Ex Parte Hull et al

Patent Trial and Appeal Board

Oct 28, 2016

12974378 (P.T.A.B. Oct. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/974,378 12/21/2010
1912 7590 11/01/2016
AMSTER, ROTHSTEIN & EBENSTEIN LLP
90 PARK A VENUE
NEW YORK, NY 10016
FIRST NAMED INVENTOR
Raymond J. Hull JR.
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.
343011191 3610
EXAMINER
CHENG, JACQUELINE
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
11/01/2016 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):
PTODOCKET@ARELA W.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAYMOND J. HULL JR., BRUCE C. JOHNSON,
PRAMOD MA VINKURVE, and LEONARD ROSENFELD
Appeal2015-000168
Application 12/974,378
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to an
intravaginal urinary incontinence device. The Examiner rejected the claims
as obvious and obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as MCNEIL-PPC, INC.,
which is a subsidiary of Johnson & Johnson (see Br. 2).
Appeal2015-000168
Application 12/974,378
Statement of the Case
Background
Appellants' "invention relates to an intra vaginal incontinence device
comprising a polymeric resilient material" (Spec. 1 :8-9). More particularly,
the device "has a working portion having a variable equivalent diameter, a
length suitable for insertion into a vagina and an anchoring mechanism for
retention in the vagina, and is made from high modulus polymers having
high tensile modulus properties along with high yield strain properties" (id.
at 1:10-14).
The Claims
Claims 1-22 are on appeal. Independent claim 1 is representative and
reads as follows (emphasis added):
1. An intravaginal urinary incontinence device having an
insertion end and an opposed withdrawal end, the device
comprising a resilient frame comprising:
a working portion disposed proximate the withdrawal end
comprising a resilient structure having a plurality of connected
elongate elements arranged and configured to define opposed
working surfaces for providing support to an associated urinary
system;
and an anchoring portion disposed proximate the
insertion end and extending beyond the working portion
comprising a plurality of connected elongate elements arranged
and configured to expand laterally within a user's vagina
wherein the elongate elements comprise a high modulus
polymer having an elastic modulus of at least 2 GPa and an
Initial Stress@ 3% Strain of at least about 30 MPa.
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Application 12/974,378
The Issues
A. The Examiner rejected claims 1-22 under 35 U.S.C. § 103(a) as
obvious over Bartning2 and Jackson,3 as evidenced by Ferguson,4 ASM,5
Plastics International, 6 Peters, 7 Engineering Thermoplastics, 8 and
Polyethers9 (Non-Final Act. 3-9; Ans. 2).
B. The Examiner rejected claims 1, 2, 5-7, and 19 under 35 U.S.C.
§ 103(a) as obvious over Bartning and Stack, 10 as evidenced by Engineering
Thermoplastics (Non-Final Act. 9-12; Ans. 3).
C. The Examiner rejected claims 3, 4, 8-18, and 20-22 under 35 U.S.C.
§ 103(a) as obvious over Bartning and Stack, as evidenced by Engineering
Thermoplastics and Guo 11 (Non-Final Act. 13-20; Ans. 3--4).
2 Bartning et al., US 2008/0033230 Al, published Feb. 7, 2008.
3 Jackson et al., US 6,585,755 B2, issued July 1, 2003.
4 Ferguson et al., US 2007/028216l 1A..l, published Dec. 6, 2007.
5 Lee McKague, Thermoplastic Resin, ASM Handbooks Online (2003)
(http ://products. asminternational. org/hbk/ do/highlight/ content/V21/D02/A1 7
/s0086879.htm (July 18, 2012)) (hereinafter "ASM").
6 ULTEM® (Polyetherimide) Flyer, Plastics International (publication date
unknown) (hereinafter "Plastics International").
7 Peters, PLASTICS: INFORMATION AND PROPERTIES OF POLYMERIC
MATERIALS, ESHBACH'S HANDBOOK OF ENGINEERING FUNDAMENTALS
392--421 (M. Kutz eds., 5th ed. 2009).
