Ex Parte MORALES

Patent Trials and Appeals Board

May 30, 2019

15103791 - (D) (P.T.A.B. May. 30, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
15/103,791 06/10/2016
77218 7590 06/03/2019
Medtronic Vascular - APV Division
c/o IP Legal Department
3576 Unocal Place
Santa Rosa, CA 95403
FIRST NAMED INVENTOR
Carlos R. MORALES
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.
355847.USN4 2882
EXAMINER
GHALI, ISIS AD
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
06/03/2019 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):
rs. docketingapv@medtronic.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CARLOS R. MORALES
Appeal2019-000315
Application 15/103,791
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and JAMIE T. WISZ,
Administrative Patent Judges.
WISZ, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 seeks review of claims
1-24. We have jurisdiction under 35 U.S.C. § 6(b).
For the reasons set forth below, we affirm.
STATEMENT OF THE CASE
The specification describes a method for treating a vein comprising
the use of a radiopaque medical cyanoacrylate composition comprising a
1 Appellant identifies the Real Party in Interest as Medtronic plc, which is
the ultimate parent entity of the assignee of record, Covidien LP. App. Br.
3.
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Application 15/103,791
cyanoacrylate monomer and a radiopacifier. Spec. 2. Claim 1, which is
illustrative, is set forth below:
1. A radiopaque medical cyanoacrylate composition
compnsmg:
a cyanoacrylate monomer; and
a radiopacifier comprising nanoparticles having a mean size
of from about 3 nanometers (nm) to about 15 nm, wherein
the nanoparticles do not substantially agglomerate within the
composition at about 20 degrees Celsius (°C), and wherein
the composition has a viscosity of between about 1,000
centipoise (cP) and about 2,000 cP.
App. Br. 19 (Claim Appendix). Independent claim 11 recites a method of
forming the claimed radiopaque medical cyanoacrylate composition and
independent claim 21 recites a method of using the composition in a patient.
Id. at 21-22.
The Examiner rejected claims 1-24 under 35 U.S.C. § 112(a) for
failing to comply with the written description requirement.
The Examiner rejected claims 1-24 under 35 U.S.C. § I03(a) as being
obvious over Porter2 and Jackson. 3
ISSUES AND ANALYSIS
We reverse the Examiner's written description rejection and affirm
the Examiner's obviousness rejection. We address the arguments raised by
Appellant below.
2 Porter, US 2003/0039696 Al, published Feb. 27, 2003 ("Porter").
3 P. Jackson et al., Evaluation of the effects of gold nanoparticle shape and
size on contrast enhancement in radiological imaging, 34 AUSTRALAS PHYS
ENG SCI MED, 2011, at 243 ("Jackson").
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Written Description
The Examiner finds that claims 1-24 fail to comply with the written
description requirement because the limitation of a mean particle size of
"from about 3 nanometers (nm) to about 15 nm," as recited in the claims, is
not disclosed with sufficient specificity. 4 Final Act. 3--4. Appellant asserts
that this limitation is supported by a number of species within the claimed
range because the specification describes examples of mean particle sizes,
including a range of "mean particle size ... less than about . . . 15 nm ... ,
or less," and "a radiopacifier comprising nanoparticles having a mean size of
less than about 15 nanometers (nm) .... " App. Br. 6 (citing Spec. ,r,r 70,
76). Appellant also points out that the specification describes specific mean
particle sizes, for example, "about 1 nm, 2 nm, 3 nm, 4 nm, 5nm, ... , or 10
nm." Id. (citing Spec. i-f70). Appellant argues that these facts are similar to
those in In re Wertheim, 541 F.2d 257,265 (CCPA 1976) because the
specification describes a range and specific examples within the range. Id.
We find that Appellant has a better position. The specification
discloses an upper range of 15 nm and discloses species within the claimed
range of about 3 nm to about 15 nm. We agree with Appellant that this
tracks the Wertheim fact pattern and reasonably provides support for the
range recited in claim 1. Therefore, to the extent that the rejection of claims
1-24 under 35 U.S.C. § 112(a) is maintained, we reverse.
4 It is not clear whether the Examiner maintains this rejection under 35
U.S.C. § 112(a); therefore, we address the rejection here in the event that the
rejection is maintained. It does appear that the Examiner withdrew the
rejection of claim 24 under 35 U.S.C. § 112(b) based on the statement in the
Jan. 17, 2018 Applicant-Initiated Interview Summary that the "rejection will
be withdrawn." Therefore, we do not address the§ 112(b) rejection.
