Ex Parte Mithieux et al

Patent Trial and Appeal Board

Jan 28, 2019

14347512 (P.T.A.B. Jan. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/347,512 03/26/2014
24353 7590 01/30/2019
BOZICEVIC, FIELD & FRANCIS LLP
Bozicevic, Field & Francis
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
FIRST NAMED INVENTOR
Suzanne Marie Mithieux
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.
FREE-015 1064
EXAMINER
DABKOWSKI, ERINNE R
ART UNIT PAPER NUMBER
1654
NOTIFICATION DATE DELIVERY MODE
01/30/2019 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SUZANNE MARIE MITHIEUX and
ANTHONY STEVEN WEISS 1
Appeal2018-003696
Application 14/347,512
Technology Center 1600
Before ERICA A. FRANKLIN, JAMES A. WORTH, and
ROBERT A. POLLOCK, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 2-9 and 14--20. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
According to the Specification, "[a]geing and tissue injury are
associated with degeneration of the extracellular matrix leading to loss of
tissue structure and/ or function. Loosened skin, relaxed subcutaneous tissue,
loss of density of the extracellular matrix, wrinkling, stretch marks and
1 Appellants identify the Real Party in Interest as Elastagen Pty Ltd. App.
Br. 3.
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Application 14/347,512
fibrosis are the physical manifestations of the degeneration." Id. at 1.
"About 20 years ago, the research effort sought to use the various molecules
of the extracellular matrix in a range of clinical and cosmetic interventions
for correcting loss of tissue structure and function." Id. "Elastin was
considered by some as advantageous for this work because . . . it could be
used to form elastic implants and fillers. The early work focused on
synthesis of recombinant forms of tropoelastin which would then be
coacervated and chemically or enzymatically cross linked, either before or
after delivery to an individual, so that an elastic implant or filler would be
formed either ex vivo or in vivo for filling tissue voids or for augmenting or
re-shaping tissue." Id. But "while an implant with elastic properties could
be provided to tissue, the nature of the implant and its elastic properties was
not suggestive of that normally ascribed to the tissue .... [ And] while
elasticity could be imparted to a tissue by the implantation of a material with
properties that include elasticity, a return to a physical appearance or
function resembling normal could not." Id. at 3.
"The initiation of a process that is like elastogenesis (i.e. one whereby
the tissue synthesises an elastic fiber de nova from a common set of factors)
in adult tissue is a desirable goal because it is believed that such a process
would restore an elastic profile to a tissue." Id. "The widely considered
hypothesis for explaining the absence of elastic fiber formation de nova in
an adult is that adult cells or the relevant tissue in which they are contained
lack one or more of the necessary factors and processes required for
elastogenesis." Id. "It follows that the provision of tropoelastin alone to
adult tissue should not in itself be sufficient to restore the elastic profile of
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the tissue, because without the relevant factors required for elastogenesis,
the tissue cannot utilise the tropoelastin to form an elastic fiber." Id. at 5.
Appellants disclose an assay system that uses adult human cells to
form elastic fiber in vitro. Id. at 11. Appellants report that "repeat
administration of tropoelastin to the system demonstrates an ongoing
capacity to form elastic fiber, indicating that the tropoelastin is the limiting
factor to elastic fiber formation." Id. at 12. According to Appellants,
subsequent clinical trial data "establishes the importance of maintaining
tropoelastin in tissue for enough time for cells to engage with the
tropoelastin." Id. In light of these findings, Appellants disclose "methods of
restoring elasticity in tissue using tropoelastin containing compositions." Id.
at Abstract, 14--17. The disclosed methods include "administering
tropoelastin to the individual according to a treatment regime that has been
selected to maintain the administered tropoelastin in the tissue for a period
of time that enables factors expressed in the tissue for formation of an elastic
fiber to engage with the administered tropoelastin for synthesis of elastic
fiber therefrom." Id. at 6.
