Ex Parte Bourne et al

Patent Trial and Appeal Board

Jan 29, 2019

14082274 (P.T.A.B. Jan. 29, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/082,274 11/18/2013
121974 7590 01/31/2019
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
George Bourne
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.
4010/l 14D3 3228
EXAMINER
PIPIC,ALMA
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
01/31/2019 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE BOURNE, MICHAEL MADDEN,
ARTHUR R. MADENJIAN, DOREEN RAO, MARCIA BUISER,
JIANMIN LI, RAYMOND RACKLEY, and BARRY N. GELLMAN 1
Appeal2017-009790
Application 14/082,274
Technology Center 1600
Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness and new matter. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 Appellant, is the Applicant, Boston Scientific Scimed, Inc., which,
according to the Brief, is the real party in interest. App. Br. 2.
Appeal2017-009790
Application 14/082,274
STATEMENT OF CASE
The following claim is representative.
14. A method for bulking mammalian tissue comprising
the steps of:
introducing a bulking agent to the mammalian tissue, the
bulking agent comprising: a carrier, and a plurality of
substantially spherical polyvinyl alcohol particles dispersed
within the carrier, the substantially spherical polyvinyl alcohol
particles comprising surface pores covering up to 80% of the
total surface area of the particles and the carrier aiding delivery
of the substantially spherical polyvinyl alcohol particles to a
site to be bulked; and
coapting the mammalian tissue with the substantially
spherical polyvinyl alcohol particles.
46. A method for bulking mammalian tissue comprising:
inserting an inflation device within a portion of a
mammal;
inflating the inflation device, thereby creating a void in
the tissue; and
at least partially filling the void with a bulking agent that
comprises a carrier and a plurality of polymeric particles
dispersed within the carrier, wherein the plurality of polymeric
particles comprise surface pores covering up to 80% of the total
surface area of the particles.
Cited References
Van Bladel et al. us 5,813,411 Sept. 29, 1998
("Van Bladel")
Bley et al. us 5,855,615 Jan. 5, 1999
("Bley")
Vanderhoff et al. US 6,214,331 Bl Apr. 10, 2001
("Vanderhoff')
Yao et al. US 6,268,405 B 1 July 31, 2001
("Yao")
Goupil et al. US 6,652,883 B2 Nov. 25, 2003
("Goupil")
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Appeal2017-009790
Application 14/082,274
Johnson et al.
("Johnson")
Bourne et al.
(Bourne '400")
Bourne et al.
("Bourne '071 ")
Grounds of Rejection
US 7,185,657 Bl
US 8,394,400 B2
US 8,586,071 B2
Mar. 6, 2007
Mar. 12, 2013
Nov. 19, 2013
1. Claims 14--17 and 34--49 are rejected under 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply
with the written description requirement.
2. Claims 14, 15, 17, 34, 35, 38--40, and 42--45 are rejected under
pre-AIA 35 U.S.C. § I03(a) as being unpatentable over Van
Bladel, Vanderhoff, and Yao.
3. Claim 16 is rejected underpre-AIA 35 U.S.C. § I03(a) as being
unpatentable over Van Bladel, Vanderhoff, Yao, and Bley.
4. Claims 36, 37, 41, and 49 are rejected under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Van Bladel, Vanderhoff, Yao,
and Goupil.
5. Claims 46--48 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Johnson in view of Van Bladel,
Vanderhoff, and Yao.
6. Claims 14, 15, 17, 34--36, 38, and 46--48 are rejected on the
ground of nonstatutory double patenting as being unpatentable
over claims 1---6 of U.S. Patent No. 8,586,071 B2 in view of
Vanderhoff and Yao.
7. Claim 16 is rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-6 of U.S. Patent
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Application 14/082,274
No. 8,586,071 B2 in view of Vanderhoff and Yao as applied to
claims 14, 15, 17, 34--36, 38, and 46-48 above and further in view
of Bley.
8. Claims 39, 40, and 42--45 are rejected on the ground of
nonstatutory double patenting as being unpatentable over claims
1---6 of U.S. Patent No. 8,586,071 B2 and Vanderhoff and Yao as
applied to claims 14, 15, 17, 34--36, 38, and 46-48 above and
further in view of Van Bladel.
9. Claims 37, 41, and 49 are rejected on the ground ofnonstatutory
double patenting as being unpatentable over claims 1-6 of U.S.
Patent No. 8,586,071 B2 and Vanderhoff and Yao as applied to
claims 14, 15, 17, 34--36, 38, and 46-48 above and further in view
of Goupil.
