Ex Parte Bosnyak et al

Patent Trial and Appeal Board

May 14, 2018

14628248 (P.T.A.B. May. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/628,248 02/21/2015
130577 7590 05/16/2018
ANDREWS KURTH KENYON LLP
600 Travis Street
Suite 4200
Houston, TX 77002
FIRST NAMED INVENTOR
Clive P. Bosnyak
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.
MORE-0019 (223865) 5087
EXAMINER
VU, JAKE MINH
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
05/16/2018 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):
patenttrademarks@andrewskurth.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLIVE P. BOSNYAK, KURT W. SWOGGER,
NANCY HENDERSON, and PAUL EVERILL
Appeal2017-000874 1
Application 14/628,248
Technology Center 1600
Before FRANCISCO C. PRATS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to carbon
nanotubes that contain a payload molecule, such as a drug, within their inner
cavities. The Examiner rejected the claims as anticipated, and for
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b)(l). We reverse.
STATEMENT OF THE CASE
The following rejections are before us for review:
1 Appellants state that the "real party in interest is Molecular Rebar Design
LLC, the assignee of record." App. Br. 2.
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Application 14/628,248
(1) Claims 1--4, 8-14, 16, and 18-22, under 35 U.S.C. § 102(a)(l) as
anticipated by Mashat, 2 as evidenced by Shen, 3 and Rosca4 (Ans. 2-5);
(2) Claims 1-5, 8-14, 16, 18-22, and 25-34, under 35 U.S.C. § 103 as
unpatentable over Mashat, Shen, Rosca, and Appellants' Specification5
(Ans. 5-7); and
(3) Claims 1-5, 8-14, 16, 18-22, and 25-34, under 35 U.S.C. § 103 as
unpatentable over Wu, 6 Shen, Rosca, Lowman, 7 and Appellants'
Specification (Ans. 8-11).
Claims 1 and 16 are the independent claims on appeal, and read as
follows:
1. A composition comprising: a plurality of
functionalized discrete multi-wall carbon nanotubes having an
innermost wall and an outermost wall, the innermost wall
defining an interior cavity, and at least one type of payload
molecule; wherein the functionalized discrete carbon nanotubes
are open on at least one end; and wherein greater than 30
weight percent of the at least one type of payload molecule is
within the interior cavity of the discrete multi-wall carbon
nanotubes.
2 Afnan Mashat et al., Zippered release from polymer-gated carbon
nanotubes, 22 J. Mater. Chem. 11503---08 (2012) (hereinafter "Mashat").
3 Mingwu Shen et al., Polyethyleneimine-Mediated Functionalization of
Multiwalled Carbon Nanotubes: Synthesis, Characterization, and In Vitro
Toxicity Assay, 113 J. Phys. Chem. 3150-56 (2009) (hereinafter "Shen").
4 Iosif Daniel Rosca et al., Oxidation of multiwalled carbon nanotubes by
nitric acid, 43 Carbon 3124--31 (2005) (hereinafter "Rosca").
5 We understand the Examiner's citation to Appellants' Specification as a
citation to admitted prior art.
6 Chia-Hsuan Wu et al., Trojan-Horse Nanotube On-Command Intracellular
Drug Delivery, 12 Nano Lett. 5475-80 (2012) (hereinafter "Wu").
7 Lowman et al., US 7,708,979 B2 (issued May 4, 2010) (hereinafter
"Lowman").
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Application 14/628,248
16. In a payload molecule delivery system
composition comprising carbon nanotubes and at least one
payload molecule, the improvement comprising using
functionalized discrete carbon nanotubes, wherein the
functionalized discrete carbon nanotubes are aqueous
dispersible, having an innermost wall and an outermost wall,
the inner-most wall defining an interior cavity; wherein the
functionalized discrete carbon nanotubes have an apparent
aspect ratio and an average actual aspect ratio and are open on
at least one end; and wherein greater than 30 weight percent
of the at least one type of payload molecule is within the
interior cavity of the discrete multi-wall carbon nanotubes;
wherein at least about 5% (volume) of the functionalized
discrete carbon nanotubes have an apparent aspect ratio from
about 50% to about 99% of the average actual aspect ratio of
the discrete carbon nanotubes.
Appeal Br. 15, 16 (emphasis added to show certain limitations at issue).
