Ex Parte Vassallo et al

Patent Trial and Appeal Board

Oct 9, 2018

13085131 (P.T.A.B. Oct. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/085, 131 04/12/2011 Charles Vassallo
23552 7590 10/11/2018
MERCHANT & GOULD P.C.
P.O. BOX 2903
MINNEAPOLIS, MN 55402-0903
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.
13033.0022USD1 1497
EXAMINER
IWAMAYE, ANDREW MICHAEL
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
10/11/2018 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):
USPT023552@merchantgould.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHARLES VASSALLO and SUSAN L. CRITZER
Appeal2017-007021
Application 13/085, 131 1
Technology Center 3700
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1, 2, 4, and 6
(Final Act. 2 1 ). Examiner entered rejections under 35 U.S.C. § 112, second
paragraph, the written description provision of 35 U.S.C. § 112, first
paragraph, 35 U.S.C. § 102(b), and 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify "MEDTRONIC XOMED, INC." as the real party in
interest (App. Br. 2).
2 Office Action mailed August 3, 2015.
Appeal2017-007021
Application 13/085, 131
STATEMENT OF THE CASE
Appellants' disclosure relates "to a treatment method and apparatus
for treating a nasal valve" (Spec. 1: 12-13). Appellants' claims are
reproduced below:
1. An apparatus for use in a treatment of a nasal valve
condition of a patient's nose where said treatment includes
surgically forming an access path to create a pocket on a side of
said nose with said pocket positioned between a soft tissue
layer and opposing upper and lower cartilages of said nose, and
with said pocket spanning a junction between upper and lower
cartilages on said side of said nose; said apparatus comprising:
a. an implant having a curvature, said implant having a
length, width and thickness sized for said implant to reside
within said pocket with:
i. said length sized to span said junction,
ii. said width sized to be less than a width of said
upper and lower cartilages on said side,
iii. said thickness separating first and second
surfaces of said implant and said thickness sized to be
smaller than either of said length and width, said first
surface defining a concave surface with an open volume
underneath the concave swface, said second surface
defining a convex surface,
iv. said implant is a disk with an annular flange
having a diameter defined by the length and width, the
length and width being equal, wherein the annular flange
is flat and extends from the concave surface;
b. said implant is non-collapsible in response to
pressures and suctions within a nostril to prevent a collapse of
said nasal valve and is configured to provide a tactile feel of the
convex surface through the soft tissue layer to assist in locating
the implant after implantation;
and
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Application 13/085, 131
c. said implant includes a tissue in-growth surface,
wherein said implant is made of a material selected from a
group of: steel, titanium, PTFE, and hydroxyl apitite, and
wherein the material is solid and is not a mesh.
(App. Br. 3 51 (emphasis added).)
2. An apparatus according to claim 1 wherein said implant is a
domed body.
(App. Br. 52.)
4. An apparatus for use in a treatment of a nasal valve
condition of a patient's nose where said treatment includes
surgically forming an access path to create a pocket on a side of
said nose with said pocket positioned between a soft tissue
layer and opposing upper and lower cartilages of said nose, and
with said pocket spanning a junction between upper and lower
cartilages on said side of said nose; said apparatus comprising:
a. an implant having a domed body that includes an
annular flange, said implant having a length, width and
thickness sized for said implant to reside within said pocket
with:
i. said length sized to span said junction,
ii. said width sized to be less than a width of said
upper and lower cartilages on said side;
iii. said thickness separating first and second
surfaces of said implant and said thickness sized to be
smaller than either of said length and width, said first
surface defining a concave surface with an open volume
underneath the concave surface, said second surface
defining a convex surface,
iv. said implant is a disk having a diameter
defined by the length and width, the length and width
being equal, wherein the concave surface has a radius of
curvature of 6.0 millimeters, wherein the annular flange
3 Appellants' October 13, 2016 Appeal Brief.
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Application 13/085, 131
is flat with a diameter of 0.5 millimeters and extends
from the concave surface; and
b. said implant is further selected to prevent collapse of
the nasal valve in response to inhalation pressures at said nasal
valve and configured to provide a tactile feel of the domed body
through the soft tissue layer to assist in locating the implant
after implantation, and wherein said implant is made of a
material selected from a group of: steel, titanium, PTFE, and
hydroxyl apitite, wherein the material is solid and is not a mesh.
(App. Br. 52-53 (emphasis added).)