10. Claims 14, 15, 17, 34, 35, 36, 38--40, and 46-48 are rejected on
the ground of nonstatutory double patenting as being unpatentable
over claims 1-21 of U.S. Patent No. 8,394,400 B2 in view of
Vanderhoff et al. and Yao.
11. Claim 16 is rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-21 of U.S. Patent
No. 8,394,400 B2 in view of Vanderhoff and Yao as applied to
claims 14, 15, 17, 34--36, 38, and 46-48 above and further in view
of Bley.
12. Claims 37, 41, and 49 are rejected on the ground ofnonstatutory
double patenting as being unpatentable over claims 1-21 of U.S.
Patent No. 8,394,400 B2 and Vanderhoff and Yao as applied to
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Application 14/082,274
claims 14, 15, 17, 34--36, 38, and 46-48 above and further in view
of Goupil.
13. Claims 42--45 are rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-21 of U.S. Pa tent
No. 8,394,400 B2 and Vanderhoff and Yao as applied to claims
14, 15, 17, 34--36, 38, and 46-48 above and further in view of Van
Bladel.
14. Claims 14, 15, 34, 35, 41, and 49 are rejected on the ground of
nonstatutory double patenting as being unpatentable over claims
1-26 of U.S. Patent No. 7,611,542 B2 and further in view of Yao.
15. Claim 16 is rejected on the ground ofnonstatutory double
patenting as being unpatentable over claims 1-26 of U.S. Patent
No. 7,611,542 B2 and Yao as applied to claims 14, 15, 34, 35, 41,
and 49 above and further in view of Bley.
16. Claims 17, 38--40, and 42--45 are rejected on the ground of
nonstatutory double patenting as being unpatentable over claims
1-26 of U.S. Patent No. 7,611,542 B2 and Yao as applied to
claims 14, 15, 34, 35, 41, and 49 above and further in view of Van
Bladel.
17. Claims 36 and 37 are rejected on the ground ofnonstatutory
double patenting as being unpatentable over claims 1-26 of U.S.
Patent No. 7,611,542 B2 and Yao as applied to claims 14, 15, 34,
35, 41, and 49 above and further in view of Goupil.
18. Claims 46-48 are rejected on the ground ofnonstatutory double
patenting as being unpatentable over claims 1-26 of U.S. Patent
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Appeal2017-009790
Application 14/082,274
No. 7,611,542 B2 and Yao as applied to claims 14, 15, 34, 35, 41,
and 49 above and further in view of Johnson.
19. Claims 14, 15, 17, 38--45, and 49 are rejected on the ground of
nonstatutory double patenting as being unpatentable over claims
1-27 of U.S. Patent No. 7,131,997 B2 in view of Yao and Van
Bladel.
20. Claim 16 is rejected on the ground ofnonstatutory double
patenting as being unpatentable over claims 1-27 of U.S. Patent
No. 7,131,997 B2, Yao, and Van Bladel as applied to claims 14,
15, 17, 38--45, and 49 above and further in view of Bley.
21. Claims 34, 35, and 36 are rejected on the ground ofnonstatutory
double patenting as being unpatentable over claims 1-27 of U.S.
Patent No. 7,131,997 B2, Yao, and Van Bladel as applied to
claims 14, 15, 17, 38--45, and 49 above and further in view of
Vanderhoff.
22. Claims 36 and 37 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1-27 of U.S.
Patent No. 7,131,997 B2, Yao, and Van Bladel as applied to
claims 14, 15, 17, 38--45, and 49 and further in view of Goupil.
23. Claims 46--48 are rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-27 of U.S. Patent
No. 7,131,997 B2, Yao, and Van Bladel as applied to claims 14,
15, 17, 38--45, and 49 above and further in view of Johnson.
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Application 14/082,274
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at pages
2--43.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Moreover, "obviousness requires a suggestion of all limitations in a
claim." CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
New Matter, 112,first paragraph Rejection 1
Claims 14--17 and 34--49 are rejected under 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with
the written description requirement.
The Examiner withdrew this rejection in the Answer. Ans. 43.
Obviousness-type Double Patenting Rejections 6-23
Rejections 6-23 as set forth in the Grounds of Rejection above are not
argued by Appellants in the Brief or Reply Brief, and therefore are
summarily affirmed. Arguments not made are waived.
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Application 14/082,274
Obviousness Rejections (Rejections 2-4)
Claims 14, 15, 17, 34, 35, 38--40, and 42--45 are rejected under pre-
AIA 35 U.S.C. § 103(a) as being unpatentable over Van Bladel, Vanderhoff,
and Yao. Claim 16 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Van Bladel, Vanderhoff, Yao, and Bley. Claims 36, 37,
41, and 49 are rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Van Bladel, Vanderhoff, Yao, and Goupil.