ANTICIPATION
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present case, Appellants persuade us that the preponderance of
the evidence does not support the Examiner's prima facie case of
anticipation as to independent claims 1 and 16. In particular, Appellants
persuade us that the Examiner has not shown sufficiently that Mashat
describes nanotube-containing compositions in which greater than 30 weight
percent of the payload molecule is within the interior cavity of discrete
multi-wall carbon nanotubes, as required by both claims 1 and 16.
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As the Examiner found, Mashat describes the preparation of
drug-carrying carbon nanotubes which are functionalized, that is "coated
with polyethylenimine (PEI) and polyvinyl alcohol (PV A) via the 'zipper
effect' that provides both support and control over drug release. PEI/PVA
provides excellent support to increase DOX [ doxorubicin] loading on the
nanocarrier." Mashat 11503 (abstract).
Mashat explains that its drug delivery system is "controlled by
changes in temperature due to the complexation (low temperature) and
decomplexation (high temperature) of PEI and PV A via hydrogen bonding."
Id. Thus, "[ w ]hen the bonds between PEI and PV A are decomplexed at high
temperature (2:40 °C), drug release was observed as verified by fluorescence
microscopy. There was no drug release at room temperature (25 °C) and a
slow release at normal body temperature (37 °C)." Id.
The Examiner relied on Shen and Rosca as evidence that the acid
treatment used to prepare Mashat' s nanotubes yields discrete nanotubes, as
recited in Appellants' claims. Ans. 4--5.
As to the requirement in Appellants' claims 1 and 16, that at least
30% by weight of the drug in the composition must be loaded into the
nanotubes' interior cavities, the Examiner stated as follows:
[T]he sample was washed 5 times (see pg. 11504, under DOX
loading), which is the similar to the wash filtration disclosed by
Applicant (see pg. 17, [0056]), thus removing the payload
molecule, such as anticancer drug doxorubicin (DOX; see
abstract; pg. 11504, under DOX loading), which is sparingly
soluble in water, from the outside and resulting in 100% of
payload molecule within the interior cavity.
Id. at 3.
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Appellants contend, for several reasons, that certain disclosures in
Mashat do not support the Examiner's finding that at least 30% of the
doxorubicin in Mashat's compositions was loaded into the nanotubes'
interior cavities. App. Br. 7-9 (citing Mashat Figs. 1, 4); Reply Br. 3-7.
The Examiner responds that one "possib[le ]" interpretation of
Mashat's Figure 1 is that the drug diffuses into the "opening on the top and
bottom of the nanotubes and the PV A zipper prevents the drug from
escaping." Ans. 12; see also id. at 13 ("Appellant's composition could be
this exact diagram" of Mashat's Figure 1 annotated to show drug entering
through an open end of a nanotube.) (emphasis added).
In particular, the Examiner contends that Mashat "is theorized to be
inherently having at least 30% drugs inside the nanotube, because
MASHA T's carbon nano tubes have every ingredients as claimed by
Applicant, unless proven otherwise." Ans. 15; see id. ("MASHAT is
inherently having at least 30% drugs inside the nanotube, because
MASHA T's carbon nano tubes have every ingredients as claimed by
Applicant.").
Having carefully considered the arguments and supporting evidence
advanced by Appellants and the Examiner, we find that Appellants have the
better position. As seen above, the Examiner's position, at best, is that it is
possible that at least 30% of Mashat's drug was loaded into the interior
cavity of its nanotubes.
It is well settled, however, that the "very essence of inherency is that
one of ordinary skill in the art would recognize that a reference unavoidably
teaches the property in question." Agilent Technologies, Inc. v. Afjj;metrix,
Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added); see also In re
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Oelrich, 666 F.2d 578, 581 (CCP A 1981) ("Inherency, however, may not be
established by probabilities or possibilities. The mere fact that a certain
thing may result from a given set of circumstances is not sufficient.").
Thus, even if we were to agree that Mashat possibly, or even
probably, discloses that at least 30% its drug was loaded into the interior
cavity of its nanotubes, that fact is insufficient to demonstrate that the
reference unavoidably, that is, inherently, describes nanotubes having that
property. Agilent, 567 F.3d at 1383; Oelrich, 666 F.2d at 581.
We agree with Appellants, moreover, that the disclosures cited by the
Examiner in support of the inherency finding do not actually support the
Examiner's position. As to the Examiner's reliance on Mashat's washing
step as removing exteriorly-bound drug, leaving behind only drug contained
in the nanotubes' interior cavities (Ans. 3), we note that, consistent with
Figure 1 of Mashat cited by Appellants, Mashat's electron microscope
studies show the PEI/PV A polymer combination as being on the exterior of
the carbon nanotubes. Mashat 11505 (discussing Fig. 3).