6. An apparatus for use in a treatment of a nasal valve
condition of a patient's nose where said treatment includes
surgically forming an access path to create a pocket on a side of
said nose with said pocket positioned between a soft tissue
layer and opposing upper and lower cartilages of said nose, and
with said pocket spanning a junction between upper and lower
cartilages on said side of said nose; said apparatus comprising:
a. an implant having a curvature with raised surface
deformations located on the curvature, wherein the raised
surface deformations are ribs that are configured to provide a
tactile feel through the soft tissue layer to assist in locating the
implant after implantation, said implant having a length, width
and thickness sized for said implant to reside within said pocket
with:
i. said length sized to span said junction,
ii. said width sized to be less than a width of said
upper and lower cartilages on said side,
iii. said thickness separating first and second
surfaces of said implant and said thickness sized to be
smaller than either of said length and width, said first
surface defining a concave surface, said second surface
defining a convex surface,
iv. said implant is a disk having a diameter
defined by the length and width, the length and width
being equal, wherein the curvature and a wall thickness
of the implant define the height of the disk; and
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b. said implant is non-collapsible in response to
pressures and suctions within a nostril to prevent a collapse of
said nasal valve and wherein said implant is made of a material
selected from a group of: steel, titanium, PTFE, and hydroxyl
apitite, and wherein the material is solid and is not a mesh.
(App. Br. 53-54 (emphasis added).)
The following grounds of rejection are on Appeal: 4
Claims 1, 2, 4, and 6 stand rejected under the written description
provision of 35 U.S.C. § 112, first paragraph.
Claims 1, 2, and 6 stand rejected under 35 U.S.C. § I02(b) as
anticipated by Ek. 5
Claim 4 stands rejected under 35 U.S.C. § I03(a) as unpatentable over
Ek.
Claims 4 and 6 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Lyman6 and Drew. 7
Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Appellants' Specification fails to provide written
descriptive support for the claimed invention?
4 Examiner withdrew the final rejection of claim 6 under 35 U.S.C. § 112,
second paragraph (see May 20, 2017 Advisory Action 2; cf Final Act. 3)
5 Ek, US 2003/0225456 Al, published Dec. 4, 2003.
6 Lyman, US 2001/0018310 Al, published Aug. 30, 2001.
7 Drewetal., US 5,159,717, issued Nov. 3, 1992.
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Application 13/085, 131
ANALYSIS
Examiner finds that each of Appellants' independent claims, 1, 4, and
6, were amended to require that the claimed implant is made of a material
that is solid and is not a mesh (see Final Act. 3). In this regard, Examiner
finds that Appellants' "originally filed specification does not preclude a
mesh, as now claimed" (id.). To the contrary, Examiner finds that
Appellants' "originally filed specification discloses that the implants are
'smooth', [and] 'smooth' is not a disclosure for 'solid and is not a mesh"'
(id.).
The written description "inquiry is a factual one and must be assessed
on a case-by-case basis." Purdue Pharma L.P. v. Paulding, Inc., 230 F.3d
1320, 1323 (Fed. Cir. 2000). "In order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue." Id.
Nonetheless, the disclosure must convey with reasonable clarity to those
skilled in the art that the Inventors were in possession of the invention as
claimed (id.). Any negative limitation or exclusionary proviso must have
basis in the original disclosure. The mere absence of a positive recitation is
not basis for an exclusion. On the other hand, a lack of literal basis in the
Specification for a negative limitation may not be sufficient to establish a
prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d
1234, 1236 (BPAI 1993). If alternative elements are positively recited in the
Specification, they may be explicitly excluded in the claims. See In re
Johnson, 558 F.2d 1008, 1019 (CCPA 1977) ("[the] specification, having
described the whole, necessarily described the part remaining").
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According to Appellants "[i]n all ofthe[ir] figures, the implants ...
are shown as being made of a solid material and not a mesh," and are,
therefore, "supported by the originally filed written description" (App. Br.
42; see also id. at 44 and 46; Reply Br. 7). We are not persuaded. As
Examiner explains, "it is not clear from the originally-filed Drawings if the
material is solid and not mesh" (Ans. 11 ).
To be complete, we recognize Appellants' reliance on Ex parte Parks
(see Reply Br. 7). The facts in Parks, however, differs from the facts before
this Panel. In contrast to this record, the Specification in Parks included a
description of the temperatures used to conduct the claimed decomposition
step generating nitric oxide, including the disclosure of a temperature for an
optimum conversion, without mention of the use of a catalyst to achieve this
optimal result. The record in Parks also included declaration testimony
from a chemistry professor that supported a finding that an equation
disclosed in the Specification indicated the reaction was conducted without a
catalyst present. In this context, the omission of a catalyst in the disclosed
process of Parks was said "to cry out for a catalyst if one were used."