These three rejections are based upon the same primary combination
of references Van Bladel and Vanderhoff. The dispositive issue for each of
the rejections is whether the primary references teach or suggest the claim
limitation that, "the substantially spherical polyvinyl alcohol particles
comprising surface pores covering up to 80% of the total surface area of the
particles." Claim 14.
The Examiner finds that
teachings of Van Bladel are related to a method of treating
urinary disorders utilizing physiologically acceptable
composition including a plurality of hydro gel particles
(Abstract). The composition is injected into tissues adjacent to a
selected tissue structure thereby deforming the selected tissue
structure.
Ans. 3.
The Examiner further finds that, "[ a ]lthough Van Bladel teaches that
the particles contain pores, they do not teach pore sizes and if the pores are
on the surface of the particles." Id.
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Application 14/082,274
With respect to the limitation of "the substantially spherical polyvinyl
alcohol particles comprising surface pores covering up to 80% of the total
surface area of the particles," the Examiner finds that
[A] person of ordinary skill in the art at the time of the
invention to have modified the particles of Van Bladel modified
with Vanderhoff by varying pore size in the range of below 125
micron and varying pore density from 10 pores/cm3 to 105
pores/cm3, with a reasonable expectation of success because
Yao teaches that pore density that ranges from 10 pores/cm3 to
105 pores/cm3 is useful for polyvinyl[] alcohol particles
intended for soft tissue augmentation. Varying these parameters
would have yielded particles that have surface pores covering
an area that is at least close enough to the claimed surface area
of up to 80% of the total surface area of the particles.
Vanderhoff teaches the presence of pores in the particles but
does not provide any guidance regarding pore density.
Therefore, a person of ordinary skill would have been
motivated to look to Yao for guidance on suitable pore densities
of polyvinyl alcohol particles that are intended for bulking
tissue. The claimed pore surface area of the particles is obvious
over the prior art particles because there is no evidence of
criticality of the claimed surface area.
Final Act. 8.
Appellants contend that, "the cited references alone and in
combination fail to teach or suggest substantially spherical polyvinyl alcohol
particles, which include surface pores covering up to 80% of the total
surface area thereof." App. Br. 10; Reply Br. 6.
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness. In particular, the Examiner has failed to
provide evidence in the cited prior art that shows substantially spherical
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Application 14/082,274
polyvinyl alcohol particles, which include surface pores covering up to 80%
of the total surface area of the particles. The Examiner argues that varying
the pore size and pore density parameters would have yielded particles that
have surface pores covering an area that is at least close enough to the
claimed surface area of up to 80% of the total surface area of the particles.
Final Act. 8.
We are not persuaded by the Examiner's arguments. While
Vanderhoff teaches particle pore sizes and Yao teaches particle pore
densities, the Examiner has not pointed to a specific teaching in the cited
references of particles that have surface pores covering an area that is at least
close enough to the claimed surface area of up to 80% of the total surface
area of the particles. The Examiner has not established with evidence, a
clear relationship between pore density and covering a surface area up to
80% of the total surface area of the particles. Put another way, the Examiner
has not established with evidence, that it was known in the art at the time of
the invention that varying particle pore size and particle pore density would
necessarily result in particles that have surface pores covering an area that is
at least close enough to the claimed surface area of up to 80% of the total
surface area of the particles.
The Examiner has not shown that any of the secondary references
overcome the deficiencies of the primary combination of references.
Rejections 2-4 are reversed.
Obviousness Rejection 5
Claims 46-48 are rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Johnson in view of Van Bladel, Vanderhoff, and Yao.
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Application 14/082,274
Appellants contend that, "[t]here is no mention in Johnson of
spherical polyvinyl alcohol particles that include surface pores, and
therefore Johnson does nothing to cure the above-noted deficiencies of Van
Bladel, Vanderhoff and Yao with respect to claim 14." App. Br. 11-12.
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness. This rejection of representative claim 46
suffers from the same deficiency as the rejection of claim 14. The Examiner
has not pointed to a specific teaching in the cited reference of particles that
have surface pores covering an area that is at least close enough to the
claimed surface area of up to 80% of the total surface area of the particles.
Adding Johnson to this rejection does not make up the deficiencies of Van
Bladel, Vanderhoff, and Yao indicated above.
Obviousness rejection 5 is reversed.
CONCLUSION OF LAW
The cited references do not support the Examiner's obviousness
rejections 2-5 as set forth in the grounds of rejection, which are reversed.
The obviousness-type double patenting rejections 6-23 are affirmed.
Because all claims remain rejected for obviousness-type double patenting,
the rejection of the pending claims is affirmed.
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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