Ex Parte Andjelic et al

Patent Trial and Appeal Board

Jan 29, 2019

13417810 (P.T.A.B. Jan. 29, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/417,810 03/12/2012
27777 7590 01/31/2019
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
FIRST NAMED INVENTOR
Sasa Andjelic
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.
ETH5660USNP 2333
EXAMINER
BABSON, NICOLE PLOURDE
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
01/31/2019 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):
jnjuspatent@corus.jnj.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SASA ANDJELIC and DENNIS D. JAMIOLKOWSKI 1
Appeal 2018-0013 82
Application 13/417 ,810
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
ELIZABETH LA VIER, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a bioabsorbable comprising a
bioabsorbable semicrystalline copolymer, which consists essentially of a
melt polymerization reaction product. The Examiner rejected the claims as
obvious under 35 U.S.C. § 103(a). Pursuant to 35 U.S.C. § 134(a),
Appellants appeal the Examiner's determination that the claims are
unpatentable. We have jurisdiction under 35 U.S.C. § 6(b ). The Examiner's
decision is affirmed.
1 The Correct Appeal Brief ("Br."; entered March 27, 2017) lists Ethicon,
Inc. as the real party in interest.
Appeal 2018-001382
Application 13/417,810
STATEMENT OF THE CASE
The Examiner finally rejected claims 50-52, 54---62, 64--72, 74--82,
84--92, and 94--104 under pre-AIA 35 U.S.C. I03(a) as obvious in view of
Venkatraman et al. (WO 2011/059408 Al, published May 19, 2011)
("Venkatraman"), Baimark et al. (Synthesis and characterization of poly(L-
lactide-co-c:-caprolactone) (B)-poly(L-lactide) (A) ABA block copolymers,
Polym. Adv. Technol., 16: 332-337, 2005) ("Baimark"), and Verser et al.
(U.S. Pat. No. 5,633,342, issued May 27, 1997) ("Verser"). Final Act. 3.
Claims 50, 60, 70, 80, and 90 are independent claims. Appellants did
not argue the claims separately. We have selected claim 60 as
representative. The remaining independent and dependent claims fall with
claim 60. Claim 60 reads as follows:
60. A bioabsorbable fiber, comprising:
a bioresorbable copolymer of the structure A-B-A,
wherein end-segments A comprise polymerized lactide blocks
and the middle segment B comprises a polymerized fully
amorphous lactide-co-epsilon-caprolactone block, and wherein
said middle segment B represents about 25 weight percent to
about 60 weight percent of the copolymer, and said copolymer
has a Young's modulus of less than about 350,000 psi, wherein
said bioabsorbable semi crystalline copolymer of the structure
A-B-A consists essentially of the melt polymerization reaction
product of:
( c) the middle segment B formed as a fully amorphous
prepolymer from melt polymerizing lactide monomer, and
epsilon-caprolactone monomer in the presence of an initiator,
wherein the mole ratio of lactide to epsilon-caprolactone in the
middle segment Bis between about 45:55 to about 30:70; and
( d) end-segments A formed from lactide monomer,
wherein the mole ratio of the polymerized lactide to
polymerized epsilon-caprolactone in said A-B-A copolymer is
about 75:25.
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DISCUSSION
All the claims are directed to bioabsorbable fibers. Because
Appellants argue all the claims together, claim 60 was selected as
representative. Claim 60 recites that the bioabsorbable fiber comprises a
bioresorbable semi crystalline copolymer of the structure A-B-A. The end
segments A comprise polymerized lactide blocks. The middle segment B
comprises "a polymerized fully amorphous lactide-co-epsilon-caprolactone
block." The A-B-A copolymer is recited in the claim to be a product of melt
polymerization. The middle segment B is "formed as a fully amorphous
prepolymer from melt polymerizing lactide monomer, and epsilon-
caprolactone monomer in the presence of an initiator."
The Examiner found that V enkatraman describes the same structure of
the claimed bioabsorbable semicrystalline copolymer. Final Act. 3-5.
However, the Examiner found that Venkatraman does not describe making
the copolymer by "melt polymerization" as required by the claims. Id. at 5.
The Examiner also found that Venkatraman does not describe a
"monofilament suture" as recited in certain dependent claims. Id.
