Ex Parte Vresilovic et al

Board of Patent Appeals and Interferences

Jul 19, 2012

11510747 (B.P.A.I. Jul. 19, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/510,747 08/25/2006 Edward Vresilovic 183401-3028 7510
50787 7590 07/19/2012
STRADLEY RONON STEVENS & YOUNG, LLP
30 VALLEY STREAM PARKWAY
GREAT VALLEY CORPORATE CENTER
MALVERN, PA 19355-1481
EXAMINER
HARVEY, JULIANNA NANCY
ART UNIT PAPER NUMBER
3733
MAIL DATE DELIVERY MODE
07/19/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte EDWARD VRESILOVIC, MICHELE S. MARCOLONGO,
ANTHONY M. LOWMAN, ALASTAIR J.T. CLEMOW, and
MICHAEL F. KEANE
__________

Appeal 2011-002321
Application 11/510,747
Technology Center 3700
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
prosthesis used to replace or supplement a portion of an intervertebral disk.
The Examiner has rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.
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STATEMENT OF THE CASE
The instant Specification describes a method and prosthesis for
replacing or supplementing the nucleus pulposus of an intervertebral disc in
a patient, and specifically an expandable balloon prosthesis comprising
biocompatible material, such as a hydrogel. (Spec. [0002], [0006].)
Claims 6, 8-14, 21, 23, 24, and 26-32 are on appeal, with claims 6 and
21 being independent. Claim 6 is representative and reads as follows
(emphasis added):
6. A prosthesis for replacing or supplementing a nucleus pulposus of
an intervertebral disk, comprising a pre-formed expandable balloon
having flexible walls defining an inner cavity, the flexible walls
having a thickness from about 0.02 mm to about 1.00 mm and a filling
tube passing through the flexible walls and in communication with the
inner cavity so that the prosthesis is fillable, said pre-formed balloon
being adapted to be inserted into the intervertebral disk through a
cannula, wherein said flexible walls are made from a material
comprising a cryogel formed from subjecting an aqueous solution
comprising poly (vinyl alcohol) to repeated freeze-thaw cycles, said
expandable pre-formed balloon being filled through the filling tube
with a biocompatible material selected from the group consisting of a
biocompatible liquid, a biocompatible polymer, and a biocompatible
hydrogel in an expanded configuration, and the prosthesis having a
tensile modulus of about 0.02 MPa to about 0.8 MPa at 30% strain.
Independent claim 21 recites a step of providing a prosthesis having
elements recited in claim 6 (e.g., a balloon with “flexible walls having a
thickness from about 0.02 mm to about 1.00 mm” and a prosthesis having a
specific “tensile modulus”), as well as additional steps in a method for
replacing or supplementing a nucleus pulposus of an intervertebral disk.

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The claims stand rejected as follows:
• Claims 6, 9, 10, 21, 24, and 26 under 35 U.S.C. §103(a) as obvious
over Ku1 in view of Desrosiers et al.2 and Bloemer et al.3
• Claims 8 and 23 under 35 U.S.C. §103(a) as obvious over Ku in
view of Desrosiers and Bloemer, and further in view of Marcolongo et al.4
• Claims 11 and 27 under 35 U.S.C. §103(a) as obvious over Ku in
view of Desrosiers and Bloemer, and further in view of Binette et al.5
• Claims 12-14 and 28-30 under 35 U.S.C. §103(a) as obvious over
Ku in view of Desrosiers and Bloemer, and further in view of Cheng et al.6
• Claims 31 and 32 under 35 U.S.C. §103(a) as obvious over Ku in
view of Desrosiers and Bloemer, and further in view of Trieu.7
I.
Issues
Does the Examiner establish that claims 6, 9, 10, 21, 24, and 26 are
obvious over Ku in view of Desrosiers and Bloemer, and specifically does
the Examiner establish that it was obvious to make or use an expandable
balloon prosthesis with “flexible walls having a thickness from about 0.02
mm to about 1.00 mm”?

