Ex Parte Tourvieille De Labrouhe et al

Patent Trial and Appeal Board

May 17, 2018

13384563 (P.T.A.B. May. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/384,563 03/27/2012
23117 7590 05/21/2018
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Arnaud Tourvieille De Labrouhe
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.
DMB-2590-373 1587
EXAMINER
AUER, LAURA A
ART UNIT PAPER NUMBER
1783
NOTIFICATION DATE DELIVERY MODE
05/21/2018 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):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte ARNAUD TOURVIELLE DE LABROUCHE, LAURENT-
DOMINIQUE PIVETEAU, and HEINRICH HOFFMAN
Appeal2017-008963
Application 13/3 84,563 1
Technology Center 1700
Before KAREN M. HASTINGS, CHRISTOPHER C. KENNEDY,
and LILAN REN, Administrative Patent Judges.
HASTINGS, Administrative Patent Judge
DECISION ON APPEAL
Appellants seek our review under 35 U.S.C. § 134(a) of the
Examiner's decision rejecting claims 1-24, and 28-342 under 35 U.S.C.
§ 103(a) as being unpatentable over Kokate et al. (US 2009/0118812 Al,
pub. May 7, 2009). We have jurisdiction over the appeal under 35 U.S.C.
§ 6(b ).
We AFFIRM.
1 Appellants identify the real party in interest as Debiotech S.A. (Appeal Br.
1 ).
2 As noted by the Examiner, claim 35 was cancelled, and the§ 112
rejections were withdrawn (Ans. 2).
Appeal2017-008963
Application 13/384,563
Independent claim 1, reproduced below, is illustrative of the subject
matter on appeal (emphasis added to highlight disputed limitation):
An element comprising a substrate and a nanoporous
adherent coating made of at least one layer, said layer being in
adherent contact with said substrate and comprising separate a
plurality of domains of nanoparticles and openings, each of said
domains having an average diameter between 1 and 1000 nm
and being separated from its neighbor domains by an opening
from the plurality of openings on a majority of its
circumference, each of the openings forming an average
distance between the domains equal or less to a diameter of the
domains.
Appellants' arguments focus solely on claim 1 's relative spacing
between the domains (Appeal Br. 9-23). While Appellants state that
independent claims 10 and 28 recite features analogous to those in claim 1
(Appeal Br. 23), claim 10 does not recite the disputed spacing between
domains (Appeal Br. 26, 27, Claims Appendix). Thus, while all the claims
stand or fall with claim 1, the rejection of claims 10-24 is affirmed because
those claims do not contain the feature relied upon by Appellants for
patentability. In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (It is well
established that limitations not appearing in the claims cannot be relied upon
for patentability).
ANALYSIS
We have reviewed each of Appellants' arguments for patentability.
However, we determine that a preponderance of the evidence supports the
Examiner's conclusion that the claimed subject matter is unpatentable within
2
Appeal2017-008963
Application 13/384,563
the meaning of§ 103 in view of Kokate. Appellants' arguments do not
show error in the Examiner's obviousness determination. Accordingly, we
will sustain the Examiner's§ 103 rejections, and we add the following
primarily for emphasis.
It has been established that "the [obviousness] analysis need not seek
out precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ." KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007); see also In re Fritch, 972 F.2d 1260, 1264--
65 (Fed. Cir. 1992) (a reference stands for all of the specific teachings
thereof as well as the inferences one of ordinary skill in the art would have
reasonably been expected to draw therefrom).
Appellants' principal argument is that since Kokate fails to recognize
the problem of delamination of a ceramic coating form its substrate, it fails
to identify a result-effective parameter to prevent delamination ( e.g., Appeal
Br. 10). Even assuming arguendo that Appellants are correct that the
porosities discussed in Kokate are with respect to the adhesion of its ceramic
coating is "for improving adherence of the second coating layer 27, made of
a polymer" versus with respect to the substrate per se (Appeal Br. 13, 14;
Reply Br. 2, 3), Appellants' arguments are unpersuasive of reversible error
in the Examiner's rejection.