To meet this deficiency, the Examiner cited the disclosure in Verser of
melt polymerization. Final Act. 5-6. The Examiner found that Verser
describes making a copolymer of lactide and epsilon-caprolactone by melt
polymerization, the same monomers as claimed. Id. at 6. The Examiner
found it would have been obvious to have utilize melt polymerization to
make Venkatraman' s polymer because,
the material costs for melt polymerization are reduced relative
to those for solution polymerization and when using melt
polymerization techniques the amount of by-products and
wastes produced are typically minimized. Verser et al. continue
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that when using melt polymerization, less equipment is needed
because there is no solvent to be removed from the synthesized
block copolymers and treated or otherwise handled and as a
result, melt polymerization generates less volatile organics than
solution polymerization, making melt polymerization a
technically less complicated and more environmentally sound
process than solution polymerization.
Final Act. 6.
The Examiner further found that Baimark describes copolymers of
lactide and epsilon-caprolactone and that such copolymers are used as
absorbable monofilament sutures. Final Act. 6.
Appellants argue that the copolymers of Venkatraman are made by a
solution polymerization process and that it "would not be possible to
manufacture Applicants' novel copolymers using the solution
polymerization process disclosed and required by Venkatraman." Br. 21.
As evidence of this, Appellants provided a first declaration under 37 C.F.R.
§ 1.132 by Sasa Andjelic, Ph.D., a co-inventor of the claimed invention
which was submitted on July 29, 2014 ("1st Andjelic Deel.").
Dr. Andjelic stated in his declaration that bioabsorbable copolymers,
having a composition similar to the polymers disclosed in his patent
application, which are made by a solution polymerization process as
disclosed in Venkatraman, would have a semi-crystalline "B" segment of the
lactide-epsilon-caprolactone copolymer because "the transesterification
reactions that would normally occur in high temperature melt polymerization
would be very much reduced (minimized) in the low temperature solvent
polymerization" of Venkatraman. 1st Andjelic Deel. ,r 5. Dr. Andjelic
explained that the "transesterification reactions scramble the sequence
distribution making it difficult to retain the chain symmetry to allow
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crystallization." Id. Dr. Andjelic provided evidence to support his opinion,
citing the Grijpma publication as showing that a lactide and epsilon-
caprolactone copolymer formed a semi-crystalline structure when prepared
by solution polymerization as in the Venkatraman process. Id. Dr. Andjelic
cited a second publication by den Dunnen to further support his opinion. Id.
Dr. Andjelic also stated that the molecular weight distribution of the
claimed polymers distinguishes them from Venkatraman. 1st Andjelic Deel.
,r 5 (p. 3). Dr. Andjelic stated the polymers made by the "patent
application", although not reported in the application, had a molecular
weight distributions which "were generally about half, or a little less" than
those of Venkatraman. Id. at ,r 5 (pp. 4--5). The referenced data were not
shown in his declaration.
Dr. Andjelic also provided a second corrected declaration executed
July 19, 2016 in which he described experiments "to determine whether the
solvent polymerization process of Venkatraman et al. would yield block
copolymers having a fully amorphous center block." 2nd Corrected
Andjelic Deel. ,r 6. Based on the test results of the experiments described in
that declaration, Dr. Andjelic reported that
Id.
copolymers having the chemical composition of the copolymers
of the present invention that were made using the solvent
process of Venkatraman et al. had a semi crystalline middle
block (prepolymer) structure in contrast to the copolymers of
the present invention which have a fully amorphous middle
block and which are made using fully amorphous prepolymer.
Dr. Andjelic also stated that it is his opinion that Baimark does not
disclose an amorphous prepolymer as claimed, and that such copolymers
would by crystalline. 2nd Corrected Andjelic Deel. ,r 7. Dr. Andjelic
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explained technically why Baimark's process utilizing solid state
polymerization would result in crystallization in contrast to the melt
polymerization in the claims. Id. While Baimark concluded their polymers
were amorphous, Dr. Andjelic stated, "their own data suggest that all of their
prepolymers are, in fact, semicrystalline." Id. (para. 7).
