Ex Parte Malinowski et al

Patent Trial and Appeal Board

Oct 31, 2012

11063135 (P.T.A.B. Oct. 31, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
11/063,135 02/22/2005 Zdzislaw B. Malinowski 40328-0023
(05-00559-01)
6277
71422 7590 11/01/2012
VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
HELLER, TAMMIE K
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
11/01/2012 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 PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ZDZISLAW B. MALINOWSKI
and SALOMO SIILAS MURTONEN
____________

Appeal 2010-008545
Application 11/063,135
Technology Center 3700
____________

Before NEAL E. ABRAMS, CHARLES N. GREENHUT,
and REMY J. VANOPHEM, Administrative Patent Judges.

ABRAMS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Zdzislaw B Malinowski et al. (Appellants) seek our review under 35
U.S.C. § 134 from the Examiner’s decision rejecting claims 1, 6-8, 16-19,
21, 23-29, 31-35, 39 and 40. We have jurisdiction over the appeal under 35
U.S.C. § 6(b).
We AFFIRM-IN-PART.

Appeal 2010-008545
Application 11/063,135

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THE INVENTION
The claimed invention is directed to methods of delivering a medical
device within the brain of a patient.
Claim 1, reproduced below, is illustrative of the subject matter on
appeal.
1. A method of delivering a medical device
within a brain of a patient, said method
comprising:
inserting a distal portion of a main cannula
into said brain, said main cannula having a
longitudinal axis and a lumen;
positioning a guiding cannula in said lumen
of said main cannula, said guiding cannula
comprising a lumen and a distal end portion
configured to bend;
adjusting an insertion depth of said guiding
cannula, wherein said distal end portion of said
guiding cannula is bent as it is advanced from said
main cannula, such that a longitudinal angle is
formed between a line perpendicular to, and
extending through, said longitudinal axis, and said
bent distal end portion when projected within a
plane that includes said line;
setting said longitudinal angle by rotating
said distal end portion within said main cannula
prior to advancing said distal end portion from said
main cannula; and
passing a medical device through said lumen
of said guiding cannula into said brain.

THE PRIOR ART
The Examiner relied upon the following as evidence of
unpatentability:
Dubach US 5,788,713 Aug. 4, 1998
Hogg US 2004/0006350 A1 Jan. 8, 2004
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Application 11/063,135

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THE REJECTIONS

Claims 1, 6-8, 16-19, 21, 23-29, 31-35, 39 and 40 stand rejected under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
Claims 1, 6-8, 16-19, 21, 23-29, 31-35, 39 and 40 stand rejected under
35 U.S.C. § 102(b) as being anticipated by Hogg.
Claims 1, 6, 7, 16, 17, 19, 21, 23-29, 31-35, 39 and 40 stand rejected
under 35 U.S.C. § 102(b) as being anticipated by Dubach.1

OPINION

Claims 1, 6-8, 16-19, 21, 23-29, 31-35, 39 and 40
35 U.S.C. §112 - Written Description

The Appellants’ invention is directed to a method of delivering a
medical device within the brain of a patient. As set forth in independent
claims 1 and 16, the method comprises the steps of inserting a main cannula
into the brain of a patient, positioning a guiding cannula in the main cannula,
adjusting the insertion depth of the guiding cannula wherein the distal end of
the guiding cannula is bent as it is advanced from the main cannula such that
a longitudinal angle is formed between a line perpendicular to and extending
through the longitudinal axis of the main cannula, and “setting said
longitudinal angle by rotating said distal end portion within said main
cannula prior to advancing said distal portion from said main cannula”

1A rejection of claims 1, 6-8, 16-19, 21, 23-29, 31-35. 39 and 40 as failing to
comply with the enablement requirement under 35 U.S.C. § 112, first
paragraph, and of claims 8 and 18 as being anticipated by Dubach under 35
U.S.C. § 102(b), were withdrawn by the Examiner. Ans. 2.
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Application 11/063,135

