Ex Parte Speck et al

Patent Trial and Appeal Board

Dec 21, 2016

13143703 (P.T.A.B. Dec. 21, 2016)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/143,703 08/18/2011 Ulrich Speck P0039122.USN8 8187
77218 7590 12/23/2016
MeHtrnnio Vasionlar - APV Division
EXAMINER
c/o IP Legal Department
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SINGH, RANDEEP
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1615
NOTIFICATION DATE DELIVERY MODE
12/23/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ULRICH SPECK, SILVIO SCHAFFNER, and
MAGDALENA RENKE-GLUSZKO
Appeal 2015-008008
Application 13/143,703
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134(a) involves claims 1—37 (Final
Act. 1). Examiner entered rejection under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellants disclose “a catheter balloon coated with paclitaxel in
crystalline hydrated form, having an immediate release and bioavailability of
1 Appellants identify the real party in interest as “Invatec Technology Center
GMBH” (App. Br. 3).
Appeal 2015-008008
Application 13/143,703
the drug at the site of intervention” (Spec. 5: 9—12). Appellants’ claim 1 is
representative and reproduced below:
1. A catheter balloon completely or partially coated with
paclitaxel in crystalline hydrated form, having an immediate
release and bioavailability of a therapeutically effective amount
of paclitaxel at the site of intervention.
(App. Br. Claims App. claim 1.)
The claims stand rejected as follows:
Claims 1—37 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Schaeffer,2 Speck,3 and Amey.4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants disclose:
By the term “an immediate release and bioavailability” is meant
a release from the balloon surface in periods of time ranging
between 1 second and 1.5 minutes, preferably between 20
seconds and 1 minute, and an absorption by the vascular tissue
in periods of time ranging between 1 second and 25 minutes,
preferably between 20 seconds and 25 minutes.
(Spec. 7: 4-10.)
2 Schaeffer, WO 2007/106441 A2, published Sept. 20, 2007.
3 Speck et al., EP 1 857 127 Al, published Aug. 26, 2003. Examiner relies
on Speck et al., US 2010/0228228 Al, Sept. 9, 2010 as an English language
document that “correspond[s] to EP185127” (see Final Act. 2). All
reference to Speck herein correspond to US 2010/0228228 Al.
4 Amey et al., US 2007/0178136 Al, published Aug. 2, 2007.
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FF 2. Schaeffer discloses “[mjedical devices comprising a releasable
taxane therapeutic agent coating” (Schaeffer 19; see Schaeffer 1157
(Schaeffer discloses that the term “medical devices” includes, inter alia,
“balloon catheters”); see Final Act. 3 and 9).
FF 3. Schaeffer discloses that
the taxane therapeutic agent is [preferably] paclitaxel, although
the taxane therapeutic agent may include one or more paclitaxel
analog or derivative. The medical device coating can include
any suitable amount(s) of one or more of the taxane solid forms
that provide a desired elution rate of the taxane therapeutic
agent, while also preferably having a desired durability and
suitable level of surface uniformity.
(Schaeffer 110; see generally Final Act. 3.)
FF 4. Schaeffer discloses that “[pjaclitaxel and taxane derivatives thereof
can be formed in an amorphous form, or in at least two different crystalline
polymorphs. Solid forms of paclitaxel at room temperature include:
amorphous paclitaxel (‘aPTX’), dihydrate crystalline paclitaxel (‘dPTX’)
and anhydrous crystalline paclitaxel” (Schaeffer | 5; id. 19 (“the taxane
therapeutic agent coating can be deposited as a solvated, crystalline or
amorphous solid form, or a combination thereof’); see Final Act. 3 and 9).
FF 5. Schaeffer discloses that “taxane solid forms often have measurably
different rates of elution from the medical device. Therefore, medical device
coatings described [in Schaeffer] can provide for desired release rates of a
taxane therapeutic agent depending on the number and distribution of solid
form(s) of the therapeutic agent in the coating” (Schaeffer 19; id. 13
(“[v]arious approaches can be used to control the rate and dose of release of
therapeutic agents from an implantable medical device”; see Final Act. 3 and
9).
