Ex Parte Copa et al

Patent Trial and Appeal Board

Oct 31, 2018

12087231 (P.T.A.B. Oct. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/087,231 11/24/2008
19487 7590 11/02/2018
AMS/Kagan Binder, PLLC
221 Main Street North, Suite 200
Stillwater, MN 55082
FIRST NAMED INVENTOR
Vincent G. Copa
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.
AMS0083US
(AMS256-PCT-US)
CONFIRMATION NO.
6022
EXAMINER
PATEL, SHEFALI DILIP
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
11/02/2018 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):
docketing@kaganbinder.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte VINCENT G. COPA,
SURANJAN ROYCHOWDHURY, SIDNEY F. HAUSCHILD,
and JUSTIN M. CRANK
Appeal 2018-001852
Application 12/087,231
Technology Center 3700
Before: CHARLES N. GREENHUT, LISA M. GUIJT, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
GREENHUT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
3, 10, 14, 19, 20, 25, 29-33, 37, 39, 40, 42, 43, 47-51, 54, and 55. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm, designating new grounds of rejection.
Appeal 2018-001852
Application 12/087,231
CLAIMED SUBJECT MATTER
The claims are directed to devices for delivery of fluid to tissue.
Claim 1, reproduced below, is illustrative of the claimed subject matter:
1 A device for needleless delivery of a fluid to a tissue of a
urethra or a prostate, the device comprising:
a device proximal end and a device distal end,
an endoscope comprising an endoscope proximal end, an
endoscope distal end, a handle at the endoscope proximal end, a
flexible shaft extending from the endoscope proximal end to the
endoscope distal end, and a working lumen extending along a
length of the flexible shaft to a working lumen tip, wherein the
handle is adapted to manipulate the endoscope distal end while
the endoscope distal end is located within the urethra, the handle
comprising a passage in communication with the working lumen,
a fluid delivery shaft comprising a fluid delivery lumen, a
fluid delivery shaft distal end and an extendable needleless fluid
delivery orifice at the fluid delivery shaft distal end, wherein the
fluid delivery shaft is disposed within and longitudinally
moveable within the working lumen and the handle passage and
wherein the needleless fluid delivery orifice is capable of being
extended from or retracted toward the flexible shaft to change a
distance between the needleless fluid delivery orifice and the
working lumen tip,
a tissue tensioner comprising an inflatable balloon at the
device distal end, the inflatable balloon in communication with
an inflation fluid reservoir at the device proximal end,
optics to allow optical communication between the
endoscope proximal end and the endoscope distal end to allow
viewing of the needleless fluid delivery orifice at a needleless
injection site in the urethra,
a fluid reservoir in fluid communication with the fluid
delivery lumen, and
a pressure source capable of pressurizing the fluid and
ejecting the fluid from the needleless fluid delivery orifice with
a pressure capable of penetrating the tissue of the urethra or the
prostate.
2
Appeal 2018-001852
Application 12/087,231
App. Br. 7 (Claims Appendix).
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Kaplan '178
Lundquist
Clark
Lemelson
Schmidt
Kaplan '689
Daellenbach
us 5,336,178
us 5,531,677
US 6,280,413 Bl
US 6,400,980 B 1
US 2002/0025327 Al
US 2002/0173689 Al
US 2004/0111055 Al
REJECTIONS
Aug. 9, 1994
July 2, 1996
Aug. 28, 2001
June 4, 2002
Feb.28,2002
Nov. 21, 2002
June 10, 2004
Claims 1-3, 10, 14, 25, 30, 32, 42, 47, 50, 54, and 55 are rejected
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
Claims 1-3, 10, 14, 19, 20, 25, 29-33, 37, 39, 40, 49-51, and 54 are
rejected under 35 U.S.C. § I03(a) as being unpatentable over Clark,
Lundquist, Kaplan' 178, and Lemelson.
Claims 42 and 43 are rejected under 35 U.S.C. § I03(a) as being
unpatentable over Clark, Lundquist, Kaplan, Lemelson, and Daellenbach.
Claims 47 and 48 are rejected under 35 U.S.C. § I03(a) as being
unpatentable over Clark, Lundquist, Kaplan '178, Lemelson, and
Kaplan '689.
Claim 55 is rejected under pre-AIA 35 U.S.C. § I03(a) as being
unpatentable over Clark, Lundquist, Kaplan' 178, and Lemelson, and
Schmidt.
3
Appeal 2018-001852
Application 12/087,231
OPINION
The§ 112,first paragraph, rejection
Claim 1 and its dependents were rejected for the addition of material
the Examiner found unsupported by the Specification. According to the
Examiner:
the Specification does not state or describe "the fluid delivery
shaft being disposed within and longitudinally moveable within
the working lumen and the handle passage" of the endoscope ...
the Specification does not state or describe optics between the
endoscope proximal end and the endoscope distal end.