8 Garbassi et al., Engineering Thermoplastics, IO KIRK-OTHMER
ENCYCLOPEDIA OF CHEMICAL TECHNOLOGY 168-228 (2001) (hereinafter
"Engineering Thermoplastics").
9 Dwain, Polyethers, Aromatic, KIRK-OTHMER ENCYCLOPEDIA OF CHEMICAL
TECHNOLOGY 1-18 (2000) (hereinafter "Polyethers").
10 Stack et al., US 2005/0021125 Al, published Jan. 27, 2005.
11 Guo et al., Isothermal physical aging characterization of Polyether-ether-
ketone (PEEK) and Polyphenylene sulfide (PPS) films by creep and stress
relaxation, 11 MECH TIME-DEPEND MATER 61-69 (2007).
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Appeal2015-000168
Application 12/974,378
D. The Examiner provisionally rejected claims 1-22 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1, 4, 5, 8-10, and 15 of copending US application 12/645,800,
filed Dec. 23, 2009 ("Hull") (Non-Final Act. 20-25; Ans. 2).
A. 35U.S.C.§103(a) over BartningandJackson
The Examiner finds that "Bartning teaches the structural elements of
independent claims 1, 8, [and] 16, but does not teach the device is made of a
high modulus polymer having the claimed material properties" (Ans. 2; see
also Non-Final Act. 3---6). The Examiner concludes that it would have been
obvious to
modify the intra vaginal incontinence device of Bartning et al. to
be made of either polyetherimide or polyetheretherketone, as
taught by Jackson et al., which discloses a finite number of
identified, predictable potential materials, because it would be a
functional substitution to utilize the mechanical properties
inherent in these t\'l/O high modulus polymers to provide for
secure anchoring of the intravaginal device (Ferguson discloses
device (10) is an elastically deformable material that allows
head (12) to move between the deployed and insertion states,
such as polyetheretherketone (PEEK) (paragraph [0059])).
(Non-Final Act. 6; see also Ans. 2.) The Examiner indicates that "[t]he
evidence references listed [] are cited to provide additional support that
polyetherimides and polyetheretherketones are known to exhibit the claimed
material properties" (Ans. 2; see also Non-Final Act. 6-9).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Bartning and Jackson render
the claims prima facie obvious?
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Application 12/974,378
Findings ofFact
1. Bartning teaches that "[a]n intravaginal device has a working
portion (e.g., intravaginal urinary incontinence device suppository, tampon)
and an anchoring portion comprising at least one member extending beyond
at least one end of the working portion to maintain the working portion in
place during use" (Bartning Abstract; see also Non-Final Act. 3-5).
2. Bartning teaches that "[ w ]orking portion ... may be made of
any elastic material that compresses and recovers with sufficient force to
provide the desired effect" (Bartning i-f 29; see also Non-Final Act. 4--5), that
"[ e ]lements of the devices of the present invention may be made from any
elastic or superelastic material" (Bartning i-f 38; see also Non-Final Act. 11),
and that "[ s ]everal physical properties of SMPs other than ability to
memorize shape are significantly altered in response to external changes in
temperature and stress, particularly at the glass transition of the soft
segment," and that "[t]hese properties include elastic modulus, hardness, and
flexibility. . .. the modulus is high and thereby providing sufficient
stiffness" (Bartning i-f 41; see also Non-Final Act. 11).
3. Jackson teaches that "[s]uitable permanent non-biodegradable
plastics for a stent would include engineering polymers such as
polyetheretherketone (peek), ... and polyetherimides" (Jackson 6:28-38;
see also Non-Final Act. 5---6).
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Appeal2015-000168
Application 12/974,378
4. Peters' Table 34 is shown below:
Tabl.e 34 Typicn! Properties of PE!s
D)
Fk>xural moclu!us \GPa:\
Fk?.ix);ral stren9'th {MP.a)
Moi.ched l: i%i
f-li.irdn1:~s \Rock·w:::ll}
GTE {10··~/:'C)
Shrink::1ry; Un-/ in.)