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FF 6. Schaeffer discloses that “the rate of release of paclitaxel can be
extended by providing paclitaxel coatings with the dihydrate solid form of
paclitaxel, alone or in combination with other paclitaxel solid forms”
(Schaeffer 140).
FF 7. Schaeffer’s Figure 6A is reproduced below:
Figure 6A
Time (mtiVit
Figure 6A shows elution profiles 700 for two medical devices
in porcine serum elution media at 25°C. The first elution
profile 710 was obtained from a first coated vascular stent
coated with a single layer of amorphous paclitaxel. The second
elution profile 720 was obtained from a second coated vascular
stent coated with a single layer of dihydrate paclitaxel. . . .
Referring to the first elution profile 710, obtained from the
amorphous paclitaxel coating, 100% of the amorphous
paclitaxel dissolved within about 6.5 hours (400 minutes),
while less than 40% of the second (dihydrate) coating [720]
eluted under the same conditions after about 24 hours.
(Schaeffer 1133; see also id. 1102 (“[t]he rate constant for aPTX in porcine
serum is about 100-times the rate constant for dPTX in porcine serum”).)
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FF 8. Schaeffer discloses that “amorphous paclitaxel [dissolved]
distinguishably more rapidly than the dihydrate paclitaxel” in different
elution media (Schaeffer 1136).
FF 9. Examiner finds that Schaeffer fails to disclose “the release of a
therapeutically effective amount of paclitaxel occurring in a period of time
ranging between 1 second and 1.5 minutes, or [absorption by the vascular
tissue in] a period of time ranging between 1 second and 25 minutes” (Final
Act. 4).
FF 10. Speck “relates to a medical apparatus that releases drugs for the
selective therapy of specific tissues or organ parts and to a method of
manufacturing such drug-coated devices” (Speck 11).
FF 11. Speck discloses that
drugs firmly adhere to the balloon while passing through
arteries with an intense blood flow on their way to their target
until the balloon is inflated, and an effective dose is released in
the short time (sometimes just a few seconds) during which the
inflated balloon is in contact with the tissue, absorbed by the
tissue in such a way that the blood flow that resumes
immediately after the balloon is deflated does not rinse it off.
(Speck 114; see id. 133 (Speck discloses “various types of medical devices
designed and manufactured [to] come into short-term contact with the tissue,
i.e. for a few seconds, minutes, or hours”).)
FF 12. Speck disclosing “[a] balloon catheter medical device comprising a
balloon surface having paclitaxel adhered thereto after being applied and
dried, wherein said dried paclitaxel is immediately released after coming
into contact with tissue” (Speck at 5: Claim 24; Final Act. 5).
FF 13. Speck prefers
the smallest particle sizes (mostly <5 microns, preferably <1
microns, particularly preferred <0.1 microns), particularly
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Application 13/143,703
preferred are amorphous non-crystalline structures of the finest
particle size that dissolve fast upon contact with tissue due to
their large surface area and despite the generally poor water-
solubility of the drugs and do not function as microcapsules, i.e.
dissolve spontaneously and fast. It is sufficient that an effective
dose is present in the form of smallest or amorphous particles.
(Speck 125 (emphasis added); see also id. at 5: Claim 33 (further limiting
the “balloon catheter medical device” of Speck’s claim 24 to require an
“effective dose of paclitaxel [that] includes amorphous structures with
particle sizes ranging from <0.1 micron to 5 microns that dissolve quickly
due to their large surface area and despite the poor water-solubility of the
paclitaxel”)
FF 14. Examiner relies on Amey to disclose, inter alia, “implantable
medical devices such as balloon catheters for the delivery of therapeutic
agents such as paclitaxel,” including “a medical device substrate containing
a polyether-polyamide block copolymer [] with a polymer coating that
contains poly(ether amide) or poly(ether urea)” (Final Act. 7).
ANALYSIS
Based on the combination of Schaeffer, Speck, and Amey, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious to make and have a catheter balloon, comprising
polyether-polyamide block copolymers, that is, at least, partially coated with
a crystalline hydrated form of paclitaxel, which will immediately release and
make bioavailable a therapeutically effective amount of paclitaxel upon
deployment at a site of intervention (see Final Act. 6 and 7—8; see generally
Final Act. 2—8).