Final Act. 6.
Appellants cite portions of pages 12, 26, 28, 29, and 57 of the
Specification to point out the Specification's disclosure of longitudinal
movement of the fluid lumen 408 within working lumen 418 (p. 57), generic
disclosures relating to use with an endoscope (p. 26), or optical features and
componentry typically used with endoscopes (pp. 12, 28-29). These
disclosures do not address the Examiner's first point above (see also Ans. 3-
4) that the claim calls for longitudinal movement within the features of the
endoscope. Nor does it address the Examiner's second point that the
Specification does not indicate that "the proximal end and the distal end are
that of an endoscope." Ans. 5.
Appellants' use of the term "endoscope" in the Specification is too
generic to provide any enlightenment as to whether the Specification, as
originally filed, supports the precise subject matter the Examiner calls into
question above. However, although the term "endoscope" is not used,
Appellants' disclosure related to the embodiment depicted in Figure 12
4
Appeal 2018-001852
Application 12/087,231
(described at Spec. p. 57-58) appears to provide the most pertinent details
regarding the issues raised by the Examiner.
Appellants' Specification describes a fluid lumen 408 longitudinally
movable within a working lumen 418. For the reasons discussed in further
detail below concerning the definition of the term "endoscope," we see no
reason to regard working lumen 418 itself, which lacks any viewing
capability, as an "endoscope." Spec. 57. Fluid delivery lumen 408 is also
described as being able to move longitudinally along the length of shaft 403.
Shaft 403 includes a fiber optic 410 and steering arrangement coupled with a
light source 416 and viewing lens 420 in handle 412. Based on Appellants'
disclosure, we see at least three possibilities: First, one could regard shaft
403 as containing both an endoscope device ( 410, 416, 420) and a fluid
delivery device (418,408), i.e., as separate devices. This understanding
would lend support to the Examiner's position that the Specification does
not disclose a fluid delivery shaft longitudinally movable within the lumen of
an endoscope. Second, one could regard shaft 403 as, consistent with the
cited passages from the Specification (p. 12), having endoscopic
componentry ( 410, 416, 420), but not necessarily forming an "endoscope"
per se. This understanding would also lend support to the Examiner's
position. Third, one might understand that, due to the presence of the
endoscopic componentry (410,416,420), the entire shaft 403, which
includes working lumen 418, could be considered to be the working lumen
of an endoscope, with the endoscope itself also including handle 412
containing lens 420. This last interpretation would allow the claim to satisfy
the requires of§ 112, first paragraph.
5
Appeal 2018-001852
Application 12/087,231
Ultimately, this inquiry hinges on what structure in the Figure 12
embodiment could be regarded as an "endoscope." Appellants do not use
the term "endoscope" in the portion of the Specification describing that
embodiment to provide any specific enlightenment on that issue and, as
mentioned above, the other mentions of the term also do not provide very
much enlightenment on this issue.
In light of the definitions discussed and reproduced below, which,
first, do not preclude the presence of other structures, such as that for fluid
delivery, within an endoscope, and second, do not seem to require any more
than a lens 420, fiber optic 410 and light source 416, we determine that the
third understanding presented above, that the entire lumen 403 can be
considered to be a lumen of an endoscope, and the endoscope includes
handle 412, is the most appropriate. In this case, working lumen 418, with
its longitudinally movable fluid delivery shaft 408, are also components of
the endoscope contrary to the Examiner's finding (Ans. 4). Similarly, the
optics 410, 416, 420 allow communication between the proximal and distal
ends of an endoscope contrary to the Examiner's finding (Ans. 5).
Accordingly, we hold the Specification as originally filed provides adequate
support for these aspects of the subject matter now claimed and do not
sustain the Examiner's rejection under§ 112, first paragraph.
The Examiner's interpretation of "endoscope" for the§ 103 (a) rejection of
claim 1 was unreasonably broad
The Examiner's§ 103 rejections of claim 1 and its dependent claims
are predicated on Clark's catheter, which lacks any capability for visually
inspecting the site to which it is inserted, falling within the broadest
6
Appeal 2018-001852
Application 12/087,231
reasonable construction of the term "endoscope." According to the
Examiner:
[The] Examiner has found definitions of "endoscope" not
requiring viewing functionality, such as an optical mechanism,
and steering functionality: "a long slender medical instrument
used for examining the interior of hollow organs including the
lung, stomach, bladder, and bowel"
(http://www.dictionary.com/browse/endoscope) and "An
instrument for examining visually the interior of a bodily canal
or hollow organ such as the colon, bladder, or stomach
(http://www.dictionary.com/browse/endoscope)."
