Ex Parte Agerup

Patent Trial and Appeal Board

Jun 10, 2016

11090141 (P.T.A.B. Jun. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111090,141 03/28/2005
21839 7590 06/14/2016
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA, VA 22313-1404
FIRST NAMED INVENTOR
Bengt Agerup
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.
1003301-000135 5566
EXAMINER
FISHER, ABIGAIL L
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
06/14/2016 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):
ADIPDOC 1@BIPC.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARDgolden
Ex parte BENGT AGERUP
Appeal2014-005079
Application 11/090, 141 1
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to particles of cross-linked
hyaluronic acid. Appellant appeals from the Examiner's final rejection of all
the pending claims as obvious under 35 U.S.C. § 103 and under non-
statutory obvious-type double-patenting. We have jurisdiction under
35 U.S.C. § 134. The rejections are affirmed.
1 The application disclosure is referred to herein as the "Specification."
Appeal2014-005079
Application 11/090, 141
STATEMENT OF CASE
Claims 1-3, 8, 9, and 31-3 5 stand finally rejected by the Examiner as
follows:
1. Claims 1-3, 8, 9, and 31-35 under 35 U.S.C. § 103(a) (pre-AIA) as
obvious in view of Agerup (U.S. Patent No. 5,827,937, issued Oct. 27,
1998), Wallace '075 (U.S. Patent No. 4,803,075, issued Feb. 7, 1989), and
Berg (European Patent Application 0 402 031 A2, published Dec. 12, 1990).
Answer 2.
2. Claims 1-3, 8, 9, and 31-35 under 35 U.S.C. § 103(a) (pre-AIA) as
obvious in view of Wallace '061 (U.S. Pat. No. 6,063,061, issued May 16,
2000) and Agerup. Answer 5.2
3. Claims 1-3, 8, 9, and 31-34 on the ground ofnonstatutory
obviousness-type double patenting as obvious in view of claims 1-6 and 33
of U.S. Pat. No. 5,827,937 and Wallace '075 and Berg. Answer 8.
Appellant has not argued the claims separately. Consequently, we
choose claim 1 as representative and all the claims stand or fall with claim 1.
37 C.F.R. § 41.37(c)(iv). Claim 1 reads as follows:
2 In the Final Rejection, the Examiner did not cite Agerup in the statement of
the rejection. Final Rej. 10. However, in setting forth the basis of the
rejection, the Examiner discussed Agerup's disclosure and explained why
the combination of Wallace '061 and Agerup made the claimed subject
matter obvious to one of ordinary skill in the art. Id. at 11-12.
Consequently, it is clear that Agerup was part of the rejection and that the
Examiner unintentionally omitted it when the statement of the rejection was
made. Accordingly, we consider the omission to be harmless error.
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Application 11/090, 141
1. Particles of cross-linked hyaluronic acid, wherein:
said cross-linked hyaluronic acid is cross-linked with a polyfunctional
crosslinking agent;
said particles of cross-linked hyaluronic acid are injectable gel
particles having a size, when subjected to a physiological salt
solution, in the range of from 1.5 to 5 mm; and
said polyfunctional cross-linking agent is 1,4 butanediol
diglycidyl ether.
REJECTION 1
Claim 1 is directed to particles of cross-linked hyaluronic acid, where
the cross-linking agent is 1,4 butanediol diglycidyl ether. The particle sizes
are "in the range of from 1.5 to 5 mm."
The Examiner found that Agerup describes a gel comprising
hyaluronic acid cross-linked with "l,4-butandiol diglycidylether" which
corresponds to the claimed hyaluronic acid cross-linked with 1,4 butanediol
diglycidyl ether. Final Rej. 3. The Examiner also found that Agerup
discloses that the gels can be particles as required by claim 1. Id. at 4. See
Agerup, col. 6, 1. 51; Appeal Br. 7 ("Agerup does mention cross-linked HA
[hyaluronic acid] gel particles, but their size is not specified or discussed.)
However, the Examiner found that Agerup does not disclose the size of the
particles. Final Rej. 4.
To meet the claimed particle sizes, the Examiner cited Wallace '075
and Berg. Wallace '075 teaches making an implant material into a
particulate in order for it to be implanted by injection. Id. The Examiner
found that Berg describes a polymeric implant having a particle size which
encompasses the claimed range. Id. Specifically, Berg teaches:
The discrete polymeric bodies present in the composition of the
invention have an average outside diameter of from about 0.005
to 0.20 inch (0.27 to 5.08 mm.). Thus they are large enough to
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Application 11/090, 141
avoid undesirable migration from the site of injection, which
was serious problem with the microparticles, for example
PTFE, used in the prior art.
Berg 3: 42--45.