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(emphasis added). According to the Examiner, paragraph [0075] of the
Specification “suggests that the longitudinal angle is set after the guiding
cannula has been advanced” (emphasis added), and therefore the Examiner
has concluded that “[t]he claim(s) contains subject matter which was not
described in the specification in such a way as to reasonably convey to one
skilled in the relevant art that the inventor(s), at the time the application was
filed, had possession of the claimed invention.” Ans. 3. The Examiner also
asserts that the longitudinal angle is not set by rotating the distal end portion
of the guiding cannula within the main cannula, as is recited in the claims,
because according to paragraph [0075] of the Specification this is
accomplished by “using a proximally-located longitude adjustment plate
105.” Ans. 3-4.
The Appellants argue in reply that paragraphs [0074], [0075] and
[0078] make it clear that the longitudinal angle is set by rotating the guide
cannula “before the distal portion of the guide cannula 103 is advanced out
of the main cannula 102.” Br. 9. With regard to the matter of rotating the
guiding cannula within the main cannula, the Appellants urge that it is “clear
that, since the longitudinal adjustment plate rotates the guide cannula about
the vertical axis of the main cannula (see paragraph [0037]), it necessarily
rotates the distal portion of the guide cannula (since the distal portion is
connected to the remaining part of the guide cannula).” Br. 10.
Paragraph [0078] of the Appellants’ Specification is directed to
further adjusting the longitudinal angle of the guiding cannula. It states that
this may include the steps of removing the microelectrode from the guiding
cannula and adjusting the depth of the distal tip of the guiding cannula to or
less than the depth of the distal end of the main cannula, whereupon “[t]he
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Application 11/063,135

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longitudinal angle is then adjusted to the new desired longitudinal angle”
(emphasis added) and “[t]he depth of the guiding cannula (103) may then be
adjusted to the new desired depth” (emphasis added). Br. 8-9. Thus,
paragraph [0078] sets forth a method in which the longitudinal angle of the
guiding cannula may be adjusted prior to advancing the distal end portion of
the guiding cannula from the main cannula to set the depth, which is the
order of steps recited in independent claims 1 and 16. This being the case,
the Examiner’s position on this matter is in error.
The Examiner also erred in concluding that the Specification does not
support the language in the claims that the distal end portion of the guiding
cannula is rotated to set the recited longitudinal angle. With specific
reference to paragraph [0035] of the Specification, the Appellants have
adequately explained that the distal end of the guiding cannula 103 may be
rotated by means of a longitudinal adjustment plate 105 which is coupled to
the proximal end of this cannula, and that because this distal end of the
guiding cannula has a preset bend that appears when it is extended from the
distal end of the main cannula, rotation of the guiding cannula results in
setting the longitudinal angle that is required by the claims. See Br. 9-10;
Reply Br.2-3.
For the reasons expressed above, the rejection under Section 112, first
paragraph, is reversed.
Claims 1, 6-8, 16-19, 21, 23-29, 31-35, 39 and 40
Anticipation – Hogg

In setting forth this rejection, the Examiner focuses upon Hogg’s Figs.
23 and 24, labeling element 452 as the main cannula recited in the claims,
element 472 (described by Hogg as a “sheath” in paragraph [0074]) as the
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Application 11/063,135