Ans. 6-7.
The version of http://www. dictionary. com/browse/ endoscope
retrieved October 24, 2018 1 contains four definitions. The first is:
a slender, tubular optical instrument used as a viewing system
for examining an inner part of the body and, with an attached
instrument, for biopsy or surgery.
The next three definitions and their corresponding subheadings are
reproduced below:
British Dictionary definitions for endoscope
a long slender medical instrument used for examining the interior
of hollow organs including the lung, stomach, bladder, and bowel
endoscope in Medicine
An instrument for examining visually the interior of a bodily
canal or hollow organ such as the colon, bladder, or stomach.
1 The Examiner does not make of record the webpage as accessed by the
Examiner (MPEP § 707 .05( e )(IV) ("Office copies of an electronic document
must be retained if the same document may not be available for retrieval in
the future. This is especially important for sources such as the Internet and
online databases")) or the date the Examiner retrieved the webpage (MPEP
§ 707 .05( e )(IV)(B) ("the date when the document was retrieved from the
electronic media")).
7
Appeal 2018-001852
Application 12/087,231
endoscope in Science
A medical instrument used for visual examination of the interior
of a body cavity or a hollow organ such as the colon, bladder, or
stomach. It is a rigid or flexible tube fitted with lenses, a fiber-
optic light source, and often a probe, forceps, suction device, or
other apparatus for examination or retrieval of tissue
Although the Examiner does not specify the subheadings from which
the Examiner's definitions were drawn,2 the definitions set forth by the
Examiner and reproduced above are the same as those under the British and
Medical subheadings above, respectively.
[T]he general meanings gleaned from reference sources, such as
dictionaries, must always be compared against the use of the
terms in context, and the intrinsic record must always be
consulted to identify which of the different possible dictionary
meanings is most consistent with the use of the words by the
inventor. "Where there are several common meanings for a claim
term, the patent disclosure serves to point away from the
improper meanings and toward the proper meanings.
Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1300 (Fed.
Cir. 2003). Here, three of the four definitions on the webpage cited by the
Examiner require at least some visual capability to be associated with an
endoscope. Similarly, Appellants' Specification, while not setting forth an
express definition of the term, alludes to the fact that an endoscope is
presumed to have an "optical feature" having the capacity "to directly view
the operation of a distal feature of the device." See Spec. 34 ( discussing
alternatives to using endoscopes). Additionally, although the particular
nomenclature used by prior-art references is not necessarily controlling, it is
2 See MPEP § 707 .05( e )(IV)(I).
8
Appeal 2018-001852
Application 12/087,231
often informative as to how one skilled in the art would understand claim
terms. In re Cortright, 165 F. 3d 1353, 1358 (Fed. Cir. 1999).3
Both the Lundquist and Lemelson references cited by the Examiner
expressly use the term "endoscope," whereas Clark does not. Clark refers to
the described device as a catheter and instead of using an "endoscope" to
position the distal end of Clark's device, Clark employs a radiopaque band
118 to track its progress on a flouroscope. Col. 5, 11. 62---65. The Examiner
does not provide any reason for applying the British definition over the
others, all of which seem more appropriate in this context. Nor does the
Examiner provide persuasive reasons to depart from or expand the meaning
of the term endoscope as it is used in Appellants' Specification and the prior
art. Accordingly, as the Examiner's finding of an "endoscope" in Clark was
based on a construction of the term exceeding the ambit of the broadest
reasonable interpretation, the Examiner's rejections predicated on this claim
construction cannot be sustained on the basis set forth by the Examiner.
3 Cortright explains:
Prior art references may be "indicative of what all those skilled
in the art generally believe a certain term means ... [and] can
often help to demonstrate how a disputed term is used by those
skilled in the art." Accordingly, the PTO's interpretation of claim
terms should not be so broad that it conflicts with the meaning
given to identical terms in other patents from analogous art.
165 F. 3d at 1358 (quoting Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d
1576, 1584 (Fed. Cir. 1996)).
9
Appeal 2018-001852
Application 12/087,231
New Grounds of Rejection
As mentioned above, both Lundquist and Lemelson demonstrate that
endoscopes were known in this art. Lundquist col. 4, 11. 39-46; col. 7, 11. 17
et seq. (discussing an embodiment for use with a cystoscope-type
endoscope); col. 11, 11. 54 et seq. (discussing an embodiment incorporating
conventional cystocopic components); Lemelson col. 5, 11. 22-26. As also
mentioned above, Clark employs a radiopaque band 118 for tracking Clark's
catheter via a fluoroscope. Col. 5, 11. 62---65. In light of the facts that Clark
demonstrates the need for a fluid-delivery catheter positioning aid, and
Lundquist demonstrates that it was known to use (col. 7, 1. 17 et seq.), or
incorporate ( col. 11, 1. 54 et seq.), an endoscopic device with a device used
to deliver treatment fluids to a target tissue (Lundquist col. 6, 11. 9-10), we
conclude that the subject matter of claim 1 results from the simple
substitution of Clark's fluoroscopic tracking and positioning system with
Lundquist's endoscopic tracking and positioning system. Such substitution
would have predictably allowed for better internal visualization capabilities
at, and in route to, the treatment site, thereby facilitating diagnostics and
treatment and, for these reasons, would have been obvious to one skilled in
the art.