\t\l'pal.ion l;ictcir <1t 1 k.Hz
R0t;;d1v2 permittivity ::Jr;:'ll $rttt~~~g~h {t ... ~p~3)
t1J·~)~C°t!f~j li'(X1 (~J/rt~)
Urin<.~1cl",$:i·d b".nd {~"'-'-Vri~~
Hr.n <:1t ·t.e 1 ~ .. 1~.:\:1 OG)
Hf.'IT B~ G .. 42 ~~P;~ (f;J
i:rn en
lh l:M V() (mrn)
(}:'~~l in®:~ (<:.-:;)
H;~t-,'I.
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208
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fli2!:·
Appeal2015-000168
Application 12/974,378
Table 36 shows that PEEK (polyetheretherketone) has a tensile modulus of
3.6 GPa and an elongation at break of 50 % (Peters 414, Table 36; see also
Final Act. 7).
6. Ferguson teaches "[a]n incontinence management device [that]
comprises a head having a first state and a second state" (Ferguson
Abstract), in which the device "comprises an elastically deformable material
that allows head ... to move between the deployed state and the insertion
state," "the deployed state comprises a natural or non-deformed shape,
which is the shape to which the device is biased to return to if elastically
deformed," and the device "may comprise a substantially elastic material,
such as ... polyetherketone (PEEK)" (id. at i-f 59; see also Non-Final Act.
6).
Principles of Law
"[T]he [obviousness] analysis need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ." KSR Int'! v. Teleflex Inc., 550 U.S.
398, 418 (2007).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
Id. at 416. "If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability." Id. at 417.
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Non-Final Act. 2-25; Ans. 2---6; FF 1-7)
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Application 12/974,378
and agree that the claims are obvious over Bartning and Jackson. We
address Appellants' arguments below.
Appellants contend that "the combination of references fails to
establish an 'obvious to try' rationale that meets the test of obviousness
under §103" (Br. 10). More particularly, Appellants argue that
At the same time the Office relies on the Engineering
Thermoplastics reference for its teaching of the mechanical
properties of engineering thermoplastic materials, this very
same reference clearly teaches that the properties of engineering
thermoplastics can "change remarkably depending upon ... the
presence of fillers and reinforcing fibers." This combination of
references is at best ambiguous, and ambiguous information
cannot establish a prima facie case of obviousness of the
presently claimed invention.
(Id.) Appellants contend that "[t]he rejection is only a hindsight
reconstruction of [Appellants'] invention" (id.).
We do not find the "obvious to try" argument persuasive. In
0 ;Farrell, the court found that
The admonition that "obvious to try" is not the standard under
§ 103 has been directed mainly at two kinds of error. In some
cases, what would have been "obvious to try" would have been
to vary all parameters or try each of numerous possible choices
until one possibly arrived at a successful result, where the prior
art gave either no indication of which parameters were critical
or no direction as to which of many possible choices is likely to
be successful.. .. In others, what was "obvious to try" was to
explore a new technology or general approach that seemed to be
a promising field of experimentation, where the prior art gave
only general guidance as to the particular form of the claimed
invention or how to achieve it.
In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988).
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Appeal2015-000168
Application 12/974,378
This is not a case where the prior art gave no direction or indication of
the critical parameters. Bartning teaches an intravaginal device in which the
"[ w ]orking portion ... may be made of any elastic material that compresses
and recovers with sufficient force to provide the desired effect" (FF 1-2).
Bartning specifically teaches an "elastic or superelastic material" (FF 2).
Bartning teaches that "[ s ]everal physical properties of SMPs other than
ability to memorize shape are significantly altered in response to external
changes in temperature and stress, particularly at the glass transition of the
soft segment," and that "[t]hese properties include elastic modulus, hardness,
and flexibility. . .. the modulus is high and thereby providing sufficient
stiffness" (FF 2).
Thus, Bartning does not give only general guidance, but rather
Bartning directs the ordinary artisan to specific materials with specific
properties and further gives direction as to which parameters were critical
and likely to be successful (FF 2).
Moreover, Jackson provides guidance on polymers that are desirable
for use in patients, teaching that "[ s ]uitable permanent non-biodegradable
plastics for a stent would include engineering polymers such as
polyetheretherketone (peek), ... and polyetherimides" (FF 3). Ferguson
evidences that "an elastically deformable material that allows head ... to
move between the deployed state and the insertion state," "may comprise a
substantially elastic material, such as ... polyetherketone (PEEK)" (FF 6).
