Ex Parte Ryan et al

Patent Trial and Appeal Board

Jul 26, 2018

13362278 (P.T.A.B. Jul. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/362,278 01/31/2012 Shawn Ryan
30636 7590 07/26/2018
FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK, NY 10038
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.
10121/14102 3014
EXAMINER
CERIONI, DANIEL LEE
ART UNIT PAPER NUMBER
3736
MAIL DATE DELIVERY MODE
07/26/2018 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 SHAWN RYAN, CAROLINE GAUDET, KAYLA BURNIM,
ANDREW WHITNEY, and BARRY WEITZNER
Appeal2017-004570
Application 13/362,278
Technology Center 3700
Before ELIZABETH A. LA VIER, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134 involving
claims to a stylet for insertion into a biopsy needle, and to a related biopsy
device. The Examiner rejected the claims as indefinite and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Boston Scientific Scimed,
Inc. App. Br. 2.
Appeal2017-004570
Application 13/362,278
STATEMENT OF THE CASE
Appellants' "invention relates to devices for needle biopsies and, in
particular, relates to a biopsy device including improved distal tip features
for tissue acquisition." Spec. ,r 6.
Claims 1--4, 19, and 22-26 are on appeal. Claims 1 and 19, the
independent claims on appeal, are illustrative and are reproduced below:
1. A stylet for insertion into a biopsy needle, comprising:
a coil at a distal end thereof such that advancement of the
stylet relative to the needle moves the coil from a closed
configuration in the needle to a tissue collecting configuration in
which the coil extends distally past the distal end of the needle;
and
an actuating mechanism including a housing and a piston
extending therethrough, a distal end of the piston coupled to a
proximal end of the stylet such that movement of the piston
distally relative to the housing moves the stylet from the closed
configuration to the tissue collecting configuration, the actuating
mechanism including a releasable, pivotable lever fixing the
stylet in the tissue collecting configuration and a biasing element
received in the housing to bias the stylet toward the closed
configuration so that, when the lever is pivoted to release the
piston, the stylet reverts to the closed configuration and is drawn
proximally into the needle.
19. A biopsy device, comprising:
a needle extending longitudinally from a proximal end to
a distal end and including a channel extending therethrough;
a stylet sized and shaped for slidable insertion through the
channel of the needle, the sty let including a coil at a distal end
thereof such that rotation of the stylet relative to the needle
moves the coil from a closed configuration in the channel to a
tissue collecting configuration in which the coil extends distally
past a distal end of the needle to be inserted into a target tissue;
and
an actuating mechanism including a housing and a piston
extending therethrough, a distal end of the piston coupled to a
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Application 13/362,278
proximal end of the stylet such that movement of the piston
distally relative to the housing moves the stylet from the closed
configuration to the tissue collecting configuration, the actuating
mechanism including a releasable, pivotable lever fixing the
stylet in the tissue collecting configuration and a biasing element
received in the housing to bias the stylet toward the closed
configuration so that, when the lever is pivoted to release the
piston, the stylet reverts to the closed configuration and is drawn
proximally into the needle.
Claims App. 2
The claims stand rejected as follows:
Claims 1--4, 24, and 26 under 35 U.S.C. § 112, second paragraph (pre-
AIA), for indefiniteness. Final Act. 3 3--4.
Claims 1--4, 19, and 22-26 under 35 U.S.C. § I03(a) as obvious over
Jans sens 4 and Sauer. 5 Final Act. 4--10.
Only those arguments made by Appellants in the Appeal Brief and
properly presented in the Reply Brief have been considered in this Decision.
Arguments not so presented in the Briefs are waived. See 37 C.F.R.
§ 4I.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474
(BP AI 2010) (informative) ("Any bases for asserting error, whether factual
or legal, that are not raised in the principal brief are waived").
2 We refer to the claims as included in the corrected Claims Appendix,
which was submitted on January 11, 2016.
