Ex Parte Goddard et al

Patent Trial and Appeal Board

Aug 24, 2017

13568713 (P.T.A.B. Aug. 24, 2017)

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.
13/568,713 08/07/2012 James Goddard 10124/10202 8215
104919 7590 08/28/2017
Fay Kaplun & Marcin, LLP — BSC
150 Broadway, suite 702
New York, NY 10038
EXAMINER
EASTWOOD, DAVID C
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
08/28/2017 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):
okaplun@fkmiplaw.com
fkmiplaw @ yahoo. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES GODDARD, ISAAC OSTROVSKY,
and DAVID SALTO1
Appeal 2016-007386
Application 13/568,713
Technology Center 3700
Before FRANCISCO C. PRATS, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
device for dilating a body passage, which have been rejected as anticipated
and obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The Specification explains that “[kjnown methods for dilating the
cervix include inserting increasingly larger rods or tubes into the cervical
canal until a desired dilation has been obtained.” (Spec. 12.) According to
1 Appellants identify the Real Party in Interest as Boston Scientific Scimed,
Inc. (App. Br. 2.)
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Application 13/568,713
the Specification, known systems and methods are time consuming and may
damage the uterine cavity. {Id.)
Appellants’ drawings illustrate embodiments of the invention.
Figures 1 and 2 from the Specification are reproduced below.
Figures 1 and 2 are cross-sectional side views of one embodiment of the
claimed dilation device (100) in a first (insertion) and second (expanded)
configuration respectively. (Spec. Tflf 4, 6.) These figures show, inter alia,
inner element (102) extending through a lumen in an outer sleeve (104). {Id.
1 6.) Inner element (102) includes an enlarged portion (112) that is received
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in an enlarged distal2 end of the lumen (118). {Id.) As shown, the enlarged
portion (102) includes a proximal end (120) and distal end (122). {Id. 17.)
Proximal movement of the inner element (102) (e.g., pulling handle
(124)/proximal end (108) of the shaft (106) to the left as depicted) relative to
the outer sleeve (104) draws the enlarged portion (112) into the proximal,
reduced diameter portion of lumen (118), expanding the distal end (116) of
the outer sleeve (104) to the expanded configuration. {Id. Tflf 6—7.)
Claims 1—5 and 21 are on appeal. Claim 1 is illustrative:
1. A device for dilating a body passage, comprising:
an inner element including a shaft portion extending
longitudinally from a proximal end to a distal end and an
enlarged portion situated on the distal end, the enlarged portion
having a cross-sectional area which increases from a proximal
end to a distal end thereof and
an outer sleeve extending longitudinally from a proximal
end to a distal end and including a lumen extending therethrough,
the lumen sized and shaped to slidably accommodate the shaft
portion of the inner element such that the device is movable
between an insertion configuration, in which the enlarged portion
extends distally past the distal end of the outer sleeve, and an
expanded configuration, in which the distal end of the outer
sleeve receives the enlarged portion of the inner element therein,
the distal end of the outer sleeve being formed of an elastic
material which radially expands to accommodate the enlarged
portion in the expanded configuration.
(App. Br. 10 (Claims App.) (emphasis added).)
2 The Specification defines “proximal” and “distal” as “intended to refer to a
direction toward (proximal) and away from (distal) a user of the device.”
(Spec. 1 5.)
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Application 13/568,713
The claims stand rejected as follows:
I. Claims 1—3, 5, and 21 under 35 U.S.C. § 102(b) by Vale.3
II. Claims 1 and 3—5 under 35 U.S.C. § 102(b) by Chin.4
III. Claim 4 under 35 U.S.C. § 103(a) over Vale.
I
Issue
Has the Examiner established by a preponderance of the evidence that
Vale discloses Appellants’ claimed invention?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 2—3 of the Final Office Action dated November 13, 2015.
(See also Adv. Act. 2 and Ans. 2-4.) We provide the following findings for
emphasis and convenient reference.
FF 1. Vale teaches a filter retrieval device that includes concentrically
oriented catheters. (See, e.g., Vale Abstract, Figs. 13—15.)
FF 2. Figure 15 of Vale is reproduced below.
