Ex Parte Kelch et al

Patent Trial and Appeal Board

Mar 30, 2016

12300870 (P.T.A.B. Mar. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/300,870
86012 7590
VLP Law Group LLP
555 Bryant Street
Suite 820
Palo Alto, CA 94301
05/14/2009
04/01/2016
FIRST NAMED INVENTOR
Steffen Kelch
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.
5661-5PUS 3559
EXAMINER
PALLAY,MICHAELB
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
04/01/2016 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):
patents@vlplawgroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEFFEN KELCH, ANDREAS LENDLEIN, and
YAKAIFENG1
Appeal2013-006423
Application 12/300,870
Technology Center 1600
Before DEMETRA J. MILLS, ULRIKE W. JENKS, and
RICHARD J. SMITH, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
uECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a multiblock copolymer with shape memory properties. The Examiner
rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is GKSS-
Forschungszentrum Geesthacht GmbH. (Br. 2.)
Appeal2013-006423
Application 12/300,870
STATEMENT OF THE CASE
Claims 1, 4, 5, and 9 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. 2 Claim 1 is representative of the claims on
appeal, and reads as follows:
1. Multiblock copolymer with shape memory properties and an
average molecular weight MW in the range of 10,000 to
100,000 g/mol, wherein the multiblock copolymer comprises:
(i) poly( depsipeptide) segments of formula (1 ):
(1)
where Xis a bridge selected from the group:
(X1)
and
{X2}
where 0 = 2 - 20 and p = 1 - 10;
R represents a group selected from H or a branched or
unbranched C1-C10 alkyl radical; and
n and m are given such that the poly( depsipeptide) segments
have an average molecular weight Mw in the range of 1,000 to
20,000 g/mol; and
(ii) poly(E-caprolactone) segments with an average molecular
2 Appellants acknowledge that claims 3, 6-8, 11, and 13-15 are withdrawn
and claims 2 and 10 have been canceled (Br. 2).
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Application 12/300,870
weight Mw in the range of 1,000 to 10,000 g/mol.
(Br. Claims Appendix.)
Appellants seek review of the Examiner's rejection of claims 1, 4, 5,
and 9 under 35 U.S.C. § 103(a) over Langer3 in view of Feng. 4 (Br. 4.)
As Appellants do not argue the claims separately, we focus our
analysis on claim 1, and claims 4, 5, and 9 stand or fall with that claim. 37
C.F.R. § 41.37 (c)(l)(iv).
Langer discloses shape memory polymers including hard and soft
segments and suggests the combination of a poly( E-caprolactone) block (soft
segment) and a polydepsipeptide (hard segment) (Final Act. 3--4). The
Examiner finds that Langer "does not disclose a specific example that
includes both a poly( E-caprolactone) block and a polydepsipeptide block."
(Id. at 3.) Additionally, the Examiner acknowledges that Langer does not
"disclose a poly( depsipeptide) segment of PIBMD" (poly(3(S)-
isobutylmorpholine-2,5-dione )diol) (Id. at 4). 5
Feng "discloses that the copolymerization of morpholine-2,5-diones
(i.e., poly( depsipeptide) segments) with E-caprolactone produces poly( ester
amide )s with a wide variety of properties" (Id. at 5). The Examiner
acknowledges that neither Feng nor Langer disclose PIBMD. The Examiner
concludes that
since PBMD and PIBMD are such close isomers, and since
3 Langer et al., US 6,388,043 Bl, issued May 14, 2002.
4 Feng et al., Synthesis and Characterization of New Block Copolymers with
Poly(ethylene oxide) and Poly[3(S)-sec-butylmorpholine-2,5-dione]
Sequences, 1 Macromol. Biosci. 30-39 (2001).
5 Appellants elected the species PCL/PIBMD in response to the
Election/Restriction requirement of February 24, 2011. (See response
submitted March 23, 2011.)
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Application 12/300,870
both are used in block polymer degradable medical materials, it
would have been prima facie obvious to one of ordinary skill in
the art at the time the invention was made to substitute an
isobutyl group for a sec-butyl group in the PBMD of Feng et al.
to produce PIBMD, with a reasonable expectation of success.