3 Final Office Action dated March 13, 2015.
4 Janssens, US 2003/0114773 Al, published June 19, 2003.
5 Sauer, US 2007/0167868 Al, published July 19, 2007.
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Application 13/362,278
INDEFINITENESS
As the Examiner explains, claim 1 is drawn to "a stylet," yet other
aspects of the claim recite elements of a biopsy device and/ or actuating
mechanism, which are not part of the sty let. Final Act. 3--4. Hence, the
Examiner concludes, the claims are unclear and indefinite under § 112,
second paragraph. Id.
Regarding claim 26, which depends from claim 19, the Examiner
concludes the claim is unclear whether the recited "lever biased toward a
locked position" relates to a function of the "biasing element," the "lever,"
or some other feature. Here too, the Examiner concludes the claim is
indefinite. Id. at 4.
As the Examiner notes, Appellants provide no argument in response
to the rejection of claims 1--4, 24, and 26 for indefiniteness. Ans. 9.
Because Appellants failed to contest the rejection, it is summarily affirmed. 6
Hyattv. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) ("When the appellant
fails to contest a ground of rejection to the Board, ... the Board may treat
any argument with respect to that ground of rejection as waived ... [and] the
PTO may affirm the rejection of the group of claims that the examiner
rejected on that ground without considering the merits of those rejections.").
6 It appears the Examiner and Appellants have discussed proposed claim
amendments as potentially traversing the rejection under§ 112, second
paragraph. See Interview Summary and Adv. Act. ( dated Sept. 17, 2015).
But those amended claims are not before us on appeal.
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Application 13/362,278
OBVIOUSNESS
Issue
Has the Examiner established by a preponderance of the evidence on
this record that claims 1--4, 19, and 22-26 would have been obvious over
Janssens and Sauer?7
Findings of Fact (FF)
The Examiner's findings of fact and statement of the rejection are
provided at pages 4--10 of the Final Office Action. See also Ans. 2-8 and
10-15 (Response to Argument). The following findings are provided for
emphasis and convenient reference.
FF 1. Janssens teaches a "[d]evice for taking a tissue sample ...
characterized in that it comprises a spirally shaped tissue-receiving
element." Janssens Abstract. More specifically, Janssens describes a
"spirally shaped tissue-receiving element ... and a cutting element" that
cooperatively provide a cutting function. Id.; see also id. at Figs. 1-3
(showing spiral tissue-receiving element (2) within cylindrical element (4)),
Figs. 13-14 (illustrating steps of tissue removal by the spirally shaped
tissue-receiving element and cylindrical element), ,r,r 40, 61---62.
FF 2. Janssens teaches that the device comprising the spirally shaped
tissue-receiving element and cylindrical element "may be made as a biopsy
needle" and "can be operated manually as well as by means of an
7 Although we have affirmed the rejection for indefiniteness (as discussed
above), we review the obviousness rejection nonetheless. See Ex parte
Tanksley, 26 USPQ2d 1384, 1387 (BPAI 1991) (exercising discretion to
reach art rejections despite indefiniteness where nature of case permitted).
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Appeal2017-004570
Application 13/362,278
appropriate apparatus." Id. ,r,r 50-51; see also id. ,r 68 ("the cylindrical
element 4 is made as a hollow needle, more particularly a biopsy needle").
FF. 3. Janssens teaches that the device/apparatus may include various
driving means within a housing to axially shift and/or rotate the cylindrical
element and tissue-receiving element. See, e.g., id. ,r,r 51-54, Fig. 6
(showing, inter alia, device (1), housing (13), extremity (18) of portion (3)
of the tissue-receiving element (2), and driving mechanism (15) for axial
movement of the tissue-receiving element (2) and related structures (3, 18)).