3 Vale et al., US 2002/0058963 Al, published May 16, 2002.
4 Chin, US 2006/0287574 Al, published Dec. 21, 2006.
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Application 13/568,713
Figure 15 is a cross-sectional side view of an embodiment of Vale’s device.
Figure 15 shows, inter alia, a centering catheter (11) that extends through
retrieval catheter (70) and terminates beyond the distal end of the retrieval
catheter (70). (Vale 73, 87.) Figure 15 also shows a tapered distal tip
(71) of retrieval catheter (70). (Id. 1 87.) Vale teaches that tip (71) is
radially expansible to enable retraction of the centering catheter tip (50)
through open mouth (40) proximally into retrieval catheter (70). (Id. 1 88;
see also id. 179 (“tip 71 is of a flexible elastomeric polymeric material, for
example polyurethane or a flexible grade of PEBA”).)
Analysis
The Examiner rejected claims 1—3, 5, and 21 as anticipated by Vale.
Appellants argue the patentability of the claims as a group. We select claim
I as representative. 37 C.F.R. § 41.37(c)(l)(iv).
According to the Examiner, Vale discloses the subject matter of claim
1. The Examiner finds, among other things, that “Vale discloses a device
capable of being used for dilating a body passage” and that the device
includes an “enlarged portion having a cross-sectional area which increases
from a proximal end to a distal end thereof’ as claimed. (Final Act. 2.)
More specifically, as to this latter claim limitation concerning the enlarged
portion, the Examiner points to “initial tapering from the diameter of shaft
II distally to the greatest diameter portion of tip 50” as illustrated in the
“arrow head shape of the distal tip” in Vale. (Id.) The Examiner further
finds that Vale teaches an “outer sleeve (70,71)” having a distal end that is
elastomeric and “radially expands to accommodate the enlarged portion in
the expanded configuration ... to enable retraction of tip 50.” (Id. at 2—3.)
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Appellants argue Vale does not anticipate claim 1 because “Vale fails
to disclose an inner element with an enlarged portion that increases ‘from a
proximal end to a distal end thereof.’” (App. Br. 3.) Rather, Appellants
contend, “Vale discloses an enlarged tip that tapers to a reduced diameter at
its distal end” and that “end portion 50 of the centering catheter 11 [of Vale]
increases slightly at a very proximal portion and then tapers to a distal
point.” (Id. at 3—4.)
The dispute here is essentially one of claim interpretation. In
particular, Appellants and the Examiner disagree on the meaning of the
phrase “the enlarged portion [situated on the distal end of the inner
element’s shaft] . . . having a cross-sectional area which increases from a
proximal end to a distal end thereof.” According to the Examiner, “[t]he
claim does not require that the distal most end or distal terminal end or
even the distal end itself have the largest diameter.” (Ans. 3.) And, the
Examiner finds, “if at any point the cross-sectional area of the enlarged
portion increases distally as one views the prior art device[,] . . . such a prior
art device would have a cross-sectional area which increases from a
proximal end to a distal end thereof ” (Id. ) Appellants, on the other hand,
contend “the limitation does [not] simply require that any point of the cross-
sectionally area increase distally” and “if an element, such as the distal end
50 of Vale, decreases in cross-section area from any point to a more distal
point, said element cannot read on the limitation.” (Reply Br. 3.)
During prosecution, we give claim terms the broadest reasonable
interpretation as understood by a person of ordinary skill in the art in light of
the specification. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997); In re
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Am. Acad. ofSci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)
(“Construing claims broadly during prosecution is not unfair to the applicant
. . . because the applicant has the opportunity to amend the claims to obtain
more precise claim coverage.”)
On the record before us, we agree with the Examiner. The phrase
“enlarged portion having a cross-sectional area which increases from a
proximal end to a distal end thereof’ is not specifically defined in the
Specification. The phrase is not otherwise limited to conical shapes, nor
does it require that a distal-most extent or “end” of the enlarged portion have
the largest diameter/cross-sectional area. Neither are we persuaded the
phrase excludes structures with any decrease in cross-sectional area along
the enlarged portion, such as one that initially increases from its proximal
extent to a larger-diameter section and then tapers back to a relatively
smaller-diameter distal end. If Appellants seek to cover an enlarged portion
that progressively increases in cross-sectional area along its length — with
no decrease in cross-sectional area — and has the largest cross-sectional area
at the distal end, there is a clearer and more concrete way of claiming such a
structure.5
Appellants’ Specification is consistent with the broader interpretation
advanced by the Examiner. Although one embodiment does show an
enlarged portion that is cone-shaped, with no decrease in cross-sectional area
(see Figs. 1—2), the Specification discloses that “a variety of shapes” may be
5 “[D]tiring patent prosecution when claims can be amended, ambiguities
should be recognized, scope and breadth of language explored, and
clarification imposed.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989).
