002-2187
Application 09/149,359
6
requires claims to set out and circumscribe a particular area
with a reasonable degree of precision and particularity. In re
Johnson, 558 F.2d 1008, 1015, 194 USPQ 187, 193 (CCPA 1977). In
determining whether this standard is met, the definiteness of the
language employed in the claims must be analyzed, not in a
vacuum, but always in light of the teachings of the prior art and
of the particular application disclosure as it would be
interpreted by one possessing the ordinary level of skill in the
pertinent art. Id.
Although the appellants’ original disclosure does not
furnish literal support for the claim limitation at issue, its
description that the nasal packings are compressed and inserted
into thin-walled, flexible gelatin retainers, as well as the
depiction thereof in the drawings, would reasonably convey to the
artisan that the appellants had possession at that time of a
method as recited in claims 17 through 19 wherein the insertion
cross-section of the resiliently deflectable device body (nasal
packing 224) is “substantially” uniform. Also, read in light of
this description, the “substantially” uniform limitation sets out
and circumscribes the insertion cross-section of the resiliently
deflectable device body with a reasonable degree of precision and
particularity.
Appeal No. 2002-2187
Application 09/149,359
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Accordingly, we shall not sustain the standing 35 U.S.C.
§ 112, first and second paragraph, rejections of claims 17
through 19.
III. The 35 U.S.C. § 102(b), 102(e) and 103(a) rejections of
claims 7 through 9 and 17 through 19
The references applied in support of these rejections
pertain to medical devices having flanges which can be deformed
or deflected to facilitate insertion of the devices into a
patient’s body.
Shikani discloses a middle meatal antrostomy ventilation
tube 10 comprising a central tubular section 12 having a
rectangular flange 22 fitted onto one end and a triangular flange
34 fitted onto the other end. As described in the reference,
[i]nsertion of the ventilation tube 10 is performed by
grasping the two long sides 30, 32 of the elongated
rectangular flange 22 and folding them over until they
lie in parallel relation 40, 42 to the side of the
central tubular section 12, whereupon they may be
securely grasped with a hemostat or forceps. . . .
With the visual assistance of an endoscope (not shown),
the hemostat or forceps can then be used to advance the
ventilation tube 10 up the nasal passage 50 to a site
where an antrostomy opening has been prepared in the
lateral nasal wall. The triangular flange 34 is
angularly urged through this antrostomy until fully
inserted within the nasal sinus 52, whereupon it comes
to rest against the lateral nasal wall 48 (i.e., the
medial wall of the maxillary sinus), with the middle
turbinate 46 free to bump against it. The elongated
rectangular flange 22 rests upon the opposite surface
Appeal No. 2002-2187
Application 09/149,359
8
of the medial wall of the maxillary sinus [column 3,
line 54, through column 4, line 34].
Blom discloses a helical coil spring implant 400 for
retaining a voice prosthesis. The implant has a diamond shape
end portion 404 extending therefrom which acts as a flange to
hold the implant in its intended position. With regard to the
method of implantation, Blom teaches that
end portion 404 of implant 400 is deflected
sufficiently to insert it into half 416 of a gelatin
capsule. Implant 400 is inserted as far as it will go
into capsule 416 and a standard insertion tool is then
inserted into implant 400 and the implant is inserted
into the fistula 408. Saliva and mucus dissolve the
half gelatin capsule 416 and end portion 404 springs
back to its undeflected orientation [column 10, lines 5
through 12].
Bouton discloses a flexible plastic sinus aerator comprising
a hollow tube 1 having two wings/flanges 2a and 2b attached at
one end and two wings/flanges 3a and 3b attached at the other
end. According to Bouton, the aerator is positioned within a
puncture in the inferior nasal meatus by a delivery device 5 (see
Figure 2) or a bent pliers inserter 7 (see Figure 4) which
function to fold the wings/flanges 3a and 3b to allow insertion
through the puncture.
Bruce discloses a middle ear ventilation tube comprising a
tubular body 10 having a flange 14 on one end and two lateral
arms/flanges 16 on the other end. Bruce indicates that the tube
Appeal No. 2002-2187
Application 09/149,359
9
is inserted through an incision in the tympanic membrane 20 by
using alligator forceps 23 to grasp and fold the arms/flanges 16
toward one another to allow them to be inserted through the
incision whereupon they are allowed to spring back to their
normal lateral position to engage the membrane when the forceps
are released.
With regard to the various prior art rejections of claims 17
through 19, the examiner relies on the deformable or deflectable
flange structures respectively disclosed by the foregoing
references as responding to the limitation in claim 17 requiring
a resiliently deflectable device body “having a substantially
uniform insertion cross-section transverse to its longitudinal
extent.” In short, however, none of Shikani’s rectangular flange
22, Blom’s diamond shape end portion 404, Bouton’s wings 3a and
3b, or Bruce’s lateral arms 16 teaches or would have suggested
this feature. The examiner’s additional determination that
Blom’s helical coil spring implant 400 constitutes a resiliently
deflectable device body having a substantially uniform insertion
cross-section transverse to its longitudinal extent because “the
cross-section taken along the diameter of the tube is reduced by
the deflection step . . . [o]therwise, it would not fit within
the capsule, which is the same diameter as the coil spring tube”
Appeal No. 2002-2187
Application 09/149,359
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(answer, pages 10 and 11) finds no factual support in the fair
teachings of Blom.
As for the prior art rejections of claims 7 through 9 based
on Blom, notwithstanding the examiner’s apparent finding to the
contrary (see pages 7, 12 and 13 in the answer), a person of
ordinary skill in the art would not reasonably view the diamond
shape end 404 extending from Blom’s surgical implant 400 as
constituting flange “provided on an outside surface of the device
body” and having “a continuous radially-extending surface which
extends radially outward from the body to a radial outer edge of
the flange” as recited in independent claim 7, or as being
suggestive of such. Although the diamond shaped end 404 embodies
a flange, a person of ordinary skill in the art would not view
its wire like construction extending from the end of the implant
as being on the outside surface of the implant or device body or
as defining a continuous radially-extending surface which extends
radially outward from the body to a radial outer edge of the
flange.
In light of the foregoing, we shall not sustain the standing
35 U.S.C. § 102(e) rejection of claims 17 and 18 based on
Shikani, the standing 35 U.S.C. § 102(b) rejection of claims 17
through 19 based on Blom, the standing 35 U.S.C. § 102(b) and
Appeal No. 2002-2187
Application 09/149,359
11
103(a) rejections of claims 17 and 18 based on Bouton, the
standing 35 U.S.C. § 102(b) and 103(a) rejections of claims 17
and 18 based on Bruce, or the standing 35 U.S.C. § 102(b) and
103(a) rejections of claims 7 through 9 based on Blom.
SUMMARY
The decision of the examiner to reject claims 7 through 9
and 17 through 19 is reversed.
REVERSED
LAWRENCE J. STAAB )
Administrative Patent Judge )
)
) BOARD OF PATENT
)
) APPEALS AND
JOHN P. MCQUADE )
Administrative Patent Judge ) INTERFERENCES
)
)
)
)
)
MURRIEL E. CRAWFORD )
Administrative Patent Judge )
JPM/kis
Appeal No. 2002-2187
Application 09/149,359
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