(Final Act. 5.)
Appellants contend that the polymers of Langer contain an infinite
number of alternatives (Br. 4-5, and 8), that the Examiner has not provided a
sufficient articulated rationale that the combination would have been
predictable (Id. at 6-7), that the combination lacks a reasonable expectation
of success (Id. at 8), that the substitution as suggested by the Examiner is not
supported (Id. at 9), and that there are unexpected results with respect to the
shape polymer (Id. at 9-10).
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of references renders the
claimed multiblock shape memory polymer obvious, and if so have
Appellants provided sufficient evidence of secondary considerations to
overcome the prima facie showing of obviousness?
Findings of Fact
FF 1. Langer teaches shape memory polymers having at least two different
shapes (see Langer col. 24, 11. 18-19). "[T]he polymer comprises
hard and soft segments and at least one of the hard and soft segments
is selected from the group consisting of polyhydroxy acids,
polyorthoesters, polyether esters, polyesters, polyamides,
polyesteramides, polydepsidpetides, aliphatic polymrethanes,
polysaccharides, polyhydroxyalkanoates, and copolymers thereof'
(Langer col. 25, 11. 3-9 (emphasis added); see also Ans. 4).
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Application 12/300,870
FF2. Langer teaches that "[t]he polymers incorporate 'hard' and 'soft'
segments. The segments preferably are oligomers. As used herein,
the term 'oligomer' refers to a linear chain molecule having a
molecular weight up to 15,000 Daltons .... Preferably, the number
average molecular weight of the polymer segment is greater than 400,
and is preferably in the range of between 500 and 15,000." (Langer
col. 6: 32--43; see also Final Act. 3.) Langer also disclosed that "[t]he
ratio by weight of the hard segment: soft segments is between about
5:95 and 95:5, preferably between 20:80 and 80:20." (Langer col. 5:
4-6.)
FF3. The Examiner finds that "poly(E-caprolactone) is a species of
polyester." (Ans. 4.)
FF4. Feng teaches "[t]he copolymerization of morpholine-2,5-diones with
D,L-lactide (DLLA), glycolide (GA) or E-caprolactone (CL) produces
poly(ester amide)s with a wide variety of properties." (Feng 30
(footnote omitted); see also Final Act. 5 ("morpholine-2,5-diones (i.e.,
poly( depsipeptide) segments)").)
FF5. Feng teaches that "[b]ecause rate of the biodegradation of PBMD
[(poly[3(S)-sec-butylmorpholine-2,5-dione ])] is low, the
copolymerization of morpholine-2,5-diones with lactones or lactides
such as CL and LA are an effective approach to improve the
degradation properties of poly(morpholine-2,5-diones)." (Feng 38.)
FF6. Feng discloses the production of PBMD/PEO (poly( ethylene oxide)
block copolymers with different architectures (Feng 30.) PBMD
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Application 12/300,870
(poly[3(S )-sec-butylmorpholine-2,5-dione]) has the following
structure:
(Feng 32).
FF7. Feng teaches an ABA triblock copolymer with a Mw 29800. (Feng
32, Table 2; see also Final Act. 4-5.) The ABA copolymer has the
following structure:
The structure shows the triblock copolymer with A= PBMD and B =
PEO (Feng 32, Table 2; see also Final Act. 5).
FF8. The Examiner finds that PIBMD (poly(3(S)-isobutylmorpholine-2,5-
dione )diol) has the following structure:
(Ans. 9.)
Principle of Law
"The question of 'structural similarity' in chemical patent cases has
generated a body of patent law unto itself. Particular types or categories of
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Application 12/300,870
structural similarity without more have, in past cases, given rise to prima
facie obviousness; see, e.g., In re Dillon, 919 F.2d 688, 692-94 (Fed. Cir.
1990) (tri-orthoesters and tetra-orthoesters), cert. denied 500 U.S. 904
(1991); In re May, 574 F.2d 1082, (CCPA 1978) (stereoisomers); In re
Wilder, 563 F.2d 457 (CCPA 1977) (adjacent homologs and structural
isomers); In re Hoch, 428 F.2d 1341(CCPA1970) (acid and ethyl ester)."