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used to design an enlarged portion with a cross-sectional area that increases
from a proximal to a distal end. (Spec. 17.) In another embodiment, the
Specification shows a shaft with a curved (i.e., elliptical-shaped) enlarged or
increased-diameter portion; the Specification discloses:
[T]he outer diameter of the increased diameter portion 212 may
increase gradually along a curve from the proximal end toward a
midpoint of maximum diameter and then may extend along the
curve back toward the outer diameter of the remaining portion
222 of the shaft 202 at its distal end.
(Id. Ill; see also id. at Figs. 3—4.) The Specification does not define,
disclaim, or clearly distinguish this additional embodiment in a way that
excludes it from the broad language recited in claim 1.
Based on the interpretation discussed above, we agree with the
Examiner that Vale discloses an “enlarged portion having a cross-sectional
area which increases from a proximal end to a distal end thereof.” The
Examiner identifies distal tip (50) of the Vale’s centering catheter (11) as the
enlarged portion. (Final Act. 2.) Distal tip (50) has an arrowhead shape that
increases in diameter/cross-sectional area initially from its proximal end to a
largest-diameter portion, then tapers to a smaller diameter tip. (Id.; FF 1—2;
Ans. 4.) This shape is encompassed by the broadest reasonable
interpretation of claim 1.
Notwithstanding the above, we do not agree with, and, thus, do not
adopt, the Examiner’s determination that the “distal end” may be satisfied by
some undefined “part” within the distal half of the device.6 (See Adv. Act.
6 This discussion from the Examiner appears to have arisen in response to
Appellants providing a definition for the word “end” from an online
dictionary. (Adv. Act. 2; Ans. 3.)
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2; Ans. 4.) The Examiner’s statements in this regard are unclear, as the
Examiner, at times, does not sufficiently explain what is being considered
the distal end of the shaft portion and what is being considered the distal end
of the enlarged portion. (Id.) Claim 1 recites more than one “distal end”
associated with more than one “portion” of the device. Inasmuch as distal
tip (50) of Vale, which the Examiner finds is the claimed “enlarged portion,”
includes a section having the largest diameter, we are unpersuaded the
skilled person would consider this largest-diameter section to be at the actual
“distal end” of the enlarged portion. The largest-diameter section of Vale is
nearer the expanded portion’s proximal end and, as Appellants point out, the
“distal half’ of the enlarged portion decreases in diameter. (App. Br. 5.)
That being said, the Examiner provided an alternative explanation of the
rejection (see Ans. 4),7 and we agree with the Examiner’s interpretation of
claim 1 as encompassing an enlarged portion that increases in cross-
sectional area anywhere along its length from its proximal end to its distal
end. Because we do not rely upon the Examiner’s discussion regarding a
distal “end” being merely a distal “part,” Appellants’ arguments regarding
the same do not persuade us that the rejection must be reversed. (App. Br.
4—5; Reply Br. 4—5.)
7 The Examiner finds “[ejven if the largest diameter portion of element 50
and portions distal toward the tip could not be considered the distal end,. . .
Vale still shows that element 50 has a cross-sectional area which increases
from a proximal end to a distal end thereof because element 50 increases in
diameter in a distal direction.” (Ans. 4.)
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Conclusion
We conclude the Examiner established by a preponderance of the
evidence that Vale discloses the subject matter of claim 1. Claims 2, 3, 5,
and 21 have not been argued separately and therefore fall with claim 1. 37
C.F.R. §41.37(c)(l)(iv).
Has the Examiner established by a preponderance of the evidence that
Chin discloses Appellants’ claimed invention?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 3—5 of the Final Office Action dated November 13, 2015.
(See also Adv. Act. 2 and Ans. 4—6.) We provide the following findings for
emphasis and convenient reference.
