Ex Parte Eloy et al

Patent Trial and Appeal Board

Mar 14, 2017

14006745 (P.T.A.B. Mar. 14, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/006,745 11/12/2013 Rosy Eloy 1003301-000473 2890
21839 7590 03/16/2017
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA, VA 22313-1404
EXAMINER
TCHERKASSKAYA, OLGA V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
03/16/2017 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):
ADIPDOCl@BIPC.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROSY ELOY and ANDERS KARLSSON1
Appeal 2016-001680
Application 14/006,745
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a combination product comprising at least one filler
product. Claims 22-45 are on appeal as rejected under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 We understand the Real Party in Interest to be GALDERMA RESEARCH
& DEVELOPMENT. App. Br. 2.
Appeal 2016-001680
Application 14/006,745
STATEMENT OF THE CASE
The Specification discloses:
The present invention relates to compositions for parenteral
application, comprising, in a physiologically acceptable medium,
at least one filler product and at least one bioresorbable and
biodegradable silica-based material. The invention also relates
to the use of these compositions for tissue augmentation, for both
therapeutical and cosmetical purposes. Preferentially, the
composition is used for treating incontinence, or aging of the
skin, in particular for treatment of wrinkles and fine lines,
fibroblast depletions, skin dehydration and scars of all types.
Spec. 1:4—10.
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claim 22 is the sole independent claim, is representative, and
reads as follows:
22. Combination product comprising at least one filler product,
which is cross-linked hyaluronic acid or a derivative thereof, and
at least one bioresorbable and biodegradable silica-based
material in the form of particles.
App. Br. 20 (Claims App’x. page 1).
The following rejection is on appeal:
Claims 22^45 stand rejected under 35 U.S.C. § 103(a) over Sadozai,2
Koskinen,3 and Lvov.4 Final Action 15.
2 U.S. Patent No. US 6,548,081 B2 (issued Apr. 15, 2003 to Sadozai et al.)
(hereinafter “Sadozai”).
3 U.S. Patent Application Pub. No. US 2009/0104245 Al (published Apr.
23, 2009) (hereinafter “Koskinen”).
4 U.S. Patent Application Pub. No. US 2011/0038939 Al (published Feb. 17,
2011) (hereinafter “Lvov”).
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FINDINGS OF FACT
Except where otherwise indicated, we adopt the Examiner’s findings
of fact, reasoning on scope and content of the prior art, and conclusions set
out in the Final Action and Answer. The facts set out below highlight
certain evidence.
FF1. Sadozai discloses “a composite and a method for reducing
post-operative adhesion of tissues [or a drug delivery vehicle]. The
composite includes a biocompatible, biodegradable support, and a
water-insoluble hyaluronic acid derivative at the support.” Sadozai
abstract; see also Final Action 2—4, 6—8, and Ans. 4—9 (discussing
Sadozai).
FF2. Sadozai discloses:
This invention has many advantages. For example, it provides a
post-operative adhesion barrier that is at least substantially
resorbable . . . [and] [a] further advantage is that it can supply
modified HA [hyaluronic acid] in a sustained release manner
over a prolonged period of time [and] a drug delivery system
which can be easily injected or implanted at a particular site,
where it provides sustained release of the drug.
Sadozai 2:60-3:3; see also Final Action 2-4, 6—8, and Ans. 4—9
(discussing Sadozai).
FF3. Sadozai discloses “[a]n embodiment of a composition of the
invention includes at least two components: a biocompatible,
biodegradable support and a derivative of HA that includes an N-
acylurea resulting from cross-linking” and “[e]xamples of the physical
form of a suitable support include: a biocompatible, biodegradable
matrix, sponge, film, mesh, and a composite of particles which may
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be in the form of beads.” Sadozai 4:10-13; see also Final Action 2—4,
6—8, and Ans. 4—9 (discussing Sadozai).
FF4. Sadozai discloses “[a] suitable support may be a matrix,
sponge, film, or particles such as beads, which may be porous . . .
porous beads may be soaked in the hyaluronic acid derivative for a
sufficient period of time to allow the hyaluronic acid derivative to be
absorbed and adsorbed by the pores of the beads.” Sadozai 8:5—12;
see also Final Action 2—4, 6—8, and Ans. 4—9 (discussing Sadozai).
FF5. Sadozai discloses “[tjhese composites provide a sustained
source of derivatized HA at the surgical site as the composite
biodegrades and is absorbed by the tissues.” Sadozai 8:64—66; see
also Final Action 2-4, 6—8, and Ans. 4—9 (discussing Sadozai).
FF6. Sadozai discloses augmenting tissue in that it teaches “[t]he
composite structure can be used as a surgical aid to separate healing
tissues or to prevent post-operative adhesion. . . . This swollen
composite, placed between or among the tissues, keeps the healing
tissues separated from each other and maintains the said separation
during the healing process.” Sadozai 9:42—50; see also Final Action
2—4, 6—8, and Ans. 4—9 (discussing Sadozai).
