Ex Parte Oliver et al

Patent Trial and Appeal Board

Nov 15, 2016

12956709 (P.T.A.B. Nov. 15, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/956,709 11/30/2010
25281 7590 11/17/2016
DICKE, BILLIG & CZAJA
FIFTH STREET TOWERS
100 SOUTH FIFTH STREET, SUITE 2250
MINNEAPOLIS, MN 55402
FIRST NAMED INVENTOR
Dana A. Oliver
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.
Ml90.160.102/PD0000278.0l 9841
EXAMINER
COUGHLIN, DANIEL F
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
11/17/2016 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):
USPTO.PA TENTS@dbclaw.com
dmorris@dbclaw.com
DBCLA W-Docket@dbclaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANA A. OLIVER, MATTHEW J. HALVORSEN, and
LEAH KA V ANAGH1
Appeal2014-002989
Application 12/956,709
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a method of making a bioresorbable foam product with a preselected in
vivo residence time. 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 to Medtronic Xomed,
Inc., a Delaware corporation. (App. Br. 3.)
Appeal2014-002989
Application 12/956,709
STATEMENT OF THE CASE
According to the Specification "[ v ]arious types of sterile packing and
stents are used in the medical and surgical fields for keeping tissues apart or
preventing adhesion" (Spec. ,-r 3). The use of bioresorbable foams can
prevent injury or discomfort associated with "packing and stents [that] have
been made from gauzes, microfibers, non-fibrous expandable packing" (id.
,-r 4 ). The Specification explains that the rate of resorption of these foams "is
controlled by adjusting the re-suspension shear parameters, the level of
crosslinking of the foam ingredients to produce the desired level; the
sterilization bombardment must also be controlled in order to control the
chain scission caused by such bombardment" (id. ,-r 30).
Claims 1-8, 11, 13-18, and 21 are on appeal,2 and can be found in the
Claims Appendix of the Appeal Brief. Claim 1 reads as follows:
1. A method of making a flexible bioresorbable foam having a
preselectable in-vivo residence time comprising the steps of:
preparing a blend consisting of crosslinked collagen
blended with a hyaluronic acid component,
mixing the blend with water to form a suspension;
freezing and lyophilizing the suspension at less than
about 0°C to form a foam product;
cross linking the foam product to form a crosslinked
foam product,
bombarding the crosslinked foam product gamma rays or
a beam of electrons to sterilize the crosslinked foam product;
and
further bombarding the crosslinked foam product with
gamma rays of a beam of electrons to cause chain scission and
2 Claim 12 has been canceled and claims 9, 10, 19, and 20 are withdrawn
(see App. Br. 3).
2
Appeal2014-002989
Application 12/956,709
provide the crosslinked foam product with a preselected in-vivo
residence time of between about 5 days and about 14 days.
(App. Br. 15, Claims Appendix). Claim 13, the only other independent
claim, similarly recites "causing chain scission on the crosslinked product to
provide the crosslinked product with a preselected in-vivo residence time of
between about 5 days and about 14 days" (id. at 17).
Appellants request review of the following rejections:
I. claims 1-3, 7, 8, 11, 13, 17, 18, and 21under35 U.S.C.
§ 103(a) as unpatentable over Yannas '9573 and Gen4 as evidenced by the
Free Dictionary;5
II. claims 1, 6, 13, and 16 under 35 U.S.C. § 103(a) as
unpatentable over Yannas '957 and Gen as evidenced by the Free
Dictionary and further in view of Tate6 and Solchaga;7 and
III. claims 1, 4, 5, and 13-15 under 35 U.S.C. § 103(a) as
unpatentable over Yannas '957 in view of Gen and Yannas '718. 8
3 Yannas et al., US 4,280,954, issued July 28, 1981 ("Yannas '954").
4 Gen, US 2003/0091646 Al, published May 15, 2003 ("Gen").
5 Definition of "foam" by the Free Online Dictionary,
http://www.thefreedictionary.com/foam, last accessed Mar. 1, 2012.