Claim 20, the sole independent claim before us, recites:
20. A method of restoring the elastic profile of skin tissue of
an individual, the method including the following steps:
- providing an individual in whom restoration of elastic profile
of skin tissue is required;
- defining a treatment area on the skin of the individual,
wherein the treatment area is an area of skin in which the elastic
profile is to be restored;
- injecting a tropoelastin composition having a concentration of
0.5 mg/ml to 200 mg/ml tropoelastin into skin tissue in a
volume of 10 µl to 100 µl within the treatment area to enable
elastic fiber formation in the treatment area;
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wherein the tropoelastin composition is injected into skin
tissue within the treatment area according to a
predetermined treatment schedule, to establish an amount
of tropoelastin within the treatment area that is increased
relative to skin outside the treatment area, said treatment
schedule defining a specified number of treatments, each
treatment in the form of an injection at a specified time
point; and
wherein at least one treatment of the treatment schedule
includes multiple injections, each injection made at an
injection site that is spaced apart from other injection
sites by a predetermined distance,
- thereby maintaining an amount of tropoelastin within the
treatment area for a predetermined period of time over the
treatment schedule to enable elastic fiber formation and thereby
restoring the elastic profile in the skin of the individual.
The Examiner rejects claims 2--4, 6-9, and 14--20 under pre-AIA 35
U.S.C. § I03(a) as unpatentable over the combination ofWeiss, 2 Benedicte
Le Bris, 3 and Smith. 4 Fin. Rej. 5-16.
The Examiner rejects claims 2-9 and 14--20 under pre-AIA 35 U.S.C.
§ I03(a) as unpatentable over the combination of Weiss, Benedicte Le Bris,
Smith, Guillen, 5 and Sommer-Knudsen. 6 Id. at 16-17.
We have reviewed Appellants' contentions that the Examiner erred in
rejecting claims 2-9 and 14--20 as obvious over the cited art. App. Br. 5-14.
2 Weiss et al., WO 2010/102337 Al, published Sept. 16, 2010.
3 Le Bris, et al., WO 2009/034559 A2, published Mar. 19, 2009.
4 S. Smith et al., Duration of wrinkle correction foil owing repeat treatment
with Juvederm hyaluronic acid fillers, 301 Arch Dermatol Res. 757-762
(2010).
5 Guillen et al., US 2011/0229574 Al, published Sept. 22, 2011.
6 Sommer-Knudsen, US 2013/0296528 Al, published Nov. 7, 2013.
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Because Appellants do not argue the claims individually, we focus our
discussion on independent claim 20. We also focus on the rejection in view
of Weiss, Benedict Le, and Smith because Appellants make no additional
substantive argument with respect to the remaining references. See App. Br.
13-14 (arguing that Smith, Guillen, and Sommer-Knudsen "fail to remedy
the deficiencies of Weiss, Benedicte Le Bris and Smith").
We disagree with Appellants' contentions and adopt the findings
concerning the scope and content of the prior art set forth in the Examiner's
Answer and the Final Rejection dated March 9, 2017. For emphasis, we
highlight and address the following:
FINDINGS OF FACT
FF 1. Weiss discloses "an injectable composition formed from tropoelastin,
the composition including a tropoelastin-containing substance, wherein
the substance further includes an agent in an amount effective for
providing the substance with properties of flow enabling injection of the
composition." Weiss at 2; see id. at 37, claim 34. According to Weiss,
"when tropoelastin is coacervated and cross linked to form elastin, and/ or
subjected to alkali polymerisation to form an elastic material ... at high
solids content of tropoelastin, a mass is formed that cannot be passed
through a surgical needle." Id. at 4. However, "formation of the
noninjectable mass at high solids content of tropoelastin may be reduced,
if not avoided, by coacervating or polymerising tropoelastin in the
presence of a coalescence-controlling agent, resulting in formation of a
composition having high solids content and properties of flow required in
an injectable composition." Id. at 4--5. "The coalescence-controlling
agent generally increases the viscosity of the liquid phase in which
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coacervation or polymerisation of tropoelastin to form elastin or an
elastic material occurs." Id. at 7; see id. at 10-14 ( describing properties
and examples of coalescence-controlling agents).