FF7. Koskinen discloses “[a] biodegradable carrier is produced
for preservation and/or controlled delivery of biologically active
agents where said biodegradable carrier is a silica xerogel.” Koskinen
abstract; see also Final Action 3—4, 6—8, and Ans. 4—9 (discussing
Koskinen).
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FF8. Koskinen discloses “[sjilica sol-gel technology is
economical and easy to use. Silica products are usually biocompatible
and non-toxic.” Koskinen | 8; see also Final Action 3—4, 6—8, and
Ans. 4—9 (discussing Koskinen).
FF9. Koskinen discloses “silica xerogel material can be
pharmacologically acceptable so that it can be used in pharmaceutical
preparations as e.g. monoliths, cones, fibers, webs or multiparticles
(particle size e.g. 1 nm-100 pm), or as coating material for different
types of implants, such as urethral and vascular stents.” Koskinen
115; see also Final Action 3—4, 6—8, and Ans. 4—9 (discussing
Koskinen).
FF10. Koskinen discloses:
The material can be used as a medicine and it can be used for the
manufacture of a medicine. This material can be used for
neurological, oncological and tissue repair applications. These
applications include for example cardiovascular therapy,
diabetes therapy, arteritis therapy, wound repair, bone lesion
repair and treatment of osteoporosis. Thus, the material can be
used to treat neurological, oncological and/or tissue illness.”
Koskinen 129; see also Final Action 3—4, 6—8, and Ans. 4—9
(discussing Koskinen).
FF11. Lvov discloses “[sjtable colloid nanoparticles.” Lvov
abstract; see also Final Action 4—6, and Ans. 4—9 (discussing Lvov).
FF12. Lvov discloses “[a] nanoparticle as described herein can
contain many types of compounds, such as therapeutic drugs or
agents. Such therapeutic agents can be, but are not limited to,
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Application 14/006,745
steroids, analgesics, local anesthetics . . . Lvov 179; see also Final
Action 4—6, and Ans. 4—9 (discussing Lvov).
FF13. Lvov discloses that nanoparticles can include layers of
“biodegradable and/or biocompatible polymers” including, inter alia,
“cross-linked hyaluronic acid.” Lvov H 83—84; see also Final Action
4—6, and Ans. 4—9 (discussing Lvov).
FF14. Lvov discloses “[i]n some instances, a nanoparticle
described herein is administered locally” including “by injection.”
Lvov 1110; see also Final Action 4—6, and Ans. 4—9 (discussing
Lvov).
FF15. Lvov discloses “[a] nanoparticle described herein is
formulated as a pharmaceutical composition that includes a suitable
amount of a physiologically acceptable excipient,” which can include,
inter alia, “silica gel.” Lvov 1116; see also Final Action 4—6, and
Ans. 4—9 (discussing Lvov).
DISCUSSION
We conclude that the Examiner has established a prima facie case that
the claims would have been obvious over Sadozai, Koskinen, and Lvov.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner’s determination of obviousness is incorrect. Only those
arguments made by Appellants in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015). We address Appellants’ arguments below.
Appellants argue the cited prior art combination is improper because
the invention is useful for “tissue augmentation.” App. Br. 4. Appellants
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argue the prior art did not recognize the problem addressed by the invention
and cannot provide the advantages provided by the invention. Id. 5—7. This
argument is not persuasive.
“In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under § 103.” KSR Int 7 Co. v.
Teleflex Inc., 550 U.S. 398, 419 (2007). “The combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.” Id. at 416. “[Wjhen the question is
whether a patent claiming the combination of elements of prior art is
obvious,” the answer depends on “whether the improvement is more than the
predictable use of prior art elements according to their established
functions.” Mat417.
Here, Sadozai is focused on medical devices for supporting proper
tissue healing that comprise cross-linked hyaluronic acid and a support
structure. FF1—FF3. Sadozai teaches that the support structure can be a
particle and that the hyaluronic acid can be coated thereover. FF3—FF4.
Sadozai teaches that in such a form, its structures provide drugs or
hyaluronic acid to tissue in need thereof or can swell to maintain desired
tissue separation to encourage proper tissue healing. FF5—FF6. Although
Sadozai discloses a considerable list of materials that may be used for its
support structure (cf. App. Br. 12—13), Koskinen discloses that silica is
economical and easy to use, which provides strong motivation to use the
material, as well that it is biocompatible and non-toxic, which are
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requirements of the support structure of Sadozai and suggest that the
combination would be successful. FF7—FF8; see also Final Action 8 and
Ans. 4 (explaining the Examiner’s rationale for motivation to combine these
references and the intended structure resulting from the combination).
