Ex Parte Horne et al

Patent Trial and Appeal Board

Jul 17, 2018

13880515 (P.T.A.B. Jul. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/880,515 07/03/2013
51957 7590 07/19/2018
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
FIRST NAMED INVENTOR
Kenneth N. Horne
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.
19414US (COR) 3832
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
07/19/2018 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):
patents_ip@allergan.com
pair_allergan@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KENNETH N. HORNE, VIVEK SHENOY,
NAVEEN JAYAKUMAR, andGEOFFREYC. GURTNER1
Appeal2017-003232
Application 13/880,515
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FRED MAN, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for making a cross-linked hyaluronic acid thread.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Allergan Industrie,
S.A.S. (Br. 3.)
Appeal2017-003232
Application 13/880,515
STATEMENT OF THE CASE
Claims on Appeal
Claims 10, 23, and 60 are on appeal. 2 (Claims Appendix, Br. 9--10.)
Claim 10 is illustrative and reads as follows:
Claim 10. A method for making a cross-linked hyaluronic acid
thread comprising:
a) combining hyaluronic acid and butanediol diglycidyl
ether in an aqueous composition until the hyaluronic acid is
substantially cross-linked to provide a substantially cross-linked
composition, wherein the ratio by weight of hyaluronic acid to
crosslinking agent in the combining step is from about 2.5: 1 to
about 1.5: 1;
b) extruding, onto a substrate, the substantially cross-
linked composition to provide a wet thread, wherein the contact
angle of the composition and the substrate has an equilibrium
contact angle of greater than about 90 degrees; and
c) drying the wet thread to provide a cross-linked
hyaluronic acid thread.
Examiner's Rejection
Claims 10, 23, and 60 stand rejected under pre-AIA 35 U.S.C. § I03(a)
as unpatentable over Stroumpoulis 3 and Prate. 4 (Final Act. 3-6.)
2 Claims 16, 22, 26-28, 36, and 37 are withdrawn as drawn to a non-elected
species. (Final Action dated Aug. 21, 2015 ("Final Act."), at 2.)
3 Stroumpoulis et al., US 2010/0255068 Al, published Oct. 7, 2010
("Stroumpoulis").
4 Prate et al., WO 02/17979 A2, published March 7, 2002 ("Prate").
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Application 13/880,515
DISCUSSION
We adopt the Examiner's findings, analysis, and conclusions,
including with regard to the scope and content of, and motivation to
combine, the prior art, as set forth in the Final Action and Answer. We
discern no error in the rejection of the claims on appeal as obvious.
Issue
Whether a preponderance of evidence of record supports the
Examiner's rejection under pre-AIA 35 U.S.C. § 103(a).
Analysis
We limit our consideration to claim 10 because the claims were not
argued separately.
Examiner's Position
The Examiner finds that Stroumpoulis teaches a composition
comprising a hydro gel thread comprising a combination of ( crosslinked/non-
crosslinked) hyaluronic acid (HA) and crosslinking agent, the crosslinking
agent taught as being butanediol diglycidyl ether (BDDE), and that the
composition can be combined in an aqueous medium and extruded. (Final
Act. 3, citing Stroumpoulis Abstract and ,r,r 16, 25-27, 40, and 46.) The
Examiner further finds that Stroumpoulis teaches that the ratio of
crosslinking agent (BDDE) to HA determines the degree of crosslinking.
(Id. at 4, citing Stroumpoulis ,r 41.)
The Examiner finds that Stroumpoulis does not directly identify that
the thread hydrogel composition is dried, but finds that Prate teaches a
hydrogel composition and the advantages of drying or dehydrating a
hydrogel. (Final Act. 4.) The Examiner points to Frate's teaching that "the
hydrogel compositions are dried or dehydrated, permitting easier packaging,
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less costly shipping and customer convenience. Subsequently, the dried or
dehydrated composition can be rewetted and hence regain substantially all of
the original aqueous composition's adhesive and viscoelastic properties."
(Ans. 2, citing Prate 22; Final Act. 4.)
The Examiner concludes that
It would have been obvious to one of ordinary skill in the
art at the time the invention was made to dry or dehydrate the
hydrogel of Stroumpoulis as taught by Prate. One would have
been motivated to do so since Prate teaches that drying or
dehydrating permits easier packaging, reduces shipping costs,
and increases customer convenience. There would be a
reasonable expectation of success since Prate teaches that upon
drying or dehydration hydrogels can be rewetted and will regain
substantially all of their original properties.
(Final Act. 4--5.)
Appellants 'Arguments
Appellants contest the Examiner's rejection by contending that there
is no suggestion or motivation to dry or dehydrate the hydrogel gel of
Stroumpoulis "at least because the proposed modification would render the
prior art being modified unsatisfactory and inoperable for its intended
purpose." (Br. 6.) Appellants support this contention with several