Parks, 30 USPQ2d at 1236.
Thus, we find that the preponderance of the evidence on this record
weighs in favor of Examiner.
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Application 13/085, 131
CONCLUSION
The preponderance of evidence on this record supports Examiner's
finding that Appellants' Specification fails to provide written descriptive
support for the claimed invention. The rejection of claims 1, 2, 4, and 6
under the written description provision of 35 U.S.C. § 112, first paragraph
affirmed.
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Ek describes Appellants' claimed invention?
ANALYSIS
Examiner finds that Ek describes Appellants' claimed invention (Final
Act. 4--7).
Claims 1 and 2:
Appellants' claim 1 requires, inter alia, an implant having a curvature
with a thickness separating first and second surfaces of the implant, wherein
the first surface defines a concave surface with an open volume underneath
the concave surface (see App. Br. 51 ).
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Application 13/085, 131
FIG. 5a
Ek's "FIG. 5a is a side view of an exemplary assembled fixation device and
implant in one embodiment of' Ek' s disclosure (Ek ,r 34 ( emphasis
omitted)).
FIG. 5b
Ek's "FIG. 5b is a perspective view of an assembled fixation device and
implant" according to one embodiment of Ek's disclosure (Ek ,r 35
( emphasis omitted)).
Examiner finds that Ek's Figures illustrate an implant having a
concave surface 42, wherein "[t]he concave curvature of surface 42 can be
clearly seen via the presence of ML and AP curves on the implant" as
illustrated in, e.g., Ek's Figure 5a (see Ans. 3 (citing Ek's Figures 4a-5d and
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19a-19c ). According to Examiner, Ek' s Figures illustrate "an open volume
under at least a portion of the concave surface 42" and Appellants' "claims,
as broadly worded, do not require the entire concave surface 42 to have an
open volume underneath it" (Ans. 3 (emphasis added)). We are not
persuaded.
As Appellants explain, their claim 1 does "not recite an open volume
underneath a portion of the concave surface," as Examiner asserts (Reply Br.
4 (emphasis added); see App. Br. 17). To the contrary, Appellants' claim 1
recites, "an open volume underneath the concave surface" (App. Br. 51 ).
We agree with Appellants that this requires the entire concave surface 42 to
have an open volume underneath it, an element that the Examiner implicitly
concedes is absent (see Ans. 3).
For the foregoing reasons, we find that Examiner failed to establish
that Ek anticipates Appellants' claim 1. Appellants' claim 2 depends from
Appellants' claim 1, therefore, Examiner's rejection of claim 2 suffers from
the same deficiency (see App. Br. 26-27).
Claim 6:
Notwithstanding Appellants' contention to the contrary, Appellants'
claim 6 does not require "an open volume underneath the concave surface"
(see App. Br. 53-54; cf Reply Br. 4). Appellants' claim 6 does, however,
require, inter alia, "an implant having a curvature with raised surface
deformations located on the curvature, wherein the raised surface
deformations are ribs that are configured to provide a tactile feel through the
soft tissue layer to assist in locating the implant after implantation" (App.
Br. 53).
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Appeal2017-007021
Application 13/085, 131
Examiner finds that Ek's Figures 3b, 5c, 19c, 25, and elements 6803,
6805, and 6807 of Ek's Figure 68A illustrate deformations located on a
curvature of an implant "that are inherently capable of providing a tactile
feel through a nasal soft tissue layer to assist in locating the implant after
implantation in nasal tissue" (Final Act. 6 ( emphasis omitted)). Ek' s Figure
19c is reproduced below:
implant" according to Ek's disclosure (Ek ,r 72). As Examiner previously
explained, "[t]he concave curvature of surface 42 can be clearly seen via the
presence of ML and AP curves on the implant" as illustrated in Ek's Figure
19c (see Ans. 3). In addition, as illustrated in Ek's Figure 19c, Ek's implant
has raised surface deformations, i.e., ribs, 45, 195 located on the curvature of
the implant (see generally Final Act. 6; Ans. 5-6). Although the raised
surface deformations, i.e., ribs illustrated in Ek's Figure 19c may have
different geometries, we find no requirement in Appellants' claim 6 that
requires a uniform rib geometry.