Appellants' claimed subject matter may be used for drug eluting
medical implants, including a stent (Spec. 18). Kokate is directed to the
importance of having a porous ceramic substrate coating in e.g., a stent, and
discusses how porosity in the ceramic material can be used to control a
desired drug release (Kokate, e.g., Abstract, ,r,r 24, 35). Kokate also
3
Appeal2017-008963
Application 13/384,563
discusses that the ceramic nanoparticle sizes may be 100 nm or less and may
"bond at contact points forming a continuous coating that is an
amalgamation of the particles," that pores within the coating may have an
average width of about 10 nm, and porosity may be from 10 to 85%
(Kokate ,r 24). One of ordinary skill in the art would have readily inferred
from at least these disclosures in Kokate that the domain sizes and spacing
of the ceramic nanoparticles on the stent substrate is a result effective
variable. "A recognition in the prior art that a property is affected by the
variable is sufficient to find the variable result-effective." In re Applied
Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012). It is well settled that
it would have been obvious for an artisan with ordinary skill to develop
workable or even optimum ranges for result-effective parameters. In re
Woodruff, 919 F.2d 1575, 1577 (Fed. Cir. 1990); In re Boesch, 617 F.2d
272, 276 (CCPA 1980); In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Indeed, the ranges de facto disclosed in Kokate for domain sizes and spacing
overlap the claimed ranges (Kokate ,r 24; Ans. 3, 4). Accordingly, a
preponderance of the evidence supports the Examiner's determination that
the subject matter of claim 1 (as well as independent claims 10 and 28) is
unpatentable over Kokate. See In re Peterson, 315 F.3d 1325, 1329 (Fed.
Cir. 2003) ("In cases involving overlapping ranges, we and our predecessor
court have consistently held that even a slight overlap in range establishes a
prima facie case of obviousness.").
Appellants also argue there is no evidence in the record, other than in
Appellants' disclosure, that Kokate discusses the problems pertinent to
adhesion and delamination of the coating and thus there is no motivation to
adjust the porosity of the coating layer (Appeal Br. 13; Reply Br. 2, 3). The
4
Appeal2017-008963
Application 13/384,563
problem faced by an applicant is a relevant factor to take into consideration
in an obviousness determination. However, an invention may be obvious for
reasons the inventor did not contemplate. See In re Dillon, 919 F.2d 688,
693 (Fed. Cir. 1990) ( en bane) ("In particular, the statement [in In re Wright]
that a prima facie obviousness rejection is not supported if no reference
shows or suggests the newly-discovered properties and results of a claimed
structure is not the law.") (overruling-in-part In re Wright, 848 F.2d 1216
(Fed. Cir. 1988)). As discussed above, Kokate recognizes the impact that
porosity of the material has on its coatings, including adhesion and desired
drug release. Appellants do not direct us to adequate evidence of any
secondary considerations, such as unexpected results, in support of
nonobviousness (Ans. 5-7; the Examiner explains why Appellants'
proffered evidence in support of unexpected results and long felt need is
inadequate). Dillon, 919 F.2d at 692 (explaining that where the prior art
gives reason or motivation to make the claimed invention, the burden and
opportunity to produce evidence such as unexpected results then falls on an
applicant to rebut that prima facie case). See also Boesch, 617 F.2d at 276
("[D]iscovery of an optimum value of a result effective variable in a known
process is ordinarily within the skill of the art.")
Appellants state that the example included in the Specification evince
unexpected results, and also rely upon the Piveteua Declaration filed Jan. 16.
2016 (Appeal Br. 15, 16). It is well established that the burden of showing
unexpected results rests on the person who asserts them by establishing that
the difference between the claimed invention and the closest prior art was
unexpectedly different. See In re Klosak, 455 F.2d 1077, 1080 (CCPA
1972). Further, the showing of unexpected results must be commensurate in
5
Appeal2017-008963
Application 13/384,563
scope with the claims. See In re Peterson, 315 F.3d 1325, 1330-31 (Fed.
Cir. 2003). The sole example in the Specification (Spec. 19, 20, 22; Appeal
Br. 16) cannot be considered commensurate in scope with the breadth of
claim 1 which, for example only, encompasses unlimited possibilities for the
material( s) for its nanoparticles as well as for its substrate ( claim 1 also has
no specified coating thickness), and, therefore, is not persuasive evidence of
nonobviousness (Ans. 5, 6). Furthermore, it is not seen how Appellant's
discussion of Wu's cracking and debond spaces that are much greater than
the maximum claimed spacing between domains ( cf 24 microns versus 1
micron) can be sufficient to show criticality of the claimed range (Appeal
Br. 16, Piveteua Declaration ,r 17). In re Woodruff, 919 F.2d at 1578 (where
the difference between the claimed invention and the prior art is some range,
the applicant must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results relative to the
prior art range).
