Ex Parte Allen et al

Board of Patent Appeals and Interferences

Dec 19, 2008

10833448 (B.P.A.I. Dec. 19, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JEFFREY W. ALLEN, DAVID S. BRIN, CHRIS M. COPPIN,
NASSER RAFIEE, and THEODORE C. LAMSON
____________

Appeal 2008-4788
Application 10/833,448
Technology Center 3700
____________

Decided: December 19, 2008
____________

Before ERIC GRIMES, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the final rejection of claims 1-19.
Jurisdiction is under 35 U.S.C. § 6(b). We affirm-in-part and enter a new
ground of rejection.

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Application 10/833,448

STATEMENT OF THE CASE
The claims are directed to a device for cardiac valve modification that
comprises a catheter, an injection assembly comprising a balloon, and an
injector which is disposed about the neck of the balloon.
Claims 1-19 are appealed and stand rejected by the Examiner as
follows:
● Claims 1, 2, and 18 under 35 U.S.C. § 102(b) as anticipated by
Machold (US 5,611,775, Mar. 18, 1997) (Ans. 3);
● Claims 3-5 and 7-17 under 35 U.S.C. § 103(a) as obvious in view of
Machold and Naimark (US 6,638,246 B1, Oct. 28, 2003) (Ans. 4, 5);
● Claim 6 under 35 U.S.C. § 103(a) as obvious in view of Machold,
Naimark, and Utterberg (US Pub. 2005/0042240 A1, Feb. 24, 2005) (Ans.
9); and
● Claim 19 under 35 U.S.C. § 103(a) as obvious in view of Machold
and Freyman (US Pub. 2003/0114793 A1, Jun. 19, 2003) (Ans. 9).
Claims 1 and 3, which are representative of the claimed subject
matter, read as follows:
1. A device for cardiac valve modification comprising:
a catheter;
an injection assembly disposed on the catheter, the
injection assembly including a balloon having a first lobe, a
second lobe, and a neck disposed between the first lobe and the
second lobe; and
at least one injector operably disposed at the neck.

3. The device of claim 1 wherein the injector is selected from
the group consisting of an injection barb and an injection
needle.

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PRINCIPLES OF LAW
Because the hallmark of anticipation is prior invention, the
prior art reference – in order to anticipate under 35 U.S.C. §
102 – must not only disclose all the elements of the claim
within the four corners of the document, but also must disclose
those elements “arranged as in the claim.” Connell v. Sears,
Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983).
Net MoneyIN, Inc. v. Verisign, Inc., 545 F3d 1359, 1369 (Fed. Cir. 2008).
In making an obviousness determination, the following factors must
be taken into consideration: (a) the scope and contents of the prior art; (b)
the differences between the prior art and the claimed subject matter; (c) the
level of skill in the pertinent art; and (d) evidence of secondary
considerations. Graham v. John Deere, 383 U.S. 1, 17 (1966).
Although common sense directs one to look with care at a
patent application that claims as innovation the combination of
two known devices according to their established functions, it
can be important to identify a reason that would have prompted
a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does. This is so
because inventions in most, if not all, instances rely upon
building blocks long since uncovered, and claimed discoveries
almost of necessity will be combinations of what, in some
sense, is already known.
KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007).
During examination, “claims … are to be given their broadest
reasonable interpretation consistent with the specification, and
… claim language should be read in light of the specification as
it would be interpreted by one of ordinary skill in the art.” In re
Bond, 910 F.2d 831, 833 (Fed. Cir. 1990).
In re American Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed.
Cir. 2004).

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Application 10/833,448

ANTICIPATION BY MACHOLD
Claims 1, 2, and 18 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Machold (Ans. 3).
Issue
Does the Machold patent describe a device for cardiac valve
modification which comprises “at least one injector” as recited in claim 1?
Findings of Fact
Specification
1. The Specification describes the invention as a “cardiac valve
modification device” comprising injectors “to inject a therapeutic agent into
a valve annulus” (Spec. 3: 9-11; Abstract).
2. The Specification states that the therapeutic agent can be “a bulking agent
such as collagen. Collagen injected into the valve annulus adds mass to the
tissue surrounding the valve. The increased mass causes the valve leaflets to
be drawn closer together reducing or eliminating valve leakage” (Spec. 4:
19-22).
3. Pro-fibrotic growth factors can also be injected “into the valve annulus”
(Spec. 12: 1-2; Fig. 7).
4. The injectors can be injection barbs or injection needles (Spec. 5: 21).
5. The Specification describes the use of a biodegradable injection barb 60
where the barb “is delivered into the valve annulus and remains there until
the injection barb 60 is absorbed” (Spec. 6: 5-6).
6. Embodiments are also described in which the injection barb is “push[ed]”
into the valve annulus and then is broken off to “leave[ ] the barbs 74 and
most of the pointed shaft 72 in the valve annulus” (Spec. 7: 11-14)