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guiding cannula (mistakenly recited by the Examiner as 474), and element
466 (described by Hogg as a “spherical body” in paragraph [0074]) as the
distal portion of the guiding cannula. According to the Examiner, element
466 “may be rotated within the main cannula to define a longitudinal angle.”
Ans. 4. In responding to the Appellants’ arguments, the Examiner further
explains that elements 472 and 466 together should be considered to be a
“guiding cannula” in that they are “integrated together at a distal end
portion,” which is “configured to bend.” Ans. 9.
The Appellants argue in rebuttal that even if sheath 472 were
considered to be the claimed guiding cannula and spherical body 466 to be
the distal end thereof, spherical body 466 is not “bent,” nor is either element
“advanced from” the main cannula as required by the claims, and it therefore
follows that neither the sheath 472 nor the guide member 464 are “rotated
prior to being advanced,” (Br. 15; Reply Br. 6; emphasis in the original).
See Br. 14-15; Reply Br. 5-6.
We find ourselves in agreement with the Appellants. Claims 1 and 16
both include the steps of positioning a guiding cannula in the lumen of a
main cannula, adjusting an insertion depth of the guide cannula wherein the
distal end portion of the guiding cannula is “bent as it is advanced from said
main cannula,” and rotating the distal end portion of the guiding cannula
“prior to advancing said distal end portion from said main cannula.” Even
conceding, arguendo, that elements 472 and 466 of Hogg together comprise
a guiding cannula whose distal end can be rotated to prescribe an angle and
therefore considered to be “bent,” it is clear that these elements are not at
any time “advanced from” the main cannula, nor do they set a longitudinal
angle “prior to advancing” from the main cannula.
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Application 11/063,135

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Since all of the required steps set forth are not described in Hogg, the
rejection independent claims 1 and 16 as being anticipated by Hogg is
reversed. It follows that the like rejection of dependent claims 6-8, 17, 18,
19, 21, 23-29, 31-35, 39 and 40 also is reversed.

Claims 1, 6, 7, 16, 17, 19, 21, 23-29, 31-35, 39 and 40
Anticipation – Dubach
Dubach is directed to a method and apparatus for stereotactic
implantation of a foreign object in tissue, such as a brain. As shown in Figs.
1A-1C, the apparatus disclosed as “implantation tool 10” comprises an outer
main cannula (guide-tube) 20 with a guiding cannula (nitinol tubing) 28
positioned within, through which a medical device (nitinol wire) 24 is
passed. Guiding cannula 28 is retractable into and extensible from the distal
end of main cannula 20. The distal portion of guiding cannula 28 has a
shaped memory curve that manifests itself when the guiding cannula is
extended from the distal end of main cannula 20. Figs. 1A and 1B; Col. 6,
ll. 10-16. The proximal ends of main cannula 20 and guiding cannula 28 are
affixed, respectively, to collar mounts 16 and 14, which in turn are slidably
mounted on guide rails 18a-18b. Col. 6, ll. 1-9. In Fig. 4 Dubach illustrates
an apparatus that can be used to position implantation tool 10 to place
medical device 24 in the subject’s brain. To do so, implantation tool 10 is
mounted on an arm 195 that is rotatable about a vertical axis (at post 120), as
a result of which main cannula 20, guiding cannula 28 and medical device
24 are rotated together about post 120. Col. 27, ll. 14-48.
Referring to Fig. 4 and column 27, lines 14-48, the Examiner
concludes that the Dubach adjustment mechanism “includes rotating the
distal end portion of the guide cannula to bed [sic bend] at a predetermined
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Application 11/063,135

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longitudinal angle” “in a fashion substantially similar to that illustrated in
Figure 2 of the [Appellants’] currently filed drawings.” Ans. 5. Further
explanation is provided in the reply to the Appellants’ arguments, wherein
the Examiner points out that the Appellants’ claims require “rotating said
distal end portion within said main cannula,” and states that “a difference
exists between the configuration where the guiding cannula is rotated within
the main cannula and where the guiding cannula is rotated with respect to
the main cannula.” Thus, the Examiner concludes, “rotation of the guiding
cannula coincident with rotation of the main cannula . . . satisfies the claim
limitations.” Ans. 12. Regarding the longitudinal angle, the Examiner has
taken the position that Dubach discloses in column 31, lines 10-15, that as
tube 28 emerges from cannula 20 “its plane of curvature (longitudinal angle)
can be oriented in any direction, but only one direction is correct” and that
“[a]s such, Dubach discloses setting the longitudinal angle by rotating said
distal end portion within the main cannula prior to advancing said distal end
portion from said main cannula.” Ans. 12.
The Appellants argue in response that while Dubach discloses that
guiding cannula 28 “is rotated with” main cannula 20, it does not disclose
that guiding cannula 28 “is rotated within” main cannula 20 (emphasis in the
original; Br. 16; Reply Br. 7-8), and that “failing to distinguish between
‘rotating within’ and ‘rotating with’ is an unreasonably broad interpretation
of the claims” (Reply Br. 7). The Appellants also assert that the Examiner’s
conclusion that in Dubach the rotation of the guide cannula within the main
cannula sets the longitudinal angle is not supported by the text cited by the
Examiner (Col. 27, ll. 43-50; Col. 30, l. 66-Col. 31, l. 2), which “simply
disclose various geometries related to the carrier-cannula plane,” and
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Application 11/063,135