FF2. Weiss teaches intradermal, intracutaneous and/or subcutaneous
injection of a tropoelastin composition to correct a tissue defect, ie., to
"provide a bulking or filling effect, reducing the appearance of wrinkles
or folds." Id. a 20. Weiss further defines "correcting a tissue defect' as
"refer[ing] to at least partially restoring and/or augmenting tissue
structure and/ or function, including supporting, enhancing, bulking, or
elasticising tissue, or facilitating tissue growth into a tissue defect." Id. at
8. The injected composition includes tropoelastin "in an amount from
about 1.5 mg/ml to about 400 mg/ml. Preferably ... in an amount of
about 10 mg/ml to about 200 mg/ml." Id. at 9. "Typically, the
composition is administered at the site of the tissue defect by injection ..
. . [ and] may be administered over a number of treatments to correct the
tissue defect and/or to achieve or maintain the desired result." Id. at 20-
21.
FF 1. Benedict Le Bris teaches mesotherapy "for aesthetic and/ or
repairing treatment of the skin," including the treatment of wrinkles
and fine lines. Benedict Le Bris, Abstract, 20:7-8. "Mesotherapy is a
treatment technique by intra-epidermal and/or intradermal and/or
subcutaneous injection of active product(s), for instance
micronutrients, vitamins and/or hyaluronic acid. The compositions
are administered according to this technique by injection in the form
of small multiple droplets into the epidermis, the dermo-epidermal
junction and/or the dermis in order especially to perform
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subcutaneous layering." Id. at 4, 19-23; see claims 1, 10-12. The
droplets may be injected via syringe or injection pistol and
"[a]dvantageously ... have an average volume ranging from 0.01 to
0.2 ml and in particular from 0.05 to 0.15 ml ... [and] may be
performed over several sessions spaced apart by a few days, for
example 1, 2, 3, 4, 5 or 6 days to a few weeks, for example 1, 2, 3 or 4
weeks." Id. at 19: 18-20: 19. "The injection points may be spaced
apart, for example, by a distance ranging from 5 mm to 1 cm." Id. at
20:20-24.
FF 1. Smith discloses a study of the effectiveness of repeat injections
of Juvederm hyaluronic acid fillers for the treatment of severe
nasiolabial folds (smile lines). See Smith, Abstract. "An initial
treatment and up to two touch-up treatments at 2-week intervals after
initial treatment were performed to achieve optimal correction in both
[nasiolabial folds] and subjects were followed through 24 weeks after
the last treatment. ... Subjects were offered repeat treatment with the
original Juvederm formulation after the 24 week treatment. Id. 758.
"Investigators determined the appropriate volume of Juvederm needed
to obtain optimal correction at the initial, touch-up, and repeat
treatments." Id.
ANALYSIS
According to the Examiner, "Weiss in view of Benedicte Le [Bris]
and Smith teach the method of the instant claims with the same composition
injected at the same concentration and overlapping volumes." Fin. Rej. 3.
"Even though Weiss does not teach specifically that the tropoelastin will
increase elasticity of the skin ... increasing elastin fiber formation would be
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inherently achieved." Id. "Furthermore, there is a reasonable expectation of
success given that Weiss specifically teaches increasing elasticity of the
skin, treating wrinkles and that elastin is formed from tropoelastin with a
coalescence controlling agent and that the tropoelastin/coalescence
controlling agent can be injected into the skin for correcting tissue defects."
Ans. 17.