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Application 15/103,791
Obviousness
The Examiner finds that Porter teaches a method for treating
vasculature abnormalities, such as an aneurysm, by administering an
embolization composition comprising cyanoacrylate and radiopacifier
powder. Final Act. 7 ( citing Porter abstract, ,r,r 6-10). The Examiner also
finds that Porter teaches that the radiopacifier powder has sub-micron sized
particles and high x-ray absorbance and that the composition has a viscosity
between 25 cP and 2,000 cP. Id. ( citing Porter ,r,r 6, 14, 15). The Examiner
concedes that Porter does not explicitly teach the claimed particle size and
relies on Jackson for this disclosure. Id. at 8. Specifically, the Examiner
finds that Jackson teaches "gold nanoparticles (AuNPs) as contrast
enhancement in radiological imaging" using nanoparticles of a size of 4-30
nm. Id. (citing Jackson 243). The Examiner concludes:
Id.
Therefore, it would have been obvious to one having
ordinary skill in the art at before the effective filing date of the
present invention to provide emobilizing composition
comprising cyanoacrylate polymer and radiopacifier of gold
particles of sub-micron size as taught by Porter, and use AuNPs
having diameter of 4-30 nm taught by Jackson in the
emobilizing composition. One would have been motivated to do
so because Porter desired to include the radiopacifier to
visualize the composition during injection by x-ray, and
because Jackson teaches that AuNPs are ideal as radiopaque
contrast agent because of their biocompatibility, and
nanoparticles of size of 4-30 nm have maximum stability
without affecting the size on contrast enhancement. One would
reasonably expect formulating biocompatible emobilizing
composition comprising cyanoacrylate polymer and AuNPs
having diameter of 4-30 nm wherein the composition has
maximum stability and wherein the particle sizes does not
affect the contrast enhancement.
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1. Claims 1-5, 9-15, 19, and 20
Appellant argues that there would have been no apparent reason that
would have caused one of ordinary skill in the art to modify the applied
references to arrive at the claimed subject matter. App. Br. 8. Specifically,
Appellant argues that Jackson does not describe that stability results from a
particle size of 4--30 nm but, rather, describes nanoparticle-based contrast
agents in this size range "'can be synthesized for maximum stability or cell
specificity ( directed cellular uptake) without consideration of effect of size
on contrast enhancement,' and Jackson specifically describes
'[h]ydrophobised gold nanoparticles stabilised by hexadecylamine,' and
'PVA polymer-stabilised gold nanoparticles[.]"' Id. at 9 (citing Jackson
244). Therefore, Appellant argues that "Jackson's stabilization is a
consequence of chemical treatment, rather than particle size" and the "mere
description that nanoparticles may have a size of 4--30 nm does not provide a
legally sufficient motivation for a person having ordinary skill in the art to
modify the radiopacifier particles of Porter to have such a size." Id.
Appellant further asserts that even if there would be an apparent
reason to modify Porter in view of Jackson, "Porter fails to recognize or
suggest the criticality of particle sizes recited by claim 1." Id. at 10.
Appellant argues that the specification describes an unexpected result
illustrating the criticality of the claimed range by describing that particles
having a particle size of "15-500 nm ... or greater size ... surprisingly, tend
to sink to the bottom and agglomerate as well." Id. (citing Spec. ,r 67).
Appellant argues that "the Examiner has failed to articulate a reason with
rational underpinning as to why a person having ordinary skill in the art
would have modified Porter's particles to have an upper limit of particle size
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of 15 nm in particular, without impermissibly relying on Appellant's own
disclosure." Id.
We are not persuaded by Appellant's arguments. With respect to the
nanoparticle size, Jackson discloses that gold nanoparticles in the size range
of 4--30 nm can effectively be used as contrast enhancement in radiological
imaging. Jackson 243. Therefore, one of skill in the art would have been
motivated to use nanoparticles of this size with the embolizing composition
disclosed in Porter with a reasonable expectation of success. "A prima facie
case of obviousness typically exists when the ranges of a claimed
composition overlap the ranges disclosed in the prior art." In re Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003).
With regard to Appellant's argument that the specification teaches
that particles with particle sizes greater than 15 nm surprisingly tend to sink
to the bottom and agglomerate, it would have been obvious to one of skill in
the art to optimize the particle size to prevent such agglomeration. See In re
Aller, 220 F.2d 454, 456 (CCP A 1955) ("[W]here 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."). Such
optimization is recognized in Porter which states that "[t]he amount and size
of the particles can be determined by one with skill in the art in the manner
that is suitable for fluoroscopic visualization of the embolic material during
injection through a suitable device, such as a microcatheter, and for
achieving the desired stability of the suspended particulates." Porter ,r 55.