In a particularly preferred embodiment of the invention the
bodies are deformable macrodisks having an average outside
diameter of from about 0.01 to 0.085 inch (0.254 to 2.159
mm.). Macrodisks having an average diameter at the upper end
of the stated range, with a few even as large as 0.10 inch (2.54
mm.) in diameter, may be injected through an l 8ga needle
(internal diameter 0.034 inch (0.884 mm.)) with no apparent
macrodisk damage.
Id. at 3: 47-51.
Berg explained why the particle size was advantageous: "Thus they
are large enough to avoid undesirable migration from the site of injection,
which was [a] serious problem with the microparticles, for example PTFE,
used in the prior art." Id. at 3: 43--45. See Final Rej. 4.
Based on these teachings, the Examiner found the skilled worker
would have had reason to select the claimed particle size range because
Berg teaches that microparticles (i.e. particles with a smaller
diameter than 0.127 to 5.08 mm) are known to migrate away
from the site of injection which is undesirable. Therefore, in
order to prevent this undesirable migration it would have been
obvious to one of ordinary skill in the art to utilize larger
particle size injectable material as taught by Berg.
Id. at 5.
The Examiner recognized that Berg's ranges were not identical to
those which are claimed, but concluded "where the claimed ranges 'overlap
or lie inside ranges disclosed by the prior art' a prima facie case of
obviousness exists. See MPEP 2144.05 [R-5]." Id.
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Application 11/090, 141
Appellant, who is also the inventor of the cited Agerup publication,
argues that the Examiner erred in rejecting the claims over Agerup, Wallace
'075, and Berg. First, Appellant contends Berg is not relevant because
Berg's particles are not made of hyaluronic acid. Appeal Br. 8. Second,
Appellant contends that the particle range in Berg is so broad that it would
not have been obvious to have optimized it to have arrived at the claimed
range. Id. at 8-9. Third, Appellant contends that Wallace '075 is not
pertinent because its particle size is different and hyaluronic acid is used as
lubricant not as a particle. Id. at 7. Appellant also contends that the claimed
range exhibits unexpected and superior results which establish the non-
obviousness of the claimed subject matter. Id. at 9-10. We address each of
these issues below.
Are Berg and Wallace '075 relevant to Agerup?
Appellant attempts to distinguish Wallace '075 because the particles
in Wallace '07 5 are not made of hyaluronic acid, but rather are made of a
different material and the hyaluronic acid is used as a lubricant. Appeal Br.
7.
Appellant's characterization of Wallace '075 as using hyaluronic acid
as lubricant is supported by the evidence. However, the Examiner relied on
Wallace '075 for the teaching that, when implant material for tissue
augmentation is injected into a mammalian subject, the material must be
particulate. Final Rej. 4. Appellant has not identified a reason why this
teaching would be inapplicable when the particles are made of hyaluronic
acid as taught by Agerup.
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Application 11/090, 141
Appellant also argues "Berg is not appropriate to use in an
obviousness rejection at least because it does not at all relate to particles of
cross-linked HA." Appeal Br. 8. Appellant contends Berg is non-analogous
art because it relates "non-biodegradable materials, such as
polyacrylonitrile." Id.
Prior art which is pertinent to the claimed invention is referred to as
"analogous" prior art. It is well-established that there are two criteria to be
applied when determining whether a reference is analogous prior art: ( 1)
whether the reference is from the "same field of endeavor" as the claimed
invention, and (2) if the reference is not within the same field of endeavor,
"whether the reference still is reasonably pertinent to the particular problem
with which the inventor is involved." In re Clay, 966 F.2d 656, 658-59
(Fed. Cir. 1992). When neither criterion is met from the perspective of a
person having ordinary skill in the art, the reference is deemed "non-
analogous" and is not considered pertinent to the § 103 determination.
In this case, the Specification describes its invention as concerning
soft tissue augmentation in a mammal. Spec. 1: 3-7. The Specification
teaches utilizing viscoelastic medium for tissue augmentation, where the
medium is in the form of injectable particles. Id. at 4: 1-6. Berg relates to
the "same field of endeavor" because it also teaches tissue augmentation.
Specifically, Berg describes its invention as "concerned with a process for
preparing said composition and to a method for treating a tissue condition,
particularly for tissue augmentation, by injecting said composition into the
site of said condition." Berg 1: 2--4. While it may be true that the claims are
drawn to the biodegradable hyaluronic acid, and Berg's material is non-
degradable, both the Specification and Berg are concerned with the same
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Application 11/090, 141
problem of tissue augmentation, but solve the problem using different
particles. Consequently, the field of endeavor-tissue augmentation with
particles-is the same and the evidence supports the Examiner's
determination that Berg is analogous art to the claimed subject matter.