1 U.S. Pat. Appl. Publ. No. 2005/0055099 A1 (published Mar. 10, 2005).
2 U.S. Pat. Appl. Publ. No. 2004/0091540 A1 (published May 13, 2004).
3 U.S. Pat. Appl. Publ. No. 2006/0009844 A1 (published Jan. 12, 2006).
4 WO 01/32100 A2 (published May 10 2001).
5 U.S. Pat. Appl. Publ. No. 2004/0078090 A1 (published Apr. 22, 2004).
6 U.S. Pat. Appl. Publ. No. 2004/0029994 A1 (published Feb. 12, 2004).
7 U.S. Pat. Appl. Publ. No. 2004/0186471 A1 (published Sep. 23, 2004).
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Findings of Fact
1. Ku describes a flexible spinal disk replacement that is “novel in that it
is made of a solid material that does not leak.” (Ku [0023], [0022].)
2. Ku discloses embodiments where the prosthesis is “made of a single
solid elastomeric material that is biocompatible,” such as a hydrogel. (Id. at
[0046], [0045].)
3. Paragraph [0056] in Ku describes a preferred embodiment where the
material used to make the prosthesis “has a swelling characteristic that
expands 50% in height when placed in a Normal saline solution.”
4. Desrosiers teaches a method for restoring a damaged intervertebral
disc involving the step of “injecting an injectable formulation, such as a
thermogelling chitosan-based aqueous solution, in the nucleus pulposus” of
the disc. (Desrosiers [0027].) Once injected, the formulation combines with
nucleus matters and host cells, becomes viscous, pasty or turns into a gel,
and increases the thickness of the disc. (Id.)
5. Bloemer describes an elastic intervertebral implant having an outer
surface that “is covered with a film 18 of polylactide, which thus forms a
sheath for the implant as a whole.” (Bloemer [0030], [0031], [0015].) The
inner cavity of the implant comprises chamber walls (14) that form cavities
(12), for example in a honeycomb form. (Id. at [0031]; see also Figures 1,
1a, 2, 2a, 2b.)
6. Paragraph [0039] in Bloemer describes injecting liquid bone cement
into cavities in the implant via a cannula inserted into the implant.
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Principles of Law
The Examiner bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). If the Examiner fails to
establish a prima facie case of unpatentability in the first instance, the
rejection is improper and must be reversed. Id.; In re Rijckaert, 9 F.3d 1531,
1532 (Fed. Cir. 1993).
Analysis
The Examiner finds that Ku discloses the prosthesis of claim 6 and the
method of claim 21, except that the reference fails to disclose:
[1] that the flexible walls have a thickness from 0.02 mm to
1.00 mm [],
[2] a filling tube passing through the flexible walls and in
communication with the inner cavity so that the prosthesis is filled
through the filling tube [],
[3] that the biocompatible material can also be a biocompatible
polymer and a biocompatible hydrogel [],
[4] that the prosthesis has a tensile modulus of about 0.02 MPa
to about 0.8 MPa at 30% strain []….
(Ans. 5. (spacing and numbering [1] – [4] added).)
The Examiner finds that Desrosiers discloses [3], and Bloemer
discloses [2], as numbered in the paragraph quoted above. (Id. at 5-6.)
Regarding [1] relating to flexible walls thickness and [4] relating to tensile
modulus, however, the Examiner does not rely on a particular reference.
Instead, the Examiner relies on the legal proposition that “where the general
conditions of a claim are disclosed in the prior art, discovering the optimum
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or workable ranges involves only routine skill in the art,” citing In re Aller,
220 F.2d 454, 456, 105 USPQ 233 (CCPA 1955). (Id. at 6, 10, 12.)
Appellants argue that “[n]one of the prior art references cited by the
Examiner disclose or suggest a prosthetic device incorporating a wall
defining an inner cavity.” (App. Br. 18.) Along the same lines, Appellants
state that the “prior art references cited by the Examiner neither disclose nor
suggest nor teach a balloon structure having flexible walls defining a fillable
inner cavity.” (Id. at 18-19.)
We agree with Appellants that Ku does not disclose “flexible walls
defining an inner cavity” as recited in independent claims 6 and 21 for the
reasons stated by Appellants (id. at 19-20). Ku describes a solid prosthesis
(FFs 1-3), not a balloon having an inner cavity that is fillable. We disagree
with the Examiner (Ans. 9, 11) that paragraphs [0023] and/or [0056] in Ku
disclose this aspect. These paragraphs do not indicate, as stated by the
Examiner, that Ku’s prosthesis “made of a solid material must have at least
one inner cavity that holds a liquid” (Ans. 11). A solid material, such as a
hydrogel, that expands when exposed to a liquid, such as saline, is not the