FF 4. Sauer relates to a "medical diagnostic instrument for the
ergonomic effective and safe harvesting of specimen at targeted remote
tissue sites[, which] includes a pistol grip style handle with a hand activated
lever and a specialized elongated flexible double tube needle shaft." Sauer
Abstract. Sauer teaches that the "ergonomic device ... enables
enhancement of obtaining larger core biopsy tissue samples ... [and]
enables enhancement of obtaining tissue samples using a traditional needle
or needle with indwelling stylet." Id. ,r,r 16-17; see also id. at Figs. 4A--4B
( showing exploded view of a fine needle aspiration instrument with handle
halves (22 and 24) separated, and showing lever (32) and its attached band
drive (34) and lever spring (36)), ,r,r 74--75 (description of Figs. 4A--4B).
FF 5. Figure 3 of Sauer is reproduced below.
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Application 13/362,278
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Figure 3 is a perspective view of aspiration instrument ( 10) without the right
handle portion (22), so that various internal mechanisms of the instrument
can be better seen. Id. ,r 72. Figure 3 depicts, among other structures, lever
(32) (attached at cylindrical pivot (32A)), band drive (34), and lever spring
(36). Sauer discloses, and Figure 3 shows, lever spring (36) attached at one
end by way of hook (36A) to spring post (32C) of lever (32), and at the other
end to lever spring post (24F). Id. Sauer teaches "spring 36 is of a
commercially available spring material such as stainless steel and operates in
accordance with common extension spring principles." Id.; see also Ans.
13-14 (Examiner's annotated versions of Sauer' s Fig. 12, illustrating
corresponding movement of lever (32) and lever spring (36)).
FF 6. Figure 14C of Sauer is reproduced below.
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Appeal2017-004570
Application 13/362,278
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Figure 14C is a perspective view of the aspiration instrument (like shown in
Fig. 3), with additional components removed for clarity. Id. ,r 96. Figure
14C shows, inter alia, lever (32), band drive (34) including drive tang
opening (34B) encompassing drive tang (56). Id. Sauer teaches:
With the pivot 32A of the lever 32 stationary and the lever
partially rotated back shown by arrow 114, the tab 32B of the
lever 32 is engaged with the lever tab opening 34A of the band
drive 34. The drive tang opening 34B encompasses the drive tang
56 and advances the grater tube 54 (not shown) via the drive tang
56 along with the cover tube 58 partially outside the flex sheath
64.
Id.; see also id. at Fig. 14D (showing the instrument with the lever rotated
fully back as shown by arrow (116)), ,r 97 (disclosing that, with lever (32)
rotated fully back, drive tang (56) advances the grater tube (54) and cover
tube (58) "completely outside" the flex sheath (64)).
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Appeal2017-004570
Application 13/362,278
Analysis
Claim 1
The Examiner finds that Janssens teaches a stylet and biopsy needle as
recited in claim 1, as well as an actuating mechanism and piston for moving
the stylet from a closed configuration to a tissue collecting configuration.
Final Act. 6. The Examiner finds, however, that Janssens does not expressly
disclose an actuating mechanism with a "releasable, pivotable lever" and
"biasing element" with the characteristics required in claim 1, so the
Examiner turns to Sauer. Id. According to the Examiner, Sauer teaches an
actuating mechanism with the claimed features. Id. at 6-7. And the
Examiner concludes it would have been obvious to use the actuating
mechanism of Sauer with the device of Janssens "to provide for a large lever
that is ergonomic and easy to grasp and thereby make operation of the
invention of Janssens easier." Id. at 7.
Except as stated below, we agree with and adopt the Examiner's
findings of fact, reasoning, and conclusion of obviousness on this record.
Final Act. 4--10; see also Ans. 2-8 and 10-15 (Response to Argument). We
address Appellants' arguments below.
Appellants argue that the combination of Janssens and Sauer fails to
disclose all the limitations of claim 1. App. Br. 4. First, Appellants argue
Sauer "does not teach ... 'a releasable, pivotable lever' fixing a stylet in a
tissue collecting configuration, as recited in claim 1." Id. According to
Appellants, "movement of the grater tube 54 and cover tube 5 8 [ of Sauer]
proximally and distally depends on the positioning of the spring button 70
and the needle control tube 68, not on the actuation of the lever 32." Id.
