Robert K. Deckman et al.

Patent Trials and Appeals Board

Nov 1, 2019

14989732 - (D) (P.T.A.B. Nov. 1, 2019)

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.
14/989,732 01/06/2016 Robert K. Deckman 31992-711.302 5078
21971 7590 11/01/2019
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
ROZANSKI, MICHAEL T
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
11/01/2019 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):
patentdocket@wsgr.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROBERT K. DECKMAN, BRIAN PLACEK,
MICHAEL A. MUNROW, CRAIG GERBI,
and JESSICA GROSSMAN

Appeal 2018-000626
Application 14/989,732
Technology Center 3700
____________

Before JOHN C. KERINS, AMEE A. SHAH, and
ROBERT J. SILVERMAN, Administrative Patent Judges.

KERINS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s decision rejecting claims 1–40.1 We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 The term “Appellant” is used herein to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Gynesonics, Inc. as the real party in
interest. Appeal Br. 3.
Appeal 2018-000626
Application 14/989,732

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THE CLAIMED SUBJECT MATTER
Appellant’s invention relates to a system and method involving
imaging and therapeutic delivery. Claim 1 is illustrative, and is reproduced
below:
1. An imaging and therapeutic delivery system comprising:

a shaft having a distal end and a proximal end;

a needle reciprocatably coupled to the shaft so that a tissue-
penetrating tip on the needle is distally advancable from the shaft
along an axial path;

a tip pivotally attached to the distal end of the shaft and movable
between a position parallel to the axial path and a position at an
acute or right angle relative to the axial path; and

an ultrasonic imaging array carried by the pivotally attached tip,
wherein the pivotally attached tip is configured to be oriented to
align a field of view of the imaging array with the needle as the
needle is advanced along the axial path so as to sweep the
ultrasound field of view relative to the needle and anatomy to be
imaged;

a handle attached to the proximal end of the shaft;

a first actuation mechanism on the handle and coupled to the
needle, wherein the first actuation mechanism is configured to be
reciprocated to advance and retract the needle along the axial
path;

a plurality of tines carried by the needle and reciprocatably
attached to the needle; and

a second actuation mechanism on the handle configured to be
reciprocated to advance and retract the plurality of tines relative
to the needle,

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wherein the first and second actuation mechanisms are movable
relative to one another.

THE REJECTIONS
The Examiner rejects:
(i) claims 20, 36, and 40 under 35 U.S.C. § 112, second paragraph, as
being indefinite for failing to particularly point out and distinctly claim the
subject matter regarded as the invention;2
(ii) claims 1–40 under 35 U.S.C. § 103(a) as being unpatentable over
Chin (US 6,171,249 B1, issued Jan. 9, 2001) in view of Deckman (US
2008/0033493 A1, published Feb. 7, 2008) and Ostrovsky (US
2005/0107781 A1, published May 19, 2005);
(iii) claims 1–40 on the ground of nonstatutory obviousness-type
double patenting over claims 1–14 of Munrow ‘427 (US 8,992,427 B2,
issued Mar. 31, 2015); and
(iv) claims 1–40, provisionally, on the ground of nonstatutory
obviousness-type double patenting over claims 1–36 of copending
Application No. 13/801,782, now Munrow ‘336 (US 9,861,336 B2, issued
Jan. 9, 2018).

2 Indefiniteness rejections directed to claims 1, 4, 5, 29, 31, and 35
appearing in the Final Action were withdrawn in an Advisory Action dated
February 22, 2017. Adv. Act. 2.
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Application 14/989,732

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ANALYSIS
Claim 20, 36, and 40--35 U.S.C. § 112, second paragraph
Appellant filed an Amendment after Final Action on February 13,
2017, presenting certain claim amendments in response to the indefiniteness
rejection under 35 U.S.C. § 112, second paragraph. The Advisory Action
noted that the amendments would be entered, and that only claims 20, 36,
and 40 remained subject to the rejection.
For claim 20, it is our understanding that the expression, “the
advancement and retraction,” recited in connection with movement of a
plurality of tines by a second actuation mechanism, lacks proper antecedent
basis. Although not explained in detail by the Examiner, this is the first
instance in claim 20, and in claim 19 from which claim 20 depends, in which
a “retraction” of the tines is recited. Claim 19 recites “advancing” a
plurality of tines, but not also “retracting” them.
A claim is properly rejected as being indefinite under 35 U.S.C. § 112,
second paragraph, if, after applying the broadest reasonable interpretation in
light of the specification, the metes and bounds of a claim are not clear
because the claim “contains words or phrases whose meaning is unclear.” In
re Packard, 751 F.3d 1307, 1310 (Fed Cir. 2014). In the present situation, a
more conventional recitation that unquestionably would provide antecedent
basis would be “an advancement and retraction of the plurality of tines.”
Nonetheless, the use of “the” instead of “an” does not render the phrase
unclear in terms of its scope. A person of ordinary skill in the art would
readily understand that “retraction” as used in the objected-to phrase refers
to movement in the direction opposite to the advancement direction. The
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Application 14/989,732