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The Machold patent
7. Appellants do not dispute the Examiner’s findings that Machold
describes a device capable of being used for cardiac valve modification that
comprises an assembly disposed around a catheter which comprises an
inflatable balloon member 45 with a lumen (“interior in fluid
communication with the annular lumen 44”), having a first inflatable lobe 47
and a second inflatable lobe 48, and a central neck section 49 disposed
between the first and second lobes (Ans. 3; see Machold, at col. 6, l. 49 to
col. 7, 12).
8. “The inflatable member 45 [of Machold’s device] has a plurality of holes
46 in the wall thereof . . . to eject liquid containing diagnostic or therapeutic
material in a plurality of jet-like streams” (Machold, at col. 6, ll. 59-63).
9. Machold states that
discrete jets . . . of the therapeutic or diagnostic fluid are ejected
out of the apertures . . . well into the tissue . . . . The injection
period will be determined by the amount of therapeutic or
diagnostic fluid which is to be delivered, the size of the
apertures . . . in the wall of the outer inflatable member . . .
and the pressure applied to the therapeutic or diagnostic fluid. .
. . Preferably, a body or reservoir of the therapeutic or
diagnostic liquid . . . is formed in the tissue spaced from the
body lumen which allows the fluid to slowly permeate or infuse
into the surrounding tissue thereby providing delivery of the
diagnostic or therapeutic material over a long period.
(Machold, at col. 6, ll. 4-21.)
Claim 1
10. Appellants also do not dispute the Examiner’s findings (Ans. 3) that
Machold’s device comprises a catheter and elements 45, 47, 48, and 49
(FF7) which meet the limitations of claim 1 of a catheter and an assembly
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disposed on the catheter “including a balloon having a first lobe, a second
lobe, and a neck disposed between the first lobe and the second lobe.”
11. Claim 1 also requires the device to comprise “at least one injector
operably disposed at the neck.”
12. While the term “injector” is not explicitly defined in the Specification,
its function is consistently described as for injecting a therapeutic agent
“into” the valve annulus (FF1-6). For instance, when collagen is used as a
therapeutic agent, it adds “mass” to the annulus because the injector is used
to introduce the collagen into the annulus tissue (FF2). Thus, the injector –
which can be a needle or barb (FF4) – is a structure which pierces the
annulus valve tissue and then enables the therapeutic agent to be injected
directly into the annulus tissue.
Analysis
The dispute in this rejection is whether Machold teaches a device that
comprises an element which serves as an “injector” as required by claim 1.
The Examiner’s position is that the holes or apertures in Machold’s device
which eject discrete jets of liquid (FF8, 9) meet the claimed limitation of an
“injector.” Appellants contend that the holes in Machold’s device would not
be understood to be injectors as required by claim 1 (App. Br. 9-10). Thus,
the issue boils down to one of claim interpretation. That is, whether the
claimed “injector” is properly interpreted to encompass an aperture which
ejects fluid.
During patent examination, claims are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art upon reading the Specification. In re American Academy Of Science
Tech Center, 367 F.3d at 1364. The Specification does not provide a
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definition of “injector,” but it sets out its purpose. The “injector” is
consistently described in the Specification as a structure for introducing
(“injecting”) a therapeutic agent “into” the valve annulus (FF12). For
instance, the injector is used to introduce collagen into the annulus to plump
the tissue up by giving it more mass (FF2). The Specification also refers to
using injection barbs as injectors which are introduced into the annulus and
then left sticking out from the tissue interior (FF5, 6). Thus, it is clear that
the injector must pierce the annulus tissue in order to introduce (“inject”) the
therapeutic agent into the tissue. In this context, we interpret an “injector”
as recited in claim 1 to be a structure which pierces the annulus valve tissue
and then enables the therapeutic agent to be directly injected into the annulus
tissue (FF12).
The holes in the inflatable member of Machold’s device do not pierce
tissue. Rather, they eject a liquid jet stream into a space outside the tissue
(FF8, 9). While Machold refers to an “injection period” (FF9), it is evident
that this is a reference to the period of time during which therapeutic or
diagnostic fluid agent is ejected from the apertures into the tissue space – not
injection into a tissue by piercing it. For this reason, we conclude that
Machold does not describe an “injector” as required by claim 1 and therefore
does not anticipate it. Net MoneyIN, Inc. v. Verisign, Inc., 545 F3d at 1369.