Appellants contend it is "the spring lock button 70 of Sauer, which fixes the
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Appeal2017-004570
Application 13/362,278
stylet, ... [as] it locks around the band drive 34 to prevent movement of the
cover tube 58, grater tube 54 and needle tip 52." Reply Br. 3--4; see also
App. Br. 4--5. Thus, Appellants argue, "Sauer does not teach or suggest a
lever that would control any longitudinal movement of a tissue collecting
device between a tissue collecting configuration and a closed configuration
wherein the tissue collecting device is withdrawn into a lumen of a needle."
App. Br. 5; Reply Br. 4.
Second, Appellants argue Sauer does not teach claim 1 's "biasing
element." App. Br. 5-6. According to Appellants, "Sauer never teaches or
suggests that the lever spring 36 biases its tissue collective device (the grater
tube 54) toward any particular configuration." Id. Appellants contend,
"Sauer only shows that the spring is connected to a spring post of the lever
and a lever spring post of the left handle portion 24." Id. ("Sauer describes
only a connection mechanism of different portions of the lever"); see also
Reply Br. 4 ("in its description of the movement of the lever in paragraphs
[0095]-[0097], describing the movement of the lever from a rotated fully
forward position to the rotated fully back position, Sauer consistently
describes the pivot 32A as remaining stationary").
Appellants' arguments are unpersuasive. As to Appellants' first
argument, we agree with the Examiner on this record that the combination of
Janssens and Sauer teaches or suggests the "releasable, pivotable lever" with
the features claimed. As described above (FF 4--6), Sauer discloses an
ergonomic pistol-grip lever (32) that, when squeezed, moves grater and
cover tubes (54 and 56, which the Examiner equates with a stylet) distally.
Ans. 4, 11-12. When the lever is released, the grater tube and cover tube
move proximally - withdrawing the "sty let" to the closed configuration as
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Appeal2017-004570
Application 13/362,278
the Examiner explains. Ans. 4. Thus, contrary to Appellants' contentions,
the lever of Sauer does control the longitudinal movement of a tissue
collecting device. FF 6; Sauer ,r,r 96-97. The fact that other structures ( e.g.,
spring button) may also facilitate movement of the alleged sty let does not
demonstrate that Sauer' s lever ( and associated structures, such as the lever
spring and band drive) lacks the features and functionality of claim 1.
Insofar as Appellants contend structures other than Sauer's lever.fix
the stylet in the tissue collecting position, we disagree. Reply Br. 3--4; App.
Br. 4--5. Appellants appear to interpret "fixing" in claim 1 as requiring
"locking." Reply Br. 3--4 (explaining that Sauer's spring lock button (70)
"locks around the band drive 34 to prevent movement"). But we are
unpersuaded "fixing" is that narrow. To the contrary, as the Examiner notes,
"the term 'fixing' does not have an explicit definition in Applicants'
specification" and, thus, "fixing" is interpreted as "'to hold or direct
stead[i]ly."' Ans. 11 (citing a Merriam-Webster.com online dictionary
definition in support of this plain meaning). Accordingly, as the Examiner
explains, "[a] user holding the lever 32 [of Sauer] stead[i]ly in the position
shown in Fig. 14D will result in stylet 54, 58 remaining steady in the
extended position." Ans. 11. Appellants provide no persuasive rebuttal to
the Examiner on these points. For these reasons, we agree with the
Examiner on this record that Appellants are arguing limitations that are not
required in claim 1. Id. at 12 ("Appellants' arguments are not commensurate
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Application 13/362,278
with the claim language of claim 1 and 19, which solely require a lever
fixing a stylet, which is shown in Figs. 14A-D of Sauer"). 8
Appellants' second argument fares no better in overcoming the
evidence of obviousness on this record. Appellants contend Sauer' s lever
spring is not a "biasing element as recited in claim 1." App. Br. 6. But
Appellants' Specification indicates that a biasing element may be a spring or
numerous other possible structures. Spec. ,r 12 ("It will be understood by
those of skill in the art that the spring may be any biasing element that biases
the piston 130, and thereby the stylet 102, toward the closed configuration").