In re Jones, 958 F.2d 347, 349-50 (Fed. Cir. 1992) (footnote omitted).
When such 'close' structural similarity to prior art compounds is
shown, in accordance with these precedents the burden of coming forward
shifts to the applicant, and evidence affirmatively supporting unobviousness
is required." In re Grabiak, 769 F.2d 729, 731 (Fed. Cir. 1985).
Analysis
After considering the evidence and the arguments, we conclude the
weight of the evidence favors the Examiner's conclusion of obviousness.
Accordingly, we adopt the Examiner's findings, analysis concerning the
scope content of the art, and reasoning (see Final Action 3-7), and agree that
the Examiner properly found Appellants' arguments unpersuasive (see
Response to Argument, Final Act. 7-9 and Ans. 2-11 ). We provide the
following points for emphasis.
We are not persuaded by Appellants' contention that the polymers of
Langer contain an infinite number of alternatives (Br. 4-5, and 8). Here, the
Examiner is relying on Langer to teach shape memory polymers made up of
hard and soft segments (see FFl and FF2). The reference teaches that in
order to produce a shape memory polymer you need to select at least one
hard and soft segment (FF 1 ). The Examiner finds that polyester
encompasses the species poly( E-caprolactone) (FF3 ). Poly( E-caprolactone)
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Application 12/300,870
is identified in Langer as belonging to the soft segment (see Ans. 4
"specifically discloses poly( E-caprolactone) in soft segments of the shape
memory multiblock copolymer compositions in Example l "). Here, the
Examiner is relying on a list of hard and soft segments in Langer that
includes a group with only 10 members and instructs that one of each kind
of segment must be included in the product. "[B]oth poly( depsipeptide) and
poly(E-caprolactone) are disclosed by Langer ... as suitable segments for
inclusion in shape memory multi block copolymer compositions" (Ans. 4).
We find a list that includes only 10 members and specifically has identified
that some of the members in the list are either belonging to the hard or soft
segment further decreases the probable combination. Accordingly, we are
note persuaded by Appellants contention that the combination in Langer is
infinite.
We are not persuaded by Appellants' contention that the Examiner has
not provided a sufficient articulated rationale that the combination would
have been predictable (Br. 6-7). Here Langer instructs that in order to make
a shape memory polymer you need to combine hard and soft segments (FFl
and FF2). Although Langer teaches the general combination of poly( E-
caprolactone) containing segments and depsipeptide containing segments in
the production of a shape memory polymer (FFl ), the Examiner
acknowledges that the reference does not exemplify such a product (see
Final Act. 3). The Examiner looks to Feng's disclosure for teaching
"copolymerization of morpholine-2,5-diones (i.e., poly( depsipeptide)
segments) with [poly(]E-caprolactone[)]." (Final Act. 5; see also FF4-FF7.)
Feng explains that the copolymerization of depsipeptide and polylactone
produced poly( ester amides) with a wide range of uses (FF 4) specifically
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Application 12/300,870
indicating that such a combination would improve the degradation properties
of the polymer (FF5).
The Examiner concludes that
A person of ordinary skill in the art at the time the invention
was made would have been motivated to combine these
teachings [ (of Langer and Feng)] in order to use a
poly( depsipeptide) having hydrophilic PEO blocks [as
disclosed in Feng] in the main chain of the polymer which
increases degradation rates due to accelerated permeation of
water into the matrix, which improves its properties as a drug
delivery system, as taught by Feng et al. Further motivation to
combine such morpholine-2,5-diones with caprolactone is also
provided by Feng et al. which discloses that such combination
is an effective approach to improve degradation properties and
greatly expand the scope of application as medical materials.
(Final Act. 6-7.) In other words, the Examiner reasons that Feng' s disclosed
polydepsipeptide, specifically PBMD, is known to have a low
biodegradation rate but this rate can be improved by incorporating either
PEO or poly( E-caprolactone) into the polymer to improve the degradation
rate (FF4 and FF5).
