Ex Parte Racz

Patent Trial and Appeal Board

Jun 27, 2013

12139233 (P.T.A.B. Jun. 27, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte NICHOLAS SANDOR RACZ
__________

Appeal 2011-008384
Application 12/139,233
Technology Center 3700
__________

Before LORA M. GREEN, JACQUELINE WRIGHT BONILLA, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal
1
under 35 U.S.C. § 134(a) from the
Examiner’s rejection of claims 9-21.
2
We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm-in-part.

1
The Real Party in Interest is Nicholas Sandor Racz (App. Br. 5).
2
Claims 1-8 are also pending, but stand withdrawn from consideration (App.
Br. 7).
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STATEMENT OF THE CASE
The invention relates to injection systems (Spec. 1, ¶ 1). The
Specification notes that needles with a blocked tip and an open side portal
are known, but as the needles are pre-made with an enclosed end, they are
more expensive to manufacture than traditional open-ended needles (id. at 2,
¶ 4). Thus, according to the Specification, “it would be desirable to create a
neural injection system that is primarily composed of a traditional open-
ended needle system, which is common and inexpensive, and retrofit such a
needle to provide a sharp-tipped, open side port, closed distal end, neural
injection system” (id. at 2, ¶ 5).
Claim 9 is representative of the claims on appeal, and reads as follows
(emphasis added):
9. A retrofitted neural injection system comprising:
an at least partially hollow cannula with a sharp distal end, wherein
said distal end has a port;
wherein said hollow cannula is defined by a first inside diameter, a
first outside diameter, a first length, and at least one side port in fluid
communication between the inside and the outside of the hollow cannula;
wherein said side port is located coaxially at a predetermined distance
from the distal end; and
wherein said port at the distal end is sealed with a sealant to
eliminate fluid communication between the inside and the outside of the
hollow cannula via the distal end.

The following grounds of rejection are before us for review:
I. Claim 9 stands rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Atil
3
and Roschak
4
(Ans. 3).

3
Atil (US 2006/0212004 A1, published Sep. 21, 2006).
4
Roschak (US 2008/0086107 A1, published Apr. 10, 2008).
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II. Claims 10-15, 18, and 20 stand rejected under 35 U.S.C. § 103(a)
as being rendered obvious by the combination
5
of Atil and
Roschak, as further combined with Lipov
6
(Ans. 5).
III. Claims 16 and 17 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination
7
of Atil, Roschak, and Lipov,
as further combined with Watson
8
(Ans. 6).
IV. Claims 19 and 21 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination
9
of Atil, Roschak, and
Watson as further combined with Epstein
10
(Ans. 7).

ANALYSIS
Claim 9 rendered obvious by the combination of Atil and Roschak
The Examiner rejects claim 9 over the combination of Atil and
Roschak (Ans. 3).
The Examiner finds that Atil teaches all of the limitations of claim 9
(Ans. 3-4), except for teaching that the port at the distal end of the cannula is
sealed with a sealant to eliminate fluid communication between the inside
and outside of the distal end (id. at 4). The Examiner finds that Roschak

