Ex Parte Racz

Patent Trial and Appeal Board

Oct 31, 2016

11853785 (P.T.A.B. Oct. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111853,785 09/11/2007
63467 7590
Ramey & Schwaller, LLP
5020 Montrose Blvd.
Suite 750
Houston, TX 77006
11/02/2016
FIRST NAMED INVENTOR
N. Sandor Racz
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.
20029.0003.NPUSOO 3648
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
11/02/2016 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):
uspto@rameyfirm.com
wramey@rameyfirm.com
bwilliams@rameyfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte N. SANDOR RACZ
Appeal2014-006943
Application 11/853,785 1
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a surgical needle. The '785
Application discloses that the needle can be used for spinal aesthesia and
nerve blockade. '785 Application 1: 8-17; 3 :2-31. The Examiner finally
rejected the claims as obvious under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 134. The Examiner's decision is affirmed.
1 "The '785 Application."
Appeal2014-006943
Application 11/853,785
STATEMENT OF CASE
Appellant appeals from the Examiner's final rejection of claims 1, 3-
9, 11, 12, 22, 23, and 25. The claims stand rejected by the Examiner as
follows:
1. Claims 1, 3, 4, 11, 12, and 22 as obvious under 35 U.S.C. § 103(a)
(pre-AIA) in view of Wang (U.S. Patent No. 5,320,110, patented June 14,
1994) and Racz (U.S. Patent No. 5,817,074, patented Oct. 6, 1998). Final
Rej. 2.
2. Claims 5-9 as obvious under 35 U.S.C. § 103(a) (pre-AIA) in view
of Wang, Racz, and Van Tassel (U.S. Publ. Application No. 2003/0130626
Al, pub. July 10, 2003). Final Rej. 6.
3. Claims 23 and 25 obvious under 35 U.S.C. § 103(a) (pre-AIA) in
view of Wang, Racz, and Yamamoto (U.S. Publ. Application No.
2004/0260241 Al, pub. Dec. 23, 2004). Final Rej. 8.
Claim 1 is illustrative of the claimed subject matter:
1. A surgical instrument, in a unitary arrangement,
compnsmg:
an elongated, at least partially hollow nerve blocking needle
shaft comprising a tip end and a connector end;
wherein the tip end is closed; and
wherein the tip end comprises at least two facets;
wherein the tip end comprises a shoulder and at least one
beveled edge extending from the shoulder to a point of the tip
end·
'
wherein the tip end is capable of insertion into a tissue of
a patient, but the tip end is not as sharp as a needle point;
at least one side port located along the elongated, at least
partially hollow shaft away from the closed tip end and
separated from the shoulder by a distance of about 1 mm to 4
mm;
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Application 11/853,785
wherein the at least one side port has at least one of an
inwardly beveled edge or an outwardly beveled edge; and
wherein the tip end is able to enter at least one tissue
without the assist of an introducer.
OBVIOUSNESS IN VIEW OF WANG AND RACZ
The Examiner found that Wang describes a surgical needle with the
features of the claimed instrument, but not where the needle's side port is
"located ... away from the closed tip end and separated from the shoulder
by a distance of about 1 mm to 4 mm" and not where the "side port has at
least one of an inwardly beveled edge or an outwardly beveled edge." Final
Rej. 2-3 (claim 1). However, the Examiner found that Racz describes a
surgical needle with both features. Id. at 3. The Examiner found it obvious
to modify Wang with these feature for the purpose of dispersing the agent in
a desired location. Id.
Side port location
Wang teaches that side port ("aperture") "located about 4 mm and 7
mm, respectively, axially rearwardly from tip 171 of trocar 166." Wang,
col. 8, 11. 3---6. Appellant contends that the claim "requires that the side port
be separated from the shoulder by a distance of about 1 mm to 4 mm," while
"Figs. 2 and 4 [of Wang] depict that the side port distance is measured to the
edge of the side port closest to the tip." Reply Br. 27. For this reason,
Appellant contends that Wang results in the side port being located in a
different position than claimed. Id. at 27-28. Appellant further argues that
the skilled worker would not have combined Wang and Racz because the
instruments have different purposes. Appeal Br. 26-27; Reply Br. 28.
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Application 11/853,785
Fig. 2 of the '785 Application shows the distance between port 30 and
shoulder 26. The shoulder 26 is shown as the distal leading edge from point
33 of the needle. Wang teaches that the port is a distance away from the
point 171 of the needle (shown in Fig. 13 of Wang). Wang, however,
teaches:
Outer trocar 166 is tubular with a hollow interior, and has a
distally positioned notch 168 and an aperture 170 positioned to
extend through the trocar side wall opposite notch 168. The
exact positioning of this aperture 170 is not critical but is
preferably in the proximal half of the waU opposite notch 168.