Appellants' Brief does not specifically address Ek's Figure 19c (see
App. Br. 23-26). Appellants' contend, however, that Ek's implant does not
have a convex or concave surface (id. at 24; see Reply Br. 2 ("[b ]ased on the
figures alone there is no way to confirm that the drawings illustrate a
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Application 13/085, 131
concave or convex surface with all of the other components shown on top of
these surfaces")). We are not persuaded. The ML and AP curves illustrated
in Ek' s Figure 19c establish that the implant has both a convex and concave
surface.
We are not persuaded by Appellants' contention that, in some
embodiments of Ek's disclosure, Ek discloses that "'the ML curve and AP
curve ... are not axially symmetrical"' and that Ek's implant may account
for"[ v ]ariations from knee to knee and within a knee" (Reply Br. 2-3
( emphasis omitted) ( citing Ek ,r,r 190 and 219); see id. at 3 ("Ek discloses
adjusting the shape of the implant with curves that are not axially
symmetrical based on the shape of the knee or hip that the implant is going
to be inserted into"); see also App. Br. 24--25 (Ek's implant does not have a
convex or concave surface because it may be "shaped specifically to model
the articular surface dimension of [a] patient")). Appellants, however, fail to
provide persuasive evidence or argument to support a finding that their
claimed invention requires axially symmetrical convex and/ or concave
surfaces; that by shaping the convex and/or convex surface of an implant to
accommodate variations in a patient's anatomy would have necessary
eliminated the convex and concave surfaces of Ek's implant; or that the
addition of a hole in a concave or convex surface renders the surface neither
convex nor concave. To be complete, we are not persuaded by Appellants'
contentions relating to other embodiments of Ek's disclosure (see App. Br.
25-26).
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Application 13/085, 131
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner's finding that Ek teaches Appellants' claimed invention with
respect to Appellants' claims 1 and 2. The rejection of claims 1 and 2 under
35 U.S.C. § 102(b) as anticipated by Ek reversed.
The preponderance of evidence on this record supports Examiner's
finding that Ek teaches Appellants' claimed invention with respect to
Appellants' claim 6. The rejection of claim 6 under 35 U.S.C. § 102(b) as
anticipated by Ek affirmed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
The rejection over Ek:
Examiner finds that Ek discloses Appellants' claimed invention with
the exception of disclosing an implant having a concave surface having "a
radius of curvature of 6.0 millimeters, wherein [an] annular flange has a
diameter of 0.5 millimeters" (Final Act. 13 ( emphasis omitted)). To make
up for this deficiency in Ek, Examiner reasons that "Ek teaches the curvature
of the implant to be a result-effective variable as it is used to mimic the
patient's natural anatomy" and that its "annular flange[] provide[s] a bone
contacting surface that resists forces that could move/dislodge the implant"
(Final Act. 13). Therefore, based on Ek, Examiner concludes that, at the
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Application 13/085, 131
time Appellants' invention was made, it would have been prima facie
obvious "to modify the implant of Ek by employing a radius of curvature as
[ required by Appellants'] claimed [invention], in order to optimize the
compatibility of the implant with the patient's natural anatomy" and "the
annular flange of Ek by employing a diameter as [required by Appellants']
claimed [invention], in order to provide an annular flange sufficiently thick
enough to resist forces that could move the implant" (id.). We are not
persuaded.
Examiner failed to establish Ek teaches an implant that has a "first
surface defining a concave surface with an open volume underneath the
concave surface," as is required by Appellants' claim 4. As discussed above
with respect to the anticipation rejection of Appellants' claim 1, Examiner
established that Ek suggests an implant comprising "an open volume under
at least a portion of the concave surface 42" (Ans. 3), which fails to make
obvious an open volume underneath the concave surface (see generally
Reply Br. 4 (Appellants' claim 4 does "not recite an open volume
underneath a portion of the concave surface"); see App. Br. 17).
The rejection over the combination of Lyman and Drew:
Lyman
relates to a passive diversion device for entertainment and stress
relief. In particular, the device has two surfaces separated by a
small distance and is configured to provide two equilibrium
positions, one having a convex shape and the other having a
concave shape when viewed from the same direction. The
largest average dimension of the surfaces is substantially
greater than the thickness of the device. By applying finger
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Appeal2017-007021
Application 13/085, 131
pressure to a surfaces of the device, the surfaces invert from one
equilibrium position to the other.
(Lyman ,r 2.) Lyman's Figure 2 is reproduced below:
I
!