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therefore “the Examiner has not shown where Dubach discloses, explicitly
or inherently” that this limitation is disclosed in Dubach. Reply Br. 7-8.
During patent examination, the pending claims must be interpreted as
broadly as their terms reasonably allow. In re Prater, 415 F.2d 1393, 1404-
1405 (CCPA 1969). The presumption that a term is given its ordinary and
customary meaning may be rebutted by the applicant by clearly setting forth
a different definition of the term in the specification. In re Morris, 127 F.3d
1048, 1054 (Fed. Cir.1997). In the present case, the Appellants have merely
argued that the Examiner’s conclusion is incorrect (Br. 16; Reply Br. 7-8),
but have not pointed out why the terminology “rotating . . . within” would be
understood by one of ordinary skill in the art to have a particular meaning
which rebuts the Examiner’s conclusion that the broadest reasonable
interpretation thereof includes the coincident rotation of the main cannula
with the guiding cannula positioned therein about an axis. Nor have the
Appellants directed us to language in their disclosure which would support
the proposition that one of ordinary skill in the art would have understood
that the broadest reasonable interpretation of “rotating . . . within” is
“rotating with respect to.” Furthermore, while the Appellants have
expressed their disagreement with the Examiner’s conclusion that Dubach
teaches setting the required longitudinal angle (Br. 16-17), they have not
explained why the specific positions set forth by the Examiner on pages 5-6
and 12 of the Answer are incorrect.
For the reasons expressed above, the rejection of independent claims 1
and 16 as being anticipated by Dubach is affirmed. Since the Appellants
have not separately argued the patentability of dependent claims 6, 7, 17, 19,
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21, 23-29 and 31-35, the rejection of those claims as being anticipated by
Dubach also is affirmed.
Claims 39 and 40, which depend respectively from claims 1 and 16,
also stand rejected as being anticipated by Dubach. These claims require the
additional steps of withdrawing the distal end portion of the guiding cannula
into the main cannula, setting the longitudinal angle again by rotating the
distal end portion within the main cannula, and advancing the withdrawn
distal end portion from the main cannula. The Examiner has concluded that
Figs. 1-3 of Dubach show the distal end portion “withdrawing . . . into said
main cannula,” “setting the longitudinal angle again,” and “advancing said
withdrawn distal end portion from said main cannula.” Ans. 13. The
argument advanced by the Appellants is that the Examiner has “failed to
point to any disclosure in Dubach that teaches the additional steps of
withdrawing, setting, and advancing” (Br. 18), and that Dubach does not
teach “setting the longitudinal angle again after the guiding cannula has been
withdrawn from the main cannula” (Reply Br. 8). We agree. The Examiner
has failed to establish that Dubach anticipates claims 39 and 40, and this
rejection is reversed.

DECISION
The rejection of claims 1, 6-8, 16-19, 21, 23-29, 31-35, 39 and 40
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement, is reversed.
The rejection of claims 1, 6-8, 16-19, 21, 23-29, 31-35, 39 and 40
under 35 U.S.C. § 102(b) as being anticipated by Hogg is reversed.
Appeal 2010-008545
Application 11/063,135

11
The rejection of claims 1, 6, 7, 16, 17, 19, 21, 23-29 and 31-35 under
35 U.S.C. § 102(b) as being anticipated by Dubach is affirmed.
The rejection of claims 39 and 40 under 35 U.S.C. § 102(b) as being
anticipated by Dubach is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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