Conclusion of Law
Machold does not describe a device for cardiac valve modification
which comprises “at least one injector” as recited in claim 1. We reverse the
anticipation rejection of claim 1, and dependent claims 2 and 18.

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OBVIOUSNESS OVER MACHOLD AND NAIMARK
Claims 3-5 and 7-17 stand rejected under 35 U.S.C. § 103(a) as
obvious over Machold and Naimark (Ans. 4, 5).
Issue
Would persons of ordinary skill in the art have been prompted to
provide Machold’s device with the micro-needles of Naimark to have made
the subject matter of claim 3?
Findings of Fact
Scope and content of the prior art
In making an obviousness determination, the scope and content of the
prior art must first be ascertained. Graham v. John Deere Co., 383 U.S. at
17. Factual findings concerning Machold have been set forth above. The
following numbered findings of fact relate to the Naimark Patent.
13. Naimark discloses a device for delivering biological materials
comprising a catheter and balloon having micro-needles (Naimark, at col. 2,
ll. 14-18).
14. Naimark describes an embodiment in which micro-needles are disposed
on the outer surface of a balloon (Naimark, at col. 6, ll. 35-37; Figs. 5A and
5B).
15. As the balloon is inflated, the “micro-needles 54 contact a surface of the
body lumen piercing the surface” (Naimark, at col. 6, ll. 46-48).
16. A biological material “is delivered . . . through the micro-needles 54
into the body lumen” (Naimark, at col. 6, ll. 50-51).
17. “After the injection is completed, the balloon 50 is deflated” (Naimark,
at col. 6, l. 52).
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18. Naimark states that the micro-needles can be of such a size to “permit
inter-cell penetration at controllable depths” (Naimark, at col. 11, ll. 42-43).
Difference between the prior art and the claimed invention
Once the scope and content of the prior art has been determined, the
next step is to identify the differences between the prior art and the claimed
invention. Graham v. John Deere Co., 383 U.S. at 17. The following
numbered findings of fact are pertinent to this issue:
19. Claim 3 is directed to the device of claim 1, and therefore incorporates
all its limitations, but further requires that the “injector” is an “injection
barb” or “injection needle.”
20. It is not disputed that Machold describes all the elements of claim 3, but
not an “injector” which is either an “injection barb” or “injection needle”
(Ans. 4).
Reason to combine the prior art
After ascertaining the differences between the prior art and the
claimed invention, the next step is to identify a reason why persons of
ordinary skill in the art would have been prompted to combine the prior art
to have made the claimed invention. KSR Int’l Co. v. Teleflex Inc., 127 S.
Ct. at 1741. The following finding, set forth by the Examiner and supported
by the preponderance of the evidence, is relevant to this determination:
21. Persons of ordinary skill in the art would have been prompted to provide
Machold’s device with the micro-needles of Naimark “to provide a device
which penetrates the treatment site such that all of the treatment material is
actually injected into the treatment site and is not subject to being washed
away by the surrounding blood flow as would happen without
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needle/injector penetration ([Naimark] col. 1, lines 40-45 and 60-63)” (Ans.
5).
Analysis
The difference between Machold and claim 3 is that Machold does not
describe “at least one injector” in its device for cardiac valve modification
(FF20). However, Naimark teaches micro-needles which are capable of
piercing and injecting material into a tissue (FF14-18), such as a cardiac
valve. The micro-needle thus meets the limitation of an injector as we have
interpreted it (see FF12). Appellants have not disputed Naimark’s micro-
needles are encompassed by the injector of claim 3 which is “an injection
needle”.
The Examiner logically reasons that persons of ordinary skill in the art
would have been prompted to have utilized Naimark’s micro-needles for
their advantage in penetrating and delivering material to the penetrated
tissue while avoiding the material from being washed away (FF21).
Appellants have not identified a defect in the Examiner’s reasoning, and as
we find none, we affirm the rejection.

Conclusion of Law
We conclude that persons of ordinary skill in the art would have been
prompted to provide Machold’s device with the micro-needles of Naimark to
have made the subject matter of claim 3. The obviousness rejection of claim
3 is affirmed. Claims 4, 5, and 7-17 fall with claim 3 because separate
reason for their patentability were not provided. 37 C.F.R. §
41.37(c)(1)(vii).

