Ex Parte VOGT et al

Patent Trial and Appeal Board

Dec 13, 2016

12254516 (P.T.A.B. Dec. 13, 2016)

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.
12/254,516 10/20/2008 SEBASTIAN VOGT 100727-142 1556
27384 7590 12/13/2016
Rrisione Kurt
EXAMINER
Norris McLaughlin & Marcus, PA
875 Third Avenue, 8th Floor
SALVITTI, MICHAEL A
New York, NY 10022 ART UNIT PAPER NUMBER
1767
MAIL DATE DELIVERY MODE
12/13/2016 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 SEBASTIAN VOGT1
and Hubert Buchner
Appeal 2015-0009832
Application 12/254,516
Technology Center 1700
Before PETER F. KRATZ, MARK NAGUMO, and JAMES C. HOUSEL,
Administrative Patent Judges.
NAGUMO, Administrative Patent Judge.
DECISION ON APPEAL
Sebastian Vogt and Hubert Buchner (“Heraeus”) timely appeal
under 35 U.S.C. § 134(a) from the Final Rejection3 of claims 1—6, 8,
and 10—17, which are all of the remaining claims. We have jurisdiction.
35 U.S.C. § 6. We affirm.
1 The real party in interest is identified as Heraeus Medical GmbH
(“Heraeus”). (Appeal Brief, filed 2 April 2014 (“Br”), 2.)
2 The hearing scheduled for 12 December 2016, was waived. (Commun.
filed 18 November 2016).
3 Office action mailed 30 July 2013 (“Final Rejection”; cited as “FR”).
Appeal 2015-000983
Application 12/254,516
OPINION
A. Introduction4
The subject matter on appeal relates to a two-component
polymethylmethacrylate (“PMMA”) bone cement that is said to not require a
waiting period before it is tack-free, that withstands bleeding pressure until it
is cured, that is easily applied, and that is provided “in a form such that the
mixing of cement components, which is associated with many possibilities
of errors, is avoided.” (Spec. 3,11. 10-17.) The ’516 Specification reveals
that these properties are obtained by forming pastes by dissolving a polymer
in a methacrylate monomer and suspending an insoluble particulate polymer
in the blend, thereby providing a dough having a high degree of internal
cohesion due to the dissolved polymer and a high viscosity due to the
insoluble particulate polymer. {Id. at 11. 18—23.) When the pastes are mixed,
a self-curing composition is obtained. {Id. at 4,11. 6—7.) According to the
Specification, “it is surprising that a weight ratio of methacrylate to soluble
polymer to insoluble polymer was found at which the dough is tack-free.”
{Id. at 3,11. 18-26.)
The term “tack free” is said to be defined by IS05833. {Id. at 1,
11. 25.) Although the Specification does not provide that definition, the
Specification does state that, “[i]n conventional PMMA bone cements, being
tack-free indicates that the cement has reached the processing phase through
4 Application 12/254,516, Paste-like polymethylmethacrylate bone cement,
filed 20 October 2008, claiming the benefit of an application filed in
Germany on 22 October 2007. We refer to the “’516 Specification,” which
we cite as “Spec.”
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Appeal 2015-000983
Application 12/254,516
the swelling of the polymers contained in the cement powder in the
monomer after the components are mixed.” {Id. at 1,11. 25—27.) The
Specification explains further that “[t]he PMMA bone cement must not
adhere to the gloves and to application aids, such as mixing systems,
crucibles or spatulas.” {Id. at 2,11. 1—2.)