6 Tate et al., WO 03/070186 A2, published Aug. 28, 2003 ("Tate").
7 Solchaga et al., Hyaluronic Acid-Based Polymers as Cell Carriers for
Tissue-Engineered Repair of Bone and Cartilage, 17 J. Ortho. Res. 205-213
( 1999) ("Solchaga").
8 Yannas et al., US 4,448,718, issued May 15, 1984 ("Yannas '718").
3
Appeal2014-002989
Application 12/956,709
I. Obviousness over Yannas ;957 and Gen
Does the preponderance of evidence of record support the Examiner's
conclusion that the claimed method of making a crosslinked collagen-
hyaluronic acid product with a preselected in vivo residence time obvious?
Findings of Fact
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art as set out in the Final Action9 and Answer.
For emphasis only we highlight the following:
FF 1. Yannas '954 teaches the production of polymers comprising
combining "collagen with a mucopolysaccharide and subsequently
covalently crosslinking" these components to create the polymer
(Yannas '954, Abstract). "Collagen can be reacted with a
mucopolysaccharide in aqueous acidic solutions" (Yannas '954, 5:65-
66; Final Act. 6)
FF2. Yannas '954 teaches that resorption rate of the polymer can be
adjusted based on the degree of crosslinking between the collagen and
the mucopolysaccharide (Yannas '954 8:5-23 ("Covalent crosslinking
also serves ... to raising the resistance to resorption of these
materials"); Final Act. 5-6).
[C]ollagen-mucopolysaccharide composites can be crosslinked
to provide any desired degree of increased resistance to
resorption over the low degree exhibited by native collagen
which is not artificially crosslinked. In fact, the crosslinking
can provide essentially complete resistance, if desired. The
ability to tailor the degree of resistance to resorption without
sacrificing mechanical properties provides a degree of design
9 Office Action mailed Apr. 1, 2013 ("Final Act.").
4
Appeal2014-002989
Application 12/956,709
flexibility for surgical prostheses, etc., heretofore unavailable
with any class of resorbable materials.
(Yannas '954, 3 :21-30; Final Act. 5).
FF3. Yannas '954 teaches the production of crosslinked collagen
mucopolysaccharide products that have residence times up to 20 days
(Yannas '954, Example 15; Final Act. 6 ("the resorption time for the
composite structure ranges from 4 to 20 days (see [Yannas '954]
Tables IX, X, Cols. 24-25)).
FF4. Yannas '954 teaches that many techniques can be employed to
crosslink the material for example by chemical, radiation, and
dehydrothermal means (Yannas '954, 3:21-30; Ans. 5) Yannas '954
recognizes that these "composites are being sterilized at the time they
are crosslinked" (Yannas '954, 8:34-36). "Covalent bonding could
be effected by a radiation grafting copolymerization technique using,
for example, y -radiation from a cobalt-60 source" (Yannas '954,
11 :58-60; Ans. 5)
FF5. Gen teaches medical materials made up of bio-absorbable and
decomposed polymer that "include natural polymers selecting of
collagen, gelatin, chitin, chitosan, silk, cellulose, hyaluronic acid"
(Gen i-f 26; Final Act. 6).
FF6. Gen teaches sterilizing medical polymer materials using "y ray
coming from 6°Co and electron beam" (Gen i-f 10; Final Act. 6). Gen
teaches:
Radiation exposed effects on the polymer materials are
distinguished by cross-linking and collapse of the polymer
chains, independent on irradiated rate, but proportional to
irradiated dose over wide range. Cross-linking is defined that
radicals are generated by irradiation process, in which new
5
Appeal2014-002989
Application 12/956,709
connections are generated inner- and intra- polymer molecules,
molecular weight of the polymer finally increases until infinity,
and the cross-linked polymer is insoluble in all kinds of
solvents. On the other hand, the collapse of the polymer is
defined that polymers happen to deteriorate their molecular
weight and mechanical properties, because the polymer chains
are cut by irradiation.