In this embodiment, notch 168 begins and the aperture is
located about 5 mm and 7 mm, respectively, axially rearwardly
from the tip 171 of trocar 166.
\Vang, col. 7, l. 66 to col. 8, l. 6 (emphasis in italic added).
Since \Vang is measured from the tip of the needle (proximal end),
while the claimed distance is from the shoulder of the tip- a more distal
location with respect the needle tip - a location of 4 mm from the shoulder
would be located even further away from the needle tip. Thus, 4 mm from
the shoulder as recited in claim l would be nwre than 4 rnm away when
measured from the tip of the needle as taught by \Vang. In other words, the
value of about 4 mm from the needle shoulder as recited in the claim is
equivalent to 4 mm plus the distance from the shoulder to the needle tip.
\Vbile there is no information on the distance between the shoulder and
needle tip, it is evident that the claimed value of "about" 4 mm is more than
about 4 mm, which brings it closer to the "about 5 mm" described by \Vang.
Wang, col. 8, 11. 3---6.
The claim requires a distance of "about l mm to 4 mm" from the
shoulder. The term "about" is a word of approximation, indicating that the
location is not exactly 4 mm from the shoulder. Appellant did not provide a
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Application 11/853,785
definition of ''abouf' that would exclude it from c01Tesponding to the "about
5 mm" value disclosed by \Vang (at col. 8, 11. 3---6).
We conclude that the term "about," coupled with the fact that Wang's
port location is measured from the needle tip, and not the needle shoulder,
makes it reasonable to find that \Vang's port ("about 5 mm") encompasses
distances at the same or at overlapping locations as required by the claim. It
is well established that, when there is a range disclosed in the prior art, and
the claimed invention overlaps or falls within that range, there is a
presumption of obviousness. Jn re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003); Iron Grip Barbell Co .. Inc. v. U51~4 Sports, Inc., 392 F.3d 1317, 1322
(Fed. Cir. 2004). Even if the location values do not precisely overlap, they
"are so close that prima facie one skilled in the art would have expected
them to have the same properties," shifting the burden to the applicant to
show they are different. Titanium Metals Corp. v. Banner, 778 F.2d 775,
783 (Fed. Cir. 1985).
In addition to these facts, Wang expressly teaches that "[t]he exact
positioning of this aperture 170 is not critical but is preferably in the
proximal half of the wall opposite notch 168." \Vang, col. 8, 11. 1-3. Thus,
while the aperture in \Vang is preferably about 5 nun and 7 rnmm from the
needle tip, \Vang explicitly teaches its placement is not critical.
Consequently, we conclude that the claimed distance of about 4 mm is
reasonably suggested by Wang.
Appellant also argues that the "fluid mechanics of a side port 1 to 4
mm away from open tip end would be different than the fluid mechanics of a
side port 1 to 4 mm from closed tip end." Appeal Br. 28. However,
Appellant has not provided evidence of this. An argument made by counsel
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Application 11/853,785
in a brief does not substitute for evidence lacking in the record. Estee
Lauder Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997).
Because \Vang alone is adequate to meet the limitation of the location
of the port, we find it unnecessary to reach the teachings in Racz with
respect to this feature. CJ In re Boyer, 363 F.2d 455, 458 n.2 (CCPA 1966).
Needle point
Claim I recites that "the tip end is capable of insertion into a tissue of
a patient, but the tip end is not as sharp as a needle point." The tip is
required by the claim to have "at least one beveled edge extending from the
shoulder to a point of the tip end." As found by the Examiner, Wang
describes a tip "sharpened" with beveled edges. Wang, col. 8, 11. 6-7. The
Examiner also found that "needle points come in various degrees of
sharpness." Answer 14.
Appellant contends that Wang teaches that its needle is sharp (Appeal
Br. 28), but doesn't explain how the claimed needle with at least beveled
edge wouldn't be as "sharp" as Wang's needle with the same features.
Furthermore, Wang doesn't require the tip to be sharpened, but discloses that
it is "preferably sharpened." Id. Consequently, a preponderance of the
evidence supports the Examiner's finding that Wang discloses or reasonably
suggests the claimed limitation of a "tip end is not as sharp as a needle
point."
Bevel andfacet
Claim 1 requires that the "tip end comprises at least two facets" and
"the tip end comprises a shoulder and at least one beveled edge." Claim 4,
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which depends from claim 1, further recites "tip end comprises at least two
beveled edges."
The Examiner found that Wang teaches "the tip end comprises at least
two facets ('beveled surfaces'; Col 8, Line 7); wherein the tip end comprises
a shoulder and at least one beveled edge extending from the shoulder to a
point of the tip end (as seen in Fig 13 and 14 ... )." Final Rej. 2.
Appellant contends that the Examiner has used the terms bevel and
facet interchangeably. Relying on a dictionary definition, Appellant argues
that a "facet" is a level plane, while a "bevel" is angled. Appeal Br. 29.
