Ex Parte Runge et al

Patent Trial and Appeal Board

Feb 8, 2019

14009987 (P.T.A.B. Feb. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/009,987 12/17/2013
26710 7590 02/12/2019
QUARLES & BRADYLLP
Attn: IP Docket
411 E. WISCONSIN A VENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Michael Brett Runge
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.
630666.00446 6624
EXAMINER
FALKOWITZ, ANNA R
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
02/12/2019 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL BRETT RUNGE and MICHAEL J. Y ASZEMSKI
Appeal2018-005480
Application 14/009,987 1
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 25 and 49--57
(Ans. 2 2; App. Br. 2). 3 Examiner entered a rejection under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify "Mayo Foundation For Medical Education And
Research, Rochester, Minnesota" as the real party in interest (Appellants'
January 2, 2018 Appeal Brief (App. Br.) 2).
2 Examiner's March 7, 2018 Answer.
3 Appellants' pending claims 1, 5, 7-10, 13, 17, and 19-22 stand withdrawn
from consideration (Ans. 2).
Appeal2018-005480
Application 14/009,987
STATEMENT OF THE CASE
Appellants' disclosure "relates to the synthesis of a polycaprolactone
fmnarate polymer useful as a material for a biocompatible scaffold for tissue
engineering" (Spec. ,r 3). Claim 25 is representative and reproduced below:
25. A scaffold for tissue regeneration, the scaffold
compnsmg:
a blend of a polymer having the Formula (I)
H-A1-I3-A2-C-A1-I3-A2-H (I)
wherein
A1 is
~~"
· .. ~:In
I3 is -0-X-0- wherein X is selected from the group consisting
of ethylene, trimethylene, tetramethylene, pentamethylene,
C1-Csalkylethylene, C1-Csalkyltrimethylene,
C1 -Csalkyltetramethylene, and C 1-Csalkylpentamethylene;
C is
.'Ey-... _I,
I~ '/~
and geometric isomers thereof;
and n is an integer from 1 to 50, and
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Application 14/009,987
a polymer having the Formula (II)
H-D1-E-D2-.f-D1-E-D2-H (II)
I
0 0
I
D:i D1
I
H H
wherein
D1 is
'-I /'--. ..... ~ .~ . ]. .... ~ T '-.../ .-.../ ~
E is -0-X-0- wherein X is selected from the group
consisting of propanetriyl, butanetriyl, pentanetriyl, C 1-C5alkyl
propanetriyl, C1-Csalkyl butanetriyl, and C1-Csalkyl
pentanetriyl;
Fis
t'.l
~~~~ 1 ~ J' and geometric isomers thereof;
and n is an integer from 1 to 50;
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Appeal2018-005480
Application 14/009,987
wherein the polymer of Formula (I) comprises 20 wt.%
to 80 wt% of the scaffold, and
the polymer of Formula (II) comprises 20 wt.% to 80 wt% of
the scaffold, and
wherein the polymer of Formula (I) is formed using a
first initiator such that Bis -0-X-O- wherein Xis selected from
the group consisting of ethylene, trimethylene, tetramethylene,
pentamethylene, C1-Csalkylethylene, C1-Csalkyltrimethylene,
C1-Csalkyltetramethylene, and C1-Csalkylpentamethylene, and
wherein the polymer of Formula (II) is formed using a
second initiator such that E is
-0-X-O- wherein Xis selected from the group consisting of
propanetriyl, butanetriyl, pentanetriyl, C1-C5alkyl propanetriyl,
C1-Csalkyl butanetriyl, and C1-Csalkyl pentanetriyl,
and
wherein the first initiator is different from the second
initiator.
(App. Br. A-l-A-3.) Claims 49-57 depend directly from Appellants' claim
25.
Ground of rejection before this Panel for review:
Claims 25 and 49-57 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Hostettler4 and Y aszemski. 5
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
4 Hostettler et al., US 3,169,945, issued Feb. 16, 1965.
5 Yaszemski et al., US 2007/0043202 Al, published Feb. 22, 2007.
4
Appeal2018-005480
Application 14/009,987
FACTUAL FINDINGS (FF)
FF 1. Hostettler "relates to lactone polyesters that are useful as plasticizers
and as intermediates for preparing elastomers and foams, and to resins
placticized with such polyesters" (Hostettler 1 :9-12; see generally Final Act.
4).
FF 2. Hostettler's "lactone polyesters ... include polyesters of individual
unsubstituted and substituted lactones, copolyesters of different substituted
lactones and copolyesters of different substituted lactones and copolyesters
of substituted and unsubstituted lactones, as well as blends thereof'
(Hostettler 1 :30-34; see id. at 1 :56-68 (Hostettler's preferred lactones are
substituted or unsubstituted epsilon-caprolactones); see also Final Act. 4).
FF 3. Hostettler discloses that
various lactones may be utilized individually or in combination.