5
Claims 10-15 and 18 depend from claim 9. The Examiner’s statement of
the rejection only includes Atil and Lipov, but that seems to be an error
based on the dependency of claims 10-15 and 18, which incorporate all of
the limitations of claim 9. Thus, we assume that the Examiner made a
typographic error in failing to also list Roschak. (See also App. Br. 18).
6
Lipov (US 2007/0239119 A1, published Oct. 11, 2007)
7
See footnote 5.
8
Watson (US 5,098,411, issued Mar. 24, 1992).
9
See footnote 5.
10
Epstein (US 7,169,127 B2, issued Jan. 30, 2007).
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teaches a device for the delivery of substances, wherein the port at the distal
end is sealed with a sealant to eliminate fluid communication between the
inside and outside of the distal end (id. (citing Roschak, ¶ 91)).
The Examiner concludes that it would have been obvious to the
ordinary artisan
to modify the device of Atil to include wherein said port at the
distal end is sealed with a sealant to eliminate fluid
communication between the inside and the outside of the
hollow cannula via the distal end, as taught and suggested by
Roschak, for the purpose of sealing off the tip of the needle
with a sealant rather than the same metal the needle is
constructed with.
(Ans. 4.)
As to the limitation that the system is “retrofitted,” the Examiner
concludes this limitation renders the claim a “product-by-process” claim,
and thus the patentability rests in the product, rather than the process (id.).
Appellant argues that the “Examiner does not provide a reasoned
explanation on why it would be obvious to modify the device of Atil using
the teachings of Roschak to include a sealed port at the distal end” (App Br.
16). According to Appellant, Roschak states that sealing the edges of the
conduit to prevent flow or leakage is not crucial (id. (citing Roschak, ¶ 91).
Appellant further assert that the sealing in Roschak occurs between the
conduit and the tissue, and the sealant is not present at the distal port, and
that Roschak in fact teaches away from a sealed port, as it teaches conduits
for maintaining the patentcy of a channel created in tissue (id. at 16-17
(citing Roschak, ¶¶ 20 and 186).).
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Appellant’s arguments are not convincing. Atil is drawn to a medical
needle having a closed tip (Atil 1, ¶ 1). Figure 2 of Atil is reproduced
below.

Figure 2 is an isometric of a needle of Atil, having a closed tip and two
openings spaced from the tip (id. at 2, ¶¶ 14 and 15). The needle is
“configured to facilitate fluid flow while minimizing tissue damage from
penetration” (id. at 1, ¶ 4). As shown in the Figure, “the side wall 22 and the
end wall 24 interface at a rim 34 circumscribing the end wall” (id. at 2, ¶
36). In addition, the needle comprises a “closed tip 30 [that] is offset from
the longitudinal axis” (id.). We agree with the Examiner that Atil discloses
the injection system of claim 9, except that the port at the distal end (i.e., the
“closed tip 30”) is sealed with material of the cannula itself, rather than a
sealant (Ans. 4).
Roschak admittedly is drawn to a device for treating the lungs by
creating channels in airways (Roschak 1, ¶ 1). Roschak teaches, however,
that sealant may be added around the exterior of a conduit to prevent side
flow or leakage (id. at 5, ¶ 91). Thus, Roschak is evidence that the ordinary
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artisan would understand that sealant could be used on a medical device to
prevent fluid flow.
“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).
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.

Id., at 417. In 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
Keller, 642 F.2d 413, 425 (CCPA 1981). In addition, a reference disclosure
is not limited only to its preferred embodiments, but is available for all that it
discloses and suggests to one of ordinary skill in the art. In re Lamberti, 545
F.2d 747, 750 (CCPA 1976).
Here, we agree with the Examiner that the ordinary artisan would
understand that a sealant could be used at the end of a cannula of Atil, rather
than using the same metal the cannula is manufactured from, to eliminate
fluid communication between the inside and the outside of the distal end of
the cannula. See KSR, 550 U.S. at 417 (The question to be asked is “whether
the improvement is more than the predictable use of prior art elements
according to their established functions.”).
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Appellant further asserts that the combination of Atil and Roschak fail
to disclose “a ‘retrofitted neural injection system’” (App. Br. 17). Appellant
argues that “retrofitted’” should be considered a limitation because of the
limitation of “wherein said port at the distal end is sealed with a sealant to
eliminate fluid communication between the inside and the outside of the
hollow cannula via the distal end” (id.). Appellant also argues that the
“needle in Atil and the passage in Roschak appear to be pre-manufactured
and not retrofitted” (id.).
Appellant’s arguments are not convincing. As discussed above, we
agree with the Examiner that the combination of Atil and Roschak suggest
the claimed injection system, wherein sealant has been used to seal the distal
end to eliminate fluid communication between the inside and the outside of
the hollow cannula. Whether that sealant is added at a factory, or added by
the user, the structure is the same. Thus, we agree with the Examiner that
the term “retrofitted” doesn’t add any structure to the claimed injection
system that would differentiate it from the injection system of the
combination of Atil and Roschak as set forth by the Examiner.