(Gen i-f 13; Final Act. 6.)
FF7. Gen teaches:
even crosslinked type polymers happen inevitably to deteriorate
mechanical properties similar to the collapsed type because the
both polymer chains are generated radicals and cut by
irradiation. Therefore, even polyethylene of easiest crosslinked
polymer by radiation happens to deteriorate mechanical
properties by time passage after irradiation. It is because
radicals generated by irradiation do not extinct in short time,
but remain long time as free radicals in raw material and cause
to cut polymer chain by reacting with oxygen by passage time.
(Gen i-f 14)
Principle of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
If a person of ordinary skill can implement a predictable
variation,§ 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.
Id. at 41 7. It is proper to "take account of the inferences and creative steps
that a person of ordinary skill in the art would employ." Id. at 418. See also
6
Appeal2014-002989
Application 12/956,709
id. at 421 ("A person of ordinary skill is also a person of ordinary creativity,
not an automaton.").
Analysis
The Examiner finds that Yannas '957 recognizes that crosslinking of
the polymer affects the residence time of the polymer in vivo (see Final Act.
5 ("crosslinking the mixture ... , in order to achieve controlled resistance of
the cross-linked materials to resorption when used in vivo"), 8; FFI & FF2.)
The Examiner finds that "Yannas '954 expressly teaches a nexus between
cross-linking of the collagen/mucopolysaccharide mixture and in vivo
residence times of the composite material, making the connection between
greater extent of cross-linking and enhanced resistance to resorption"
(Ans. 3). The Examiner, however, acknowledges that Yannas '954 does not
exemplify "freeze-drying or lyophilization of a mixture of collagen and ...
hyaluronic acid .... nor the use of gamma-irradiation to control the extent
of cross-linking and, therefore, in vivo residence time of the implanted
composite materials" (Final Act. 6). In other words, Yannas '954 discloses
the use and application of the individual components, the reference just does
not exemplify a collagen hyaluronic acid polymer.
The Examiner finds, and Appellants do not contest, that Gen
"expressly teaches the use of chain scission through irradiation and its effect
on collagen cross-linking and, ultimately, all of the physicochemical
properties of collagen-based constructs" (Ans. 2; see App. Br. 9 ("Gen
describes that the irradiation can cut polymer chains, which deteriorates the
mechanical properties of the product")).
7
Appeal2014-002989
Application 12/956,709
We agree with the Examiner's that the ordinary artisan of ordinary
creativity familiar with the production of biopolymers for use as implants
would have known to balance between the production of the crosslinked
product with the breakdown of the crosslinkages in order to arrive at a
polymer with the desired residence time (see Ans. 3; FF1-FF7). The art
teaches that "the extent of crosslinking was known to be correlated with in
vivo residence times ... and the duration of exposure to sterilizing radiation
was recognized as affecting collapse and degradation of the polymer
materials due to cutting of the polymer chains by the radiation (e.g., chain
scission)" (Ans. 3; FF6). Applying the KSR standard of obviousness to the
findings of fact, we agree with the Examiner's conclusion:
that it would have been prima facie obvious to one of ordinary
skill in the art at the time of the invention to influence in vivo
residence times of between 4 and 20 days through control of
crosslinking via manipulating the balance between
physicochemical crosslinking and a limited breakdown of
covalent crosslinking (chain scission) through y= irradiation as
taught by Yannas '954 and Gen.
(Ans. 3, emphasis omitted). Here, the combination of references provides
the "predictable use of prior art elements according to their established
functions." KSR, 550 U.S. at 417.