When the lactone polyesters prepared in accordance with the
invention are intended to be used as intermediates for reaction
with diisocyanates in the preparation of polyurethanes, it is
generally preferred to utilize mixtures of substituted and
unsubstituted lactones in order to achieve optimum non-
hardening characteristics. If on the other hand the lactone
polyesters are to be employed as plasticizers, optimum results
are obtainable with polyesters derived from monomethyl
substituted lactones and with copolyesters derived from
unsubstituted and monomethyl substituted lactones. Generally,
[however,] the choice of initial lactone or combinations of
lactones is practically unlimited except, in so far as is pointed
out with reference to the tendency of highly substituted lactones
to revert to monomeric forms, particularly at higher
temperatures.
Polymerization of the lactone in accordance with ...
[Hostettler's] method ... is initiated by reaction with one or
more compounds having at least one reactive hydrogen capable,
with or without the aid of a catalyst, of opening the lactone ring
and adding it as an open chain without forming water of
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Appeal2018-005480
Application 14/009,987
condensation. Compounds that are suitable for initiating the
polymerization, and therefore referred to herein as initiators,
include monofunctional initiators such as alcohols and amines,
and polyfunctional initiators such as polyols, polyamines,
amino alcohols, and vinyl polymers, as well as amides,
sulfonamides, hydrozones, semicarbazones, oximes,
polycarboxylic acids, hydroxy carboxylic acids and
aminocarboxylic acids.
(Hostettler 2:25-55 (emphasis added); see Final Act. 4--5; see also App. Br.
2-3.)
FF 4. Hostettler discloses "[ d]iols that are suitable as bifunctional initiators
includ[ing] ... polyoxyalkylated derivatives of difunctional compounds
having two reactive hydrogen atoms" and "are obtainable by reacting diols
of the class HO(CH2)nOH, where n equals 2 to 10, propylene glycol ... "
(Hostettler 3:5---6; id. at 3:71-73; id. at 4:2--4; see Final Act. 4--5).
FF 5. Hostettler discloses "[h ]igher functional alcohols suitable for
initiating the polymerization of lactones in accordance with the method of
the invention include triols such as glycerol, trimethylolpropane, 1,2,4-
butanetriol, 1,2,6-hexanetriol, triethanolamine, and triisopropanolamine;
various tetrols like erythritol, pentaerythritol, N,N,N',N'-tetrakis(2-
hydroxyethyl)ethylenediamine, ... " (Hostettler 4:40--45; see Final Act. 5).
FF 6. Examiner finds that
Hostettler fails to disclose wherein the H-Al-B-A2-H precursor
taught therein is polymerized to form a polymer having the
Formula (I): H-Al-B-A2-C-Al-B-A2-H; wherein C is a
bridging fumarate group, the composition is a scaffold, and the
H-Al-B-A2-H precursor polymerized to form Formula (II):
wherein C is fumarate groups, and geometric isomers thereof.
(Final Act. 6.)
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Application 14/009,987
FF 7. Yazemski "relates to the synthesis of a poly-( caprolactone-fumarate)
polymer useful as a biocompatible, bioresorbable, injectable, and in-situ
hardening scaffold for tissue engineering applications" (Yazemski ,r 4; see
generally Final Act. 6).
FF 8. Yazemski discloses
a biomaterial [] synthesized by reacting fumaryl chloride or
fumaric acid with poly( E:-caprolactone) of low molecular weight
in the range of 500-10000 daltons to produce poly( E: -
caprolactonefumarate) using [a] method of condensation
polymerization. Low molecular weight poly( E:-caprolactone)
can be fabricated into scaffolds by melting or solvent casting
but it does not have suitable mechanical properties as a scaffold
for regeneration of hard tissues.
(Y azemski ,r 15; see id. ,r 14 (Y azemski "provides for the synthesis of
poly( E:-caprolactone-fumarate) as a biocompatible, bioresorbable, injectable,
and self-crosslinkable polymer for bone tissue engineering"); see also Final
Act. 6; Ans. 8.)
FF 9. Y azemski discloses a
Method for preparing [a] copolymer, [wherein] a fumaric acid
salt such as a fumaryl halide (e.g., fumaryl chloride) or fumaric
acid, which contains unsaturated carbon-carbon double bonds
that can be used for in situ crosslinking, is copolymerized with
a poly( caprolactone) macromer ( e.g., poly( E:-caprolactone)
having a molecular weight in the range of 500-10000 daltons)
that has a flexible backbone such that the resulting copolymer
may selfcrosslink in the absence of a crosslinking agent.
(Yazemski ,r 27; see Final Act. 6.)
FF 10. Y azemski discloses "[ s ]caffolds were fabricated from the
poly(caprolactone-fumarate) copolymer with salt as the porogen, benzoyl
peroxide as the chemical initiator, and dimethyltoluidine as the accelerator"
(Yazemski ,r 50; see Final Act. 6).
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Appeal2018-005480
Application 14/009,987
ANALYSIS
Based on the combination of Hostettler and Y azemski, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious to have selected specific polycaprolactone
macromers encompassed by Hosteller's disclosures and "incorporated
[these] polycaprolactone macromers ... within the polycaprolactone
fumarate composition disclosed by Yaszemski to form a polymer of
Formulas (I) and (II) wherein C is a bridging fumarate group" (Final Act. 6).