same thing as a balloon with an inner cavity that expands via flexible walls.
That said, we find that another reference cited by the Examiner, Bloemer,
describes or at least suggests this feature. (FFs 5-6.)
In any event, in relation to flexible walls, Appellants and the
Examiner agree that Ku fails to disclose an expandable balloon with
“flexible walls having a thickness from about 0.02 mm to about 1.00 mm.”
(App. Br. 17-18, 22-23; Ans. 5.) As discussed above, the Examiner does not
rely on Ku or any other reference to teach or suggest this element, but
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instead relies on the legal premise that “where the general conditions of a
claim are disclosed in the prior art, discovering the optimum or workable
ranges involves only routine skill in the art,” citing Aller.
In Aller, the cited prior art disclosed relevant general conditions at
issue (i.e., temperature and sulphuric acid concentration used in a chemical
process). 220 F.2d at 457-58. By contrast, the Examiner here does not
indicate where Ku or another cited reference (such as Bloemer) refers in the
first instance to the general condition at issue, i.e., any particular wall
thickness in an expandable balloon prosthesis. In other words, the Examiner
points to nothing in the references that might have suggested to one of skill
in the art to optimize flexible wall thickness, and therefore discover the
specific thickness range recited in the independent claims. Likewise, the
Examiner does not show where the cited references suggest that wall
thickness in an expandable balloon prosthesis was “recognized to be a result-
effective variable….” In re Antonie, 559 F.2d 618, 620 (CCPA 1977).
Absent more here, the Examiner does not establish a prima facie case of
obviousness of claims 6 and 21.
Because claims 9, 10, 24, and 26 each depend on claim 6 or claim 21,
and therefore also require an expandable balloon prosthesis with “flexible
walls having a thickness from about 0.02 mm to about 1.00 mm,” the
Examiner fails to present a prima facie case of obviousness regarding these
claims for the same reasons discussed above for claims 6 and 21.
Conclusion of Law
We conclude that the Examiner does not establish that 6, 9, 10, 21, 24,
and 26 are obvious over Ku in view of Desrosiers and Bloemer. The
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Examiner’s reliance on Aller is insufficient to establish that it was obvious to
make or use an expandable balloon prosthesis with “flexible walls having a
thickness from about 0.02 mm to about 1.00 mm.”
II.
Issue
Does the Examiner establish that claims 8 and 23, 11 and 27, 12-14
and 28-30, and 31 and 32 are obvious over Ku in view of Desrosiers and
Bloemer, in further view of Marcolongo, Binette, Cheng, or Trieu?
Analysis
Claims 8 and 11-14 each depend, either directly or indirectly, on
independent claim 6. Claims 23, 27, and 28-32 each depend, either directly
or indirectly, on independent method claim 21. Thus, all of these claims
require an expandable balloon prosthesis with “flexible walls having a
thickness from about 0.02 mm to about 1.00 mm,” as recited in the
independent claims.
When rejecting dependent claims 8 and 23, 11 and 27, 12-14 and 28-
30, and 31 and 32, the Examiner relies on Aller as discussed above regarding
a specific flexible wall thickness recited in independent claims. (Ans. 6-9,
10, 12.) With regard to Marcolongo, Binette, Cheng, or Trieu, the Examiner
does not assert that these references teach or suggest any flexible wall
thickness. (Id. at 6-9.)
Because claims 8 and 23, 11 and 27, 12-14 and 28-30, and 31 and 32
all depend on independent claim 6 or 21, and therefore also require the same
specific flexible wall thickness recited in the independent claims, the
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Examiner fails to present a prima facie case of obviousness regarding these
claims for the same reasons discussed above for claims 6 and 21.
Conclusion of Law
We conclude that the Examiner fails to establish that claims 8 and 23,
11 and 27, 12-14 and 28-30, and 31 and 32 are obvious over Ku in view of
Desrosiers and Bloemer, in further view of Marcolongo, Binette, Cheng, or
Trieu.
SUMMARY
We reverse the obviousness rejections under 35 U.S.C. §103(a) of
claims 6, 9, 10, 21, 24, and 26 over Ku in view of Desrosiers and Bloemer,
claims 8 and 23 over Ku in view of Desrosiers and Bloemer, and further in
view of Marcolongo, claims 11 and 27 over Ku in view of Desrosiers and
Bloemer, and further in view of Binette, claims 12-14 and 28-30 over Ku in
view of Desrosiers and Bloemer, and further in view of Cheng, and claims
31 and 32 over Ku in view of Desrosiers and Bloemer, and further in view of
Trieu.
REVERSED

cdc