Similarly, Jackson states that "[w]e advise that for design of prospective
nanoparticulate contrast media in this measured size range, particle diameter
and shape be tailored to achieve optimal safety and retention profiles."
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Jackson 248. Furthermore, Appellant does not provide comparative
evidence of unexpected results relative to the closest prior art. See In re
Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.").
Appellant also asserts that the viscosity of 50-2,000 cP described by
Porter is significantly broader than the viscosity of between about 1,000 cP
and 2,000 cP as recited in claim 1 and that one of ordinary skill in the art
would not have readily envisioned employing the "much narrower" viscosity
range of the claims. Id.
Similarly, we are not persuaded by Appellant's arguments. The
Examiner has established that Porter discloses a radiopaque cyanoacrylate
composition with a viscosity range of 50-2,000 cP, which overlaps with the
claimed range of about 1,000 to about 2,000 cP. "In cases involving
overlapping ranges, we and our predecessor court have consistently held that
even a slight overlap in range establishes a prim a facie case of obviousness."
Peterson, 315 F.3d at 1329.
Furthermore, although Appellant argues that the viscosity range
disclosed in Porter is broader than the claimed range, Appellant has not
submitted evidence establishing criticality of the claimed range or
comparing representative samples of the claimed compositions with
representative samples of the compositions disclosed in the prior art to
establish unexpected results, nor is there such exemplification in Appellant's
specification. "The law is replete with cases in which the difference
between the claimed invention and the prior art is some range or other
variable within the claims. These cases have consistently held that in such a
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situation, 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." In re Woodruff, 919 F. 2d 1575, 1578 (Fed.
Cir. 1990). Consequently, we do not find Appellant has established
unexpected results or other criticality of the claimed range.
For the foregoing reasons, Appellant does not persuade us that the
Examiner erred in rejecting claim I for obviousness over Porter and Jackson.
Claims 2----5, 9, and 10 are not argued separately and fall with claim 1. See
37 C.F.R. § 4I.37(c)(l)(iv).
With respect to independent claim 11, the Examiner finds that "the
method requires only the step of mixing the ingredients that [are] implied by
Porter." Final Act. 11. Appellant makes the same arguments as those made
for claim 1. App. Br. 15-16. Therefore, for the reasons stated above with
respect to claim 1, we are also not persuaded that the Examiner erred in
rejecting claim 11 for obviousness over Porter and Jackson. Claims 12----15,
19, and 20 are not argued separately and fall with claim 11. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
2. Claims 6 and 16
Claim 6 recites the composition of claim 1, "wherein the composition
has a shelf life without the nanoparticles agglomerating in the composition
of greater than about two weeks." App. Br. 20. Claim 16 recites the same
shelf-life limitation with respect to a method of using the composition. Id. at
21.
The Examiner finds that because the cited references teach the
composition of claim 1 ( and method of claim 11 ), "it is expected that the
composition would display the same property, such as absence of
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agglomeration and shelf-life, since materials and their properties are
inseparable." Final Act. 9-10. Appellant argues that the references do not
teach the composition of claim 1 and that "the Examiner has not established
that a person having ordinary skill in the art, by modifying Porter's
composition in view of Jackson, would have arrived at a composition having
a shelf life of greater than two weeks." App. Br. 12-13.
We are not persuaded by Appellant's argument. As discussed above,
one of skill in the art could optimize the particle size of the nanoparticles to
reduce agglomeration, thereby optimizing the shelf life of the composition.
Furthermore, with regard to viscosity, Appellant has not demonstrated that
the claimed viscosity range is more beneficial than the range provided in
Porter with respect to shelf-life.
For the foregoing reasons, Appellant does not persuade us that the
Examiner erred in rejecting claims 6 and 16 for obviousness over Porter and
Jackson.
3. Claims 7 and 17
Claim 7 recites the composition of claim 1 "wherein the nanoparticles
include a surface treatment configured to prevent surface oxidation." App.
Br. 20. Claims 17 recites the same "surface treatment" limitation with
respect to the method of using the composition. Id. at 22.