Examiner finds that such a combination is nothing more than the
combination of
prior art elements according to known methods to yield
predictable results ... because Hostettler teaches the formation
of various polycaprolactone macromers[;] wherein Yaszemski
adds specificity to the composition by teaching additional
copolymerization components, such as fumaryl chloride, which
can be use[d] [to] optimize the composition taught by
Hostettler.
(Final Act. 9-10).
More specifically, Examiner explains that "[t]he unsubstituted
caprolactone disclosed by Hostettler is the most basic caprolactone disclosed
by Hostettler, and forms [the] [] Al and A2" groups of Appellants' Formula
(I) (Ans. 7). The B group of Appellants' Formula (I) "is from the initiator[,
i.e. alkane polyol, such as ethylene diol,] that is used to open the
[ caprolactone] ring" (id. at 8; see also Final Act. 4--5). As Examiner
explains, "[i]t would have been equally obvious to pick any known ring
opening initiator that is disclosed by Hostettler" (Ans. 8). As for the C
group of Appellants' Formula (I), Examiner further explains that "adding
fumarates to caprolactone [] is a known way to functionalize caprolactone to
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Appeal2018-005480
Application 14/009,987
produce a product that is safe to work with as it is biocompatible,
bioresorbable as evidenced by ... Yaszemski" (id. (citing Yaszemski ,r 14);
FF 8). Therefore, Examiner concludes that "[t]he combination of Hostettler
and Yaszemski disclose the structure of the scaffold comprising the instantly
claimed blend of polymer of Formula (I) and Formula (II)" (Ans. 12).
Appellants contend that "Hostettler teaches an infinite number of
blends of different caprolactones, none of which are linked to a fumarate
group" (App. Br. 9). In this regard, Appellants contend that Hostettler
expressly discloses that "the choice of initial lactone or combinations of
lactones is practically unlimited" and, in addition, directs those of ordinary
skill in this art to an endless number of polymer combinations by discloses a
preference "to utilize mixtures of substituted and unsubstituted lactones"
(Reply Br. 2-3 (citing Hostettler 2:24--41); see FF 3).
In addition, Appellants contend that although "Y aszemski teaches a
poly( E: caprolactone-fumarate) bone tissue scaffold," Yaszemski "does not
teach a blend of linear and branched polymers or either claimed Polymer (I)
or Polymer (II) of independent claim 25" (id. at 10). Thus, Appellants'
contend that, taken in combination, neither of Hostettler nor Yaszemski
disclose a material that would narrow down, motivate, or otherwise guide a
person of ordinary skill in this art to select the claimed scaffold, which
comprises a combination of the polymers of Formula (I) and Formula (II), in
the claimed weight percentages, from the various caprolactone blends
disclosed by "[Hostettler] in order to create a polymer material with
beneficial properties for a tissue scaffold" (id. at 9-10; see also Reply Br. 3-
4 ). We agree.
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Application 14/009,987
"The fact that a claimed compound may be encompassed by a
disclosed generic formula does not by itself render that compound obvious."
In re Baird, 16 F.3d 380,382 (Fed. Cir. 1994).
[A] patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was,
independently, known in the prior art. Although common sense
directs one to look with care at a patent application that claims
as innovation the combination of two known devices according
to their established functions, it can be important to identify a
reason that would have prompted a person of ordinary skill in
the relevant field to combine the elements in the way the
claimed new invention does.
KSR Int'! Co. v. Teleflex Inc., 127 S.Ct. 1727, 1741 (2007); In re Kotzab,
217 F.3d 1365, 1371 (Fed. Cir. 2000) ("a rejection cannot be predicated on
the mere identification ... of individual components of claimed limitations.
Rather particular findings must be made as to the reason the skilled artisan,
with no knowledge of the claimed invention, would have selected these
components for combination in the manner claimed.").
On this record, we acknowledge Hostettler' s disclosure of lactone
polyester compositions and preference for substituted or unsubstituted
epsilon-caprolactones (FF 1-2). We also acknowledge that Yazemski
"provides for the synthesis of poly( E: -caprolactone-fumarate) as a
biocompatible, bioresorbable, injectable, and self-crosslinkable polymer for
bone tissue engineering" (FF 8). What is missing, however, is a reason why
a person of ordinary skill in this art would have selected specific polymers of
Appellants' Formula (I) and Formula (II), which may result from the
combination of Hostettler and Yazemski, to formulate a scaffold comprising
a polymer blend that is specifically 20 wt.% to 80 wt.% Formula (I) and 20
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Application 14/009,987
wt.% to 80 wt.% Formula (II), as is required by Appellants' claim 25 (see
App. Br. A-l-A-3).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 25 and 49-57
under 35 U.S.C. § I03(a) as unpatentable over the combination of Hostettler
and Y aszemski is reversed.
REVERSED
11