Appellants recognize that Schaeffer discloses a catheter balloon that is
at least partially coated with a taxane, such as a crystalline hydrated form of
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paclitaxel (App. Br. 10, citing Schaeffer || 156—157; see FF 2—4). In this
regard, Schaeffer discloses that: the “rate of release of paclitaxel can be
extended by providing paclitaxel coatings with the dehydrate solid form of
paclitaxel, alone or in combination with other paclitaxel solid forms;”
exemplifies the elution profiles of dehydrate paclitaxel and amorphous
paclitaxel from medical devices in different elution media; and concludes
that “amorphous paclitaxel [dissolved] distinguishably more rapidly than the
dehydrate paclitaxel” under the conditions disclosed by Schaeffer (FF 6—8;
see generally App. Br. 10—15).
Schaeffer, however, is not limited to its preferred or exemplified
embodiments, but is instead available for all that it discloses and suggests to
one of ordinary skill in the art (see Ans. 3). See In re Lamberti, 545 F.2d
747, 750 (CCPA 1976). In this regard, Schaeffer discloses that: a catheter
balloon “coating can include any suitable amount(s) of one or more of the
taxane solid forms that provide a desired elution rate of the taxane
therapeutic agent, while also preferably having a desired durability and
suitable level of surface uniformity” and “[v]arious approaches can be used
to control the rate and dose of release of therapeutic agents from an
implantable medical device” (FF 3 (emphasis added) and 5; see also Final
Act. 9—10; Ans. 3). We find no evidence on this record to support a
conclusion that the various approaches recognized by Schaeffer, as known in
the art at the time of Appellants’ claimed invention, that may be applied to
implantable medical devices, would not also be useful to control the rate and
dose of release of therapeutic agents from a catheter balloon or, to the extent
that such approaches may differ, a person of ordinary skill in this art would
not have recognized that various approaches may also be applied to the
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coating of a catheter balloon in order to control the rate and dose of release
of therapeutic agents from a catheter balloon (see FF 5; cf. App. Br. 13—14
(Schaeffer teaches away from Appellants’ claimed invention); App. Br. 13,
quoting In re Hedges, 783 F.3d 1038, 1041 (Fed. Cir. 1986) (“Examiner did
not consider Schaeffer [] ‘as a whole’” and “impermissibly picked from
[Schaeffer] ‘only so much of it as will support a given position, to the
exclusion of other parts necessary to the full appreciation of what such
reference fairly suggests to one of ordinary skill in the art”)).
Speck discloses one such approach, wherein paclitaxel, such as a
crystalline hydrated form of paclitaxel, having a fine or small particle size is
coated onto a balloon catheter so that the particles will “dissolve fast upon
contact with tissue due to the[] [resulting] large surface area” of the particles
(FF 13). Thus, Speck discloses “[a] balloon catheter medical device
comprising a balloon surface having paclitaxel adhered thereto[, which] is
immediately released after coming into contact with tissue” (FF 12; see Ans.
5).
Therefore, the combination of Schaeffer and Speck makes obvious a
catheter balloon that is, at least partially, coated with fine or small particle
sized paclitaxel in crystalline hydrated form, which will immediately release
and make bioavailable a therapeutically effective amount of paclitaxel upon
deployment at a site of intervention (see FF 2—14; cf. App. Br. Claims App.
claim 1; FF 1).
For the foregoing reasons, we are not persuaded by Appellants’
contention that Schaeffer “do[es] not provide any teaching or suggestion for
the type of coating to use or guidance regarding a composition of paclitaxel
that would be immediately released and bioavailable,” which fails to
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consider Schaeffer’s disclosure as a whole or account for Speck’s
contribution to the combination of Schaeffer and Speck (see App. Br. 10).
For the same reasons, we are not persuaded by Appellants’ contentions that
Schaeffer’s disclosure is limited to “methods of providing sustained release,
not immediate release” and Schaeffer’s disclosure of‘“a desired release rate’
does not teach or suggest an immediate release rate,” which fails to account
for Speck’s contribution to the combination to Schaeffer and Speck (App.
Br. 10-11).