Appellants also state that they have provided evidence of a long-felt
need (Appeal Br. 18-22). The Examiner states that Appellants' evidence
(articles) fails to establish that others tried and failed to solve the problem,
and also states the articles are directed to a specific coating type not claimed
herein (Ans. 7). 3 Appellants' proffered evidence of unexpected results and
3 Establishing long-felt need requires objective evidence that an art-
recognized problem existed in the art for a long period of time without
solution. In particular, the evidence must show that the need was a
persistent one that was recognized by those of ordinary skill in the art. In re
Gershon, 372 F.2d 535, 538 (CCPA 1967). The relevance of long-felt need
and the failure of others to the issue of obviousness depends on several
factors. First, the need must have been a persistent one that was recognized
by those of ordinary skill in the art. Orthopedic Equip. Co. v. All
6
Appeal2017-008963
Application 13/384,563
long felt need are thus inadequate at least for the reasons set out by the
Examiner (Ans. 5-7). Appellants' conclusory remarks (Reply Brief 3
(Appellants request "proper analysis of the secondary considerations")) do
not direct us to any error in the Examiner's analysis of the evidence. 4
Orthopedic Appliances, Inc., 707 F.2d 1376, 1383 (Fed. Cir. 1983); see also
Gershon, 372 F.2d at 538. Second, the long-felt need must not have been
satisfied by another before the invention by applicant. Newell Companies,
Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) ("[O]nce
another supplied the key element, there was no long-felt need or, indeed, a
problem to be solved"). Third, the invention must in fact satisfy the long-
felt need. In re Cavanagh, 436 F.2d 491,496 (CCPA 1971). "[L]ong-felt
need is analyzed as of the date of an articulated identified problem and
evidence of efforts to solve that problem." Texas Inst., Inc. v. US. Int 'l
Trade Comm 'n, 988 F.2d 1165, 1178 (Fed. Cir. 1993).
4 In addition, we emphasize that, although secondary considerations such as
unexpected results must be taken into account, they do not necessarily
control the obviousness conclusion. Sud-Chemie, Inc. v. Multisorb Techs.,
Inc., 554 F.3d 1001, 1009 (Fed. Cir. 2009) ("evidence of unexpected results
and other secondary considerations will not necessarily overcome a strong
prima facie showing of obviousness"); Agrizap, Inc. v. Woodstream Corp.,
520 F.3d 1337, 1344 (Fed. Cir. 2008) (Secondary considerations "including
substantial evidence of commercial success, praise, and long-felt need, were
inadequate to overcome a strong showing of primary considerations that
rendered the claims at issue invalid."); Pfizer, Inc. v. Apotex, Inc., 480 F.3d
1348, 1372 (Fed. Cir. 2007) ("[T]his secondary consideration does not
overcome the strong showing of obviousness in this case. Although
secondary considerations must be taken into account, they do not necessarily
control the obviousness conclusion"). Here, the case of obviousness appears
to be strong enough that Appellants' alleged long-felt unmet need ( as well as
the proffered example of unexpected results) is ultimately insufficient, since
the applied prior art evinces the known use of domain sizes (i.e., aggregate
particle size) and spacing in a nanoparticle ceramic coating for a stent as
encompassed by claims 1, 10 and 28.
7
Appeal2017-008963
Application 13/384,563
Accordingly, balancing all the evidence anew, it is our conclusion that
the evidence for obviousness outweighs the evidence against obviousness.
As a result, a preponderance of the evidence in the record supports the
Examiner's rejection of claim 1 (as well as claims 10 and 28; again noting
that claims 10-24 do not even recite the disputed limitation regarding
domain spacing). Appellants' arguments do not identify a reversible error in
the Examiner's rejection. Appellants do not argue any of the claims
separately from claim 1 (Appeal Br. 22, 23).
Accordingly, the Examiner's§ 103 rejection on appeal is affirmed.
DECISION
The Examiner's decision is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED
8