The Examiner was correct in finding that Lemelson discloses "optics"
allowing for optical communication between the ends of a diagnostic
imaging catheter to transmit images out of the body. Final Act. 9 ( citing
Lemelson col. 21, 11. 34--3 8). However, we note that "optics" sufficient to
satisfy the limitations recited in claim 1 are also disclosed in Lundquist ( col.
4, 11. 44--46) and would have been an obvious component to include for the
endoscopic or cystoscopic functionality.
10
Appeal 2018-001852
Application 12/087,231
Although we disagreed with the Examiner's broad interpretation of
endoscope for the reasons discussed above, for the foregoing reasons we
nevertheless agree with the Examiner's ultimate conclusion of obviousness
in view of the cited references. We modify the Examiner's rejection to
include our reasoning discussed above and designate our decision as
including new grounds of rejection for claim 1 and its dependent claims so
as to afford Appellants a full and fair opportunity to respond.
Claim 19 and Appellants ' remaining arguments
As the Examiner correctly points out, claim 19 does not recite an
endoscope like claim 1. Ans. 6. Thus, Appellants' arguments concerning
the breadth of the Examiner's construction of endoscope do not appear to be
relevant to claim 19, which is not separately argued. We address
Appellants' remaining arguments in tum.
Appellants argue that Clark delivers a drug or agent to blood without
penetrating the vessel or artery that carries the blood. App. Br. 12-13.
Although Clark may release its agent into the blood flow, it does so with the
purpose of delivery to the arterial walls as opposed to the blood itself. Col.
4, 11. 38-39; col. 5, 11. 1-3. Furthermore, Clark expressly suggests
modification so as to deliver drugs or other agents to the urethra, bladder, or
prostate. See Final Act. 15 ( citing Clark col. 1, 11. 18-22 ). It is the Kaplan
reference, not Clark alone, that the Examiner specifically, and
uncontrovertedly, relies upon for the aspects of claims 1 and 19 related to a
pressure source capable of producing a pressure capable of penetrating the
tissue of the urethra or prostate. Final Act. 8. Clark's express suggestion to
modify the device so as to make it suitable to deliver drugs or other agents to
11
Appeal 2018-001852
Application 12/087,231
the urethra, bladder, or prostate rebuts Appellants' contention that
modification with Kaplan's teachings in this regard would render Clark
unsuitable for its intended purpose or change its principle of operation (App.
Br 14).
The basis for Appellants' argument that Lundquist's handle features
"would have no purpose if added to the Clark vascular catheter" (App. Br.
13) is not clear. Steering and control functions would seem similar
regardless of whether the device is considered a catheter or endoscope.
Lundquist (col. 4, 11. 41--46) and Lemelson (col. 5, 11. 22-26) both expressly
evince this.
The basis for Appellants' emphasis of the term, "needleless delivery
device" (App. Br. 13) is also unclear. Appellants do not apprise us of any
reasons why Clark's ports 112 (Final Act. 7) would not suffice to meet the
claim language in this regard.
Appellants do not raise any issues concerning the Examiner's reliance
on Lemelson specifically.
For the foregoing reasons we sustain the Examiner's rejection of
claim 19 and the Examiner's rejections of those claims depending therefrom
which are not separately argued.
DECISION
The Examiner's rejection under§ 112, first paragraph, is reversed.
The Examiner's§ 103 rejections of claims 1-3, 10, 14, 25, 30, 32, 47,
50, 54, and 55 are affirmed, and we designate our affirmance as including
new grounds of rejection.
12
Appeal 2018-001852
Application 12/087,231
The Examiner's§ 103 rejections of claims 19, 20, 29, 31, 33, 37, 39,
40, 43, 48, 49, and 51 are affirmed.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
13
Appeal 2018-001852
Application 12/087,231
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)(l )(iv).
AFFIRMED4; 37 C.F.R. § 4I.50(b)
4 "The affirmance of the rejection of a claim on any of the grounds specified
constitutes a general affirmance of the decision of the examiner on that
claim, except as to any ground specifically reversed." 37 C.F.R.
§ 4I.50(a)(l).
14