We have reviewed Appellants' contentions that the Examiner erred in
rejecting the claims as obvious over the cited art (App. Br. 7-10). We
disagree with Appellants' contentions and adopt the findings, conclusions,
and responses to Appellants arguments as set forth in the Examiner's
Answer and the Final Action. For emphasis, we highlight and address the
following:
8
Appeal2014-002989
Application 12/956,709
Appellants contend that it is chain scission and only the chain scission
that determines the residence time of their crosslinked product. Specifically,
Appellants contend that the claim requires that the gamma ray
"bombardment was selectively continued for more than the duration needed
to achieve sterilization" (App. Br. 9). (App. Br. 9, see also Reply Br. 3("the
Examiner has failed to provide a suggestion or motivation why a person of
ordinary skill in the art would have performed chain scission on the
crosslinked product to increase the solubility of the crosslinked product and
thereby decrease the in-vivo residence time")).
The phrase at issue is "and further bombarding the crosslinked foam
product with gamma rays of a beam of electrons to cause chain scission and
provide the crosslinked foam product with a preselected in-vivo residence
time of between about 5 days and about 14 days" as recited in claim 1. We
understand that "further"10 can be interpreted to mean in "addition to,"
however, it could also be interpreted to mean "to a greater degree or extent"
or to "promote." "[D]uring examination proceedings, claims are given their
broadest reasonable interpretation consistent with the specification." In re
Hyatt, 211F.3d1367, 1372 (Fed. Cir. 2000). Here, the Specification does
not support Appellants interpretation that gamma ray bombardment is
separate and distinct step from the gamma ray bombardment used for
sterilization. The Specification provides that "[a ]fter crosslinking, the foam
is then ready for compression, packaging and sterilization, typically by
bombardment with gamma rays or electron beam bombardment. The
bombardment both kills bacteria and performs chain scission on the foam."
10 Definition of "further" by The Free Dictionary,
http://www.thefreedictionary.com/further, last accessed Nov. 8, 2016.
9
Appeal2014-002989
Application 12/956,709
(Spec. il 36). Specifically, the Specification explains that it is the
combination of several factors: the re-suspension shear parameters, the level
of crosslinking, and the sterilization bombardment all, contribute to the
residence time of the foam product (id. i-f 30). We find that the limitation
"and further bombarding the crosslinked foam product" is reasonably
interpreted to encompass the gamma ray bombardment required to the extent
of or to promote sterilization and does not require bombardment that is
additional to the level required for sterilization.
Based on this interpretation we agree with the Examiner that
Appellants' arguments are "not found persuasive because the extent of
crosslinking was known to be correlated with in vivo residence times
(Y annas '954, supra), and the duration of exposure to sterilizing radiation
was recognized as affecting collapse and degradation of the polymer
materials due to cutting of the polymer chains by the radiation (e.g., chain
scission)" (Ans. 3; see FF1-FF7).
We recognize, but are not persuaded by, Appellants contention that
"[t]he Examiner has failed to provide a suggestion or motivation why a
person of ordinary skill in the art would have performed chain scission on
the crosslinked product to increase the solubility of the crosslinked and
thereby decrease residence time" (Reply Br. 3). As acknowledged by the
Examiner, Yannas '954 does not disclose adjusting crosslinking in the
product using gamma radiation (Final Act. 6). The Examiner relies on the
teaching of Gen to teach that gamma radiation effects the polymer chain due
to cutting of the polymer (id.). "It is a general rule that merely discovering
and claiming a new benefit of an old process cannot render the process again
patentable." In re Woodruff, 919 F. 2d 1575, 1578 (Fed. Cir. 1990). Gen
10
Appeal2014-002989
Application 12/956,709
teaches that gamma radiation achieves both the crosslinking and cutting of
the polymer chain (FF5-FF7). Here, the old process is the use of gamma
radiation to sterilize the product, this process would also cause chain cutting
that would have an effect on the residence time of the polymer in vivo. We
agree with the Examiner's conclusion that arriving at an "in vivo residence
times of between 4 and 20 days through control of crosslinking via
manipulating the balance between physicochemical crosslinking and a
limited breakdown of covalent crosslinking (chain scission) through y-
irradiation" is obvious (Ans. 3). In other words, the in vivo residence time is
ultimately dependent on the level of crosslinking in the product regardless of
how the level crosslinking is achieved. The fact that the crosslinked end
product can be affected by multiple processes does not render any one
process less obvious over the other. We agree with the Examiner's
conclusion that it is the balance between the production of the crosslinkages
and any crosslinkage loss as a byproduct of sterilization that ultimately
determines the in vivo residence time of the final product.