-, -F iD
"<: ,ii
~~~
I ,
''' ' ~ ' }
/
/
Lyman's "FIG. 2 is a side view of [Lyman's] device ... illustrating one
equilibrium position and illustrating the second equilibrium position by
dashed lines" (Lyman ,r 11 (emphasis omitted)). Examiner finds that Lyman
discloses a device within the scope of Appellants' claims 4 and 6, with the
exception of disclosing: (a) a concave surface having "a radius of curvature
of 6.0 millimeters" and (b) a device "made of a material selected from a
group of: steel, titanium, PTFE, and hydroxyl apitite" (Final Act. 8-9
( emphasis omitted)).
With regard to the radius of curvature, Examiner finds that
Lyman teaches the device to have a curvature such that there
are concave and convex surfaces and for the device to have any
range/ combination of dimensional measurements based on
personal preference and the hand size of the user, and to tailor
the desired appearance, desired tactile response, and the desired
life.
(Final Act. 9.) Thus, based on Lyman, Examiner concludes that, at the time
Appellants' invention was made, it would have been prima facie obvious to
modify the curvature radius of Lyman's device, to that required by
Appellants' claimed invention, because "it is a matter of design choice based
on personal preference and the hand size of the user and in order to optimize
the desired appearance, desired tactile response, and the desired life" (id.).
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In addition, Examiner finds that, "[ a ]bsent any criticality, ... employing any
radius of curvature would have been obvious to one having ordinary skill in
the art in order to tailor the device based on the user's/manufacturer's
preferences" (id.).
With respect to the material used to make the device, Examiner finds
that Drew "teaches a flexible device for hands that comprises flexible
convex/concave layers of polymer material, wherein the polymer is PTFE or
those disclosed by Lyman" (Final Act. 9 ( citing Drew 6: 12-32)).
Thus, based on the combination of Lyman and Drew, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious to modify the curvature radius of Lyman's device,
to that required by Appellants' claimed invention, because "it is a matter of
design choice based on personal preference and the hand size of the user and
in order to optimize the desired appearance, desired tactile response, and the
desired life" (id.). In addition, Examiner finds that, "[ a ]bsent any criticality,
... employing any radius of curvature would have been obvious to one
having ordinary skill in the art in order to tailor the device based on the
user's/manufacturer's preferences" (id.).
Therefore, Examiner concludes that, at the time Appellants' invention
was made, it would have been prima facie obvious, in view of the
combination of Lyman and Drew, "to modify the device of Lyman by
making it from PTFE, as taught by Drew, as it is a mere substitution of one
known polymer for another" (id.). We are not persuaded.
Examiner recognizes that "Lyman and Drew are concerned with the
same field of endeavor, namely flexible devices for the hand" (id.).
Nevertheless, Examiner asserts that a device suggested by the combination
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of Lyman and Drew "is inherently capable of being used[, as an implant,] in
a treatment of a nasal valve condition of a patient's nose" (id. at 7 (emphasis
omitted)). In this regard, Examiner asserts, inter alia, that Appellants'
claims do not require a
specific inhalation pressure. . . . Therefore, it is [] Examiner's
position that if the device [ suggested by the combination of]
Lyman and Drew were implanted, it would be able to prevent
collapse of the nasal valve in response to very low inhalation
pressures at said nasal valve, specifically any nasal pressure less
than the threshold pressure required to collapse the device of
Lyman.
(Ans. 9; Final Act. 8 ("it is[] Examiner's position that the device of Lyman
is further selected to prevent collapse of the nasal valve as claimed in
response to very small inhalation pressures that do not exceed the manual
manipulation pressure/force threshold that causes the device to invert")).
We are not persuaded.
Initially, we agree with Appellants' contention that neither Lyman nor
Drew relate to "an implant or any type of implantable medical device" (App.
Br. 27-28) and, on this record, "there is no reason that would have prompted
a person of ordinary skill in the art to look [to] entertainment devices and
hand padding devices to form a nasal implant" (Reply Br. 6; see also App.
Br. 28-29). Nevertheless, even if a person of ordinary skill in this art would
have looked to the field of flexible devices for the hand to teach or suggest a
nasal implant, Examiner failed to identify an evidentiary basis on this record
to support a conclusion that the device suggested by the combination of
Lyman and Drew would not collapse, as illustrated in Lyman's Figure 2,
when implanted in the nose of a patient (see generally, App. Br. 30-32 and
35-36). Stated differently, although Examiner asserts that nasal pressure is
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not sufficient to invert, or otherwise collapse, a device suggested by the
combination of Lyman and Drew, Examiner fails to identify an evidentiary
basis on this record to support that conclusion. In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006) ("rejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness").
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable
over Ek is reversed.
The rejection of claims 4 and 6 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Lyman and Drew is reversed.
TIME PERIOD FOR RESPONSE
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
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