We have considered the 1st and 2nd Andjelic declarations, but are not
persuaded that they demonstrate an error in the rejection. Primarily, while
Dr. Andjelic's declarations explain why the process described in
V enkatraman and Baimark would not result in the claimed amorphous
polymer, the Examiner specifically cited Verser for teaching the melt
polymerization process to produce the claimed copolymer with the
amorphous component. Thus, while certain process conditions in
Venkatraman and Baimark might produce crystalline polymers, the rejection
was based on Verser' s process, not on those of Venkatraman and Baimark.
Nonetheless, Venkatraman describes making its B segment
amorphous. Venkatraman ,r,r 23, 42. Verser, as found by the Examiner,
"further teach that the pre-copolymer has 'reduced crystallinity' and is
exemplified as having no melting peak, which would indicate an amorphous
pre-copolymer ( e.g. column 4, lines 55-63; Example 50)." Final Act 6.
Thus, as found by the Examiner, the skilled worker reading Venkatraman's
disclosure of making the B segment amorphous would had reason to use
Verser's melt polymerization process to make a polymer with reduced
crystallinity and amorphous. Final Act. 6.
Appellants also argue that Verse teaches that its polymers "are
environmentally degradable for use in plastic bags and packaging films
having accelerated degradation after disposal" and "distinguish their
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polymers from biodegradable plastics that are implanted in the body and
teach away from bioabsorbable implantable polymers (See col. 3, lines 20-
30)." Br. 22.
While we agree that Verser distinguishes its polymers from ones
utilized in the body, Verser specifically states this is a preferred
embodiment. ("Preferably, the environmentally degradable block
copolymers of the present invention can be distinguishable from
biodegradable plastics which are used in the body ... "). Verser col. 3, 11.
20-22. Thus, Verser is not limited to such embodiments.
Moreover, the Examiner did not rely on Verser for disclosing the
claimed copolymer structure, rather the Examiner cited Venkatraman for
described the claimed bioabsorbable copolymers. See Venkatraman ,r,r 2--4,
6, and 44 ( describing the polymers as "biodegradable"). Baimark also
describes a copolymer of lactide and epsilon-caprolactone as biodegradable
and biocompatible materials. Baimark §332. Thus, even if Verser teaches
that its polymers are preferably distinguished from biodegradable plastics,
both Venkatraman and Baimark teach biodegradable polymeric materials
made from the same monomers which are recited in the claims. Appellants
did not establish that one of ordinary skill in the art would have been
dissuaded from utilizing melt polymerization, as taught by Verser, for
making bioabsorbable polymers as required by all the rejected claims.
Mole ratio
Appellants contend that the mole ratio of lactide to epsilon-
caprolactone described in the claims is not disclosed in either Venkatraman
or Baimark. Br. 23. This argument is not persuasive.
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Claims 60 recites "the mole ratio of lactide to epsilon-caprolactone in
the middle segment Bis between about 45:55 to about 30:70." The
Examiner found that the claimed mole ratio of the two components overlaps
with the ratio described in Venkatraman. Final Act. 4. It is well established
that, when there is a range disclosed in the prior art, and the claimed
invention overlaps or falls within that range, as there is here, there is a
presumption of obviousness. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed.
Cir. 2004).
[The] law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims .. .in such a situation, the applicant
must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results
relative to the prior art range.
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990).
Appellants have not provided evidence that the claimed ratio of
lactide to epsilon-caprolactone is critical, achieves unexpected results, or has
different properties that the broader ranges disclosed in Venkatraman.
Reasonable expectation of success
Appellants contend "that a person skilled in this art would have no
reasonable expectation of success in obtaining Applicants' novel fibers and
polymers by combining the references cited by the Examiner." Br. 23.
Appellants also contend that the "novel polymers and fibers surprisingly and
unexpectedly provide" certain advantages that "derive from the morphology
of Applicants' novel block copolymers having a fully amorphous center
block formed from a fully amorphous prepolymer." Id. at 21.
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First, Appellants have not provided persuasive evidence or
explanation as to why it would not have been expected that Verser's process
could be used to produce a polymer of Venkatraman. Appellants have
simply made conclusory statements, without identifying a specific reason as
to why melt polymerization as described in Verser would not have been
reasonably expected to successfully produce Venkatraman's polymer. As
explained above, the declarations by Dr. Andjelic address the process
described in Verser and Baimark, but not the melt polymerization process of
Verser, which formed the basis of the obviousness rejection of the claims.