We are also unpersuaded by Appellants' contention that the
combination lacks a reasonable expectation of success (Br. 8) and that "none
of the copolymers described in Feng has shape memory effects" (Br. 9).
Here, Feng discloses the production of a triblock copolymer with
PEO/PBMD (FF6 and FF7). Feng suggests that in order to improve the
biodegradation of these polymers you want to copolymerize PBMD with a
poly( E-caprolactone) (FF5). Langer teaches that combinations of a polyester
and a polydepsipeptide produce compositions that have shape memory
character. (See FFl, FF4, and FF5.) Langer also teaches that is desirable to
make the polymer biodegradable. "Biodegradable polymers degrade at a
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Application 12/300,870
controlled rate depending on the composition and crosslinking of the
polymer. Degradable polymeric implants eliminate the need for implant
retrieval and can be used simultaneously to deliver therapeutic agents."
(Langer col. 16: 30-37; see also Final Act. 3.) Here, the combination as
suggested by the Examiner would result in a copolymer that is readily
degradable as suggested by Feng.
The law does not require that the teachings of the reference be
combined for the reason or advantage contemplated by the inventor, as long
as some suggestion to combine the elements is provided by the prior art as a
whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig,
539 F.2d 1300, 1304 (CCPA 1976). Here, the record establishes that when
PBMD is combined with poly( E-caprolactone) this makes the polymer more
readily degradable (FF5), and Langer tells us that this polymer should have
shape memory because it is made of hard and soft segments (FF 1; see also
Ans. 5). Even if the Examiner's reason for combining the references is not
for the purpose of creating a shape memory polymer, that feature is a natural
result of the combination of PBMD with poly(E-caprolactone) (see FF6) and
therefore renders the claim obvious.
We are also unpersuaded by Appellants' contention that the
substitution as suggested by the Examiner is not supported (Br. 9). The
Examiner identified that "PIBMD is a close position isomer of PBMD[], the
prior art suggests that the results of use of PIBMD as the polydepsipeptide
block in Langer []would have been predictable and that there would have
been a reasonable expectation of success" (Ans. 5; see also FF6 and FF8).
Additionally, the Examiner finds that "the structures of PBMD and PIBMD
are identical except that a single methyl group from PBMD noted as 7 as
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drawn is moved one position from position 6 to position 8 as drawn, to form
PIBMD. Hence, the chemical name changes from a sec-butyl to an iso-
butyl." (Ans. 9; see also FF6 and FF8.) There is a presumption that
compounds that have close structural similarity will also have similar
properties. See In re Dillon, 919 F.2d 688, 692-94, In re Wilder, 563 F.2d
457. Because of the structural similarity between PBMD and PIBMD we
find no error with the Examiner's position that the teachings of Feng can be
extrapolated to include copolymers of PIBMD and poly( E-caprolactone) for
the purpose of making multiblock copolymers that have improved
biodegradation properties.
We find that the Examiner has presented sufficient evidence to
support the conclusion that the combination of references renders the
multiblock copolymers having shape memory properties obvious. Because
the Examiner presents a prima facie case of obviousness, we consider
whether Appellants submit sufficient evidence or argument in rebuttal. See
In re Grabiak, 769 F.2d 729, 731.
Appellants contend that their polymers show unexpected results with
the shape polymer (Br. 9-10). We agree with the Examiner's position that
Appellants have provided insufficient evidence to establish "that it is
unexpected that poly( depsipeptide) segments have sufficient elastic behavior
to be useful as a compound of a shape memory polymer" (Ans. 10).
Attorney's argument in a brief cannot take the place of evidence." In re
Pearson, 494 F.2d 1399, 1405(CCPA) (citation omitted).
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient evidence of secondary considerations that outweighs the
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evidence supporting the prima facie case. As Appellants do not argue the
claims separately, claims 4, 5, and 9 fall with claim 1. 37 C.F.R. § 41.37
( c )(1 )(iv).
SUMMARY
We affirm the rejection of claims 1, 4, 5, and 9 under 35 U.S.C.
§ 103(a) over Langer in view of Feng.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
AFFIRMED
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