Particle size
The claimed range is from 1.5 to 5 mm. Berg teaches a range of 0.27
to 5.08 mm (Berg 3: 42-45) and preferred range of 0.254 to 2.159 mm (id. at
3: 47-51).
Appellant contends that the range disclosed in Berg "is so broad that it
encompasses a very large number of possible distinct combinations, which
under any circumstance makes the claimed range of 1.5-5 mm a selection
invention, analogous to the non-obviousness of a species when the prior art
broadly discloses a genus." Appeal Br. 8.
The claimed range falls within Berg's broader range, and overlaps
with Berg's narrower range. When there is a range disclosed in the prior art,
and the claimed invention overlaps or falls within that range, 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). Consequently, the Examiner properly found that the claimed
range would have been obvious to one of ordinary skill in the art.
The upper bound of Berg's broadest range touches near the endpoint
of the claimed range (5.08 versus 5), and the endpoint of Berg's preferred
range falls close to the middle of the claimed range (2.159 versus 5). As
held in Peterson, there is a "normal desire of scientists or artisans to improve
upon what is already generally known." Peterson, 315 F.3d at 1329-1330.
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Berg provides a reason to improve or optimize its range, when particles of a
different material are utilized, i.e., the particle must be "large enough to
avoid undesirable migration from the site of injection, which was serious
problem with the microparticles, for example PTFE, used in the prior art."
Berg 3: 43--46. Consequently, one of ordinary skill in the art, utilizing the
hyaluronic particles of Agerup, would have had reason to optimize the
particles to achieve a suitable size as taught by Berg to avoid migration from
the injection site.
Unexpected results
When ranges overlap, touch, or fall within a prior art range, it
generally must be shown "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).
To rebut the obviousness presumption, Appellant provided a
declaration by Katrina L.M. Edsman, Ph.D. (dated Aug. 20, 2010). Dr.
Edsman produced hyaluronic particles of different sizes. Edsman Deel. 3
("Material and Methods"). Dr. Edsman did not disclose in this declaration
whether the particles had been cross-linked as required by claim 1. Dr.
Edsman determined the cohesion between the particles. Id. at 2-3. Two
experiments are described in the declaration.
In Experiment 1, utilizing particles less than the claimed endpoint of
1.5 mm, Dr. Edsman found the "cohesion was larger for the larger particles,
i.e., more work is required for the particles to move relative to each other."
Id. at 4. Dr. Edsman concluded: "If more work is required for the particles
to move relative to each other in an implant the implant will more easily
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Application 11/090, 141
keep its shape and the particles in the implant will not as easily be
displaced." Id.
In Experiment 2, Dr. Edsman tested a larger variation in particle size,
including 2 particle sizes less than the claimed endpoint of 1.5 mm and 2
particle sizes greater than the claimed endpoint of 1.5 mm. See Fig. 4 of
Edsman Deel. Dr. Edsman concluded:
it is evident that the work of cohesion was considerably larger
for particles with a mean size well above 1.0 mm, whereas no
or little increase in work of cohesion was observed when the
mean size was increased from approximately 0.4 mm to
approximately 0.8 mm.
Id. at 6.
Dr. Edsman's declaration is insufficient to establish the nonobvious of
the claimed invention.
First, Dr. Edsman does not make a statement that the results were
unexpected or surprising. Under In re Soni, 54 F.3d 746, 750 (Fed. Cir.
199 5), a showing of "unexpected results" can be used to demonstrate the
non-obviousness of the claimed invention. Those results must be "surprising
or unexpected" to one of ordinary skill in the art when considered in the
context of the closest prior art. Id. ("One way for a patent applicant to rebut
a prim a 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."). "[W]hen an applicant demonstrates
substantially improved results, as Soni did here, and states that the results
were unexpected, this should suffice to establish unexpected results in the
absence of evidence to the contrary." Id. at 751. The requirement that a
statement be made that the results are "unexpected" to one of ordinary in the
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Application 11/090, 141
art is not a hypertechnicality of the law. Rather, the statement ensures that
one of ordinary skill in the art evaluated the results in the context of the
relevant cited prior art and concluded the results to be "unexpected" and
unobvious.
In summing up her results, Dr. Edsman stated:
The larger work of cohesion for particles with a mean size well
above 1.0 mm implies that these larger particles will be more
cohesive, which in tum suggests that the injected material will
be more prone to keep its desired shape in the body. In addition,
large particles size promotes diminishing displacement of the
implant and facilitating removal of the implant.
Edsman Deel. 6.