Second, Appellants have not provide adequate evidence of unexpected
results. A showing of "unexpected results" can be used to demonstrate the
non-obviousness of the claimed invention. In re Soni, 54 F.3d 746, 750
(Fed. Cir. 1995).
Id.
One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of 'unexpected results,' i.e.,
to show that the claimed invention exhibits some superior
property or advantage that a person of ordinary skill in the
relevant art would have found surprising or unexpected.
Appellants state in the Appeal Brief that the claimed polymers have
surprisingly and unexpected advantages, but provided no extrinsic, objective
evidence that such properties are possessed by the claimed polymers and not
by other polymers, namely, no "showing" under Soni was made.
In addition to this, to establish unexpected results, the claimed subject
matter must be compared with the closest prior art. Soni, 54 F.3d at 750;
Iron Grip Barbell, 392 F.3d at 1322 (A showing of "new and unexpected
results" must be "relative to the prior art."); In re Baxter Travenol Labs., 952
F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen unexpected results are used as
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evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art"). Appellants did not provide a
comparison with the closest prior art to establish that the properties asserted
to be surprising and unexpected were actually not possessed by the cited
prior art polymers.
Unexpected results must be "commensurate in scope with the degree
of protection sought by the claimed subject matter." In re Harris, 409 F.3d
1339, 1344 (Fed. Cir. 2005). Appellants have not explained or provided
evidence that the surprising and unexpected results are for the full scope of
each rejected independent and dependent claim.
Consisting essentially
The claims recite that the absorbable semi crystalline segmented
copolymer "consists essentially" of the product of the melt polymerization
reaction. The phrase "consisting essentially of' in a patent claim "has long
been understood to permit inclusion of components not listed in [a] claim,
provided that they do not 'materially affect the basic and novel properties of
the invention."' AK Steel Corp. v. Sollac, 344 F.3d 1234, 1239 (Fed. Cir.
2003) (citations omitted). The Examiner states that if "applicant" contends
that "additional steps or materials in the prior art are excluded by the
recitation of 'consists essentially of,' applicant has the burden of showing
that the introduction of additional steps or components would materially
change the characteristics of applicant's invention." Final Act. 8. Cf PPG
Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998).
Appellants argue that the addition of additives and monomers would
"reduce the crystallinity and such additives or monomers would materially
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affect the basic and novel characteristics of their polymer." Br. 25.
Appellants state that the use of "consisting essentially" in the claims is "to
exclude ... additives and monomers that materially affect their polymers is
proper and is in contradistinction to Venkatraman et al. who may include
additives which may materially alter ('influence') the properties of their
polymers as disclosed in their Paragraph [0029]." Id.
This argument does not persuade us that the Examiner erred.
The "bioabsorbable fiber" of the claim preamble is "comprising" the
"bioabsorbable semicrystalline copolymer." The phrase "consists essentially
of' applies to the "bioabsorbable semicrystalline copolymer of the structure
A-B-A" which "consists essentially of the melt polymerization reaction
product." The bioabsorbable fiber is thus open to the addition of
components not recited in the claim. See, e.g., In re Crish, 393 F.3d 1253,
1257 (Fed. Cir. 2004). Appellants have not provided evidence that the
addition of the components in paragraph 29 of Venkatraman to the claimed
"bioabsorbable fiber", which is permitted by the claims, would affect the
properties of the bioabsorbable semi crystalline copolymer, particularly the
amorphous middle segment B.
While certain additives described in paragraph 29 of Venkatraman are
said to affect the crystallinity of the polymer A, 2 which is the end polymer of
the A-B-A structure, V enkatraman does not teach the components affect the
amorphous polymer B segment. Appellants have not established that the
2 "[0029] In addition to the above, in one embodiment of the present
invention an additive may be added to the polymer A. An additive according
to the present invention may be any compound that may influence the
properties of polymer A."
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crystallinity of the A segment is basic and novel property of the claimed
bioabsorbable fiber. In addition, as pointed out by the Examiner,
Appellants' own Specification on pages 15-16 describes that additional
monomers may be added to achieve desired characteristics.
For the foregoing reasons the obviousness rejection of claim 60 is
affirmed. Claims 50-52, 54--59, 61, 62, 64--72, 74--82, 84--92, and 94--104
were not argued separately and fall with claim 60. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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