We note, moreover, Mashat's disclosure, cited by Appellants, that
doxorubicin becomes bound to the nanotubes only when the PEI/PV A
polymer combination is applied to the tubes. See id. (disclosing that control
nanotube samples having no bound polymer, or only bound PEI but no PV A,
"show little DOX load efficiencies ... after washing"). And as noted above,
Mashat discloses that its drug is only released upon heating the nanotubes to
a temperature at which the PEI/PV A combination "decomplex[ es]." Id. at
11503 (abstract) (disclosing effective drug release at temperatures 2:40 °C),
but "slow release" at 37 °C").
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Rather than performing its washing step at a temperature that allows
drug release from the exterior of the nanotubes, the washing step cited by the
Examiner involves washing drug-loaded PEI/PVA coated nanotubes after
the tubes were "cooled down in an ice bath for 2 h[ours]." Id. at 11504.
Thus, Mashat' s washing step was not performed under conditions that
would allow removal of the drug from the exterior of the nanotubes. The
Examiner does not persuade us, therefore, that Mashat's washing step would
remove the exteriorly-bound drug from the nanotubes, leaving only drug
bound to the nanotubes' interior cavities, such that Mashat's compositions
inherently meet the requirement in claims 1 and 16, that at least 30% by
weight of the drug in the compositions is present in the nanotubes' inner
cavities.
Accordingly, because we are not persuaded that a preponderance of
the evidence supports the Examiner's finding that Mashat describes
compositions having all of the features required by independent claims 1 and
16, we reverse the Examiner's rejection of those claims, and their
dependents, as anticipated by Mashat.
OBVIOUSNESS-
MASHAT, SHEN, ROSCA,
AND APPELLANTS' SPECIFICATION
In rejecting claims 1-5, 8-14, 16, 18-22, and 25-34 for obviousness
over Mashat, Shen, Rosca, and Appellants' Specification, the Examiner
relied on the teachings in Mashat, Shen, and Rosca, discussed above, and
cited Appellants' Specification as evidence that it was "well known in the art
to provide directed delivery of a drug to a particular tissue in vivo, such as a
tumor tissue by antibodies." Ans. 6. The Examiner reasoned, therefore, that
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it would have been obvious to bind tissue-targeting antibodies to Mashat's
cancer-treating compositions. Id.
The Examiner also conceded that the cited references "do not
specifically teach the length, size, ratios, carboxylates and amount as
claimed by Applicant." Id. The Examiner found, however, that the "length,
size, ratios, and amount of CNTs [carbon nanotubes] are clearly result
effective parameters that a person of ordinary skill in the art would routinely
optimize." Id. The Examiner concluded, therefore, that claims reciting
specific values for those parameters would have been obvious to an ordinary
artisan. Id. at 7.
As is evident, the Examiner does not identify, nor do we discern, any
specific teachings in any of the cited prior art that remedy the deficiencies,
discussed above, of Mashat with respect to claims 1 and 16. Accordingly,
we reverse this rejection as well.
OBVIOUSNESS-
WU, SHEN, ROSCA, LOWMAN,
AND APPELLANTS' SPECIFICATION
In rejecting claims 1-5, 8-14, 16, 18-22, and 25-34 for obviousness
over Wu, Shen, Rosca, Lowman, and Appellants' Specification, the
Examiner cited Wu as describing functionalized nanotubes containing a drug
loaded into the nanotubes' interior cavities, but conceded that Wu's
compositions differed from the claimed compositions in that "WU does not
teach the carbon nanotubes are mul[t]i-walled." Ans. 9.
To address that deficiency, the Examiner cited Shen as evidence that
multi-walled carbon nanotubes were known in the art. Id. The Examiner
concluded, therefore, that it "would have been obvious to the person of
ordinary skill in the art at the time the invention was made to use multi-
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walled CNTs." Id. at 10. The Examiner reasoned that an ordinary artisan
"would have been motivated to make those modifications, because it would
[sic, provide?] drug loading in other types of carbon nanotubes and
reasonably would have expected success because CNTs only come in single-
walled or multi-walled." Id.
In KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the
Supreme Court emphasized "an expansive and flexible approach" to the
obviousness question, id. at 415, the Court also reaffirmed the importance of
determining "whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue." Id. at 418
(emphasis added).