8 To the extent the Examiner implies that consideration of intrinsic evidence
to reach the broadest reasonable interpretation ("BRI") of claims undergoing
examination is inappropriate ("Although claims of issued patents are
interpreted in light of the specification, prosecution history, prior art, and
other claims, this is not the mode of claim interpretation to be applied during
examination." (Ans. 10)), the Examiner is incorrect. BRI must, for example,
still account for, and be consistent with, the specification. See, e.g.,
Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2016)
(holding that, even under BRI, the Patent Office cannot construe claims "so
broadly that its constructions are unreasonable under general claim
construction principles"); In re Smith Int 'l, Inc., 871 F.3d 1375, 1382-83
(Fed. Cir. 2017) (holding that the BRI is "not simply an interpretation that is
not inconsistent with the specification"). Nevertheless, we are persuaded the
Examiner arrived at the correct conclusion as to the BRI of "fixing," a term
which appears nowhere in the Specification. The Specification also does not
use the word "fix," and the word "fixed" is used just once in a manner
unrelated to the lever. Spec. ,r 11 ("The proximal end of the sty let 102 is
fixed to the piston ... "). Conversely, when "locking" was the meaning
intended, that term was specifically used in the Specification. Id. ,r 13 ("The
spring ... urges the piston 130 against the engaging element 158, locking
the device in the tissue sampling configuration"); see also claim 26
("wherein the lever biased toward a locked position ... the lever is
automatically pivoted to lock the stylet").
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Application 13/362,278
Moreover, the Examiner has shown persuasively- with the help of
annotated drawings - how Sauer' s spring works to bias the sty let toward
the closed configuration as recited in claim 1. Ans. 12-14. In short, as
Sauer's lever (32) is pulled, lever spring (36) is put under tension and
stretches. Id. at 13. When the lever is released, the spring will contract to its
pre-extended state, moving the lever back to its forward position. Id. at 14;
see also FF 4---6. The Examiner explains that this is how the skilled artisan
would understand the lever spring's operation in Sauer, and Sauer is
consistent in describing its spring as operating in accordance with these
basic principles. Ans. 15; FF 4; Sauer ,r 72. And, as already discussed,
when Sauer's lever moves to the forward position, the alleged "stylet" is
drawn proximally into a closed configuration. FF 4---6; Ans. 4.
Appellants point out that Sauer's lever is connected to a pivot (32A),
which remains stationary. Reply Br. 4. This argument misses the point.
The lever itself moves. See Ans. 12-14 (annotated drawings). So does the
lever spring. Id. And when that spring contracts, it pulls on the spring post
(32C) at the upper portion of the lever - urging that post and upper portion
downward and the lever's bottom portion (i.e., the handle portion) forward.
Id.; see also FF 4---6. These two portions, thus, rotate around the pivot. That
the lever's pivot itself remains stationary does not demonstrate error with the
rejection on appeal.
Claim 19
The Examiner provides substantially the same findings and reasoning
in support of the conclusion that claim 19 would have been obvious over
Janssens and Sauer. Final Act. 8-10; Ans. 5-7. Appellants do not provide
separate argument on claim 19, instead arguing " [ fJ or at least similar reasons
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Application 13/362,278
as discussed above with respect to claim 1, Janssen[s] and Sauer, taken alone
or in combination, do not disclose or suggest a releasable, pivotable lever or
a biasing element as recited in Applicant's claim 1." App. Br. 6. We again
agree with the Examiner on this record and find Appellants' arguments
unpersuasive as explained above.
Conclusion of Law
The preponderance of the evidence supports the Examiner's
conclusion that claims 1 and 19 would have been obvious over Janssens and
Sauer. Claims 2--4 and 22-26 have not been argued separately and,
therefore, fall with claims 1 and 19. See 37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1--4, 24, and 26 for indefiniteness.
We further affirm the rejection of claims 1--4, 19, and 22-26 for
obviousness.
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).
AFFIRMED
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