Schaeffer discloses paclitaxel, such as the crystalline hydrated form of
paclitaxel, coatings on devices such as a catheter balloon (see FF 2-4). For
this reason, in addition to the reasons discussed above, we are not persuaded
by Appellants’ contention that
a skilled artisan would not have looked to Schaeffer [] when
attempting to provide a therapeutically effective amount of
paclitaxel at the site of intervention using a catheter balloon at
least because the disclosure of Schaeffer [] is directed to
compositions that extend or delay release — not compositions
that promote release during the short period a catheter balloon
is in contact with the intervention site
(App. Br. 11.)
Appellants’ contend that Speck “do[es] not remedy the defects of
Schaefer [] because Speck specifically [prefers the] us[e] [of] amorphous
paclitaxel” (App. Br. 12; Reply Br. 3 (Speck “reinforce[s] the teachings of
Schaefer [] to use amorphous paclitaxel — not crystalline forms of paclitaxel
— to achieve immediate release” and “Examiner identified nothing in Speck
[] that would have motivated a skilled artisan to use paclitaxel in crystalline
hydrated form [] to achieve [] immediate release”); see FF 13; cf. Final Act.
10 (a reference is not limited to its preferred embodiments)). We are not
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persuaded. See Lamberti, 545 F.2d at 750. As Appellants recognize,
Speck’s disclosure “do[es] not exclude [the use of] crystalline, crystalline
hydrated, or crystalline solvated hydrated [forms of] paclitaxel” as a catheter
balloon coating for the immediate release of paclitaxel after the catheter
balloon comes into contact with tissue (see App. Br. 12; see also FF 10-12).
In this regard, Speck discloses the use of “the smallest particle sizes” of the
crystalline, crystalline hydrated, or crystalline solvated hydrated forms of
paclitaxel to achieve the immediate release and bioavailability of paclitaxel
from such a paclitaxel coated catheter balloon (see FF 11—12; see generally
App. Br. 14). We recognize Appellants’ contentions with regard to
Schaeffer’s exemplifications and disclosure of the release rates of various
paclitaxel forms (see App. Br. 12; Reply Br. 2—3; see e.g., FF 5—8).
Appellants, however, fail to establish an evidentiary basis on this record to
support a conclusion that Schaeffer’s disclosed release rates for various
paclitaxel forms relates to the use of “the smallest particle sizes” of the
crystalline, crystalline hydrated, or crystalline solvated hydrated forms of
paclitaxel, which, as disclosed by Speck, result in the immediate release and
bioavailability of paclitaxel, including paclitaxel in crystalline hydrated form
(see App. Br. 12; cf FF 10—12; see Final Act. 10 (the combination of
Schaeffer and Speck suggest that various release and bioavailability rates,
including immediate release and bioavailability, of paclitaxel in crystalline
hydrated form can be obtained through routine optimization); Ans. 4 and 6).
See In re Alter, 220 F.2d 454, 456 (CCPA 1955) (“where the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation”).
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For the foregoing reasons, when the combination of Schaeffer and
Speck are considered as a whole, we are not persuaded by Appellants’
contentions that
in light of the teachings of Schaeffer[,alone,] a skilled artisan
would not have had a reasonable expectation that paclitaxel in
crystalline hydrated form would be successful to provide
immediate release and bioavailability when used on a catheter
balloon ...[;] would not have been motivated to select
dehydrate crystalline paclitaxel and would not have expected
this form of paclitaxel to provide immediate release and
bioavailability.
(App. Br. 13; see generally id. at 14; Reply Br. 3—4, citing United States v.
Adams, 383 U.S. 39, 52 (1966) (Examiner conclusion of obviousness
‘“required that person reasonably skilled in the prior art must ignore’ the
teachings of Schaeffer [] and Speck [] to use amorphous paclitaxel”).)
Having found no deficiency in the combination of Schaeffer and
Speck, we are not persuaded by Appellants’ contention that Amey fails to
“cure the deficiencies of the combination of Schaeffer [] and Speck []” (App.
Br. 14; cf. FF 14).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner support a
conclusion of obviousness. The rejection of claim 1 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Schaeffer, Speck, and
Amey. Claims 2—37 are not separately argued and fall with claim 1.
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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