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 rebuttal evidence or evidence of secondary
considerations that outweighs the evidence supporting the prima facie case.
As Appellants do not argue the claims separately, claims 2, 3, 7, 8, 11, 13,
17, 18, and 21 fall with claim 1. 37 C.F.R. § 41.37 (c)(l)(iv).
II. Obviousness over Yannas '957, Gen, Tate, and Solchaga
With respect to this rejection, Appellants rely on the same arguments
relied upon with respect to Yannas '957 and Gen, discussed above. (App.
11
Appeal2014-002989
Application 12/956,709
Br. 12; see Reply Br. 3--4.) Appellants contend that "[n]either Tate nor
Solchaga teach or suggest the use of chain scission alone or in conjunction
with controlling in vivo residence time of a bioresorbable foam" and thereby
do not make of for the deficiency of Yannas '957 and Gen, (App. Br. 11 ).
We are unpersuaded for the same the reasons discussed above, and find that
the Examiner has established a prima facie showing of obviousness with
respect to claims 1 and 13, which Appellants have failed to rebut.
Accordingly, we affirm the rejection of these claim 1, 6, 13, and 16 for the
reason set out by the Examiner in the Final Action and Answer.
III. Obviousness over Yannas '957, Gen, and Yannas '718
With respect to this rejection, Appellants rely on the same arguments
relied upon with respect to Yannas '957 and Gen, discussed above. (App.
Br. 12; see Reply Br. 3--4.) Appellants contend that "Yannas '718 does not
teach or suggest the use of chains cission alone or in conjunction with
controlling in-vivo residence time of a bioresorbable foam" and thereby do
not make of for the deficiency ofYannas '957 and Gen, (App. Br. 13). We
are unpersuaded for the same the reasons discussed above, and find that the
Examiner has established a prima facie showing of obviousness with respect
to claims 1 and 13, which Appellants have failed to rebut. Accordingly, we
affirm the rejection of these claim 1, 4, 5, 13-16 for the reason set out by the
Examiner in the Final Action and Answer.
12
Appeal2014-002989
Application 12/956,709
SUMMARY
We affirm the rejection of all claims.
TIME PERIOD FOR RESPONSE
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
13
*
*
Notice of References Cited
Documeni Number
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Document Number
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Date
MM-YYYY
Date
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Application/Control No.
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Examiner
U.S. PATENT DOCUMENTS
Name
FOREIGN PATENT DOCUMENTS
Couniry
NON-PATENT DOCUMENTS
Name
Appiicant(s)IPatent Under Patent
Appeal No.
2014-002989
Art Unit
l 1619 I Page 1 of1
Classifica1ion
Classifica1ion
* Include as applicable: Au1hor, Tille Date. Pub!isher. Edition or Volume, Pe1iinen1 Pages)
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Dates in MM-YVYY forrna.t are publication dates. Classifications n1ay be US or foreign.
U.S. Pa.tent and Trademaok Oftice
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http ://wvvw. thefreedictionary. com/further 11/8/2016
Further - definition of further by The Free Dictionary Page 6 of7
http ://wvvw. thefreedictionary. com/further 11/8/2016
Further - definition of further by The Free Dictionary Page 7of7
http ://wvvw. thefreedictionary. com/further 11/8/2016