Claims 10-15, 18, and 20 rendered obvious by the combination of Atil
and Roschak as further combined with Lipov
Appellant essentially reiterates the arguments made with respect to
claim 9 as to claims 10, 11, 13-15, 18, and 20 (App. Br. 18-22), which
arguments are not found to be convincing for the reasons set forth above
with respect to claim 9.
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As to claim 12, Appellant argues that Lipov does not teach that the
stylet may be “fixedly secured,” but in fact teaches that after the needle
engages the target, the stylet is withdrawn from the cannula to allow for
removal of nuclear material (App. Br. 19). Thus, Appellant asserts, “Lipov
teaches away from a stylet that is fixedly secured within a first portion of
said hollow cannula” (id.).
Claim 12 (which is indirectly dependent on claim 9 through claim 10)
is drawn to a neural injection system that comprises a stylet (claim 10),
wherein the “stylet is fixedly secured within a first portion of said hollow
cannula.” The Examiner relies on Lipov for teaching a stylet fixedly secured
within a first portion of a hollow cannula (Ans. 5 (citing Lipov, ¶ 18)).
Lipov discloses a device that “comprises an adjustable needle, having
a flexible cannula with a bore and a stylet sized to be inserted into the bore”
(Lipov 1, ¶ 5). As taught by Lipov, “[i]nserting the stylet into the cannula
deflects the cannula from the first configuration and causes the cannula to
conform to the second configuration” (id.).
Specifically, Lipov teaches:
As shown in FIGS. 3 and 4, the configuration of needle
10 is adjusted by inserting or withdrawing shaft 28 of stylet 14
from bore 24 of cannula 12. FIG. 3 shows stylet 14 partially
inserted into bore 24, which deflects the linear configuration of
cannula 12 and causes it to conform to the curved configuration
of the stylet. As shaft 28 is inserted into cannula 12, the curved
configuration 38 travels along the length of cannula 12-i.e. as
shown by comparison of FIGS. 3 and 4. As shaft 28 is
withdrawn from cannula 12, the memory characteristics of the
cannula cause the portion of body 16 from which shaft 28 is

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withdrawn to substantially return to its original linear
configuration 40.

(Id. at 2, ¶ 18.)
We agree with Appellant that Lipov does not teach a stylet fixedly
secured within a first portion of a hollow cannula. As the Examiner has not
provided a reason as to why the ordinary artisan would fixedly secure the
stylet within the cannula, we reverse the rejection as to claim 12.

Claims 16 and 17 rendered obvious by the combination of Atil and
Roschak as further combined with Watson
Appellant essentially reiterates the arguments made with respect to
claim 9 (App. Br. 22-23), which arguments are not found to be convincing
for the reasons set forth above with respect to claim 9.

Claims 19 and 21 rendered obvious by the combination of Atil,
Roschak, and Watson as further combined with Epstein
Appellant essentially reiterates the arguments made with respect to
claim 9 (App. Br. 23-25), which arguments are not found to be convincing
for the reasons set forth above with respect to claim 9.

SUMMARY
We affirm the rejections of
claim 9 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Atil and Roschak;
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claims 16 and 17 under 35 U.S.C. § 103(a) as being rendered obvious
by the combination of Atil, Roschak, and Lipov, as further combined with
Watson; and
claims 19 and 21 under 35 U.S.C. § 103(a) as being rendered obvious by
the combination of Atil, Roschak, and Watson as further combined with
Epstein.
We also affirm the rejection of claims 10-15, 18, and 20 under 35
U.S.C. § 103(a) as being rendered obvious by the combination of Atil and
Roschak, as further combined with Lipov as to claims 10, 11, 13-15, 18, and
20, but reverse as to claim 12.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED-IN-PART

ELD