Further, and upon considering the Declaration of Anthony Steven
Weiss under 37 C.F.R. § 1.132, the Examiner finds that "Applicants have
failed to show unexpected results with regards to the specific concentration
range, volume range and treatment schedule." Id.; see Ans. 16-17. "In the
absence of unexpected results or criticality of a claimed range, it would have
been obvious for one of ordinary skill to discover the optimum workable
ranges (frequency of the injections, location and distance of the injections
and volume of the injections) of the methods disclosed by the prior art by
normal optimization procedures known in the pharmaceutical arts for
improving appearance of the skin." Fin. Rej. 4.
Appellants contend that "the cited references fail, individually and in
combination, to teach or suggest a method of enabling elastic fiber formation
in the treatment area as claimed, let alone a method of administering a
tropoelastin composition to enable elastic fiber formation." App. Br. 6.
"Rather, the methods of the prior art are merely directed to methods of
injecting an elastic material derived from tropoelastin for the purpose of
plumping or bulking skin tissue." Id. at 6-7.
We do not find Appellants' arguments persuasive and agree with the
Examiner that Weiss teaches the injection of tropoelastin compositions into
the skin for "correcting a tissue defect," which
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refers to a least partially restoring and/or augmenting tissue
structure and/or function, including supporting, enhancing,
bulking, or elasticizing tissue, or facilitating tissue growth into
a tissue defect (see page 8, fourth paragraph). Thus, Weiss
teaches injecting tropoelastin into [the] skin to improve the
appearance of the skin via elasticizing the tissue or facilitating
growth which would meet the limitations of 'restoring elastic
profile' and that the compositions were not just for a "bulking
effect."
Ans. 18. We further agree with the Examiner's conclusion that "[e]ven
though Weiss does not teach specifically that the tropoelastin will increase
elasticity via increased elastic fiber formation per se ... Weiss in view of
Benedicte Le Bris and Smith teach the method of the instant claims with the
same composition injected at the same concentration and overlapping
volumes." Id. at 11. Accordingly, "the result of increasing elastin fiber
formation would inherently be achieved." Id.
We further agree with the Examiner that one of ordinary skill in the
art would have been motivated to combine the teachings of Weiss, Benedicte
Le Bris, and Smith "to achieve uniform distribution and the desired visual
effect" or appearance of the skin. Id. at 13. We find no error in the
Examiner's conclusion that "[i]t would have been obvious to optimize the
injection protocol to create a layer so that the composition of the invention is
uniformly distributed in the cutaneous area to be treated and optimize the
number of treatments to obtain the desired therapeutic effect." Id. at 14--15.
In this respect, we agree with the Examiner that the claimed ranges are result
effective variables such that it would have been obvious for one of ordinary
skill in the art to discover through routine experimentation, the optimum
ranges for injection frequency, location, and distance as claimed. See id. at
9, 14; see also id. at 16 ("based on the teachings of Weiss of increasing
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elasticity of the skin via injection of tropoelastin compositions, the Examiner
disagrees that the finding of increased elastic fibre formation is
unexpected"). Nevertheless, to the extent Appellants results might have
been unexpected, they do not overcome the Examiner's evidence of
obviousness. See, e.g., Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 1372 (Fed.
Cir. 2007). ("Here, the record establishes such a strong case of obviousness
that Pfizer's alleged unexpectedly superior results are ultimately
insufficient.").
For the above reasons, and as set forth in the Examiner's Answer and
Final Rejection, we affirm the rejection of claim 20 in view of Weiss,
Benedict Le Bris and Smith. Claims 2--4, 6-9, and 14--19, which Appellants
do not separately argue, fall with claim 20. 37 C.F.R. § 41.37(c)(l)(iv). The
rejections of claims 2-9 and 14--20 in view of Weiss, Benedite Le Bris and
Smith, further in view of Guillen, and Sommer-Knudsen are affirmed for the
same reasons.
SUMMARY
For the reasons above, we affirm the Examiner's decision rejecting
claims 2--4, 6-9, and 14--20.
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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