Example 13 (Spec. 11), which describes an embodiment of the
claimed invention, consists of two pastes, A and B, which can be provided
separately in twin-cartridges and mixed “right before application by placing
a static mixer on top of the twin-cartridge” {id. at 4,11. 16—17). Pastes A
and B both contain insoluble cross-linked particulate PMMA, “Polymer 2”
(Degacryl 6690) {id. at 8,11. 3—4), as well as a solution of poly-
methylmethacrylate-co-methylacrylate dissolved in hexan-l,6-diol-
dimethacylate (“polymer solution 1”; id. at 7,11. 20-24), and zirconium
dioxide, a radiopaque material {id. at 4,11. 1—2). Paste A further contains the
calcium salt of 1-cyclohexyl-5-ethyl barbituric acid (“CaCHEBA”), which is
a free-radical polymerization initiator {id. at 5,11. 15—20, and at 7,11. 1—10).
Paste A also comprises a mixture of zirconium dioxide and copper
carbonate, the latter of which is disclosed to be an accelerator {id. at 5,
11. 11—12). Paste B further contains 2-ethylhexanoic acid, which apparently
reacts with the copper carbonate in paste A when the pastes are mixed to
form copper(II)-2-ethyl-hexanoate, a preferred accelerator {id. at 5,1. 21).
Paste B also contains ALIQUAT 336 [a quaternary ammonium salt], the
function of which is not described. The composition is said to start
curing 4 minutes and 5 seconds after the pastes are mixed. (Id. at 11, last
line.)
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Application 12/254,516
The Specification also teaches that monomers are advantageously
distillable in order to remove cytotoxic residual contaminants such as
methacrylic acid and methacrylic acid chloride. (Id. at 4,11. 8—11.)
Sole independent claim 1 is representative and reads:
Paste-like PMMA bone cement comprising
(a) first a paste-like component, comprising
(i) a first methacrylate monomer that can be distilled
and polymerised by radical polymerisation;
(ii) polymer that is soluble in said first methacrylate
monomer;
(iii) at least one particulate polymer that is insoluble in
said first methacrylate monomer and has a particle size
of no more than 500 pm; and
(iv) at least one radical initiator; and a
(b) second paste-like component, comprising
(i) a second methacrylate monomer that can be
distilled and polymerised by radical polymerisation;
(ii) at least one polymer that is soluble in said second
methacrylate monomer;
(iii) at least one particulate polymer that is insoluble
in said second methacrylate monomer and has a
particle size of less than 500 pm;
(iv) and at least one accelerator,
wherein the first and second insoluble polymers are cross-
linked polymethylmethacrylate or cross-linked poly-
methylmethacrylate-co-methylacrylate, and
wherein the first and second methacrylate monomers are
collectively present at between 25—50 parts by weight,
and the first and second insoluble polymers are
collectively present at between about 40-70 parts by
weight.
(Claims App., Br. 10; some indentation, and paragraphing added.)
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Application 12/254,516
The Examiner maintains the following grounds of rejection5:
A. Claims 1, 3, 4, 8, and 14 stand rejected under
35 U.S.C. § 103(a) in view of the combined teachings of Jia,6
Vallo,7 Bonfield,8 and Hsu.9
A1. Claim 2 stands rejected under 35 U.S.C. § 103(a) in view of
the combined teachings of Jia, Vallo, Jia ’960,10 Bonfield,
and Hsu.
A2. Claims 5 and 6 stand rejected under 35 U.S.C. § 103(a) in
view of the combined teachings of Jia, Vallo, and Puska.* 11
A3. Claims 10-13 stand rejected under 35 U.S.C. § 103(a) in
view of the combined teachings of Jia, Vallo, Hecht,12
Bonfield and Hsu.
5 Examiner’s Answer mailed 20 August 2014 (“Ans.”).
6 Weitao Jia and Shuhua Jin, Self etch all purpose dental compositions . . . ,
U.S. Patent Application Publication 2007/0197683 A1 (23 August 2007),
based on an application filed 22 February 2007.
7 C.I. Vallo et al., Influence of cross-linked PMMA beads on the mechanical
behavior of self-curing acrylic cements, J. Biomed. Res. Part B 407-416
(2004).
8 William Bonfield et al., Self curing cements, U.S. Patent Application
Publication 2004/0220297 Al (2004).