The Examiner finds that Porter teaches that the radiopaque particles
are surface modified using thiol compounds to improve the stability of the
particles within the composition, just as the specification discloses surface
treatment using thiol compounds as a capping agent. Final Act. 7, 10 ( citing
Porter ,r 57). In response, Appellant argues:
Firstly, Porter's use of thiol as a coupling agent is different
from a surface treatment by a thiol ( where the thiol would be at
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the surface). Instead, the thiol of Porter is not exposed or at a
surface, and is instead coupled between C6 polymers and the
surface. Secondly, the Examiner has not established that a
person having ordinary skill in the art would have understood
thiol coupling a C6 polymer to a surface would have resulted in
"a surface treatment configured to prevent surface oxidation,"
as recited by claim 7. To the extent the Examiner relied on
Appellant's description of "surface treatment of [] nanoparticles
with a capping agent or other method to avoid surface
oxidation," and "treating the particles surface with 1-
decanethiol for surface capping," such description is of surface
capping with a thiol, not coupling a different species to a
surface. Such surface capping is different from the coupling
described by Porter.
App. Br. 13-14 (internal citations omitted).
We are not persuaded by Appellant's argument. The specification at
paragraph 72 describes a "surface treatment of the nanoparticles with a
capping agent or other method to avoid surface oxidation." Spec.
,r 72. The following paragraph of the specification then appears to provide
specific examples of such surface treatments by listing agents that "modify
the surface chemistry of the particles," including a modification by thiol
coupling to Au. Spec. ,r 73. Porter discloses the same list of surface
treatments of the radiopaque particles (compare Porter ,r 57 to Spec. ,r 73),
including thiol coupling to Au. Porter ,r 57. Therefore, the Examiner
reasonably finds that the thiol coupling to Au disclosed in Porter is a surface
treatment configured to prevent surface oxidation as required by claim 7.
This finding shifted the burden to Appellant to demonstrate, with
evidence, that the surface modifications disclosed in Porter do not prevent
surface oxidation. Appellant provides no such evidence. See In re Best, 562
F.2d 1252, 1255 (CCPA 1977) ("Where, as here, the claimed and prior art
products are identical or substantially identical ... the PTO can require an
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applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product."). Although Appellant
argues that such thiol coupling is different than thiol capping and does not
necessarily prevent surface oxidation, they have not provided sufficient
information to explain why this is the case nor to explain why the surface
modifications disclosed in paragraph 73 of the specification ( and in
paragraph 57 of Porter) are different than the surface treatments disclosed in
paragraph 72 of the specification.
For the foregoing reasons, Appellant does not persuade us that the
Examiner erred in rejecting claims 7 and 17 for obviousness over Porter and
Jackson.
4. Claims 8 and 18
Claim 8 recites the composition of claim 7, "wherein the surface
treatment comprises a capping agent." App. Br. 20. Claim 18 recites the
same "capping agent" limitations with respect to the method claim. Id. at
22.
As discussed above, the Examiner finds that "Porter teaches thiol
treatment of the surface of metal particles, and applicants disclosed surface
treatment using thiol compounds as a capping agent." Final Act. 10.
Specifically, the specification states that "1-decanethiol is a capping agent
used to repeal electric surface charges and to avoid surface particle
agglomeration." Spec. ,r 134.
Appellant argues that "[t]o the extent the Examiner has taken the
position that Porter's C6 polymers coupled to the particles constitutes surface
capping, Porter fails to disclose or suggest that the C6 polymers prevent
surface oxidation." Ans. 15.
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As discussed above, Appellant has not demonstrated, with evidence,
that the surface modifications disclosed in Porter do not prevent surface
oxidation. Furtherrnore, use of capping agents on nanoparticles is known as
shown, for example, in Jackson. ("The effect of nanopmiicle size and
capping agent (surfactant) on changes in attenuation coefficient, as relevant
to X-ray absorption spectroscopy (XAS), has been well documented."
Jackson 244). Porter similarlv discloses the addition of a surfactant as a
, ~
possible surface treatment. Porter ,-r 57.
For the foregoing reasons, Appellant does not persuade us that the
Examiner erred in rejecting claims 8 and 18 for obviousness over Porter and
Jackson.
5. Claims 21-24
Claim 21 recites a method of injecting the claimed composition into a
body lumen of a patient. App. Br. 22. The Examiner finds that Porter
teaches injection of the composition disclosed therein to a vessel that is
obviously an artery or vein. Final Act. 10. Appellant argues that the
Examiner erred for the same reasons discussed for claim 1. Therefore, for
the reasons explained above for claim 1, Appellant does not persuade us that
the Examiner eITed in rejecting claim 21 for obviousness over Porter and
Jackson. Claims 22----24 are not argued separately and fall with claim 1. See
37 C.F.R. § 4I.37(c)(l)(iv).
CONCLUSION
We reverse the Examiner's written description rejection of claims 1-
24. We affirm the Examiner's obviousness rejection of claims 1-24.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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