This argument is not persuasive. During patent examination:
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary usage
as they would be understood by one of ordinary skill in the art,
taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant's specification.
Irz re Morris; 127 F.3d 1048; 1054 (Fed. Cir. 1997).
In this case, the '785 Application discloses that the "angle of bevel is
capable of being the same for all facets." '785 Application 9:2. Based on
this description, the skilled worker reading the '785 Application would have
understood that a "facet" can be a "bevel." Wang, as found by the
Examiner, describes the tip of its instrument as having "beveled surfaces"
(Wang, col. 8, 11. 6-7) and shows two beveled surfaces in Fig. 13.
Consequently, Wang teaches a tip with at least two facets ("beveled
surfaces"), where one of these facets is beveled, as required by claim 1.
The claim also requires "at least one side port has at least one of an
inwardly beveled edge or an outwardly beveled edge." The Examiner found
that Racz describes a side port having "a beveled edge (as seen in Fig 2,3)."
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Final Rej. 3. Appellant contends that this feature is not described by Racz.
Reply Br. 26. Although the Examiner found that this feature was met by
Racz in the Rejection dated Feb. 7, 2013, Appellant did not respond until the
Reply Brief. The Board will not considered new arguments "not raised in
the appeal brief, or is not responsive to an argument raised in the examiner's
answer ... unless good cause is shown." 37 CFR41.41(b)(2). Appellant
did not explain why they waited until after the Appeal Brief to respond.
Consequently, we shall not consider this new argument.
Claim 11
Claim 11 has substantially the same structural limitations as claim 1,
but further recites:
the surgical instrument realizes at least one benefit selected
from the group consisting of enhanced injection characteristics,
increased operational efficiency, reduced cost per unit, reduced
incidence of injury through intraneural/intravascular injection,
and reduced incidence of injury through pricking/piercing.
As discussed above, the cited prior art reasonably suggests all the
structural features of claim 1, including the position of the side port. Absent
evidence to the contrary, utilizing a needle with such features would result in
the recited benefits.
Appellant argues that the location of the side port would result in at
least one of the claimed benefits. Appeal Br. 31. Appellant also makes the
same unsubstantiated argument about how the position of the port affects the
fluid mechanics. Id. However, since Wang discloses or reasonably suggests
such a location, we conclude that such benefits would be an inherent
property of placing the port in such location. Appellant did not provide
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Application 11/853,785
evidence that such benefit was unexpected nor absent from the needle of
Wang. Consequently, we affirm the rejection of claim 11.
Claim 12
Claim 12, depends from claim 11, and further recites "wherein the
connection is a plug and use connection." The Examiner found this
limitation met by Wang's teaching of a proximal end "secured in a needle
support." Final Rej. 5.
Appellant contends that Wang does not describe a wire connector.
Appeal Br. 32.
Appellant's argument is not persuasive. Claim 12 does not require a
wire plug and use connection. We do not read limitations into the claim.
Nevertheless, the Examiner found that a plug and use connector explicitly
comprising a wire as recited in claims 5 and 7-9 is described by VanTassel
in combination with Wang and Racz. Final Rej. 7.
Claim 22
Appellant provides separate arguments for independent claim 22.
However, these arguments are the same as those found unpersuasive
regarding claims 1 and 11.
Summary
The obviousness rejection of claims 1, 3, 4, 11, 12, and 22 is affirmed.
To the extent claims were not argued separately, they fall with claim 1. See
37 C.F.R. § 41.37(c)(l)(iv).
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OBVIOUSNESS IN VIEW OF WANG, RACZ, AND VANTASSEL
Claims 5-9 depend from claim 1 and further require a wire plug and
use connector (claims 5 and 7-9) and an insulation around the shaft of the
needle (claim 6). The Examiner found that these limitations are described in
VanTassel. Final Rej. 7-8. The Examiner explained why it would have
been obvious to one of ordinary skill in the art to have added such features to
Wang. Id. Appellant makes the same unpersuasive arguments as for claim
1. Appeal Br. 34--36. Consequently, we affirm the rejection of claims 5-9
for the reasons set forth by the Examiner.
OBVIOUSNESS IN VIEW OF WANG, RACZ, AND YAMAMOTO
Claims 23 and 25 have substantially the same limitations as claim, but
further require insulation along the needle shaft. The Examiner found that
Yamamoto describes insulation that meets the claim limitation and explained
why it would have been obvious to one of ordinary skill in the art to apply
Yamamoto' s teaching to Wang and Racz. Final Rej. 10-11. Appellant
makes the same unpersuasive arguments as they did for claims 1, 11, and 22.
Consequently, we affirm the rejection of claims 23 and 25 for the reasons set
forth by the Examiner.
TIME PERIOD
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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