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OBVIOUSNESS OVER MACHOLD, NAIMARK, AND UTTERBERG
Claim 6 stands rejected under 35 U.S.C. § 103(a) as obvious in view
of Machold, Naimark, and Utterberg (Ans. 9).
Claim 6 depends on claim 4 which depends on claim 1. Claim 6 is
directed to the device of claim 1 wherein the “the neck includes an inner
balloon and at least one port, the injector being disposed behind the port and
the inner balloon being disposed behind the injector” (claim 4) and where
“the injector is enclosed in a viscous material” (claim 6). The Examiner
states
Machold in view of Naimark disclose the device substantially
as claimed including an injector, however, Machold in view of
Naimark do not disclose an injector that is enclosed in a viscous
material. Utterberg, however, discloses a viscous antibacterial
material that is used to enclose and surround any type of
injector (paragraph [0047] and abstract) to provide an anti\[sic]-
bacterial coating and protective barrier for the injector.
Therefore it would have been obvious to one of ordinary skill in
the art at the time of the invention to have modified Machold in
view of Naimark with the viscous material enclosing the
injector, in order to prevent unnecessary contaminants from
entering the treatment site.
(Ans. 9).
Appellants do not identify any deficiency in the Examiner’s
reasoning, and as we find none, we affirm the rejection.

Conclusion of Law
The obviousness rejection of claim 6 is affirmed.

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OBVIOUSNESS OVER MACHOLD AND FREYMAN
Claim 19 stands rejected under 35 U.S.C. § 103(a) as obvious in view
of Machold and Freyman (Ans. 9).
Claim 19 depends on claim 18 which depends on claim 1. Therefore,
claim 19 incorporates all the limitations of claim 1. As we agree with
Appellants that Machold does not describe an injector as required by claim
1, and the Examiner has not adequately explained how such an injector
would have been suggested by Freyman, we are compelled to reverse the
rejection of claim 19.

Conclusion of Law
The obviousness rejection of claim 19 is reversed.

NEW GROUND OF REJECTION
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new ground of rejection:
Claims 1, 2, and 18 are rejected under 35 U.S.C. § 103(a) as obvious
in view of Machold and Naimark.
Claim 3 depends on independent claim 1 and thus incorporates all the
limitations of the independent claim. Having determined that the narrower
claim 3 would have been obvious in view of Machold and Naimark, we are
compelled to conclude, for the same reason, that the broader claim 1 (with
fewer limitations than recited in claim 3) is also obvious over the same
combination of patents.
The difference between Machold and claim 1 is that the Machold does
not describe an injector in its device. However, Naimark teaches micro-
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needles which pierce tissue and enable a therapeutic agent to be injected
directed into the pierced tissue (FF15). Thus, Naimark’s micro-needle meets
the limitation of an “injector” as we have interpreted it (FF12). The same
reason that the Examiner gave for combining Machold and Naimark in the
rejection of claim 3 (FF21) is equally applicable to claim 1.
Claim 2 is directed to the device of claim 1 “wherein the first lobe and
the second lobe are inflatable.” This limitation is expressly taught in
Machold (FF7).
Claim 18 is directed to the device of claim 1 “wherein the injection
assembly includes a lumen.” Machold teaches that the balloon assembly
with holes – which corresponds to the claimed injection assembly – has an
interior (FF7; col. 6, ll. 55-56) which meets the claimed limitation of a
“lumen.”
TIME PERIOD
Regarding the affirmed rejection(s), 37 C.F.R. § 41.52(a)(1) provides
“Appellant[s] may file a single request for rehearing within two months from
the date of the original decision of the Board.”
In addition to affirming the Examiner's rejection of one or more
claims, this decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12,
2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 C.F.R. §
41.50(b) provides “new grounds of rejection pursuant to this paragraph shall
not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
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one of the following two options with respect to the new grounds of
rejection to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the claims so
rejected or new evidence relating to the claims so rejected, or both, and have
the matter reconsidered by the Examiner, in which event the proceeding will
be remanded to the Examiner. . . .

(2) Request rehearing. Request that the proceeding be reheard under § 41.52
by the Board upon the same record. . . .

Should the Appellants elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If the Appellants elect prosecution before the Examiner and this does
not result in allowance of the application, abandonment or a second appeal,
this case should be returned to the Board of Patent Appeals and Interferences
for final action on the affirmed rejections, including any timely request for
rehearing thereof.

AFFIRMED-IN-PART; § 41.50(b)

Ssc:

Medtronic Vacular, Inc.
3576 Unocal Place
Santa Rosa, CA 95403

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