FF 3. Chin teaches an apparatus “for dilation of tissue” comprising “a
tissue expansion device positioned on an inner cannula with an outer
overlying expansive sheath that expands upon translation of the tissue
expansion device therethrough.” (Chin Abstract.)
FF 4. Figure IB of Chin is reproduced below.
II
Issue
mm
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Figure IB is a perspective view of a mechanical dilator device (128),
showing tissue expansion device (104) and inner cannula (100) partially
retracted into expansible sheath (112). {Id. Tffl 15—17 and Figs. 1A-C.) Chin
teaches that retracting the tissue expansion device (104) as shown exerts an
outward force on expansible sheath (112), pushing shells (132) outward and
thus dilating surrounding tissues. {Id. 115.)
FF 6. Chin also teaches a tissue expansion device and expansible
sheath “that ends in a solid transparent tapered cone distally and a solid
sleeve proximally.” {Id. 15.)
Analysis
Appellants argue the patentability of the rejected claims (claims 1 and
3—5) as a group, and we select claim 1 as representative. (App. Br. 6—8.)
The Examiner finds that Chin anticipates claim 1. Among other
things, the Examiner finds that Chin’s tissue expansion device (104) is the
claimed “enlarged portion” and cites “figures la-c in which element 104
enlarges from a proximal end to a distal maximum diameter cross-section
point interpreted as the distal end, [and] in the alternative the Examiner
would further note paragraph 5 which discloses element 104 may be realized
as a cone.” (Final Act. 4.)
Appellants argue “Chin discloses an ellipsoidal expansion device” that
“increases in diameter to a mid-line thereof and then tapers to a decreased
diameter at a distal end thereof.” (App. Br. 6.) Similar to its arguments
concerning Vale, Appellants contend Chin’s ellipsoidal-shaped expansion
device does not satisfy claim l’s limitation of an “enlarged portion having a
cross-sectional area which increases from a proximal end to a distal end
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thereof.” (Id. at 6—7.) Regarding Chin’s cone-shaped embodiment,
Appellants argue “the tapered cone would have a cross-sectional area that
decreases from a proximal end to a distal end,” which Appellants contend is
“the exact opposite of what the Appellants are claiming.” (Id. at 7.)
Appellants’ arguments are unpersuasive. As discussed above (Section
1), we do not agree with Appellants’ narrower interpretation of claim 1.
And, as already explained, the disputed limitation does not exclude a curved
or ellipsoidal-shaped enlarged portion, such as depicted in Chin. (FF 4—5.)
Furthermore, as the Examiner determined, Chin teaches a cone shape
may be used. (Final Act. 4; FF 6.) In response to Appellants’ contention
that Chin’s cone is the opposite of what is claimed, the Examiner responds
that Appellants quote Chin out of context: “the term distally [as recited in
paragraph 5 of Chin] is not referring to the direction of taper of the cone but
is referring to the position of the cone relative to the solid sleeve.” (Ans. 5—
6.) Also, according to the Examiner, “in order for the device of Chin to
operate as disclosed the cone would have to increase in diameter from a
proximal end to a distal end.” (Ans. 5 (interpreting the cone embodiment to
increase in diameter, starting at its proximal end, like the initial increase in
diameter at the proximal end of the alternative ellipsoidal-shaped expansion
device shown in Chin).) Appellants repeat their contentions, but provide no
argument or evidence that persuasively rebuts the Examiner on these points.
(See, e.g., Reply Br. 8.) We thus agree with the Examiner’s interpretation of
Chin’s cone-shaped embodiment.
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Conclusion
We conclude the Examiner established by a preponderance of the
evidence that Chin anticipates claim 1. Claims 3—5 have not been argued
separately and fall with claim 1.
Ill
The Examiner rejected claim 4 as obvious over Vale. (Final Act. 6—
7.) Appellants provide no separate argument regarding this rejection.
Rather, Appellants argue “claim 4 is allowable over Vale for at least the
same reasons presented with respect to claim 1.” (App. Br. 8.) This
argument is unpersuasive for the reasons explained in Section I above.
SUMMARY
We affirm the rejection: (I) of claims 1—3, 5, and 21 as anticipated by
Vale; (II) of claims 1 and 3—5 as anticipated by Chin; and (III) of claim 4 as
obvious over Vale.
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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