arguments (id. at 7-8), all of which are unpersuasive for the reasons set forth
below.
Appellants argue that "[ d]rying the Stroumpoulis gel would defeat the
purpose of the Stroumpoulis invention, as it would only make the
Stroumpoulis gel more difficult to package and less convenient to the
customer." (Id. at 7.) According to Appellants, "drying the Stroumpoulis
gel would result in the gel strands being difficult to package into a syringe,
for example, without the dried strands losing their strand-like structure and
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Application 13/880,515
potentially breaking into micron-sized fragments - something Stroumpoulis
teaches against." (Id., citing Stroumpoulis ,r 18.) Appellants further argue
that "Stroumpoulis expressly teaches that the multiple thin, hydrogel strands
are 'packaged for use as an injectable filler while the material [is] in the
form of said multiple thin strands."' (Id. at 7-8, citing Stroumpoulis ,r 15
(emphasis Appellants').)
We are not persuaded. As an initial matter, Appellants' arguments
regarding the effect of drying the Stroumpoulis gel on packaging are merely
attorney argument, unsupported by evidence. See Estee Lauder Inc. v.
L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997) (attorney argument cannot
take the place of evidence). Furthermore, the citations to Stroumpoulis
relied on by Appellants do not support the arguments for which they are
cited. Paragraph 18 of Stroumpoulis does not "teach away" from
"potentially breaking into micron-sized fragments," but rather indicates that
conventional wisdom teaches that crosslinked hydrogel must be reduced
down to micron-sized particles in order to facilitate extrusion through a fine
gauge needle and encourage a smooth appearance in the skin. (Stroumpoulis
,r 18.) Thus, Stroumpoulis does not teach away because it does not criticize,
discredit, or otherwise discourage the claimed invention. See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004). In addition, paragraph 15 of
Stroumpoulis refers to "one embodiment" in which the method comprises
"packaging the product for use as an injectable soft tissue filler while the
material is in the form of said multiple thin strands." (Stroumpoulis ,r 15.)
That statement is limited to "one embodiment," does not stand for the
proposition that the hydrogel strands are packaged in a syringe, and is not
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Application 13/880,515
evidence that drying the hydrogel would cause it to lose its strand-like
structure or break. (See Ans. 2-3.)
Appellants also contend that drying the Stromnpoulis product would
not improve customer convenience because it "would require that the
physician rehydrate the dried strands before use which would be far less
convenient, not more convenient." (Br. 8.) We are not persuaded. Again,
Appellants rely on attorney argument rather than evidence. Moreover, Prate
expressly teaches "customer convenience" and that "the dried or dehydrated
composition can be rewetted and hence regain substantially all of the
original aqueous composition's adhesive and viscoelastic properties." (Prate
22.) Furthermore, we agree with the Examiner that "convenience is
measured in many ways." (Ans. 3--4.)
Finally, Appellants argue that packaging the Stroumpoulis product in
dried form would render it inoperable for its intended purpose, purportedly
because the product is described as retaining its strand-like configuration
"during injection thereof into [a] target soft tissue site." (Br. 8, citing
Stroumpoulis ,r 1 7 ( emphasis omitted).) According to Appellants,
"packaging such threads in a syringe in a dried form and then rehydrating
same before use would likely destroy the integrity of the final product and
make it inoperable, not useful." (Br. 8.)
We are not persuaded. As the Examiner points out "the instant claims
are directed to a method of 'making' wherein the teachings of Stroumpoulis
in view of Prate clearly teach the method of making a composition that is
similar, if not the same as the instantly claimed composition." (Ans. 4.)
That is, claim 10 is not directed to method of using the crosslinked
hyaluronic acid thread. As the Examiner further points out, Prate teaches
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that drying and rehydrating the hydrogel does not render it inoperable. (Id.)
Moreover, Appellants' attorney argument that "packaging such threads in a
syringe in a dried form and then rehydrating same before use would likely
destroy the integrity of the final product" is not supported with evidence.
See Estee Lauder, 129 F.3d at 595.
Accordingly, for the reasons of record and as set forth above, we
affirm the rejection of claim 10. Claims 23 and 60 fall with claim 10
because they were not argued separately.
Conclusion of Law
A preponderance of evidence of record supports the Examiner's
rejection of claims 10, 23, and 60 under pre-AIA 35 U.S.C. § 103(a).
SUMMARY
We affirm the rejection of all claims on appeal.
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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