Ultimately, therefore, "[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art." In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
In the present case, having carefully considered the arguments and
evidence advanced by Appellants and the Examiner, Appellants persuade us
that the Examiner has not shown by a preponderance of the evidence that the
cited references would have rendered obvious the subject matter recited in
Appellants' independent claims 1 and 16. In particular, Appellants persuade
us that the cited references would not have suggested using multi-wall
carbon nanotubes in Wu's compositions.
Claims 1 and 16 both recite compositions that contain multi-wall
carbon nanotubes. Appeal Br. 15 (claim 1 reciting "functionalized discrete
multi-wall carbon nanotubes" (emphasis added)); see also id. at 16 (claim 16
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reciting discrete carbon nanotubes having at least two walls, "an innermost
wall and an outermost wall," and also reciting that greater than 30 weight
percent of the claimed composition's payload molecule is within the interior
cavity "of the discrete multi-wall carbon nanotubes" (emphasis added)).
In contrast, as the Examiner concedes, Wu describes compositions
that contain single-wall carbon nanotubes. See, e.g., Wu 5476 (Fig. lb
showing an electron micrograph of an array of Wu's synthesized nanotubes,
each having a single tubular wall).
The Examiner contends that substituting a multi-wall nanotube, such
as disclosed in Shen, for the single wall nanotubes used in Wu's
compositions, would have been obvious
because there are only two types of walls for carbon nanotubes,
such as single-walled and multi-walled. There is no such thing
as a "no-walled" nanotube. One skilled in the art would have to
pick one or both. Thus, it would have been obvious for one
skilled in the art to pick one or both.
Ans. 17.
As Appellants point out, however, Wu contrasts its carbon nanotubes
from conventional ones, and describes a specialized process for preparing its
carbon nanotubes and loading them with a drug:
In contrast to conventional CNTs, the CNTs used here
have a relatively large diameter ( ~40 nm inner diameter). The
CNTs are fabricated in an array with a perfectly aligned vertical
orientation by growing them in a highly ordered and uniform
anodic aluminum oxide (AAO) nanopore array template by
chemical vapor deposition (CVD). After fabrication the CNTs
undergo either a mechanical or chemical treatment to open both
ends while embedded in the template, which provides access to
the interior space for en-masse loading of molecules. Drug
loading was accomplished by depositing droplets of the drug
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solution on top of the vertically aligned nanotube array
membrane while applying vacuum suction at the bottom.
The template-synthesized carbon nanotubes are
intrinsically conductive but possess higher electrical resistivity
than those synthesized by arc-discharging. This property is
beneficial for our purpose ....
Wu 5476.
Thus, contrary to the Examiner's contention that multi-wall and
single-wall nanotubes may be arbitrarily substituted for each other in Wu's
compositions, Wu expressly contrasts conventional nanotubes from the
single-walled nanotubes produced by its specialized process, and further
discloses that the single-walled nanotubes produced by its specialized
process are particularly suited to its drug delivery techniques. Given the
specialized nature of the single-wall nanotubes used in Wu's compositions,
the Examiner does not persuade us that an ordinary artisan would have been
motivated to arbitrarily replace Wu's nanotubes with multi-wall nanotubes.
The Examiner, moreover, does not identify in the record any specific
evidence suggesting that the multi-wall nanotubes described in Shen, or any
other multi-wall nanotubes, would be suitable, or even useful, for the
particular applications described in Wu. In that regard, we note that Rosca,
Lowman, and Appellants' Specification were cited as evidence of the
obviousness of features not relating to the requirement in claims 1 and 16 for
the composition to contain multi-wall nanotubes. See Ans. 9.
In sum, the Examiner does not provide a specific evidentiary basis to
support a finding that an ordinary artisan would have considered multi-wall
nanotubes equivalently useful to the single-wall nanotubes used in Wu's
compositions. The Examiner does not persuade us, therefore, that an
ordinary artisan would have considered it obvious to substitute multi-wall
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nanotubes for the single-wall nanotubes used in Wu's compositions.
Accordingly, because a preponderance of the evidence does not support the
Examiner's conclusion that Wu, Shen, Rosca, Lowman, and Appellants'
Specification teach or suggest a composition having all of the elements
required by Appellants' independent claims 1 and 16, we reverse the
Examiner's obviousness rejection of those claims, and their dependents, over
the cited prior art.
SUMMARY
For the reasons discussed, we reverse each of the Examiner's
rejections.
REVERSED
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