9 Steve Lien-Chung Hsu and Wen-chang Liao, A novel liquid thermal
polymerization resist for nanoimprint lithography with low shrinkage and
high flowability, 2 Nanotechnology Iss. 6, pp. 1—3 (2007).
10 Weitao Jia, Self-etching primer adhesive . . . , U.S. Patent Application
Publication 2003/0207960 Al (2003).
11 Mervi A. Puska et al., Flexural properties of crosslinked and oligomer-
modified glass-fibre reinforce acrylic bone cement, 15 J. Mat. Sci: Mat. in
Med. 1037-43 (2004).
12 Reinhold Hecht and Manfred Ludsteck, Initiator system for acid dental
formulations, U.S. Patent Application Publication 2004/0097613 Al (2004).
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B. Discussion
Findings of fact throughout this Opinion are supported by a
preponderance of the evidence of record.
Heraeus does not raise substantively distinct arguments for claims
other than claim 1. Accordingly, all claims stand or fall with claim 1.
37 C.F.R. § 41.37(c)(l)(iv) (2013).
Heraeus urges the Examiner erred in finding motivation to combine
the teachings of Jia with those of Vallo because “[t]he differences between
the claimed invention and the prior art are outside the level of ordinary skill
in the art.” (Br. 5,11. 19-20.) More specifically, Heraeus urges that adding a
soluble polymer to each of the two paste-like components, and that adding
an insoluble polymer having the specified particulate size of less
than 500 pm to each of the two paste-like components, in the required ratios
to the monomers, “are simply outside the scope of the ordinary level of skill
in the art.” {Id. at 6,11. 6—7.) Heraeus urges further that there would have
been no motivation to modify the compositions taught by Jia because such
an addition “usually results in a suspension, wherein the solid components of
the suspension show no cohesion.” {Id. at 11. 10-11.) Heraeus also urges
that it was unforeseeable at the time of the invention that “stable, moldable
compositions providing plastically deformable bone cement” could be
obtained by the combination of components required by the claims.
{Id. at 11. 14—16.) Finally, Heraeus appears to argue that Vallo provides no
basis to add soluble and insoluble polymers in the required amounts to the
compositions disclosed by Jia. Those amounts, Heraeus urges, are critical to
“ensure that the inventive paste can be achieved.” {Id. at 7,1. 2.)
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These arguments are not persuasive of harmful error in the appealed
rejections. First, Heraeus does not support any of its arguments by citation
to evidence of record. We decline in the first instance to search the record
for evidence that might support an appellant’s arguments and weigh that
evidence against the evidence advanced by the Examiner. Our function is
review, not advocacy. To the extent Heraeus raises questions of fact, the
absence of cited evidence vitiates the force of arguments based on those
questions. Thus, Heraeus has not substantiated the scope of ordinary skill in
the art, or explained why the amount of effort involved in determining
suitable concentrations of soluble and insoluble polymers would have been
undue. In contrast, the Examiner has explained that flexural strength
correlates with the amount of cross-linked polymer particles (which are, as
shown by electron micrographs in Vallo, Figures 8—11, less than 100 pm in
diameter), as shown by Vallo, Figure 5. (FR 3,11. 10—16.) Moreover, the
Examiner has cited Bonfield in support of the proposition that bone cements
(discussed by Vallo) and dental cements (disclosed by Jia) are similar self­
curing compositions having similar components, and that persons skilled in
the art would therefore consider teachings in both references when
considering possible extensions and modifications. Heraeus has not
disputed these findings substantively. Similarly, the arguments for
patentability based on unexpected results are not supported with credible
evidence commensurate in scope with the claimed subject matter; nor are
there any comparative examples that would allow some evaluation of the
advantages alleged for the claimed compositions.
We are not persuaded of harmful error in the appealed rejections.
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C. Order
It is ORDERED that the rejection of claims 1—6, 8, and 10—17 is
affirmed.
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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