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phrase also makes clear that the “retraction” to which it refers is the
retraction of the plurality of tines by a second retraction mechanism.
The rejection of claim 20 as being indefinite is not sustained.
For claims 36 and 40, it appears that the remaining issue is whether
the absence of the article “the,” preceding “reciprocating carriage,” in the
expression “wherein the second actuation mechanism is reciprocally coupled
to reciprocating carriage,” renders unclear the metes and bounds of that
limitation. The Examiner’s statement that “it appears ‘the’ should be
inserted before ‘reciprocating,’” (Final Act. 3), evidences that the Examiner
understands, as would a person of ordinary skill in the art, that the recitation
of “reciprocating carriage” refers back to the “first actuation mechanism
compris[ing] a reciprocating carriage” recited in the clause immediately
preceding. Accordingly, under the Packard standard noted above, the
claims is sufficiently definite for the purposes of the provision in 35 U.S.C.
§ 112, second paragraph.
The rejection of claims 36 and 40 as being indefinite is not sustained.

Claims 1–40--35 U.S.C. § 103--Chin/Deckman/Ostrovsky
The Examiner cites to Chin as disclosing many of the elements recited
in claim 1, but acknowledges that Chin does not disclose a first actuation
mechanism on a handle and coupled to a needle, which is configured to be
reciprocated to advance and retract the needle along an axial path. Final
Act. 4–5.3 The Examiner turns to Deckman as disclosing a device for

3 The Examiner mistakenly states that Chin discloses “all features of the
claimed invention but do[es] not disclose the first actuator for
advancing/retracting the needle.” Final Act. 5. The grounds for rejection
later make clear that Chin also does not disclose the claimed plurality of
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fibroid treatment that includes a treatment needle 112 that is advanced by a
slide mechanism 20 including a carriage structure coupled to the needle. Id.
The Examiner concludes that it would have been obvious to modify Chin to
include a slide mechanism to deploy a needle, “in order to facilitate
controlled deployment of the needle and tines.” Id.
The Examiner, somewhat in contradistinction to the above reference
to controlled deployment of “the needle and tines” in Deckman by a slide
mechanism, correctly observes that Deckman contains “no explicit
disclosure regarding how the tines 114, 116 are advanced from the needle.”
Final Act. 5. The Examiner cites to Ostrovsky as disclosing a tissue ablation
device in which a handle is “provided to manipulate an insertion needle and
tines wherein a sliding control lever or other conventional device [is]
adapted to cause the deployment of the fines [sic, tines] from the needle[].”
Id. (citing Ostrovsky ¶ 73). The Examiner further concludes that it would
have been obvious to modify Chin, as previously modified in view of
Deckman, to include a second actuating mechanism in order to improve
control and guidance of the tines as they are deployed from the needle. Id.
Implicitly recognizing that none of the references individually
discloses use of first and second actuators, the Examiner notes that “it is
apparent that the actuators,” in the proposed modification of the Chin device,
“would be movable relative to one another, as they are separate structures,”
and that they would move independently of one another. Id. at 5–6.
Appellant argues, in part, that incorporating a slide mechanism as
taught by Deckman into the Chen device would adversely affect the use of