Dr. Edsman's conclusion is not new. Berg teaches that larger sized
particles are more desirable in tissue implants. We have already quoted
Berg's teaching on this point, but we do so again:
The discrete polymeric bodies present in the composition of the
invention have an average outside diameter of from about 0.005
to 0.20 inch (0.27 to 5.08 mm.). Thus they are large enough to
avoid undesirable migration from the site of injection, which
was serious problem with the microparticles, for example
PTFE, used in the prior art. However, because of the
deformability characteristic described hereinabove, they are still
small enough to be injectable without undergoing irreversible
damage.
Berg 3: 42--46.
Berg thus expressly teaches that large particles are advantageous
because they "avoid undesirable migration from the site of injection" which
was a problem with smaller sized particles. Dr. Edsman made the same
conclusion: "large particles size promotes diminishing displacement of the
implant." The Specification similarly states "[t]he invention is based on the
finding that subepidermal administration of an implant comprising gel
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Application 11/090, 141
particles made of a viscoelastic medium which are considerably larger than
previously used in implants made of viscoelastic media are useful in
avoiding migration and/or displacement of the implant." Spec. 4:7-12. In
sum, the statements about the advantages of larger sized particles that appear
in the Edsman Declaration, and in the Specification, cannot form the basis of
patentability because Berg had already made these observations. The
claimed range falls within Berg's broad range, and overlaps with Berg's
narrower range, both described by Berg to avoid the "undesirable
migration."
Appellant argues in the Reply Brief that it is not only the particle size
"which promotes diminishing displacement and facilitates removal of the
implant, but it is the concomitant and unexpected cohesive behavior of the
cross linked HA gel particles in the claimed size range which prevents
displacement." Reply Br. 4.
We have not been directed to a statement by Dr. Edsman that the
cohesive properties reported in her experiments are a result of using
"crosslinked HA gel particles." Dr. Edsman did not provide experimental
evidence that the HA particles contributed to the adhesion, rather than the
particle size. For example, Dr. Edsman did not compare the cohesive
properties of the hyaluronic acid particles to particles of the same size, but
made of the material described in Berg. To establish unexpected results, the
claimed subject matter must be compared with the closest prior art. In re
Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Because a
comparison was not performed, there is insufficient evidence that it was the
hyaluronic acid properties that contributed to the results observed by Dr.
Edsman, rather than particle size as taught by Berg.
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For the foregoing reasons, we affirm the rejection of claim 1 as
obvious. Claims 2, 3, 8, 9, and 31-35 were not separately argued and fall
with claim 1. See 37 C.F.R. § 41.37(c)(iv).
REJECTION 2
The Examiner cited Wallace '061 for describing a hydrogel
comprising cross-linked polysaccharides, such as glycosaminoglycan, for
delivery to tissue and having subunit sizes of 0.5 to 5 mm. Final Rej. 11.
The Examiner acknowledged that Wallace '061 does not disclose hyaluronic
acid cross-linked with 1,4 butanediol diglycidyl ether as required by claim 1.
Id. However, the Examiner found that Agerup describes these components.
Id. at 11-12. The Examiner found that it would have been obvious to have
utilized Agerup's hyaluronic acid in Wallace '061 because it is a
glycosaminoglycan which Wallace '061 teaches as useful for its hydrogel.
Id. at 12. With respect to the particle size, the Examiner found that Wallace
'061 discloses sizes which overlap with the claimed amount. The Examiner
concluded "where the claimed ranges 'overlap or lie inside ranges disclosed
by the prior art' a prima facie case of obviousness exists. See MPEP
2144.05 [R-5] ." Id. at 13.
Appellant attempts to distinguish the claimed subject matter by
arguing the cited publications separately, stating that Wallace '061 is
deficient because it doesn't disclosed the claimed cross-linked hyaluronic
acid. Appeal Br. 13. However, the Examiner provided a fact-based reason
for utilizing hyaluronic acid in Wallace '061. Final Rej. 11-13. Appellant
has not identified a persuasive error in the Examiner's reasoning. Appellant
also contends the claims are unobvious because of unexpected results as
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discussed in the Edsman declaration. Appeal Br. 14. As discussed, we
considered Dr. Edsman's experiments but did not find them to persuasively
establish the nonobviousness of the claimed subject matter.
For the foregoing reasons and those of the Examiner, we affirm the
rejection of claim 1 as obvious. Claims 2, 3, 8, 9, and 31-35 were not
separately argued and fall with claim 1. See 37 C.F.R. § 41.37(c)(iv).
REJECTION 3
Appellant makes the same unpersuasive arguments for the obvious-
type double patenting rejection as for the rejection over Agerup, Wallace
'075, and Berg. We affirm the rejection for the reason set forth by the
Examiner and as discussed above.
SUMMARY
We affirm the rejection of claim 1 as obvious as stated in Rejections
1, 2, and 3. Claims 2, 3, 8, 9, and 31-35 fall with claim 1 because separate
reason for their patentability were not provided.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv).
AFFIRMED
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