Using the guidance of Bartning, Jackson, and Ferguson, the Examiner
relies upon Peters to evidence the particular elastic polymers taught as useful
by Jackson in patients have properties that meet the requirements of
Bartning. Specifically, Peters teaches that PEI (polyetherimide) has a tensile
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Appeal2015-000168
Application 12/974,378
modulus of3.59 GPa and an elongation at break of 60 %, and that PEEK
(polyetheretherketone) has a tensile modulus of 3. 6 GP a and an elongation at
break of 50 % (FF 4--5).
We thus agree with the Examiner that one skilled in the art would
have had reason to choose polyetherimide or polyetheretherketone from the
list polymers in Ferguson because "Ferguson provides a teaching,
suggestion, or motivation to use polyethereterketone (PEEK) ... , because it
is a material that is substantially elastic to allow a device to move between a
deployed and insertion state (paragraph [0059] of Ferguson)" (Ans. 4).
As the Examiner explains,
The properties of the polymer itself would not change with the
presence of fillers or fibers, just the property of the resulting
material. The claims recite "wherein the elongate elements
comprise a high modulus polymer" so the properties of the
elongate elements that are made from the polymer and the
additional elements [might possibly] change, but not the
properties of the polymer itself. Nothing in the claim language
limits the elongate elements to being made from only a high
modulus polymer (i.e. the claim language uses "comprise"
rather than "consist").
(Id. at 4--5.)
The Examiner also explains that
Since claim 5, which specifies the high modulus polymer as
polyetherimides, polyetheretherketones, or combinations
thereof, depends from claim 1, polyetherimides and
polyetheretherketones thereof must therefore possess the
material properties recited in claim 1. The evidence references
are cited to provide additional support that polyetherimides and
polyetheretherketones are known to exhibit material properties
of the claimed values, which are open-ended numerical ranges,
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Application 12/974,378
claiming, for example, "at least 2 GPa" or "an Aged Stress @
3 % strain that is greater than about 3 5 MP a."
(Id. at 5.)
We also agree with the Examiner that given Bartning's specific
requirements for elastic materials and the known elastic materials disclosed
by Jackson,
The experimentation disclosed in the specification involves
testing material properties of sample materials including
expansion force test, elastic modulus and yield strain, and stress
relaxation testing (see pages 9-14 of the Specification), which
describes optimizing a result effective variable, something that
has been determined to involve only routine skill in the art.
(Id. at 5.) See In re Aller, 220 F.2d 454, 456 (CCP A 1955) ("where the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation").
"[T]he discovery of an optimum value of a variable in a known process is
usually obvious." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir.
2007). Appellants do not identify any secondary consideration, such as
unexpected results, that would overcome the prima facie case of obviousness
based on routine optimization of selecting the appropriate polymers for an
intravaginal device as disclosed by Bartning and Jackson.
We recognize, but find unpersuasive, Appellants' contention that
the properties of the NITINOL material used in the example of
Bartning in paragraph [0058] and those of the high modulus
polymers of the presently claimed invention can vary widely.
Indeed, it can be critical to the performance of the invention of
claim 15 to balance the material properties with the cross-
section of the elongate elements to provide the desired
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Application 12/974,378
mechanical properties of the finished intravaginal unnary
incontinence device.
(Br. 9-10.) Appellants' argument fails to address the combination of
teachings of Bartning and Jackson, with the evidentiary references, as
discussed above. "Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references []. [The reference] must be read, not in isolation,
but for what it fairly teaches in combination with the prior art as a whole."
In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). See also In
re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) ("[A]ttomey argument [is]
not the kind of factual evidence that is required to rebut a prima facie case of
obviousness").