tines, nor a second actuation mechanism for advancing and retracting tines
relative to the needle. Id.
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the Chen device in the performance of inserting and removing a biopsy
sample collection needle from the handle in Chen. Appeal Br. 15.
Appellant maintains that providing a slide mechanism or actuator coupled to
the needle to advance and retract it would integrate the needle into the
handle such that it could not be separately removed as needed to collect the
biopsy sample. Id.
The Examiner replies that “there is nothing to indicate that Chin could
not be performed as intended simply because the needle is advanced via a
slide as opposed to manual operation. A slide would not prohibit the needle
from being retracted/advanced to take multiple biopsies.” Ans. 8.
Appellant’s point, in this respect, was not that a slide would prohibit the
advancement or retraction of a needle within the device of Chin, but rather
would prohibit or interfere with the removal of a needle from the Chin
device to collect a biopsy sample, and the reinsertion of the or another
needle to collect an additional sample. The rejection provides little to no
specific discussion as to how the Chin device would be modified to include a
slide mechanism or other actuator. It thus appears that Appellant’s concern
as to the continued viability of the Chin device to be used to collect biopsy
samples if modified to couple the needle to a slide mechanism has merit.
Appellant additionally takes issue with the Examiner’s proposal to
include a plurality of tines within the biopsy needle of Chin to be advanced
from the needle. Appeal Br. 15. Appellant argues that the provision of such
tines is of questionable benefit in a biopsy needle system, and additionally
maintains that any such tines might well obstruct the aperture of the Chin
needle and thereby hinder the acquisition of a biopsy sample if the tines are
deployed after the needle is moved to its desired position. Id.; Reply Br. 4.
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We note initially that the rejection as stated in the Final Action
presents no reason to modify Chin so as to include tines within the needle,
and such that the tines are to be separately advanced from the needle. See
Final Act. 4–6. That Deckman and Ostrovsky include tines carried within a
needle for deployment therefrom does not necessarily render obvious their
incorporation in the Chin device, which is mainly provided for a different
purpose than the Deckman and Ostrovsky devices. The Examiner responds
to Appellant’s arguments by rationalizing that “[t]he usage of tines for
treating tissue is a supplemental function relative to obtaining a biopsy and a
biopsy needle already in position at the target tissue would actually facilitate
the subsequent tissue treatment.” Ans. 8.
The Examiner’s position appears to ignore that, in the proposed
modified structure, the same needle bore seemingly would be used for both
obtaining a biopsy sample cut from the tissue with the sharp needle edge to
fit within the bore, and to advance tines therethrough for the supplemental
function of treating the tissue. Absent any better and more technologically
sound explanation of the operation of the proposed modified device,
Appellant has the better position that the inclusion of tines within the Chen
needle tines would appear to obstruct the aperture of the Chin needle and
thereby hinder the acquisition of a biopsy sample.
Accordingly, the Examiner’s proposed modification of Chen in view
of Deckman and Ostrovsky is lacking in rational underpinnings in the above-
noted respects. The rejection of claim 1 as being unpatentable over Chen,
Deckman, and Ostrovsky is therefore not sustained. Independent claims 19,
31, 35, 36, and 40 include similar limitations to those discussed above, and
the rejection of those claims is not sustained for the same reasons. The
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rejection is further not sustained as to claims 2–18, 20–30, 32–34, and 37–
39, which each depend from one of the independent claims.

Claims 1–40--Nonstatutory Double Patenting--claims 1–14 of Munrow ‘427
The entire substance of the rejections of claims 1–40 over claims 1–14
of Munrow ‘427 is “’427 features a treatment probe having a shaft, handle,
needle, needle slider, and tine slider.” Final Act. 9. Further, although not
stated as such, the rejection appears to rely on Chin in combination with one
or more undesignated claims of Munrow ‘427 as rendering obvious the
limitation found in claim 1 on appeal requiring the presence of a pivotable
tip with an ultrasound array. Id. In response to certain arguments advanced
by Appellant relative to the claims of Munrow ‘427 having only a single
slider, the Examiner points to claim 10 of Munrow ‘427 as additionally
reciting a tine slide. Ans. 9.
Section 804(II)(B)(2) of the Manual of Patent Examining Procedure
(MPEP) provides that:
Any nonstatutory double patenting rejection made under the
obviousness analysis should make clear:
(A) The differences between the inventions defined by the
conflicting claims — a claim in the patent compared to a claim
in the application; and
(B) The reasons why a person of ordinary skill in the art would
conclude that the invention defined in the claim at issue would
have been an obvious variation of the invention defined in a
claim in the patent.
The Examiner’s rejection fails to adequately address both of these
aspects of a proper nonstatutory double patenting rejection. The claim
language in the claims of Munrow ‘427 and in the claims on appeal is
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sufficiently different that the analysis called for in the MPEP and quoted
above is necessary in order to determine the propriety of the rejection.
Accordingly, the rejection is not sustained.

Claims 1–40--Provisional Nonstatutory Double Patenting--claims 1–36 of
Application No. 13/801,782, now Munrow ‘336
The provisional nonstatutory double patenting rejection over
Application No. 13/801,782 is deficient for essentially the same reasons
noted above with respect to the rejection in view of Munrow ‘427. The lack
of rigor in comparing the claims limitation-by-limitation precludes us from
sustaining this rejection as well.
We further note that the application cited in this rejection has issued
as Munrow ‘336, and although claim 1 in Munrow ‘336 appears to be
similar in scope to claim 1 in the cited application, Munrow ‘336 issued with
less than the 36 claims that were pending in Application No. 13/801,782 at
the time the rejection was made.

DECISION
The rejection of claims 20, 36, and 40 under 35 U.S.C. § 112, second
paragraph, is reversed.
The rejection of claims 1–40 under 35 U.S.C. § 103 as being
unpatentable over Chin, Deckman, and Ostrovsky is reversed.
The rejection of claims 1–40 on the ground of nonstatutory
obviousness-type double patenting over claims 1–14 of Munrow ‘427 is
reversed.
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11
The rejection of claims 1–40, provisionally, on the ground of
nonstatutory obviousness-type double patenting over claims 1–36 of
copending Application No. 13/801,782, now Munrow ‘336, is reversed.

CONCLUSION

In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
20, 36, 40 § 112, ¶ 2 20, 36, 40
1–40 § 103 Chin, Deckman, Ostrovsky 1–40
1–40 Nonstatutory double
patenting, Munrow ‘427
1–40
1–40 Provisional nonstatutory
double patenting, Munrow
‘336
1–40
Overall
Outcome

1–40

REVERSED