Moreover, Koskinen’s devices are disclosed as useful for similar purposes as
the devices of Sadozai (FF9), which indicates that one could reasonably
expect their combination to be successful. Furthermore, Sadozai teaches a
tissue adhesion barrier (FF2), providing hyaluronic acid to be absorbed by
tissues (FF5), and surgical aids to separate healing tissue upon application
and swelling (FF6), while Koskinen teaches tissue repair applications,
wound repair, and treatments for tissue illness (FF10), which can all be
considered therapeutic tissue augmentation. Cf, e.g., Spec. 1:6—7, 1:12—13,
8:32-34.
Appellants argue one of skill in the art would not combine Koskinen,
Lvov, and Sadozai to achieve the claimed invention because doing so would
require replacing the hyaluronic acid coating of Sadozai with the silica gel of
Koskinen if one wanted drug delivery (because these are the drug delivering
components disclosed, respectively). App. Br. 8. Similarly, Appellants
argue combining the silica gel of Koskinen with Sadozai would render
Sadozai inoperable because the hyaluronic acid is essential to Sadozai’s
structures. App. Br. 9. These arguments are not persuasive.
As discussed above, the Examiner has identified that the skilled
artisan would combine the silica of Koskinen with Sadozai’s structures as a
support for the hyaluronic acid because it is economical, easy to use,
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biodegradable, and non-toxic. See, e.g., Ans. 4. Therefore, Appellants’
arguments are not persuasive.
Appellants argue the claimed invention provides unexpected results,
citing Example 3 in the Specification. App. Br. 10; Spec. 14—15. This
argument is not persuasive.
The Specification’s Example 3 compares the invention to cross-linked
hyaluronic acid gel alone and finds the invention “was easily palpable as
harder,material [sic] while the hyaluronic acid gel of reference was more
soft.” Spec. 15:7—8. Why such a trait is unexpected, what the closest prior
art may be, and what was expected of the invention are not explained by
Appellants’ evidence.
“[A]n unexpected result or property does not by itself support a
finding of nonobviousness.” Bristol-Myers Squibb Co. v. leva Pharms.
USA, Inc., 752 F.3d 967, 976 (Fed. Cir. 2014) (citing In re Dillon, 919 F.2d
at 693, 697, where “additional unexpected properties [] did not upset an
already established motivation to modify a prior art compound based on the
expected properties of the resulting compound”). “[B]y definition, any
superior property must be unexpected to be considered evidence of non­
obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir.
2007). “To be particularly probative, evidence of unexpected results must
establish that there is a difference between the results obtained and those of
the closest prior art, and that the difference would not have been expected by
one of ordinary skill in the art at the time of the invention.” Bristol-Myers
Squibb, 752 F.3d at 977. Further, the “evidence [of unexpected results] must
fail [if] the record is devoid of any evidence of what the skilled artisan
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would have expected,” as the Federal Circuit refused to make any
presumptions on the issue. Pfizer, 480 F.3d at 1371. Appellants’ evidence
fails in these requirements.
Appellants separately argue claim 23 is patentable in that it recites
particles ranging from 50 to 250 microns. App. Br. 11. Appellants argue
Koskinen’s particles having a size of 1 nm to 100 microns do not make the
claimed range obvious as there is no reason to modify them to be the
claimed size range. Id. 11—12. This argument is not persuasive.
“A prima facie case of obviousness typically exists when the ranges
of a claimed composition overlap the ranges disclosed in the prior art.” In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). This is the circumstance
here, where there is a substantial overlap in particle size range between the
prior art and the claim.
Appellants separately argue claim 24 is patentable in that it recites the
cross-linked hyaluronic acid filler is in the form of particles. App. Br. 13.
This argument is not persuasive.
Each of the cited prior art references in the Examiner’s combination
discloses particles and, in the case of Sadozai and Lvov, those particles
include hyaluronic acid. FF3, FF4, FF9, FF13. Thus, the claim element is
disclosed by and obvious over the prior art combination.
Appellants separately argue claims 32 and 33 are patentable in that
they recite “methods of augmenting tissue,” which is not taught in the prior
art combination. App. Br. 15. This argument is not persuasive.
As discussed, supra, Sadozai teaches a tissue adhesion barrier (FF2),
providing hyaluronic acid to be absorbed by tissues (FF5), and surgical aids
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to separate healing tissue upon application and swelling (FF6), while
Koskinen teaches tissue repair applications, wound repair, and treatments for
tissue illness (FF10), which can all be considered therapeutic tissue
augmentation. Cf., e.g., Spec. 1:6—7, 1:12—13, 8:32—34. Therefore, the
claim element is disclosed by and would have been obvious over the prior
art.
SUMMARY
The rejection of claims 22^45 under 35 U.S.C. § 103(a) is affirmed.
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
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