B-C. 35 U.S.C. § 103(a) over Bartning and Stack
The Examiner finds that "Bartning teaches the strt1ctural elements of
claim 1, but does not teach the device is made of a high modulus polymer
having the claimed material properties" (Ans. 3; see also Non-Final Act. 9-
11 ). The Examiner concludes that it would have been obvious to "substitute
the resilient plastic, such as PEEK, taught by Stack for the shape memory
polymer taught by Bartning as a simple substitution in order to achieve the
predictable result of a radially outward, expandable support element (Stack,
paragraph [0045])" (Non-Final Act. 11 ). The Examiner indicates that "[t]he
additional evidence reference listed [] is cited to provide additional support
that polyetheretherketone is known to exhibit the claimed material
properties" (Ans. 3; see also Non-Final Act. 11-12).
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Application 12/974,378
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Bartning and Stack render the
claims prima facie obvious?
Findings of Fact
7. Stack teaches an "expandable support element ... may
comprise materials exhibiting shape memory properties, such as spring steel,
Nitinol, superelastic or shape memory nickel-titanium alloys, and resilient
engineering plastics such as polysulfones, PEEK, ... " (Stack i-f 45; see also
Ans. 3, Non-Final Act. 11).
Analysis
We agree with the Examiner that the claims are obvious over Bartning
and Stack. We address Appellants' arguments below.
Appellants contend that "[a]gain, this is a classic 'Obvious to try'
rationale, described in MPEP §2143 (E). As in the rejection based upon
Bartning/Jackson, above, it must fail" (Br. 17, 21). Appellants also contend
that "[t]he resort to Engineering Thermoplastics and Guo for additional
hindsight selection of physical properties that are not disclosed or suggested
in either Bartning or Stack is further evidence of the improper hindsight
rejection" (id. at 18, 21-22).
We are not persuaded. These arguments are similar to Appellants'
previous contentions based on the combination of Bartning and Jackson (see
also Ans. 5---6). Accordingly, we are not persuaded for the reasons discussed
above.
Appellants contend that "Stack merely lists 'spring steel, Nitinol,
Superelastic or shape memory nickel-titanium alloys, and resilient
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Application 12/974,378
engineered plastics such as polysulfones, PEEK, polysulfides, LCPs, etc.'
(Stack, pages 4--5, paragraph [0045])" (Br. 17, 21). Appellants also contend
that "the disclosure of Stack is primarily directed to a sheath for delivery of
a vascular stent. The particular physical properties of this stent do not
appear to be critical to the invention of Stack" (id. at 17-18, 21 ).
This argument is unpersuasive. The Examiner combines the teachings
of Stack only for the polymeric material, PEEK, with Bartning ("substitute
the resilient plastic, such as PEEK, taught by Stack for the shape memory
polymer taught by Bartning as a simple substitution in order to achieve the
predictable result of a radially outward, expandable support element" (Non-
Final Act. 11). See In re Merck & Co., 800 F.2d at 1097.
D. Obviousness-type double patenting over claims 1, 4, 5, 8-10, and 15
of Hull
Appellants "request that [this] rejection be held in abeyance until
claims are determined to be allowable in either application" (Br. 25). We
therefore summarily affirm the obviousness-type double patenting rejection
based upon the Examiner's explanation and reasoning (Non-Final 20-25).
See In re Berger, 279 F.3d 975, 984 (Fed. Cir. 2002).
SUMMARY
In summary, we affirm the rejection of claims 1, 8, 14, and 16 under
35 U.S.C. § 103(a) as obvious over Bartning and Jackson, as evidenced by
Ferguson, ASM, Plastics International, Peters, Engineering Thermoplastics,
and Polyethers. Claims 2-7 and 19 fall with claim 1, claims 9-13 and 20
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Application 12/974,378
fall with claim 8, claims 15 and 21 fall with claim 14, and claims 17, 18, and
22 fall with claim 16.
We affirm the rejection of claims 1, 2, 5-7, and 19 under 35 U.S.C.
§ 103(a) as obvious over Bartning and Stack, as evidenced by Engineering
Thermoplastics. Claims 2, 5-7, and 19 fall with claim 1.
We affirm the rejection of claims 3, 4, 8-18, and 20-22 under 35
U.S.C. § 103(a) as obvious over Bartning and Stack, as evidenced by
Engineering Thermoplastics and Guo.
We affirm the rejection of claims 1-22 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1, 4, 5, 8-10, and 15 of Hull.
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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